December 20, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 88
Healthy Home and Lead Hazard Control Grant Programs Data Collection; Progress Reporting
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. This data collection is designed to provide HUD timely information on progress of Healthy Homes Demonstration Program, Healthy Homes Technical Studies Program, Lead Base paint Hazard Control program, Lead Hazard Reduction Demonstration Program, Lead Outreach Program, Lead Technical Studies Program, and Operation Lead Elimination Action Program grant activities. HUD will provide Congress with status report as required by statute.
Reasonable Charges for Medical Care or Services; V3.12, 2013 Calendar Year Update and National Average Administrative Prescription Drug Charge Update
This Department of Veterans Affairs (VA) notice informs the public of the updated data for calculating the ``Reasonable Charges'' collected or recovered by VA for medical care or services and of the updated ``National Average Administrative Costs'' for purposes of calculating VA's charges for prescription drugs that were not administered during treatment but provided or furnished by VA to a veteran for: a nonservice-connected disability for which the veteran is entitled to care (or the payment of expenses for care) under a health plan contract; a nonservice-connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or a nonservice- connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations insurance. The charge tables and supplemental tables that are applicable to this notice can be viewed on the Veterans Health Administration Chief Business Office's Internet Web site. These changes are effective January 1, 2013.
Request for Information (RFI): Use of National Science Foundation Overseas Offices in Paris, Tokyo, Beijing by Broader Stakeholder Community
Purpose: As part of an assessment investigating the function of the three National Science Foundation overseas offices, this RFI seeks to solicit input from as large a set of stakeholders as possible.
Notice of Availability of Proposed National Pollutant Discharge Elimination System (NPDES) General Permit for Offshore Oil and Gas Exploration, Development and Production Operations off Southern California
EPA Region 9 is proposing to reissue its general NPDES permit (permit No. CAG280000) for discharges from offshore oil and gas exploration, development and production facilities located in Federal waters off the coast of Southern California. This permit was issued on September 22, 2004, and modified on November 30, 2009. This notice announces the availability of the proposed general permit and fact sheet for public comment. For the most part, the proposed permit is very similar to the 2004 permit. The major changes from the 2004 permit include the following: (1) Reduced geographic area of coverage reflecting a reduction in the number of lease blocks considered active by the Bureau of Ocean Energy Management (BOEM); (2) revised effluent limits and monitoring requirements for produced water based on an updated reasonable potential analysis; (3) revised whole effluent toxicity (WET) requirements for produced water; (4) study requirement for cooling water intake structures; and (5) new requirements for an on-line oil and grease monitor for produced water. These changes are discussed in more detail below, and in the fact sheet accompanying the proposed general permit.
Significant New Use Rules on Certain Chemical Substances
EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 9 chemical substances which were the subject of premanufacture notices (PMNs). This action requires persons who intend to manufacture, import, or process any of these 9 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Fisheries of the Exclusive Economic Zone Off Alaska; Big Skate in the Central Regulatory Area of the Gulf of Alaska
NMFS is prohibiting retention of big skate in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2012 total allowable catch of big skate in the Central Regulatory Area of the GOA has been reached.
Agency Information Collection Activities: Submission for OMB Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at 301-443-1984.
Publication of State Plan Pursuant to the Help America Vote Act
Pursuant to Sections 254(a)(11)(A) and 255(b) of the Help America Vote Act (HAVA), Public Law 107-252, as amended by Section 622 of the Consolidated Appropriations Act, 2012, the U.S. Election Assistance Commission (EAC) hereby causes to be published in the Federal Register this notice in reference to the changes made to the HAVA State plan previously submitted by American Samoa. The revised State plan will be posted on the EAC Web site at www.eac.gov.
Multistakeholder Meetings To Develop Consumer Data Privacy Code of Conduct Concerning Mobile Application Transparency
The National Telecommunications and Information Administration (NTIA) will convene meetings of a privacy multistakeholder process concerning mobile application transparency.
Culturally Significant Objects Imported for Exhibition Determinations: “Projects 99: Meiro Koizumi”
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Projects 99: Meiro Koizumi,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Museum of Modern Art in New York, New York from on or about January 9, 2013, until on or about May 6, 2013, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Labeling Requirements for Commercial and Industrial Equipment
The Energy Policy and Conservation Act as amended prescribes energy conservation standards for certain commercial and industrial equipment, and requires the Department of Energy (DOE) to administer an energy conservation program for the equipment, including the development of labeling requirements. In this notice, DOE requests information from interested parties regarding the potential for establishing labeling requirements for covered commercial and industrial equipment, including information about the technical and economic feasibility of labeling such equipment, the extent to which labeling would assist consumers in making purchasing decisions, the potential for significant energy savings resulting from labeling, the potential content and format of prospective labels for each type of equipment, the ideal location of placement for any such labels, and prospective burdens on manufacturers associated with labeling of covered equipment. Additional input and suggestions relevant to labeling of commercial and industrial equipment are also welcome.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register Notice with a 60-day comment period on this information collection on September 5, 2012 (77 FR 54617). 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: NRC Form 398, ``Personal Qualification StatementLicensee.'' 3. Current OMB approval number: 3150-0090. 4. The form number if applicable: NRC Form 398. 5. How often the collection is required: Upon application for an initial or upgrade operator license and every 6 years for the renewal of operator or senior operator licenses. 6. Who will be required or asked to report: Facility licensees who are tasked with certifying that the applicants and renewal operators are qualified to be licensed as reactor operators and senior reactor operators. 7. An estimate of the number of annual responses: 1,436. 8. The estimated number of annual respondents: 1,436. 9. An estimate of the total number of hours needed annually to complete the requirement or request: 3,680.25. 10. Abstract: NRC Form 398 is used to transmit detailed information required to be submitted to the NRC by a facility licensee on each applicant applying for new and upgraded licenses or license renewals to operate the controls at a nuclear reactor facility. This information is used to determine that each applicant or renewal operator seeking a license or renewal of a license is qualified to be issued a license and that the licensed operator would not be expected to cause operational errors and endanger public health and safety. The public may examine and have copied for a fee, publicly available documents, including the final supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments and questions should be directed to the OMB reviewer listed below by January 22, 2013. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. Chad Whiteman, Desk Officer, Office of Information and Regulatory Affairs (3150-0090), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be emailed to Chad_S_Whiteman@omb.eop.gov or submitted by telephone at 202-395-4718. The NRC Clearance Officer is Tremaine Donnell, 301-415-6258.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register Notice with a 60-day comment period on this information collection on August 17, 2012 (77 FR 49833). 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: NRC's Policy Statement on Cooperation with States at Commercial Nuclear Power Plants and Other Nuclear Production and Utilization Facilities. 3. Current OMB approval number: 3150-0163. 4. The form number if applicable: N/A. 5. How often the collection is required: On occasion, when a State wishes to observe NRC inspection or perform inspections for the NRC. 6. Who will be required or asked to report: Nuclear Power Plant Licensees, Materials Security Licensees and those States interested in observing or performing inspections. 7. An estimate of the number of annual responses: 70. 8. The estimated number of annual respondents: 55. 9. An estimate of the total number of hours needed annually to complete the requirement or request: 1,000. 10. Abstract: States are involved and interested in monitoring the safety status of nuclear power plants and radioactive materials. This involvement is, in part, in response to the States' public health and safety responsibilities and, in part, in response to their citizens' desire to become more knowledgeable about the safety of nuclear power plants and radioactive materials. States have identified NRC inspections as one possible source of knowledge for their personnel regarding plant and materials licensee activities, and the NRC, through the policy statement on Cooperation with States, has been amenable to accommodating the States' needs in this regard. Additionally, the NRC has entered into reimbursable Agreements with certain States under Section 274i of the Act, as amended, to employ their resources to conduct radioactive materials security inspections against NRC Orders. The public may examine and have copied for a fee, publicly available documents, including the final supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments and questions should be directed to the OMB reviewer listed below by January 22, 2013. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. Chad Whiteman, Desk Officer, Office of Information and Regulatory Affairs (3150-0163), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be emailed to Chad_S_Whiteman@omb.eop.gov, or submitted by telephone at 202-395-4718. The NRC Clearance Officer is Tremaine Donnell, 301-415-6258.
Decision and Order Granting a Waiver to GE Appliances From the Department of Energy Residential Refrigerator and Refrigerator-Freezer Test Procedures
The U.S. Department of Energy (DOE) gives notice of the decision and order (Case No. RF-023) that grants to GE Appliances (GE) a waiver from the DOE electric refrigerator and refrigerator-freezer test procedures for the basic models set forth in its petition for waiver in Case RF-023. In its petition, GE provides an alternate test procedure that is the same as the test procedure DOE published in a final rule dated January 25, 2012 (77 FR 3559). Under today's decision and order, GE shall be required to test and rate these refrigerator- freezers using an alternate test procedure as adopted in DOE's final rule dated January 25, 2012 (77 FR 3559) that takes multiple defrost cycles into account when measuring energy consumption.
Decision and Order Granting a Waiver to Samsung From the Department of Energy Residential Refrigerator and Refrigerator-Freezer Test Procedures
The U.S. Department of Energy (DOE) gives notice of the decision and order (Case No. RF-021) that grants to Samsung Electronics America, Inc. (Samsung) a waiver from the DOE electric refrigerator and refrigerator-freezer test procedures for the basic models set forth in its petition for waiver in Case RF-021. In its petition, Samsung provides an alternate test procedure that is the same as the test procedure DOE published in a final rule dated January 25, 2012 (77 FR 3559). Under today's decision and order, Samsung shall be required to test and rate these refrigerator-freezers using an alternate test procedure as adopted in DOE's final rule dated January 25, 2012 (77 FR 3559) that takes multiple defrost cycles into account when measuring energy consumption.
Agency Information Collection Activities: Application for Naturalization, Form Number N-400; Revision of a Currently Approved Collection
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Ocean Energy Safety Advisory Committee (OESC); Notice of Meeting
OESC will meet at the Department of the Interior's South Interior Building in Washington, DC.
Draft Safety Culture Policy Statement: Request for Public Comments
The Bureau of Safety and Environmental Enforcement (BSEE) is issuing this Draft Statement of Policy to announce its expectation that individuals and organizations performing or overseeing activities regulated by BSEE establish and maintain a positive safety culture commensurate with the significance of their activities and the nature and complexity of their organizations and functions. The BSEE defines safety culture as the core values and behaviors resulting from a collective commitment by leaders and individuals to emphasize safety, over competing goals, to ensure protection of people and the environment. This draft policy statement would apply to all lessees, the owners or holders of operating rights, designated operators or agents of the lessee(s), pipeline right-of-way holders, State lessees granted a right-of-use and easement, and contractors. The BSEE is requesting comments on the Draft Safety Culture Policy Statement and associated questions.
Notice of Public Meeting; Central Montana Resource Advisory Council
In accordance with the Federal Land Policy and Management Act Land the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Central Montana Resource Advisory Council (RAC) will meet as indicated below.
Notice of Public Meeting: Resource Advisory Councils, NV
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972 (FACA), the Department of the Interior, Bureau of Land Management (BLM) Nevada will hold a joint meeting of its three Resource Advisory Councils (RACs), the Sierra Front-Northwestern Great Basin RAC, the Northeastern Great Basin RAC, and the Mojave-Southern Great Basin RAC in Las Vegas, Nevada. The meeting is open to the public and a public comment period will be available.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 757 and Model 767 airplanes. This proposed AD was prompted by a standby power relay failure and subsequent illumination of the ``STANDBY BUS OFF'' light, which led the flightcrew to set the standby power switch to the ``BAT'' position, isolating the battery and standby buses, disabling the battery charger, and eventually causing the main battery to be depleted. This proposed AD would require doing wiring changes and installing a new air/ground relay to the battery charger system. We are proposing this AD to prevent discharge of the main battery, which could result in multiple system degradation, reduced airplane controllability, and runway excursion upon landing.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council will convene a meeting of the Reef Fish Committee meeting.
Renewal of the Veterans' Advisory Board on Dose Reconstruction
Under the provisions of the Federal Advisory Committee Act of 1972, (5 U.S.C. Appendix), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.50(a), the Department of Defense gives notice that it is renewing the charter for the Veterans' Advisory Board on Dose Reconstruction (hereinafter referred to as ``the Board''). The Board has been determined to be in the public interest. The Board is a non-discretionary federal advisory committee that shall provide review and oversight of the Radiation Dose Reconstruction Program and make such recommendations on modifications in the mission, procedures, and administration of the Radiation Dose Reconstruction Program as it considers appropriate as a result of the audits conducted under the authority of Section 601(c)(3)(A) of Title VI of Public Law 108-183. The Board shall: a. Conduct periodic, random audits of dose reconstructions under the Radiation Dose Reconstruction Program and of decisions by the Department of Veterans Affairs on claims for service connection of radiogenic diseases; b. Assist the Department of Veterans Affairs and the Defense Threat Reduction Agency in communicating to veterans information on the mission, procedures, and evidentiary requirements of the Radiation Dose Reconstruction Program; c. Carry out such other activities with respect to the review and oversight of the Radiation Dose Reconstruction Program as the Secretary of Defense and Secretary of Veterans Affairs shall jointly specify; d. Make recommendations on modifications to the mission and procedures of the Dose Reconstruction Program as the Board considers appropriate as a result of the audits conducted pursuant to paragraph (a) above; e. Any additional actions the Secretary of Defense and the Secretary of Veterans Affairs jointly determine are required to ensure that the quality assurance and quality control mechanisms of the Radiation Dose Reconstruction Program are adequate and sufficient for purpose of the program; and f. Any additional actions the Secretary of Defense and the Secretary of Veterans Affairs jointly determine are required to ensure that the mechanisms of the Radiation Dose Reconstruction Program for communication and interaction with veterans are adequate and sufficient for the program. The Board, pursuant to Section 601(c)(2) of Title VI of Public Law 108-183, shall be comprised of: a. At least one expert in historical dose reconstruction of the type conducted under the Radiation Dose Reconstruction Program. b. At least one expert in radiation health matters. c. At least one expert in risk communications matters. d. A representative of the Defense Threat Reduction Agency and a representative of the Department of Veterans Affairs. e. At least three veterans, including at least one Veteran who is a member of an atomic veterans group. The Secretary of Defense and the Secretary of Veterans Affairs will jointly approve the appointment of Board members, and according to DoD policy the appointments will be renewed on an annual basis. Board members, who are not full-time or permanent part-time federal officers or employees shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109 and serve as special Government employees members. Each member of the Board is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. With the exception of travel and per diem for official travel, Board members shall serve without compensation. Board members, with the approval of the Secretary of Defense and the Secretary of Veteran Affairs, may serve a term of service on the Board of one-to-four years; however, no member, unless authorized by the Secretary of Defense, may serve more than two consecutive terms of service on the Board, to include its subcommittees. The Department, when necessary and consistent with the Board's mission and DoD policies/procedures, may establish subcommittees, task forces, or working groups to support the Board. Establishment of subcommittees will be based upon written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense, or the Board's sponsor. Such subcommittees or work groups shall not work independently of the Board, and shall report all their recommendations and advice solely to the Board for full deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the chartered Board; nor can any subcommittee or its members update or report, verbally or in writing, on behalf of the Board; nor can any subcommittee or its members update or report directly to the DoD or any Federal officers or employees. All subcommittee members shall be jointly appointed by the Secretary of Defense and the Secretary of Veterans Affairs according to governing DoD policies/procedures, even if the member in question is already a Board member. Subcommittee members, if not full-time or part-time Government employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109, and serve as special Government employee members, whose appointments must be renewed by the Secretary of Defense and Secretary of Veteran Affairs on an annual basis. Subcommittee members, with the approval of the Secretary of Defense and the Secretary of Veteran Affairs, may serve a term of service on the subcommittee of one-to-four years; however, no member shall serve more than two consecutive terms of service on the subcommittee, unless authorized by the Secretary of Defense and the Secretary of Veterans Affairs. With the exception of travel and per diem, subcommittee members shall serve without compensation. Each subcommittee member is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. All subcommittees, task forces, working groups shall operate under the provisions of the FACA, the Government in the Sunshine Act, governing Federal statutes and regulations, and governing DoD policies/ procedures. Currently, DoD has approved the following permanent subcommittees to the Board to meet the requirements of Public Law 108-163. a. The Subcommittee on DTRA Dose Reconstruction Procedures shall be composed of no more than four members and is responsible for reviewing and recommending improvements to the dose reconstruction process. The estimated number of meetings is two per year. b. The Subcommittee on Veterans Affairs (VA) Claims Adjudication Procedures shall be composed of no more than four members and deals directly with the Department of Veterans Affairs to improve the process for handling Atomic Veterans claims. The estimated number of meetings is two per year. c. The Subcommittee on Quality Management and VA Process Integration with DTRA Nuclear Test Personnel Review Program shall be composed of no more than four members and deals with quality issues with DTRA's nuclear test personnel review and VA in its claims adjudication process for Atomic Veterans. The estimate number of meetings is two per year. d. The Subcommittee on Communication and Outreach shall be composed of no more than four members and deals with veteran outreach and communication programs. The estimated number of meetings is two per year.
Renewal of Department of Defense Federal Advisory Committees
Under the provisions of 10 U.S.C. 1114, the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b) (``the Sunshine Act''), and 41 CFR 102-3.50(a), the Department of Defense (DoD) gives notice that it is renewing the charter for the Department of Defense Medicare-Eligible Retiree Health Care Board of Actuaries (``the Board''). The Board is a non-discretionary Federal advisory committee that shall provide the Secretary of Defense with independent advice and recommendations related to actuarial matters associated with the Department of Defense Medicare-Eligible Retiree Health Care Fund (``the Fund''). The Board, under the authority of FACA, shall provide independent advice and recommendations related to actuarial matters associated with the Fund and on matters referred by the Secretary of Defense, including those regarding: (a) Valuation of the Fund under 10 U.S.C. 1115(c); (b) Recommendations for such changes as in the Board's judgment are necessary to protect the public interest and maintain the Fund on a sound actuarial basis; and (c) Advise the Secretary of Defense on all actuarial matters necessary to make determinations in order to finance liabilities of the Fund on an actuarially sound basis. The Board shall report to the Secretary of Defense. The Board shall report annually on the actuarial status of the Fund, and the Board shall furnish its advice and opinion on matters referred to it by the Secretary. The Board shall report periodically, but not less than once every four years, to the President and the Congress on the status of the Fund and shall include recommendations for such changes as in the Board's judgment are necessary to protect the public interest and maintain the Fund on a sound actuarial basis. The Secretary of Defense, through the Under Secretary of Defense for Personnel and Readiness (USD(P&R)), may act upon the Board's advice and recommendations. The Board shall be composed of three members who are appointed by the Secretary of Defense from among qualified professional actuaries who are members of the Society of Actuaries. The Board members shall serve for a term of 15 years; except those Board members appointed to fill a vacancy occurring before the end of the term for which the predecessor was appointed, shall serve only until the end of such term. Board members may serve after the end of the term until a successor has taken office. Members of the Board shall be appointed by the Secretary of Defense and their appointments shall be renewed on an annual basis according to DoD policies/procedures. Members of the Board who are not full-time or permanent part-time Federal employees shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109 and serve as special Government employees (SGEs) and shall, under the authority of 10 U.S.C. 1114(a)(3), serve with compensation, to include travel and per diem for official travel, in accordance with 5 U.S.C. 5703. Each member of the Board is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. A member of the Board may be removed by the Secretary of Defense for misconduct or failure to perform functions vested in the Board and for no other reason. The chairperson of the Board shall be designated by the USD (P&R), on behalf of the Secretary of Defense. The Department, when necessary, and consistent with the Board's mission and DoD policies/procedures, may establish subcommittees, task groups, and working groups to support the Board. Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense or the USD(P&R). Such subcommittees shall not work independently of the chartered Board, and shall report all of their recommendations and advice solely to the Board for full deliberation and discussion. Subcommittees have no authority to make decisions and recommendations, verbally, or in writing, on behalf of the Board; nor can any subcommittee or its members update or report directly to the DoD or any Federal officer or employees. The Secretary or the Deputy Secretary of Defense may approve the appointment of subcommittee members for one-to-four year terms of service; however, no member, unless authorized by the Secretary, may serve more than two consecutive terms of service. These individuals may come from the parent committee or may be new nominees, as recommended by the USD(P&R) and based upon the subject matters under consideration. Subcommittee members, if not full-time or part-time Government employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109, and shall serve as SGEs, whose appointments must be renewed by the Secretary of Defense on an annual basis. With the exception of travel and per diem for official travel related to the Board or its subcommittees, subcommittee members shall serve without compensation. Each subcommittee member is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. All subcommittees operate under the provisions of FACA, the Sunshine Act, governing Federal statutes and regulations, and governing DoD policies/procedures.
Establishment of Department of Defense Federal Advisory Committees
Under the provisions of section 2852(b), of the Ike Skelton National Defense Authorization Act (NDAA) for Fiscal Year 2011 (Pub. L. 111-383), the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b) (``the Sunshine Act), and 41 CFR 102-3.50(a), the DoD gives notice that it is establishing the charter for the Independent Review Panel on Military Medical Construction Standards (``the Panel''). The Panel, pursuant to section 2852(b), of the Ike Skelton NDAA for Fiscal Year 2011 (Pub. L. 111-383), is a non-discretionary Federal advisory committee established to provide the Secretary of Defense independent advice and recommendations regarding a construction standard for military medical centers to provide a single standard of care, as set forth below: a. Reviewing the unified military medical construction standards to determine the standards consistency with industry practices and benchmarks for world class medical construction; b. Reviewing ongoing construction programs within the DoD to ensure medical construction standards are uniformly applied across applicable military centers; c. Assessing the DoD approach to planning and programming facility improvements with specific emphasis on facility selection criteria and proportional assessment system; and facility programming responsibilities between the Assistant Secretary of Defense for Health Affairs and the Secretaries of the Military Departments; d. Assessing whether the Comprehensive Master Plan for the National Capital Region Medical (``the Master Plan''), dated April 2010, is adequate to fulfill statutory requirements, as required by section 2714 of the Military Construction Authorization Act for Fiscal Year 2010 (division B of Pub. L. 111-84; 123 Stat. 2656), to ensure that the facilities and organizational structure described in the Master Plan result in world class military medical centers in the National Capital Region; and e. Making recommendations regarding any adjustments of the Master Plan that are needed to ensure the provision of world class military medical centers and delivery system in the National Capital Region. The Panel, not later than 120 days after the first meeting, shall submit to the Secretary of Defense a written report containing an assessment of the adequacy of the plan to address the above items relating to the purpose of the Panel and the recommendations of the Panel to improve the Master Plan. Additional ReportsEach year until the Panel terminates, it shall submit, no later than February 1, an annual report to the Secretary of Defense on the Panel's findings and recommendations to address any identified deficiencies. The Panel or its members, with the Department's approval, may visit military treatment centers and military headquarters in connection with the official duties of the Panel. Such visits shall be undertaken through the Under Secretary of Defense for Personnel and Readiness (USD(P&R)) and in coordination with the appropriate Military Departments and installation commanders. The Panel is not established to provide advice on individual DoD procurements. No matter shall be assigned to the Panel for its consideration that would require any Panel members to participate personally and substantially in the conduct of any specific procurement or place him or her in the position of acting as a contracting or procurement official. The Panel reports to the Secretary of Defense. The USD(P&R), pursuant to DoD policy, may act upon the Panel's advice and recommendations. The Panel shall be comprised of no more than 14 members appointed by the Secretary of Defense. The Secretary of Defense shall appoint 10 members. Those members shall include medical facility design experts; military healthcare professionals; representatives of premier health care centers in the United States; and former retired senior military officers with joint operational and budgetary experience. The Chairman and ranking members of the Committees on the Armed Services of the Senate and the House of Representatives may each designate one member of the Panel, for a total of four members. Individuals designated by the Chairman and ranking members of the Committees on the Armed Services of the Senate and the House of Representatives shall be appointed by the Secretary of Defense. Panel members appointed by the Secretary of Defense shall be appointed for the duration of the Panel, with annual renewals of appointments. Panel members, who are not full-time or permanent part- time Federal officers or employees, shall be appointed to serve as experts or consultants under the authority of 5 U.S.C. 3109 and serve as special Government employee (SGE) member. Each member of the Panel is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. With the exception of travel and per diem for travel related to the Panel, members of the Panel shall serve without compensation. Under the provisions of Public Law 111-383 Sec. 2852(b)(2)(D), any additional experts or consultants adviser called in for consultation on behalf of the Panel shall also be reimbursed for necessary travel expenses. The Secretary of Defense may appoint additional experts and consultants, with relevant expertise, to assist the Panel on an ad-hoc basis. These non-member experts and consultants, who do not count toward the Panel's total membership, shall be appointed to serve as SGEs under the authority of 5 U.S.C. 3109; however, these experts and consultants have no voting rights on the Panel and are prohibited from engaging in Panel deliberations. The Department, when necessary and consistent with the Panel's mission and DoD policies/procedures, may establish subcommittees, task groups, and working groups to support the Panel. Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense, or the USD(P&R). Such subcommittees shall not work independently of the Panel and shall report all of their recommendations and advice solely to the Panel for full deliberation and discussion. Subcommittees have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Panel; nor can any subcommittee or its members update or report directly to DoD or any Federal officers or employees. All subcommittee members shall be appointed in the same manner as the Panel members; that is, the Secretary of Defense shall appoint subcommittee members even if the member in question is already a Panel member. Subcommittee members, with the approval of the Secretary of Defense, may serve a term of service for the life of the Panel with annual renewals; however, no member shall serve more than two consecutive terms of service on the subcommittee. Subcommittee members, if not full-time or part-time Government employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. 3109, and serve as SGEs, whose appointments must be renewed by the Secretary of Defense on an annual basis. With the exception of travel and per diem for official travel related to the Panel or its subcommittees, subcommittee members shall serve without compensation. Each subcommittee operates under the provisions of FACA, the Sunshine Act, governing Federal statutes and regulations, and governing DoD policies/procedures.
Meeting of the Department of Defense Military Family Readiness Council (MFRC); Cancellation of Meeting and Rescheduling of Meeting
On November 27, 2012 (77 FR 70740), the Department of Defense Military Family Readiness Council (MFRC) announced a meeting to be held on Thursday, January 31, 2013, from 1:00 p.m. to 3:00 p.m. at Pentagon Conference Center B6. The meeting on January 31, 2013 has been cancelled. The meeting is rescheduled for Tuesday, January 22, 2013, from 2:00 p.m. to 4:00 p.m. at Pentagon Conference Center B6.
Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE StudiesSmall Entity Compliance Guide.'' These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled ``Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,'' published in the Federal Register on September 29, 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses understand and comply with the regulations issued by FDA concerning safety reporting requirements for investigational new drug applications (IND) and bioavailability (BA) and bioequivalence (BE) studies.
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