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Federal Register Summary for week of 21 May

    Agriculture

  • Notice of the Specialty Crop Committee's Stakeholder Listening Session

    AGENCY: Research, Education, and Economics, USDA.

    ACTION: Notice of stakeholder listening session.


    SUMMARY: In accordance with the Federal Advisory Committee Act, 5 U.S.C. App 2, the United States Department of Agriculture announces a stakeholder listening session of the Specialty Crop Committee, under the auspices of the National Agricultural Research, Extension, Education, and Economics Advisory Board (NAREEE).

    DATES: The Specialty Crop Committee will hold the stakeholder listening session on May 25, 2010 from 9 a.m.-3 p.m.

    ADDRESSES: The stakeholder listening session of the Specialty Crop Committee will take place at the San Antonio Marriott Riverwalk, 889 East Market Street, San Antonio, Texas 78205.

    The public may file written comments before or up to two weeks after the listening session with the contact person identified in this notice at: The National Agricultural Research, Extension, Education, and Economics Advisory Board Office, U.S. Department of Agriculture, Room 344-A, Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington, DC 20250-2255.

    FOR FURTHER INFORMATION CONTACT: David Kelly, Acting Executive Director, National Agricultural Research, Extension, Education, and Economics Advisory Board; telephone: (202) 720-4421; fax: (202) 720- 6199; or e-mail: David.kelly@ars.usda.gov.

    http://edocket.access.gpo.gov/2010/2010-11690.htm

  • Environmental Protection Agency

  • Guidance for Federal Land Management in the Chesapeake Bay Watershed

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice of availability.


    SUMMARY: This notice announces the availability of a final Guidance for Federal Land Management in the Chesapeake Bay Watershed which EPA is publishing pursuant to Section 502 of Executive Order (EO) 13508 ("Chesapeake Bay Protection and Restoration'', published on May 12, 2009). This guidance will allow the federal government to lead the way in protecting the Bay and its watershed with the most effective tools and practices available to reduce water pollution from a variety of nonpoint sources, including agricultural lands, urban and suburban areas, forestry, riparian areas, septic systems, and hydromodification. This guidance is the first product under the Chesapeake Bay Executive Order to provide technical tools that will be needed to restore the Bay. Section 501 of the Executive Order directs federal agencies with ten or more acres within the Chesapeake Bay watershed to implement the Section 502 guidance as expeditiously as practicable and to the extent permitted by law.

    FOR FURTHER INFORMATION CONTACT: Katie Flahive, USEPA, Office of Water, Office of Wetlands, Oceans and Watersheds, 1200 Pennsylvania Ave., NW., MC 4503T, Washington, DC; telephone number: (202) 566-1206; fax number: (202) 566-1437; e-mail: Flahive.Katie@epa.gov.

    http://edocket.access.gpo.gov/2010/2010-11693.htm

  • Science Advisory Board Staff Office; 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 SAB on June 16, 2010 to conduct quality reviews of two draft SAB reports. In addition, the SAB will discuss its draft report on EPA's strategic research directions.

    DATES: The public teleconference will be held on June 16, 2010 from 11 a.m. to 2 p.m. (Eastern Daylight Time).

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

    FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to obtain general information concerning this public teleconference should contact Dr. Angela Nugent, Designated Federal Officer (DFO), EPA Science Advisory Board (1400F), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; via telephone/voice mail (202) 343-9981; fax (202) 233-0643; or e-mail at nugent.angela@ epa.gov. General information concerning the EPA Science Advisory Board can be found on the SAB Web site at http://www.epa.gov/sab.

    http://edocket.access.gpo.gov/2010/2010-11691.htm

  • Science Advisory Board Staff Office; Notification of a Public Teleconference of the Science Advisory Board Integrated Nitrogen Committee

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice.


    SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the SAB Integrated Nitrogen Committee to discuss the Committee's draft report.

    DATES: The public teleconference will be held on Tuesday, June 8, 2010 from 1 to 5 p.m. (Eastern Time).

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

    FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to obtain further information concerning this public teleconference should contact Dr. Thomas Armitage, Designated Federal Officer (DFO), EPA Science Advisory Board (1400F), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; via telephone/voice mail (202) 343-9995; fax (202) 233-0643; or e-mail at armitage.thomas@epa.gov. General information concerning the EPA Science Advisory Board can be found on the SAB Web site at http://www.epa.gov/sab.

    http://edocket.access.gpo.gov/2010/2010-11986.htm

  • Science Advisory Board Staff Office; Notification To Convene Workgroups of Experts for Rapid Advice on Scientific and Technical Issues Related to the Gulf of Mexico Oil Spill

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice.


    SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces it's intent to convene workgroups of experts drawn from the U.S. EPA SAB to provide rapid advice on scientific and technical issues related to the Gulf of Mexico oil spill.

    FOR FURTHER INFORMATION CONTACT: Members of the public who wish to obtain information about the rapid consultative advice process and projects may contact Dr. Anthony F. Maciorowski, Deputy Director, Science Advisory Board Staff Office, by telephone at (202) 343-9983; by e-mail at maciorowski.anthony@epa.gov; or by mail at the U.S. EPA, Science Advisory Board (1400F), 1200 Pennsylvania Avenue, NW., Washington, DC 20460.

    http://edocket.access.gpo.gov/2010/2010-11987.htm

  • Health and Human Services

  • FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice of availability; request for comments.


    SUMMARY: As part of the second phase of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled "FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration.'' The report includes 21 draft proposals about expanding disclosure of information by the agency while maintaining confidentiality of trade secrets and individually identifiable patient information. FDA is seeking public comment on the draft proposals, as well as on which draft proposals should be given priority. Some of the draft proposals may require extensive resources to implement, and some may require changes to regulations or legislation.

    DATES: Submit either electronic or written comments by July 20, 2010.

    ADDRESSES: Submit electronic comments to http://www.regulations.gov or on the FDA Web site, www.fda.gov/transparency. Submit written comments 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 at the heading of this document.

    FOR FURTHER INFORMATION CONTACT: Afia Asamoah, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 1, rm. 2220, Silver Spring, MD 20993, 301-796-4625, FAX: 301-847- 3531, e-mail: Afia.Asamoah@fda.hhs.gov.

    http://edocket.access.gpo.gov/2010/2010-12314.htm

  • Office of the Director, National Institutes of Health; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Recombinant DNA Advisory Committee.

    The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    Name of Committee: Recombinant DNA Advisory Committee.

    Date: June 16-17, 2010.

    Time: June 16, 2010, 8 a.m. to 5:30 p.m.

    Agenda: The Recombinant DNA Advisory Committee will review and discuss selected human gene transfer protocols, a proposed Major Action under Section III-A-1 of the NIH Guidelines, as well as related data management activities. Please check the meeting agenda at http://oba.od.nih.gov/rdnarac/racmeetings.html for more information.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Time: June 17, 2010, 8 a.m. to 4 p.m.

    Agenda: The Recombinant DNA Advisory Committee will review and discuss selected human gene transfer protocols, and proposed changes to the NIH Guidelines regarding the use of synthetic nucleic acids in human gene transfer, as well as related data management activities. Please check the meeting agenda at http://oba.od.nih.gov/rdnarac/racmeetings.html for more information.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Chezelle George, Office of Biotechnology Activities, Office of Science Policy/OD, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 20892, 301-496- 9838, georgec@od.nih.gov.

    Information is also available on the Institute's/Center's home page: http://oba.od.nih.gov/rdna/rdna.html, where an agenda and any additional information for the meeting will be posted when available.

    http://edocket.access.gpo.gov/2010/2010-11988.htm

  • Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors

    AGENCY: Department of Health and Human Services.

    ACTION: Notice of proposed rulemaking.


    SUMMARY: The Department of Health and Human Services (HHS or the Department) and the HHS Public Health Service (PHS), proposes to amend its regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among Government, research institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, have led to the proposal of amendments that would expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators' financial conflicts of interests, as well as NIH's compliance oversight.

    DATES: Comments must be received on or before July 20, 2010 in order to ensure we will be able to consider the comments when preparing the final rule.

    ADDRESSES: Individuals, organizations and institutions interested in submitting comments identified by RIN 0925-AA53 and Docket Number [NIH- 2010-0001] may do so by any of the following methods:

    Electronic Submissions

    You may submit electronic comments in the following way:

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

    To ensure timely processing of comments, NIH is no longer accepting comments submitted to the agency by e-mail.

    Written Submissions

    You may submit written comments in the following ways:

    Fax: 301-402-0169.

    Mail: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669.

    Instructions: All submissions received must include the agency name and Regulatory Information Number (RIN) [0925-AA53] and docket number [NIH-2010-0001] for this rulemaking action. All comments may be posted without change, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received concerning this rulemaking action, go to the eRulemaking.gov Portal: http://www.regulations.gov and follow the instructions provided for conducting a search, using the docket number [NIH-2010-0001].

    FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669, telephone 301-496-4607, fax 301-402-0169, e-mail jm40z@nih.gov, concerning questions about the rulemaking process and Dr. Sally Rockey, NIH Deputy Director for Extramural Research, concerning substantive questions about the proposed rule, e-mail FCOI-NPRM@mail.nih.gov.

    http://edocket.access.gpo.gov/2010/2010-11885.htm

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