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Federal Register Summary for week of 17 May

    Agriculture

  • Environmental Impact Statement; Feral Swine Damage Management

    AGENCY: Animal and Plant Health Inspection Service, USDA.

    ACTION: Notice of intent to prepare an environmental impact statement and notice of public meeting.


    SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service plans to prepare an environmental impact statement (EIS) to address the need for a national feral swine damage management program to protect agriculture, natural resources, property, and human health and safety. This notice identifies potential issues and alternatives that will be studied in the EIS, requests public comments to further delineate the scope of the alternatives and environmental impacts and issues, and provides notice of public meeting.

    DATES: We will consider all comments that we receive on or before June 12, 2013. We will also consider comments received at a public meeting to be held on May 23, 2013, from 1 p.m. to 5 p.m.

    ADDRESSES: The meeting will be held at the USDA Center at Riverside, Oklahoma City Memorial Conference Center, 4700 River Road, Riverdale, MD 20737.

    You may submit comments by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2013-0031-0002.

    Postal Mail/Commercial Delivery: Please send your comment to Project Managers, Feral Swine EIS, USDA APHIS-WS, 732 Lois Drive, Sun Prairie, WI 53590.

    At the public meeting in person at the USDA Center at Riverside, Oklahoma City Memorial Conference Center, 4700 River Road, Riverdale, MD 20737.

    By visiting http://www.aphis.usda.gov/wildlifedamage/feralswine/index.shtml for details on how to access the public meeting via the Internet and to submit comments.

    Supporting documents and any comments we receive on this notice may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2013- 0031 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    Additional information about feral swine may be viewed by visiting the APHIS feral swine Web page at: http://www.aphis.usda.gov/wildlifedamage/feralswine/index.shtml.

    FOR FURTHER INFORMATION CONTACT: Dr. Kimberly Wagner, Staff Wildlife Biologist, Wildlife Services, APHIS, 732 Lois Drive, Sun Prairie, WI 53590; (608) 837-2727.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-13/html/2013-11271.htm

  • Defense

  • Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Meeting

    AGENCY: Department of Defense.

    ACTION: Notice.


    SUMMARY: Under the provisions of 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, as amended), and 41 CFR 102-3.150, the Department of Defense announces an open meeting of the Strategic Environmental Research and Development Program, Scientific Advisory Board (SAB). This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).

    DATES: Wednesday, June 12, 2013 from 9:00 a.m. to 4:30 p.m.

    ADDRESSES: Virginia Tech Briefing Center--Falls Church Room, 900 North Glebe Road, 2nd Floor, Arlington, VA 22203.

    FOR FURTHER INFORMATION CONTACT: Mr. Jonathan Bunger, SERDP Office, 4800 Mark Center Drive, Suite 17D08 Alexandria, VA 22350-3600, by telephone at (571) 372-6384.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-17/html/2013-11763.htm

  • Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Meeting

    AGENCY: Department of Defense.

    ACTION: Notice.


    SUMMARY: Under the provisions of 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, as amended), and 41 CFR 102-3.150, the Department of Defense announces an open meeting of the Strategic Environmental Research and Development Program, Scientific Advisory Board (SAB). This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).

    DATES: Thursday, June 13, 2013 from 9:00 a.m. to 4:15 p.m.

    ADDRESSES: Virginia Tech Briefing Center--Falls Church Room, 900 North Glebe Road, 2nd Floor, Arlington, VA 22203.

    FOR FURTHER INFORMATION CONTACT: Mr. Jonathan Bunger, SERDP Office, 4800 Mark Center Drive, Suite 17D08, Alexandria, VA 22350-3600, by telephone at (571) 372-6384.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-17/html/2013-11785.htm

  • Energy

  • Biomass Research and Development Technical Advisory Committee

    AGENCY: Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION: Notice of open meeting.


    SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory Committee. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register.

    DATES: June 5, 2012 8:30 a.m.-5:45 p.m.; June 6, 2012 8:30 a.m.-12 p.m.

    ADDRESSES: Embassy Suites Hotel Orlando, International Drive/Convention Center, 8978 International Drive, Orlando, Florida.

    FOR FURTHER INFORMATION CONTACT: Elliott Levine, Designated Federal Officer, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; (202) 586-1476; email: Elliott.Levine@ee.doe.gov or Roy Tiley at (410) 997-7778 ext. 220; email: rtiley@bcs-hq.com.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-17/html/2013-11786.htm

  • Environmental Protection Agency

  • Notification of a Public Teleconference of the Chartered Science Advisory Board

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice.


    SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the Chartered Science Advisory Board Panel to discuss three planned actions identified in the agency's regulatory agenda and their supporting science.

    DATES: The public teleconference will be held on Wednesday, June 5, 2013 from 1:00 p.m. to 3:00 p.m. (Eastern Time).

    Location: The public teleconference will be conducted by telephone only.

    FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to obtain information concerning the public meeting may contact Dr. Angela Nugent, Designated Federal Officer (DFO), EPA Science Advisory Board Staff Office (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; by telephone/voice mail at (202) 564-2218 or at nugent.angela@epa.gov. General information about the SAB as well as any updates concerning the meeting announced in this notice may be found on the EPA Web site at http://www.epa.gov/sab.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-13/html/2013-11320.htm

  • Health and Human Services

  • Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

    SUMMARY: The NIH Office of Biotechnology Activities (NIH OBA) proposes to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline review of certain human gene transfer trials that present a low biosafety risk. Specifically, the NIH OBA proposes to remove the requirement that institutional biosafety committees (IBCs) review and approve certain human gene transfer clinical trials that use plasmids and certain attenuated, non-integrating viral vectors, provided the clinical trial follows an initial study in humans that was previously approved by an IBC registered with the OBA. This initial trial will have established the safety of the proposed dose of the gene transfer product (vector and transgene) in a comparable population (adults or children). The initial study should have been conducted in the same country as the proposed study to control for potential variability in infectious disease backgrounds of the participants.

    An initial IBC review is important to evaluate the safety of the product and to set standards for administration; however, for well- characterized vectors, in the absence of any unexpected toxicities in the initial study, subsequent biosafety assessments may not provide any additional information. While a single IBC review does not pose an undue burden, as the gene transfer field advances and more Phase II and Phase III multisite trials are developed, the time, effort and expense associated with multiple IBC reviews can be significant without adding commensurate value in the form of additional recommendations to protect the health and safety of the subject, health care worker, and community.

    IBCs play a critical role in the evaluation of new products and their review can inform other oversight bodies, such as Institutional Review Boards. However, given the competing demands on IBCs, this change will provide IBCs with the option of focusing their efforts on those clinical trials where review will be most productive. While IBCs will no longer be required to review all clinical trials using the same product, each institution can implement its own policies regarding the need to review such trials and the information that a principal investigator (PI) should submit regarding the safety of the previous trial. For example, an institution may designate the Biological Safety Officer and the IBC Chair to review data from the initial trial and determine whether a subsequent trial using the same agent meets the exemption criteria outlined herein. The institution may also set its own policies regarding the need for the PI to inform the IBC about enrollment, any relevant new biosafety findings, and completion of the trial.

    This policy will only exempt human gene transfer clinical trials from IBC review under Section III-C-1. It does not apply to basic, nonclinical research. In addition, it does not create an exemption from registration of the trial with the NIH OBA or the Recombinant DNA Advisory Committee (RAC) review and reporting requirements. By continuing to require registration and reporting on these trials, the NIH OBA will be able to continue to monitor adverse events or incident reports of accidental exposures by health care workers delivering these agents and, if necessary, provide information regarding these events to investigators, IBCs, and the public. The NIH OBA will also be able to assess whether this change in policy has any adverse impact on the biosafety of gene transfer trials.

    DATES: All comments should be submitted by June 12, 2013.

    ADDRESSES: Comments may be submitted to the NIH OBA by email at oba@od.nih.gov; by fax to 301-496-9839; or by mail to the NIH Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892-7985. All written comments received in response to this notice will be available for public inspection in the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland, weekdays between the hours of 8:30 a.m. and 5:00 p.m.

    FOR FURTHER INFORMATION CONTACT: If you have questions, or require additional information about these proposed changes, please contact the NIH OBA by email at oba@od.nih.gov or telephone at 301-496-9838. Comments can be submitted to the same email address or by fax to 301-496-9839 or mail to the NIH Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892-7985. Background information may be obtained by contacting the NIH OBA by email at oba@od.nih.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-13/html/2013-11222.htm

  • Interior

  • Notice of Request for Nominees for the Advisory Committee on Water Information

    AGENCY: United States Geological Survey (USGS), Interior.

    ACTION: Notice of request for nominees.


    SUMMARY: The U.S. Department of the Interior (Interior) is seeking nominations for individuals to be considered as Committee members and/ or alternates to serve on the Advisory Committee on Water Information (ACWI).

    Membership represents a wide range of water resources interests and functions. The ACWI will have a maximum of 35 members. Members will represent the interests of water oriented organizations and will be selected from among, but not limited to the following groups: Federal agencies, professional water-related associations, State and country water-related associations, academia, private industry, water utility associations, civil engineering societies, watershed and land conservation associations, ecological societies, lake, coastal, and ocean associations, environmental and educational groups.

    Member organizations designate their representatives and alternates. Membership rests not with the individual person but rather with the member organization, who names their representative, and sometimes an alternate.

    Nominations should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the ACWI and permit the Department of the Interior to contact a potential member.

    No individual who is currently registered as a Federal lobbyist is eligible to serve as a member of the ACWI.

    The Committee functions solely as an advisory body, and in compliance with the provisions of the Federal Advisory Committee Act. Nominations for member organizations should be submitted to the Executive Secretary, at the address listed below.

    FOR FURTHER INFORMATION CONTACT: Ms. Wendy E. Norton (Executive Secretary), Chief, Water Information Coordination Program, U.S. Geological Survey, 12201 Sunrise Valley Drive, MS 417, Reston VA 20192. Telephone: 703-648-6810; Fax: 703-648-5644.

    http://www.gpo.gov/fdsys/pkg/FR-2013-05-13/html/2013-11218.htm

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