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Federal Register Summary for week of 8 April

    Agriculture

  • Solicitation of Letters of Interest To Participate in National Environmental Policy Act Pilot Project

    AGENCY: Animal and Plant Health Inspection Service, USDA.

    ACTION: Notice.


    SUMMARY: The Animal and Plant Health Inspection Service is soliciting letters of interest from entities subject to the regulations governing the introduction of genetically engineered (GE) organisms in 7 CFR part 340 to participate in a National Environmental Policy Act (NEPA) Pilot Project. The NEPA Pilot Project will test new approaches to developing environmental analyses and documents required under NEPA to determine the extent to which these approaches improve the quality, timeliness, and cost effectiveness of such analyses and documents. The pilot project will focus only on NEPA analyses and documents associated with petitions for nonregulated status for GE organisms.

    DATES: Letters of interest may be submitted through April 8, 2013 to the person listed under FOR FURTHER INFORMATION CONTACT.

    FOR FURTHER INFORMATION CONTACT: Mr. David Reinhold, Assistant Director, Environmental Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1238; (301) 734-0660; e-mail: david.reinhold@aphis.usda.gov.

    http://edocket.access.gpo.gov/2011/2011-8329.htm

  • Health and Human Services

  • Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

    Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee.

    General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

    Date and Time: The meeting will be held on May 31, 2011, from 2:30 p.m. to 6:15 p.m.

    Location: National Institutes of Health (NIH) Campus, 29 Lincoln Dr., Bldg. 29B, Conference Rooms A and B, Bethesda, MD 20892.

    The public is welcome to attend the meeting at NIH, Building 29B, Conference Rooms A and B, where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at http://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver's license, passport, green card, etc. Detailed information about security procedures is located at http://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation.

    Contact Person: Gail Dapolito or Sheryl Clark (HFM-71), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

    Agenda: On May 31, 2011, the committee will meet in open session to hear brief overviews of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, Center for Drug Evaluation and Research; and the Laboratory of Cell Biology, the Laboratory of Molecular and Developmental Immunology, the Laboratory of Molecular Oncology, Division of Monoclonal Antibodies, Center for Drug Evaluation and Research.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.

    Procedure: On May 31, 2011, from 2:30 p.m. to approximately 5:15 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 24, 2011. Oral presentations from the public will be scheduled between approximately 4:15 p.m. and 5:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 16, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 17, 2011.

    Closed Committee Deliberations: On May 31, 2011, from 5:15 p.m. to 6:15 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss a report of intramural research programs and make recommendations regarding personnel staffing decisions.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    http://edocket.access.gpo.gov/2011/2011-7968.htm

  • Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent for Emergency Research; Availability

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice.


    SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research.'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA-regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR). FDA determined that guidance is needed in interpreting and complying with these regulations, particularly in the areas of planning and conducting community consultation and public disclosure activities, and the establishment of informed consent procedures to be used when feasible. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2006.

    DATES: Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 (1-888-463-6332 or 301-796- 3400), or the Office of Communication, Outreach and Development (HFM- 40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852- 1448 (1-800-835-4709 or 301-827-1800); or the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993 (1-800- 638-2041 or 301-796-7100). Send one self-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT: Sara Goldkind, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8340.

    http://edocket.access.gpo.gov/2011/2011-7846.htm

  • National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members

    AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

    ACTION: Notice of request for nominations for public members.


    SUMMARY: 42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

    Seven current members' terms will expire in November 2011. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.

    DATES: Nominations should be received on or before 60 days after date of publication.

    ADDRESSES: Nominations should be sent to Ms. Karen Brooks, AHRQ, 540 Gaither Road, Room 3006, Rockville, Maryland 20850. Nominations may also be e-mailed to Karen.Brooks@ahrq.hhs.gov.

    FOR FURTHER INFORMATION CONTACT: Ms. Karen Brooks, AHRQ, at (301) 427- 1801.

    http://edocket.access.gpo.gov/2011/2011-8023.htm

  • Interior

  • National Cooperative Geologic Mapping Program (NCGMP) and National Geological and Geophysical Data Preservation Program (NGGDPP) Advisory Committee

    AGENCY: U.S. Geological Survey, Interior.

    ACTION: Notice of meeting.


    SUMMARY: Pursuant to Public Law 106-148, the NCGMP and NGGDPP Advisory Committee will meet on June 22nd and June 23rd, 2011, in room 3A417 of the U.S. Geological Survey Headquarters building, 12201 Sunrise Valley Drive, Reston, Virginia 20192. The Advisory Committee, comprising representatives from Federal agencies, State agencies, academic institutions, and private companies, shall advise the Director of the U.S. Geological Survey on planning and implementation of the geologic mapping and data preservation programs.

    The Committee will hear updates on progress of the NCGMP toward fulfilling the purposes of the National Geological Mapping Act of 1992; the Federal, State, and education components of the NCGMP; and the National Geological and Geophysical Data Preservation Program.

    DATES: June 22-23, 2011, commencing at 8:30 a.m. on June 22 and adjourning by 5 p.m. on June 23.

    FOR FURTHER INFORMATION CONTACT: Stephanie Brown, U.S. Geological Survey, Mail Stop 908, National Center, Reston, Virginia 20192, (703) 648-6948.

    http://edocket.access.gpo.gov/2011/2011-8400.htm

  • Nominations of New Members to the Invasive Species Advisory Committee (ISAC)

    AGENCY: Office of the Secretary, National Invasive Species Council.

    ACTION: Request for Nominations for the Invasive Species Advisory Committee.


    SUMMARY: The U.S. Department of the Interior, on behalf of the interdepartmental National Invasive Species Council, proposes to appoint new members to the Invasive Species Advisory Committee (ISAC). The Secretary of the Interior, acting as administrative lead, is requesting nominations for qualified persons to serve as members of the ISAC.

    DATES: Nominations must be postmarked by June 3, 2011.

    ADDRESSES: Nominations should be sent to Lori Williams, Executive Director, National Invasive Species Council (OS/NISC), Regular Mail: 1849 C Street, NW. (MS 1201 EYE), Washington, DC 20240; Express Mail: 1201 Eye Street, NW., 5th Floor, Washington, DC 20005.

    FOR FURTHER INFORMATION CONTACT: Kelsey Brantley, Program Specialist and ISAC Coordinator, at (202) 513-7243, fax: (202) 371-1751, or by e- mail at Kelsey_Brantley@ios.doi.gov.

    http://edocket.access.gpo.gov/2011/2011-7916.htm

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