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Federal Register Summary for week of 19 February

    Agriculture

  • Notice of Availability of the Draft Supplemental Environmental Impact Statement for the Conservation Reserve Program

    AGENCY: Commodity Credit Corporation and Farm Service Agency, USDA.

    ACTION: Notice of availability (NOA) and request for comments.


    SUMMARY: This notice announces that the Farm Service Agency (FSA), on behalf of the Commodity Credit Corporation (CCC), has completed a Draft Supplemental Environmental Impact Statement (SEIS) to examine the potential environmental consequences associated with implementing changes to the Conservation Reserve Program (CRP) required by the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill), and assist in developing new regulations. FSA is requesting comments on the Draft SEIS.

    DATES: We will consider comments that we receive by April 5, 2010.

    ADDRESSES: We invite you to submit comments on this Draft SEIS. In your comments, include the volume, date, and page number of this issue of the Federal Register. You may submit comments by any of the following methods:

    E-Mail: CRPcomments@tecinc.com.

    Online: Go to the Web site at http://public.geo-marine.com. Follow the online instructions for submitting comments.

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting comments.

    Fax: (757) 594-1469.

    Mail: CRP SEIS, c/o TEC, 11817 Canon Blvd., Suite 300, Newport News, VA 23606.

    Hand Delivery or Courier: Deliver comments to the above address.

    Comments may be inspected in the Office of the Director, CEPD, FSA, USDA, 1400 Independence Ave., SW., Room 4709 South Building, Washington, DC, between 8:00 a.m. and 4:30 p.m., Monday through Friday, except holidays. A copy of the Draft SEIS is available through the FSA home page at http://www.fsa.usda.gov/FSA/webapp?area=home&subject=ecrc&topic=nep-cd or at http://public.geo-marine.com.

    FOR FURTHER INFORMATION CONTACT: Matthew Ponish, National Environmental Compliance Manager, USDA, FSA, CEPD, Stop 0513, 1400 Independence Ave., SW., Washington, DC 20250-0513, (202) 720-6853, or e-mail: matthew.ponish@wdc.usda.gov. Persons with disabilities who require alternative means for communication (Braille, large print, audio tape, etc.) should contact the USDA Target Center at (202) 720-2600 (voice and TDD).

    http://edocket.access.gpo.gov/2010/2010-3272.htm

  • Commerce

  • Taking of Marine Mammals Incidental to Commercial Fishing Operations; Harbor Porpoise Take Reduction Plan Regulations

    AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION: Final rule.


    SUMMARY: NMFS issues this final rule to amend the regulations implementing the Harbor Porpoise Take Reduction Plan (HPTRP) to address the increased incidental mortality and serious injury of the Gulf of Maine/Bay of Fundy (GOM/BOF) stock of harbor porpoises (Phocoena phocoena) in gillnet fisheries throughout the stock's U.S. range.

    DATES: Effective March 22, 2010.

    ADDRESSES: Copies of the final Environmental Assessment (EA) and Regulatory Impact Review/Final Regulatory Flexibility Analysis (RIR/ FRFA) for this action, as well as the Harbor Porpoise Take Reduction Team (HPTRT) meeting summaries and supporting documents, may be obtained from the HPTRP Web site (http://www.nero.noaa.gov/hptrp) or by writing to Diane Borggaard, NMFS, Northeast Region, Protected Resources Division, 55 Great Republic Drive, Suite 04-400, Gloucester, MA 01930.

    FOR FURTHER INFORMATION CONTACT: Amanda Johnson, NMFS, Northeast Region, 978-282-8463, amanda.johnson@noaa.gov; or Melissa Andersen, NMFS, Office of Protected Resources, 301-713-2322, melissa.andersen@noaa.gov.

    http://edocket.access.gpo.gov/2010/2010-3273.htm

  • Health and Human Services

  • Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice.


    SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled "Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled "Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.

    DATES: Submit written or electronic comments on the collection of information by April 19, 2010.

    ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.

    http://edocket.access.gpo.gov/2010/2010-3028.htm

  • Meeting of the Secretary's Advisory Committee on Human Research Protections

    AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science.

    ACTION: Notice.


    SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-second meeting. The meeting will be open to the public.

    DATE: The meeting will be held on Tuesday, March 9, 2010 from 8:30 a.m. until 5 p.m. and Wednesday, March 10, 2010 from 8:30 a.m. until 5 p.m.

    ADDRESSES: U.S. Department of Health & Human Services, 200 Independence Avenue, SW., Hubert H. Humphrey Building, Room 800, Washington, DC 20201.

    FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP), or Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240-453-8141; fax: 240-453-6909; e-mail address: sachrp@osophs.dhhs.gov.

    http://edocket.access.gpo.gov/2010/2010-3271.htm

  • Reporting Information Regarding Falsification of Data

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Proposed rule.


    SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.

    DATES: Submit written or electronic comments on this proposed rule by May 20, 2010. See section V of this document for the proposed effective date of a final rule based on this document. Submit comments regarding the information collection by March 22, 2010 to OMB (see ADDRESSES).

    ADDRESSES: You may submit comments, identified by Docket No. FDA-2008- N-0115 and/RIN number 0910-AC59, by any of the following methods: Electronic Submissions

    Submit electronic comments in the following ways:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Written Submissions

    Submit written submissions in the following ways:

    FAX: 301-827-6870.

    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under Electronic Submissions.

    Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the "Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    Information Collection Provisions: Submit written comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure that comments on the information collection are received, please submit written comments to OMB by FAX to 202-395-7285 or by e-mail to OIRA_submission@omb.eop.gov. Mark your comments to the attention of the FDA desk officer and reference this rulemaking.

    FOR FURTHER INFORMATION CONTACT:

    For information regarding human drugs: Leslie K. Ball, Center for Drug Evaluation and Research, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5342, Silver Spring, MD 20993-0002, 301-796-3150, FAX: 301-847-8750.

    For information regarding biologics: Steve Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 5515 Security Lane, rm. 5130, Rockville, MD 20852, 301- 827-6210.

    For information regarding medical devices and radiological health: Michael E. Marcarelli, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3444, Silver Spring, MD 20993-0002, 301-796-5490.

    For information regarding veterinary medicine: Gail L. Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8300.

    For information regarding foods: Linda Katz, Center for Food Safety and Applied Nutrition (HFS-032), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1910.

    For information regarding good laboratory practices for nonclinical laboratory studies: Karen Stutsman, Office of Regulatory Affairs (HFC- 230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6847.

    For information regarding good clinical practice: Kathleen Pfaender, Office of Good Clinical Practice (HF-34), 5600 Fishers Lane, rm. 16-85, Rockville, MD 20857, 301-827-3340.

    http://edocket.access.gpo.gov/2010/2010-3123.htm

  • Tennessee Valley Authority

  • Meeting of the Regional Resource Stewardship Council

    AGENCY: Tennessee Valley Authority (TVA).

    ACTION: Notice of meeting.


    SUMMARY: The TVA Regional Resource Stewardship Council (RRSC) will hold a meeting on Thursday, March 4, and Friday, March 5, 2010, to consider various matters.

    The RRSC was established to advise TVA on its natural resource stewardship activities. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2.

    The management of the Tennessee Valley reservoirs and the lands adjacent to them has long been integral components of TVA's mission. As part of implementing the TVA Environmental Policy, TVA is developing a Natural Resource Plan (NRP) and Environmental Impact Study (EIS) under the process established by the National Environmental Policy Act (NEPA) that will help prioritize techniques for the management of TVA's sustainable land use activities, natural resource management activities, recreation and water resource protection and improvement activities. TVA would like to utilize the RRSC as a key stakeholder group throughout the EIS period to advise TVA on the issues, tradeoffs, and focus of environmental stewardship activities. At the March meeting, TVA will be seeking advice from the Council on issues regarding the scope of the study and the preliminary draft alternatives that will support the Draft EIS and direction of the study. TVA will also be seeking recommendations and advice on the NRP objectives and activities that complement the use of public lands with the protection of these natural resources.

    The meeting agenda includes the following:

    1. Introductions.

    2. Natural Resource Plan Background, Components of the Plan, Preliminary Draft Alternatives.

    3. RRSC Discussion Topic: Natural Resource Plan scope, preliminary draft alternatives included in the components of the NRP (e.g., Natural Resource Management, Reservoir Lands Planning, Water Resources, and Recreation) and uncertainties impacting the development of various portfolios and scenarios.

    4. Public Comments.

    5. Council Discussion and Advice.

    The TVA RRSC will hear opinions and views of citizens by providing a public comment session. The public comment session will be held at 10 a.m., EST, on Friday, March 5. Persons wishing to speak are requested to register at the door by 9 a.m. on Friday, March 5 and will be called on during the public comment period. Handout materials should be limited to one printed page. Written comments are also invited and may be mailed to the Regional Resource Stewardship Council, Tennessee Valley Authority, 400 West Summit Hill Drive, WT-11 B, Knoxville, Tennessee 37902.

    DATES: The meeting will be held on Thursday, March 4 from 8:30 a.m. to 4:30 p.m., and Friday, March 5, from 8 a.m. to 12 noon, EST.

    ADDRESSES: The meeting will be held at the Auditorium of the TVA Headquarters at 400 West Summit Hill Drive, Knoxville, Tennessee 37902, and will be open to the public. Anyone needing special access or accommodations should let the contact below know at least a week in advance.

    FOR FURTHER INFORMATION CONTACT: Beth Keel, 400 West Summit Hill Drive, WT-11 B, Knoxville, Tennessee 37902, (865) 632-6113.

    http://edocket.access.gpo.gov/2010/2010-3050.htm

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