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Federal Register Summary for week of 29 October

    Agriculture

  • Lacey Act Implementation Plan; Definitions for Exempt and Regulated Articles

    AGENCY: Animal and Plant Health Inspection Service, USDA.

    ACTION: Proposed rule; reopening of comment period.


    SUMMARY: We are reopening the comment period for our proposed rule that would establish definitions for the terms "common cultivar'' and "common food crop.'' This action will allow interested persons additional time to prepare and submit comments.

    DATES: We will consider all comments that we receive on or before November 29, 2010.

    ADDRESSES: You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0018 to submit or view comments and to view supporting and related materials available electronically.

    Postal Mail/Commercial Delivery: Please send one copy of your comment to Docket No. APHIS-2009-0018, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2009-0018.

    Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room 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) 690-2817 before coming.

    Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

    FOR FURTHER INFORMATION CONTACT: Mr. George Balady, Senior Staff Officer, Quarantine Policy Analysis and Support, PPQ, APHIS, 4700 River Road Unit 60, Riverdale, MD 20737-1231; (301) 734-8295.

    http://edocket.access.gpo.gov/2010/2010-27425.htm

  • Commerce

  • Technology Innovation Program (TIP) Seeks White Papers

    AGENCY: National Institute of Standards and Technology (NIST), Department of Commerce.

    ACTION: Notice.


    SUMMARY: The National Institute of Standards and Technology's (NIST) Technology Innovation Program (TIP) announces that it is seeking white papers from any interested party, including academia; Federal, State, and local governments; industry; national laboratories; professional organizations/societies, and others. White papers will be used to identify and select areas of critical national need and the associated technical challenges to be addressed in future TIP competitions.

    DATES: The due dates for submission of white papers are November 29, 2010, February 15, 2011, May 10, 2011, and July 12, 2011.

    ADDRESSES: Please submit white papers to National Institute of Standards and Technology, Technology Innovation Program, 100 Bureau Drive, Stop 4750, Gaithersburg, MD 20899-4750. Attention: Critical National Needs Ideas. White papers may also be submitted via e-mail to tipwhitepaper@nist.gov.

    If you have previously submitted a white paper please do not resubmit the same white paper. White papers previously submitted continue to be considered as part of the selection process for future competitions.

    FOR FURTHER INFORMATION CONTACT: Thomas Wiggins at 301-975-5416 or by e-mail at thomas.wiggins@nist.gov.

    http://edocket.access.gpo.gov/2010/2010-27435.htm

  • Environmental Protection Agency

  • 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 November 22, 2010 to conduct a quality review of a draft SAB report.

    DATES: The public teleconference will be held on November 22, 2010 from 2 p.m. 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 general information concerning this public teleconference should contact Dr. Angela Nugent, Designated Federal Officer (DFO), EPA Science Advisory Board (1400R), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; via telephone/voice mail (202) 564-2218; fax (202) 565-2098; 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/2010/2010-26909.htm

  • Science Advisory Board Staff Office; Request for Nominations of Experts for the Review of EPA's Draft Oil Spill Research Strategy

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice.


    SUMMARY: The EPA Science Advisory Board (SAB) Staff Office requests public nominations for technical experts to form a SAB panel to peer review the Agency's Draft Oil Spill Research Strategy. EPA's Office of Research and Development will be developing the strategy to discuss EPA's proposed research and collaborative approaches for four activities: dispersants, alternative remediation technologies, coastal restoration, and human health effects identified during the Gulf of Mexico oil spill.

    DATES: Nominations should be submitted by November 9, 2010 per instructions below.

    FOR FURTHER INFORMATION CONTACT: Any member of the public wishing further information regarding this Notice and Request for Nominations may contact Mr. Thomas Carpenter, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at (202) 564-4885, by fax at (202) 565-2098, or via e-mail at carpenter.thomas@epa.gov. General information concerning the EPA SAB can be found at the EPA SAB Web site at http://www.epa.gov/sab.

    http://edocket.access.gpo.gov/2010/2010-27073.htm

  • Health and Human Services

  • Guidelines for Use of Stored Specimens and Access to Ancillary Data and Proposed Cost Schedule: Stored Biologic Specimens and Ancillary Data From the Collaborative Perinatal Project (CPP)

    ACTION: Notice and request for comments.


    SUMMARY: The Division of Epidemiology, Statistics and Prevention Research (hereafter, Division) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) maintains an extensive repository of datasets from completed studies, biospecimens, and ancillary data. The Division intends to make datasets and biospecimens more widely available to the research community for use by qualified researchers and to establish procedures for access consistent with the National Institutes of Health (NIH) Data Sharing Policy. The Division has established an internal committee, the Biospecimen Repository Access and Data Sharing Committee (BRADSC), to oversee the repository access and data sharing program. The purpose of this notice is to request comments on this program and present the initial proposed cost schedule. After full consideration of comments submitted in response to this notice, the BRADSC will finalize proposal guidelines and procedures, publish the cost schedule to the Division Web site, and begin to accept proposals for use of the stored biologic samples and for access to ancillary data that may not be available electronically. The first specimens and ancillary data that will be made available under this program are those from the national Collaborative Perinatal Project (CPP).

    The CPP is a large, prospective cohort study, conducted by the National Institute of Neurological Diseases and Stroke (NINDS) of the National Institutes of Health (NIH), which recruited and enrolled 48,197 women who contributed 54,390 pregnancies that were prospectively followed from 1959-1966 at twelve academic medical centers across the United States. Custody for disposition of the CPP serum specimens was transferred to the Division from the NINDS in 1993 and for the microfiche archives in 1999. However, under the Federal Privacy Act of 1974 the samples and archive still belong to NINDS. Since 1992, the specimens have had limited public availability through Division investigators. Going forward, the Biospecimen Repository Access and Data Sharing Committee (BRADSC) will oversee the repository access and data sharing program. Access to other Division resources will be announced on the Division Web site. The BRADSC reserves the right to amend the procedures and costs schedules as necessary to maintain the integrity of the program and to suit the conditions under which other specimens were collected. Announcements and current proposal guidelines will be available under the Research link at http://despr.nichd.nih.gov, and interested researchers should consult the Division Web site for resources available, the most recent guidelines for proposal submission and evaluation, and cost schedules. Procedures may vary depending on the age and nature of the samples and original institutional review board (IRB) approval, although the general outline of the procedures should remain the same. Cost schedules may vary depending on the nature and complexity of the request.

    No funding is provided as part of this notice nor will any be available as part of the program either to support laboratory analyses or data management. Samples will only be provided to approved projects upon receipt of evidence of necessary IRB approval(s), funding and payment of repository costs and shipping. Approved projects that do not obtain funding will be canceled within one year of their approval date. A more complete description of this program follows. Comments or requests for clarification on all aspects of the program are welcome.

    DATES:

    Comment Receipt Date: December 15, 2010.

    Invitation to Submit Proposal: Proposals can be submitted on an ongoing basis.

    Scientific Review Dates: Technical Panels for reviews will be assembled beginning on January 1, May 1, or September 1 of the calendar year so that proposals can be evaluated well in advance of Federal funding deadlines.

    Anticipated Distribution of Samples: Within one month of demonstrable proof of applicant IRB approval and receipt of payment to cover repository costs and shipping.

    ADDRESSES: To send comments and to request information, contact: Dr. Mary L. Hediger, Division of Epidemiology, Statistics and Prevention Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Blvd, Room 7B03, MSC 7510, Rockville, MD 20852, Phone: 301-435-6897, E-mail: hedigerm@exchange.nih.gov.

    http://edocket.access.gpo.gov/2010/2010-27183.htm

  • Public Meeting of the Presidential Commission for the Study of Bioethical Issues

    AGENCY: Department of Health and Human Services, Office of the Assistant Secretary for Health, The Presidential Commission for the Study of Bioethical Issues.

    ACTION: Notice of Meeting.


    SUMMARY: The Presidential Commission for the Study of Bioethical Issues (PCSBI) will conduct its third meeting in November. At this meeting, the Commission will continue discussing the emerging science of synthetic biology, including its potential benefits and risks, and appropriate ethical boundaries and principles. The Commission will develop and finalize recommendations concerning any actions that the Federal Government should take to ensure that America reaps the benefits of this developing field of science while identifying appropriate ethical boundaries and minimizing risks. It will also identify suggestions for future study, if any.

    DATES: The meeting will take place Tuesday, November 16, 2010, from 10:30 a.m. to approximately 4:15 p.m., and Wednesday, November 17, 2010, from 9 a.m. to approximately 11:30 a.m.

    ADDRESSES: Emory Conference Center Hotel, 1615 Clifton Road, Atlanta, GA 30329. Phone 404-712-6000.

    FOR FURTHER INFORMATION CONTACT: Judy Crawford, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue, NW., Suite C-100, Washington, DC 20005. Telephone: 202/233-3960. E- mail: judy.crawford@bioethics.gov. Additional information may be obtained by viewing the Web site: http://www.bioethics.gov.

    http://edocket.access.gpo.gov/2010/2010-27233.htm

  • Science Board Advisory Committee; Notice of Meeting

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice of meeting.


    This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

    Name of Committee: Science Board to the Food and Drug Administration (Science Board).

    General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues, as well as emerging issues within the scientific community in industry and academia. Additionally, the Science Board provides advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs.

    DATES: Date and Time: The meeting will be held on Monday, November 15, 2010, from 8:30 a.m. to 4 p.m.

    ADDRESSES: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814.

    Contact Person: Martha Monser, Office of the Commissioner, Food and Drug Administration, WO Bldg. 32, rm. 4286, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4627, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 301-451-2603. 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: The Science Board will receive information from the ongoing review of the Pharmacovigilance Program at the Center for Drug Evaluation and Research (CDER). The Center for Food Safety and Applied Nutrition (CFSAN) will present its evaluation and review of the final report of the CFSAN Research Review Subcommittee of the Science Board to the Food and Drug Administration and provide an overview of its strategic plan. New information and updates will be provided concerning FDA's activities in support of Comparative Effectiveness Research. In addition, the Board will be provided with updates on the development and broad priorities of FDA's Strategic Science Plan, and the FDA Medical Countermeasures Initiative, including planning for its regulatory science component.

    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: 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 Monday, November 8, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make 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 Friday, October 29, 2010. 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 Monday, November 1, 2010.

    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 Martha Monser, 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/AboutAdvisory Committee/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/2010/2010-26828.htm

  • Interior

  • Endangered and Threatened Wildlife and Plants; Assisting States, Federal Agencies, and Tribes in Managing White-Nose Syndrome in Bats; Draft National Plan

    AGENCY: Fish and Wildlife Service, Interior.

    ACTION: Notice of document availability for review and comment.


    SUMMARY: The U.S. Fish and Wildlife Service (FWS) announces the availability for public review of a draft national plan to assist States, Federal agencies, and tribes in managing white-nose syndrome in bats. This draft plan was prepared by representatives of the U.S. Department of Agriculture's Animal and Plant Health Inspection Service and Forest Service; U.S. Department of Defense's Army Corps of Engineers; U.S. Department of the Interior's Bureau of Land Management, National Park Service, and FWS; St. Regis Mohawk Tribe; Kentucky Department of Fish and Wildlife Resources; Missouri Department of Conservation; New York State Department of Environmental Conservation; Pennsylvania Game Commission; Vermont Department of Fish and Wildlife; and Virginia Department of Game and Inland Fisheries. The FWS is requesting review and comment on the draft plan from all interested parties.

    DATES: Comments on the draft plan must be received on or before November 29, 2010.

    ADDRESSES: An electronic copy of the draft plan is available at http://www.fws.gov/WhiteNoseSyndrome/. The document is also available by request from the U.S. Fish and Wildlife Service, New York Field Office, 3817 Luker Road, Cortland, NY 13045 (phone: 607-753-9334). Requests for copies of the draft plan and written comments regarding this plan should be addressed to Dr. Jeremy Coleman, National White-Nose Syndrome Coordinator, at the New York Field Office. In addition, FWS is accepting electronic comments on the draft plan at the following e-mail address: WhiteNoseBats@fws.gov.

    FOR FURTHER INFORMATION CONTACT: Dr. Jeremy Coleman, National White- Nose Syndrome Coordinator, at the New York Field Office. See ADDRESSES above.

    http://edocket.access.gpo.gov/2010/2010-27340.htm

  • Endangered and Threatened Wildlife and Plants; Reinstatement of Protections for the Gray Wolf in the Northern Rocky Mountains in Compliance With a Court Order

    AGENCY: Fish and Wildlife Service, Interior.

    ACTION: Final rule.


    SUMMARY: We, the U.S. Fish and Wildlife Service (Service), are issuing this final rule to comply with a court order that has the effect of reinstating the regulatory protections under the Endangered Species Act of 1973, as amended (ESA), for the gray wolf (Canis lupus) in most of the northern Rocky Mountains. Pursuant to the District of Montana court order dated August 5, 2010, this rule corrects the gray wolf listing for the northern half of Montana, the northern panhandle of Idaho, the eastern third of Washington and Oregon, and north-central Utah as endangered and reinstates the former special rules designating the gray wolf in the remainder of Montana and Idaho as nonessential experimental populations. Because ESA protections were not removed in Wyoming by our April 2, 2009 (74 FR 15123), final delisting rule, Wyoming is not impacted by this final rule.

    DATES: This action is effective October 26, 2010. However, the court order had legal effect immediately upon its filing at 2:43 p.m. Mountain Daylight Time on August 5, 2010.

    ADDRESSES: This final rule is available on the Internet at http://www.regulations.gov. It will also be available for inspection, by appointment, during normal business hours at U.S. Fish and Wildlife Service, Office of the Western Gray Wolf Recovery Coordinator, 585 Shepard Way, Helena, Montana 59601. Call (406) 449-5225 to make arrangements.

    FOR FURTHER INFORMATION CONTACT: For information on wolves in the northern Rocky Mountains, contact Edward E. Bangs, Western Gray Wolf Recovery Coordinator, U.S. Fish and Wildlife Service, at our Helena office (see ADDRESSES) or telephone (406) 449-5225, extension 204. Individuals who are hearing-impaired or speech-impaired may call the Federal Relay Service at 1-800-877-8337 for TTY assistance.

    http://edocket.access.gpo.gov/2010/2010-26765.htm

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