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Federal Register Summary for week of 24 September

    Commerce

  • Listing Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Atlantic Bluefin Tuna as Threatened or Endangered under the Endangered Species Act

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

    ACTION: 90-day petition finding; request for information.


    SUMMARY: We, NMFS, announce a 90-day finding for a petition to list Atlantic bluefin tuna (Thunnus thynnus) as endangered or threatened under the Endangered Species Act (ESA) and to designate critical habitat concurrently with a listing. We find that the petition presents substantial scientific information indicating the petitioned action may be warranted. We will conduct a status review of Atlantic bluefin tuna to determine if the petitioned action is warranted. To ensure that the review is comprehensive, we solicit information pertaining to this species from any interested party.

    DATES: Information related to this petition finding must be received by November 22, 2010.

    ADDRESSES: You may submit comments, identified by RIN 0648-XW96, by any of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal http//www.regulations.gov. Follow the instructions for submitting comments.

    Mail or hand-delivery: Assistant Regional Administrator, NMFS, Northeast Regional Office, 55 Great Republic Drive, Gloucester, MA 01930.

    All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

    NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.

    The petition and other pertinent information are also available electronically at the NMFS website at http://www.nero.noaa.gov/prot_res/CandidateSpeciesProgram/csr.htm.

    FOR FURTHER INFORMATION CONTACT: Kim Damon-Randall, NMFS, Northeast Regional Office (978) 282-8485 or Marta Nammack, NMFS, Office of Protected Resources (301) 713-1401.

    http://edocket.access.gpo.gov/2010/2010-23486.htm

  • Notice of Availability of a Draft NOAA Climate Service Strategic Vision and Framework for Public Review, and Notice of Informational Webinar Meetings

    ACTION: Notice of availability of a draft NOAA Climate Service strategic vision and framework for public review, and notice of informational webinar meetings.


    SUMMARY: On February 8, 2010, the Department of Commerce and the National Oceanic and Atmospheric Administration (NOAA) announced their intent to establish a new NOAA Climate Service (NCS). The new service will directly support NOAA's vision of "an informed society that uses a comprehensive understanding of the role of the oceans, coasts, and atmosphere in the global ecosystem to make the best social and economic decisions.'' It will also contribute to NOAA's mission "to understand and anticipate changes in Earth's environment, and conserve and manage coastal and marine resources to meet our Nation's economic, social and environmental needs.'' The reorganization of existing agency assets is intended to help NOAA better work with our partners to respond to the growing demands for climate information from the public, business, industry, local, state and Federal agencies, and decision makers.

    As part of the process to establish a new NCS, NOAA recently completed a strategic vision and framework document that describes how NOAA proposes to respond to society's growing need for climate services. The document describes the vision and outlines how the NCS can achieve new strategic goals related to the delivery and development of reliable, timely, and authoritative climate science and service to enable a climate-resilient society to grow and prosper.

    NOAA will accept comments on the strategic vision from September 21 to midnight on October 18, 2010. A copy of the draft document and instructions on how to submit comments can be found at http://www.noaa.gov/climate.

    is also hosting a series of informational webinars for individuals and organizations to learn more about the proposed NCS vision and timeline and to provide an opportunity for to answer questions, and obtain feedback. Each webinar is targeted to a specific sector, and will begin with a presentation from Dr. Chet Koblinsky, Director, NOAA Climate Program Office and Transitional Deputy Director, NOAA Climate service, and will be followed by a question and answer session.

    DATES: The webinar meeting dates are: 1. Friday, September 24, 2010, 1 p.m. to 2:30 p.m. EST, for the academic research community. 2. Friday, September 24, 2010, 3 p.m. to 4:30 p.m. EST, for state and local government officials. 3. Wednesday, September 29, 2010, 3:30 p.m. to 5 p.m. EST, for the corporate and business community. 4. Thursday, September 30, 2010, 3:30 p.m. to 5 p.m. EST, for non- governmental and non-profit organizations.

    For specific instructions for each webinar, please visit http://www.noaa.gov/climateresources/meetings. Additional information about the proposed NOAA Climate Service, including questions and answers can be found at http://www.noaa.gov/climate.

    FOR FURTHER INFORMATION CONTACT: Brady Phillips, NOAA Office of Communications and External Affairs, 14th and Constitution Avenue, NW., Washington, DC 20230. (Phone: 202-482-2365, Fax: 202-482-3154, E-mail: brady.phillips@noaa.gov); or visit http://www.noaa.gov/climateresources/meetings.

    http://edocket.access.gpo.gov/2010/2010-23630.htm

  • Environmental Protection Agency

  • 2010 Release of CADDIS (Causal Analysis/Diagnosis Decision Information System)

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice of public release.


    SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing the public release of the 2010 version of the Causal Analysis/Diagnosis Decision Information System (CADDIS). This Web site was developed to help scientists find, develop, organize, and use environmental information to improve causal assessments of biological impairment. The CADDIS Web site was developed and prepared by EPA's National Center for Environmental Assessment (NCEA), in the Office of Research and Development (ORD), and is available at http://www.epa.gov/caddis.

    DATES: The 2010 CADDIS Web site will become publically available on September 24, 2010.

    Additional Information: For additional information on the CADDIS Web site, please contact the Information Management Team via mail: Mailcode 8601P, National Center for Environmental Assessment, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-8561; facsimile: 703-347-8691; or e-mail: caddis@epa.gov.

    http://edocket.access.gpo.gov/2010/2010-23966.htm

  • Science Advisory Board Staff Office Request for Nominations of Experts for the Review of Great Lakes Restoration Initiative Action Plan

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice.


    SUMMARY: The EPA Science Advisory Board (SAB) Staff Office is requesting public nominations for technical experts to form an SAB panel to review the interagency Great Lakes Restoration Initiative (GLRI) Action Plan which describes restoration priorities, goals, objectives, measurable ecological targets, and specific actions.

    DATES: Nominations should be submitted by October 15, 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 Ms. Iris Goodman, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at (202) 564-2164, by fax at (202) 565-2098, or via e-mail at goodman.iris@epa.gov. General information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa.gov/sab.

    http://edocket.access.gpo.gov/2010/2010-23982.htm

  • Health and Human Services

  • Clinical Investigator Training Course

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice.


    SUMMARY: The Food and Drug Administration (FDA), Office of Critical Path Programs, in cosponsorship with the Clinical Trials Transformation Initiative (CTTI), is announcing a 3-day training course for health care professionals responsible for, or involved in, the conduct and/or design of clinical trials (clinical investigators). This course is intended to assist clinical investigators in understanding what preclinical and clinical information is needed to support the investigational use of medical products, as well as the scientific, regulatory, and ethical considerations involved in the conduct of clinical trials.

    DATES: The training course will be held on November 8 and 9, 2010, from 8 a.m. to 5 p.m. and on November 10, 2010, from 8 a.m. to 3 p.m.

    ADDRESSES: The training course will be held at the National Labor College, 10000 New Hampshire Ave., Silver Spring, MD 20993-0002.

    FOR FURTHER INFORMATION CONTACT: Nancy Masiello, Office of Critical Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4166, Silver Spring, MD 20993-0002, 301-796-8498, Nancy.Masiello@fda.hhs.gov.

    Registration: Register by November 1, 2010, at the registration/ information Web site at https://www.trialstransformation.org/fda-clinical-investigator-training-course/. Registration materials, payment procedures, accommodation information, and a detailed description of the course can be found at the registration/information Web site. The registration fee is $350 per person. The fee includes course materials and onsite lunch. Early registration is recommended because seating is limited. There will be no onsite registration. Persons attending the course are advised that FDA is not responsible for providing access to electrical outlets. If you need special accommodations due to a disability, please contact Nancy Masiello at least 7 days in advance.

    http://edocket.access.gpo.gov/2010/2010-23493.htm

  • Draft Revision of the Federalwide Assurance

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

    ACTION: Notice.


    SUMMARY: The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of the draft revised Federalwide Assurance (FWA) form and Terms of Assurance, and is seeking comment on these draft documents. OHRP is proposing several changes to simplify and shorten the FWA form and Terms of Assurance. Institutions engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services (HHS) must hold an OHRP-approved FWA. The draft revised FWA form and Terms of Assurance, when finalized, will supersede the current FWA documents available on the OHRP Web site at http://www.hhs.gov/ohrp/assurances/assurances_index.html. OHRP will consider comments received before implementing any revisions to the FWA documents.

    DATES: Submit written comments by October 25, 2010.

    ADDRESSES: Submit written requests for single copies of the draft revised FWA form and Terms of Assurance 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 revised FWA documents.

    You may submit comments, identified by docket ID number HHS-OPHS- 2010-0023, 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]: Irene Stith-Coleman, PhD, Office for Human Research Protections, 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: Irene Stith-Coleman, PhD, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Irene.StithColeman@hhs.gov.

    http://edocket.access.gpo.gov/2010/2010-23759.htm

  • Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

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

    ACTION: Notice.


    SUMMARY: The Office for Human Research Protections (OHRP), within the Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled, "Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf, is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,'' that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and organizations, and those comments were considered as the guidance was finalized.

    DATES: Comments on OHRP guidance documents are welcome at any time.

    ADDRESSES: Submit written requests for a single copy of the guidance document entitled, "Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues,'' 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 guidance document.

    Submit written comments to COMMENTS ON SUBJECT WITHDRAWAL GUIDANCE, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to ohrp@hhs.gov or via facsimile at 240-402-2071.

    FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Irene.StithColeman@hhs.gov.

    http://edocket.access.gpo.gov/2010/2010-23517.htm

  • Office of Biotechnology Activities, Office of Science Policy, Office of the Director; 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 the meeting of the National Science Advisory Board for Biosecurity (NSABB).

    Name of Committee: National Science Advisory Board for Biosecurity.

    Date: October 19, 2010.

    Time: 8:30 a.m. to 4 p.m. Eastern Daylight Time (Times are approximate and subject to change).

    Agenda: Presentations and discussions regarding: (1) Update of Federal activities relevant to the mission of the NSABB; (2) activities of NSABB Working Groups on Codes of Conduct; Culture of Responsibility; International Engagement; Journal Review Policies; and Outreach and Education; (3) consideration of advances in synthetic biology in relation to NSABB recommendations regarding biosecurity concerns raised by this field; (4) planning for future NSABB meetings and activities; and (5) other business of the Board.

    Place: National Institutes of Health, Building 31, Center Drive, C-Wing, 6th Floor, Conference Room 10, Bethesda, Maryland 20892.

    Contact Person: Ronna Hill, NSABB Program Assistant, NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892, (301) 496-9838, hillro@od.nih.gov.

    Under authority 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established the NSABB to provide advice, guidance and leadership regarding federal oversight of dual use research, defined as biological research that generates information and technologies that could be misused to pose a biological threat to public health and/or national security.

    The meeting will be open to the public, however pre-registration is strongly recommended due to space limitations. Persons planning to attend should register online at: http://oba.od.nih.gov/biosecurity/biosecurity_meetings.html or by calling Palladian Partners, Inc. (Contact: Joel Yaccarino at 301-650-8660.) Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should indicate these requirements upon registration.

    This meeting will also be webcast. To access the webcast, as well as the draft meeting agenda and pre-registration information, connect to: http://oba.od.nih.gov/biosecurity/biosecurity_meetings.html. Please check this site for updates.

    Any member of the public interested in presenting oral comments relevant to the mission of the NSABB at the meeting may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of an organization may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments relevant to the mission of the NSABB. All written comments must be received by October 12, 2010 and should be sent via e-mail to nsabb@od.nih.gov with "NSABB Public Comment'' as the subject line or by regular mail to 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, Attention: Ronna Hill. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person.

    http://edocket.access.gpo.gov/2010/2010-23947.htm

  • Risk Communication 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). The meeting will be open to the public.

    Name of Committee: Risk Communication 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 November 8, 2010, from 8 a.m. to 5 p.m. and November 9, 2010, from 8 a.m. to 2 p.m.

    Location: FDA White Oak Campus, Building 31 Conference Center, Great Room, 10903 New Hampshire Ave., Silver Spring, MD 20993. Please note visitors can park in the southwest garage near Building 31 or the northwest parking lot near Building 22 (for a campus map, see http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/UCM194893.pdf). Visitors to the White Oak Campus must have a valid driver's license or other picture ID, and must enter through Building 1.

    Contact Person: Lee L. Zwanziger, Office of Policy, Planning and Preparedness, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3278, Silver Spring, MD, 20993, 301-796-9151, FAX: 301- 847-8611, e-mail: RCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732112560. 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 November 8 and 9, 2010, the Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's Strategic Plan for Risk Communication, FDA's Transparency Initiative, and the challenges of effectively communicating with patients and caregivers about appropriate use of medical devices when a patient is prescribed a medical device for home use.

    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 October 29, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on November 8, 2010, and 10:30 to 11:30 a.m. on November 9, 2010. 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 October 21, 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 October 22, 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 Lee Zwanziger 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/2010/2010-23368.htm