[December 10, 2007 (Volume 72, Number 236)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [DOCID: f:ua071001.wais] [Page 69737-69742] Regulatory Information Service Center ----------------------------------------------------------------------- Part II ----------------------------------------------------------------------- Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions Federal Register / Vol. 72, No. 236 / Monday, December 10, 2007 / The Regulatory Plan Federal Register / Vol. 72, No. 236 / Monday, December 10, 2007 / The Regulatory Plan [[Page 69737]] REGULATORY INFORMATION SERVICE CENTER Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions AGENCY: Regulatory Information Service Center. ACTION: Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions. _______________________________________________________________________ SUMMARY: The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), as amended, and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. Section 4 of Executive Order 12866 also directs that each agency prepare, as part of its submission to the fall edition of the Unified Agenda, a regulatory plan of the most important significant regulatory actions that the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year. The Regulatory Plan (Plan) and the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) help agencies fulfill these requirements. Prior editions of the Unified Agenda have been printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying Regulatory Agenda information to the maximum extent legally permissible. The complete Unified Agenda, including The Regulatory Plan, is available to the public at http://reginfo.gov. The fall 2007 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules which are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. The complete fall 2007 Unified Agenda contains the plans of 29 Federal agencies and the regulatory agendas for these and 29 other Federal agencies. ADDRESSES: Regulatory Information Service Center (MI), General Services Administration, 1800 F Street NW., Suite 3039, Washington, DC 20405. FOR FURTHER INFORMATION CONTACT: For further information about specific regulatory actions, please refer to the Agency Contact listed for each entry. To provide comment on or to obtain further information about this publication, contact: John C. Thomas, Executive Director, Regulatory Information Service Center (MI), General Services Administration, 1800 F Street NW., Suite 3039, Washington, DC 20405, (202) 482-7340. You may also send comments to us by e-mail at: RISC@gsa.gov SUPPLEMENTARY INFORMATION: TABLE OF CONTENTS Page Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions I. What Are The Regulatory Plan and the Unified Agenda?......... 69738 II. Why Are The Regulatory Plan and the Unified Agenda 69739 Published?..................................................... III. How Are The Regulatory Plan and the Unified Agenda 69739 Organized?..................................................... IV. What Information Appears for Each Entry?.................... 69740 V. Abbreviations................................................ 69741 VI. How Can Users Get Copies of the Plan and the Agenda?........ 69742 Introduction to the Fall 2007 Regulatory Plan................... 69743 AGENCY REGULATORY PLANS Cabinet Departments Department of Agriculture....................................... 69755 Department of Commerce.......................................... 69785 Department of Defense........................................... 69793 Department of Education......................................... 69796 Department of Energy............................................ 69799 Department of Health and Human Services......................... 69802 Department of Homeland Security................................. 69819 Department of Housing and Urban Development..................... 69852 Department of the Interior...................................... 69856 Department of Justice........................................... 69866 Department of Labor............................................. 69871 Department of Transportation.................................... 69888 Department of the Treasury...................................... 69910 Department of Veterans Affairs.................................. 69921 Other Executive Agencies Environmental Protection Agency................................. 69922 Equal Employment Opportunity Commission......................... 69957 General Services Administration................................. 69959 National Aeronautics and Space Administration................... 69960 National Archives and Records Administration.................... 69961 Office of Personnel Management.................................. 69962 Pension Benefit Guaranty Corporation............................ 69964 Small Business Administration................................... 69965 Social Security Administration.................................. 69966 Independent Regulatory Agencies Consumer Product Safety Commission.............................. 69979 Federal Housing Finance Board................................... 69981 Federal Maritime Commission..................................... 69982 Federal Trade Commission........................................ 69983 National Indian Gaming Commission............................... 69994 Postal Regulatory Commission.................................... 69996 AGENCY AGENDAS Cabinet Departments Department of Agriculture....................................... 69999 Department of Commerce.......................................... 70013 Department of Defense........................................... 70037 Department of Energy............................................ 70041 Department of Health and Human Services......................... 70043 Department of Homeland Security................................. 70065 Department of Housing and Urban Development..................... 70075 Department of the Interior...................................... 70079 Department of Justice........................................... 70081 Department of Labor............................................. 70087 Department of Transportation.................................... 70095 Other Executive Agencies Environmental Protection Agency................................. 70117 [[Page 69738]] General Services Administration................................. 70125 National Foundation on the Arts and the Humanities Institute of Museum and Library Services...................... 70129 National Endowment for the Arts............................... 70131 Office of Personnel Management.................................. 70133 Small Business Administration................................... 70135 Social Security Administration.................................. 70141 Joint Authority Department of Defense/General Services Administration/National 70143 Aeronautics and Space Administration (Federal Acquisition Regulation).................................................... Independent Regulatory Agencies Federal Communications Commission............................... 70147 Federal Energy Regulatory Commission............................ 70193 Federal Reserve System.......................................... 70195 Federal Trade Commission........................................ 70199 Nuclear Regulatory Commission................................... 70203 Securities and Exchange Commission.............................. 70207 INTRODUCTION TO THE REGULATORY PLAN AND THE UNIFIED AGENDA OF FEDERAL REGULATORY AND DEREGULATORY ACTIONS I. What Are The Regulatory Plan and the Unified Agenda? The Regulatory Plan serves as a defining statement of the Administration's regulatory and deregulatory policies and priorities. The Plan is part of the fall edition of the Unified Agenda. Each participating agency's regulatory plan contains: (1) A narrative statement of the agency's regulatory priorities and, for most agencies, (2) a description of the most important significant regulatory and deregulatory actions that the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year. This edition includes the regulatory plans of 29 agencies. The Unified Agenda provides information about regulations that the Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register twice each year since 1983 and has been available online since 1995. In order to further the Administration's commitment to use modern technology to deliver better service to the American people for lower cost, beginning with the fall 2007 edition, the Internet is the basic means for conveying Regulatory Agenda information to the maximum extent legally permissible. The complete Unified Agenda, including The Regulatory Plan, is available to the public at http://reginfo.gov. The online Unified Agenda offers flexible search tools and, by early 2008, access to the entire historic Unified Agenda database. The fall 2007 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules which are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at http://reginfo.gov. These changes meet the publication mandates of the Regulatory Flexibility Act and Executive Order 12866, as amended, as well as move the Agenda process toward the Administration's goal of e-Government, while providing a substantial reduction in printing costs. The changes do not reduce the amount of information available to the public, but they do limit most of the content of the Agenda to online access. The complete online edition of the Unified Agenda includes regulatory agendas from 58 Federal agencies. Agencies of the United States Congress are not included. The following agencies have no entries identified for inclusion in the printed regulatory flexibility agenda. An asterisk (*) indicates agencies that appear in the Regulatory Plan. The regulatory agendas of these agencies are available to the public at http://reginfo.gov. Department of Education * Department of State Department of the Treasury * Department of Veterans Affairs * Agency for International Development Architectural and Transportation Barriers Compliance Board Commission on Civil Rights Commodity Futures Trading Commission Committee for Purchase From People Who Are Blind or Severely Disabled Consumer Product Safety Commission * Corporation for National and Community Service Court Services and Offender Supervision Agency for the District of Columbia Equal Employment Opportunity Commission * Farm Credit Administration Federal Deposit Insurance Corporation Federal Housing Finance Board * Federal Maritime Commission * Federal Mediation and Conciliation Service National Aeronautics and Space Administration * National Archives and Records Administration * National Credit Union Administration National Endowment for the Humanities National Indian Gaming Commission * Office of Federal Housing Enterprise Oversight Office of Government Ethics Office of Management and Budget Peace Corps Pension Benefit Guaranty Corporation * Postal Regulatory Commission * Privacy and Civil Liberties Oversight Board Railroad Retirement Board Selective Service System Surface Transportation Board The Regulatory Information Service Center (the Center) compiles the Plan and the Unified Agenda for the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget. OIRA is responsible for overseeing the Federal Government's regulatory, paperwork, and information resource management activities, including implementation of Executive Order 12866. The Center also provides information about Federal regulatory activity to the President and his Executive Office, the Congress, agency managers, and the public. [[Page 69739]] The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters. Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change. Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The Regulatory Plan and the Unified Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it. II. Why Are The Regulatory Plan and the Unified Agenda Published? The Regulatory Plan and the Unified Agenda help agencies comply with their obligations under the Regulatory Flexibility Act and various Executive orders and other statutes. Regulatory Flexibility Act The Regulatory Flexibility Act requires agencies to identify those rules that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Agencies meet that requirement by including the information in their submissions for the Unified Agenda. Agencies may also indicate those regulations that they are reviewing as part of their periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272 entitled ``Proper Consideration of Small Entities in Agency Rulemaking,'' signed August 13, 2002 (67 FR 53461) provides additional guidance on compliance with the Act. Executive Order 12866 Executive Order 12866 entitled ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735) requires covered agencies to prepare an agenda of all regulations under development or review. The Order also requires that certain agencies prepare annually a regulatory plan of their ``most important significant regulatory actions,'' which appears as part of the fall Unified Agenda. The requirements for regulatory plans were amended by Executive Order 13422 entitled ``Further Amendment to Executive Order 12866 on Regulatory Planning and Review,'' signed January 18, 2007 (72 FR 2763). Executive Order 13132 Executive Order 13132 entitled ``Federalism,'' signed August 4, 1999 (64 FR 43255) directs agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have ``federalism implications'' as defined in the Order. Under the Order, an agency that is proposing regulations with federalism implications, which either preempt State law or impose nonstatutory unfunded substantial direct compliance costs on State and local governments, must consult with State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the Office of Management and Budget a federalism summary impact statement for such regulations, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications. Unfunded Mandates Reform Act of 1995 The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II) requires agencies to prepare written assessments of the costs and benefits of significant regulatory actions ``that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more . . . in any 1 year . . . .'' The requirement does not apply to independent regulatory agencies, nor does it apply to certain subject areas excluded by section 4 of the Act. Affected agencies identify in the Unified Agenda those regulatory actions they believe are subject to title II of the Act. Executive Order 13211 Executive Order 13211 entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,'' signed May 18, 2001 (66 FR 28355) directs agencies to provide, to the extent possible, information regarding the adverse effects that agency actions may have on the supply, distribution, and use of energy. Under the Order, the agency must prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, for ``those matters identified as significant energy actions.'' As part of this effort, agencies may optionally include in their submissions for the Unified Agenda information on whether they have prepared or plan to prepare a Statement of Energy Effects for their regulatory actions. Small Business Regulatory Enforcement Fairness Act The Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, title II) established a procedure for congressional review of rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the effective date of a ``major'' rule for at least 60 days from the publication of the final rule in the Federal Register. The Act specifies that a rule is ``major'' if it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of OIRA will make the final determination as to whether a rule is major. III. How Are The Regulatory Plan and the Unified Agenda Organized? The Regulatory Plan appears in part II of a daily edition of the Federal Register. The Plan is a single document beginning with an introduction, followed by a table of contents, followed by each agency's section of the Plan. Following the Plan in the Federal Register, as separate parts, are the regulatory flexibility agendas for each agency whose agenda includes entries for rules which are likely to have a significant economic impact on a substantial number of small entities or rules that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Each printed agenda appears as a separate part. The sections [[Page 69740]] of the Plan and the parts of the Unified Agenda are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority (Agenda only); and independent regulatory agencies. Agencies may in turn be divided into subagencies. Unlike the printed edition, the online, complete Unified Agenda has no fixed ordering. In the online Agenda, users can select the particular agencies whose agendas or plans they want to see. Users also have broad flexibility to specify the characteristics of the entries of interest to them. Each agency's section of the Plan contains a narrative statement of regulatory priorities and, for most agencies, a description of the agency's most important significant regulatory and deregulatory actions. Each agency's part of the Agenda contains a preamble providing information specific to that part. The printed agency agendas have a table of contents that lists their printed entries. Following the table of contents is a description of the agency's regulatory and deregulatory actions. In the online Agenda, users can see a listing of an agency's entries by selecting the agency. In the Agenda, each agency presents its entries under one of five rulemaking stages. In the Plan, only the first three stages are applicable. Some agencies use subheadings to identify regulations that are grouped according to particular topics. The rulemaking stages are: 1. Prerule Stage -- actions agencies will undertake to determine whether or how to initiate rulemaking. Such actions occur prior to a Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of Proposed Rulemaking (ANPRMs) and reviews of existing regulations. 2. Proposed Rule Stage -- actions for which agencies plan to publish a Notice of Proposed Rulemaking as the next step in their rulemaking process or for which the closing date of the NPRM Comment Period is the next step. 3. Final Rule Stage -- actions for which agencies plan to publish a final rule or an interim final rule or to take other final action as the next step. 4. Long-Term Actions -- items under development but for which the agency does not expect to have a regulatory action within the 12 months after publication of this edition of the Unified Agenda. Some of the entries in this section may contain abbreviated information. 5. Completed Actions -- actions or reviews the agency has completed or withdrawn since publishing its last agenda. This section also includes items the agency began and completed between issues of the Agenda. A bullet () preceding the title of an entry indicates that the entry is appearing in the Unified Agenda for the first time. In the printed edition, all entries are numbered sequentially from the beginning to the end of the publication. The sequence number preceding the title of each entry identifies the location of the entry in this edition. This sequence number is used as the reference in the printed table of contents. Sequence numbers are not used in the online Unified Agenda because the unique Regulation Identifier Number (RIN) is able to provide this cross-reference capability. Previous editions of the Unified Agenda contained several indexes, which identified entries with various characteristics. These included regulatory actions for which agencies believe that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for periodic review under section 610(c) of the Regulatory Flexibility Act, and actions that may have federalism implications as defined in Executive Order 13132 or other effects on levels of government. These indexes are no longer compiled, because users of the online Unified Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the Federal Register Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases. IV. What Information Appears for Each Entry? All entries in the Unified Agenda contain uniform data elements including, at a minimum, the following information: Title of the Regulation -- a brief description of the subject of the regulation. In the printed edition, the notation ``Section 610 Review'' following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated completions of section 610 reviews or rulemaking actions resulting from completed section 610 reviews. In the online edition, these notations appear as separate fields. Priority -- an indication of the significance of the regulation. Agencies assign each entry to one of the following five categories of significance. (1) Economically Significant As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The definition of an ``economically significant'' rule is similar but not identical to the definition of a ``major'' rule under 5 U.S.C. 801 (Pub. L. 104-121). (See below.) (2) Other Significant A rulemaking that is not Economically Significant but is considered Significant by the agency. This category includes rules that the agency anticipates will be reviewed under Executive Order 12866 or rules that are a priority of the agency head. These rules may or may not be included in the agency's regulatory plan. (3) Substantive, Nonsignificant A rulemaking that has substantive impacts but is neither Significant, nor Routine and Frequent, nor Informational/Administrative/Other. (4) Routine and Frequent A rulemaking that is a specific case of a multiple recurring application of a regulatory program in the Code of Federal Regulations and that does not alter the body of the regulation. (5) Informational/Administrative/Other A rulemaking that is primarily informational or pertains to agency matters not central to accomplishing the agency's regulatory mandate but that the agency places in the Unified Agenda to inform the public of the activity. In addition, if a rule is ``major'' under 5 U.S.C. 801 (Pub. L. 104-121) because it has resulted or is likely to result in [[Page 69741]] an annual effect on the economy of $100 million or more or meets other criteria specified in that Act, this is indicated under the ``Priority'' heading. The Act provides that the Administrator of the Office of Information and Regulatory Affairs will make the final determination as to whether a rule is major. Unfunded Mandates -- whether the rule is covered by section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act requires that, before issuing an NPRM likely to result in a mandate that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of more than $100 million in 1 year, agencies, other than independent regulatory agencies, shall prepare a written statement containing an assessment of the anticipated costs and benefits of the Federal mandate. If the agency believes the entry is not subject to the Act, this data element will not be printed. Legal Authority -- the section(s) of the United States Code (U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s) the regulatory action. Agencies may provide popular name references to laws in addition to these citations. CFR Citation -- the section(s) of the Code of Federal Regulations that will be affected by the action. Legal Deadline -- whether the action is subject to a statutory or judicial deadline, the date of that deadline, and whether the deadline pertains to an NPRM, a Final Action, or some other action. Abstract -- a brief description of the problem the regulation will address; the need for a Federal solution; to the extent available, alternatives that the agency is considering to address the problem; and potential costs and benefits of the action. Timetable -- the dates and citations (if available) for all past steps and a projected date for at least the next step for the regulatory action. A date printed in the form 02/00/08 means the agency is predicting the month and year the action will take place but not the day it will occur. In some instances, agencies may indicate what the next action will be, but the date of that action is ``To Be Determined.'' ``Next Action Undetermined'' indicates the agency does not know what action it will take next. Regulatory Flexibility Analysis Required -- whether an analysis is required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because the rulemaking action is likely to have a significant economic impact on a substantial number of small entities as defined by the Act. Small Entities Affected -- the types of small entities (businesses, governmental jurisdictions, or organizations) on which the rulemaking action is likely to have an impact as defined by the Regulatory Flexibility Act. Some agencies have chosen to indicate likely effects on small entities even though they believe that a Regulatory Flexibility Analysis will not be required. Government Levels Affected -- whether the action is expected to affect levels of government and, if so, whether the governments are State, local, tribal, or Federal. Federalism -- whether the action has ``federalism implications'' as defined in Executive Order 13132. This term refers to actions ``that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' If the action does not have federalism implications, this data element will not be printed. Independent regulatory agencies are not required to supply this information. Agency Contact -- the name and phone number of at least one person in the agency who is knowledgeable about the rulemaking action. The agency may also provide the title, address, fax number, e-mail address, and TDD for each agency contact. Some agencies have provided the following optional information: URL for More Information -- the Internet address of a site that provides more information about the entry. URL for Public Comments -- the Internet address of a site that will accept public comments on the entry. Alternatively, timely public comments may be submitted at the governmentwide e-rulemaking site, http://www.regulations.gov. Additional Information -- any information an agency wishes to include that does not have a specific data element. Compliance Cost to the Public -- the estimated gross compliance cost of the action. Affected Sectors -- the industrial sectors that the action may most affect, either directly or indirectly. Affected Sectors are identified by North American Industry Classification System (NAICS) codes. Energy Effects -- an indication of whether the agency has prepared or plans to prepare a Statement of Energy Effects for the action, as required by Executive Order 13211 ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,'' signed May 18, 2001 (66 FR 28355). Related RINs -- one or more past or current RINs associated with activity related to this action, such as merged RINs, split RINs, new activity for previously completed RINs, or duplicate RINs. Entries appearing in The Regulatory Plan include one or more of the following additional data elements, but will, at a minimum, include information in Statement of Need and in Anticipated Costs and Benefits: Statement of Need -- a description of the need for the regulatory action. Summary of the Legal Basis -- a description of the legal basis for the action, including whether any aspect of the action is required by statute or court order. Alternatives -- a description of the alternatives the agency has considered or will consider as required by section 4(c)(1)(B) of Executive Order 12866. Anticipated Costs and Benefits -- a description of preliminary estimates of the anticipated costs and benefits of the action. Risks -- a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk and this risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction. V. Abbreviations The following abbreviations appear throughout this publication: ANPRM -- An Advance Notice of Proposed Rulemaking is a preliminary notice, published in the Federal Register, announcing that an agency is considering a regulatory action. An agency may issue an ANPRM before it develops [[Page 69742]] a detailed proposed rule. An ANPRM describes the general area that may be subject to regulation and usually asks for public comment on the issues and options being discussed. An ANPRM is issued only when an agency believes it needs to gather more information before proceeding to a notice of proposed rulemaking. CFR -- The Code of Federal Regulations is an annual codification of the general and permanent regulations published in the Federal Register by the agencies of the Federal Government. The Code is divided into 50 titles, each title covering a broad area subject to Federal regulation. The CFR is keyed to and kept up to date by the daily issues of the Federal Register. EO -- An Executive order is a directive from the President to Executive agencies, issued under constitutional or statutory authority. Executive orders are published in the Federal Register and in title 3 of the Code of Federal Regulations. FR -- The Federal Register is a daily Federal Government publication that provides a uniform system for publishing Presidential documents, all proposed and final regulations, notices of meetings, and other official documents issued by Federal agencies. FY -- The Federal fiscal year runs from October 1 to September 30. NPRM -- A Notice of Proposed Rulemaking is the document an agency issues and publishes in the Federal Register that describes and solicits public comments on a proposed regulatory action. Under the Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum: a statement of the time, place, and nature of the public rulemaking proceeding; a reference to the legal authority under which the rule is proposed; and either the terms or substance of the proposed rule or a description of the subjects and issues involved. PL (or Pub. L.) -- A Public Law is a law passed by Congress and signed by the President or enacted over his veto. It has general applicability, unlike a private law that applies only to those persons or entities specifically designated. Public laws are numbered in sequence throughout the 2-year life of each Congress; for example, PL 110-4 is the fourth public law of the 110th Congress. RFA -- A Regulatory Flexibility Analysis is a description and analysis of the impact of a rule on small entities, including small businesses, small governmental jurisdictions, and certain small not- for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires each agency to prepare an initial RFA for public comment when it is required to publish an NPRM and to make available a final RFA when the final rule is published, unless the agency head certifies that the rule would not have a significant economic impact on a substantial number of small entities. RIN -- The Regulation Identifier Number is assigned by the Regulatory Information Service Center to identify each regulatory action listed in The Regulatory Plan and the Unified Agenda, as directed by Executive Order 12866 (section 4(b)). Additionally, OMB has asked agencies to include RINs in the headings of their Rule and Proposed Rule documents when publishing them in the Federal Register, to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development. Seq. No. -- The Sequence Number identifies the location of an entry in the printed edition of the Agenda. Note that a specific regulatory action will have the same RIN throughout its development but will generally have different sequence numbers in different editions of The Regulatory Plan and the Agenda. USC -- The United States Code is a consolidation and codification of all general and permanent laws of the United States. The USC is divided into 50 titles, each title covering a broad area of Federal law. VI. How Can Users Get Copies of the Plan and the Agenda? Printed copies of this edition of the Federal Register are available from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone: (202) 512-1800 or 1-866-512-1800 (toll-free). Copies of individual agency materials may be available directly from the agency or may be found on the agency's website. Please contact the particular agency for further information. All editions of The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions, since fall 1995, are currently available in electronic form in the format used previously. By early 2008, users of the online edition will have access to the entire historic Unified Agenda database. You can search the Agenda and the Plan at: http://reginfo.gov In accordance with regulations for the Federal Register, the Government Printing Office's GPO Access website contains copies of the Agendas and Regulatory Plans that have been printed in the Federal Register. These documents are available at: http://www.gpoaccess.gov/ua/index.html Dated: November 21, 2007. John C. Thomas, Executive Director. [Page 69743-69997] The Regulatory Plan ____________________________________________________________________ [[Page 69743]] INTRODUCTION TO THE FALL 2007 REGULATORY PLAN Federal regulation is a fundamental instrument of national policy. It is one of the three major tools -- in addition to spending and taxing -- used to implement policy. It is used to advance numerous public objectives, including homeland security, environmental protection, educational quality, food safety, transportation safety, health care quality, equal employment opportunity, energy security, immigration control, and consumer protection. The Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) is responsible for overseeing and coordinating the Federal Government's regulatory policies. The Regulatory Plan is published as part of the fall edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions, and serves as a statement of the Administration's regulatory and deregulatory policies and priorities. The purpose of the Plan is to make the regulatory process more accessible to the public and to ensure that the planning and coordination necessary for a well-functioning regulatory process occurs. The Plan identifies regulatory priorities and contains information about the most significant regulatory actions that agencies expect to undertake in the coming year. An accessible regulatory process enables citizen centered service, which is a vital part of the President's Management Agenda. Federal Regulatory Policy The Bush Administration supports Federal regulations that are sensible and based on sound science, economics, and the law. Accordingly, the Administration is striving for a regulatory process that adopts new rules when markets fail to serve the public interest, simplifies and modifies existing rules to make them more effective or less costly or less intrusive, and rescinds outmoded rules whose benefits do not justify their costs. In pursuing this agenda, OIRA has adopted an approach based on the principles of regulatory analysis and policy espoused in Executive Order 12866, signed by President Clinton in 1993. Effective regulatory policy is not uniformly pro- regulation or anti-regulation. It begins with the authority granted under the law. Within the discretion available to the regulating agency by its statutory authority, agencies apply a number of principles articulated in Executive Order 12866, as well as other applicable Executive Orders, in order to design regulations that achieve their ends in the most efficient way. This means bringing to bear on the policy problem sound economic principles, the highest quality information, and the best possible science. This is not always an easy task, as sometimes economic and scientific information may point in very different directions, and therefore designing regulations does not mean just the rote application of quantified data to reach policy decisions. In making regulatory decisions, we expect agencies to consider not only benefit and cost items that can be quantified and expressed in monetary units, but also other attributes and factors that cannot be integrated readily in a benefit-cost framework, such as fairness and privacy. However, effective regulation is the result of the careful use of all available high-quality data, and the application of broad principles established by the President. [[Page 69744]] In pursuing this goal of establishing an effective, results-oriented regulatory system, the Bush Administration has increased the level of public involvement and transparency in the development of regulations, including in OMB's review of new and existing regulations. The Administration's e-rulemaking initiative is designed to improve the public's ability to get involved in the rulemaking process. Visitors to the website, http://www.regulations.gov, can view and comment electronically on regulations proposed by Federal departments and agencies. Starting with this edition, the Regulatory Plan and Unified Agenda are available electronically in searchable database format at http://reginfo.gov. Additionally, beginning in early 2008, prior editions of the Regulatory Plan and Unified Agenda will also be made available in searchable format at http://reginfo.gov. For new rulemakings and programs, OIRA has enhanced the transparency of OMB's regulatory review process. OIRA's website now enables the public to find which rules are formally under review at OMB and which rules have recently been cleared or have been returned to agencies for reconsideration. OIRA has also increased the amount of information available on its website. In addition to information on meetings and correspondence, OIRA makes available communications from the OIRA Administrator to agencies, including ``prompt letters,'' ``return letters,'' and ``post clearance letters,'' as well as the Administrator's memorandum to the President's Management Council (September 20, 2001) on presidential review of agency rulemaking by OIRA. For existing rulemakings, OIRA has initiated a modest series of calls for reform nominations in 2001, 2002, and 2004. In the draft 2001 annual Report to Congress on the Costs and Benefits of Federal Regulation, OMB asked for suggestions from the public about specific regulations that should be modified in order to increase net benefits to the public. We received suggestions regarding 71 regulations, 23 of which OMB designated as high priorities. After a similar call for reforms in the 2002 draft Report, OMB received recommendations on 316 distinct rules, guidance documents, and paperwork requirements from over 1,700 commenters. Many of the nominations involved rules and guidance documents that were recently issued or already under review by the agencies, or involved independent agency rules or guidance documents. OMB determined that the remaining 122 rules and 34 guidance documents were not under active review, and referred them to the agencies for their evaluation as possible reforms. Finally, in the 2004 draft Report, OMB requested public nominations of promising regulatory reforms relevant to the manufacturing sector. In particular, commenters were asked to suggest specific reforms to rules, guidance documents, or paperwork requirements that would improve manufacturing regulation by reducing unnecessary costs, increasing effectiveness, enhancing competitiveness, reducing uncertainty, and increasing flexibility. In response to the solicitation, OMB received 189 distinct reform nominations from 41 commenters. Of these, Federal agencies and OMB have determined that 76 of the 189 nominations have potential merit and justify further action. For further information, all of these Reports are available on OIRA's website at http://www.whitehouse.gov/omb/ inforeg/regpol.html. The Bush Administration has also moved aggressively to establish basic quality performance goals for all information disseminated by Federal agencies, including information disseminated in support of proposed and final regulations. The Federal agencies issued guidelines on October 1, 2002 under the Information Quality Act to ensure the ``quality, objectivity, utility, and integrity'' of all information disseminated by Federal agencies. Under these guidelines, Federal agencies are taking appropriate steps to incorporate the information quality performance standards into agency information dissemination practices, and developing pre- dissemination review procedures to substantiate the quality of information before it is disseminated. Under the [[Page 69745]] agency information quality guidelines, ``affected persons'' can request that the agencies correct information if they believe that scientific, technical, economic, statistical or other information disseminated does not meet the agency and OMB standards. If the requestor is dissatisfied with the initial agency response to a correction request, an appeal opportunity is provided by the agencies. With the implementation of these guidelines, agencies are now aware that ensuring the high quality of government information disseminations is a high priority of the Administration. Further information on OIRA's activities implementing the Information Quality Act is available on OIRA's website at http:// www.whitehouse.gov/omb/inforeg/infopoltech.html. As part of its efforts to improve the quality, objectivity, utility, and integrity of information disseminated by the Federal agencies, on December 16, 2004, OMB issued a Final Information Quality Bulletin for Peer Review. This Bulletin establishes government- wide guidance aimed at enhancing the practice of peer review of government science documents. The Bulletin describes minimum standards for when peer review is required and how intensive the peer review should be for different information. The Bulletin requires the most rigorous form of peer review for highly influential scientific assessments. Further information on peer review is available on OIRA's website at http:/ /www.whitehouse.gov/omb/memoranda/fy2005/m05-03.pdf. Recognizing the importance of agency interpretations of existing regulations, OIRA recently changed its policies concerning the development and review of agency ``guidance documents.'' On January 18, 2007, the President issued Executive Order 13422, ``Amendment to Executive Order 12866 for Regulatory Planning and Review.'' On that same day, OMB issued its Bulletin on Agency Good Guidance Practices. The primary focus of the Executive Order and the Good Guidance Bulletin is to increase the quality, transparency, and accountability of guidance documents. The Good Guidance Bulletin, which OMB issued after seeking public comment on a proposed version, established policies and procedures for agencies to apply in their development and issuance of ``significant'' and ``economically significant'' guidance documents. This Bulletin will ensure that guidance documents are of high quality, developed with appropriate agency review and public participation, and readily accessible by the public. The principal change to E.O. 12866 is a new process that will provide an opportunity for interagency coordination and review of significant guidance documents prior to their issuance. E.O. 12866 was amended in several other ways. For example, to ensure appropriate accountability, the E.O. modifies the procedures for an agency's adoption of its annual Regulatory Plan and requires that an agency's Regulatory Policy Officer be a Presidential appointee. The E.O. also updates the Principles of Regulation in E.O. 12866 to reflect the guidance-coordination provisions in pre-existing OMB guidance. In addition to increasing the level of public involvement and transparency in its review of regulations, the Bush Administration has sought to enhance the role of analysis in the development of effective regulations. On September 17, 2003, OMB issued revised guidance to agencies on regulatory analysis.\1\ Key features of the revised guidance include more emphasis on cost-effectiveness, more careful evaluation of qualitative and intangible values, and a greater emphasis on considering the uncertainty inherent in estimates of impact. OIRA was very interested in updating the guidance in light of these and other innovations now commonplace in the research community. ------------ \1\ See Circular A-4, ``Regulatory Analysis,'' published as part of OMB's 2003 Report to Congress on the Costs and Benefits of Federal Regulations. The report is available on OMB's website at http:// www.whitehouse.gov/omb/inforeg/2003--cost-ben--final-- rpt.pdf [[Page 69746]] Further, in 2007 OMB and the Office of Science and Technology Policy (OSTP) issued an updated memorandum outlining principles for conducting analyses of health, safety, and environmental risk. The memorandum reaffirms risk analysis principles previously released by OMB in 1995 and reinforces them with more recent guidance from the scientific community, Congress, and the Executive Branch. The 2007 Regulatory Plan continues OIRA's effort to ensure coordination across Federal agencies in pursuing analytically sound regulatory policies. The Administration's 2007 Regulatory Priorities With regard to Federal regulation, the Bush Administration's objective is quality, not quantity. Those rules that are adopted promise to be more effective, less intrusive, and more cost-effective in achieving national objectives while demonstrating greater durability in the face of political and legal attack. The Regulatory Plan is integral to enhancing the quality of Federal regulations, and OMB seeks to ensure that the public is provided with the information needed to understand and comment on the Federal regulatory agenda. Accordingly, the 2007 Regulatory Plan highlights the following themes: Regulations that are particularly good examples of the Administration's ``smart'' regulation agenda to streamline regulations and reporting requirements, which is a key part of the President's economic plan. Regulations that are of particular concern to small businesses. Regulations that respond to public nominations submitted to OMB in 2001 or 2002. Regulations that address 2004 nominations for promising regulatory reforms in the manufacturing sector. Conclusion Smarter regulatory policies, created through public participation, transparency, and cooperation across Federal agencies, are a key Administration objective. The following department and agency plans provide further information on regulatory priorities. All agencies' plans are a reflection of the Administration's Federal Regulatory Policy objectives, which aim at implementing an effective and results- oriented regulatory system. [[Page 69747]] DEPARTMENT OF AGRICULTURE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 1 National Organic Program: Add Standards for the Organic Certification of Wild Captured Aquatic 0581-AB97 Prerule Stage Animals (TM-01-08) 2 Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Fish, Perishable Agricultural 0581-AC26 Final Rule Stage Commodities, and Peanuts (LS-03-04) 3 Mandatory Reporting for Dairy Programs (DA-06-07) 0581-AC66 Final Rule Stage 4 Livestock Mandatory Reporting: Revise Reporting Regulation for Swine, Cattle, Lamb, and Boxed Beef 0581-AC67 Final Rule Stage (LS-07-01) 5 Regulation of Genetically Engineered Animals 0579-AC37 Prerule Stage 6 Animal Welfare; Regulations and Standards for Birds 0579-AC02 Proposed Rule Stage 7 Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not 0579-AC03 Proposed Rule Authorized for Importation Pending Risk Assessment Stage 8 Introduction of Organisms and Products Altered or Produced Through Genetic Engineering 0579-AC31 Proposed Rule Stage 9 Nutrition Standards in the National School Lunch and School Breakfast Programs 0584-AD59 Proposed Rule Stage 10 Child and Adult Care Food Program: Improving Management and Program Integrity 0584-AC24 Final Rule Stage 11 FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002 0584-AD30 Final Rule Stage 12 Quality Control Provisions of Title IV of Public Law 107-171 0584-AD31 Final Rule Stage 13 Special Nutrition Programs: Fluid Milk Substitutions 0584-AD58 Final Rule Stage 14 Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant, 0584-AD60 Final Rule Stage and Runaway Children for Free Meals in the NSLP, SBP, and SMP 15 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): WIC Vendor Cost 0584-AD71 Final Rule Stage Containment 16 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC 0584-AD77 Final Rule Stage Food Packages 17 Egg Products Inspection Regulations 0583-AC58 Proposed Rule Stage 18 Changes to Regulatory Jurisdiction Over Certain Food Products Containing Meat and Poultry 0583-AD28 Proposed Rule Stage 19 Public Health-Based Poultry Slaughter Inspection 0583-AD32 Proposed Rule Stage 20 Performance Standards for the Production of Processed Meat and Poultry Products; Control of 0583-AC46 Final Rule Stage Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products 21 Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products 0583-AC60 Final Rule Stage 22 Availability of Lists of Retail Consignees During Meat or Poultry Product Recalls 0583-AD10 Final Rule Stage 23 Forest Service National Environmental Policy Act Procedures 0596-AC49 Proposed Rule Stage 24 Special Areas; State-Specific Inventoried Roadless Area Management: Idaho 0596-AC62 Proposed Rule Stage 25 Special Areas; State-Specific Inventoried Roadless Area Management: Colorado 0596-AC74 Proposed Rule Stage 26 Planning Subpart A - National Forest System Land Management Planning 0596-AC70 Final Rule Stage 27 Delivery Enhancement for Guaranteed Loans 0570-AA65 Final Rule Stage 28 Rural Broadband Access Loans and Loan Guarantees 0572-AC06 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF COMMERCE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 29 Provide Guidance for the Limited Access Privilege Program Provisions of the Magnuson-Stevens 0648-AV48 Proposed Rule Fishery Conservation Reauthorization Act of 2006 Stage 30 Certification of Nations Whose Fishing Vessels Are Engaged in IUU Fishing or Bycatch of Protected 0648-AV51 Proposed Rule Living Marine Resources Stage [[Page 69748]] 31 Guidance for Annual Catch Limits (ACLs) and Accountability Measures (AMs) To End Overfishing 0648-AV60 Proposed Rule Stage 32 Right Whale Ship Strike Reduction 0648-AS36 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF EDUCATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 33 Title IV of the Higher Education Act of 1965, as Amended 1840-AC93 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF ENERGY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 34 Energy Conservation Standards for Residential Electric and Gas Ranges and Ovens and Microwave 1904-AB49 Prerule Stage Ovens, Dishwashers, Dehumidifiers, and Commercial Clothes Washers 35 Energy Efficiency Standards for Packaged Terminal Air Conditioners and Packaged Terminal Heat Pumps 1904-AB44 Proposed Rule Stage 36 Energy Efficiency Standards for Commercial Refrigeration Equipment 1904-AB59 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 37 Control of Communicable Diseases, Interstate and Foreign Quarantine 0920-AA12 Final Rule Stage 38 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910-AC52 Proposed Rule Stage 39 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for 0910-AF11 Proposed Rule Pregnancy and Lactation Labeling Stage 40 Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61 Proposed Rule Stage 41 Medical Device Reporting; Electronic Submission Requirements 0910-AF86 Proposed Rule Stage 42 Electronic Registration and Listing for Devices 0910-AF88 Proposed Rule Stage 43 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and 0910-AB88 Final Rule Stage Dietary Supplements 44 Prevention of Salmonella Enteritidis in Shell Eggs 0910-AC14 Final Rule Stage 45 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and 0910-AC41 Final Rule Stage Response Act of 2002 46 Expanded Access to Investigational Drugs for Treatment Use 0910-AF14 Final Rule Stage 47 Standards for E-Prescribing Under Medicare Part D (CMS-0016-P) 0938-AO66 Proposed Rule Stage 48 Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process (CMS- 0938-AO87 Proposed Rule 4127-P) Stage 49 Medicare Supplemental Policies (CMS-4084-P) 0938-AP10 Proposed Rule Stage 50 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center 0938-AP17 Proposed Rule Payment System for CY 2009 (CMS-1404-P) Stage [[Page 69749]] 51 Revisions to Payment Policies Under the Physician Fee Schedule and Ambulance Fee Schedule for CY 0938-AP18 Proposed Rule 2009 (CMS-1403-P) Stage 52 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-F) 0938-AG82 Final Rule Stage 53 Hospice Care Conditions of Participation (CMS-3844-F) 0938-AH27 Final Rule Stage 54 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family and Medical 0938-AL88 Final Rule Stage Leave Act (CMS-2158-F) -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 55 Implementation of the United States Visitor and Immigrant Status Indicator Technology Program (US- 1601-AA34 Proposed Rule VISIT); Biometric Requirements for Exit at Air and Sea Ports Stage 56 Minimum Standards for Driver's Licenses and Identification Cards Acceptable to Federal Agencies for 1601-AA37 Final Rule Stage Official Purposes 57 Reduction of the Number of Acceptable Documents and Other Changes to Employment Verification 1615-AA01 Proposed Rule Requirements Stage 58 Special Immigrant and Nonimmigrant Religious Workers 1615-AA16 Final Rule Stage 59 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status 1615-AA60 Final Rule Stage 60 Changes to Requirements Affecting H-2A Nonimmigrants 1615-AB65 Final Rule Stage 61 Implementation of the 1995 Amendments to the International Convention on Standards of Training, 1625-AA16 Proposed Rule Certification, and Watchkeeping (STCW) for Seafarers, 1978 (USCG-2004-17914) Stage 62 Commercial Fishing Industry Vessels (USCG-2003-16158) 1625-AA77 Proposed Rule Stage 63 Navigation Equipment; SOLAS Chapter V Amendments and Electronic Chart System (USCG-2004-19588) 1625-AA91 Proposed Rule Stage 64 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System (USCG- 1625-AA99 Proposed Rule 2005-21869) Stage 65 Increasing Passenger Weight Standard for Passenger Vessels (USCG 2005-22732) 1625-AB20 Proposed Rule Stage 66 Transportation Worker Identification Credential (TWIC); Card Reader Requirements (USCG-2007-28915) 1625-AB21 Proposed Rule Stage 67 Outer Continental Shelf Activities (USCG-1998-3868) 1625-AA18 Final Rule Stage 68 Advance Information on Private Aircraft Arriving and Departing the United States 1651-AA41 Proposed Rule Stage 69 Importer Security Filing and Additional Carrier Requirements 1651-AA70 Proposed Rule Stage 70 Documents Required for Travelers Entering the United States at Sea and Land Ports-of-Entry From 1651-AA69 Final Rule Stage Within the Western Hemisphere 71 Aircraft Repair Station Security 1652-AA38 Proposed Rule Stage 72 Secure Flight Program 1652-AA45 Proposed Rule Stage 73 Large Aircraft Security Program, Other Aircraft Operator Security Program, and Airport Operator 1652-AA53 Proposed Rule Security Program Stage 74 Public Transportation--Security Plan 1652-AA56 Proposed Rule Stage 75 Railroads-Security Training of Employees 1652-AA57 Proposed Rule Stage [[Page 69750]] 76 Railroads--Vulnerability Assessment and Security Plan 1652-AA58 Proposed Rule Stage 77 Over-the-Road Buses--Security Training of Employees 1652-AA59 Proposed Rule Stage 78 Over-the-Road Buses--Vulnerability Assessment and Security Plan 1652-AA60 Proposed Rule Stage 79 Security Threat Assessments of Certain Transportation Personnel 1652-AA61 Proposed Rule Stage 80 Rail Transportation Security 1652-AA51 Final Rule Stage 81 Public Transportation-Security Training of Employees 1652-AA55 Final Rule Stage 82 Special Community Disaster Loans Program 1660-AA44 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 83 HUD's Regulation of Fannie Mae and Freddie Mac: Housing Goals (FR-4960) 2501-AD12 Proposed Rule Stage 84 Real Estate Settlement Procedures Act (RESPA); To Simplify and Improve the Process of Obtaining 2502-AI61 Proposed Rule Mortgages and Reduce Consumer Costs (FR-5180) Stage 85 Capital Fund Program (FR-4880) 2577-AC50 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 86 Placement of Excess Spoil 1029-AC04 Proposed Rule Stage 87 Oil Shale Leasing and Operations 1004-AD90 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF JUSTICE -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 88 Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities 1190-AA44 Proposed Rule Stage 89 Nondiscrimination on the Basis of Disability in State and Local Government Services 1190-AA46 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF LABOR -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 90 Family and Medical Leave Act of 1993; Conform to the Supreme Court's Ragsdale Decision 1215-AB35 Proposed Rule Stage 91 Senior Community Service Employment Program 1205-AB48 Proposed Rule Stage 92 YouthBuild Program 1205-AB49 Proposed Rule Stage [[Page 69751]] 93 Apprenticeship Programs, Labor Standards for Registration, Amendment of Regulations 1205-AB50 Proposed Rule Stage 94 Federal-State Unemployment Compensation Program; Interstate Arrangement for Combining Employment 1205-AB51 Proposed Rule and Wages Stage 95 Senior Community Service Employment Program; Performance Accountability 1205-AB47 Final Rule Stage 96 Fee and Expense Disclosures to Participants in Individual Account Plans 1210-AB07 Proposed Rule Stage 97 Amendment of Standards Applicable to General Statutory Exemption for Services 1210-AB08 Proposed Rule Stage 98 Prohibited Transaction Exemption for Provision of Investment Advice to Participants in Individual 1210-AB13 Proposed Rule Account Plans Stage 99 Periodic Pension Benefit Statements 1210-AB20 Proposed Rule Stage 100 Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the 1210-AA54 Final Rule Stage Health Insurance Portability and Accountability Act of 1996 101 Section 404 Regulation--Default Investment Alternatives Under Participant Directed Individual 1210-AB10 Final Rule Stage Account Plans 102 Continuous Personal Dust Monitors 1219-AB48 Prerule Stage 103 Diesel Particulate Matter: Conversion Factor From Total Carbon to Elemental Carbon 1219-AB55 Proposed Rule Stage 104 Asbestos Exposure Limit 1219-AB24 Final Rule Stage 105 Sealing of Abandoned Areas 1219-AB52 Final Rule Stage 106 Mine Rescue Teams 1219-AB53 Final Rule Stage 107 Occupational Exposure to Crystalline Silica 1218-AB70 Prerule Stage 108 Cranes and Derricks 1218-AC01 Proposed Rule Stage 109 Hazard Communication 1218-AC20 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 110 Nondiscrimination on the Basis of Disability in Air Travel 2105-AC97 Final Rule Stage 111 Automatic Dependent Surveillance--Broadcast (ADS-B) Equipage Mandate To Support Air Traffic Control 2120-AI92 Proposed Rule Service Stage 112 Pilot Age Limit 2120-AJ01 Proposed Rule Stage 113 Aging Aircraft Program (Widespread Fatigue Damage) 2120-AI05 Final Rule Stage 114 Transport Airplane Fuel Tank Flammability Reduction 2120-AI23 Final Rule Stage 115 National Registry of Certified Medical Examiners 2126-AA97 Proposed Rule Stage 116 Commercial Driver's License Testing and Commercial Learner's Permit Standards 2126-AB02 Proposed Rule Stage 117 Medical Certification Requirements as Part of the Commercial Driver's License 2126-AA10 Final Rule Stage 118 New Entrant Safety Assurance Process 2126-AA59 Final Rule Stage 119 Requirements for Intermodal Equipment Providers and Motor Carriers and Drivers Operating Intermodal 2126-AA86 Final Rule Stage Equipment 120 Electronic On-Board Recorders for Hours-of-Service Compliance 2126-AA89 Final Rule Stage 121 Roof Crush Resistance 2127-AG51 Proposed Rule Stage 122 Light Truck Corporate Average Fuel Economy Standards, Model Years 2012 and Beyond 2127-AK08 Proposed Rule Stage 123 Reduced Stopping Distance Requirements for Truck Tractors 2127-AJ37 Final Rule Stage 124 Regulatory Relief for Electronically Controlled Pneumatic Brake System Implementation 2130-AB84 Proposed Rule Stage [[Page 69752]] 125 Major Capital Investment Projects--New/Small Starts 2132-AA81 Proposed Rule Stage 126 Pipeline Safety: Distribution Integrity Management 2137-AE15 Proposed Rule Stage 127 Hazardous Materials: Enhancing Rail Transportation Safety and Security for Hazardous Materials 2137-AE02 Final Rule Stage Shipments -------------------------------------------------------------------------------------------------------------------------------------------------------- DEPARTMENT OF THE TREASURY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 128 Implementation of a Revised Basel Capital Accord (Basel II) 1557-AC91 Final Rule Stage 129 Implementation of a Revised Basel Capital Accord (Basel II) 1550-AB56 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 130 Review of the National Ambient Air Quality Standards for Lead 2060-AN83 Prerule Stage 131 Endocrine Disruptor Screening Program (EDSP); Implementing the Screening and Testing Phase 2070-AD61 Prerule Stage 132 Nanoscale Materials Under TSCA 2070-AJ30 Prerule Stage 133 Implementing Periodic Monitoring in Federal and State Operating Permit Programs 2060-AN00 Proposed Rule Stage 134 Revisions to the Definition of Potential to Emit (PTE) 2060-AN65 Proposed Rule Stage 135 Risk and Technology Review Phase II Group 2 2060-AN85 Proposed Rule Stage 136 Rulemaking To Address Greenhouse Gas Emissions From Motor Vehicles 2060-AO56 Proposed Rule Stage 137 Test Rule; Testing of Certain High Production Volume (HPV) Chemicals 2070-AD16 Proposed Rule Stage 138 Pesticides; Data Requirements for Antimicrobials 2070-AD30 Proposed Rule Stage 139 Pesticides; Competency Standards for Occupational Users 2070-AJ20 Proposed Rule Stage 140 Pesticides; Agricultural Worker Protection Standard Revisions 2070-AJ22 Proposed Rule Stage 141 Pesticides; Data Requirements for Plant-Incorporated Protectants (PIPs) 2070-AJ27 Proposed Rule Stage 142 Revisions to the Spill Prevention, Control, and Countermeasure (SPCC) Rule 2050-AG16 Proposed Rule Stage 143 Revisions to Land Disposal Restrictions Treatment Standards and Amendments to Recycling 2050-AG34 Proposed Rule Requirements for Spent Petroleum Refining Hydrotreating and Hydrorefining Catalysts Stage 144 NPDES Vessel Vacatur 2040-AE93 Proposed Rule Stage 145 Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): 2060-AL75 Final Rule Stage Debottlenecking, Aggregation and Project Netting 146 Control of Emissions from New Locomotives and New Marine Diesel Engines Less Than 30 Liters per 2060-AM06 Final Rule Stage Cylinder 147 Control of Emissions From Nonroad Spark-Ignition Engines and Equipment 2060-AM34 Final Rule Stage 148 Amendment of the Standards for Radioactive Waste Disposal in Yucca Mountain, Nevada 2060-AN15 Final Rule Stage 149 Review of the National Ambient Air Quality Standards for Ozone 2060-AN24 Final Rule Stage 150 Prevention of Significant Deterioration and Nonattainment New Source Review: Emission Increases for 2060-AN28 Final Rule Stage Electric Generating Units [[Page 69753]] 151 Final Rule for Implementation of the New Source Review (NSR) Program for PM2.5 2060-AN86 Final Rule Stage 152 Lead-Based Paint; Amendments for Renovation, Repair and Painting 2070-AC83 Final Rule Stage 153 Regulation of Oil-Bearing Hazardous Secondary Materials From the Petroleum Refining Industry 2050-AE78 Final Rule Stage Processed in a Gasification System to Produce Synthesis Gas 154 Expanding the Comparable Fuels Exclusion Under RCRA 2050-AG24 Final Rule Stage 155 Definition of Solid Wastes Revisions 2050-AG31 Final Rule Stage 156 NPDES Permit Requirements for Peak Wet Weather Discharges From Publicly Owned Treatment Work 2040-AD87 Final Rule Stage Treatment Plants Serving Sanitary Sewer Collection Systems Policy 157 Concentrated Animal Feeding Operation Rule 2040-AE80 Final Rule Stage 158 Water Transfers Rule 2040-AE86 Final Rule Stage 159 Implementation Guidance for Mercury Water Quality Criteria 2040-AE87 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- EQUAL EMPLOYMENT OPPORTUNITY COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 160 Coordination of Retiree Health Benefits With Medicare and State Health Benefits 3046-AA72 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- NATIONAL ARCHIVES AND RECORDS ADMINISTRATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 161 Federal Records Management 3095-AB16 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- SMALL BUSINESS ADMINISTRATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 162 Small Business Lending Company and Lender Oversight Regulations 3245-AE14 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- SOCIAL SECURITY ADMINISTRATION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 163 Revised Medical Criteria for Evaluating Immune (HIV) System Disorders 0960-AG71 Prerule Stage 164 Revised Medical Criteria for Evaluating Mental Disorders (886P) 0960-AF69 Proposed Rule Stage 165 Revised Medical Criteria for Evaluating Hearing Loss (2862P) 0960-AG20 Proposed Rule Stage 166 Additional Insured Status Requirements for Certain Alien Workers (2882P) 0960-AG22 Proposed Rule Stage 167 Amendments to the Administrative Law Judge, Appeals Council, and Decision Review Board Appeals 0960-AG52 Proposed Rule Levels (3401P) Stage 168 Representation of Claimants (3396P) 0960-AG56 Proposed Rule Stage 169 Revised Medical Criteria for Malignant Neoplastic Diseases (3429P) 0960-AG57 Proposed Rule Stage 170 Amendments and Clarifications to the Adjudicatory Process (3431P) 0960-AG58 Proposed Rule Stage [[Page 69754]] 171 Requirement That Professional Representatives File Requests for Reconsideration and Administrative 0960-AG59 Proposed Rule Law Judge Hearings Via the Internet (3432P) Stage 172 Amendments to Hearings Level Adjudication (3434P) 0960-AG61 Proposed Rule Stage 173 Updates to Medical-Vocational Guidelines 0960-AG68 Proposed Rule Stage 174 Clarify Applicability of Res Judicata 0960-AG69 Proposed Rule Stage 175 Eliminate Re-interviewing of Representative Payees 0960-AG70 Proposed Rule Stage 176 Revised Medical Criteria for Evaluating Immune System Disorders (804F) 0960-AF33 Final Rule Stage 177 Amendments to the Ticket To Work and Self-Sufficiency Program (967F) 0960-AF89 Final Rule Stage 178 Privacy and Disclosure of Official Records and Information; Availability of Information and Records 0960-AG14 Final Rule Stage to the Public (2562F) 179 Consultative Examination--Annual Onsite Review of Medical Examiners (3338F) 0960-AG41 Final Rule Stage 180 Suspension of New Claims to the Federal Reviewing Official Review Level (3394F) 0960-AG53 Final Rule Stage 181 Nonpayment of Benefits to Fugitive Felons and Probation or Parole Violators (2222F) 0960-AG55 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- CONSUMER PRODUCT SAFETY COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 182 Flammability Standard for Upholstered Furniture 3041-AB35 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- FEDERAL TRADE COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 183 Fair and Accurate Credit Transactions Act of 2003 3084-AA94 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- NATIONAL INDIAN GAMING COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 184 Technical Standards for Gaming Machines and Gaming Systems 3141-AA29 Proposed Rule Stage 185 Game Classification Standards 3141-AA31 Proposed Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- POSTAL REGULATORY COMMISSION -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Rulemaking Stage Number Number -------------------------------------------------------------------------------------------------------------------------------------------------------- 186 System of Rate Regulation for Market Dominant Products 3211-AA02 Final Rule Stage 187 Competitive Products 3211-AA03 Final Rule Stage -------------------------------------------------------------------------------------------------------------------------------------------------------- [FR Doc. 07-05122 Filed 12-07-07; 8:45 am] BILLING CODE 6820-27-S [[Page 69755]] DEPARTMENT OF AGRICULTURE (USDA) Statement of Regulatory Priorities USDA's regulations cover a broad range of issues. Within the rulemaking process is the department-wide effort to reduce burden on participants and program administrators alike by focusing on improving program outcomes, and particularly on achieving the performance measures specified in the USDA and agency Strategic Plans. Significant focus is being placed on efficiencies that can be achieved through eGov activities, the migration to efficient electronic services and capabilities, and the implementation of focused, efficient information collections necessary to support effective program management. Important areas of activity include the following: Legislation covering major farm, trade, conservation, rural development, nutrition assistance and other programs (``Farm Bill'') expires at the end of fiscal year 2007. Regulations will need to be promulgated to implement any new or modified programs reauthorized included in the new Farm Bill that is now under development. It is anticipated that a number of high priority regulations will be developed during FY 2008 to implement the Farm Bill, but additional details are not available for inclusion in this plan. USDA will continue regulatory work to protect the health and value of U.S. agricultural and natural resources while facilitating trade flows. This includes amending regulations related to the importation of fruits and vegetables, nursery products, and animals and animal products, and continuing work related to regulation of plant and animal biotechnologies. In addition, USDA will propose specific standards for the humane handling, care, treatment, and transportation of birds under the Animal Welfare Act. In the area of food safety, USDA will continue to develop science-based regulations that improve the safety of meat, poultry, and egg products in the least burdensome and most cost-effective manner. Regulations will be revised to address emerging food safety challenges, streamlined to remove excessively prescriptive regulations, and updated to be made consistent with hazard analysis and critical control point principles. To assist small entities to comply with food safety requirements, the Food Safety and Inspection Service will continue to collaborate with other USDA agencies and State partners in the enhanced small business outreach program. As changes are made for the nutrition assistance programs, USDA will work to foster actions that will help improve diets, and particularly to prevent and reduce overweight and obesity. In 2008, FNS will continue to promote nutritional knowledge and education while minimizing participant and vendor fraud. USDA has priority projects in the Rural Development mission area to strengthen the regulations for its broadband access program to better focus on areas without such access, and to consolidate and streamline its regulations relating to the delivery of its guaranteed loan programs. USDA will continue to promote economic opportunities for agriculture and rural communities through its BioPreferred Program (formerly the Federal Biobased Product Preferred Procurement Program). USDA will continue to designate groups of biobased products to receive procurement preference from Federal agencies and contractors. In addition, USDA intends to publish rules establishing the Voluntary Labeling Program for biobased products. Reducing Paperwork Burden on Customers USDA has made substantial progress in implementing the goal of the Paperwork Reduction Act of 1995 to reduce the burden of information collection on the public. To meet the requirements of the Government Paperwork Elimination Act (GPEA) and the E-Government Act, agencies across USDA are providing electronic alternatives to their traditionally paper-based customer transactions. As a result, producers increasingly have the option to electronically file forms and all other documentation online. To facilitate the expansion of electronic government, USDA implemented an electronic authentication capability that allows customers to ``sign-on'' once and conduct business with all USDA agencies. Supporting these efforts are ongoing analyses to identify and eliminate redundant data collections and streamline collection instructions. The end result of implementing these initiatives is better service to our customers enabling them to choose when and where to conduct business with USDA. The Role of Regulations The programs of USDA are diverse and far reaching, as are the regulations that attend their delivery. Regulations codify how USDA will conduct its business, including the specifics of access to, and eligibility for, USDA programs. Regulations also specify the responsibilities of State and local governments, private industry, businesses, and individuals that are necessary to comply with their provisions. The diversity in purpose and outreach of USDA programs contributes significantly to USDA being near the top of the list of departments that produce the largest number of regulations annually. These regulations range from nutrition standards for the school lunch program, to natural resource and environmental measures governing national forest usage and soil conservation, to emergency producer assistance as a result of natural disasters, to regulations protecting American agribusiness (a major dollar value contributor to exports) from the ravages of domestic or foreign plant or animal pestilence, and they extend from farm to supermarket to ensure the safety, quality, and availability of the Nation's food supply. Many regulations function in a dynamic environment, which requires their periodic modification. The factors determining various entitlement, eligibility, and administrative criteria often change from year to year. Therefore, many significant regulations must be revised annually to reflect changes in economic and market benchmarks. Almost all legislation that affects USDA programs has accompanying regulatory needs, often with a significant impact resulting in the modification, addition, or deletion of many programs. In 2008, USDA anticipates implementing a new Farm Bill through regulations on major programs covering domestic commodity support, crop insurance, conservation, export and foreign food assistance, bioenergy, rural development, agricultural research, and food and nutrition programs. Major Regulatory Priorities This document represents summary information on prospective significant regulations as called for in Executive Order 12866. The following agencies are represented in this regulatory plan, [[Page 69756]] along with a summary of their mission and key regulatory priorities for 2008: Food and Nutrition Service Mission: The Food and Nutrition Service (FNS) increases food security and reduces hunger in partnership with cooperating organizations by providing children and low-income people access to food, a healthful diet, and nutrition education in a manner that supports American agriculture and inspires public confidence. Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS's 2007 regulatory plan supports USDA's Strategic Goal 5, ``Improve the Nation's Nutrition and Health,'' and its three related objectives: Improve Access to Nutritious Food. This objective represents FNS's efforts to improve nutrition by providing access to program benefits (Food Stamps, WIC food vouchers and nutrition services, school meals, commodities) and distributing State administrative funds to support program operations. To advance this objective, FNS plans to finalize rules implementing provisions of the Farm Security and Rural Investment Act of 2002 (P.L. 107-171) to simplify program administration, support work, and improve access to benefits in the Food Stamp Program (FSP). The Agency will also issue rules implementing provisions of the Child Nutrition and WIC Reauthorization Act of 2004 (P.L. 108-265) to establish automatic eligibility for homeless children for school meals. Promote Healthier Eating Habits and Lifestyles. This objective represents FNS's efforts to improve nutrition knowledge and behavior through nutrition education and breastfeeding promotion, and to ensure that program benefits meet the appropriate nutrition standards to effectively improve nutrition for program participants. In support of this objective, FNS plans to propose regulations updating nutrition standards in the school meals programs, and finalize a rule revising requirements that allow schools to substitute nutritionally-equivalent non-dairy beverages for fluid milk at the request of a recipient's parent in addition to medical care providers. FNS will also publish an interim final rule making improvements in food packages in the WIC program to reflect current dietary guidance, based on recommendations made by an Institute of Medicine expert panel. Improve Nutrition Assistance Program Management and Customer Service. This objective represents FNS's ongoing commitment to maximize the accuracy of benefits issued, maximize the efficiency and effectiveness of program operations, and minimize participant and vendor fraud. In support of this objective, FNS plans to finalize rules in the Child and Adult Care Food Program (CACFP) and the Special Supplemental Nutrition Program for Women, Infants and Children Program (WIC) to improve program management and prevent vendor fraud, as well as finalize rules in the FSP to improve the Quality Control process. Food Safety and Inspection Service Mission: The Food Safety and Inspection Service (FSIS) is responsible for ensuring that meat, poultry, and egg products in commerce are wholesome, not adulterated, and properly marked, labeled, and packaged. Priorities: FSIS is committed to developing and issuing science-based regulations intended to ensure that meat, poultry, and egg products are wholesome and not adulterated or misbranded. FSIS continues to review its existing authorities and regulations to streamline excessively prescriptive regulations, to revise or remove regulations that are inconsistent with the Agency's hazard analysis and critical control point regulations, and to ensure that it can address emerging food safety challenges. FSIS is also working with the Food and Drug Administration (FDA) to better delineate the two agencies' jurisdictions over various food products. In February 2001, FSIS proposed a rule to establish food safety performance standards for all processed ready-to-eat (RTE) meat and poultry products and for partially heat-treated meat and poultry products that are not ready-to-eat. The proposal also contained provisions addressing post-lethality contamination of RTE products with Listeria monocytogenes. In June 2003, FSIS published an interim final rule requiring establishments to prevent Listeria monocytogenes contamination of RTE products. The Agency is evaluating the effectiveness of this interim final rule, which in 2004 was the subject of a regulatory reform nomination to OMB. FSIS has carefully reviewed its economic analysis of the interim final rule in response to this recommendation and is planning to adjust provisions of the rule to reduce the information collection burden on small businesses. FSIS also is planning further action with respect to other elements of the 2001 proposal, based on quantitative risk assessments of target pathogens in processed products. FSIS plans to amend the poultry products inspection regulations to provide for a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. Although this new system would be available initially only to young chicken slaughter, FSIS anticipates that this proposed rule would provide the framework for action to provide public health-based inspection in all establishments that slaughter amenable poultry species. This proposed rule will be designed based on some data from the HACCP-based Inspection Models (HIMP) pilot and will reflect FSIS' and establishments' experience under HIMP, which began in 1997. The proposed rule will also reflect information FSIS has gathered at public meetings on risk-based inspection for processing and slaughter this past year. In the same regulations that propose to establish a public-health based poultry products inspection system, FSIS intends to replace, with a performance standard, the requirement for ready-to-cook poultry products to be chilled to 40 [deg]F or below within certain time limits according to the weight of the dressed carcasses. Under the performance standard, poultry establishments would have to carry out slaughtering, dressing, and chilling operations in a manner that ensures no significant growth of pathogens, as demonstrated by control of the pathogens or indicator organisms. The existing time/temperature chilling regulations would remain available for use by establishments as a ``safe harbor'' for compliance with the new standard. FSIS proposed on March 7, 2006, to amend the Federal meat and poultry product inspection regulations to provide that the Agency would make available to individual consumers lists of the retail consignees of meat and poultry products that a federally inspected meat or poultry products establishment has voluntarily recalled. FSIS believes this action will improve public health by making available more information on where recalled products were sold. With this information, consumers will be more likely to identify and dispose of the products or return them to the stores that sold them. FSIS is collaborating with the FDA in an effort to rationalize the division of food protection responsibilities between the two agencies and eliminate [[Page 69757]] confusion over which agency has jurisdiction over which kinds of products. The agencies are taking an approach that involves considering how the meat or poultry ingredients contribute to the characteristics and basic identity of food products. Thus, FSIS plans to propose amending its regulations to exclude from its jurisdiction cheese and cheese products prepared with less than 50 percent meat or poultry; breads, rolls, and buns prepared with less than 50 percent meat or poultry; dried poultry soup mixes; flavor bases and reaction/process flavors; pizza with meat or poultry; and salad dressings prepared with less than 50 percent meat or poultry from the requirements. FSIS also plans to clarify that bagel dogs, natural casings, and close-faced meat or poultry sandwiches are subject to the requirements of the Federal Meat Inspection Act and the Poultry Products Inspection Act. FSIS also is planning to propose requirements for federally inspected egg product plants to develop and implement HACCP systems and sanitation standard operating procedures. The Agency will be proposing pathogen reduction performance standards for egg products. Further, the Agency will be proposing to remove requirements for FSIS approval of egg-product plant drawings, specifications, and equipment before their use, and to end the system for pre-marketing approval of labeling for egg products. Small business implications. The great majority of businesses regulated by FSIS are small businesses. With the possible exception of the planned poultry inspection system regulations, the regulations listed above substantially affect small businesses. FSIS recognizes the difficulties faced by many small and very small establishments in complying with necessary, science-based food-safety or other consumer protection requirements and in assuming the associated technical and financial burdens. FSIS attempts to reduce the burdens of its regulations on small business by providing alternative dates of compliance, furnishing detailed compliance guidance material, and conducting outreach programs to small and very small establishments. FSIS conducts a small business outreach program that provides critical training, access to food safety experts, and information resources (such as compliance guidance and questions and answers on various topics) in forms that are uniform, easily comprehended, and consistent. The Agency collaborates in this effort with other USDA agencies and cooperating State partners. For example, FSIS makes plant owners and operators aware of loan programs, available through USDA's Rural Business and Cooperative programs, to help them in upgrading their facilities. FSIS employees meet proactively with small and very small plant operators to learn more about their specific needs and provide joint training sessions for small and very small plants and FSIS employees. Animal and Plant Health Inspection Service Mission: A major part of the mission of the Animal and Plant Health Inspection Service (APHIS) is to protect the health and value of American agricultural and natural resources. APHIS conducts programs to prevent the introduction of exotic pests and diseases into the United States and conducts surveillance, monitoring, control, and eradication programs for pests and diseases in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health. APHIS also conducts programs to ensure the humane handling, care, treatment, and transportation of animals under the Animal Welfare Act. Priorities: APHIS is continuing work that will result in a revision of its regulations concerning the introduction of organisms and products altered or produced through genetic engineering. This work consists of two parts. The first is to amend the existing plant-related regulations to reflect new consolidated authorities under the Plant Protection Act. The second is to begin with an advance notice of proposed rulemaking to consider regulatory approaches for transgenic animals. These regulatory changes are needed to ensure that USDA regulations for plant and animal health keep pace with advances in technology. APHIS also plans to propose changes to the regulations for importing nursery stock that will enhance our ability to protect plant health. The Agency also plans to propose changes to its regulations concerning bovine spongiform encephalopathy (BSE) to provide a more comprehensive framework for the importation of certain animals and products. With regard to animal welfare, APHIS plans to propose standards for the humane handling, care, treatment, and transportation of birds covered under the Animal Welfare Act. Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agricultural Marketing Service Mission: The Agricultural Marketing Service (AMS) provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. The AMS also manages the Government's food purchases, supervises food quality grading, maintains food quality standards, and supervises the Federal research and promotion programs. Priorities: AMS would continue work in several areas. The July 3, 2007, interim final rule establishing a Dairy Product Mandatory Reporting Program requires dairy product manufacturers to report to the National Agricultural Statistics Service (NASS) information on price, quantity, and moisture content of products sold. Information must also be reported about the amount of dairy product stored, per statute. AMS has implemented a program to audit information reported to NASS. Provisions of the interim final rule will expire 12 months from the date of publication unless further regulatory action is taken; AMS intends to finalize the rule. Under the August 8, 2007, proposed rule to implement the Livestock Mandatory Reporting Act, AMS would collect information about the marketing of cattle, swine, lambs, and related products. AMS intends to finalize the rule. By statute, country of origin labeling requirements will apply to all covered commodities on September 30, 2008. Covered commodities include beef, lamb and pork, fish and shellfish, perishable agricultural commodities, and peanuts. The intent of this law is to provide consumers with additional information on which to base their purchasing decisions. AMS intends to finalize rulemaking to meet the statutory deadline. AMS Program Rulemaking Pages: All of AMS's rules, published in the Federal Register, are available on the Internet at http:// www.regulations.gov. This site also includes commenting instructions and addresses, links to news releases and background material, and comments received on various rules. Rural Development Mission: Rural Development's mission is to support increased economic opportunities and improved quality of life in rural America. This support is provided through loan, grant and technical assistance for rural housing, [[Page 69758]] community facilities, business and industry, and electric and telecommunication facilities. Priorities: Current priorities include strengthening the regulations for the rural broadband access program to address infrastructure and services deployment issues. Another priority is to consolidate and streamline regulations relating to enhancing delivery of loan guarantees through a unified regulation on common provisions. Forest Service Mission: The mission of the Forest Service is to sustain the health, productivity, and diversity of the Nation's forests and rangelands to meet the needs of present and future generations. This includes protecting and managing National Forest System lands; providing technical and financial assistance to States, communities, and private forest landowners; and developing and providing scientific and technical assistance and scientific exchanges in support of international forest and range conservation. Priorities: The Forest Service's priorities for fall 2007 are to publish a proposed regulation to a proposed rule for National Forest System land management planning, and then adopting a final rule at 36 CFR 219, subpart A. This rulemaking is the result of a U.S. district court order dated March 30, 2007, which enjoined the United States Department of Agriculture from implementation and utilization of the land management planning rule published in 2005 (70 FR1023) until it complies with the court's order regarding the National Environmental Policy Act, the Endangered Species Act, and the Administrative Procedure Act (Citizens for Better Forestry et al. v. USDA, C.A. C05- 1144 (N. D. Cal.)). On January 12, 2001, the Department of Agriculture promulgated the Roadless Area Conservation Rule (RACR) to provide for the conservation and management of approximately 58.5 million acres of inventoried roadless areas within the National Forest System under the principles of the Multiple-Use Sustained-Yield Act of 1960. On July 14, 2003, the U.S. District Court for the District of Wyoming found the 2001 roadless rule to be unlawful and ordered that the rule be permanently enjoined. The State of Idaho and the State of Colorado have petitioned the Secretary pursuant to 5 U.S.C. -553(e) and 7 C.F.R. -1.28 for state- specific rules to replace this national rule in their respective States. The Forest Service is proposing to move existing agency NEPA procedures, required by the Council on Environmental Quality (CEQ) and codified at 40 CFR 1507.3, from the internal Forest Service Environmental Policy and Procedures Handbook (FSH) 1909.15 to the Code of Federal Regulations (CFR) at 36 CFR part 220. New procedures would be added and existing procedures would be revised where clarity is needed to incorporate CEQ guidance and align agency NEPA procedures with agency decision processes. Office of the Chief Economist Mission: The mission of the Office of the Chief Economist (OCE) is to advise the Secretary of Agriculture on the economic implications of USDA policies, programs, and proposed legislation; to ensure the public has consistent, objective, and reliable agricultural forecasts; and to promote effective and efficient rules governing USDA programs. Priorities: The regulatory priority for OCE is to continue implementing the BioPreferred Program (formerly the Federal Biobased Product Preferred Procurement Program) authorized under section 9002 of the 2002 Farm Bill (Public Law 107-171). Included in this priority are proposed and final regulations designating items for preferred Federal procurement. These regulations will assist in the expansion of market opportunities for manufacturers of biobased products, resulting in economic opportunities for American agricultural producers and rural communities. These efforts support USDA's strategic goal ``To enhance the competitiveness and sustainability of rural and farm economies.'' In addition, OCE will look to begin implementation of the BioPreferred labeling program. Once implemented, this program will allow biobased manufacturers to receive a label to be used in the commercial market to distinguish their products as biobased. Aggregate Costs and Benefits Per the amendments to E.O. 12866, we are providing an aggregate estimate of costs and benefits of final regulations included in the Regulatory Plan that will be made effective in calendar year 2008. However, any aggregate estimate of total costs and benefits must be highly qualified. Problems with aggregation arise due to differing baselines, data gaps, and inconsistencies in methodology and the type of regulatory costs and benefits considered. In addition, aggregation omits benefits and costs that cannot be reliably quantified, such as improved health resulting from increased access to more nutritious foods and higher levels of food safety and increased quality of life derived from investments in rural infrastructure. Some benefits and costs associated with rules listed in the Regulatory Plan cannot currently be quantified as the rules are still being formulated. With these caveats noted, USDA anticipates aggregate annual monetized benefits to range from $1.1 billion to $1.5 billion. Aggregate annual monetized costs are anticipated to be approximately $0.5 billion. _______________________________________________________________________ USDA--Agricultural Marketing Service (AMS) ----------- PRERULE STAGE ----------- 1. NATIONAL ORGANIC PROGRAM: ADD STANDARDS FOR THE ORGANIC CERTIFICATION OF WILD CAPTURED AQUATIC ANIMALS (TM-01-08) Priority: Other Significant Legal Authority: 7 USC 6501 through 6522 CFR Citation: 7 CFR 205 Legal Deadline: None Abstract: The Agricultural Marketing Service (AMS) is revising regulations pertaining to labeling of agricultural products as organically produced and handled (7 CFR part 205). The term ``aquatic animal'' will be incorporated in the definition of livestock to establish production and handling standards for operations that capture aquatic animals from the wild. Production standards for operations producing aquatic animals will incorporate requirements for livestock origin, feed ration, health care, living conditions, and recordkeeping. Handling standards for such operations will address prevention of commingling of organically produced commodities and prevention of contact between organically produced and prohibited substances. Statement of Need: This amendment to the National Organic Program is intended to [[Page 69759]] facilitate interstate commerce and marketing of fresh and processed aquatic animals that are organically produced and to assure consumers that such products meet consistent, uniform standards. Also, this amendment will establish national standards for the production and handling of organically produced aquatic animals and products, including a national list of substances approved and prohibited for use in organic production and handling. Summary of Legal Basis: This amendment is proposed under the Organic Foods Production Act of 1990 (OFPA). OFPA includes fish for food in its definition of livestock. Additionally, on April 12, 2003, Congress amended OFPA section 2107 (7 U.S.C. 6506) to authorize certification of wild seafood. Alternatives: AMS is fulfilling a congressional mandate to proceed with rulemaking for the establishment of national standards for the organic production and handling of aquatic animals. Other options are to do nothing or to propose regulations prohibiting the labeling of aquatic animals as organically produced. Neither alternative is viable inasmuch as Congress has amended OFPA to authorize certification of wild seafood. Anticipated Costs and Benefits: Potential benefits to consumers include more information on organic aquatic animals and protection from false and misleading organic claims. This proposal will address the problem of existing certifying agents using different standards. This proposal will also resolve the issue of whether aquatic animals can be labeled as organically produced. The costs of this proposed regulation are the direct costs to comply with the specific standards. USDA-accredited certifying agents potentially will incur additional costs of accreditation should they opt to certify producers and handlers of aquatic animals. New applicants for accreditation to certify producers and handlers of aquatic animals under the National Organic Program will incur fees for accreditation. Producers and handlers of organically produced and handled aquatic animals will incur costs for certification levied by USDA-accredited certifying agents. USDA would not levy any fees on the certified operations. Producers and handlers will face numerous provisions that will regulate their production and handling methods. Retailers would not be directly regulated but would be subject to the same requirements for organic animals and products as they are currently for other foods under the NOP. AMS believes this action will have a minimal impact on retailers. Certified handlers will have to comply with requirements regarding the approved use of labels. The USDA, States operating State programs, and certifying agents will incur costs for enforcement of these new organic standards. Certifying agents, producers, and handlers would incur costs for reporting and recordkeeping. Certifying agents will be required to file reports and documents with the USDA and to maintain records regarding their accreditation and the certification of their clients. Certified operations will be required to develop and annually update an organic system plan and to maintain records regarding their certification and the administration of their operation. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 08/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Mark A. Bradley Associate Deputy Administrator, National Organic Program Department of Agriculture Agricultural Marketing Service Room 4008, South Building 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-3252 Fax: 202 205-7808 Email: mark.bradley@usda.gov RIN: 0581-AB97 _______________________________________________________________________ USDA--AMS ----------- FINAL RULE STAGE ----------- 2. MANDATORY COUNTRY OF ORIGIN LABELING OF BEEF, PORK, LAMB, FISH, PERISHABLE AGRICULTURAL COMMODITIES, AND PEANUTS (LS-03-04) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 7 USC 1621 through 1627, Agricultural Marketing Act of 1946 CFR Citation: 7 CFR 60 Legal Deadline: Final, Statutory, September 30, 2008. Abstract: The Farm Security and Rural Investment Act of 2002 (Farm Bill) (Pub. L. 107-171) and the 2002 Supplemental Appropriations Act (2002 Appropriations) (Pub. L. 107-206) amended the Agricultural Marketing Act of 1946 (Act) (7 U.S.C. 1621 et seq.) to require retailers to notify their customers of the country of origin of covered commodities beginning September 30, 2004. Covered commodities include muscle cuts of beef (including veal), lamb, and pork; ground beef, ground lamb, and ground pork; farm-raised fish and shellfish; wild fish and shellfish; perishable agricultural commodities; and peanuts. The FY 2004 Consolidated Appropriations bill (2004 Appropriations) (Pub. L. 108- 199) delayed implementation of mandatory Country of Origin Labeling (COOL) for all covered commodities except wild and farm-raised fish and shellfish until September 30, 2006. The FY 2006 Agriculture Appropriations Bill further delayed the implementation date for other covered commodities until September 30, 2008. Statement of Need: Under current Federal laws and regulations, country of origin labeling is not universally required for the covered commodities. In particular, labeling of U.S. origin is not mandatory, and labeling of imported products at the consumer level is required only in certain circumstances. This intent of the law is to provide consumers with additional information [[Page 69760]] on which to base their purchasing decisions. Summary of Legal Basis: Section 10816 of Public Law 107-171 amended the Agricultural Marketing Act of 1946 to require retailers to inform consumers of the country of origin for covered commodities beginning September 30, 2004. The 2004 Appropriations delayed the implementation of mandatory COOL for all covered commodities except wild and farm-raised fish and shellfish until September 30, 2006. The FY 2006 Agriculture Appropriations Bill further delayed the implementation date for the other covered commodities until September 30, 2008. Alternatives: The October 30, 2004, proposed rule specifically invited comment on several alternatives including alternative definitions for ``processed food item,'' alternative labeling of mixed origin, and alternatives to using ``slaughtered'' on the label. In addition, the October 5, 2004, interim final rule contained an impact analysis which included an analysis of alternative approaches. The interim final rule also invited comment on several key issues including the definition of a processed food item. Anticipated Costs and Benefits: USDA has examined the economic impact of the rule as required by Executive Order 12866. The estimated benefits associated with this rule are likely to be small. The estimated 1st-year incremental cost for directly affected firms are estimated at $89 million for fish and shellfish only. The estimated cost to the U.S. economy in terms of reduced purchasing power resulting from a loss in productivity after a 10-year period of adjustment are estimated at $6.2 million. A final cost benefit assessment for the other covered commodities will be completed in the final rule. Risks: AMS has not identified any risks at this time. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 10/30/03 68 FR 61944 NPRM Comment Period End 12/29/03 Interim Final Rule 10/05/04 69 FR 59708 Interim Final Rule Comment Period End 01/03/05 Interim Final Rule Effective 04/04/05 Comment Period Extended 11/27/06 71 FR 68431 Comment Period End 02/26/07 Comment Period Extended 06/20/07 72 FR 33851 Comment Period End 08/20/07 Final Action 09/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Additional Information: The U.S. Department of Agriculture issued an interim final rule with request for comments for the labeling of fish and shellfish covered commodities that became effective on April 4, 2005. A final regulatory action for all covered commodities will be issued by September 30, 2008. Agency Contact: Martin O'Connor Chief Department of Agriculture Agricultural Marketing Service 14th & Independence Avenue, SW Washington, DC 20250-6456 Phone: 202 720-4486 Fax: 202 690-4119 Email: cool@usda.gov RIN: 0581-AC26 _______________________________________________________________________ USDA--AMS 3. MANDATORY REPORTING FOR DAIRY PROGRAMS (DA-06-07) Priority: Other Significant Legal Authority: PL 106-532 CFR Citation: 7 USC 1621 through 1677 Legal Deadline: None Abstract: The Agricultural Marketing Service is proposing to establish a Dairy Product Mandatory Reporting Program. The program would: (1) Require persons engaged in manufacturing dairy products to provide the Department of Agriculture certain information including price, quantity, and moisture content of dairy products sold by the manufacturer and (2) require manufacturers and other persons storing dairy products to report to USDA information on the quantity of dairy products stored. Statement of Need: The Department and industry must be confident in the accuracy of dairy product prices and inventories that are reported to the Department. This is especially so, given that the information collected on manufactured dairy products is used by the Secretary to establish minimum prices for Class III and Class IV milk under Federal milk marketing orders. As mandated by the Dairy Market Enhancement Act of 2000 and the Farm Security and Rural Investment Act of 2002, this rule establishes the Dairy Product Mandatory Reporting Program (DMRP). Implementation of this program will result in timely, accurate, and reliable market information to facilitate more informed marketing decisions. Summary of Legal Basis: This program is mandated by the Agricultural Marketing Act of 1946 as amended by the Dairy Market Enhancement Act of 2000 and the Farm Security and Rural Investment Act of 2002. Alternatives: The Agricultural Marketing Service is fulfilling a congressional mandate to proceed with rulemaking to establish the DMRP and to implement a plan to verify the price information submitted by various dairy product manufacturing plants. Several alternatives to this program were initially identified, but were not considered due to the specific language contained in the Dairy Market Enhancement Act of 2000. These alternatives included: (1) the use of non-mandatory surveys, (2) the use of alternative data sources such as the Chicago Mercantile Exchange, and (3) collecting data less frequently. Anticipated Costs and Benefits: Impact on Dairy Farmers It is in the industry's best interest that NASS-reported prices be as accurate as possible for calculating milk prices. Although dairy farmers under the Federal milk marketing order program account for 61 percent (approximately 103 billion pounds of milk in 2004) of U.S. milk production, all U.S. dairy [[Page 69761]] farmers are affected to some degree by the Federal order pricing. Imprecise price information can be costly. For example, a 1 cent per pound error in the May 2005 cheese price would cause a 9.65 cent per hundredweight error in the Class III price and a 3.76 cent per hundredweight error in the all market uniform or blend price (price paid to dairy farmers). Multiplying the price error (3.76 cents) times the quantity of milk marketed in Federal milk marketing order system indicates that either producers would have received $4 million less for their milk in the month of May 2005, than they did, or that manufacturers would have paid $4 million more for milk in May 2005, than they did. Impact on Dairy Manufacturers The cost to the dairy manufacturers and cold storage facilities of completing the survey is assumed to be comparable to the hourly rate of those collecting the data. Manufacturers must submit products prices 52 times a year and it is estimated that each report takes 20 minutes to complete. Cold storage facilities must report their inventories 12 times a year and it is estimated that each report takes 30 minutes to complete. The salary for employees completing the survey is estimated at $22 per hour. Therefore, the annual cost to a manufacturer reporting product prices is estimated at $381.26 and the annual cost to cold storage facilities completing reports is $132. Most manufacturers subject to reporting under the Dairy Product Mandatory Reporting Program already report this information to NASS. Therefore, the incremental cost of implementing the program will be for those manufacturers who do not already report to NASS. When the mandatory reporting program is implemented an additional 25 manufacturing plants will be required to submit product price reports. Therefore, the incremental cost to the industry of implementing the mandatory pricing program is estimated to be $9,531.50. It is estimated that 110 cold storage facilities meet the mandatory reporting requirements. Thus, the annual total incremental cost to cold storage facilities is estimated to be $14,520. The total incremental cost borne by dairy manufacturers and warehouses is approximately $24,000. With respect to total annual costs, the costs to cold storage facilities completing reports is $132 per facility for a total annual cost of $14,520. The cost to manufacturers reporting product prices is estimated at $381.26 per plant for a total annual cost of $37,363. Thus, the total annual cost for submitting information under the mandatory program is $51,883.48. Impact on Government Costs Background: In 2005, NASS collected prices information from 98 plants that were submitted on 71 reports from 60 unique locations. Reports generally are filed via fax with the appropriate State NASS office. Some reports are sent via fax directly to the NASS headquarters office in Washington, DC. Some reports are filed via NASS' electronic data reporting (EDR) system. In all cases, the reports are keyed into NASS' Dairy Product Prices (DPP) system (a SAS) database. The headquarters NASS staffer who is responsible for the published report, queries the DPP to generate various reports. Among these reports is the data listing which has individual report information. For the AMS prices verification program, NASS will generate a report from the data listing matching AMS' requirements. Assumptions for Incremental Cost Estimates: As stated in the preliminary cost-benefit analysis, for the first year of all of the 60 reporting entities will be visited and the information contained in each of the 71 reports will be verified for a specific review period. Sales transaction records for all of the 98 plants will be analyzed. The review period will be four weeks in the same month, with the selected month varying according to the Verification Plan. It will take 4 hours to analyze the sales transactions for one week; two full days per plant. The hourly salary for the verifier is $40 with a 30-percent benefits rate. The travel cost per location is $100; per diem cost is $75. In the subsequent years, those reporting locations that account for top 80 percent of the reported volume will be visited each year, as well as one-third of the reporting locations that account for the remaining 20 percent of reported volume. Reporting locations in the latter category will be visited at least once every three years. The other assumptions concerning review period, length of time to analyze records, and cost figures apply the same as for the first year. First Year Incremental Cost Estimate: $102,236 Travel -- $6,000 (60 locations X $100) Per Diem -- $14,700 (98 plants X 2 days X $75/day) Salary/Benefits -- $81,536 (98 plants X 16 hours (2 days) X $52/hour) Second & Subsequent Years Incremental Cost Estimate: $69,594 Travel -- $3,800 (38 locations X $100) Per Diem -- $10,050 (67 plants X 16 hours (2 days) X $52/hour) Salary/Benefits -- $55,744 (67 plants X16 hours (2 days) X $52/hour) Benefits. The major benefit of mandatory price reporting is to assure accurate price reporting by dairy manufacturers. The total incremental cost of implementing the program is estimated to be $126,287.50 in the first year and $93,645.50 in subsequent years. The incremental benefit of the program cannot be quantified; therefore, net benefits cannot be quantified. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 07/03/07 72 FR 36341 Interim Final Rule Effective 08/02/07 Final Action 06/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: John Mengel Chief Economist Department of Agriculture Agricultural Marketing Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-4664 Email: john.mengel@usda.gov RIN: 0581-AC66 _______________________________________________________________________ USDA--AMS 4. LIVESTOCK MANDATORY REPORTING: REVISE REPORTING REGULATION FOR SWINE, CATTLE, LAMB, AND BOXED BEEF (LS-07-01) Priority: Other Significant Legal Authority: 7 USC 1621 CFR Citation: 7 CFR 59 [[Page 69762]] Legal Deadline: None Abstract: This rule is necessary to re-establish the regulatory authority for the Livestock Mandatory Reporting Program's continued operation and to implement the changes to the swine reporting provision made to the Act, as well as other changes to enhance the program's overall operation and efficiency based on AMS' experience in the administration of the program over the last 5 years. Statement of Need: This rulemaking is necessary to re-establish the regulatory authority for the program's continued operation and incorporate the swine reporting changes contained within the Reauthorization Act as well as make other changes to enhance the program's overall effectiveness and efficiency based on AMS' experience in the administration of the program over the last 6-years. Summary of Legal Basis: On April 2, 2001, the Agricultural Marketing Service (AMS) implemented the Livestock Mandatory Reporting (LMR) program as required by the Livestock Mandatory Reporting Act of 1999 (1999 Act). The statutory authority for the program lapsed on September 30, 2005. In October 2006, legislation was enacted to reauthorize the 1999 Act until September 30, 2010, and to amend the swine reporting requirements of the 1999 Act (Pub. Law 109-296) (Reauthorization Act.) Alternatives: AMS is fulfilling a Congressional mandate to proceed with rulemaking to reestablish and revise the mandatory reporting regulation for swine, cattle, lamb, and boxed beef. Other options are to do nothing or to propose regulations for voluntary reporting of market information for swine, cattle, lamb, and boxed beef. Neither alternative is viable given that the Livestock Mandatory Reporting Act was reauthorized to require mandatory reporting of market information by certain livestock processing plants and directs the USDA to promulgate regulations to implement the law. Anticipated Costs and Benefits: The proposed rule facilitates open, transparent price discovery and provides all market participants, both large and small, with comparable levels of market information. The proposed rule is expected to reduce the time and resources that market participants would otherwise expend to assess current market conditions and reduce risk and uncertainty. This proposed rule is strictly an informational measure and does not impose any restrictions on the form, timing, or location of procurement and sales arrangements in which subject packers and importers may engage. Therefore, costs of the proposed rule are simply the costs associated with the system development and maintenance, data submission, and recordkeeping activities of the packers and importers required to report information under this proposed rule, plus costs to the Federal Government for operation of the program. However, most of the entities that would be required to report under this proposed rule already reported information prior to expiration of the 1999 Act on September 30, 2005, and have since continued to do so voluntarily. As a result, incremental costs for implementation of this proposed rule are negligible relative to total costs associated with the program. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/08/07 72 FR 44672 NPRM Comment Period End 09/07/07 Final Action 05/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Warren Preston Department of Agriculture Agricultural Marketing Service 14th & Independence Ave., S.W. Washington, DC 20250 Phone: 202-720-6231 Fax: 202 690-3732 Email: warren.preston@usda.gov RIN: 0581-AC67 _______________________________________________________________________ USDA--Animal and Plant Health Inspection Service (APHIS) ----------- PRERULE STAGE ----------- 5. REGULATION OF GENETICALLY ENGINEERED ANIMALS Priority: Other Significant Legal Authority: 7 USC 8301 to 8317 CFR Citation: Not Yet Determined Legal Deadline: None Abstract: APHIS is considering the need to regulate the movement (which includes importation, containment, and field release) of genetically engineered animals to ensure that the genetically engineered traits do not present a health risk to livestock. Biotechnology research and development have resulted in genetically engineered animals and animal products that are ready for commercialization. Although these applications may provide significant agricultural, human/animal health, and societal benefits, there are also potential risks, concerns, and environmental impacts associated with the technology that may require Federal oversight. Statement of Need: APHIS currently regulates the introduction (movement into the United States or interstate, or release into the environment) of genetically engineered organisms that may present a plant pest risk under 7 CFR part 340, ``Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests.'' In consultation with other Federal agencies, APHIS is beginning to develop a regulatory framework for transgenic animals and other organisms to address animal health issues such as pest and disease risks to livestock. Biotechnology research and development have resulted in genetically-engineered (GE) animals and animal products that are ready for commercialization. Although these applications may provide significant agricultural, human/animal health and societal benefits, there are also [[Page 69763]] potential risks, concerns, and environmental impacts associated with the technology that requires Federal oversight. Summary of Legal Basis: The primary authority is provided by the Animal Health Protection Act, which authorizes the Secretary of Agriculture to prohibit or restrict the importation, entry, and interstate movement of any article if necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock. Such articles may include genetically engineered products. Alternatives: To be identified. Anticipated Costs and Benefits: To be determined. Risks: Animals and other organisms may be genetically engineered to exhibit a trait that could present an animal health risk. The purpose of this rulemaking is to address animal health risks, such as disease and pest risks to livestock, that may be presented by these organisms. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 01/00/08 ANPRM Comment Period End 03/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: John Turner Director, Policy Coordination Division, BRS Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 146 Riverdale, MD 20737-1236 Phone: 301 734-5720 RIN: 0579-AC37 _______________________________________________________________________ USDA--APHIS ----------- PROPOSED RULE STAGE ----------- 6. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS Priority: Other Significant Legal Authority: 7 USC 2131 to 2159 CFR Citation: 9 CFR 1 to 3 Legal Deadline: None Abstract: APHIS intends to establish standards for the humane handling, care, treatment, and transportation of birds other than birds bred for use in research. Statement of Need: The Farm Security and Rural Investment Act of 2002 amended the definition of animal in the Animal Welfare Act (AWA) by specifically excluding birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research. While the definition of animal in the regulations contained in 9 CFR part 1 has excluded rats of the genus Rattus and mice of the genus Mus bred for use in research, that definition has also excluded all birds (i.e., not just those birds bred for use in research). In line with this change to the definition of animal in the AWA, APHIS intends to establish standards in 9 CFR part 3 for the humane handling, care, treatment, and transportation of birds other than those birds bred for use in research. Summary of Legal Basis: The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to promulgate standards and other requirements governing the humane handling, care, treatment, and transportation of certain animals by dealers, research facilities, exhibitors, operators of auction sales, and carriers and immediate handlers. Animals covered by the AWA include birds that are not bred for use in research. Alternatives: To be identified. Anticipated Costs and Benefits: To be determined. Risks: Not applicable. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/00/08 NPRM Comment Period End 06/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Darrel Styles Veterinary Medical Officer, Animal Care Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 84 Riverdale, MD 20737-1234 Phone: 301 734-0658 RIN: 0579-AC02 _______________________________________________________________________ USDA--APHIS 7. IMPORTATION OF PLANTS FOR PLANTING; ESTABLISHING A NEW CATEGORY OF PLANTS FOR PLANTING NOT AUTHORIZED FOR IMPORTATION PENDING RISK ASSESSMENT (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 21 USC 136 and 136a CFR Citation: 7 CFR 319 Legal Deadline: None Abstract: This action would establish a new category in the regulations governing the importation of nursery stock, also known as plants for planting. This category would list taxa of plants for planting whose importation is not authorized pending risk assessment. We [[Page 69764]] would allow foreign governments to request that a pest risk assessment be conducted for a taxon whose importation is not authorized pending risk evaluation. After the pest risk assessment was completed, we would conduct rulemaking to remove the taxon from the proposed category if determined appropriate by the risk assessment. We are also proposing to expand the scope of the plants regulated in the plants for planting regulations to include non-vascular plants. These changes would allow us to react more quickly to evidence that a taxon of plants for planting may pose a pest risk while ensuring that our actions are based on scientific evidence. Statement of Need: APHIS typically relies on inspection at a Federal plant inspection station or port of entry to mitigate the risks of pest introduction associated with the importation of plants for planting. Importation of plants for planting is further restricted or prohibited only if there is specific evidence that such importation could introduce a quarantine pest into the United States. Most of the taxa of plants for planting currently being imported have not been thoroughly studied to determine whether their importation presents a risk of introducing a quarantine pest into the United States. The volume and the number of types of plants for planting have increased dramatically in recent years, and there are several problems associated with gathering data on what plants for planting are being imported and on the risks such importation presents. In addition, quarantine pests that enter the United States via the importation of plants for planting pose a particularly high risk of becoming established within the United States. The current regulations need to be amended to better address these risks. Summary of Legal Basis: The Secretary of Agriculture may prohibit or restrict the importation or entry of any plant if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States of a plant pest or noxious weed (7 USC 7712). Alternatives: APHIS has identified one alternative to the approach we are considering. We could prohibit the importation of all nursery stock pending risk evaluation, approval, and notice-and-comment rulemaking, similar to APHIS's approach to regulating imported fruits and vegetables. This approach would lead to a major interruption in international trade and would have significant economic effects on both U.S. importers and U.S. consumers of plants for planting. Anticipated Costs and Benefits: Undetermined. Risks: In the absence of some action to revise the nursery stock regulations to allow us to better address pest risks, increased introductions of plant pests via imported nursery stock are likely, causing extensive damage to both agricultural and natural plant resources. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/00/08 NPRM Comment Period End 08/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: None Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Arnold T. Tschanz Senior Import Specialist, Commodity Import Analysis & Operations, PPQ Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 141 Riverdale, MD 20737-1236 Phone: 301 734-5306 RIN: 0579-AC03 _______________________________________________________________________ USDA--APHIS 8. INTRODUCTION OF ORGANISMS AND PRODUCTS ALTERED OR PRODUCED THROUGH GENETIC ENGINEERING Priority: Other Significant Legal Authority: 7 USC 7701 to 7772; 7 USC 7781 to 7786; 31 USC 9701 CFR Citation: 7 CFR 340 Legal Deadline: None Abstract: APHIS is considering changes to its regulations regarding the importation, interstate movement, and environmental release of genetically engineered organisms. We are seeking public comment on the regulatory alternatives we have identified through scoping and on the draft environmental impact statement (DEIS) we have prepared relative to those alternatives. This notice reflects the Agency's current thinking on policy and program design issues affecting our biotechnology programs. The DEIS evaluates the alternatives we have identified so far in terms of their potential effects on the human environment compared to our current regulatory program. Statement of Need: APHIS currently regulates the introduction (movement into the United States or interstate, or release into the environment) of genetically engineered organisms that may present a plant pest risk under 7 CFR part 340, ``Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests.'' APHIS is evaluating its regulatory program to determine if there is a need to revise its regulations in light of our current knowledge and experience and advances in science and technology. Summary of Legal Basis: The primary authority is provided by the Plant Protection Act, which authorizes the Secretary of Agriculture to prohibit or restrict the importation, entry, and movement in interstate commerce any plant, plant product, biological control organism, noxious weed, or other article if necessary to prevent the introduction into or dissemination within the United States of any plant pest or noxious weed. Such articles may include genetically engineered products. Alternatives: A draft environmental impact statement (DEIS) prepared for this action evaluates all of the regulatory alternatives under consideration by the Agency. Some key alternatives considered include whether APHIS should broaden the scope of the regulations to reflect its authority over noxious weeds and biological control organisms; whether and how to revise [[Page 69765]] the regulations to make the Agency's use of risk-based categories-- where genetically engineered organisms are classified according to risk and familiarity so that oversight and confinement vary by category-- more refined, more explicit and more transparent to the industry and the public and what criteria should be used to establish risk-based categories; how to manage genetically engineered organisms that present only minor unresolved risks that can be mitigated effectively, and what factors should be considered in establishing appropriate mitigations; whether new or additional regulatory mechanisms are needed to ensure that genetically engineered organisms producing pharmaceutical or industrial compounds are subject to requirements and oversight commensurate with the potential risks; for organisms that might be commercialized but that do not meet the criteria for deregulation, whether a new type of permitting system would be more appropriate in terms of efficiency and effectiveness than the current system; whether APHIS should establish a new regulatory approach to address incidents of low-level presence of genetically engineered plant material; whether APHIS should establish a new regulatory mechanism to allow for imports of commodities for nonpropagative use, that is, for food, feed, or processing, in cases where these commodities might not have been deregulated in the United States; and whether to expand its current exemption from interstate movement restrictions additional well- studied, low-risk, genetically engineered research organisms. Anticipated Costs and Benefits: To be determined. Risks: While APHIS has always used a risk-based approach in regulating genetically engineered organisms, there is a trend toward more highly varied organisms. For example, genetic engineering technology has advanced to the point where organisms can be developed that produce novel proteins and other substances with biological activity or industrial utility. We have initiated this rulemaking because APHIS recognizes that the regulatory process may need greater flexibility and rigor to more appropriately regulate the increasing variety of organisms. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice of Intent to Prepare an Environmental Impact Statement 01/23/04 69 FR 3271 Comment Period End 03/23/04 Notice of Availability of Draft Environmental Impact Statement 07/17/07 72 FR 39021 Comment Period End 09/11/07 NPRM 05/00/08 NPRM Comment Period End 07/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Agency Contact: Michael Wach Biotechnology Regulatory Services Department of Agriculture Animal and Plant Health Inspection Service 4700 River Road, Unit 147 Riverdale, MD 20737-1236 Phone: 301 734-0485 RIN: 0579-AC31 _______________________________________________________________________ USDA--Food and Nutrition Service (FNS) ----------- PROPOSED RULE STAGE ----------- 9. NUTRITION STANDARDS IN THE NATIONAL SCHOOL LUNCH AND SCHOOL BREAKFAST PROGRAMS Priority: Other Significant Legal Authority: PL 108-265, sec 103 CFR Citation: 7 CFR 210; 7 CFR 220 Legal Deadline: None Abstract: Public Law 108-265 requires the Secretary to issue regulations that reflect specific recommendations for increased consumption of foods and food ingredients in school nutrition programs based on the most recent Dietary Guidelines for Americans. The current regulations require that reimbursable meals offered by schools meet the applicable recommendations of the Dietary Guidelines for Americans. This proposed rule would revise the regulations on meal patterns and nutrition standards to ensure that school meals reflect the 2005 Dietary Guidelines for Americans. (04-017) Statement of Need: This action is needed to update the NSLP and SBP requirements to promote the consumption of fruits, vegetables, whole grains, and low- fat and fat-free milk consistent with the 2005 Dietary Guidelines for Americans. This action is also needed to update the nutrient and calorie requirements to reflect the Dietary Reference Intakes. Summary of Legal Basis: These changes are being made in response to provisions in Public Law 108-265. Alternatives: FNS considered several options to implement the 2005 Dietary Guidelines in the school meal programs in the most effective and least burdensome manner. Several alternatives were discussed to update the age/grade groups, calorie requirements, and menu planning approaches. Anticipated Costs and Benefits: This proposed rule would allow USDA's school meal programs to deliver wholesome and nutrient-dense meals that reflect the latest nutrition science, as stated in the 2005 Dietary Guidelines for Americans and the Dietary Reference Intakes. Implementation of this proposal would support the Federal government's efforts to reduce the proportion of children and adolescents who are overweight or obese to five percent by the year 2010, which is one of the objectives in the report ``Healthy People 2010''. This proposed rule would not result in an increase in Federal spending. Risks: Failure to update the NSLP and SBP regulations as proposed by this action would jeopardize the ability of these nutrition programs to safeguard the health and well-being of children, as intended by the National School Lunch Act. [[Page 69766]] Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/07 NPRM Comment Period End 03/00/08 Final Action 09/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov RIN: 0584-AD59 _______________________________________________________________________ USDA--FNS ----------- FINAL RULE STAGE ----------- 10. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM INTEGRITY Priority: Other Significant Legal Authority: 42 USC 1766; PL 103-448; PL 104-193; PL 105-336 CFR Citation: 7 CFR 226 Legal Deadline: None Abstract: This rule amends the Child and Adult Care Food Program (CACFP) regulations. The changes in this rule result from the findings of State and Federal program reviews and from audits and investigations conducted by the Office of Inspector General. This rule revises: State agency criteria for approving and renewing institution applications; program training and other operating requirements for child care institutions and facilities; and State and institution-level monitoring requirements. This rule also includes changes that are required by the Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336). The changes are designed to improve program operations and monitoring at the State and institution levels and, where possible, to streamline and simplify program requirements for State agencies and institutions. (95-024) Statement of Need: In recent years, State and Federal program reviews have found numerous cases of mismanagement, abuse, and in some instances, fraud, by child care institutions and facilities in the CACFP. These reviews revealed weaknesses in management controls over program operations and examples of regulatory noncompliance by institutions, including failure to pay facilities or failure to pay them in a timely manner; improper use of program funds for non-program expenditures; and improper meal reimbursements due to incorrect meal counts or to miscategorized or incomplete income eligibility statements. In addition, audits and investigations conducted by the Office of Inspector General (OIG) have raised serious concerns regarding the adequacy of financial and administrative controls in CACFP. Based on its findings, OIG recommended changes to CACFP review requirements and management controls. Summary of Legal Basis: Some of the changes proposed in the rule are discretionary changes being made in response to deficiencies found in program reviews and OIG audits. Other changes codify statutory changes made by the Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336). Alternatives: In developing the proposal, the Agency considered various alternatives to minimize burden on State agencies and institutions while ensuring effective program operation. Key areas in which alternatives were considered include State agency reviews of institutions and sponsoring organization oversight of day care homes. Anticipated Costs and Benefits: This rule contains changes designed to improve management and financial integrity in the CACFP. When implemented, these changes would affect all entities in CACFP, from USDA to participating children and children's households. These changes will primarily affect the procedures used by State agencies in reviewing applications submitted by, and monitoring the performance of, institutions which are participating or wish to participate in the CACFP. Those changes which would affect institutions and facilities will not, in the aggregate, have a significant economic impact. Data on CACFP integrity is limited, despite numerous OIG reports on individual institutions and facilities that have been deficient in CACFP management. While program reviews and OIG reports clearly illustrate that there are weaknesses in parts of the program regulations and that there have been weaknesses in oversight, neither program reviews, OIG reports, nor any other data sources illustrate the prevalence and magnitude of CACFP fraud and abuse. This lack of information precludes USDA from estimating the amount of money lost due to fraud and abuse or the reduction in fraud and abuse the changes in this rule will realize. Risks: Operating under interim rules puts State agencies and institutions at risk of implementing Program provisions subject to change in a final rule. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/12/00 65 FR 55103 NPRM Comment Period End 12/11/00 Interim Final Rule 09/01/04 69 FR 53502 Interim Final Rule Effective 10/01/04 Interim Final Rule Comment Period End 09/01/05 Final Action 03/00/08 [[Page 69767]] Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov RIN: 0584-AC24 _______________________________________________________________________ USDA--FNS 11. FSP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM SECURITY AND RURAL INVESTMENT ACT OF 2002 Priority: Economically Significant. Major under 5 USC 801. Legal Authority: PL 107-171, secs 4101 to 4109, 4114, 4115, and 4401 CFR Citation: 7 CFR 273 Legal Deadline: None Abstract: This rulemaking will amend Food Stamp Program regulations to implement 11 provisions of the Farm Security and Rural Investment Act of 2002 that establish new eligibility and certification requirements for the receipt of food stamps. (02-007) Statement of Need: The rule is needed to implement the food stamp certification and eligibility provisions of Public Law 107-171, the Farm Security and Rural Investment Act of 2002. Summary of Legal Basis: The legal basis for this rule is Public Law 107-171, the Farm Security and Rural Investment Act of 2002. Alternatives: This final rule deals with changes required by Public Law 107-171, the Farm Security and Rural Investment Act of 2002. The Department has limited discretion in implementing provisions of that law. Most of the provisions in this rule were effective October 1, 2002, and must be implemented by State agencies prior to publication of this rule. Anticipated Costs and Benefits: The provisions of this rule simplify State administration of the Food Stamp Program, increase eligibility for the program among certain groups, increase access to the program among low-income families and individuals, and increase benefit levels. The provisions of Public Law 107-171 implemented by this rule have a 5-year cost of approximately $1.9 billion. Risks: The FSP provides nutrition assistance to millions of Americans nationwide--working families, eligible non-citizens, and elderly and disabled individuals. Many low-income families don't earn enough money and many elderly and disabled individuals don't receive enough in retirement or disability benefits to meet all of their expenses and purchase healthy and nutritious meals. The FSP serves a vital role in helping these families and individuals achieve and maintain self- sufficiency and purchase a nutritious diet. This rule implements the certification and eligibility provisions of Public Law 107-171, the Farm Security and Rural Investment Act of 2002. It simplifies State administration of the Food Stamp Program, increases eligibility for the program among certain groups, increases access to the program among low-income families and individuals, and increases benefit levels. The provisions of this rule increase benefits by approximately $1.95 billion over 5 years. When fully effective in FY 2006, the provisions of this rule will add approximately 415,000 new participants. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 04/16/04 69 FR 20724 NPRM Comment Period End 06/15/04 Final Action 04/00/08 Final Action Effective 08/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Federal, Local, State, Tribal Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov RIN: 0584-AD30 _______________________________________________________________________ USDA--FNS 12. QUALITY CONTROL PROVISIONS OF TITLE IV OF PUBLIC LAW 107-171 Priority: Other Significant Legal Authority: 7 USC 2011 to 2032; PL 107-171 CFR Citation: 7 CFR 273; 7 CFR 275 Legal Deadline: None Abstract: This rule finalizes the interim rule ``Non-Discretionary Quality Control Provisions of Title IV of Public Law 107-171'' (published October 16, 2003 at 68 FR 59519) and the proposed rule ``Discretionary Quality Control Provisions of Title IV of Public Law 107-171'' (published September 23, 2005 at 70 FR 55776). The following quality control (QC) provisions required by sections 4118 and 4119 of the Farm Security and Rural Investment Act of 2002 (title IV of Public Law 107-171) and contained in the interim rule are implemented by this final rule: 1) Timeframes for completing quality control reviews; 2) Timeframes for completing the arbitration process; 3) Timeframes for determining final error rates; 4) The threshold for potential sanctions and time period for sanctions; 5) The calculation of State error rates; 6) The formula for determining States' liability amounts; 7) Sanction notification and method of payment; and [[Page 69768]] 8) Corrective action plans. The following provisions required by sections 4118 and 4119 and additional policy and technical changes, and contained in the proposed rule, are implemented by this final rule: Legislative changes based on or required by sections 4118 and 4119: 1) Eliminate enhanced funding; 2) Establish timeframes for completing individual quality control reviews; and 3) Establish procedures for adjusting liability determinations following appeal decisions. Policy and technical changes: 1) Require State agency QC reviewers to attempt to complete review when a household refuses to cooperate; 2) Mandate FNS validation of negative sample for purposes of high performance bonuses; 3) Revise procedures for conducting negative case reviews; 4) Revise time frames for household penalties for refusal to cooperate with State and Federal QC reviews; 5) Revise procedures for QC reviews of demonstration and SSA processed cases; 6) Eliminate requirement to report variances resulting from Federal information exchange systems (FIX) errors; 7) Eliminate references to integrated QC; and 8) Update definitions section to remove out-dated definitions. (02-014) Statement of Need: The rule is needed to implement the food stamp quality control provisions of Public Law 107-171, the Farm Security and Rural Investment Act of 2002. Summary of Legal Basis: The legal basis for this rule is Public Law 107-171, the Farm Security and Rural Investment Act of 2002. Alternatives: This rule deals with changes required by Public Law 107-171, the Farm Security and Rural Investment Act of 2002. The Department has no discretion in implementing the time frames for completing quality control reviews, the arbitration process, and determining the final error rates; the threshold for potential sanctions and the time period for the sanctions; the calculation for State error rates; the formula for determining liability amounts; the sanction notification; method of payment for liabilities; corrective action planning, and the elimination of enhanced funding. These provisions were effective for the fiscal year 2003 quality control review period and must have been implemented by FNS and State agencies during fiscal year 2003. This rule also deals in part with discretionary changes to the quality control system resulting from Public Law 107-171. The provision addressing results of appeals is required to be regulated by Public Law 107-171. The remaining changes amend existing regulations and are required to make technical changes resulting from these changes or to update policy consistent with current requirements. Anticipated Costs and Benefits: The provisions of this rule are not anticipated to have any impact on benefit levels or administrative costs. Risks: The FSP provides nutrition assistance to millions of Americans nationwide. The quality control system measures the accuracy of States providing food stamp benefits to the program recipients. This rule is intended to implement the quality control provisions of Public Law 107- 701, the Farm Security and Rural Investment Act of 2002. It will significantly revise the system for determining State agency liabilities and sanctions for high payment error rates. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 10/16/03 68 FR 59519 Interim Final Rule Effective 12/15/03 Interim Final Rule Comment Period End 01/14/04 NPRM 02/23/05 70 FR 55776 NPRM Comment Period End 12/22/05 Final Action 06/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal, Local, State Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov Related RIN: Merged with 0584-AD37 RIN: 0584-AD31 _______________________________________________________________________ USDA--FNS 13. SPECIAL NUTRITION PROGRAMS: FLUID MILK SUBSTITUTIONS Priority: Other Significant Legal Authority: PL 108-265, sec 102 CFR Citation: 7 CFR 210; 7 CFR 220 Legal Deadline: None Abstract: Currently, by regulation, schools must make substitutions for fluid milk for students with a disability when the request is authorized by a licensed physician and may make substitutions for students with medical or other dietary needs if requested by recognized medical authority. These regulatory provisions were included in Public Law 108-265 which amended the Richard B. Russell National School Lunch Act. Public Law 108-265 also amended the current law to allow schools to substitute non-dairy beverages nutritionally equivalent (as established by the Secretary) to fluid milk for medical or other special dietary needs at the request of a parent/guardian. In response to Public Law 108-265, the National School Lunch Program and School Breakfast Program regulations will be revised to add these provisions. (04-016) Statement of Need: The changes made to the Richard B. Russell National School Lunch Act concerning substitutions for fluid milk are intended to assist children who cannot consume milk due to medical reasons. This regulation allows schools to make substitutions at the request of a parent or guardian, which assists families that are unable to obtain a doctor's statement. However, the Secretary must develop criteria to limit [[Page 69769]] the substitutions for milk to nutritionally equivalent beverages. The determination of nutritionally equivalent beverages will require careful research and consultation. Summary of Legal Basis: These changes are being made in response to provisions in Public Law 108-265. Alternatives: USDA worked with other Federal agencies to develop criteria for nutritionally equivalent substitutes for fluid milk as well as conducting research. USDA issued a proposed rule on November 9, 2006, and received 107 public comments. Anticipated Costs and Benefits: Schools may incur additional costs in obtaining and offering substitute beverages. However, children who cannot consume milk will now have a beverage nutritionally equivalent to milk. Risks: USDA must be diligent in making any determinations of nutritional equivalency to milk. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 11/09/06 71 FR 65753 NPRM Comment Period End 01/08/07 Final Action 01/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov RIN: 0584-AD58 _______________________________________________________________________ USDA--FNS 14. DIRECT CERTIFICATION OF CHILDREN IN FOOD STAMP HOUSEHOLDS AND CERTIFICATION OF HOMELESS, MIGRANT, AND RUNAWAY CHILDREN FOR FREE MEALS IN THE NSLP, SBP, AND SMP Priority: Other Significant Legal Authority: PL 108-265, sec 104 CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 245 Legal Deadline: None Abstract: In response to Public Law 108-265, which amended the Richard B. Russell National School Lunch Act, 7 CFR 245, Determining Eligibility for Free and Reduced Price Meals and Free Milk in Schools, will be amended to establish categorical (automatic) eligibility for free meals and free milk upon documentation that a child is (1) homeless as defined by the McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant programs under the Runaway and Homeless Youth Act; or (3) migratory as defined in section 1309(2) of the Elementary and Secondary Education Act. The rule also requires phase-in of mandatory direct certification for children who are members of households receiving food stamps and continues discretionary direct certification for other categorically eligible children. (04-018) Statement of Need: The changes made to the Richard B. Russell National School Lunch Act concerning direct certification are intended to improve program access, reduce paperwork, and improve the accuracy of the delivery of free meal benefits. This regulation will implement the statutory changes and provide State agencies and local educational agencies with the policies and procedures to conduct mandatory and discretionary direct certification. Summary of Legal Basis: These changes are being made in response to provisions in Public Law 108-265. Alternatives: FNS will be working closely with State agencies to implement the changes made by this regulation and will be developing extensive guidance materials in conjunction with our cooperators. Anticipated Costs and Benefits: This regulation will reduce paperwork, target benefits more precisely, and will improve program access of eligible school children. Risks: This regulation may require adjustments to existing computer systems to more readily share information between schools, food stamp offices, and other agencies. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 12/00/07 Interim Final Rule Comment Period End 12/00/08 Final Action 12/00/09 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Local, State Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov Related RIN: Merged with 0584-AD62 RIN: 0584-AD60 _______________________________________________________________________ USDA--FNS 15. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC): WIC VENDOR COST CONTAINMENT Priority: Other Significant Legal Authority: 42 USC 1786 CFR Citation: 7 CFR 246 Legal Deadline: Final, Statutory, June 30, 2006. [[Page 69770]] Abstract: This final rule amends the WIC regulations to strengthen vendor cost containment. The rule incorporates into program regulations new legislative requirements that affect the selection, authorization, and reimbursement of retail vendors. These requirements are contained in the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108- 265), which was enacted on June 30, 2004. The rule reflects the statutory provisions that require WIC State agencies to implement a vendor peer group system, competitive price selection criteria, and allowable reimbursement levels in a manner that ensures that the WIC Program pays authorized vendors competitive prices for supplemental foods. It also requires State agencies to ensure that vendors that derive more than 50 percent of their annual food sales revenue from WIC food instruments do not result in higher food costs to the program than do other vendors. The intent of these provisions is to maximize the number of women, infants, and children served with available Federal funding. (04-029) Statement of Need: This action is needed to implement the vendor cost containment provisions of the Child Nutrition and WIC Reauthorization Act of 2004, Public Law 108-265. The rule requires WIC State agencies to operate vendor management systems that effectively contain food costs by ensuring that prices paid for supplemental foods are competitive. The rule also responds to data which indicate that WIC food expenditures increasingly include payments to a type of vendor whose prices are not governed by the market forces that affect most retail grocers. As a result, the prices charged by these vendors tend to be higher than those of other retail grocery stores participating in the program. To ensure that the program pays competitive prices, this rule codifies the new statutory requirements for State agencies to use in evaluating vendor applicants' prices during the vendor selection process and when paying vendors for supplemental foods following authorization. Summary of Legal Basis: Section 203(e)(10) of Public Law 108-265, Child Nutrition and WIC Reauthorization Act of 2004. Alternatives: This rule implements the vendor peer group provisions of the Child Nutrition and WIC Reauthorization Act of 2004, which FNS believes is an effective means of controlling WIC food costs. While this Act mandates that States establish peer groups, competitive price criteria, and allowable reimbursement levels, and states that these requirements must result in the outcome of paying above-50-percent vendors no more than regular vendors, the rule does not specify particular criteria for peer groups or acceptable methods of setting competitive price criteria and allowable reimbursement levels. FNS considered mandating specific means of developing peer groups, competitive price criteria, and allowable reimbursement levels in order to ensure that the outcome of this legislation was achieved. However, given States' responsibility to manage WIC as a discretionary grant program and the varying market conditions in each State, FNS believes that States need flexibility to develop their own peer groups, competitive price criteria, and allowable reimbursement levels. At the October 2004 meeting the FNS convened to gain input for this rule, States indicated that they needed the ability to design cost containment practices that would be effective in their own markets and would ensure participant access. In addition, there is little information about the effectiveness of particular cost containment practices in the variety of markets represented by the 89 WIC State agencies. Mandating more specific means of developing peer groups, competitive price criteria, and allowable reimbursement levels could have unintended negative consequences for participant access, food costs and administrative burden. As States gain experience and the results of their vendor cost containment practices become apparent, FNS may develop further regulations and guidance to improve vendor cost containment. In the interim, FNS believes that the current rule will substantially accomplish the goal of the Act of containing food costs and ensuring that above-50-percent vendors do not result in higher costs to the WIC Program than regular vendors. Anticipated Costs and Benefits: Costs: This rule places new requirements on State agencies; therefore, the cost implications of this rule relate primarily to administrative burden for WIC State agencies. These cost implications are partially dependent on the current practices of State agencies relative to the requirements of the rule. Detailed information regarding the cost implications of this rule is contained in the Regulatory Impact Analysis developed by FNS to accompany this rulemaking. Benefits: The WIC Program will benefit from the provisions of this rule by reducing unnecessary food expenditures, thus increasing the potential to serve more eligible women, infants, and children for the same cost. This rule should have the effect of ensuring that payments to vendors, particularly vendors that derive more than 50 percent of their annual food sales revenue from WIC food instruments, reflect competitive prices for WIC foods. The Regulatory Impact Analysis prepared by FNS to accompany this rulemaking projects an estimated monthly cost savings of over $6.25 million. (Details of this projection can be found in the complete Regulatory Impact Analysis.) Risks: Because the vendor peer group provisions in the Child Nutrition and WIC Reauthorization Act of 2004 and this rule provide for some flexibility in implementation, and because there is a wide degree of variation in food prices and current vendor cost containment practices across State agencies, the impact of many of the provisions of this rule is uncertain. Uncertainties include the administrative burden State agencies will incur and the savings that can be realized nationally or in any State agency. The major uncertainties for both administrative burden and program savings are discussed in greater detail in the Regulatory Impact Analysis. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Interim Final Rule 11/29/05 70 FR 71708 Interim Final Rule Comment Period End 11/29/06 Interim Final Rule Effective 12/29/05 Final Action 02/00/08 Final Action Effective 03/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Governmental Jurisdictions Government Levels Affected: Federal, Local, State, Tribal [[Page 69771]] URL For More Information: www.fns.usda.gov/wic Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov RIN: 0584-AD71 _______________________________________________________________________ USDA--FNS 16. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 42 USC 1786 CFR Citation: 7 CFR 246 Legal Deadline: Final, Statutory, November 2006. CN and WIC Reauthorization Act of 2004 (Public Law 108-265) requires issuance of final rule within 18 months of release of IOM Report. Abstract: This interim final rule implements the first comprehensive revisions to the WIC food packages since 1980. These revised food packages were developed to better reflect current nutrition science and dietary recommendations than do current food packages, within the parameters of current program costs. This interim final rule revises regulations governing the WIC food packages to align the WIC food packages with the Dietary Guidelines for Americans (DGA) (1) and current infant feeding practice guidelines of the American Academy of Pediatrics, better promote and support the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. (05-006) Statement of Need: As the population served by WIC has grown and become more diverse over the last 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. A rule is needed to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science. Summary of Legal Basis: The Child Nutrition and WIC Reauthorization Act of 2004, enacted on June 30, 2004, requires the Department to issue a final rule within 18 months of receiving the Institute of Medicine's report on revisions to the WIC food packages. This report was published and released to the public on April 27, 2005. Alternatives: FNS is in the process of developing a regulatory impact analysis that will address a variety of alternatives that are considered in the interim final rulemaking. A regulatory impact analysis will be published as an appendix to the interim final rulemaking. Anticipated Costs and Benefits: The regulatory impact analysis for the proposed rule provides a reasonable estimate of the anticipated effects of the interim final rule. This analysis estimated that the provisions of the proposed rule would have a minimal impact on the costs of overall operations of the WIC Program over 5 years. The regulatory impact analysis was published as an appendix. Risks: The proposed rule to revise regulations pertaining to the supplemental foods provided through the WIC Program was published in the Federal Register on August 7, 2006 (71 FR 44784), with a 90-day comment period. The regulatory impact analysis was published as an appendix. A total of 46,502 comment letters were received on the proposed rule. The interim final rule also provides a comment period. Opportunities for training on and discussion of the revised WIC food packages will be offered to State agencies and other entities as necessary. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/07/06 71 FR 44784 NPRM Comment Period End 11/06/06 Interim Final Rule 12/00/07 Interim Final Rule Effective 02/00/08 Interim Final Rule Comment Period End 02/00/10 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Local, State, Tribal URL For More Information: www.fns.usda.gov/wic URL For Public Comments: www.fns.usda.gov/wic Agency Contact: Sharon Ackerman Agency Regulatory Officer Department of Agriculture Food and Nutrition Service Room 918 3101 Park Center Drive Alexandria, VA 22302 Phone: 703 305-2246 Email: sheri.ackerman@fns.usda.gov RIN: 0584-AD77 _______________________________________________________________________ USDA--Food Safety and Inspection Service (FSIS) ----------- PROPOSED RULE STAGE ----------- 17. EGG PRODUCTS INSPECTION REGULATIONS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 21 USC 1031 to 1056 CFR Citation: 9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . . Legal Deadline: None Abstract: The Food Safety and Inspection Service (FSIS) is proposing to require egg [[Page 69772]] products plants and establishments that pasteurize shell eggs to develop and implement Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (SOPs). FSIS also is proposing pathogen reduction performance standards that would be applicable to egg products and pasteurized shell eggs. FSIS is proposing to amend the Federal egg products inspection regulations by removing current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to their use in official plants. The Agency also plans to eliminate the prior label approval system for egg products. This proposal will not encompass shell egg packers. In the near future, FSIS will initiate non-regulatory outreach efforts for shell egg packers that will provide information intended to help them to safely process shell eggs intended for human consumption or further processing. Statement of Need: The actions being proposed are part of FSIS' regulatory reform effort to improve FSIS' shell egg and egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg products regulations as consistent as possible with the Agency's meat and poultry products regulations. FSIS also is taking these actions in light of changing inspection priorities and recent findings of Salmonella in pasteurized egg products. This proposal is directly related to FSIS' PR/HACCP initiative. Summary of Legal Basis: This proposed rule is authorized under the Egg Products Inspection Act (21 U.S.C. 1031 to 1056). It is not the result of any specific mandate by the Congress or a Federal court. Alternatives: A team of FSIS economists and food technologists is conducting a cost- benefit analysis to evaluate the potential economic impacts of several alternatives on the public, egg products industry, and FSIS. These alternatives include: (1) Taking no regulatory action; (2) requiring all inspected egg products plants to develop, adopt, and implement written sanitation SOPs and HACCP plans; and (3) converting to a lethality-based pathogen reduction performance standard many of the current highly prescriptive egg products processing requirements. The team will consider the effects of a uniform, across-the-board standard for all egg products; a performance standard based on the relative risk of different classes of egg products; and a performance standard based on the relative risks to public health of different production processes. Anticipated Costs and Benefits: FSIS is analyzing the potential costs of this proposed rulemaking to industry, FSIS and other Federal agencies, State and local governments, small entities, and foreign countries. The expected costs to industry will depend on a number of factors. These costs include the required lethality, or level of pathogen reduction, and the cost of HACCP plan and sanitation SOP development, implementation, and associated employee training. The pathogen reduction costs will depend on the amount of reduction sought and on the classes of product, product formulations, or processes. Relative enforcement costs to FSIS and Food and Drug Administration may change because the two agencies share responsibility for inspection and oversight of the egg industry and a common farm-to-table approach for shell egg and egg products food safety. Other Federal agencies and local governments are not likely to be affected. Egg and egg product inspection systems of foreign countries wishing to export eggs and egg products to the U.S. must be equivalent to the U.S. system. FSIS will consult with these countries, as needed, if and when this proposal becomes effective. This proposal is not likely to have a significant impact on small entities. The entities that would be directly affected by this proposal would be the approximately 80 federally inspected egg products plants, most of which are small businesses, according to Small Business Administration criteria. If necessary, FSIS will develop compliance guides to assist these small firms in implementing the proposed requirements. Potential benefits associated with this rulemaking include: Improvements in human health due to pathogen reduction; improved utilization of FSIS inspection program resources; and cost savings resulting from the flexibility of egg products plants in achieving a lethality-based pathogen reduction performance standard. Once specific alternatives are identified, economic analysis will identify the quantitative and qualitative benefits associated with each alternative. Human health benefits from this rulemaking are likely to be small because of the low level of (chiefly post-processing) contamination of pasteurized egg products. In light of recent scientific studies that raise questions about the efficacy of current regulations, however, it is likely that measurable reductions will be achieved in the risk of foodborne illness. The preliminary anticipated annualized costs of the proposed action are approximately $7.0 million. The preliminary anticipated benefits of the proposed action are approximately $90.0 million per year. Risks: FSIS believes that this regulatory action may result in a further reduction in the risks associated with egg products. The development of a lethality-based pathogen reduction performance standard for egg products, replacing command-and-control regulations, will remove unnecessary regulatory obstacles to, and provide incentives for, innovation to improve the safety of egg products. To assess the potential risk-reduction impacts of this rulemaking on the public, an intra-Agency group of scientific and technical experts is conducting a risk management analysis. The group has been charged with identifying the lethality requirement sufficient to ensure the safety of egg products and the alternative methods for implementing the requirement. FSIS has developed new risk assessments for SE in eggs and for Salmonella spp. in liquid egg products to evaluate the risk associated with the regulatory alternatives. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Governmental Jurisdictions Government Levels Affected: Federal, State Federalism: Undetermined [[Page 69773]] Agency Contact: Victoria Levine Program Analyst, Regulations and Petitions Policy Staff Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 720-5627 Fax: 202 690-0486 Email: victoria.levine@fsis.usda.gov RIN: 0583-AC58 _______________________________________________________________________ USDA--FSIS 18. CHANGES TO REGULATORY JURISDICTION OVER CERTAIN FOOD PRODUCTS CONTAINING MEAT AND POULTRY Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 U.S.C. 601(j); 21 U.S.C. 454(f) CFR Citation: 9 CFR 303.1; 9 CFR 381.15 Legal Deadline: None Abstract: The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) have concluded that a clearer approach to determining jurisdiction over meat and poultry products is possible. This approach involves considering the contribution of the meat or poultry ingredients to the identity of the food. FSIS is proposing to amend the Federal meat and poultry products inspection regulations to provide consistency and predictability in the jurisdiction over nine products or product categories for which there has historically been confusion concerning whether these products fall within the jurisdiction of FSIS or FDA. These proposed changes would exempt cheese and cheese products prepared with less than 50% meat or poultry; breads, rolls and buns prepared with less than 50% meat or poultry; dried poultry soup mixes; flavor bases and flavors; pizza with meat or poultry; and salad dressings prepared with less than 50% meat or poultry from the requirements of the Federal Meat Inspection Act and the Poultry Product Inspection Act and would clarify that bagel dogs, natural casings, and close faced-sandwiches are subject to the requirements of the Federal Meat Inspection Act and the Poultry Products Inspection Act. Statement of Need: Over the years, FSIS has made decisions about the jurisdiction under which food products containing meat or poultry ingredients are produced based on the amount of meat or poultry in the product; whether the product is represented as a meat or poultry product (that is, whether a term that refers to meat or poultry is used on labeling); whether the product is perceived by consumers as a product of the meat or poultry industries; and whether the product contains poultry or meat from an accepted source. With regard to the consumer perception factor, FSIS made decisions on a case-by-case basis, mostly in response to situations involving determinations for compliance and enforcement. Although this case-by-case approach resulted in decisions that made sense at the time that they were made, a review in 2004-2005 by a working group of FSIS and FDA representatives highlighted that some of the decisions do not appear to be fully consistent with other product decisions and that the reasoning behind various determinations were not fully articulated or supported. Summary of Legal Basis: Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1032), and the regulations that implement these Acts, FSIS has authority over all meat food and poultry products and processed egg products. Under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the regulations that implement it, FDA has authority over all foods not under FSIS' jurisdiction, including dairy, bread and other grain products, vegetables and other produce, and other products, such as seafood. According to the provisions of the FMIA and PPIA, the Secretary has the authority to exempt certain human food products from the definition of a meat food product (21 U.S.C. 601(j)) or a poultry product (20 U.S.C. 454(f)) based on either of two factors: (1) the product contains only a relatively small proportion of livestock ingredients or poultry ingredients, or (2) the product historically has not been considered by consumers as a product of the meat food or poultry industry, and under such conditions as he or she may prescribe to ensure that the livestock or poultry ingredients are not adulterated and that the products are not represented as meat food or poultry products. Alternatives: FSIS has considered over the years a number of variations to clarify the confusion regarding jurisdiction for these various products. Alternative 1: Maintain the status quo. Although FSIS has considered taking no action at this time, the Agency does not recommend this option because of the continued confusion that exists among industry and consumers as to jurisdictional coverage for nine categories of products. Alternative 2: Reassess the statutory factors for making jurisdiction decision and recommend an amendment. The amendment of the statute would be from the historical perception factor because that is the factor, of the two statutory factors, that the working group identified as leading to the state of confusion about the jurisdiction of certain products containing meat or poultry. Alternative 3: Adopt some of the FDA/FSIS working group's suggested approach to making clear and transparent jurisdiction decisions by proposing changes to regulations to codify the current policies on exempted products. Anticipated Costs and Benefits: FSIS estimates that the net costs of the rule would be approximately $12 million. This consists of approximately $18 million of one-time and annual costs for establishments producing product that will transfer to FSIS jurisdiction and net savings of $6 million for establishments producing time product that will transfer to FDA jurisdiction. FSIS' preliminary estimate of total benefits of the rule is approximately $15 million. Benefits would accrue to FSIS and FDA for personnel time saved and to industry for personnel saved. Risks: None Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/00/08 Regulatory Flexibility Analysis Required: Undetermined Small Entities Affected: Businesses [[Page 69774]] Government Levels Affected: None Agency Contact: Charles Gioglio Labeling and Program Delivery Division Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-3625 Fax: 202 720-0582 Email: charles.gioglio@fsis.usda.gov RIN: 0583-AD28 _______________________________________________________________________ USDA--FSIS 19. PUBLIC HEALTH-BASED POULTRY SLAUGHTER INSPECTION Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 U.S.C. 451, et seq. CFR Citation: 9 CFR 381.66; 9 CFR 381.67 9 CFR 381.76; 9 CFR 381.83 9 CFR 381.91; 9 CFR 381.94 Legal Deadline: None Abstract: FSIS is proposing a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. This new system would be available initially only to young chicken slaughter establishments. Establishments that slaughter broilers, fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170) would be considered as ``young chicken establishments.'' FSIS is also proposing to revoke the provisions that allow young chicken slaughter establishments to operate under the current Streamlined Inspection System (SIS) or the New Line Speed (NELS) Inspection System. The proposed rule would establish new performance standards to reduce pathogens. FSIS anticipates that this proposed rule would provide the framework for action to provide public health-based inspection in all establishments that slaughter amenable poultry species. Under the proposed new system, young chicken slaughter establishments would be required to sort chicken carcasses and to conduct other activities to ensure that carcasses are not adulterated before they enter the chilling tank. Statement of Need: Because of the risk to the public health associated with pathogens on young chicken carcasses, FSIS is proposing a new inspection system that would allow for more effective inspection of young chicken carcasses, would allow the Agency to more effectively allocate its resources, would encourage industry to more readily use new technology, and would include new performance standards to reduce pathogens. This proposed rule is an example of regulatory reform because it would facilitate technological innovation in young chicken slaughter establishments. It would likely result in more cost-effective dressing of young chickens that are ready to cook or ready for further processing. Similarly, it would likely result in more efficient and effective use of Agency resources. Summary of Legal Basis: The Secretary of Agriculture is charged by the Poultry Products Inspection Act (PPIA--21 U.S.C. 451, et seq.) with carrying out a mandatory poultry products inspection program. The Act requires post- mortem inspection of all carcasses of slaughtered poultry subject to the Act and such reinspection as deemed necessary (21 U.S.C. 455(b)). The Secretary is authorized to promulgate such rules and regulations as are necessary to carry out the provisions of the Act (21 U.S.C. 463(b)). The Agency has tentatively determined that this rule would facilitate FSIS post-mortem inspection of young chicken carcasses. The proposed new system would likely result in more efficient and effective use of Agency resources and in industry innovations. Alternatives: FSIS considered the following options in developing this proposal: 1) No action. 2) Propose to implement HACCP-Based Inspection Models Pilot in regulations. 3) Propose to establish a mandatory, rather than a voluntary, new inspection system for young chicken slaughter establishments. 4) Propose standards of identity regulations for young chickens that include trim and processing defect criteria and that take into account the intended use of the product. 5) Propose a voluntary new inspection system for young chicken slaughter establishments and propose standards of identity for whole chickens, regardless of the products' intended use. Anticipated Costs and Benefits: The proposed performance standards and the implementation of public health-based inspection would likely improve the public health. FSIS is conducting a risk assessment for this proposed rule to assess the likely public health benefits that the implementation of this rule may achieve. Establishments that volunteer for this proposed new inspection system alternative would likely need to make capital investments in facilities and equipment. They may also need to add labor (trained employees). However, one of the beneficial effects of these investments would likely be the lowering of the average cost per pound to dress poultry properly. Cost savings would likely result because of increased line speeds, increased productivity, and increased flexibility to industry. The expected lower average unit cost for dressing poultry would likely give a marketing advantage to establishments under the new system. Consumers would likely benefit from lower retail prices for high quality poultry products. The rule would also likely provide opportunities for the industry to innovate because of the increased flexibility it would allow poultry slaughter establishments. In addition, in the public sector, benefits would accrue to FSIS from the more effective deployment of FSIS inspection program personnel to verify process control based on risk factors at each establishment. Risks: Salmonella and other pathogens are present on a substantial portion of poultry carcasses inspected by FSIS. Foodborne salmonella cause a large number of human illnesses that at times lead to hospitalization and even death. There is an apparent relationship between human illness and prevalence levels for salmonella in young chicken carcasses. FSIS believes that through better allocation of inspection resources and the use of performance standards, it would be able to reduce the prevalence of salmonella and other pathogens in young chickens. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No [[Page 69775]] Government Levels Affected: State Agency Contact: Dr. Daniel L. Engeljohn Deputy Assistant Administrator, Office of Policy, Program, and Employee Development Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-0495 Fax: 202 401-1760 Email: daniel.engeljohn@fsis.usda.gov RIN: 0583-AD32 _______________________________________________________________________ USDA--FSIS ----------- FINAL RULE STAGE ----------- 20. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND POULTRY PRODUCTS; CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT MEAT AND POULTRY PRODUCTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 451 et seq; 21 USC 601 et seq CFR Citation: 9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR 325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431 Legal Deadline: None Abstract: FSIS has proposed to establish pathogen reduction performance standards for all ready-to-eat (RTE) and partially heat-treated meat and poultry products, and measures, including testing, to control Listeria monocytogenes in RTE products. The performance standards spell out the objective level of pathogen reduction that establishments must meet during their operations in order to produce safe products but allow the use of customized, plant-specific processing procedures other than those prescribed in the earlier regulations. With HACCP, food safety performance standards give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls, while providing objective, measurable standards that can be verified by Agency inspectional oversight. This set of performance standards will include and be consistent with standards already in place for certain ready-to-eat meat and poultry products. Statement of Need: Although FSIS routinely samples and tests some ready-to-eat products for the presence of pathogens prior to distribution, there are no specific regulatory pathogen reduction requirements for most of these products. The proposed performance standards are necessary to help ensure the safety of these products; give establishments the incentive and flexibility to adopt innovative, science-based food safety processing procedures and controls; and provide objective, measurable standards that can be verified by Agency oversight. Summary of Legal Basis: Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues regulations governing the production of meat and poultry products prepared for distribution in commerce. The regulations, along with FSIS inspection programs, are designed to ensure that meat and poultry products are safe, not adulterated, and properly marked, labeled, and packaged. Alternatives: As an alternative to all of the proposed requirements, FSIS considered taking no action. As alternatives to the proposed performance standard requirements, FSIS considered end-product testing and requiring ``use- by'' date labeling on ready-to-eat products. Anticipated Costs and Benefits: Benefits are expected to result from fewer contaminated products entering commercial food distribution channels as a result of improved sanitation and process controls and in-plant verification. FSIS believes that the benefits of the rule would exceed the total costs of implementing its provisions. FSIS currently estimates net benefits from the 2003 interim final rule from $500 to $700 million, with annual costs at $98.7 million, if FSIS discounts the capital cost at 7%. FSIS is continuing to analyze the potential impact of the other provisions of the proposal. The other main provisions of the proposed rule are: Lethality performance standards for Salmonella and E. coli O157:H7 and stabilization performance standards for C. perfringens that firms must meet when producing RTE meat and poultry products. Most of the costs of these requirements would be associated with one-time process performance validation in the first year of implementation of the rule and with revision of HACCP plans. Benefits are expected to result from the entry into commercial food distribution channels of product with lower levels of contamination resulting from improved in-plant process verification and sanitation. Consequently, there will be fewer cases of foodborne illness. Risks: Before FSIS published the proposed rule, FDA and FSIS had estimated that each year L. monocytogenes caused 2,540 cases of foodborne illness, including 500 fatalities. The Agencies estimated that about 65.3 percent of these cases, or 1660 cases and 322 deaths per year, were attributable to RTE meat and poultry products. The analysis of the interim final rule on control of L. monocytogenes conservatively estimated that implementation of the rule would lead to an annual reduction of 27.3 deaths and 136.7 illnesses. FSIS is continuing to analyze data on production volume and Listeria controls in the RTE meat and poultry products industry and is using the FSIS risk assessment model for L. monocytogenes to determine the likely risk reduction effects of the rule. Preliminary results indicate that the risk reductions being achieved are somewhat greater than those estimated in the analysis of the interim rule. FSIS is also analyzing the potential risk reductions that might be achieved by implementing the lethality and stabilization performance standards for products that would be subject to the proposed rule. The risk reductions to be achieved by the proposed rule and that are being achieved by the interim rule are intended to contribute to the Agency's public health protection effort. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/27/01 66 FR 12590 NPRM Comment Period End 05/29/01 NPRM Comment Period Extended 07/03/01 66 FR 35112 NPRM Comment Period End 09/10/01 Interim Final Rule 06/06/03 68 FR 34208 [[Page 69776]] Interim Final Rule Effective 10/06/03 Interim Final Rule Comment Period End 01/31/05 NPRM Comment Period Reopened 03/24/05 70 FR 15017 NPRM Comment Period End 05/09/05 Affirmation of Interim Final Rule 03/00/08 Final Action 08/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Dr. Daniel L. Engeljohn Deputy Assistant Administrator, Office of Policy, Program, and Employee Development Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-0495 Fax: 202 401-1760 Email: daniel.engeljohn@fsis.usda.gov RIN: 0583-AC46 _______________________________________________________________________ USDA--FSIS 21. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR CHOPPED MEAT AND POULTRY PRODUCTS Priority: Economically Significant. Major under 5 USC 801. Legal Authority: 21 USC 601 et seq; 21 USC 451 et seq CFR Citation: 9 CFR 317; 9 CFR 381 Legal Deadline: None Abstract: FSIS has proposed to amend the Federal meat and poultry products inspection regulations to require nutrition labeling for the major cuts of single-ingredient, raw meat and poultry products, either on their label or at their point-of-purchase, unless an exemption applies. FSIS also proposed to require nutrition information on the label of ground or chopped meat and poultry products, unless an exemption applies. The requirements for ground or chopped products will be consistent with those for multi-ingredient products. FSIS also proposed to amend the nutrition labeling regulations to provide that when a ground or chopped product does not meet the regulatory criteria to be labeled ``low fat,'' a lean percentage claim may be included on the label or in labeling, as long as a statement of the fat percentage also is displayed on the label or in labeling. Statement of Need: The Agency will require that nutrition information be provided for the major cuts of single-ingredient, raw meat and poultry products, either on their label or at their point-of-purchase, because during the most recent surveys of retailers, the Agency did not find significant participation in the voluntary nutrition labeling program for single- ingredient, raw meat and poultry products. Ground or chopped products are similar to multi-ingredient products. This rule is necessary so that consumers can have the information they need to construct healthy diets. Summary of Legal Basis: This action is authorized under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the Poultry Products Inspection Act (21 U.S.C. 451 to 470). Alternatives: No action; nutrition labels required on all single-ingredient, raw products (major cuts and non-major cuts) and all ground or chopped products; nutrition labels required on all major cuts of single- ingredient, raw products (but not non-major cuts) and all ground or chopped products; nutrition information at the point-of-purchase required for all single-ingredient, raw products (major and non-major cuts) and for all ground or chopped products. Anticipated Costs and Benefits: Costs will include the equipment for making labels, labor, and materials used for labels for ground or chopped products. The cost of providing nutrition labeling for the major cuts of single-ingredient, raw meat and poultry products should not be significant, because retail establishments would have the option of providing nutrition information through point-of-purchase materials. Benefits of the nutrition labeling rule would result if consumers modify their diets in response to new nutrition information concerning ground or chopped products and the major cuts of single-ingredient, raw products. Reductions in consumption of fat and cholesterol are associated with reduced incidence of cancer and coronary heart disease. FSIS has concluded that the quantitative benefits will exceed the quantitative costs of the rule. FSIS estimates that the discounted annual benefits of the rule will range from approximately $200 to $250 million using a 7% discount rate. FSIS estimates that the discounted annual costs will be approximately $30 million, using a 7% discount rate. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 01/18/01 66 FR 4970 NPRM Comment Period End 04/18/01 Extension of Comment Period 04/20/01 66 FR 20213 NPRM Comment Period End 07/17/01 Final Action 08/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Charles Gioglio Labeling and Program Delivery Division Department of Agriculture Food Safety and Inspection Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-3625 Fax: 202 720-0582 Email: charles.gioglio@fsis.usda.gov RIN: 0583-AC60 _______________________________________________________________________ USDA--FSIS 22. AVAILABILITY OF LISTS OF RETAIL CONSIGNEES DURING MEAT OR POULTRY PRODUCT RECALLS Priority: Other Significant Legal Authority: 5 USC 301, 552 [[Page 69777]] CFR Citation: 9 CFR 390 Legal Deadline: None Abstract: The Food Safety and Inspection Service (FSIS) has proposed to amend the federal meat and poultry products inspection regulations to provide that the Agency will make available to the public lists of the retail consignees of meat and poultry products that have been voluntarily recalled by a federally inspected meat or poultry products establishment. FSIS has proposed this action because it believes that making this information available will be of significant value to consumers and the industry. It will clarify what products should be removed from commerce and from consumers' possession because there is reason to believe they are adulterated or misbranded. Statement of Need: This regulatory action is necessary to provide important information to help consumers identify recalled products. Consumer activists and States have increasingly demanded the public release of information on where recalled meat and poultry products have been shipped. The States have requested this information be provided without the limitations imposed by FSIS's regulations. Consumer groups have claimed that the public needs this information to fully protect itself. In response to these requests, FSIS is proposing to make available to the public the names of likely retail consignees of recalled meat and poultry products. Summary of Legal Basis: This regulatory action is authorized under 5 U.S.C. 301, Departmental regulations, and 5 U.S.C. 552, Public information; agency rules, opinions, orders, records, and proceedings. It is not the result of any specific mandate by the Congress or a Federal court. Alternatives: FSIS has prepared a regulatory impact analysis to evaluate the potential economic impacts of several alternatives on the public, the meat and poultry industry, and FSIS. These alternatives include: (1) Including local health departments as entities that could receive recall distribution lists; (2) making available to the general public recall distribution lists only in response to a Freedom of Information request; and (3) making lists available to State agencies with agreements with FSIS under 9 CFR 390.9. Anticipated Costs and Benefits: FSIS is analyzing the potential costs of this proposed rulemaking. This regulatory action would provide information to consumers about meat and poultry products sold at retail establishments that are believed to be adulterated or misbranded and are therefore subject to being recalled. The consumption of such products may cause food borne illness and other adverse health consequences, including death. If consumers use retail consignee information and are better able to identify and return recalled meat and poultry products to the stores where they purchased them, the recall process will be more timely and effective. Potential benefits of the proposal are expected as a result of making more information available to consumers regarding the location of meat and poultry products subject to recall. The Agency does not expect the benefits to be significant. There is no research or empirical evidence upon which to quantify potential benefits. Risks: N/A Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/07/06 71 FR 11326 NPRM Comment Period End 06/11/06 71 FR 27211 Final Action 07/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Mr. Philip Derfler Assistant Administrator, Office of Policy, Program, and Employee Development Department of Agriculture Food Safety and Inspection Service Room 350, Jamie L. Whitten Building 1400 Independence Avenue SW Washington, DC 20250-3700 Phone: 202 720-2709 Fax: 202 720-2025 Email: philip.derfler@fsis.usda.gov RIN: 0583-AD10 _______________________________________________________________________ USDA--Forest Service (FS) ----------- PROPOSED RULE STAGE ----------- 23. FOREST SERVICE NATIONAL ENVIRONMENTAL POLICY ACT PROCEDURES Priority: Other Significant Legal Authority: 40 CFR 1507.3 CFR Citation: 36 CFR 220 Legal Deadline: None Abstract: The Forest Service is proposing to move existing Agency NEPA procedures required by 40 CFR 1507.3 from Forest Service Handbook 1909.15 to the CFR, add new procedures, and edit some existing procedures. Presently, Forest Service procedures are combined with Agency guidance in FSH 1909.15 along with quotations from the Council on Environmental Quality regulations. Having Agency NEPA procedures in regulations, separate from guidance, will make it easier for the Forest Service to provide guidance through the agency directive system. Agency internal processes will continue to reside in FSH 1909.15 with references to both CEQ and Forest Service NEPA procedures. Statement of Need: The Forest Service is proposing to move existing agency NEPA procedures, required by the Council on Environmental Quality (CEQ) and codified at 40 CFR 1507.3, from the internal Forest Service Environmental Policy and Procedures Handbook (FSH) 1909.15 to the Code of Federal Regulations. New procedures would be added and existing procedures would be revised where clarity is needed to incorporate CEQ guidance and align agency NEPA procedures with agency decision processes. Presently, the Forest Service NEPA procedures are combined with Agency guidance in FSH 1909.15 along with quotations from the CEQ regulations. This handbook contains general guidance such as how to select an interdisciplinary team, thereby associating guidance with NEPA procedures. Guidance and quotes from the CEQ regulations are important to [[Page 69778]] internal Agency work, but bear little similarity to the Agency procedures contemplated in the CEQ regulations (40 CFR 1507.3(b)). Changes to Agency guidance in FSH 1909.15 currently involve consultation with CEQ because the handbook does not differentiate between NEPA guidance and ``procedures.'' This makes it more difficult to update simple guidance. Summary of Legal Basis: The Council on Environmental Quality (CEQ) regulations (40 CFR 1507.3) direct Federal agencies to develop NEPA procedures to supplement the CEQ regulations. The CEQ regulations require agencies to provide for public notice and comment and CEQ consultation when developing and revising Agency NEPA procedures. Alternatives: A possible alternative would be to have the CEQ revise its regulations or seek legislative changes. Anticipated Costs and Benefits: Codifying agency NEPA procedures in regulation, separate from guidance, would make it easier for the Forest Service to provide guidance through the agency directive system. General guidance and internal processes would reside in the FSH 1909.15 handbook with references to both CEQ and Forest Service NEPA procedures set out in the CFR. This will make future revisions to internal agency guidance more responsive to new ideas and information. Having the agency NEPA procedures at the same level as the CEQ regulations would also give them equal status in court. New procedures and revisions to existing procedures would further define how the agency must comply with NEPA where the CEQ regulations lack clarity, when additional CEQ guidance has been issued, or when there are more efficient or applicable procedures appropriate to Agency decisionmaking. With more flexibility in how NEPA documents are prepared, the NEPA process is expected to be more efficient and responsive to decision maker needs. Risks: More NEPA procedural requirements could be added which would add to the present processes. Also, given that some of the proposed procedures would allow more flexibility and options to comply with NEPA, the results could be a more complex set of regulations for the field to understand. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 11/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Andria D. Weeks Regulatory Analyst Department of Agriculture Forest Service ATTN: ORMS, D&R Branch 1400 Independence Avenue SW Washington, DC 20250-0003 Phone: 202 205-3610 Fax: 202 260-6539 Email: aweeks@fs.fed.us RIN: 0596-AC49 _______________________________________________________________________ USDA--FS 24. SPECIAL AREAS; STATE-SPECIFIC INVENTORIED ROADLESS AREA MANAGEMENT: IDAHO Priority: Other Significant Legal Authority: 5 USC 553(e); 7 CFR 1.28 CFR Citation: 36 CFR 294 Legal Deadline: None Abstract: On October 5, 2006, the Governor of Idaho submitted a petition under the provisions of the Administrative Procedure Act (5 U.S.C. 553(e)) and Agriculture Department regulation (7 CFR 1.28) to promulgate regulations, in cooperation with the State, for management of 9.3 million acres of inventoried roadless areas within the State. After review and recommendation by the Roadless Area Conservation National Advisory Committee, the Secretary accepted the Governor's petition and initiated a proposed rulemaking for the roadless areas in Idaho. The proposed rulemaking would manage Idaho's inventoried roadless areas under four main themes listed from most restrictive to least: Wildland Recreation (1.4 million acres), Primitive (1.7 million acres), Backcountry (5.5 million acres), and General Forest (0.5 million acres). The proposed rulemaking also will establish three important tribal and historical sites as ``Special Areas'' (0.2 million acres). Road construction and reconstruction plus timber harvesting would be prohibited in certain inventoried roadless areas on the Boise, Caribou- Targhee, Clearwater, Idaho Panhandle, Kootenai (portions), Nez Perce, Payette, Salmon-Challis, Sawtooth, and Wallowa-Whitman (portions) National Forests in Idaho. Exceptions to the prohibitions would be allowed for certain health, safety, valid existing rights, resource protection, and ecological management needs. Statement of Need: The Department of Agriculture is committed to conserving and managing roadless values and considers inventoried roadless areas an important component of the National Forest System. The roadless rule has been the subject of 10 lawsuits in Federal district courts in Idaho, Utah, North Dakota, Wyoming, Alaska, and the District of Columbia. On July 14, 2003, the U.S. District Court for the District of Wyoming found the 2001 roadless rule to be unlawful and ordered that the rule be permanently enjoined. On May 13, 2005 the Forest Service promulgated the State Petitions Rule. The State Petitions Rule allowed Governors to voluntarily seek establishment of or adjustment of management requirements for National Forest System inventoried roadless areas within their States. If a petition was not received within 18 months, inventoried roadless areas would be guided by individual land management plans. In also established the Roadless Area Conservation National Advisory Committee (RACNAC) to make recommendations on State-petitions to the Secretary. With the promulgation of the State Petitions Rule, the Tenth Circuit, which was reviewing an appeal by intervenors of the Wyoming court's decision, dismissed the case as moot. Under the guidance of the State Petitions Rule the States of California, Idaho, New Mexico, North Carolina, South Carolina, and Virginia filed a petition with the Secretary. The Secretary instructed the Forest Service to enter into rulemaking for North Carolina, South Carolina, and Virginia. Two lawsuits were filed against the State Petitions Rule in the Federal district court for the Northern District of California. [[Page 69779]] One suit was filed by the States of California, New Mexico, Oregon, and Washington with the State of Montana being amicus curiae in support of plaintiffs; and the States of Alaska and Idaho are amici curiae to USDA. The other lawsuit was filed by a coalition of environmental groups. On September 20, 2006, the Federal district court enjoined the State Petitions Rule and reinstated the RACR. In an effort to again re- enjoin the RACR, the State of Wyoming filed a second lawsuit in the Federal district court for Wyoming on January 12, 2007. Oral hearing for this lawsuit is schedule for October 19. With the reinstatement of RACR, the Under Secretary announced that interested States could still petition the Secretary pursuant to 5 U.S.C. Sec. 553(e) and 7 C.F.R. Sec. 1.28. On October 5, 2006, Idaho Governor James Risch resubmitted his petition under these authorities. The RACNAC reviewed the petition and made recommendations to the Secretary on December 19, 2006. On December 22, 2006, the Secretary directed the Forest Service to begin the rulemaking process with the State. Collaboratively working on the establishment of a State-specific roadless rule for the petitioning State will allow the State the level of management of inventoried roadless areas it seeks to best meet its needs in balance with the Department's and Forest Service's goals for the conserving and managing roadless values nationally. In addition, it will allow for the management of these lands in that State without being affected by other legal actions concerning the roadless rule or State Petitions Rule. Summary of Legal Basis: On January 12, 2001, the Department of Agriculture promulgated the Roadless Area Conservation Rule (RACR) to provide for the conservation and management of approximately 58.5 million acres of inventoried roadless areas within the National Forest System under the principles of the Multiple-Use Sustained-Yield Act of 1960. The State of Idaho petitioned the Secretary pursuant to 5 U.S.C. Sec. 553(e) and 7 C.F.R. Sec. 1.28 for state-specific rules to replace this national rule in that State. Alternatives: The Forest Service is preparing environmental impact statements in support of the rulemaking effort. Besides the proposed rule, two alternatives are being considered (1) continuation of the RACR for management of these inventoried roadless areas, and (2) using existing forest plans and future forest plan revisions to determine the management of these areas. Anticipated Costs and Benefits: Three alternatives have been analyzed for benefits, costs, and distributional effects are: 2001 Roadless Rule, existing forest plan, and the proposed rule are analyzed. A range of baseline conditions, represented by the 2001 Rule and existing forest plans alternatives, are adopted to characterize the mix of goods and services provided by National Forests and Grasslands in the near future in the absence of the proposed rule. The proposed rule is programmatic in nature, consisting of direction for road construction, road reconstruction, timber harvesting, and discretionary mineral activities, which would be applied to future management activities on inventoried roadless areas in Idaho. In general, the proposed rule does not affect the efficiency of individual operations or activities (e.g., individual timber sale) associated with forest resources and/or services, but may instead affect the number or extent of opportunities as a function of activities permitted on National Forest system lands. Because the proposed rule does not prescribe site-specific activities, it is difficult to quantify the benefits under the different alternatives. Risks: The rule is programmatic in nature and would constrain certain activities that would reduce roadless area characteristics. Reducing or controlling the development of these lands will reduce the risk of environmental effects associated with development activities like road construction, timber harvesting, and mineral extraction. Therefore soil, water, and air quality; sources of drinking water; diversity of plant and animal communities; habitat for threatened, endangered, proposed, candidate, and sensitive species dependent on large, undisturbed areas of land; scenic quality; traditional cultural properties and sacred sites; and other locally unique characteristics would be maintained. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/00/07 Regulatory Flexibility Analysis Required: No Government Levels Affected: State, Tribal Agency Contact: Andria D. Weeks Regulatory Analyst Department of Agriculture Forest Service ATTN: ORMS, D&R Branch 1400 Independence Avenue SW Washington, DC 20250-0003 Phone: 202 205-3610 Fax: 202 260-6539 Email: aweeks@fs.fed.us Related RIN: Related to 0596-AC58, Related to 0596-AC59, Related to 0596-AC60 RIN: 0596-AC62 _______________________________________________________________________ USDA--FS 25. SPECIAL AREAS; STATE-SPECIFIC INVENTORIED ROADLESS AREA MANAGEMENT: COLORADO Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: Not Yet Determined CFR Citation: 36 CFR 294 Legal Deadline: None Abstract: On April 11, 2007, Governor of Colorado Ritter submitted a petition under the provisions of the Administrative Procedure Act (5 U.S.C. 553(e)) and Agriculture Department regulation (7 CFR 1.28) to promulgate regulations, in cooperation with the State, for the management of inventoried roadless areas within the State of Colorado. After review and recommendation by the Roadless Area Conservation National Advisory Committee, the Secretary accepted the Governor's petition and initiated a proposed rulemaking for inventoried roadless areas in Colorado. The proposed rulemaking would manage Colorado's inventoried roadless areas by prohibiting road building and tree cutting, with some exceptions, on 4.1 million acres of inventoried roadless areas in Colorado. The 4.1 million acres reflect the most updated IRA boundaries for Colorado, which incorporate planning rule revisions since 2001 on several Colorado national forests. Inventoried roadless areas that [[Page 69780]] are allocated to ski area special uses (approximately 10,000 acres) would also be removed from roadless designation. Road construction and reconstruction plus timber harvesting would be prohibited in inventoried roadless areas, with some exceptions, on the Arapaho- Roosevelt, Grand Mesa-Uncompahgre, Gunnison, Manti-La Sal, Pike-San Isabel, Rio Grande, Routt, San Juan, and White River National Forests in Colorado. Exceptions to the prohibitions would be allowed for certain health, safety, valid existing rights, resource protection, and ecological management needs. The goal of the Department is to have the State-Specific Rule for Inventoried Roadless Areas in Colorado in place by September 2008. Statement of Need: The Department of Agriculture is committed to conserving and managing roadless values and considers inventoried roadless areas an important component of the National Forest System. The roadless rule has been the subject of 10 lawsuits in Federal district courts in Idaho, Utah, North Dakota, Wyoming, Alaska, and the District of Columbia. On July 14, 2003, the U.S. District Court for the District of Wyoming found the 2001 roadless rule to be unlawful and ordered that the rule be permanently enjoined. On May 13, 2005, the Forest Service promulgated the State Petitions Rule. The State Petitions Rule allowed Governors to voluntarily seek establishment of or adjustment of management requirements for National Forest System inventoried roadless areas within their States. If a petition was not received within 18 months, inventoried roadless areas would be guided by individual land management plans. In also established the Roadless Area Conservation National Advisory Committee (RACNAC) to make recommendations on State- petitions to the Secretary. With the promulgation of the State Petitions Rule, the Tenth Circuit, which was reviewing an appeal by intervenors of the Wyoming court's decision, dismissed the case as moot. Under the guidance of the State Petitions Rule the States of California, Idaho, New Mexico, North Carolina, South Carolina, and Virginia filed a petition with the Secretary. The Secretary instructed the Forest Service to enter into rulemaking for North Carolina, South Carolina, and Virginia. Two lawsuits were filed against the State Petitions Rule in the Federal district court for the Northern District of California. One suit was filed by the States of California, New Mexico, Oregon, and Washington with the State of Montana being amicus curiae in support of plaintiffs; and the States of Alaska and Idaho are amici curiae to USDA. The other lawsuit was filed by a coalition of environmental groups. On September 20, 2006, the Federal district court enjoined the State Petitions Rule and reinstated the roadless rule. In an effort to again re-enjoin the roadless rule, the State of Wyoming filed a second lawsuit in the Federal district court for Wyoming on January 12, 2007. Oral hearing for this lawsuit is schedule for October 19. With the reinstatement of roadless rule, the Under Secretary announced that interested States could still petition the Secretary pursuant to 5 U.S.C. Sec. 553(e) and 7 C.F.R. Sec. 1.28. On November 13, 2006, Colorado Governor Bill Owens submitted his petition under these authorities. On April 11, 2007, Colorado Governor Bill Ritter resubmitted the petition with amendments. The RACNAC reviewed the petition and made recommendations to the Secretary on August 2, 2007. Collaboratively working on the establishment of a State-specific roadless rule for the petitioning State will allow the State the level of management of inventoried roadless areas it seeks to best meet its needs in balance with the Department's and Forest Service's goals for the conserving and managing roadless values nationally. In addition, it will allow for the management of these lands in that State without being affected by other legal actions concerning the roadless rule or State Petitions Rule. Summary of Legal Basis: On January 12, 2001, the Department of Agriculture promulgated the Roadless Area Conservation Rule to provide for the conservation and management of approximately 58.5 million acres of inventoried roadless areas within the National Forest System under the principles of the Multiple-Use Sustained-Yield Act of 1960. The State of Colorado has petitioned the Secretary pursuant to 5 U.S.C. Sec. 553(e) and 7 C.F.R. Sec. 1.28 for state-specific rules to replace this national rule. Alternatives: The Forest Service is preparing environmental impact statements in support of the rulemaking effort. Besides the proposed rule, two alternatives are being considered (1) continuation of the RACR for management of these inventoried roadless areas, and (2) using existing forest plans and future forest plan revisions to determine the management of these areas. Anticipated Costs and Benefits: It is anticipated that this proposed rule will not be an economically significant rule, and will not have an annual effect of $100 million or more on the economy nor adversely affect productivity, competition, jobs, the environment, public health or safety, nor State or local governments. This proposed rule is not expected to interfere with an action taken or planned by another Agency nor raise new legal or policy issues. This proposed rule will not alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients of such programs. Furthermore, the proposed rule is programmatic in nature, consisting of direction for road construction, road reconstruction, timber harvesting, special uses including ski resorts, and discretionary mineral activities, which would be applied to future management activities on inventoried roadless areas in Colorado. Risks: The rule is programmatic in nature and would constrain certain activities that would reduce roadless area characteristics. Reducing or controlling the development of these lands will reduce the risk of environmental effects associated with development activities like road construction, timber harvesting, and mineral extraction. Therefore soil, water, and air quality; sources of drinking water; diversity of plant and animal communities; habitat for threatened, endangered, proposed, candidate, and sensitive species dependent on large, undisturbed areas of land; scenic quality; traditional cultural properties and sacred sites; and other locally unique characteristics would be maintained. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Proposed Rule 03/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal, State, Tribal URL For More Information: http://www.roadless.fs.fed.us. [[Page 69781]] Agency Contact: Andria D. Weeks Regulatory Analyst Department of Agriculture Forest Service ATTN: ORMS, D&R Branch 1400 Independence Avenue SW Washington, DC 20250-0003 Phone: 202 205-3610 Fax: 202 260-6539 Email: aweeks@fs.fed.us RIN: 0596-AC74 _______________________________________________________________________ USDA--FS ----------- FINAL RULE STAGE ----------- 26. PLANNING SUBPART A - NATIONAL FOREST SYSTEM LAND MANAGEMENT PLANNING Priority: Other Significant Legal Authority: 5 USC 301; 16 USC 1604, 1614 CFR Citation: 36 CFR Part 219 Legal Deadline: None Abstract: The Forest Service is proposing to provide notice and seek comment from the public on the 2005 planning rule (70 FR 1022) as published in the Federal Register on January 5, 2005. This action responds to an order dated March 30, 2007 by Phyllis J. Hamilton, United States District Court Judge in Citizens for Better Forestry et al. v. US DA (N.D. Calif.)). The judge enjoined the USDA from implementation and utilization of the 2005 planning rule until it provides notice and comment and complies with APA, ESA, and NEPA. The rule, cost benefit analysis, and civil rights impact analysis have been cleared by the Department and OMB as documented in the January 5, 2005 Federal Register notice. This action is a continuation of the 2005 planning rule that describes the National Forest System land management planning framework; establishes requirements for sustainability of social, economic, and ecological systems and developing, amending, revising, and monitoring land management plans; and clarifies that land management plans under this final rule, absent extraordinary circumstances, are strategic in nature and are one stage in an adaptive cycle of planning for management of National Forest System lands. Statement of Need: The Forest Service is providing notice and opportunity for comment on a proposed rule for National Forest System land management planning, and then adopting a final rule at 36 CFR 219, subpart A. This rulemaking is the result of a U.S. district court order dated March 30, 2007, which enjoined the United States Department of Agriculture from implementation and utilization of the land management planning rule published in 2005 (70 FR1023) until it complies with the court's order regarding the National Environmental Policy Act, the Endangered Species Act, and the Administrative Procedure Act (Citizens for Better Forestry et al. v. USDA, C.A. C05-1144 (N. D. Cal.)). The purpose of this rulemaking is to respond to the court's ruling about notice and comment requirements under the Administrative Procedure Act by publishing the 2005 rule as a proposed rule. In addition, the Agency is preparing an environmental impact statement under the National Environmental Policy Act and will comply with the court's order regarding the Endangered Species Act. The Agency is committed to transparent rulemaking and public participation, and provided a notice and comment period for the proposed 2005 rule (December 6, 2002, 67 FR 72770). In the final 2005 rule, the Agency changed the provisions for timber management requirements, changed the provisions for making changes to the monitoring program, and added provisions for environmental management system (EMS). The Environmental Management System provisions require the Agency to define a structure and system of organizational activities, responsibilities, practices, and procedures for carrying out the Agency environmental policy. The court found that the proposed rule did not provide sufficient notice to the public of these changes to the final rule such that the final rule was not the logical outgrowth of the proposed rule. Therefore, the Agency is providing notice and seeking comment on a proposed rule that is essentially identical to the 2005 final rule, including the changes made to the final 2005 planning rule. Regarding NEPA, the court further found that the 2005 planning rule did not fit the Agency's categorical exclusion for servicewide administrative procedures. That categorical exclusion, developed with public participation, is a recognized method of NEPA compliance. Under the court's order, however, further environmental analysis under NEPA is required. The Agency published a Notice of Intent to Prepare an Environmental Impact Statement in the Federal Register on May 11, 2007 (72 FR 26775), to start the public involvement process pursuant to NEPA. Summary of Legal Basis: The Forest and Rangeland Renewable Resources Planning Act of 1974 (88 Stat. 476 et seq.), as amended by the National Forest Management Act of 1976 (NFMA) (90 Stat. 2949 et seq.), requires the Secretary to promulgate regulations under the principles of the Multiple-Use Sustained-Yield Act of 1960 that set out the process for the development and revision of land management plans (16 U.S.C. 1604(g)). Alternatives: The draft environmental impact statement accompanying the proposed rule documents detailed analysis of the proposed rule and four other alternatives. Those other alternatives are the 2000 planning rule, the 1982 planning rule, and two variations of the 2005 planning rule. Anticipated Costs and Benefits: Annualized costs of implementing the proposed rule (2005 rule) have been estimated and discounted at three percent and seven percent discount rates for the period 2008 to 2022. Those discounted costs are $99 million at three percent and $99.2 million at seven percent. This represents an estimated annualized savings over the 2000 rule of $30 million at three percent and $28 million at seven percent. Numerous non-quantifiable benefits are expected to result from the final planning rule. The overall goal of the proposed rule is more clearly based on the Multiple-Use Sustained-Yield Act (MUSYA) and better describes the relationship of the MUSYA to sustainability. This feature more clearly defines Agency responsibilities to weigh and balance uses of NFS lands for the benefit of the American people. The proposed rule is based on a stronger emphasis on working with the public, other Federal agencies, federally recognized Indian Tribes, and others, and should result in more social satisfaction with Agency efforts and [[Page 69782]] management. The incorporation of ecologically-based management principles, improved monitoring and evaluation, and consideration of science in planning, should result in a flexible process that reduces the burden on both the public and the Agency. An efficient planning process that addresses public concerns and leads to improved health of public lands has value beyond the cost savings estimated in the analysis. Therefore, it is highly likely that the proposed rule is beneficial to the public interest. Risks: The Forest Service is responsible for managing the lands and resources of the National Forest System (NFS), which include 193 million acres in 44 states, Puerto Rico, and the Virgin Islands. The NFS is composed of 155 national forests, 20 national grasslands, one national prairie, and other miscellaneous lands under the jurisdiction of the Secretary of Agriculture (the Secretary). The planning rule would establish administrative procedures whereby land management plans for NFS units are developed, revised, and amended. The 2005 planning rule was developed to take advantage of the experience gained from 25 years of implementing the National Forest Management Act. The rule improves on both the 1982 and 2000 planning rules. The findings from two reviews of the 2000 planning rule can be summarized as follows: it has both definitions and analytical requirements that are very complex, unclear, and, therefore, subject to inconsistent implementation across the Agency; compliance with the regulatory direction on such matters as ecological sustainability and science consistency checks would be difficult, if not impossible, to accomplish; and, the complexity of the 2000 rule makes it difficult and expensive to implement. This newest planning rule is intended to provide a planning process that is readily understood, is within the Agency's capability to implement, is consistent with the capabilities of National Forest System lands, recognizes the strategic programmatic nature of planning, and meets the intent of the National Forest Management Act (NFMA) while making cost effective and efficient use of resources allocated to the Agency for land management planning. Absent this rule, the Agency would have to continue to use the 2000 rule with all of its identified deficiencies. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Final Action 11/00/07 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Andria Weeks Regulatory Anaylst Department of Agriculture Forest Service ATT: ORMS, D&R Branch 1400 Independence Avenue SW Washington, DC 20250-0003 Phone: 202 205-3610 Fax: 202 260-6539 Email: aweeks@fs.fed.us RIN: 0596-AC70 _______________________________________________________________________ USDA--Rural Business-Cooperative Service (RBS) ----------- FINAL RULE STAGE ----------- 27. DELIVERY ENHANCEMENT FOR GUARANTEED LOANS Priority: Other Significant Legal Authority: 5 USC 301; 7 USC 1926(a)(1); 7 USC 1932(a); 7 USC 8106 CFR Citation: 7 CFR 4279, subpart A; 7 CFR 4279, subpart B; 7 CFR 4287, subpart B; 7 CFR 4280, subpart B; 7 CFR 3575, subpart A Legal Deadline: None Abstract: Rural Development is proposing a unified guaranteed loan platform for enhanced delivery of four existing Rural Development guaranteed loan programs--Community Facility; Water and Waste Disposal; Business and Industry; and Renewable Energy Systems and Energy Efficiency Improvement Projects. The proposed rulemaking would eliminate the existing loan guarantee regulations for these four programs and consolidate them under a new, single part. Statement of Need: The proposed rule will consolidate certain provisions of the existing regulations for guaranteed loans under the community facilities, water and waste disposal, business and industry, and renewable energy systems and energy efficiency improvement programs. The consolidation will result in greater consistency among common program provisions, as well as, increased management efficiency while reducing program losses. Summary of Legal Basis: Consolidated Farm and Rural Development Act, as amended, and section 9006 of the farm Security and Rural investment Act of 2002 (107 Pub. L. 171) Alternatives: Leave the existing regulations supporting the four Rural Development guaranteed loan programs intact and unconsolidated, which requires lenders and borrowers to be separately determined eligible and approved for each of the four programs, and to be adept and knowledgeable of each programs separate regulations and forms. Anticipated Costs and Benefits: The Agency's benefit cost analysis indicates that the benefits derived from the rule are reduced paper work and risk of loss to the Government. The benefit cost analysis estimates that the consolidation and streamlining program delivery will reduce paperwork costs by 30 percent for a savings of $1.3 million for lenders and borrowers. The Government will benefit from reduced losses resulting from improved program management and there could be some modest administrative cost savings. Risks: The proposed rule would reduce project risk by implementing new requirements for determining minimum project eligibility, including certain debt coverage and loan to value ratio requirements. The proposed rule would reduce institutional risk by establishing criteria for approved and preferred lenders. With more stringent eligibility requirements, including specific experience requirements, the agency expects to benefit from preferred lenders seeking guarantees on higher quality loans. The proposed rule would reduce agency risk exposure by allowing approved lenders to submit a low [[Page 69783]] documentation application, if the borrower meets increased financial requirements for debt coverage and loan to value ratios and has a credit score comparable to private commercial lending practices. The maximum loan guarantee will be reduced by 10 percent when approved lenders submit low documentation applications under $5 million. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/14/07 72 FR 52618 NPRM Comment Period End 11/13/07 Final Action 06/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Undetermined Agency Contact: Michael Foore Program Advisor, Office of the Administrator Department of Agriculture Rural Business-Cooperative Service 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 205-0056 Fax: 202 690-4737 Email: michael.foore@wdc.usda.gov Related RIN: Merged with 0570-AA41 RIN: 0570-AA65 _______________________________________________________________________ USDA--Rural Utilities Service (RUS) ----------- FINAL RULE STAGE ----------- 28. RURAL BROADBAND ACCESS LOANS AND LOAN GUARANTEES Priority: Other Significant Legal Authority: PL 107-171; 7 USC 901 et seq CFR Citation: 7 CFR 1738 Legal Deadline: None Abstract: There has been more than $1.1 billion in loans for broadband deployment with more than 1,000 rural communities that will receive broadband services. Even with this level of success, the program needs to be adjusted to better serve unserved or underserved communities. In response, we are revising the broadband rule to address this and other critical issues, and further facilitate the deployment of broadband service in rural America as directed by Congress by: (1) Clearly defining served, underserved markets based on service availability and existing competitors and target unserved an underserved areas; (2) Providing potential applicants with a clear definition of which communities are eligible for funding; (3) Establishing a minimum data transmission rate that the facilities financed must be able to deliver to the consumer; (4) Establishing equity requirements that mitigate risks; (5) Modifying market survey requirements based on service territories and existing availability of service; and (6) Imposing new time limits for build-out and deployment to ensure prudent use of loan funds and timely delivery services to rural customers. Statement of Need: Since the Broadband Loan Program's inception, the Agency has faced and continues to face significant challenges in administering the program, including the fierce competitive nature of the broadband market, the fact that many companies proposing to offer broadband service are start-up organizations with limited resources, continually evolving technology, and economic factors such as the higher cost of serving rural communities. Because of these challenges, the Agency has been reviewing the characteristics of the Broadband Loan Program and has determined that modifications are required to accelerate the deployment of broadband service to the rural areas of the country. The Broadband Loan Program is important to the revitalization of our rural communities and their economies. A lack of private capital has been cited as a reason for slow broadband deployment. However, an adequate supply of investment capital alone may not be sufficient to universally deploy broadband facilities in rural America--primarily due to the high cost of deployment outside of more densely populated areas. Due to market uncertainties and risks associated with startup ventures, non-federal sources of funding are restricting and raising the cost of capital, particularly in costly rural markets. Better access to low cost capital is a primary initiative of this program in facilitating as increase in the rate of rural broadband deployment. Summary of Legal Basis: On May 13, 2002, the Farm Security and Rural Investment Act of 2002, Public Law 107-171 (``Farm Bill'') was signed into law. Title VI of the Farm Bill authorized the Agency to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. Anticipated Costs and Benefits: The program costs associated with lending activity are relatively low. The average subsidy rate since the programs inception is 2.4 percent, or $24,000 in appropriated budget authority for every $1 million in loans. The residents and businesses of rural communities are the beneficiaries. Rural Development is responsible for helping rural America transition from an agricultural base economy to a platform for new business and economic opportunity. Rural Development seeks to leverage its financial resources with private investment to facilitate the development of the changing rural economy. The Broadband Loan Program provides rural America with the platform on which to achieve these goals. With access to the same advanced telecommunications networks as its urban counterparts, especially broadband networks designed to accommodate distance learning, telework and telemedicine, rural America will eventually see improving educational opportunities, health care, economies, safety and security, and ultimately higher employment. The Agency shares the assessment of Congress, state and local officials, industry representatives, and rural residents that broadband service is a critical component to the future of rural America. The Agency is committed to ensuring that rural America will have access to affordable, reliable, broadband services, and to provide a healthy, safe and prosperous place to live and work. Risks: Building broadband infrastructure in sparsely populated rural communities is very capital intensive. The Broadband Loan Program continues to face risk factors that pose challenges in ensuring that proposed projects can and do deliver robust, affordable broadband services to rural consumers. These factors include the sometimes competitive nature of the broadband market, the fact that many companies [[Page 69784]] proposing to offer broadband service are start-up organizations with limited resources, rapidly evolving technology, and economic factors such as the higher cost of serving rural communities. While many of the smallest rural communities understand the importance of broadband infrastructure to their economic development, they often have difficulty attracting service providers to their communities. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/11/07 72 FR 26742 NPRM Comment Period End 07/10/07 Final Action 03/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Michele L Brooks Acting Director, Program Development and Regulatory Analysis Department of Agriculture Rural Utilities Service Room 5159 South Building Stop 1522 1400 Independence Avenue SW Washington, DC 20250 Phone: 202 690-1078 Fax: 202 720-8435 Email: michele.brooks@usda.gov RIN: 0572-AC06 BILLING CODE 3410-90-S [[Page 69785]] DEPARTMENT OF COMMERCE (DOC) Statement of Regulatory and Deregulatory Priorities Enhancing long-term economic growth is a central focus of the President's policies and priorities. The mission of the Department of Commerce is to promote job creation, economic growth, technological competitiveness, sustainable development, and improve living standards for all Americans by working in partnership with businesses, universities, communities, and workers to: Build for the future and promote U.S. economic competitiveness in the global marketplace by strengthening and safeguarding the Nation's economic infrastructure; Keep America competitive with cutting-edge science and technology and an unrivaled information base; and Provide effective management and stewardship of our Nation's resources and assets to ensure sustainable economic opportunities. The DOC mission statement, containing our three strategic themes, provides the vehicle for understanding the Department's aims, how they interlock, and how they are to be implemented through our programs. This statement was developed with the intent that it serve as both a statement of departmental philosophy and as the guiding force behind the Department's programs. The importance that this mission statement and these strategic themes have for the Nation is amplified by the vision they pursue for America's communities, businesses, and families. Commerce is the smallest Cabinet agency, yet our presence is felt, and our contributions are found, in every State. The DOC touches Americans, daily, in many ways--we make possible the weather reports that all of us hear every morning; we facilitate the technology that all of us use in the workplace and in the home each day; we support the development, gathering, and transmitting of information essential to competitive business; we make possible the diversity of companies and goods found in America's (and the world's) marketplace; and we support environmental and economic health for the communities in which Americans live. The DOC has a clear and powerful vision for itself, for its role in the Federal Government, and for its roles supporting the American people, now and in the future. We confront the intersection of trade promotion, civilian technology, economic development, sustainable development, and economic analysis, and we want to provide leadership in these areas for the Nation. We work to provide programs and services that serve our country's businesses, communities, and families, as initiated and supported by the President and the Congress. We are dedicated to making these programs and services as effective as possible, while ensuring that they are being delivered in the most cost-effective ways. We seek to function in close concert with other agencies having complementary responsibilities so that our collective impact can be most powerful. We seek to meet the needs of our customers quickly and efficiently, with programs, information, and services they require and deserve. As a permanent part of the Federal Government, but serving an Administration and Congress that can vary with election results, we seek to serve the unchanging needs of the Nation, according to the priorities of the President and the Congress. The President's priorities for the Department range from issues concerning the economy to the environment. For example, the President directs the Department to promote electronic commerce activities; encourage open and free trade; represent American business interests abroad; and assist small businesses to expand and create jobs. We are able to address these priorities effectively by functioning in accordance with the legislation that supports our programs and by working closely with the President and the committees in Congress that have programmatic and financial oversight for our programs. The DOC also promotes and expedites American exports, helps nurture business contacts abroad, protects U.S. firms from unfair foreign competition, and makes how-to-export information accessible to small and mid-sized companies throughout the Nation, thereby ensuring that U.S. market opportunities span the globe. The DOC encourages development in every community, clearing the way for private-sector growth by building and rebuilding economically deprived and distressed communities. We promote minority entrepreneurship to establish businesses that frequently anchor neighborhoods and create new job opportunities. We work with the private sector to enhance competitive assets. As the Nation looks to revitalize its industries and communities, the DOC works as a partner with private entities to build America with an eye on the future. Through technology, research and development, and innovation, we are making sure America continues to prosper in the short term, while also helping industries prepare for long-term success. The DOC's considerable information capacities help businesses understand clearly where our national and world economies are going and take advantage of that knowledge by planning the road ahead. Armed with the Department's economic and demographic statistics, businesses can undertake new ventures, investments, and expansions that make our economy grow. The DOC has instituted programs and policies that lead to cutting-edge, competitive, and better paying jobs. We work every day to boost exports, to deregulate business, to help smaller manufacturers battle foreign competition, to advance the technologies critical to our future prosperity, to invest in our communities, and to fuse economic and environmental goals. The DOC is American business' surest ally in job creation, serving as a vital resource base, a tireless advocate, and its Cabinet-level voice. The Regulatory Plan tracks the most important regulations that implement these policy and program priorities, several of which involve regulation of the private sector by the Department. Responding to the Administration's Regulatory Philosophy and Principles The vast majority of the Department's programs and activities do not involve regulation. Of the Department's 12 primary operating units, only the National Oceanic and Atmospheric Administration (NOAA) will be planning actions that are considered the ``most important'' significant preregulatory or regulatory action for fiscal year 2008. During the next year, NOAA plans to publish four rulemaking actions that are designated as Regulatory Plan actions. Further information on these actions is provided below. Though not principally a regulatory agency, the DOC has long been a leader in advocating and using market-oriented regulatory approaches in lieu of traditional command-and-control regulations when such approaches offer a better alternative. All regulations are designed and implemented to maximize societal benefits while placing the [[Page 69786]] smallest possible burden on those being regulated. The DOC is also refocusing on its regulatory mission by taking into account, among other things, the President's regulatory principles. To the extent permitted by law, all preregulatory and regulatory activities and decisions adhere to the Administration's statement of regulatory philosophy and principles, as set forth in section 1 of Executive Order 12866. Moreover, we have made bold and dramatic changes, never being satisfied with the status quo. We have emphasized, initiated, and expanded programs that work in partnership with the American people to secure the Nation's economic future. At the same time, we have downsized, cut regulations, closed offices, and eliminated programs and jobs that are not part of our core mission. The bottom line is that, after much thought and debate, we have made many hard choices needed to make this Department ``state of the art.'' The Department has a long-standing policy to prohibit the issuance of any regulation that discriminates on the basis of race, religion, gender, or any other suspect category, and requires that all regulations be written so as to be understandable to those affected by them. The Secretary also requires that the Department afford the public the maximum possible opportunity to participate in departmental rulemakings, even where public participation is not required by law. National Oceanic and Atmospheric Administration The National Oceanic and Atmospheric Administration (NOAA) establishes and administers Federal policy for the conservation and management of the Nation's oceanic, coastal, and atmospheric resources. It provides a variety of essential environmental services vital to public safety and to the Nation's economy, such as weather forecasts and storm warnings. It is a source of objective information on the state of the environment. NOAA plays the lead role in achieving the departmental goal of promoting stewardship by providing assessments of the global environment. Recognizing that economic growth must go hand-in-hand with environmental stewardship, the Department, through NOAA, conducts programs designed to provide a better understanding of the connections between environmental health, economics, and national security. Commerce's emphasis on ``sustainable fisheries'' is designed to boost long term economic growth in a vital sector of the US economy while minimizing any economic dislocation necessary to ensure long term economic growth. The Department is where business and environmental interests intersect, and the classic debate on the use of natural resources is transformed into a ``win-win'' situation for the environment and the economy. Three of NOAA's major components, the National Marine Fisheries Services (NMFS), the National Ocean Service (NOS), and the National Environmental Satellite, Data, and Information Service (NESDIS), exercise regulatory authority. NMFS oversees the management and conservation of the Nation's marine fisheries, protects marine mammals, and promotes economic development of the U.S. fishing industry. NOS assists the coastal States in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages the Nation's national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy. NESDIS administers the civilian weather satellite program and licenses private organizations to operate commercial land-remote sensing satellite systems. The Administration is committed to an environmental strategy that promotes sustainable economic development and rejects the false choice between environmental goals and economic growth. The intent is to have the Government's economic decisions guided by a comprehensive understanding of the environment. The Department, through NOAA, has a unique role in promoting stewardship of the global environment through effective management of the Nation's marine and coastal resources and in monitoring and predicting changes in the Earth's environment, thus linking trade, development, and technology with environmental issues. NOAA has the primary Federal responsibility for providing sound scientific observations, assessments, and forecasts of environmental phenomena on which resource management and other societal decisions can be made. In the environmental stewardship area, NOAA's goals include: rebuilding and maintaining strong U.S. fisheries by using market based ecosystem approaches to management; increasing the populations of depleted, threatened, or endangered species of marine mammals by implementing recovery plans that provide for their recovery while still allowing for economic and recreational opportunities; promoting healthy coastal ecosystems by ensuring that economic development is managed in ways that maintain biodiversity and long-term productivity for sustained use; and modernizing navigation and positioning services. In the environmental assessment and prediction area, goals include: modernizing the National Weather Service; implementing reliable seasonal and interannual climate forecasts to guide economic planning; providing science-based policy advice on options to deal with very long-term (decadal to centennial) changes in the environment; and advancing and improving short-term warning and forecast services for the entire environment. Magnuson-Stevens Fishery Conservation and Management Act Magnuson-Stevens Fishery Conservation and Management Act (Magnuson- Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. 3- to 200-mile Exclusive Economic Zone. Among the several hundred rulemakings that NOAA plans to issue in fiscal year 2008, a number of the preregulatory and regulatory actions will be significant. The exact number of such rulemakings is unknown, since they are usually initiated by the actions of eight regional Fishery Management Councils (FMCs) that are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for drafting implementing regulations for each managed fishery. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens Act places stringent deadlines upon NMFS by which it must exercise its rulemaking responsibilities. The Magnuson-Stevens Act, which is the primary legal authority for federal regulation to conserve and manage fishery resources, establishes eight regional FMCs, responsible for preparing FMPs and FMP amendments. NMFS issues regulations to implement FMPs and FMP amendments. FMPs address a variety of issues including maximizing fishing opportunities on health stocks, rebuilding overfished stocks, and addressing gear conflicts. One of the problems that FMPs may address is preventing overcapitalization (preventing excess fishing capacity) of fisheries. This may be resolved by market based systems such as allocating the resource through individual transferable quotas, which can be sold on the open market to other participants [[Page 69787]] or those wishing access. Quotas set on sound scientific information, whether as a total fishing limit for a species in a fishery or as a share assigned to each vessel participant, enable stressed stocks to rebuild. Other measures include staggering fishing seasons or limiting gear types to avoid gear conflicts on the fishing grounds, and establishing seasonal and area closures to protect fishery stocks. The FMCs provide a forum for public debate and, using the best scientific information available, make the judgments needed to determine optimum yield on a fishery-by-fishery basis. Optional management measures are examined and selected in accordance with the national standards set forth in the Magnuson-Stevens Act. This process, including the selection of the preferred management measures, constitutes the development, in simplified form, of an FMP. The FMP, together with draft implementing regulations and supporting documentation, is submitted to NMFS for review against the national standards set forth in the Magnuson-Stevens Act, in other provisions of the Act, and other applicable laws. The same process applies to amending an existing approved FMP. The Magnuson-Stevens Act contains ten national standards against which fishery management measures are judged. NMFS has supplemented the standards with guidelines interpreting each standard, and has updated and added to those guidelines. One of the national standards requires that management measures, where practicable, minimize costs and avoid unnecessary duplication. Under the guidelines, NMFS will not approve management measures submitted by an FMC unless the fishery is in need of management. Together, the standards and the guidelines correspond to many of the Administration's principles of regulation as set forth in section 1(b) of Executive Order 12866. One of the national standards establishes a qualitative equivalent to the Executive Order's ``net benefits'' requirement--one of the focuses of the Administration's statement of regulatory philosophy as stated in section 1(a) of the Executive Order. On January 17, 2007, the President signed into law the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 (MSRA). This important new law is identified by the President as one of his priority actions in the U.S. Ocean Plan. The enactment of the law reaffirms the importance of the goals of the Magnuson-Stevens Act, but more importantly, it implements important groundbreaking provisions that could enhance fisheries management. The new measures implemented by this law would work to end overfishing; promote market-based management approaches; improve science by providing a stronger role for peer review and for the Councils' Science and Statistical Committees (SSC) in decision-making, and improving the collection of accurate and precise fishing data; and enhance international cooperation by addressing Illegal Unreported and Unregulated (IUU) fishing and bycatch of protected living marine resources. NMFS will be initiating several rulemakings in the coming year to implement these important provisions. Marine Mammal Protection Act The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the take of marine mammals. Exceptions include the collection of wild animals for scientific research or public display or to enhance the survival of a species or stock. NMFS initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. The Act also established the Marine Mammal Commission, which makes recommendations to the Secretaries of the Departments of Commerce and the Interior and other Federal officials on protecting and conserving marine mammals. The Act underwent significant changes in 1994 to allow for takings incidental to commercial fishing operations, to provide certain exemptions for subsistence and scientific uses, and to require the preparation of stock assessments for all marine mammal stocks in waters under U.S. jurisdiction. Endangered Species Act The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be ``endangered'' or ``threatened,'' and the conservation of the ecosystems on which these species depend. The ESA authorizes both NMFS and the Fish and Wildlife Service (FWS) to jointly administer the provision in the Act. NMFS manages marine and ``anadromous'' species and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the 1,310 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over approximately 60 species. NMFS' rulemaking actions are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing, and revising critical habitat for any listed species. In addition, under the ESA's procedural framework, federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect one of the listed species or designated critical habitat, or is likely to jeopardize proposed species or adversely modify proposed critical habitat that is under NMFS' jurisdiction. NOAA's Regulatory Plan Actions While most of the rulemakings undertaken by NOAA do not rise to the level necessary to be included in the Department's Regulatory Plan, NMFS is undertaking four actions that rise to the level of ``most important'' of the Departments significant regulatory actions, and thus are included in this year's Regulatory Plan. Three actions implement provisions of the Magnuson-Steven Reauthorization Act (MSRA), and are summarized below: ``Provide Guidance for the Limited Access Privilege Program Provisions of the Magnuson-Stevens Fishery Conservation Reauthorization Act of 2006'' -- This action would provide regions with interpretive guidance on the use of Limited Access Privilege Programs (LAPP) as fishery management tools. The guidance is intended to assist the fishery management councils and NMFS regional offices in developing and implementing LAPPS. ``Guidance for Annual Catch Limits and Accountability Measures to End Overfishing'' -- In this action, NMFS would implement provisions that require fishery management plans to establish annual catch limits (ACLs), including regulations and annual specifications, at a level such that overfishing does not occur in a fishery. In addition, this action would implement measures to ensure accountability. ``Certification of Nations Whose Fishing Vessels Are Engaged in IUU Fishing or Bycatch of Protected Living Marine Resources'' -- In this action, NMFS would establish a process of identification and certification to address Illegal, Unreported, or [[Page 69788]] Unregulated (IUU) activities and bycatch of protected species in international fisheries. Nations whose fishing vessels engage, or have been engaged, in IUU fishing or bycatch of protected living marine resources would be identified in a biennial report to Congress. NMFS would subsequently certify whether identified nations have taken appropriate corrective action with respect to the activities of its fishing vessels, as required under section 403 of MSRA. In addition to actions related to the Magnuson-Stevens Reauthorization Act, NMFS is developing one action under the authority of the ESA entitled ``Endangered Fish and Wildlife; Implement Speed Restrictions to Reduce the Threat of Ship Collisions with North Atlantic Right Whales.'' In this action, NMFS proposes to impose speed restrictions on ships in certain areas during certain times of the year in an attempt to reduce mortalities to North Atlantic right whales as a result of collisions with vessels, which account for more confirmed right whale deaths than any other human-related activity. The strategy addresses the lack of recovery of the endangered North Atlantic right whale by reducing the likelihood of ship strike mortalities to the species. NMFS has developed a framework of proposed, new operational measures for the shipping industry as an element of this strategy, including consideration of routing and speed restrictions. These operational measures would be limited to areas and times when North Atlantic right whales and ships overlap to reduce the likelihood of ship strikes to the extent practicable. NOAA's four Regulatory Plan actions support several of the President's priorities as stated in the U.S. Ocean Action Plan. Specifically, NMFS' regulatory actions implement the President's ongoing effort to combat international illegal, unregulated and unreported fishing activities through its proposed identification and certification process; support the goal to use market-based systems for fisheries management by using dedicated access privileges as fishery management tools; and support the President's overall goal of enhancing conservation of marine mammals, sharks and sea turtles, which are species that are of special concern and that face a variety of threats from human actives. At this time, NOAA is unable to determine the aggregate cost of the identified Regulatory Plan actions as the majority of these actions are currently under development. For the one action where an economic analysis has been completed (right whale ship collision rule), NOAA anticipates the costs associated with the rule could be as much as $116 million. Bureau of Industry and Security The Bureau of Industry and Security (BIS) promotes U.S. national and economic security and foreign policy interests by managing and enforcing the Department's security-related trade and competitiveness programs. BIS plays a key role in challenging issues involving national security and nonproliferation, export growth, and high technology. The Bureau's continuing major challenge is combating the proliferation of weapons of mass destruction while furthering the growth of U.S. exports, which are critical to maintaining our leadership in an increasingly competitive global economy. BIS strives to be the leading innovator in transforming U.S. strategic trade policy and programs to adapt to the changing world. Major Programs and Activities The Export Administration Regulations (EAR) provide for export controls on dual-use goods and technology (primarily commercial goods that have potential military applications) not only to fight proliferation, but also to pursue other national security, short supply, and foreign policy goals (such as combating terrorism). Simplifying and updating these controls in light of the end of the Cold War has been a major accomplishment of BIS. BIS is also responsible for: Enforcing the export control and antiboycott provisions of the Export Administration Act (EAA), as well as other statutes such as the Fastener Quality Act. The EAA is enforced through a variety of administrative, civil, and criminal sanctions. Analyzing and protecting the defense industrial and technology base, pursuant to the Defense Production Act and other laws. As the Defense Department increases its reliance on dual-use high technology goods as part of its cost-cutting efforts, ensuring that we remain competitive in those sectors and subsectors is critical to our national security. Helping Ukraine, Kazakhstan, Belarus, Russia, and other newly emerging countries develop effective export control systems. The effectiveness of U.S. export controls can be severely undercut if ``rogue states'' or terrorists gain access to sensitive goods and technology from other supplier countries. Working with former defense plants in the Newly Independent States to help make a successful transition to profitable and peaceful civilian endeavors. This involves helping remove unnecessary obstacles to trade and investment and identifying opportunities for joint ventures with U.S. companies. Assisting U.S. defense enterprises to meet the challenge of the reduction in defense spending by converting to civilian production and by developing export markets. This work assists in maintaining our defense industrial base as well as preserving jobs for U.S. workers. _______________________________________________________________________ DOC--National Oceanic and Atmospheric Administration (NOAA) ----------- PROPOSED RULE STAGE ----------- 29. PROVIDE GUIDANCE FOR THE LIMITED ACCESS PRIVILEGE PROGRAM PROVISIONS OF THE MAGNUSON-STEVENS FISHERY CONSERVATION REAUTHORIZATION ACT OF 2006 Priority: Other Significant Legal Authority: 16 USC 1801 et seq. CFR Citation: 50 CFR 600 Legal Deadline: None Abstract: This rule will provide regions with interpretive guidance on the use of Limited Access Privilege Programs as fishery management tools. The guidance is intended to assist the fishery management councils and NMFS regional offices in developing and implementing LAPPS. Statement of Need: The National Oceanic and Atmospheric Administration (NOAA) National Marine Fisheries Service (NMFS) intends to proposed this rulemaking to create national guidance for the new Limited Access Privilege Program (LAPP) provisions found in section 303(A) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), as amended by the [[Page 69789]] Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 (MSRA). The LAPP provisions provide new incentive-based options for fisheries management. NMFS has received numerous requests from constituent groups, Regional Fishery Management Councils (Councils), and Congress to develop such guidance. This guidance will assist Councils develop LAPPs with full consideration of national perspectives and concerns. Summary of Legal Basis: NMFS is proposing these regulations pursuant to its rulemaking authority under the MSA. 5 U.S.C. 561, 16 U.S.C. 773, et seq., and 16 U.S.C. 1801 et seq. Alternatives: Because this rule is presently in the beginning stages of development, no alternatives have been formulated or analyzed at this time. Anticipated Costs and Benefits: Because this rule is presently in the beginning stages of development, no analysis has been completed at this time to asses the amount that would be saved or imposed as a result of this rule. However, this rule does not meet the $100 million annual economic impact threshold and thus has not been determined to be economically significant under EO 12866. Risks: Without this rulemaking, there is a risk that new LAPP programs will be developed that do not meet the requirements of section 303(A), and therefore may detrimentally impact the fish stocks that they are designed to manage, the fisheries, or the human environment. Among other things, reducing capacity; and promote fishing safety, fishery conservation and management, and social and economic benefits. Without guidance, LAPP programs may be developed that do not meet these requirements. Properly designed LAPPs mitigate environmental risk, ensure fair and equitable initial allocations, prevent excessive shares, protect the basic cultural and social framework of the fisheries and fishing communities, and contribute to public safety and economic prosperity. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Alan Risenhoover Director, Office of Sustainable Fisheries Department of Commerce National Oceanic and Atmospheric Administration 1315 East-West Highway Room 13362 Silver Spring, MD 20910 Phone: 301 713-2334 RIN: 0648-AV48 _______________________________________________________________________ DOC--NOAA 30. CERTIFICATION OF NATIONS WHOSE FISHING VESSELS ARE ENGAGED IN IUU FISHING OR BYCATCH OF PROTECTED LIVING MARINE RESOURCES Priority: Other Significant Legal Authority: 16 USC 1801 et seq; 16 USC 1826d to 1826k CFR Citation: 50 CFR 300 Legal Deadline: NPRM, Statutory, January 12, 2009, Identification of nations whose vessels are engaged (or have been engaged in) illegal, unreported or unregulated fishing. Abstract: The National Marine Fisheries Service (NMFS) is establishing a process of identification and certification to address Illegal, Unreported, or Unregulated (IUU) activities and bycatch of protected species in international fisheries. Nations whose fishing vessels engage, or have been engaged, in IUU fishing or bycatch of protected living marine resources would be identified in a biennial report to Congress, as required under section 403 of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA) of 2006. NMFS would subsequently certify whether identified nations have taken appropriate corrective action with respect to the activities of its fishing vessels, as required under section 403 of MSRA. Statement of Need: The National Oceanic and Atmospheric Administration's National Marine Fisheries Service (NMFS) proposes regulations to set forth identification and certification procedures for nations whose vessels engage in illgeal, unregulated and unreported (IUU) fishing activities or bycatch of protected living marine resources pursuant to the High Seas Fishing Moratorium Protection Act (Moratorium Protection Act). Specifically, the Moratorium Protection Act requires the Secretary of Commerce to identify in a biennial report to Congress those foreign nations whose vessels are engaged in IUU fishing or fishing that results in bycatch of protected living marine resources. The Moratorium Protection Act also requires the establishment of procedures to certify whether nations identified in the biennial report are taking appropriate corrective actions to address IUU fishing or bycatch of protected living marine resources by fishing vessels of that nation. Based upon the outcome of the certification procedures developed in this rulemaking, nations could be subject to import prohibitions on certain fisheries products and other measures under the authority provided in the High Seas Driftnet Fisheries Enforcement Act if the are not positively certified by the Secretary of Commerce. Summary of Legal Basis: NOAA is proposing these regulations pursuant to its rulemaking authority under sections 609 and 610 of the High Seas Driftnet Fishing Moratorium Protection Act (16 U.S.C. 1826j-k), as amended by the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act. Alternatives: NMFS is currently in the process of developing alternatives, and will provide this information at a later date. Anticipated Costs and Benefits: Because this rule is under development, NMFS does not currently have estimates of the amount of product that is imported into the United States from other nations whose vessels are engaged in illegal, unreported, and unregulated (IUU) fishing or bycatch of protected living marine resources. Therefore, quantification of the economic impacts of this rulemaking is not possible at this time. This rulemaking does not meet the $100 million annual economic impact threshold and thus has not been [[Page 69790]] determined to be economically significant under EO 12866. Risks: The risks associated with not pursuing the proposed rulemaking include allowing IUU fishing activities and/or bycatch of protected living marine resources by foreign vessels to continue without an effective tool to aid in combating such activities. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 06/11/07 72 FR 32052 ANPRM Comment Period End 07/26/07 NPRM 01/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: None Agency Contact: Dr. Rebecca Lent Regional Administrator, Southwest Region, NMFS Department of Commerce National Oceanic and Atmospheric Administration 501 West Ocean Boulevard Long Beach, CA 90802-4213 Phone: 562 980-4001 RIN: 0648-AV51 _______________________________________________________________________ DOC--NOAA 31. GUIDANCE FOR ANNUAL CATCH LIMITS (ACLS) AND ACCOUNTABILITY MEASURES (AMS) TO END OVERFISHING Priority: Other Significant Legal Authority: 16 USC 1853 CFR Citation: 50 CFR 600.310 Legal Deadline: None Abstract: Section 104(b) of the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 (MSRA), requires that in fishing year 2010, for fisheries determined by the Secretary to be subject to overfishing, and in fishing year 2011, for all other fisheries, that fishery management plans establish ACLs, including regulations and annual specifications, at a level such that overfishing does not occur in a fishery, including measures to ensure accountability. The National Marine Fisheries Service intends to prepare guidance on how to establish adequate ACLs and AMs by revising its National Standard 1 (NS1) guidelines at 50 CFR 600.310. This is because NS1 of the Magnuson-Stevens Act states that ``Conservation and management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the United States fishing industry.'' Statement of Need: The National Oceanic and Atmospheric Administration (NOAA) National Marine Fisheries Service (NMFS) is developing guidance for ending overfishing and rebuilding overfished fish stocks. NMFS takes this action to ensure that fish stocks managed by Federal fishery management plans (FMPs) under the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (MSRA) implement annual catch limits (ACLs) and accountability measures (AMs) to ensure that overfishing is prevented. ACLs and AMs are required by fishing year 2010, for all stocks undergoing overfishing, and by 2011, for all stocks. Summary of Legal Basis: NOAA is proposing these regulations pursuant to the MSRA of 2006 (P.L. 109-479). This includes a new required provision that any FMP shall ``establish a mechanism for specifying annual catch limits in the plan (including a multiyear plan), implementing regulations, or annual specifications, at a level such that overfishing does not occur in the fishery, including measures to ensure accountability.'' Provisions and guidance related to overfishing best fit under the current National Standard 1 which states: ``Conservation and management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the United States fishing industry.'' Alternatives: NMFS is currently in the process of developing alternatives, and will provide more complete information at a later date. Preliminary alternatives outlined in the Notice of Intent to prepare an Environmental Impact Statement include no action, developing performance standards that ACLs and AMs must meet but do not provide guidance on specific mechanisms, and finally develop ACL and AM guidelines that provide performance standards that ACLs must meet. Anticipated Costs and Benefits: This rule does not meet the $100 million annual economic impact threshold and thus has not been determined to be economically significant under EO 12866. Specific benefits and costs from having ACL and AM mechanisms and actual ACLs and AMs for various fisheries will not be known until ACLs and AMs are implemented in 2010, for stocks undergoing overfishing, and by 2011, for all stocks. Regional Fishery Management Councils, and NMFS, in the case of Atlantic highly migratory species, will perform environmental and socioeconomic analyses to describe specific effects for their fisheries once they determine what ACLs and AMs are needed for each stock. In general, ending overfishing immediately, rather than allowing it to continue would reduce short- term revenues for a brief period, but increase revenues at a sustainable level for the fishery earlier. Risks: Overfishing still occurs at various levels in 48 fisheries in U.S. waters, although NMFS and the Regional Fishery Management Councils have made significant improvements in recent years. A priority in the MSRA is to strengthen the Act to ensure an end to overfishing. Without this rulemaking, there is a risk that there will be more instances of overfishing, which would delay rebuilding. By implementing ACLs and AMs, mechanisms will be in place to address overfishing more quickly, thus ensuring the timely rebuilding of overfished stocks. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 11/00/07 NPRM Comment Period End 12/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None [[Page 69791]] Agency Contact: Alan Risenhoover Director, Office of Sustainable Fisheries Department of Commerce National Oceanic and Atmospheric Administration 1315 East-West Highway Room 13362 Silver Spring, MD 20910 Phone: 301 713-2334 RIN: 0648-AV60 _______________________________________________________________________ DOC--NOAA ----------- FINAL RULE STAGE ----------- 32. RIGHT WHALE SHIP STRIKE REDUCTION Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: 16 USC 1361 CFR Citation: 50 CFR 224 Legal Deadline: None Abstract: These regulations would establish speed restrictions to reduce the likelihood of North Atlantic right whale mortality as a result of collisions with vessels. Restrictions would be limited to areas and times when North Atlantic right whales and ships overlap to reduce the likelihood of ship strikes to the extent practicable. Statement of Need: The North Atlantic right whale population is depleted from past levels. Collisions with vessels are the greatest known human threat to right whales. NMFS is required under the ESA and MMPA to develop actions to recover this species. The National Oceanic and Atmospheric Administration (NOAA) proposed to establish speed restrictions on vessels 65 ft (19.8m) or greater in overall length in certain locations and at certain times of the year along the East Coast of the United States to reduce this threat. The purpose of these proposed regulatory measures is to reduce the likelihood of deaths and serious injuries to endangered North Atlantic right whales that result from collisions with ships. Summary of Legal Basis: NOAA proposed these regulations pursuant to its rulemaking authority under Marine Mammal Protection Act (MMPA) section 112(a) (16 U.S.C. 1382(a)), and Endangered Species Act (ESA) section 11(f) (16 U.S.C. 1540(f)). These proposed regulations also are consistent with the purpose of the ESA ``to provide a program for the conservation of [. . .] endangered species'' and ``the policy of Congress that all Federal departments and agencies shall seek to conserve endangered species [. . .] and shall utilize their authorities in furtherance of the purposes of [the ESA].'' 16 U.S.C. 1531(b),(c). Alternatives: NMFS identified five alternatives to the proposed action. Alternative 1 is No Action (Status Quo) in which NMFS would continue to implement existing measures and programs, largely nonregulatory, to reduce the likelihood of mortality from ship strikes. Alternative 2 includes all elements of Alternative 1 and involves use of Dynamically Managed Areas (DMA), which consists of certain vessel speed restrictions applying only when and where right whale sightings occur. Alternative 3 is vessel speed restrictions in designated areas. It includes all elements of Alternative 1 and implements large scale speed restrictions throughout the range of North Atlantic right whales. Alternative 4 is the use of recommended shipping routes. It includes all the elements of Alternative 1 and relies on altering some current vessel patterns to move vessels away from areas where whales are known to congregate. Alternative 5 is a combination that includes all elements of Alternatives 1 to 4. Alternative 6 (the proposed alternative) includes a combination of operational measures (routing measures and speed restrictions). The principal difference between Alternatives 5 and 6 is that Alternative 6 does not include large scale speed restrictions (as identified in Alternative 3) but instead relies on speed restrictions in much smaller Seasonally Managed Areas. Anticipated Costs and Benefits: Benefits: The benefits of effective measures to reduce the risk of right whale mortality caused by ship strikes are expected to be considerable. Because ship strikes are the human activity that pose the greatest known threat to right whales, adopting effective measures to reduce the incidences of ship strikes will aid in the recovery of this highly endangered species. However, monetary estimates of these benefits are currently unavailable; therefore, the discussion of these benefits specific to right whales is descriptive. Costs: The estimated costs associated with the speed restrictions are being analyzed and will be provided in the Final Environmental Impact Statement and in the accompanying Economic Analysis. Risks: The North Atlantic right whale is in danger of extinction. Absent effective action to reduce fatal ship strikes and other sources of mortality and injuries caused by human activity, the North Atlantic right whale population faces a risk of continued decline. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 06/01/04 69 FR 30857 ANPRM Comment Period Extended 07/09/04 69 FR 41446 ANPRM Comment Period Extended 09/13/04 69 FR 55135 NPRM 06/26/06 71 FR 36299 Comment Period Extended 08/14/06 71 FR 46440 NPRM Comment Period End 08/25/06 Comment Period End 10/05/06 Final Action 12/00/07 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Public Compliance Cost: Initial Cost: $0 Yearly Recurring Cost: $116,000,000 Base Year for Dollar Estimates: 2005 URL For More Information: www.nmfs.noaa.gov/pr/pr2 [[Page 69792]] Agency Contact: James H. Lecky Director, Office of Protected Resources Department of Commerce National Oceanic and Atmospheric Administration 1315 East-West Highway Silver Spring, MD 20910 Phone: 301 713-2332 RIN: 0648-AS36 BILLING CODE 3510-BW-S [[Page 69793]] DEPARTMENT OF DEFENSE (DOD) Statement of Regulatory Priorities Background The Department of Defense (DoD) is the largest Federal Department consisting of three Military Departments (Army, Navy, and Air Force), 9 Unified Combatant Commands, 17 Defense Agencies, and 11 DoD Field Activities. It has over 1,365,000 military personnel and 637,000 civilians assigned as of May 31, 2007, and over 200 large and medium installations in the continental United States, U. S. territories, and foreign countries. The overall size, composition, and dispersion of DoD, coupled with an innovative regulatory program, presents a challenge to the management of the Defense regulatory efforts under Executive Order 12866 ``Regulatory Planning and Review'' of September 30, 1993. Because of its diversified nature, DoD is affected by the regulations issued by regulatory agencies such as the Departments of Energy, Health and Human Services, Housing and Urban Development, Labor, Transportation, and the Environmental Protection Agency. In order to develop the best possible regulations that embody the principles and objectives embedded in Executive Order 12866, there must be coordination of proposed regulations among the regulating agencies and the affected DoD Components. Coordinating the proposed regulations in advance throughout an organization as large as DoD is straightforward, yet a formidable undertaking. DoD is not a regulatory agency but occasionally issues regulations that have an effect on the public. These regulations, while small in number compared to the regulating agencies, can be significant as defined in Executive Order 12866. In addition, some of DoD's regulations may affect the regulatory agencies. DoD, as an integral part of its program, not only receives coordinating actions from the regulating agencies, but coordinates with the agencies that are affected by its regulations as well. Overall Priorities The Department needs to function at a reasonable cost, while ensuring that it does not impose ineffective and unnecessarily burdensome regulations on the public. The rulemaking process should be responsive, efficient, cost-effective, and both fair and perceived as fair. This is being done in DoD while it must react to the contradictory pressures of providing more services with fewer resources. The Department of Defense, as a matter of overall priority for its regulatory program, fully incorporates the provisions of the President's priorities and objectives under Executive Order 12866. Administration Priorities: 1. Rulemakings that Support the Administration's Regulation Agenda to Streamline Regulations and Reporting Requirements The Department plans to: Direct use of electronic subcontracting and reporting system for both the summary and individual subcontract reporting, in conjunction with and as part of the integration with Federal Procurement Data System (FPDS). Require the processing of all invoices and acceptance reports and other supporting payment documentation electronically through Wide Area Workflow. Require contractors to provide item unique identification (IUID) data electronically in the IUID Registry for all DoD personal property in possession of the contractor. Simplify other Defense Federal Acquisition Regulation Supplement (DFARS) regulations relating to acquisition of Government property, consistent with the recent significant revisions to the Federal Acquisition Regulation (FAR) Part 45. Simplify and clarify the DFARS coverage of multi-year acquisitions. Simplify and clarify the DFARS regulations on patents, data and copyrights, dramatically reducing the amount of regulatory text and the number of required clauses. Waive specialty metals restrictions at 10 U.S.C. 2533b for the acquisition of commercially available off-the-shelf items. 2. Regulations of Particular Interest to Small Business Of interest to Small Businesses are regulations to: Revise the FAR to clarify the relationship among small business programs. Implement the Small Business Administration regulation requiring re-representation of size status under certain circumstances. Provide an increased claim threshold for small business concerns to appeal a contracting officer's decision under small claim procedures of the agency board of contract appeals, in accordance with Section 857 of the Fiscal Year 2007 National Defense Authorization Act. Amend the FAR to implement changes in the HUBZone Program, in accordance with Small Business Administration regulations. 3. Suggestions From the Public for Reform-Status of DoD Items Rulemaking Actions in Response to Public Nominations The Army Corps of Engineers has not undertaken any rulemaking actions in response to the public nominations submitted to the Office of Management and Budget in 2001, 2002, or 2004. Those nominations were discussed in: Making Sense of Regulation: 2001 Report to Congress on the Costs and Benefits of Regulations and Unfunded Mandates on State, Local, and Tribal Entities. Stimulating Smarter Regulation: 2002 Report to Congress on the Costs and Benefits of Regulations and Unfunded Mandates on State, Local, and Tribal Entities. Progress in Regulatory Reform: 2004 Report to Congress on the Costs and Benefits of Federal Regulations and Unfunded Mandates on State, Local, and Tribal Entities. Specific DoD Priorities: For this Regulatory Plan, there are four specific DoD priorities, all of which reflect the established regulatory principles. In those areas where rulemaking or participation in the regulatory process is required, DoD has studied and developed policy and regulations that incorporate the provisions of the President's priorities and objectives under the Executive Order. DoD has focused its regulatory resources on the most serious environmental, health, and safety risks. Perhaps most significant is that each of the priorities described below promulgates regulations to offset the resource impacts of Federal decisions on the public or to improve the quality of public life, such as those regulations concerning civil functions of the U.S. Army Corps of Engineers, acquisition, health affairs, and the National Security Personnel System. The Department does not anticipate promulgating any economically significant regulations. 1. Regulatory Program of the U.S. Army Corps of Engineers [[Page 69794]] Compensatory Mitigation in the Army Regulatory Program Section 314 of the National Defense Authorization Act for Fiscal Year 2004 (Public Law 108-136) requires the Secretary of the Army, acting through the Chief of Engineers, to issue regulations that establish performance standards and criteria for the use of compensatory mitigation for wetland functions lost as a result of activities authorized by Department of the Army (DA) permits. The statute also requires the regulation to contain provisions for the application of equivalent standards and criteria to each type of compensatory mitigation. The proposed rule was published for public comment on March 28, 2006 (71 FR 15520). The comment period expired on June 30, 2006 (71 FR 29604). The proposed regulation was developed by considering concepts in current Federal compensatory mitigation guidance documents, and updating and modifying those concepts to improve compensatory mitigation decision-making and processes. The proposed rule takes a watershed approach to compensatory mitigation for permitted impacts to wetlands, streams, and other aquatic resources. Although the statute refers only to wetlands, the proposed rule is broader in scope, and addresses compensatory mitigation requirements for impacts to other aquatic resources, such as streams, in addition to wetlands. Comments received in response to the proposed rule have been evaluated, and a final rule is being prepared. Army Regulatory Program's Compliance with the National Historic Preservation Act In 1990, the Army Corps of Engineers published as appendix C of 33 CFR part 325, a rule that governs compliance with the National Historic Preservation Act (NHPA) for the Army's Regulatory Program. Over the years, there have been substantial changes in policy, and the NHPA was amended in 1992, leading to the publication in December 2000 of new implementing regulations at 36 CFR part 800, issued by the Advisory Council on Historic Preservation (ACHP). Those regulations were amended on July 6, 2004. The ACHP's regulations allow Federal agencies to utilize alternate procedures in lieu of the regulations at 36 CFR part 800. In 2005 and 2007, the Corps Headquarters issued supplemental guidance on compliance with the NHPA while efforts were underway to revise or replace Appendix C. To solicit public comment on the appropriate mechanism for revising the Army Regulatory Program's process for considering effects to historic properties resulting from activities authorized by DA permits, the Army Corps of Engineers published an Advance Notice of Proposed Rulemaking (ANPRM) to obtain the views of interested parties. After reviewing the comments received in response to the ANPRM, the Army Corps of Engineers held facilitated stakeholder meetings to determine the best course of action for revising its procedures to comply with the requirements of Section 106 of the National Historic Preservation Act. The Corps also held additional focus group meetings facilitated by our eight division offices to gather input from federally recognized tribes on their recommendations concerning how government-to-government consultation could occur. After reviewing those recommendations, the Corps developed a consultation plan, and is currently in the process of conducting government-to-government consultation with federally recognized tribes. Also, our division offices have solicited information on topics that any new alternative procedure should address. 2. Defense Procurement and Acquisition Policy The Department of Defense continuously reviews the DFARS and continues to lead Government efforts to: Improve the DFARS to enhance the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce flexibility to innovate. The DFARS contains only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant impact on contractors, offerors, and/or the public. Establish a new restriction on acquisition of specialty metals under 10 U.S.C. 2533b, with new exception for commercially available electronic components and a one-time waiver for items produced, manufactured, or assembled in the U.S. prior to November 16, 2006. Also provides an exception for nonavailability if the specialty metal cannot be obtained when needed and in the required form. Revise the uniform treatment of contractor personnel who are authorized to accompany the U.S. Armed Forces deployed outside the United States in contingency operations, humanitarian or peacekeeping operations, other military operations, or training exercises designated by the combatant commander, to implement the new DoD Instruction and respond to public comments. Implement the DoD Law of War Program, requiring contractors to report violations. Coordinate with the Department of State to finalize a FAR rule to address uniform treatment of other contractor personnel who are performing outside the United States in a theater of operations during contingency operations; humanitarian or peacekeeping operations; other military operations; military exercises designated by the combatant commander; or at a diplomatic or consular mission, when designated by the chief of mission. Provide incentives for development and deployment of anti- terrorism technologies, in accordance with the DHS regulations on the Safety Act. Prohibit trafficking in persons by contractors, contractor employees, and subcontractors. Inform potential offerors that export control regulations apply to performance of certain contracts, and the contractor is responsible for compliance with those regulations. Improve debt collection by evaluating existing FAR controls and procedures for ensuring contract debts are identified and recovered in a timely manner, properly accounted for in each agency's books and records, and properly coordinated with the appropriate Government officials. Exempt certain contracts from coverage under the Service Contract Act if certain conditions are met, as specified by the Department of Labor. Evaluate the continued need for provisional award fee payments. Address quality control in the procurement of ship critical safety items, as required by Section 130 of the Fiscal Year 2007 National Defense Authorization Act. Provide criteria for the release of supplies by the contractor based on complexity and criticality. Require contractors to establish a code of ethics and business conduct, and establish on-going training program and internal control system commensurate with the size of the business. Authorize set-asides for awards based on specific geographic areas under the [[Page 69795]] Robert T. Stafford Disaster Relief and Emergency Assistance Act, in order to implement the Local Community Recovery Act of 2006. 3. Health Affairs, Department of Defense The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care by operating an extensive network of medical treatment facilities. This network includes DoD's own military treatment facilities supplemented by civilian healthcare providers, facilities, and services under contract to DoD through the TRICARE program. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system. The program's goal is to increase access to health care services, improve health care quality, and control health care costs. The TRICARE Management Activity plans to submit the following rules: Final rule concerning Certain Survivors of Deceased Active Duty Members and Adoption Intermediaries. The rule addresses two provisions of the National Defense Authorization Act for Fiscal Year 2006 (NDAA-06), Pub. L. 109-163. For certain dependents of Active Duty Service Members (ADSM) who die while on active duty for more than 30 days, Section 715 of the NDAA-06 extends the time frame for which they shall receive TRICARE medical benefits at active duty dependent payment rates. Second, Section 592 modifies the requirement for intermediaries who provide adoption placements. The economic impact of this rule is estimated to be less than $100 million. The interim final rule was published January 19, 2007 (72 FR 2444). Comment period ended March 20, 2007. Proposed rule on TRICARE Outpatient Prospective Payment System (OPPS). The rule implements a prospective payment system for hospital outpatient services similar to that furnished to Medicare beneficiaries, as set forth in section 1833(t) of the Social Security Act. The rule also recognizes applicable statutory requirements and changes arising from Medicare's continuing experience with its system, including certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. While TRICARE intends to remain as true as possible to Medicare's basic OPPS methodology (i.e., adoption and updating of the Medicare data elements used in calculating the prospective payment amounts), there will be some significant deviations required to accommodate the uniqueness of the TRICARE program. These deviations have been designed to accommodate existing TRICARE benefit structure and claims processing procedures implemented under the TRICARE Next Generation Contracts (T-NEX) while at the same time eliminating any undue financial burden to TRICARE Prime, Extra and Standard beneficiary populations. The economic impact of this rule is estimated to be less than $100 million. It is anticipated that an interim final rule will be required to be promulgated in order to implement a provision of the National Defense Authorization Act for Fiscal Year 2007 to expand the TRICARE Reserve Select program to allow all members of the Selected Reserve to purchase their health care through the Military Health System at the same low cost, regardless of the member's duty status. The economic impact of this rule is estimated to be less than $100 million. 4. National Security Personnel System, Department of Defense On November 1, 2005 (70 FR 66115-66164), the Department of Defense (DoD) and the Office of Personnel Management (OPM) issued final regulations to establish the National Security Personnel System, a DoD human resources management system authorized by the National Defense Authorization Act (Pub. L. 108-136, November 24, 2003). These regulations govern basic pay, staffing, classification, performance management, labor relations, adverse actions, and employee appeals. These regulations are designed to ensure that the DoD's human resources management and labor relations systems align with its critical mission requirements and protect the civil service rights of its employees. Subsequent litigation and potential legislation present the possibility that the NSPS regulation will require revision in the upcoming year. DoD and OPM will consider several alternative approaches to address the final outcomes by either the courts or new legislation. A proposed rule may be published within 90 days of the final court decision or enactment of legislation. This could result in publication as early as January 2008. BILLING CODE 5001-06-S [[Page 69796]] DEPARTMENT OF EDUCATION (ED) Statement of Regulatory and Deregulatory Priorities General We support States, local communities, institutions of higher education, and others in improving education Nationwide and to help ensure that all Americans receive a quality education. Our roles include providing leadership and financial assistance for education to agencies, institutions, and individuals in situations in which there is a national interest, such as in helping all students to reach grade-level standards in reading/language arts and mathematics; monitoring and enforcing the implementation of Federal civil rights laws in programs and activities that receive Federal financial assistance; supporting research, evaluation, and dissemination of findings to improve the quality of education; and assisting students in their pursuit of postsecondary education. We administer programs that affect nearly every American during his or her life. For the 2007-2008 school year, we expect about 50 million students to attend some 97,000 elementary and secondary schools in approximately 14,000 public school districts, and about 17.9 million students to enroll in degree-granting postsecondary schools. We have worked effectively with a broad range of interested parties and the general public to develop regulations, guidance, technical assistance, and approaches to compliance. In developing and implementing regulations, we are committed to working closely with affected persons and groups, including parents, students, and educators; State, local, and tribal governments; and neighborhood groups, schools, colleges, rehabilitation service providers, professional associations, advocacy organizations, businesses, and labor organizations. In particular, we continue to seek greater and more useful public participation in our rulemaking activities through the use of transparent and interactive rulemaking procedures and new technologies. If we determine that the development of regulations is necessary, we seek public participation at all key stages in the rulemaking process. We invite the public to submit comments on all proposed regulations through the Internet or by regular mail. To facilitate the public's involvement, we participate in the Federal Docketing Management System (FDMS), a new, electronic single Governmentwide access point (www.regulations.gov) that enables the public to search, read, download, and submit comments on different types of Federal regulatory documents. In the case of our Department, this system provides the public with the opportunity to file a comment electronically on any notice of proposed rulemaking or interim final regulations open for comment, as well as read and print any supporting regulatory documents. In addition, FDMS enables the public to read comments filed by other members of the public during the public comment period and to respond to those comments. We are continuing our efforts to streamline information collections, reduce the burden on information providers involved in our programs, and make information maintained by us easily accessible to the public. No Child Left Behind We look forward to congressional reauthorization of the Elementary and Secondary Education Act of 1965, and to building on the results of its most recent reauthorization through the No Child Left Behind Act of 2001. No Child Left Behind has increased accountability for States, school districts, and schools; provided greater choice for parents and students, particularly those students attending low-performing schools; provided more flexibility for States and local educational agencies in the use of Federal education dollars; and placed a stronger emphasis on using scientifically based research to guide instruction, especially in reading for our youngest children. The major principles of No Child Left Behind are: the establishment of meaningful State academic content and academic achievement standards and aligned assessments to measure progress toward meeting these standards; school and district accountability for meeting the standards; having every child performing at or above grade level by 2014; conducting annual assessments and disaggregating data to identify and close the achievement gap; having highly qualified teachers provide instruction in core academic subjects in every classroom; and providing options for parents of students in schools that do not make progress in meeting State standards, including public school choice and free tutoring. The Administration will continue to work with Congress to give educators, policymakers, and parents the tools to get the job done, without straying from these core principles. To make No Child Left Behind even more effective, we are proposing greater flexibility and other improvements that will help each State meet the goal of having all children at grade-level proficiency, as defined by the State. To ensure students' success, we will build on the results of No Child Left Behind by promoting a stronger effort to close the achievement gap through high State standards and accountability, by giving States flexibility and new tools to measure achievement more accurately and to restructure chronically underperforming schools, and by giving families more options. We also will promote greater use of growth models in State accountability systems as one way to provide better measurement. Growth models allow States to measure individual students' progress over time, giving schools credit for improvement from year to year and providing another way to show whether achievement gaps are closing. Additionally, our goals for No Child Left Behind are: (1) to give States and districts assistance in bringing about meaningful high school reform; and (2) to assist States in improving the quality of secondary education and ensuring that every student not only graduates from high school on time, but also graduates prepared to enter college or the 21st-century workforce with the skills vital for success. Our proposals include a more accurate graduation rate calculation; the development by 2010-11 of course-level academic standards for two years of high school English and math, and by 2012-13 of assessments aligned with these standards; the promotion of rigorous high school coursework; increased funding for high schools that serve low-income students; and meeting the need for additional teachers of math, science, and other subjects through a new Adjunct Teacher Corps. As necessary, we intend to amend current regulations to accommodate these efforts to strengthen No Child Left Behind. Individuals with Disabilities Education Act The Individuals with Disabilities Education Improvement Act of 2004 (Pub. L. 108-446) made substantial changes to the Individuals with Disabilities Education Act (IDEA). In addition to final regulations designed to improve implementation of the education of children with disabilities program (including preschool services) under part B of IDEA that were published in August 2006 (71 FR [[Page 69797]] 46540), we plan to issue later this year a notice of proposed rulemaking that would address issues in part B that were not covered by those final regulations. Also, in May 2007 we issued proposed regulations to implement changes to the part C program--the early intervention program for infants and toddlers with disabilities. We hope to publish final regulations for this program in the third quarter of 2008. Higher Education This fall, the Department published final regulations affecting the Federal student aid programs, including regulations for the Academic Competitiveness Grant and National Science and Mathematics Access to Retain Talent Grant programs, the Federal Family Education Loan (FFEL) program, the Federal Perkins Loan program, and the William D. Ford Federal Direct Loan (Direct Loan) program. These final regulations will take effect on July 1, 2008, and accordingly we will be working over the next year toward their implementation. The recently-enacted College Cost Reduction and Access Act of 2007 (CCRAA), Pub. L. 110-84, amended certain provisions of the Higher Education Act of 1965 (HEA) on which the Department plans to regulate in 2008. The areas for regulation would include the new Teacher Education Assistance for College and Higher Education (TEACH) Grant program and issues pertaining to the FFEL and Direct Loan programs. We also note that there are other bills pending in Congress to reauthorize or otherwise amend the HEA. Any regulatory activity resulting from amendments to the HEA would need to balance reduction in burden on program participants, especially students, with the need to adequately safeguard taxpayers' funds. The HEA also authorizes other important programs, and changes to regulations may be necessary to improve the implementation of the teacher-quality-enhancement programs under title II, the institutional-assistance programs under titles III and V, the international and foreign language studies programs under title VI, and the graduate education and postsecondary education improvement programs under title VII. Other Potential Regulatory Activities Congress is considering legislation to reauthorize the Adult Education and Family Literacy Act (AEFLA) (title II of the Workforce Investment Act of 1998)--including the National Institute for Literacy--and the Rehabilitation Act of 1973. The Administration is working with Congress to ensure that any changes to these laws improve and streamline the State grant and other programs providing assistance for adult basic education under the AEFLA and for vocational rehabilitation and independent living services for persons with disabilities under the Rehabilitation Act of 1973, and that they provide greater accountability in the administration of programs under both statutes. Changes to our regulations may be necessary as a result of the reauthorization of these two statutes. During the coming year, other regulations may be necessitated by legislation or programmatic experience. In developing and promulgating any additional regulations we will be guided by the following Principles for Regulating: Principles for Regulating Our Principles for Regulating determine when and how we will regulate. Through consistent application of the following principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without any regulations or with only limited regulations. We will regulate only if regulating improves the quality and equality of services to our customers. We will regulate only if absolutely necessary and then in the most flexible, most equitable, and least burdensome way possible. In deciding when to regulate, we consider: Whether regulations are essential to promote quality and equality of opportunity in education. Whether a demonstrated problem cannot be resolved without regulation. Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity. Whether entities or situations to be regulated are so diverse that a uniform approach through regulation does more harm than good. In deciding how to regulate, we are mindful of the following principles: Regulate no more than necessary. Minimize burden to the extent possible, and promote multiple approaches to meeting statutory requirements when possible. Encourage federally funded activities to be coordinated with State and local reform activities. Ensure that benefits justify costs of regulation. Establish performance objectives rather than specify compliance behavior to the extent possible. Encourage flexibility to the extent possible so institutional forces and incentives achieve desired results. _______________________________________________________________________ ED--Office of Postsecondary Education (OPE) ----------- PROPOSED RULE STAGE ----------- 33. TITLE IV OF THE HIGHER EDUCATION ACT OF 1965, AS AMENDED Priority: Other Significant Legal Authority: 20 USC 1098a CFR Citation: Not Yet Determined Legal Deadline: None Abstract: The Secretary proposes regulations to implement provisions of the recently-enacted College Cost Reduction and Access Act of 2007 (CCRAA), Pub. L. 110-84, which amended the Higher Education Act of 1965. These regulations would address issues relating to the new TEACH Grant program created by the CCRAA and regulatory changes to the Federal Family Education Loan Program and William D. Ford Direct Loan Program resulting from the CCRAA. Statement of Need: These regulations are needed to implement the provisions of the College Cost Reduction and Access Act of 2007, Pub. L. 110-84, which amended the Higher Education Act of 1965. Summary of Legal Basis: These regulations are proposed to implement provisions of the College Cost Reduction and Access Act of 2007, Pub L. 110-84. Alternatives: To be identified. Anticipated Costs and Benefits: To be determined. Risks: None. [[Page 69798]] Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 06/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Agency Contact: John A. Kolotos Program Specialist Department of Education Office of Postsecondary Education 1990 K Street, NW Washington, DC 20006-8502 Phone: 202 502-7762 RIN: 1840-AC93 BILLING CODE 4000-01-S [[Page 69799]] DEPARTMENT OF ENERGY (DOE) Statement of Regulatory and Deregulatory Priorities The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to: Promote dependable, affordable and environmentally sound production and distribution of energy; Foster energy efficiency and conservation; Provide responsible stewardship of the Nation's nuclear weapons; Clean up the Department's sites and facilities, which include sites dating back to the Manhattan Project; Lead in the physical sciences and advance the biological, environmental and computational sciences; and Provide premier instruments of science for the Nation's research enterprise. The Department's regulatory activities are essential to achieving its critical mission and to implementing major initiatives of the President's National Energy Policy. Among other things, the Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year to fulfill the Department's commitment to meeting deadlines for issuance of energy conservation standards and related test procedures. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, reduce regulatory burden, and increase responsiveness to the public. Energy Efficiency Program for Consumer Products and Commercial Equipment On January 31, 2006, the Department released a schedule for setting new appliance efficiency standards that will save American consumers billions of dollars in energy costs. The five-year plan outlines how DOE will address the appliance standards rulemaking backlog and meet the statutory requirements established in the Energy Policy and Conservation Act (EPCA) and the Energy Policy Act of 2005 (EPACT 2005). EPCA requires DOE to set appliance efficiency standards at levels that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. Standards already in place for residential products are expected to save consumers nearly $93 billion by 2020, and to save enough energy to operate all U.S. homes for approximately two years. The five-year plan, which was developed considering the public comments received on the appliance standards program, provides for the issuance of one rulemaking for each of the 18 products in the backlog. The plan also provides for setting appliance standards for products required under EPACT 2005. The Department is aggressively implementing process improvements to speed up the development and issuance of appliance standards rules. The overall plan for implementing the schedule is contained in the Report to Congress under section 141 of EPACT 2005, which was released January 31, 2006. The report is posted at: http://www.eere.energy.gov/ buildings/appliance--standards/2006--schedule--setting.html. The report identifies all products for which DOE has missed the deadlines established in EPCA (42 U.S.C. Sec. 6291 et seq.). It also describes the reasons for such delays and the Department's plan for expeditiously prescribing new or amended standards. The latest semi-annual update to the report was released in August 2007. Information and timetables concerning these actions can also be found in the Department's Regulatory Agenda, which is posted online at: www.reginfo.gov. Estimate of Combined Aggregate Costs and Benefits All of the regulatory actions included in this Regulatory Plan are in the early stages of rulemaking, and the Department has not yet proposed candidate standards levels for the covered products or equipment. Consequently, DOE cannot provide an estimate of combined aggregate costs and benefits. _______________________________________________________________________ DOE--Energy Efficiency and Renewable Energy (EE) ----------- PRERULE STAGE ----------- 34. ENERGY CONSERVATION STANDARDS FOR RESIDENTIAL ELECTRIC AND GAS RANGES AND OVENS AND MICROWAVE OVENS, DISHWASHERS, DEHUMIDIFIERS, AND COMMERCIAL CLOTHES WASHERS Priority: Other Significant Legal Authority: 42 USC 6295(g) to (h)(cc); 42 USC 6313(e) CFR Citation: 10 CFR 430 Legal Deadline: Final, Judicial, March 31, 2009. Abstract: The Energy Policy and Conservation Act (EPCA), as amended, establishes initial energy efficiency standard levels for most types of major residential appliances, as well as certain commercial appliances. The statute generally requires DOE to undertake two subsequent rulemakings to determine whether the existing standard for a covered product should be amended. Through this combined rulemaking, the Department is evaluating potential amendments to update the current energy efficiency standards for residential electric and gas ranges and ovens (including a new provision specific to microwave ovens) and dishwashers. The Department is also considering establishing initial energy efficiency standards for dehumidifiers and commercial clothes washers, as required by the Energy Policy Act of 2005, which further amended EPCA. Statement of Need: EPCA requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market. Summary of Legal Basis: EPCA establishes initial energy efficiency standards for most types of major residential appliances and certain commercial equipment. EPCA generally requires DOE to subsequently undertake rulemaking, at specified [[Page 69800]] times, to determine whether the standard for a covered product should be made more stringent. Pursuant to EPCA, the Department has established energy efficiency standards for residential electric and gas ranges and ovens, as well as dishwashers. In addition, the Energy Policy Act of 2005 amended EPCA to authorize the Department to set standards for energy (and water, where appropriate) used in the operation of dehumidifiers and commercial clothes washers. Alternatives: The statute requires the Department to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, the Department conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by statute. Anticipated Costs and Benefits: The specific costs and benefits for this rulemaking have not been established because the Department is still in the early stages of rulemaking and has not yet determined candidate standard levels for these products. As a general matter, in setting any efficiency standard different than those set by statute, the Secretary must first determine that such standard is both technologically feasible and economically justified. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 11/00/07 NPRM 07/00/08 Final Action 03/00/09 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Local, State Additional Information: Merged dishwashers from RIN 1904-AA89 and added residential dehumidifiers and commercial clothes washers. Agency Contact: Stephen Witkowski Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-7463 Email: stephen.witkowski@ee.doe.gov Related RIN: Merged with 1904-AA89 RIN: 1904-AB49 _______________________________________________________________________ DOE--EE ----------- PROPOSED RULE STAGE ----------- 35. ENERGY EFFICIENCY STANDARDS FOR PACKAGED TERMINAL AIR CONDITIONERS AND PACKAGED TERMINAL HEAT PUMPS Priority: Other Significant Legal Authority: 42 USC 6313(a)(6)(A) CFR Citation: 10 CFR 431 Legal Deadline: Final, Judicial, September 30, 2008. Abstract: The Energy Policy and Conservation Act (EPCA) provides that if the energy efficiency levels in ASHRAE/IESNA Standard 90.1 for certain commercial and industrial equipment are amended after specified dates, the Department of Energy (DOE) must establish an amended uniform national standard for such equipment at the new minimum level in Standard 90.1, unless the Secretary determines that a more stringent standard is technologically feasible and economically justified and would result in significant additional energy conservation. This rulemaking was initiated to consider whether DOE should adopt amended ASHRAE/IESNA efficiency levels for certain commercial air conditioners and heat pumps. On March 7, 2007, DOE published a final rule addressing standards for five categories of products, but decided to consider if evidence supported higher standards for packaged terminal air conditioners and heat pumps (PTAC/PTHP). As required by EPCA, DOE has undertaken this further rulemaking to determine standards for packaged terminal air conditioners and heat pumps. Statement of Need: EPCA requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market Summary of Legal Basis: The Energy Policy and Conservation Act (EPCA) provides that if the energy efficiency levels in ASHRAE/IESNA Standard 90.1 for certain commercial and industrial equipment are amended after specified dates, the Department of Energy (DOE) must establish an amended uniform national standard for such equipment at the new minimum level in Standard 90.1, unless the Secretary determines that a more stringent standard is technologically feasible and economically justified and would result in significant additional energy conservation. This rulemaking was initiated to consider whether DOE should adopt amended ASHRAE/IESNA efficiency levels for certain commercial air conditioners and heat pumps. On March 7, 2007, DOE published a final rule addressing standards for five categories of products, but decided to consider if evidence supported higher standards for packaged terminal air conditioners and heat pumps. As required by EPCA, DOE has undertaken this further rulemaking to determine standards for packaged terminal air conditioners and heat pumps. Alternatives: The statute requires the Department to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, the Department conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by statute. Anticipated Costs and Benefits: The specific costs and benefits for this rulemaking have not been established because the Department is still in the early stages of rulemaking and has not yet determined candidate standard levels for these products. As a general matter, in setting any efficiency standard different than those set by statute, the Secretary must first determine that such standard is both technologically feasible and economically justified. [[Page 69801]] Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ Notice of Availabilitiy 03/13/06 71 FR 12634 Comment Period End 04/27/06 Final Rule (except PTAC/ PTHP) 03/07/07 72 FR 10038 NPRM (PTAC/PTHP) 01/00/08 Final Action 09/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: Local, State Agency Contact: Wesley Anderson Mechanical Engineer Department of Energy Energy Efficiency and Renewable Energy Office of Building Technologies Program, EE-2J 1000 Independence Avenue, SW. Washington , DC 20585 Phone: 202-586-7335 Email: wes.anderson@ee.doe.gov Related RIN: Merged with 1904-AB16, Merged with 1904-AB17 RIN: 1904-AB44 _______________________________________________________________________ DOE--EE 36. ENERGY EFFICIENCY STANDARDS FOR COMMERCIAL REFRIGERATION EQUIPMENT Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: 42 USC 6313(c) CFR Citation: 10 CFR 431 Legal Deadline: Final, Statutory, January 1, 2009. Abstract: The Energy Policy Act of 2005 (EPACT 2005) amendments to the Energy Policy and Conservation Act (EPCA) require that DOE establish standards for ice cream freezers; self-contained commercial refrigerators, freezers, and refrigerator-freezers without doors; and remote- condensing commercial refrigerators, freezers, and refrigerator- freezers. Statement of Need: EPCA requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market. Summary of Legal Basis: The EPACT 2005 amendments to EPCA authorize DOE to establish energy conservation standards for commercial refrigeration equipment. Alternatives: The statute requires the Department to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, the Department conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by statute. Anticipated Costs and Benefits: The specific costs and benefits for this rulemaking have not been established because the Department is still in the early stages of rulemaking and has not yet determined candidate standard levels for these products. As a general matter, in setting any efficiency standard different than those set by statute, the Secretary must first determine that such standard is both technologically feasible and economically justified. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 07/26/07 72 FR 41162 ANPRM Comment Period End 10/09/07 NPRM 05/00/08 Final Action 01/00/09 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Local, State Agency Contact: Charles Llenza Office of Building Technologies Program, EE-2J Department of Energy Energy Efficiency and Renewable Energy 1000 Independence Avenue SW. Washington, DC 20585 Phone: 202 586-2192 Email: charles.llenza@ee.doe.gov RIN: 1904-AB59 BILLING CODE 6450-01-S [[Page 69802]] DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Statement of Regulatory Priorities The Department of Health and Human Services (HHS) conducts a broad range of programs mandated by Congress to protect and promote the health and well-being of all Americans, but focused especially on those least able to help themselves. HHS responsibilities include: Medicare, Medicaid, support for public health preparedness, biomedical research, substance abuse and mental health treatment and prevention, assurance of safe and effective drugs and other medical products, food safety, financial assistance to low income families, Head Start, services to older Americans, and direct health services delivery. Since assuming the leadership of HHS, Secretary Michael O. Leavitt has consistently sought to make transparent his approach to overseeing the Department's programs. His current statement of the Department's priorities is available for public review at http://www.hhs.gov/ secretary/priorities/index.html. The regulatory actions noted below reflect this policy framework. Health Information Technology The Secretary's strategy for promoting improvements in the Nation's health sector stresses maximum use of electronic information technology. The FY 2008 Regulatory Plan accordingly includes a notice of proposed rulemaking to require that clinical study data be provided to the Food and Drug Administration (FDA) in electronic format, using standard data structures, terminology, and code sets. The change would further increase the efficiency of the agency's review processes, speeding up the availability of new therapies. Additionally, the Plan includes: proposed actions to require medical-device firms to register electronically with the FDA, as well as to report post-marketing information to the agency electronically; and a proposal for the adoption of final standards for the electronic transmission of basic prescription drug data. Medicare Modernization The Secretary's statement of priorities includes a focus on Medicare modernization. The Regulatory Plan, accordingly, highlights: final rules to update the requirements that end-stage-renal disease and hospice facilities must meet to participate in the Medicare program; final rules establishing annual adjustments in payment amounts under Medicare for physicians' services and for hospital outpatient services for calendar year 2009. Medicare Part D The Secretary believes that every senior must have access to affordable prescription drugs, and that a reinforced regulatory framework for implementing the Medicare prescription drug benefit can further connect beneficiaries with the Part D program. The Plan accordingly includes a proposal to establish additional guidance for expediting the program's appeal processes. Disease Prevention Also included among the Secretary's priorities is an emphasis on disease prevention and the need for individual responsibility for personal wellness. Three actions in the Plan reflect this concern: a final rule clarifying an exemptions process for the recently established good manufacturing practices for the dietary- supplement products favored by many Americans; a proposal to modify prescription drug labeling so that health care providers may better understand and communicate to their patients the risks and benefits associated with the use of prescribed medicines during pregnancy and lactation, and a proposal to amend existing regulations governing investigational new drugs -- the rule would delineate new avenues of access for patients to obtain investigational drugs for treatment use. Food Safety The Secretary recently chaired the Interagency Working Group on Import Safety, established by a July 2007 Executive Order requiring that the Executive branch take all appropriate steps to promote the safety of imported products. Reflecting the importance of this subject, the Regulatory Plan includes: a proposal to require owners or consignees to label imported food that has previously been refused entry into the United States. This action would prevent the introduction of unsafe food and facilitate the examination of imported food; and a final rule completing the rulemaking process requiring that the Food and Drug Administration be notified prior to the entry of imported food into the United States. _______________________________________________________________________ HHS--Centers for Disease Control and Prevention (CDC) ----------- FINAL RULE STAGE ----------- 37. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: Not Yet Determined CFR Citation: 42 CFR 70 to 71 Legal Deadline: None Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Quarantine regulations are divided into two parts: Part 71 dealing with foreign arrivals and part 70 dealing with interstate matters. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC maintains quarantine stations at 20 ports of entry staffed with medical and public health officers who respond to reports of diseases from carriers. According to the statutory scheme, the President determines through Executive order which diseases may subject individuals to quarantine. The current disease list, which was last updated in April 2005, includes cholera, diphtheria, tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome (SARS), and influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic. Statement of Need: The quarantine or isolation of persons believed to be infected with or exposed [[Page 69803]] to a communicable disease are public health prevention measures that have been used effectively to contain the spread of disease. As diseases evolve due to natural occurrences or man-made events, it is important to ensure that prevention procedures reflect new threats and uniform ways to contain them. Recent experiences with emerging infectious diseases such as West Nile Virus, SARS, and monkeypox have illustrated both the rapidity with which disease may spread throughout the world and the impact that communicable diseases, when left unchecked, may have on the global economy. Stopping an outbreak-- whether it is naturally occurring or intentionally caused--requires the use of the most rapid and effective public health tools available. Two of these tools are isolation and quarantine. Isolation refers to the separation or restriction of movement of ill persons with an infectious disease in order to prevent transmission to those who are not ill. Quarantine refers to the separation and restriction of movement of persons who, while not yet ill, have been exposed to an infectious agent and therefore may become infectious. Isolation and quarantine of ill and exposed persons may be one of the best initial strategies to prevent the uncontrolled spread of highly dangerous biologic agents-- especially when combined with other health strategies such as vaccination, prophylactic drug treatment, and other appropriate infection control measures. Summary of Legal Basis: These regulations would be proposed under the authority of 25 U.S.C. 198, 231, 2001; 42 U.S.C. 243, 264 to 271. In addition, section 361(b) of the Public Health Service Act (42 U.S.C. 264(b)) authorizes the ``apprehension, detention, or conditional release'' of persons to prevent the introduction, transmission, and spread of specified communicable diseases from foreign countries into the United States and from one State or possession into another. Among other public health powers, the lawful ability to inspect property, to medically examine and monitor persons, and to detain or quarantine exists in current regulations. Acknowledging the critical importance of protecting the public's health, long-standing court decisions uphold the ability of Congress and State legislatures to enact quarantine and other public health laws and to have them executed by public health officials. Alternatives: These regulations are necessary to ensure that HHS has the tools it needs to respond to public health emergencies and disease threats. Any less stringent alternatives would prevent the Department from the most effective possible pursuit of this objective. Anticipated Costs and Benefits: The primary cost impact of the proposed rule would be data collection, transmission, storage and retrieval, and costs associated with contact tracing. The benefits of this rule will offer procedures that more completely describe the 21st century implementation of disease containment measures such as isolation and quarantine. These procedures are expected to expedite and improve CDC operations by allowing immediate medical follow-up of potentially infected passengers and their contacts. The benefits of the rule would be measured in terms of the number of deaths and illnesses prevented by rapid intervention. Risks: Failure to move forward with this rulemaking would hinder the Nation's ability to use the most rapid and effective public health tools available when responding to public health emergencies and disease threats. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 11/30/05 70 FR 71892 Final Action 07/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Ram Koppaka M.D., Ph.D. Department of Health and Human Services Centers for Disease Control and Prevention MS-E-03 1600 Clifton Road Atlanta, GA 30333 Phone: 404 498-2308 RIN: 0920-AA12 _______________________________________________________________________ HHS--Food and Drug Administration (FDA) ----------- PROPOSED RULE STAGE ----------- 38. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Priority: Other Significant. Major status under 5 USC 801 is undetermined. Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR 314.96 Legal Deadline: None Abstract: The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments, be provided in an electronic format that FDA can process, review, and archive. The proposal would also require that FDA periodically issue guidance on the use of standardized data structure, terminology, and code sets (e.g., the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review. Statement of Need: Before a drug is approved for marketing, FDA must determine that the drug is safe and effective for its intended use. This determination is based in part on clinical study data and bioequivalence data that are submitted as part of the marketing application. Study data submitted to FDA in electronic format have generally been more efficient to process and review. FDA's proposed rule would require the submission of study data in a standardized electronic format, and it provides that the specific format will be announced in FDA guidance. Electronic submission of study data would improve patient safety and [[Page 69804]] enhance health care delivery by enabling FDA to process, review, and archive data more efficiently. Standardization would also enhance the ability to share study data and communicate results. Investigators and industry would benefit from the use of standards throughout the lifecycle of a study--in data collection, reporting, and analysis. The proposal would work in concert with ongoing agency and national initiatives to support increased use of electronic technology as a means to improve patient safety and enhance health care delivery. Summary of Legal Basis: Our legal authority to amend our regulations governing the submission and format of clinical study data and bioequivalence data for human drugs and biologics derives from sections 505 and 701 of the act (U.S.C. 355 and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262). Alternatives: FDA considered issuing a guidance document outlining the electronic submission and the standardization of study data, but not requiring electronic submission of the data in the standardized format. This alternative was rejected because the agency would not fully benefit from standardization until it became the industry standard, which could take up to 20 years. We also considered a number of different implementation scenarios, from shorter to longer time-periods. The 2-year time-period was selected because the agency believes it would provide ample time for applicants to comply without too long a delay in the effective date. A longer time-period would delay the benefit from the increased efficiencies, such as standardization of review tools across applications, and the incremental cost savings to industry would be small. Anticipated Costs and Benefits: Standardization of clinical data structure, terminology, and code sets will increase the efficiency of the agency review process. FDA estimates that the costs to industry resulting from the proposal would include some one-time costs and possibly some annual recurring costs. One-time costs would include, among other things, the cost of converting data to standard structures, terminology, and cost sets (i.e., purchase of software to convert data); the cost of submitting electronic data (i.e., purchase of file transfer programs); and the cost of installing and validating the software and training personnel. Additional annual recurring costs may result from software purchases and licensing agreements for use of proprietary terminologies. The proposal could result in many long-term benefits for industry, including improved patient safety through faster, more efficient, comprehensive, and accurate data review, as well as enhanced communication among sponsors and clinicians. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Martha Nguyen Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Regulatory Policy Suite 1101 (HFD-7), 5515 Security Lane Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: martha.nguyen@fda.hhs.gov RIN: 0910-AC52 _______________________________________________________________________ HHS--FDA 39. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Priority: Other Significant Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 CFR Citation: 21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80 Legal Deadline: None Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR part 201.56, 201.57, and 201.80). Statement of Need: Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug during pregnancy. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women's health researchers, and women of childbearing age. These stakeholders have expressed the view that the current categories are confusing and overly simplistic and thus are not adequate to communicate risks effectively. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product's risks to pregnant women and to women of childbearing age. It has also been strongly recommended that pregnancy labeling address the situation where a woman has taken drugs before she realizes she is pregnant. The labeling that would be required under the proposed rule would be responsive to the concerns discussed above, and others that have been expressed by critics of the current category system. Summary of Legal Basis: FDA has broad authority under sections 201, 301, 501, 502, 503, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321, 331, 351 to 353, 355, and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262) to help ensure that prescription drugs (including biological products that are regulated as drugs) are safe and effective for their intended uses. A major part of FDA's efforts concerning the safe and effective use of drug products involves review, approval, and monitoring of drug labeling. Under section 502(f)(1) of the Act, a drug is misbranded unless its [[Page 69805]] labeling bears ``adequate directions for use'' or it is exempted from this requirement by regulation. Under section 201.100 (21 CFR part 201.100), a prescription drug is exempted from the requirement in section 502(f)(1) of the Act only if, among other things, it contains the information required and in the format specified by sections 201.56 and 201.57. Under section 502(a) of the Act, a drug product is misbranded if its labeling is false or misleading in any particular. Under section 505(d) and 505(e) of the Act, FDA must refuse to approve an application or may withdraw approval of an application if the labeling for the drug is false or misleading in any particular. Section 201(n) of the Act provides that in determining whether the labeling of a drug is misleading, there shall be taken into account not only representations or suggestions made in the labeling, but also the extent to which the labeling fails to reveal facts that are material in light of such representations or material with respect to consequences that may result from use of the drug product under the conditions of use prescribed in the labeling or under customary conditions of use. These statutory provisions, combined with section 701(a) of the Act and section 351 of the Public Health Service Act, clearly authorize FDA to publish a proposed rule designed to help ensure that practitioners prescribing drugs (including biological products) to pregnant women and women of childbearing age would receive information essential to the safe and effective use of these drugs. Alternatives: The alternatives to the proposal include not amending our existing regulation governing the format and content of labeling for human prescription drugs and biological products. This alternative is inconsistent with widespread stakeholder dissatisfaction with the pregnancy labeling provided pursuant to the current regulation. Anticipated Costs and Benefits: The proposed rule would impose one-time costs for firms to modify drug product labeling and annual costs to print longer labeling. The extent of these modifications would depend on whether a product's labeling is affected by the physician labeling final rule (PLR) and on the scope of the implementation. The revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. A better understanding of risks and benefits would help women and their health care providers make informed decisions about whether or not to use drugs during pregnancy and lactation. Labeling under the rule would also provide information geared to women who took drugs before they knew they were pregnant. Such information may often be reassuring to women and their health care providers. Risks: None. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 03/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Christine F. Rogers Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Suite 1101 5515 Security Lane Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF11 _______________________________________________________________________ HHS--FDA 40. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Priority: Other Significant Legal Authority: 15 USC 1453 to 1455 ; 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 CFR Citation: 21 CFR 1.98 Legal Deadline: None Abstract: The proposed rule would require owners or consignees to label imported food that is refused entry into the United States. The label would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would describe the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Statement of Need: In 1998, the General Accounting Office issued a report titled, ``Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and Unreliable.'' The report stated that some food importers evade import controls and are able to introduce contaminated, adulterated, or unsafe food into the United States even after FDA refused to admit the food and the Customs Service ordered the food to be reexported or destroyed. Additionally, in 1998, the Senate Permanent Subcommittee on Investigations conducted hearings on the safety of food imports. The subcommittee heard testimony about reimporting refused foods through another port (a practice known as ``port shopping''). On July 3, 1999, then-President Clinton issued a memorandum to the Secretary of Health and Human Services and the Secretary of the Treasury directing them, in part, to take all actions available to ``prohibit the reimportation of food that has been previously refused admission and has not been brought into compliance with United States laws and regulations'' by requiring the marking of shipping containers and/or papers of imported food that is refused admission for safety reasons. Consequently, on January 22, 2001, FDA and the Department of the Treasury jointly issued a proposed rule (66 FR 6502) that would have required that imported food that has been refused admission for safety reasons be marked as ``UNITED STATES: REFUSED ENTRY.'' The mark would make it easier to detect previously refused food and reduce, if not [[Page 69806]] eliminate, ``port shopping.'' However, on June 12, 2002, before FDA and Treasury could prescribe a final rule, the Bioterrorism Act became law. Section 308(a) of the Bioterrorism Act created a new section 801(n) of the Federal Food, Drug, and Cosmetic Act (the act) to clarify FDA's authority to require the owner or consignee of a food that had been refused admission into the United States to ``affix to the container of the food a label that clearly and conspicuously bears the statement: `UNITED STATES: REFUSED ENTRY'.'' Although section 308(c) of the Bioterrorism Act stated that ``nothing in this section shall be construed to limit the authority of the Secretary of Health and Human Services or the Secretary of the Treasury to require the marking of refused articles of food under any other provision of law,'' the new statutory provision differed from the January 22, 2001, proposed rule and prompted FDA to withdraw the proposal on August 21, 2002 (67 FR 54138). The new proposal would describe the label requirements for imported food that has been refused admission into the United States. Summary of Legal Basis: Section 801(a) of the act authorizes FDA to refuse to admit imported food if the food has been manufactured, processed, or packed under insanitary conditions, is forbidden or restricted in sale in the country in which it was produced, or is adulterated or misbranded. Additionally, as explained earlier, section 801(n) of the act gives FDA express authority to require the owner or consignee of a food that had been refused admission into the United States to ``affix to the container of the food a label that clearly and conspicuously bears the statement: `UNITED STATES: REFUSED ENTRY'.'' Sections 402 and 403 of the act describe when a food is adulterated or misbranded, respectively. Section 701(a) of the act authorizes FDA to issue regulations for the efficient enforcement of the Act, while section 701(b) of the act authorizes FDA and the Department of the Treasury to jointly prescribe regulations for the efficient enforcement of section 801 of the act. The proposed rule is within FDA's authority at sections 402, 403, 701, and 801 of the act. In general, unsafe food is often adulterated under section 402 of the act and may also be misbranded under section 403 of the act. Requiring a label on refused foods that have been so refused will make it easier for FDA to refuse to admit previously refused, adulterated, or misbranded food imports into the United States. Additionally, section 301 of the Public Health Service Act (PHS act) authorizes FDA to ``render assistance'' to appropriate health authorities in the conduct of or to promote coordination of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of disease. Section 361 of the PHS act authorizes FDA to issue regulations to prevent the introduction, transmission, or spread of communicable diseases into the United States. Affixing a label would alert foreign officials to previously refused food and help prevent the introduction, transmission, or spread of communicable diseases into the United States by making it more difficult for unsafe food to reenter the United States. Alternatives: FDA considered exempting small businesses from the rule, but, because most importers and consignees would qualify as small businesses, this would negate the rule's purpose. The agency also considered ordering the destruction of all refused food imports, but this would not be feasible because it would divert Federal resources to supervising or otherwise ensuring that the refused food imports are stored until they can be destroyed and that they are destroyed. FDA also rejected affixing the label on some, but not all, imported food refused entry for safety reasons. While this alternative would be less costly, it would also be less efficient because some refused food imports would be able to reenter the United States and because a previously refused, but unlabeled, food would be difficult to detect compared to a previously refused and labeled food. This alternative would also result in arguments as to the criteria to be applied and whether a particular food should be labeled. Anticipated Costs and Benefits: Importers and consignees would bear the costs associated with affixing the label to refused food imports. The rule's costs would, therefore, consist of labor costs (to affix the label) and equipment costs (the label equipment used). FDA will estimate these costs in the proposed rule. The rule's principal benefit would be a reduction in the number of illnesses and injuries caused by unsafe imported food. The Agency is unable to quantify the amount of illegal importation of previously refused foods, so it cannot accurately predict the value of reduced illnesses and injury. Risks: There is a possible risk previously refused, unpackaged food (such as loose grain in a railroad car) would be able to enter the United States because the food itself cannot be labeled, although the proposed rule would require the importer or consignee to affix a label on papers accompanying the product. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Philip L. Chao Senior Policy Analyst Department of Health and Human Services Food and Drug Administration Office of Policy and Planning (HF-23) Room 14C-17 5600 Fishers Lane Rockville, MD 20857 Phone: 301 827-0587 Fax: 301 827-4774 Email: philip.chao@fda.hhs.gov RIN: 0910-AF61 _______________________________________________________________________ HHS--FDA 41. MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS Priority: Other Significant Legal Authority: 21 USC 352; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374 CFR Citation: 21 CFR 803 Legal Deadline: None Abstract: The Food and Drug Administration (FDA) is proposing to amend its [[Page 69807]] postmarket medical device reporting regulations to require that reports submitted to the Agency by persons subject to mandatory reporting requirements be transmitted electronically in a form that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the Agency to more quickly review safety reports and identify emerging public health issues. Statement of Need: The proposed rule would require user facilities and medical device manufacturers and importers to send medical device adverse event reports electronically instead of using a paper form. FDA is taking this action to improve its adverse event reporting program by enabling it to more quickly receive and process these reports. Summary of Legal Basis: The Agency has legal authority under section 519 of the Federal Food, Drug, and Cosmetic Act to require adverse event reports. The proposed rule would require manufacturers, importers, and user facilities to change their procedures to send reports of medical device adverse events to FDA electronically instead of using a hard copy form. Alternatives: The alternatives to this rulemaking include not updating the medical device reporting requirements and not requiring electronic submission of this information. For over 20 years, medical device manufacturers, importers, and user facilities have sent adverse event reports to FDA on paper forms. Processing paper forms is a time consuming and expensive process. FDA believes this rulemaking is the preferable alternative. Anticipated Costs and Benefits: The principal benefit would be to public health because the increased speed in the processing and analysis of the 100,000 medical device reports currently submitted in paper. In addition, requiring electronic submission would reduce FDA annual operating costs by $1.25 million. The total one-time cost for modifying SOPs and establishing electronic submission capabilities is estimated to range from $58.6 million to $79.7 million. Annually recurring costs totaled $8.9 million and included maintenance of electronic submission capabilities, including renewing the electronic certificate, and for some firms the incremental cost to maintain high-speed internet access. Risks: None Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (HFZ-215) PI50 RM150F 1350 Piccard Drive Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF86 _______________________________________________________________________ HHS--FDA 42. ELECTRONIC REGISTRATION AND LISTING FOR DEVICES Priority: Other Significant Legal Authority: PL 107-188, sec 321; 21 USC 360(p) CFR Citation: 21 CFR 807 Legal Deadline: None Abstract: FDA is proposing to amend the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the new requirements in section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 510(p) of the Federal Food, Drug, and Cosmetic Act, which was added by section 207 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). This proposed rule would require domestic and foreign device establishments to submit registration and listing data electronically via the Internet using FDA's Unified Registration and Listing System. This proposed rule would convert the registration and listing process to a paperless process. For those companies that do not have access to the web, FDA would offer an avenue by which they can register, list, and update information with a paper submission. Statement of Need: FDA is proposing to amend the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the new requirements in section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 207 of MDUFMA. This proposed rule would improve FDA's device establishment registration and listing system and utilize the latest technology in the collection of this information. Summary of Legal Basis: The statutory basis for our authority includes sections 510(a) through (j), 510(p), 701, 801, and 903 of the Federal Food, Drug, and Cosmetic Act. Alternatives: The alternatives to this rulemaking include not updating the registration and listing regulations and not requiring the electronic submission of registration and listing information. Because of the new statutory requirements, and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative to the paper system currently in place. Anticipated Costs and Benefits: The Agency believes that there may be some one-time costs associated with the rulemaking, which involve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information by domestic firms would probably remain the same or decrease because a paper submission and postage is not required. There might be some increase in the financial burden on foreign firms since they will have to supply additional registration information as required by section 321 of the BT Act. Risks: None [[Page 69808]] Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (HFZ-215) PI50 RM150F 1350 Piccard Drive Rockville, MD 20850 Phone: 240 276-2347 Fax: 240 276-2352 Email: myrna.hanna@fda.hhs.gov RIN: 0910-AF88 _______________________________________________________________________ HHS--FDA ----------- FINAL RULE STAGE ----------- 43. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264 CFR Citation: 21 CFR 111 Legal Deadline: None Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34572), on current good manufacturing practice (CGMP) regulations for dietary supplements. The final rule (the CGMP rule) was published to establish the minimum CGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, labeling or holding dietary supplements, they do so in a manner that will ensure the quality of the dietary supplements -- i.e., to ensure that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. FDA also published an interim final rule (IFR) in the June 25, 2007 Federal Register (72 FR 34959) that sets forth a procedure for requesting an exemption from the requirement in the final rule described above that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request. Statement of Need: FDA published the CGMP rule for dietary supplements because FDA is concerned that some firms may not be taking appropriate steps during the manufacture of dietary supplements to ensure the quality of dietary supplement. FDA is aware of products that contain potentially harmful contaminants because of apparently inadequate manufacturing controls and quality control procedures. There also have been cases of misidentified ingredients harming consumers using dietary supplements. The Agency believes that a system of CGMPs is the most effective and efficient way to ensure the quality of dietary supplements. With respect to the specific requirement for 100 percent identity testing of dietary ingredients, FDA recognizes that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, FDA is adding to the CGMP rule an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the agency for such an exemption to 100 percent identity testing and the agency grants such exemption. Such a procedure would be consistent with FDA's stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. FDA is providing an opportunity for interested persons to comment on whether this exemption procedure should be modified, and if so, whether there is any additional information that may be helpful to articulate with respect to what a petition needs to show that may inform future guidance. Summary of Legal Basis: Under the CGMP rule, failure to manufacture, pack, label or hold dietary supplements under CGMPs renders the dietary supplement adulterated under section 402(g) of the Act. Alternatives: The two principal alternatives to comprehensive CGMPs are end product testing and Hazard Analysis Critical Control Points (HACCP). The Agency asked whether different approaches may be better able to address the needs of the broad spectrum of firms that conduct one or more distinct operations, such as the manufacture of finished products, or solely the distribution and sale of finished products at the wholesale or retail level. Anticipated Costs and Benefits: The costs of the CGMP rule will include the value of resources devoted to increased sanitation, process monitoring and controls, testing, and written records. The benefits of the CGMP rule are to improve product quality. We estimate that the regulation will reduce the number of sporadic human illnesses and rare catastrophic illnesses from contaminated products. The current quality of these products is highly variable. The CGMP rule will have a significant impact on a substantial number of small businesses, so it is significant under the Regulatory Flexibility Act. We anticipate that small [[Page 69809]] businesses will bear a proportionately larger cost than large businesses. The IFR, as one piece of the CGMP rule, is not an economically significant regulatory action as defined under Executive Order 12866. FDA has identified 1,460 establishments that may apply to FDA for an exemption from dietary ingredient identity testing as provided for by this IFR. FDA expects some cost savings from reduced dietary ingredient identity testing depending on the number of firms that successfully apply to FDA for exemption. The IFR provisions will cause no net change in the benefits of dietary supplement current good manufacturing practices as outlined in the final rule. Risks: Any potential for consumers to be provided adulterated (e.g., contaminated with industrial chemicals, pesticides, microbial pathogens, or dangerous misidentified ingredients or toxic components of ingredients) products must be considered a very serious risk because of the possibility that such contamination could be widespread, affecting whole segments of the population, causing some severe long- term effects and even loss of life. Dietary supplements are used by a large segment of the American public. Moreover, they are often used by segments of the population that are particularly vulnerable to adulterated products, such as the elderly, young children, pregnant and nursing women, and persons who may have serious illnesses or are taking medications that may adversely interact with dietary supplements. FDA has adopted manufacturing controls for a number of foods and commodities that present potential health hazards to consumers if not processed properly, including seafood, juice products, and fruits and vegetables, and it is appropriate that FDA consider whether manufacturing controls are necessary to assure consumers that dietary supplements are not adulterated during the manufacturing, packing, labeling or holding process. If an incorrect dietary ingredient is added to a dietary supplement, consumers could be exposed to a biologically active substance without their knowledge. For example, FDA is aware of a case in which Digitalis lanata was misidentified as plantain and, as a result, a young woman experienced a life-threatening abnormal heart function after consuming a dietary supplement containing D. lanata in lieu of plantain. Manufacturers who petition FDA for an exemption from the requirement for 100 percent identity testing would be required to show that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ ANPRM 02/06/97 62 FR 5700 ANPRM Comment Period End 06/06/97 NPRM 03/13/03 68 FR 12157 NPRM Comment Period End 08/11/03 Final Action 06/25/07 72 FR 34752 Interim Final Rule 06/25/07 72 FR 34959 Interim Final Rule Comment Period End 10/24/07 Final Action 06/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Undetermined Agency Contact: Linda Kahl Senior Policy Analyst Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition (HFS-024) 5100 Paint Branch Parkway College Park, MD 20740 Phone: 301 436-1209 Fax: 301 436-2964 Email: linda.kahl@fda.hhs.gov RIN: 0910-AB88 _______________________________________________________________________ HHS--FDA 44. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: This action may affect the private sector under PL 104-4. Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 393; 42 USC 243; 42 USC 264; 42 USC 271; . . . CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118 Legal Deadline: None Abstract: Publication of this final rule is an action item in the Food Protection Plan announced by the Department of Health and Human Services (HHS) in November 2007. In July 1999, the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) committed to developing an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. FDA and FSIS held a public meeting on August 26, 1999, to obtain stakeholder input on the draft goals, as well as to further develop the objectives and action items for the action plan. The Egg Safety Action Plan was announced on December 11, 1999. The goal of the Action Plan is to reduce egg-related SE illnesses by 50 percent by 2005 and eliminate egg-related SE illnesses by 2010. The Egg Safety Action Plan consists of eight objectives covering all stages of the farm-to-table continuum as well as support functions. On March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 31, 2000 (Washington, DC), joint public meetings were held by FDA and FSIS to solicit and discuss information related to the implementation of the objectives in the Egg Safety Action Plan. On September 22, 2004, FDA published a proposed rule that would require egg safety measures to prevent the contamination of shell eggs with SE during egg production. The proposal also solicited comment on whether recordkeeping requirements should include a written SE prevention plan and records for compliance with the SE prevention measures, and whether safe egg handling and preparation practices should be mandated for retail establishments that specifically serve a highly susceptible population (e.g., nursing homes, hospitals, day care centers). The proposed egg production SE prevention measures included: (1) Provisions for procurement of chicks and pullets; (2) a biosecurity program; (3) a rodent and pest control program; (4) cleaning and disinfection of poultry houses that have had an environmental or egg test positive for SE; (5) egg testing when an environmental test is positive; and (6) refrigerated storage of eggs held at the farm. Additionally, to [[Page 69810]] verify that the measures have been effective, the rule proposes that producers test the poultry house environment for SE. If the environmental test is positive, eggs from that environment must be tested for SE, and if the egg test is positive, the eggs must be diverted to egg products processing or a treatment process that achieves at least a five-log destruction of SE. The proposed rule was a step in a broader farm-to-table egg safety effort that includes FDA's requirements for safe handling statements on egg cartons, and refrigerated storage of shell eggs at retail, and egg safety education for consumers and retail establishments. The rule had a 90-day comment period, which ended December 21, 2004. To discuss the proposed rule and solicit comments from interested stakeholders, FDA held three public meetings: October 28, 2004, in College Park, MD; November 9, 2004, in Chicago, IL; and November 16, 2004, in Los Angeles, CA. The comment period was reopened until July 25, 2005, to solicit further comment and information on industry practices and programs that prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. Statement of Need: FDA proposed regulations as part of the farm-to-table safety system for eggs outlined by the President's Council on Food Safety in its Egg Safety Action Plan. FDA intends to publish a final egg safety rule because of the continued reports of outbreaks of foodborne illness and death caused by SE that are associated with the consumption of shell eggs. The agency believes that this rule, when final, will have significant effect in reducing the risk of illness from SE-contaminated eggs and will contribute significantly to the interim public health goal of a 50 percent reduction in egg-related SE illness. Summary of Legal Basis: FDA's legal basis derives in part from sections 402(a)(4) and 701(a) of the Federal Food, Drug, and Cosmetic Act (the Act) ((21 U.S.C. 342(a)(4) and 371(a)). Under section 402(a)(4) of the Act, a food is adulterated if it is prepared, packed, or held in insanitary conditions whereby it may have been contaminated with filth or may have been rendered injurious to health. Under section 701(a) of the Act, FDA is authorized to issue regulations for the efficient enforcement of the Act. FDA's legal basis also derives from section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease. Alternatives: There are several alternatives that the Agency considered in the proposed rule. The principal alternatives included: (1) No new regulatory action; (2) alternative testing requirements; (3) alternative on-farm prevention measures; (4) alternative retail requirements; and (5) HACCP. Anticipated Costs and Benefits: The benefits from a final regulation to control Salmonella enteritidis in shell eggs derive from improved practices that reduce contamination and generate benefits measured as the value of the human illnesses prevented. FDA has produced estimates of costs and benefits for a number of options. The mitigations considered include on-farm rodent control, changes in retail food preparation practices, diversion of eggs from infected flocks to pasteurization, recordkeeping, refrigeration, and feed testing. The actual costs and benefits of the final rule will depend upon the set of mitigations chosen and the set of entities covered. Risks: The potential for contamination of eggs with SE and its subsequent survival or growth must be considered a very serious risk because of the possibility that such contamination, survival, and growth could cause widespread foodborne illness, including some severe long-term effects and even loss of life. FDA's decision to publish a final rule to reduce this risk of SE contamination of shell eggs is based on a considerable body of evidence, literature and expertise in this area. In addition, this decision was also based on the USDA risk assessment on SE in shell eggs and egg products and the identified public health benefits associated with controlling SE in eggs at the farm and retail levels. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 09/22/04 69 FR 56824 NPRM Comment Period End 12/21/04 NPRM Reopened Comment Period End 06/09/05 70 FR 24490 NPRM Extension of Reopened Comment Period End 07/25/05 70 FR 33404 Final Action 04/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: John F. Sheehan Director Department of Health and Human Services Food and Drug Administration Division of Plant and Dairy Food Safety (HFS-315) Room 3B-012 5100 Paint Branch Parkway College Park, MD 20740 Phone: 301 436-2367 Fax: 301 436-2632 Email: john.sheehan@fda.hhs.gov RIN: 0910-AC14 _______________________________________________________________________ HHS--FDA 45. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002 Priority: Other Significant Legal Authority: PL 107-188, sec 307 CFR Citation: 21 CFR 1.276 et seq Legal Deadline: Final, Statutory, December 12, 2003. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notice requirements for all imported food by December 12, 2003. If FDA fails to issue final regulations by this date, the statute is self-executing on this date, and requires FDA to receive prior notice of not less than eight hours, nor [[Page 69811]] more than five days, until final regulations are issued. Abstract: This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 801(m) of the Federal Food, Drug, and Cosmetic Act (the act), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), requires notification to FDA prior to the entry of imported food. The regulation explains the information that the prior notice is required to contain, the method of submission of the notice, and the minimum and maximum period of advance notice required. Section 307 also states that if FDA does not receive prior notice or receives inadequate prior notice, the imported food shall be refused admission and held at the port of entry until proper notice is provided. Section 307 authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. FDA and the Bureau of Customs and Border Protection (CBP) issued an interim final rule (IFR) on October 10, 2003 (68 FR 58974). The IFR originally provided a 75-day comment period to ensure that those that comment on the IFR have the benefit of our outreach and educational efforts and have the experience with the systems, timeframes, and data elements. We reopened the comment period for an additional 90 days in April through July 2004, to allow for additional comment on the industry's experience with the prior notice system, and comment on the Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes. The final rule currently is under development, and it will confirm or amend the IFR, as appropriate. This final rule is not expected to have a significant impact on a substantial number of small entities. Statement of Need: This final rule is needed to complete the rulemaking process to implement section 307 of the Bioterrorism Act. The proposed rule was published on February 3, 2003, (68 FR 5428) and the interim final rule on October 10, 2003 (68 FR 58974). Summary of Legal Basis: Section 307 of the Bioterrorism Act amended the act by adding section 801(m), which authorizes the Secretary through FDA to establish by regulation requirements for the notification to FDA prior to the entry of imported food. In addition, section 307 of the Bioterrorism Act also amends section 301 of the act by making the offering of a food for import or the importing of a food without prior notification, as required by the new regulations, a prohibited act. Alternatives: An alternative is to leave the IFR in place and not to issue a final rule. However, we received numerous comments in response to the IFR that require a response. Finalizing this rule will assist industry and the public in better understanding and complying with the prior notice requirements. Anticipated Costs and Benefits: The final rule will amend the interim final rule already in place. We do not expect the changes from the interim final rule to be economically significant. This final rule will require that FDA be notified prior to the arrival of the food. Having prior notice of imported food will help deter deliberate and accidental contamination of food shipments. Knowledge of when, where, and how imported food will enter the United States will help mitigate the effects of any potential food contamination issues. Risks: Regulations implementing legislation to protect the health of citizens against bioterrorism and other public health threats would advance the development, organization, and enhancement of public health prevention systems and tools. The magnitude of the risks addressed by such systems and tools is at least as great as the other risk reduction efforts within HHS' jurisdiction. These regulations will improve the FDA's ability to address bioterrorism events and public-health threats associated with imported food. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/03/03 68 FR 5428 Interim Final Rule 10/10/03 68 FR 58974 Interim Final Rule Comment Period Reopened 04/14/04 69 FR 19763 Interim Final Rule Comment Period Reopened End 07/13/04 Final Rule 04/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: Federal Agency Contact: May Nelson Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740 Phone: 301 436-1722 Fax: 301 436-2637 Email: may.nelson@fda.hhs.gov RIN: 0910-AC41 _______________________________________________________________________ HHS--FDA 46. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE Priority: Other Significant Legal Authority: 21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262 CFR Citation: 21 CFR 312.42; 21 CFR 312.300; 21 CFR 312.305; 21 CFR 312.310; 21 CFR 312.315; 21 CFR 312.320 Legal Deadline: None Abstract: The Food and Drug Administration proposed in the Federal Register of December 14, 2006 (75 FR 75147), to amend the regulations governing investigational new drugs to describe the ways patients may obtain investigational drugs for treatment use under expanded access programs. Such use of investigational drugs would be available to: (1) Individual patients, including in emergencies; (2) intermediate size patient populations; and (3) larger populations under a treatment protocol or treatment IND. Statement of Need: The Food and Drug Administration Modernization Act of 1997 (Modernization Act) amended the Federal Food, Drug, and Cosmetic Act [[Page 69812]] (the Act) to include specific provisions concerning expanded access to investigational drugs for treatment use. In particular, section 561(b) of the Act permits any person, acting through a licensed physician, to request access to an investigational drug to diagnose, monitor, or treat a serious disease or condition provided that a number of conditions are met. The rule is needed to incorporate into FDA's regulations this and other provisions of the Modernization Act concerning access to investigational drugs. In addition, the agency seeks to increase awareness and knowledge of expanded access programs and the procedures for obtaining investigational drugs for treatment use. The rule will assist in achieving this goal by describing in detail the criteria, submission requirements, and safeguards applicable to different types of treatment uses. Summary of Legal Basis: FDA has the authority to impose requirements concerning the treatment use of investigational drugs under various sections of the Act, including sections 505(i), 561, and 701(a) (21 U.S.C. 355(i), 360bbb, and 371(a)). Section 505(i) of the Act directs the Secretary to promulgate regulations exempting from the operation of the new drug approval requirements drugs intended solely for investigational use by experts qualified by scientific training and expertise to investigate the safety and effectiveness of drugs. The proposed rule explains procedures and criteria for obtaining FDA authorization for treatment uses of investigational drugs. The Modernization Act provides significant additional authority for this rulemaking. Section 561(a) states that the Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. Section 561(b) allows any person, acting through a physician licensed in accordance with State law, to request from a manufacturer or distributor an investigational drug for the diagnosis, monitoring, or treatment of a serious disease or condition if certain conditions are met. Section 561(c) closely tracks FDA's existing regulation at 21 CFR part 312.34 providing for treatment use by large patient populations under a treatment protocol or treatment IND if a number of conditions are met. Section 701(a) provides the Secretary with the general authority to promulgate regulations for the efficient enforcement of the Act. By clarifying the criteria and procedures relating to treatment use of investigational products, this proposed rule is expected to aid in the efficient enforcement of the Act. Alternatives: One alternative to this rulemaking that FDA considered was not to promulgate regulations implementing the expanded access provisions of the Modernization Act. However, the agency believes that promulgating regulations would further improve the availability of investigational drugs for treatment use by providing clear direction to sponsors, patients, and licensed physicians about the criteria for authorizing treatment use and what information must be submitted to FDA. Another alternative FDA considered was a regulation describing only individual patient and large scale expanded access criteria. However, the agency concluded that it would be preferable to have a third category of expanded access for intermediate size patient populations. Anticipated Costs and Benefits: FDA expects that the total one-time costs of the rule will be negligible. The agency expects that the annual and annualized costs of the rule will range from a low of about $130,000 to $260,000 in the first year following publication of a final rule based on the proposal, to a high of about $350,000 to $690,000 in the fourth and fifth years. These estimates suggest that total annual and annualized costs for the rule would be between $1.4 million and $2.7 million for the 5-year period following implementation of any final rule based on the proposal. The agency also expects that the estimated incremental cost burdens associated with this rule are likely to be widely dispersed among affected entities. The benefits of the rule are expected to result from improved patient access to investigational drugs generally and from treatment use being made available for a broader variety of disease conditions and treatment settings. In particular, the clarification of eligibility criteria and submission requirements would enhance patient access by easing the administrative burdens on individual physicians seeking investigational drugs for their patients and on sponsors who make investigational drugs available for treatment use. Risks: The agency foresees no risks associated with the rule. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/14/06 71 FR 75147 NPRM Comment Period End 03/14/07 Final Action 09/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Organizations Government Levels Affected: None Agency Contact: Christine F. Rogers Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Suite 1101 5515 Security Lane Rockville, MD 20852 Phone: 301 594-2041 Fax: 301 827-5562 Email: christine.rogers@fda.hhs.gov RIN: 0910-AF14 _______________________________________________________________________ HHS--Centers for Medicare & Medicaid Services (CMS) ----------- PROPOSED RULE STAGE ----------- 47. STANDARDS FOR E-PRESCRIBING UNDER MEDICARE PART D (CMS-0016-P) Priority: Other Significant Unfunded Mandates: This action may affect State, local or tribal governments and the private sector. Legal Authority: 42 USC 1395 CFR Citation: 42 CFR 423 Legal Deadline: Final, Statutory, April 1, 2008. [[Page 69813]] Abstract: This rule proposes standards for electronic prescribing (e-prescribing) under Medicare Part D. This rule would require Medicare Part D and Medicare Advantage plans to support electronic transmission of basic prescription data to and from doctors and pharmacies and to adopt final standards for e-prescribing as required by section 101 of the MMA. Statement of Need: This rule would implement section 101 of the MMA, which includes the requirement that the Secretary promulgate final uniform standards for the electronic transmission of prescriptions and certain other information for covered Part D drugs prescribed for Part D eligible individuals. Summary of Legal Basis: Section 101 of the MMA requires that the Secretary promulgate final uniform standards for the electronic transmission of prescriptions and certain other information for covered Part D drugs prescribed for Part D eligible individuals by no later than April 1, 2008. Alternatives: This is a statutory requirement. Anticipated Costs and Benefits: All Medicare drug plans would be required to implement the standards. We expect that the standards would include transactions for communicating medication history and formulary information to prescribers, which would result in fewer adverse drug events and increased formulary compliance. Risks: If this regulation is not published timely, plans may not be aware of the uniform standards. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 11/16/07 72 FR 64900 NPRM Comment Period End 01/15/08 Final Action 04/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses Government Levels Affected: State Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Denise Buenning Senior Advisor Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop S2-26-17 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-6711 Email: denise.buenning@cms.hhs.gov RIN: 0938-AO66 _______________________________________________________________________ HHS--CMS 48. APPLICATION OF CERTAIN APPEALS PROVISIONS TO THE MEDICARE PRESCRIPTION DRUG APPEALS PROCESS (CMS-4127-P) Priority: Other Significant. Major status under 5 USC 801 is undetermined. Unfunded Mandates: Undetermined Legal Authority: sec 1102, 1860D-1 to 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1395w-101 to 1395w-152, and 1395hh) CFR Citation: 42 CFR 560 to 638 Legal Deadline: None Abstract: The voluntary prescription drug benefit program was enacted into law by section 101 of title 1 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). The implementing regulations for the Part D program were published in a final rule on January 28, 2005, and became effective March 22, 2005. These regulations provide that the Medicare Advantage (MA) rules regarding appeals and reopenings will apply to the Part D appeals process to the extent they are appropriate. The MA regulations in turn apply the fee-for-service (FFS) appeals regulations (concerning the administrative review and hearing processes and representation of parties under titles II and XVIII of the Act) to the extent they are appropriate. Based on this regulatory framework, we noted in the January 28, 2005, rule that differences in the appeals procedures for Part D enrollees would be addressed in a future Part D rulemaking document. The purpose of the proposed rule is to provide additional guidance on the differences in appeals procedures for Part D enrollees by proposing more detailed regulations governing Part D appeals at the ALJ, MAC, and Federal district court levels and reopenings of determinations and decisions that follow the Part A and Part B procedures set forth in the part 405 rule, as appropriate. Statement of Need: This rule proposes the procedures that the Department of Health and Human Services would follow at the Administrative Law Judge (ALJ) and Medicare Appeals Council (MAC) levels in deciding appeals brought by individuals who have enrolled in the Medicare prescription drug benefit program and the reopening procedures that would be followed at all levels of appeal. Summary of Legal Basis: The voluntary prescription drug benefit program (``Part D'') was enacted into law by Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA specified that the prescription drug benefit would become available on January 1, 2006 for individuals entitled to benefits under Medicare Part A or enrolled under Medicare Part B. The implementing regulations for the Part D program were published in a final rule on January 28, 2005, and became effective March 22, 2005. Alternatives: In addition to developing regulations, the agency also considered providing this guidance through a CMS Ruling. Similarly, we also weighed the option of not issuing any additional guidance, and allowing individual adjudicators to determine how the provisions apply to part D appeals and reopenings. Anticipated Costs and Benefits: In the current Part D appeals process, there are no explicit procedures for processing appeal requests at the ALJ, MAC, or Federal court levels or for processing reopening requests. The absence of clear and efficient procedures for upper level appeals and reopenings may delay beneficiary access and/or delay the actual processing of appeals at these levels and reopenings. The costs associated with these outcomes are likely to be increased costs for beneficiaries. [[Page 69814]] Beneficiaries who have difficulty accessing the appeals or reopenings processes or who cannot access these processes, may elect to pay for their medications out-of-pocket. Similarly, beneficiaries who experience delays in receiving appeals decisions, may choose to pay for their medications while awaiting a decision. Finally, beneficiaries who are without their medications for extended periods of time because they experience long delays in processing appeals may experience adverse health consequences, including additional hospitalizations. Risks: Under the current regulatory framework, the absence of specific rules governing the adjudication of upper level Part D appeals requires each adjudicator to make his/her own determination about how the provisions apply to the Part D appeals and reopenings processes. Relying on individual adjudicators could result in inconsistencies in the process for beneficiaries. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 01/00/08 Regulatory Flexibility Analysis Required: No Government Levels Affected: None Federalism: Undetermined Agency Contact: Anthony Culotta Director, Medicare Enrollment & Appeals Group Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop C2-12-16 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-4661 Email: anthony.culotta@cms.hhs.gov RIN: 0938-AO87 _______________________________________________________________________ HHS--CMS 49. MEDICARE SUPPLEMENTAL POLICIES (CMS-4084-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: Sec. 1882 of the Social Security Act CFR Citation: 42 CFR 403.200 et seq Legal Deadline: None Abstract: The regulation outlines procedures for the States and for CMS to certify the Medigap policies of private issuers. This rule is authorized under the Medigap program. Statement of Need: The current regulation was initially published in 1982 as an interim final rule, but was never finalized. Section 902 of the MMA requires that proposed or interim final rules be finalized within 3 years of the initial publication or the rule will sunset; therefore, CMS is publishing this update as a proposed rule. These regulations outline the requirements for States and CMS to develop a process to certify Medigap policies of health insurance issuers. Since 1982 there have been several legislative enactments (including OBRA `90 and the MMA) that have changed the process and these changes must be incorporated into the rules. We believe there will be a positive reaction to the proposed rule since it will be incorporating the certification process that has been updated by statute. Summary of Legal Basis: Section 1882 of the Social Security Act. Alternatives: We considered not publishing an update because most of the provisions are in the statute, but we did not want to leave the current regulation in an outdated status. Anticipated Costs and Benefits: Since States have incorporated the updated certification process, there should be no cost in complying with the proposed rules. Risks: This rule addresses the risk of having an outdated regulation create confusion with the certification process for Medigap policies. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 08/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: No Government Levels Affected: State Agency Contact: Cathy Windfield-Jones Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21144 Phone: 410 786-6674 Email: cathy.windfield@cms.hhs.gov RIN: 0938-AP10 _______________________________________________________________________ HHS--CMS 50. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND AMBULATORY SURGICAL CENTER PAYMENT SYSTEM FOR CY 2009 (CMS- 1404-P) Priority: Economically Significant. Major under 5 USC 801. Legal Authority: BBA; PPRA; BIPA; MMA; 42 USC 1302 et al. CFR Citation: Not Yet Determined Legal Deadline: Final, Statutory, November 1, 2008. Abstract: This rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. The rule also proposes changes to the Ambulatory Surgical Center Payment System list of services and rates. These changes would be applicable to services furnished on or after January 1 annually. [[Page 69815]] Statement of Need: Medicare pays over 4,200 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory payment classifications (APCs). CMS annually revises the APC payment amounts based on claims data, proposes new payment polices, and updates the payments for inflation using the market basket. The proposed rule solicits comments on the proposed OPPS payment rates and new policies. This final does not impact payments to critical access hospitals as they are not paid under the OPPS. CMS will issue a final rule containing the payment rates for the 2009 OPPS at least 60 days before January 1, 2009. Summary of Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services. The final rule revises the Medicare hospital OPPS to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. In addition, the proposed and final rules describe changes to the outpatient APC system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2009. Alternatives: None. This is a statutory requirement. Anticipated Costs and Benefits: Total expenditures will be adjusted for CY 2009. Risks: If this regulation is not published timely, outpatient hospital services will not be paid appropriately, beginning January 1, 2009. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: Federal Federalism: This action may have federalism implications as defined in EO 13132. Agency Contact: Alberta Dwivedi Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop, C5-01-26 7500 Security Boulevard Baltimore, MD 21207 Phone: 410 786-0763 Email: alberta.dwivedi@cms.hhs.gov RIN: 0938-AP17 _______________________________________________________________________ HHS--CMS 51. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE AND AMBULANCE FEE SCHEDULE FOR CY 2009 (CMS-1403-P) Priority: Economically Significant. Major under 5 USC 801. Unfunded Mandates: Undetermined Legal Authority: Social Security Act sec 1102; Social Security Act sec 1871 CFR Citation: 42 CFR 405; 42 CFR 410 to 411; 42 CFR 413 to 414; 42 CFR 426 Legal Deadline: Final, Statutory, November 1, 2008. Abstract: This major proposed rule would make changes affecting Medicare Part B payment to physicians and other Part B suppliers. It also updates the ambulance fee schedule. Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This major proposed rule would make changes affecting Medicare Part B payment to physicians and other Part B suppliers. It also updates the ambulance fee schedule. The final rule has a statutory publication date of November 1, 2008, and implementation of January 1, 2009. Summary of Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes a deadline of no later than November 1 for publication of the final physician fee schedule rule. Alternatives: None. This is a statutory requirement. Anticipated Costs and Benefits: Total expenditures will be adjusted for CY 2009. Risks: If this regulation is not published timely, physician services will not be paid appropriately. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 07/00/08 Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined Federalism: Undetermined Agency Contact: Diane Milstead Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mailstop, C4-03-06 7500 Security Bouldvard Baltimore, MD 21244 Phone: 410 786-3355 Email: diane.milstead@cms.hhs.gov RIN: 0938-AP18 _______________________________________________________________________ HHS--CMS ----------- FINAL RULE STAGE ----------- 52. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-F) (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 42 USC 1395rr et al CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 413 to 414; 42 CFR 488; 42 CFR 494 [[Page 69816]] Legal Deadline: Final, Statutory, February 4, 2008, MMA sec. 902. Abstract: This final rule revises the requirements that end stage renal disease (ESRD) facilities must meet to be certified under the Medicare program. Statement of Need: This rule finalizes the February 4, 2005 proposed rule entitled ``Medicare Program; Conditions for Coverage for End Stage Renal Disease Facilities.'' The requirements were last revised in their entirety in 1976. The final rule establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates some procedural requirements, and preserves strong process measures when necessary to promote patient safety and well being, and continuous quality improvement. This final rule implements current professional standards of practice, provides a structure for internal facility quality improvement, and a framework for external oversight. Summary of Legal Basis: The Social Security Act (the Act) authorizes benefits for individuals who have been determined to have end stage renal disease. The Act authorizes payments on behalf of such individuals to providers of services and renal dialysis facilities ``which meet requirements as the Secretary shall by regulation prescribe.'' ESRD conditions for coverage may be revised as needed under the Secretary's rulemaking authority. Alternatives: Retain the current conditions and rely upon the various quality improvement initiatives (e.g., the Dialysis Facility Compare website and the CMS Clinical Performance Measures Project) that have improved beneficiaries' quality of care. Anticipated Costs and Benefits: We expect some Medicare savings resulting from this final rule due to an increase in the number of patients who will be exposed to the advantages of obtaining an arteriovenous fistula (AVF), and an increase in the number of patients choosing the option of self-care (home) dialysis as a result of it being discussed and explained to them. Risks: The final rule must be published by February 4, 2008 in order to comply with section 902 of the Medicare Modernization Act. In addition, failure to update the requirements would result in outdated ESRD conditions for coverage that are over 31 years old and do not reflect current medical practices or scientific advances in the field. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 02/04/05 70 FR 6184 Final Action 02/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Teresa Casey Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Clinical Standards Group S3-02-01 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-7215 Email: mary.casey@cms.hhs.gov Lynn M Riley Health Insurance Specialist, Department of Health and Human Services Centers for Medicare & Medicaid Services S3-02-01 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-1286 Email: lynn.riley@cms.hhs.gov RIN: 0938-AG82 _______________________________________________________________________ HHS--CMS 53. HOSPICE CARE CONDITIONS OF PARTICIPATION (CMS-3844-F) (SECTION 610 REVIEW) Priority: Other Significant Legal Authority: 42 USC 1302; 42 USC 1395hh CFR Citation: 42 CFR 418 Legal Deadline: Final, Statutory, May 27, 2008, MMA sec. 902. Abstract: This final rule is a regulatory reform initiative that revises existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The requirements focus on the actual care delivered to patients and patients' families by hospices and the results of that care, reflect an interdisciplinary view of patient care, and allow hospices greater flexibility in meeting quality standards. These changes are an integral part of our efforts to achieve broad-based improvements and measurements of the quality of care furnished through Federal programs while at the same time reducing procedural burdens on providers. Statement of Need: This final rule revises and reorganizes the existing conditions of participation (CoPs) for Medicare participating hospice providers first published in 1983. The final rule focuses on the care delivered to patients and patients' families by hospices and the outcomes of that care. The requirements continue to reflect an interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration's efforts to achieve broad-based improvements in the quality of health care furnished through the Medicare and Medicaid programs. This rule codifies hospice language in the Balanced Budget Act of 1997 and the Medicare Modernization Act of 2003. Summary of Legal Basis: The Social Security Act (the Act) provides the statutory qualifications and requirements that a hospice must meet to receive payment for hospice care given to Medicare beneficiaries who elect the hospice benefit under the Medicare and Medicaid programs. This section gives the Secretary broad authority to establish standards for hospices. Under this authority, the Secretary established conditions of participation (CoPs) for hospices. In addition, the Act gives the Secretary the authority to make and publish such rules and regulations as may be necessary to the efficient administration of the functions with which he is charged under the Act. This section of the Act gives the Secretary broad authority to establish requirements for [[Page 69817]] hospices that are necessary for the efficient administration of the Medicare program. Alternatives: Rely on the current CoPs: We concluded that this was not a reasonable option because the current CoPs are not patient-focused but rather problem-focused, an approach that has inherent limits. Trying to ensure quality through the enforcement of prescriptive health and safety standards, rather than trying to improve quality of care for all patients, adversely affects agency improvement efforts and does not stimulate broad-based quality of care initiatives. On the other hand, revising the current CoPs would take advantage of continuing advances in health care delivery. Increase prescriptive requirements relative to patient rights, drugs and durable medical equipment, and personnel qualifications: We decided not to pursue this approach because the additional burden that would be placed on hospices would outweigh any potential benefits. Exclude the revisions to the comprehensive assessment and interdisciplinary group requirements: Since these areas represent two of the most frequently cited deficiencies noted during hospice surveys and have a great impact on patient care, we decided that these sections did, in fact, need to be strengthened. Anticipated Costs and Benefits: Provisions within the final rule may require that some hospices provide patient care and patient care related services that they are not currently providing. These services will most likely require a cost outlay. Since these rules have not been revised for over 20 years, we believe that many of the improvements that are being made are already being implemented in whole or in part by a portion of hospices. Risks: This final rule must be published by May 26, 2008 in order to comply with section 902 of the Medicare Modernization Act. In addition, failure to update these outdated regulations will not address the needs of patients or providers. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 05/27/05 70 FR 30840 Final Action 05/00/08 Regulatory Flexibility Analysis Required: Yes Small Entities Affected: Businesses Government Levels Affected: None Agency Contact: Mary Rossi-Coajou Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Clinical Standards Group Mailstop S3-02-01 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-6051 Email: mary.rossicoajou@cms.hhs.gov Danielle Shearer Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Clinical Standards Group S3-02-01 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-6617 Email: danielle.shearer@cms.hhs.gov RIN: 0938-AH27 _______________________________________________________________________ HHS--CMS 54. HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-F) Priority: Other Significant Legal Authority: 42 USC 300gg; PL 104-191 CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.120; 45 CFR 146.145 Legal Deadline: None Abstract: This final rule will clarify certain portability requirements for group health plans and issuers of health insurance coverage offered in connection with a group health plan. It also implements changes made to the Internal Revenue Code, the Employee Retirement Income Security Act, and the Public Health Service Act enacted as part of the Health Insurance Portability and Accountability Act of 1996. Statement of Need: This rule is needed to implement certain portability provisions of the Public Health Service Act as it pertains to private health plans and issuers. Specifically, it addresses the tolling of the 63-day break in creditable coverage when notices are not received, interactions of the law with the Family Medical and Leave Act, and special enrollment provisions. Summary of Legal Basis: The Public Health Service Act provides the authority to implement this rule. Alternatives: Since this is a statutory requirement, no alternatives were considered. Anticipated Costs and Benefits: Promulgation of this rule will make it easier for individuals to transfer from one group health plan to another group health plan in the event of the loss of a job, a job transfer, the loss of spouse, or a divorce. Risks: This rule addresses the risk of individuals not being able to obtain health insurance because they did not receive proper notification that their prior coverage had been terminated. The tolling of the permitted 63-day break in coverage, when an individual does not receive notice of termination of prior coverage, will provide those individuals additional time to obtain coverage through another health plan without being subject to pre-existing condition exclusions. Timetable: _______________________________________________________________________ Action Date FR Cite _______________________________________________________________________ NPRM 12/30/04 69 FR 78800 Final Action 08/00/08 Regulatory Flexibility Analysis Required: No Small Entities Affected: Businesses, Organizations Government Levels Affected: Federal, Local, State Federalism: This action may have federalism implications as defined in EO 13132. [[Page 69818]] Agency Contact: Adam Shaw Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Beneficiary Choices Employer and Policy Operations Group 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-1091 Email: adam.shaw@cms.hhs.gov Karen Levin Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Center for Beneficiary Choices Employer and Policy Operations Group 7500 Security Boulevard Baltimore, MD 21244 Phone: 410 786-5445 Email: karen.levin@cms.hhs.gov RIN: 0938-AL88 BILLING CODE 4150-24-S [[Page 69819]] DEPARTMENT OF HOMELAND SECURITY (DHS) Statement of Regulatory Priorities The Department of Homeland Security (DHS or the Department) was created in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107- 296. DHS is comprised of 22 Federal agencies brought together for the common mission of preventing terrorist attacks in the United States, reducing the vulnerability of the United States to terrorist attacks, and minimizing damage and assisting in recovery from acts of terrorism, natural disasters, or other emergencies that might occur in the United States. The Department's Strategic Plan governs the development of DHS' strategies, programs and projects, and ultimately is reflected in the Department's budget and regulatory agenda. DHS' Strategic Plan is posted on the Department's Web site: http://www.dhs.gov/xabout/ strategicplan. DHS' Strategic Goals are: AWARENESS- Identify and understand threats, assess vulnerabilities, determine potential impacts, and disseminate timely information to our homeland security partners and the American public. PREVENTION - Detect, deter, and mitigate threats to our homeland. PROTECTION- Safeguard our people and their freedoms, critical infrastructure, property, and the economy of our Nation from acts of terrorism, natural disasters, or other emergencies. RESPONSE- Lead, manage, and coordinate the national response to acts of terrorism, natural disasters, or other emergencies. RECOVERY - Lead national, state, local, and private sector efforts to restore services and rebuild communities after acts of terrorism, natural disasters, or other emergencies. SERVICE - Serve the public effectively by facilitating lawful trade, travel, and immigration. ORGANIZATIONAL EXCELLENCE - Value our most important resource, our people. Create a culture that promotes a common identity, innovation, mutual respect, accountability, and teamwork to achieve efficiency, effectiveness, and operational synergies. In 2005, the Secretary of Homeland Security announced a six-point agenda to ensure that the Department's policies, operations, and structures are aligned in the best way to address the potential threats that face our nation. The Secretary's six-point agenda is intended to: Increase overall preparedness, particularly for catastrophic events; Create better transportation security systems to move people and cargo more securely and efficiently; Strengthen border security and interior enforcement and reform immigration processes; Enhance information sharing with our partners; Improve DHS financial management, human resource development, procurement and information technology; and Realign the DHS organization to maximize mission performance. The regulations summarized in the Department's 2007 Fall Regulatory Program and in the Unified Agenda support the Department's Strategic Goals and the Secretary's six-point agenda and will improve the Department's ability to accomplish its primary missions. DHS strives for organizational excellence and uses a centralized and unified approach in managing its regulatory resources. The Department's regulatory program, including the Unified Regulatory Agenda and Regulatory Plan, is managed by the Office of the General Counsel. In addition, DHS senior leadership reviews each significant regulatory project to ensure that the project fosters and supports the Department's Strategic Goals. DHS also is committed to ensuring that all of its regulatory initiatives are aligned with its guiding principles to protect civil rights and civil liberties, integrate our actions, build coalitions and partnerships, develop human resources, innovate and be accountable to the American public. The Department values public involvement in the development of its Regulatory Plan, Unified Agenda and regulations, and takes particular concern with the impact its rules have on small businesses. DHS and each of its components continue to emphasize the use of plain language in our notices and rulemaking documents to promote better understanding of regulations and increased public participation in the Department's rulemakings. The Fall 2007 Regulatory Plan for DHS includes regulations issued by the Office of the Secretary of Homeland Security, as well as the Department's major divisions or directorates, Science and Technology Directorate and the Management Directorate. Further, effective March 21, 2007, the former-Preparedness Directorate was reorganized and moved under FEMA in accordance with the Post-Katrina Emergency Management Reform Act of 2006 (P.L. 109-296)(PKEMRA). Accordingly, active regulatory matters previously issued as Office of the Secretary rules by the former Preparedness Directorate, will now be identified as FEMA regulatory actions. In addition, DHS also established the National Protection and Programs Directorate (NPPD). NPPD, which houses such offices as the Office of Cyber Security, the Office of Infrastructure Protection and US-VISIT, is responsible for several regulatory actions set forth in this Agenda. DHS also has several components that have active regulatory programs, including the U.S. Coast Guard (Coast Guard), the U.S. Secret Service, the Transportation Security Administration (TSA), the Federal Emergency Management Administration (FEMA), U.S. Citizenship and Immigration Services (USCIS), the U.S. Immigration and Customs Enforcement (ICE), and U.S. Customs and Border Protection (CBP). The Fall 2007 Regulatory Plans for the Office of the Secretary and those DHS regulatory components with submissions for the 2007 Plan are discussed below. Office of the Secretary REAL ID During the Fall of 2007, DHS will be issuing a final rule to establish minimum standards for State-issued driver's licenses and identification cards that Federal agencies would accept for official purposes as required under the REAL ID Act of 2005. The REAL ID Act, prohibits Federal agencies, effective May 11, 2008, from accepting a driver's license or personal identification card (license) for an ``official purpose'' unless it has been issued by a State that has certified to, and been determined by DHS to meet, the requirements of the Act. The Act sets forth minimum document requirements, minimum issuance standards, and other requirements, including the following: Information and features that must appear on the face of the license, and inclusion of a common machine readable portion of a driver's license or identification card; Presentation and verification of information an applicant must [[Page 69820]] provide before a license may be issued, including evidence that the applicant is a U.S. citizen or has lawful status in the United States; Physical security of locations where licenses are produced, the security of document materials and papers from which licenses are produced, and the background check of certain employees involved in the manufacture and production of licenses, and; Physical security of the licenses to prevent tampering, counterfeiting, and duplication of the documents for a fraudulent purpose. On March 9, 2007, DHS issued a Notice of Proposed Rulemaking (NPRM) in this action. The Department received over 21, 000 comments on this rulemaking action. Section 205(b) of the Act authorizes DHS to grant extensions of the time requirements under the Act to States who provide adequate justification for their inability to comply. In the March 9 NPRM, DHS indicated that any State that requested an extension no later than February 10, 2008, will be granted an extension until December 31, 2009. In the final rule, we are moving the deadline for submission of requests for extensions until April 10, 2008. In addition, DHS is providing States with the opportunity to request a second extension beyond December 31, 2009, upon demonstrating that the State has achieved certain core benchmarks towards full compliance. DHS is issuing this rule in consultation with the Department of Transportation, other representatives of the Federal Government, and representatives from many States, as required under the Act. US-VISIT United States Visitor and Immigrant Status Indicator Technology (US- VISIT) is an integrated, automated entry-exit system that records the arrival and departure of aliens, verifies aliens' identities, and authenticates aliens' travel documents by comparison of biometric identifiers. The goals of US-VISIT are to enhance the security of the United States citizens and visitors to the United States, facilitate legitimate travel and trade, ensure the integrity of the United States immigration system, and protect the privacy of visitors