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Federal Register Summary for week of 6 November

    Commerce

  • Pacific Coast Groundfish Fishery; Intent To Prepare an Environmental Impact Statement for the 2011-2012 Biennial Harvest Specifications and Management Measures

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

    ACTION: Notice of intent to prepare an environmental impact statement (EIS); request for written comments; notice of public scoping meetings.


    SUMMARY: NMFS and the Pacific Fishery Management Council (Council) announce their intent to prepare an EIS in accordance with the National Environmental Policy Act (NEPA) to analyze the impacts on the human, biological, and physical environment of setting harvest specifications and management measures for 2011 and 2012, pursuant to the Pacific Coast Groundfish Fishery Management Plan.

    DATES: Public scoping will be conducted through regular meetings of the Pacific Fishery Management Council and its advisory bodies starting with the October 31-November 5, 2009, Council meeting and continuing through the June 12-17, 2010, meeting. Written comments will be accepted through December 3, 2009 (see SUPPLEMENTARY INFORMATION). Written, faxed or e-mailed comments must be received by 5 p.m. Pacific Daylight time on December 3, 2009.

    ADDRESSES: You may submit comments, on issues and alternatives, identified by 0648-XS46 by any of the following methods:

    E-mail: GroundfishSpex2011_12.nwr@noaa.gov. Include 0648- XS46 and enter AScoping Comments@ in the subject line of the message.

    Fax: 503-820-2299, attention: John DeVore.

    Mail: Donald McIsaac, Pacific Fishery Management Council, 7700 NE Ambassador Pl., Suite 101, Portland, OR 97220, attention: John DeVore.

    FOR FURTHER INFORMATION CONTACT: Mr. John DeVore, Pacific Fishery Management Council, phone: 503-820-2280, fax: 503-820-2299 and e-mail: john.devore@noaa.gov.

    http://edocket.access.gpo.gov/2009/E9-26223.htm

  • Energy

  • Biomass Research and Development Technical Advisory Committee

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

    ACTION: Notice of open meeting.


    SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory Committee under Section 9008(d) of the Food, Conservation, and Energy Act of 2008. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that agencies publish these notices in the Federal Register to allow for public participation. This notice announces the meeting of the Biomass Research and Development Technical Advisory Committee.

    Dates and Times: December 1, 2009 at 8 a.m. to 5:30 p.m.; December 2, 2009 at 8 a.m. to 3 p.m.

    ADDRESSES: Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington, DC 20001.

    FOR FURTHER INFORMATION CONTACT: Laura McCann (formerly Neal), Designated Federal Official for the Committee, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585; (202) 586-7766; E-mail: laura.neal@ee.doe.gov or T.J. Heibel at (410) 997-7778 ext. 223; E- mail: theibel@bcs-hq.com.

    http://edocket.access.gpo.gov/2009/E9-26691.htm

  • Environmental Protection Agency

  • Integrated Risk Information System (IRIS); Announcement of Availability of Literature Searches for IRIS Assessments

    AGENCY: Environmental Protection Agency.

    ACTION: Announcement of availability of literature searches for IRIS assessments; request for information.


    SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing the availability of literature searches for three IRIS assessments that were or may be started in 2009 and requesting scientific information on health effects that may result from exposure to these chemical substances. The Integrated Risk Information System (IRIS) is an EPA database that contains information on human health effects that may result from exposure to chemical substances in the environment.

    DATES: EPA will accept information related to the specific substances included herein as well as any other compounds being assessed by the IRIS Program. Please submit any information in accordance with the instructions provided below.

    ADDRESSES: Please submit relevant scientific information identified by docket ID number EPA-HQ-ORD-2007-0664, online at http://www.regulations.gov (EPA's preferred method); by e-mail to ord.docket@epa.gov; mailed to Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Information on a disk or CD- ROM should be formatted in Word or as an ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above.

    FOR FURTHER INFORMATION CONTACT: For information on the IRIS program, contact Dr. Abdel-Razak Kadry, IRIS Program Director, National Center for Environmental Assessment, (mail code: 8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: (703) 347-8545, facsimile: (703) 347-8689; or e-mail: kadry.abdel@epa.gov.

    For general questions about access to IRIS, or the content of IRIS, please call the IRIS Hotline at (202) 566-1676 or send electronic mail inquiries to hotline.iris@epa.gov.

    http://edocket.access.gpo.gov/2009/E9-26335.htm

  • Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice of public hearings.


    SUMMARY: The EPA is announcing 2 public hearings to be held for the proposed rule "Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule'' which published in the Federal Register on October 27, 2009. The hearings will be held on Wednesday, November 18, 2009, in Arlington, VA, and on Thursday, November 19, 2009, in Rosemont, IL.

    DATES: The public hearings will be held on November 18, 2009, and November 19, 2009.

    ADDRESSES: The November 18, 2009 hearing will be held at the Hyatt Regency Crystal City at Reagan National Airport, Second Floor, Room Tidewater 2, 2799 Jefferson Davis Highway, Arlington, VA 22202; phone number (703) 418-1234. The November 19, 2009 will be held at the Donald E. Stephens Convention Center, Level 2, Room 46, 5555 North River Road, Rosemont, IL 60018; phone number (847) 692-2220. Both public hearings will convene at 10 a.m. and continue until 7 p.m. (local time) or later, if necessary, depending on the number of speakers wishing to participate. The EPA will make every effort to accommodate all speakers that arrive and register before 7 p.m. A lunch break is scheduled from 12:30 p.m. until 2 p.m. during both hearings. The EPA Web site for the rulemaking, which includes the proposal and information about the public hearings, can be found at: http://www.epa.gov/nsr.

    FOR FURTHER INFORMATION CONTACT: If you would like to speak at the public hearing, please contact Ms. Pamela Long, U.S. Environmental Protection Agency, OAQPS, Air Quality Planning Division, (C504-03), Research Triangle Park, NC 27711, telephone (919) 541-0641, fax number (919) 541-5509, e-mail address long.pam@epa.gov, no later than November 13, 2009. If you have any questions relating to the public hearing, please contact Ms. Long at the above number.

    Questions concerning the October 27, 2009, proposed rule should be addressed to Mr. Joseph Mangino, U.S. EPA, Office of Air Quality Planning and Standards, Operating Permits Group, (C504-05), Research Triangle Park, NC 27711, telephone number (919) 541-9778, e-mail at mangino.joseph@epa.gov.

    http://edocket.access.gpo.gov/2009/E9-26537.htm

  • Science Advisory Board Staff Office; Notification of a Public Teleconference of the Science Advisory Board Ecological Processes and Effects Committee

    SUMMARY: The Environmental Protection Agency (EPA or Agency) Science Advisory Board (SAB) Staff Office announces a public teleconference of the SAB Ecological Processes and Effects Committee Augmented for the Review of Nutrient Criteria Guidance. The Committee will discuss its draft advisory report.

    DATES: The public teleconference will be held on December 3, 2009 from 12 (noon) to 2 p.m. (Eastern Time).

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

    FOR FURTHER INFORMATION CONTACT: Members of the public who wish to obtain the call-in number and access code to participate in the teleconference may contact Dr. Thomas Armitage, Designated Federal Officer (DFO), EPA Science Advisory Board (1400F), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone/voice mail: (202) 343-9995; fax (202) 233-0643; or via e-mail at: armitage.thomas@epa.gov. General information about the EPA SAB, as well as any updates concerning the teleconference announced in this notice, may be found on the SAB Web site at http://www.epa.gov/sab.

    http://edocket.access.gpo.gov/2009/E9-26418.htm

  • Health and Human Services

  • Draft Guidance on Institutional Review Board Approval of Research With Conditions

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

    ACTION: Notice.


    SUMMARY: The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled "Guidance on IRB Approval of Research with Conditions,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

    DATES: Submit written comments by January 5, 2010.

    ADDRESSES: Submit written requests for single copies of the draft guidance document entitled "Guidance on IRB Approval of Research with Conditions'' to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.

    You may submit comments, identified by docket ID number HHS-OPHS- 2009-0017, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Enter the above docket ID number in the "Enter Keyword or ID'' field and click on "Search.'' On the next Web page, click on the "Submit a Comment'' action and follow the instructions.

    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

    Comments received, including any personal information, will be posted without change to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov.

    http://edocket.access.gpo.gov/2009/E9-26830.htm

  • Draft Guidance on Institutional Review Board Continuing Review of Research

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

    ACTION: Notice.


    SUMMARY: The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, "Guidance on IRB Continuing Review of Research,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, will represent OHRP's current thinking on this topic and will supersede OHRP's January 15, 2007 guidance document entitled "Guidance on Continuing Review,'' available at http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm. The draft document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

    DATES: Submit written comments by January 5, 2010.

    ADDRESSES: Submit written requests for single copies of the draft guidance document entitled, "Guidance on IRB Continuing Review of Research,'' to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.

    You may submit comments, identified by docket ID number HHS-OPHS- 2009-0016, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Enter the above docket ID number in the "Enter Keyword or ID'' field and click on "Search.'' On the next Web page, click on the "Submit a Comment'' action and follow the instructions.

    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

    Comments received, including any personal information, will be posted without change to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov.

    http://edocket.access.gpo.gov/2009/E9-26828.htm

  • Public Workshop: International Conference on Harmonisation S2 Genetic Toxicology Issues; Request for Comments

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice of public workshop; request for comments.


    SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled "ICH S2 Genetic Toxicology Issues.'' The 1-day public workshop is intended to seek constructive input from experts in the field of genetic toxicology on proposed changes to the International Conference on Harmonisation (ICH) guidance "S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use'' that was published in March 2008.

    DATES: The public workshop will be held on January 25, 2010, from 8:30 a.m. to 5 p.m. Register by January 15, 2010, to make a presentation at the workshop. See section II in the SUPPLEMENTARY INFORMATION section for information on how to attend the workshop. We are opening a docket to receive your written or electronic comments. Written or electronic comments must be submitted to the docket by February 24, 2010, to receive consideration.

    ADDRESSES: The public workshop will be held at the Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD 20857. Submit written or electronic requests to make a presentation to Adele Seifried (see FOR FURTHER INFORMATION CONTACT). Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT: Adele Seifried, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6482, Silver Spring, MD 20993-0002, 301- 796-0535, FAX: 301-796-9855, e-mail: Adele.Seifried@fda.hhs.gov.

    http://edocket.access.gpo.gov/2009/E9-26397.htm

  • Interior

  • Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); Fifteenth Regular Meeting; Provisional Agenda; Announcement of Public Meeting

    AGENCY: Fish and Wildlife Service, Interior.

    ACTION: Notice.


    SUMMARY: The United States, as a Party to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), will attend the fifteenth regular meeting of the Conference of the Parties to CITES (CoP15) in Doha, Qatar, March 13-25, 2010. Currently, the United States is developing its negotiating positions on proposed resolutions, decisions, and amendments to the CITES Appendices (species proposals), as well as other agenda items that have been submitted by other Party countries and the CITES Secretariat for consideration at CoP15. With this notice we announce the provisional agenda for CoP15, solicit your comments on the items on the provisional agenda, and announce a public meeting to discuss the items on the provisional agenda.

    DATES: The public meeting will be held on December 2, 2009, at 1:30 p.m. In developing the U.S. negotiating positions on proposed resolutions, decisions, and species proposals, and other agenda items submitted by other Party countries and the CITES Secretariat for consideration at CoP15, we will consider written information and comments you submit if we receive them by January 4, 2010.

    ADDRESSES:

    Public Meeting

    The public meeting will be held in the Sidney Yates Auditorium at the Department of the Interior at 18th and C Streets, NW, Washington, DC. Directions to the building can be obtained by contacting the Division of Management Authority (see FOR FURTHER INFORMATION CONTACT). For more information about the meeting, see "Announcement of Public Meeting'' under SUPPLEMENTARY INFORMATION.

    Comment Submission

    Comments pertaining to proposed resolutions, decisions, and/or agenda items should be sent to the Division of Management Authority, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 212, Arlington, VA 22203, or via e-mail at: cop15@fws.gov. Comments pertaining to species proposals should be sent to the Division of Scientific Authority, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 110, Arlington, VA 22203, or via e-mail at: scientificauthority@fws.gov. Comments and materials received will be available for public inspection, by appointment, from 8 a.m. to 4 p.m., Monday through Friday, at either the Division of Management Authority or the Division of Scientific Authority.

    FOR FURTHER INFORMATION CONTACT: For information pertaining to resolutions, decisions, and agenda items contact: Robert R. Gabel, Chief, Division of Management Authority (phone, 703-358-2095; e-mail, cop15@fws.gov). For information pertaining to species proposals contact: Dr. Rosemarie Gnam, Chief, Division of Scientific Authority (phone, 703-358-1708; e-mail, scientificauthority@fws.gov).

    http://edocket.access.gpo.gov/2009/E9-26619.htm

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