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Federal Register Summary for week of 27 August

    Agriculture

  • Notice of Request for Extension of Approval of an Information Collection; Importation of Animals and Poultry, Animal and Poultry Products, Certain Animal Embryos, Semen, and Zoological Animals

    AGENCY: Animal and Plant Health Inspection Service, USDA.

    ACTION: Extension of approval of an information collection; comment request.


    SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request extension of approval of an information collection associated with the importation of animals and poultry, animal and poultry products, and animal germplasm.

    DATES: We will consider all comments that we receive on or before October 26, 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-2010-0080) 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-2010-0080, 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-2010-0080.

    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: For information on the importation of animals and poultry, animal and poultry products, and animal germplasm, contact Dr. Betzaida Lopez, Staff Veterinarian, Technical Trade Services Team--Animals, NCIE, VS, APHIS, 4700 River Road Unit 39, Riverdale MD 20737; (301) 734-5677. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

    http://edocket.access.gpo.gov/2010/2010-21458.htm

  • Commerce

  • Pacific Fishery Management Council; Public Meetings

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

    ACTION: Notice of public meetings.


    SUMMARY: The Pacific Fishery Management Council's Salmon Technical Team (STT), Scientific and Statistical Committee's (SSC) Salmon Subcommittee, and Model Evaluation Workgroup (MEW) will review proposed salmon methodology and conservation objective changes in a joint work session, which is open to the public.

    DATES: The work session will be held Tuesday, October 19, 2010, from 10 a.m. to 4:30 p.m., and Wednesday October 20, 2010, from 8:30 a.m. to 4 p.m.

    ADDRESSES: The work session will be held at the Hyatt Place Hotel Portland Airport, 9750 NE Cascades Parkway, Portland, OR 97220, 503- 288-2808.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384, 503-820-2280.

    FOR FURTHER INFORMATION CONTACT: Mr. Chuck Tracy, Salmon Management Staff Officer, Pacific Fishery Management Council, 503 820-2280.

    http://edocket.access.gpo.gov/2010/2010-20961.htm

  • Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Management and Oversight of the National Estuarine Research Reserve System.

    OMB Control Number: 0648-0121.

    Form Number(s): NA.

    Type of Request: Regular submission (renewal of a currently approved information collection).

    Number of Respondents: 29.

    Average Hours per Response: Applications for funding, 1 hour; management plans, site nominations and site profiles, 2,000 hours each.

    Burden Hours: 10,682.

    Needs and Uses: The Coastal Zone Management Act of 1972 (CZMA; 16 U.S.C. 1461 et seq.) provides for the designation of estuarine research reserves representative of various regions and estuarine types in the United States to provide opportunities for long-term research, education and interpretation. During the site selection and designation process, information is collected from states in order to prepare a management plan and environmental impact statement. The designated reserves apply annually for operations funds by submitting a work plan; subsequently progress reports are required every six months for the duration of the award. Each reserve compiles an ecological characterization or site profile to describe the biological and physical environment of the reserve, research to date and research gaps. A competitive research program provides an opportunity for two researchers to focus their work at each reserve. Reserves are evaluated every three years, per section 312 of the Act, and revise their management plans every five years. This information is required to ensure that reserves are adhering to regulations and keeping with the purpose for which they were designated.

    Affected Public: Not-for-profit organizations; state, local and tribal government.

    Frequency: Annually or one-time.

    Respondent's Obligation: Required to obtain or retain benefits.

    OMB Desk Officer: David Rostker, (202) 395-3897.

    Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6616, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at dHynek@doc.gov).

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to David Rostker, OMB Desk Officer, FAX number (202) 395-7285, or David_Rostker@omb.eop.gov.

    http://edocket.access.gpo.gov/2010/2010-20944.htm

  • Health and Human Services

  • Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice of public workshop.


    SUMMARY: The Food and Drug Administration (FDA) New Jersey District Office, in cosponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRBs, and research sponsors.

    Date and Time: The public workshop will be held on November 4 and 5, 2010, from 8 a.m. to 5 p.m.

    Location: The public workshop will be held at the Hyatt Regency Jersey City, Two Exchange Pl., Jersey City, NJ 07302, 1-800-233-1234. (The hotel is connected to the PATH Train to New York City). Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $169 plus applicable taxes (available until October 20, 2010, or until the SoCRA room block is filled).

    Contact: Joan Lytle, Food and Drug Administration, 120 North Central Dr., North Brunswick, NJ 08902, 732-940-8946 ext. 33, FAX: 732- 940-8936, or Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., suite 109, Chalfont, PA 18914, 800-762-7292, FAX: 215-822- 8633, email: SoCRAmail@aol.com, Web site: http://www.SoCRA.org.

    Registration: The registration fee covers the cost of actual expenses, including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order or receipt of registration. Those accepted into the workshop will receive confirmation. The cost of registration is as follows: SoCRA member ($575.00), SoCRA nonmember (includes membership) ($650.00), FDA/Federal Government member ($450.00), FDA/Federal Government nonmember ($525.00).

    If you need special accommodations due to a disability, please contact SoCRA (see Contact) at least 10 days in advance.

    Extended periods of question and answer and discussion have been included in the program schedule. This program offers 13.3 hours of continuing medical education (CME) and continuing nursing education (CNE) credit. CME for Physicians: SoCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: SoCRA is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation (ANCC). ANCC/PSNA Provider Reference Number: 205-3-A-09.

    Registration instructions: To register, please submit a registration form with your name, affiliation, mailing address, phone, fax number, and email, along with a check or money order payable to "SoCRA''. Mail to: SoCRA (see Contact for address). To register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

    Payment by major credit card is accepted (Visa/MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SoCRA (see Contacts).

    http://edocket.access.gpo.gov/2010/2010-20834.htm

  • National Cancer Institute's Best Practices for Biospecimen Resources

    AGENCY: National Institutes of Health (NIH), National Cancer Institute (NCI).

    ACTION: Notice with request for comment.


    SUMMARY: As part of the commitment to maintaining current and scientifically accurate best practices, the National Cancer Institute (NCI) is seeking public comment on a revised version of the NCI Best Practices for Biospecimen Resources. This revised version of the NCI Best Practices is intended to both respond to comments received from the biospecimen resource community and provide more current and detailed recommendations related to biospecimen and data quality. Major revisions include the addition of new sections on Biospecimen Resource Management and Operations and Conflict of Interest, expansion of recommendations related to Custodianship and Informed Consent based on NCI workshops, addition of current references throughout the document and harmonization with current federal guidance documents and recommendations from international biospecimen organizations.

    DATES: Effective Date: The updated NCI Best Practices for Biospecimen Resources are open for public comment for a period of 30 days. Comments must be received by September 22, 2010 in order to ensure consideration. After the public comment period has closed, the comments received by NCI will be considered in a timely manner by the NCI Office of Biorepositories and Biospecimen Research. Subsequently, appropriate changes will be made on the Best Practices Web site http://biospecimens.cancer.gov/bestpractices/.

    ADDRESSES: Comments submitted via e-mail should use nciobbr@mail.nih.gov and enter "NCI Best Practices'' in the subject line. While NCI prefers that comments be sent by email, NCI will accept written comments. Written comments may be sent to: NCI/OBRR, NIH, 11400 Rockville Pike, Rockwall I Building, Bethesda, MD 20892, Attn: Dr. Nicole Lockhart.

    FOR FURTHER INFORMATION CONTACT: Implementation assistance and inquiries should be directed to senior staff of the relevant NCI Extramural and Intramural Program offices.

    http://edocket.access.gpo.gov/2010/2010-20872.htm

  • Proposed Collection; Comment Request; Request; OMB No. 0925-0177 "Special Volunteer and Guest Researcher Assignment,'' Form 590

    SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection, the Office of Human Resources, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

    Proposed Collection: Title: Special Volunteer and Guest Researcher Assignment for use in NIH facilities.

    Type of Information Collection Request: Reinstatement, OMB 0925- 0177, Expiration Date July 31, 2005.

    Need and Use of Information Collection Request:

    Form Number: NIH-590. A single Form NIH-590 is completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/ her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file.

    Frequency of Response: Once.

    Affected Public: Individuals.

    Type of Respondents: Non-federal scientific professionals and/or individuals.

    The annual Reporting burden is as follows:

    Estimated Number of Respondents: 1660;

    Estimated Number of Responses per Respondent: 1.0;

    Average Burden Hours per Response: 0.1; and

    Estimated Total Annual Burden Hours Requested: 166. The estimated annualized cost to respondents is $2,275.

    Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Mrs. Wanda Darwin, Office of Human Resources, Office of The Director, NIH, Building 31, Room 1C31E, One Center Drive, Bethesda, MD 20892-2269, or call non-toll-free number 301-402-2820, or E-mail your request, including your address to: darwinw@od.nih.gov.

    Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

    http://edocket.access.gpo.gov/2010/2010-21099.htm

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

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

    ACTION: Notice of meeting.


    SUMMARY: The Presidential Commission for the Study of Bioethical Issues will conduct a meeting in September. 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.

    DATES: The meeting will take place Monday, September 13, 2010, from 8:50 a.m. to approximately 4:15 p.m., and Tuesday, September 14, 2010, from 9 a.m. to approximately noon.

    ADDRESSES: Monday, September 13, The Inn at Penn, 3600 Sansom Street, Philadelphia, PA 19104. Phone 215-222-0200. Tuesday, September 14, The Annenberg Public Policy Center, 202 South 36th Street, Philadelphia, PA 19104. Phone 215-898-9400.

    FOR FURTHER INFORMATION CONTACT: Ms. Diane M. Gianelli, Director of Communications, 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: info@bioethics.gov. Additional information may be obtained by viewing the Web site: http://www.bioethics.gov.

    http://edocket.access.gpo.gov/2010/2010-21267.htm

  • Request for Comments on Synthetic Biology

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

    ACTION: Notice.


    SUMMARY: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the emerging science of synthetic biology, including its potential applications and risks, as well as appropriate ethical boundaries to assure that America reaps the benefits of this new technology.

    DATES: To assure consideration, comments must be received by October 1, 2010.

    ADDRESSES: Individuals, groups, and organizations interested in commenting on this topic may submit comments by e-mail to info@bioethics.gov or by mail to the following address: Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave., NW., Suite C-100, Washington, DC 20005.

    FOR FURTHER INFORMATION CONTACT: Ms. Diane M. Gianelli, Director of Communications, 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: info@bioethics.gov. Additional information may be obtained by viewing the Web site: http://www.bioethics.gov.

    http://edocket.access.gpo.gov/2010/2010-21359.htm

  • Interior

  • Bureau of Ocean Energy Management, Regulation and Enforcement Outer Continental Shelf (OCS) Scientific Committee (SC); Announcement of Plenary Session

    AGENCY: Bureau of Ocean Energy Management, Regulation and Enforcement (BOEM), Interior.

    ACTION: Notice of meeting.


    SUMMARY: The OCS Scientific Committee will meet at the Embassy Suites Dulles North in Ashburn, Virginia.

    DATES: Tuesday, September 14, 2010, from 9 a.m. to 5 p.m.; Wednesday, September 15, 2010, from 8 a.m. to 4:30 p.m.; and Thursday, September 16, 2010, from 10 a.m. to 4 p.m.

    ADDRESSES: Embassy Suites Dulles North, 44610 Waxpool Road, Ashburn, Virginia 20147, telephone (703) 723-5300.

    FOR FURTHER INFORMATION CONTACT: A copy of the agenda may be requested from BOEM by e-mailing Ms. Carolyn Beamer at carolyn.beamer@boemre.gov. Other inquiries concerning the OCS SC meeting should be addressed to Dr. James Kendall, Executive Secretary to the OCS SC, Bureau of Ocean Energy Management, Regulation and Enforcement, 381 Elden Street, Mail Stop 4043, Herndon, Virginia 20170-4817, or by calling (703) 787-1656 or via e-mail at james.kendall@boemre.gov.

    http://edocket.access.gpo.gov/2010/2010-21251.htm

  • Notice of Public Meeting, North Slope Science Initiative-Science Technical Advisory Panel

    AGENCY: Bureau of Land Management, Alaska State Office, North Slope Science Initiative, Interior.

    ACTION: Notice of public meeting.


    SUMMARY: In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, North Slope Science Initiative (NSSI)- Science Technical Advisory Panel (STAP) will meet as indicated:

    DATES: The meeting will be September 21-23, 2010, in Barrow, Alaska. The meeting begins each day at 9 a.m., in the Inupiat Heritage Center, Barrow, Alaska. The public can make comments between 3 p.m. and 4 p.m. on Wednesday, September 22, 2010.

    FOR FURTHER INFORMATION CONTACT: John F. Payne, Executive Director, North Slope Science Initiative, AK-9 10, c/o Bureau of Land Management, 222 W. Seventh Avenue, 13, Anchorage, AK 99513, (907) 271-3431 or e-mail johnfpayne@blm.gov.

    http://edocket.access.gpo.gov/2010/2010-20955.htm

  • Public Review of Draft Coastal and Marine Ecological Classification Standard

    AGENCY: Department of the Interior, U.S. Geological Survey.

    ACTION: Notice; request for comments on draft Coastal and Marine Ecological Classification Standard.


    SUMMARY: The Federal Geographic Data Committee (FGDC) is conducting a public review of the draft Coastal and Marine Ecological Classification Standard (CMECS). CMECS provides a means of classifying ecological and habitat units using a common terminology. It provides a uniform protocol for identifying, characterizing and naming ecological units in support of monitoring, protection, and restoration of unique biotic assemblages, protected species, critical habitat, and important ecosystem components. The FGDC Coastal and Marine Spatial Data Subcommittee, chaired by the National Oceanic and Atmospheric Administration (NOAA), developed this draft standard. The FGDC Coordination Group, comprised of representatives of Federal agencies, approved releasing this draft standard for public review at its July 20, 2010 meeting. The FGDC invites all stakeholders in coastal and marine ecology and management to comment on this standard to ensure that the standard meets their needs.

    The draft Coastal and Marine Ecological Classification Standard may be downloaded at http://www.csc.noaa.gov/benthic/cmecs/CMECS_doc.pdf. Comments shall be submitted online at http://www.surveymonkey.com/s/22G2S67.

    Comments that concern specific issues/changes/additions may result in revisions to the draft Coastal and Marine Ecological Classification Standard. Reviewers may obtain information about how comments were addressed upon request. After formal endorsement of the standard by the FGDC, the standard and a summary analysis of the changes will be made available to the public on the FGDC Web site.

    DATES: Comments on the draft Coastal and Marine Ecological Classification Standard must be submitted no later than Monday, December 13, 2010.

    FOR FURTHER INFORMATION: Ms. Julie Binder Maitra, U.S. Geological Survey, Federal Geographic Data Committee, jmaitra@fgdc.gov, 703-648- 4627.

    http://edocket.access.gpo.gov/2010/2010-20851.htm

  • National Science Foundation

  • Notice of Availability of a Draft Site-Specific Environmental Assessment and Notice of Public Hearings; Correction

    AGENCY: National Science Foundation.

    ACTION: Notice of the availability of a Draft Site-Specific Environmental Assessment (Draft SSEA) for the Ocean Observatories Initiative (OOI), request for public comment on the Draft SSEA, and notice of public hearings; Correction.


    SUMMARY: The National Science Foundation (NSF) published a document in the Federal Register of August 16, 2010, concerning requests for public comment on a Draft Site-Specific Environmental Assessment for the Ocean Observatories Initiative (OOI). The document did not include the dates and times for the open house sessions.

    Correction

    In the Federal Register of August 16, 2010, in FR Doc. 2010-20107, on page 50008, in the second column, correct the DATES and ADDRESSES caption to read:

    DATES and ADDRESSES: All hearings will start with an open house session from 7 p.m. to 7:45 p.m. A presentation and formal public comment period will be held from 7:45 p.m. to 9 p.m. Public hearings will be held on the following dates and at the following locations:

    Wednesday, September 1, 2010, at Westport Maritime Museum, Westport, WA.

    Thursday, September 2, 2010, at Guin Library Seminar Room, Hatfield Marine Science Center, Newport, OR.

    Wednesday, September 8, 2010 date, at New Bedford Library, 613 Pleasant Street, New Bedford, MA 02740-6203.

    FOR FURTHER INFORMATION CONTACT: Copies of the Draft SSEA are available upon request from: Jean McGovern, NSF, Division of Ocean Sciences, 4201 Wilson Blvd., Arlington, VA 22230; Telephone: (703) 292-7591. The Draft SSEA is also available at the following Web site: http://www.nsf.gov/geo/oce/envcomp/index.jsp.

    http://edocket.access.gpo.gov/2010/2010-21154.htm