AGENCY: Forest Service, USDA.
ACTION: Notice of availability; request for comment.
SUMMARY: The draft 2010 Resources Planning Act (RPA) Assessment is available for review and comment at http://www.fs.fed.us/research/rpa/. The RPA Assessment is a legislatively mandated periodic assessment of the condition and trends of the Nation's renewable resources on forests and rangelands.
DATES: Comments must be received in writing or electronically on or before September 30, 2011, to be assured of consideration. Comments received after that date will be considered to the extent practicable.
ADDRESSES: Comments concerning this notice should be addressed to Dr. Linda Langner, Quantitative Sciences Staff, Forest Service, 1400 Independence Avenue, SW., Mailstop 1115, Washington, DC 20250-1115. Comments also may be submitted via facsimile to 703-605-5131 or by email using the comment form on the Web site http://www.fs.fed.us/research/rpa/. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at USDA Forest Service, 1400 Independence Avenue, SW., Washington DC, during normal business hours. Visitors are encouraged to call ahead to 202-205-1665 to facilitate entry to the building.
FOR FURTHER INFORMATION CONTACT: Dr. Linda Langner, Quantitative Sciences Staff by phone at 703-605-4886 or by email to firstname.lastname@example.org. Additional information about the RPA Assessment can be obtained on the Internet at http://www.fs.fed.us/research/rpa/.
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday.
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
SUMMARY: We are proposing to amend the regulations to implement an amendment to the Animal Welfare Act (AWA). The Food, Conservation, and Energy Act of 2008 added a new section to the AWA to restrict the importation of certain live dogs. Consistent with this amendment, this proposed rule would, with certain limited exceptions, prohibit the importation of dogs from any part of the world into the continental United States or Hawaii for purposes of resale, research, or veterinary treatment, unless the dogs are in good health, have received all necessary vaccinations, and are at least 6 months of age. This proposed rule is necessary to implement the amendment to the AWA and would help to ensure the welfare of imported dogs.
DATES: We will consider all comments that we receive on or before October 31, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0053-0001.
Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2009-0053, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737- 1238.
Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2009- 0053 or in our reading room, which 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: Dr. Gerald Rushin, Veterinary Medical Officer, Animal Care, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737-1231; (301) 734-0954.
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of meeting.
SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces a joint public teleconference of the Chartered SAB and Board of Scientific Counselors (BOSC) to discuss a draft report providing advice on Office of Research and Development's (ORD's) new strategic directions for research.
DATES: The public teleconference will be held on Monday, September 19, 2011 from 12 p.m. to 3 p.m. (Eastern Daylight Time).
ADDRESSES: The public teleconference will be conducted by telephone only.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes further information concerning the teleconference may contact Dr. Angela Nugent, Designated Federal Officer (DFO), EPA Science Advisory Board (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; via telephone/voice mail (202) 564- 2218, fax (202) 565-2098; or e-mail at email@example.com. General information concerning the SAB can be found on the EPA Web site at http://www.epa.gov/sab.
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: The EPA Science Advisory Board (SAB) Staff Office is requesting public nominations of technical experts to serve on an expert panel under the auspices of the SAB to conduct a peer review of EPA's development of air emission estimating methodologies for animal feeding operations.
DATES: Nominations should be submitted by September 22, 2011 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. Edward Hanlon, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at (202) 564-2134, or via e-mail at firstname.lastname@example.org.
General information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa.gov/sab. For questions concerning EPA's air emission estimating methodologies for animal feeding operations, please contact Mr. Larry Elmore of EPA's Office of Air Quality Planning and Standards by phone at (919) 541- 5433, or via e-mail at email@example.com.
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.'' This guidance is intended to assist sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data. The guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities when conducting investigational new drug (IND) or investigational device exemption (IDE) studies.
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 28, 2011.
ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or the Office of Communication, Education and Radiation Programs, Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ann Meeker-O'Connell, Center for Drug Evaluation and Research (HFD-45), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5339, Silver Spring, MD 20993-0002, 301-796-3150; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Chrissy Cochran, Center for Devices and Radiological Health (HFZ-311), Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 66, rm. 3453, Silver Spring, MD 20993-0002, 301-796-5490.
AGENCIES: The Office of the Secretary, HHS, and the Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; extension of comment period.
SUMMARY: The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. That ANPRM was published in the Federal Register on July 26, 2011.
DATES: The comment period for the proposed rule published July 26, 2011, at 76 FR 44512 is extended. Comments will be received through October 26, 2011.
ADDRESSES: You may submit comments, identified by docket ID number HHS- OPHS-2011-0005, 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 "Submit a Comment'' action and follow the instructions.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] to: Jerry Menikoff, M.D., J.D., 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: Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; e- mail: firstname.lastname@example.org.
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of petition finding and initiation of status review.
SUMMARY: We, the U.S. Fish and Wildlife Service, announce a 90-day finding on a petition to list all chimpanzees (Pan troglodytes) as endangered under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing all chimpanzees as endangered may be warranted. Therefore, with the publication of this notice, we are initiating a review of the status of the species to determine if listing the entire species as endangered is warranted. To ensure that this status review is comprehensive, we are requesting scientific and commercial data and other information regarding this species. Based on the status review, we will issue a 12- month finding on the petition, which will address whether the petitioned action is warranted, as provided in section 4(b)(3)(B) of the Act.
DATES: To allow us adequate time to conduct this review, we request that we receive information on or before October 31, 2011.
ADDRESSES: You may submit information by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Search for Docket No. FWS-R9-ES-2010-0086 and then follow the instructions for submitting comments.
U.S. mail or hand-delivery: Public Comments Processing, Attn: FWS-R9-IA-2008-0123; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, MS 2042-PDM; Arlington, VA 22203.
We will post all information received on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Information Solicited section below for more details).
FOR FURTHER INFORMATION CONTACT: Janine Van Norman, Chief, Branch of Foreign Species, Endangered Species Program, U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Room 420, Arlington, VA 22203; telephone 703-358-2171; facsimile 703-358-1735. If you use a telecommunications device for the deaf (TDD), please call the Federal Information Relay Service (FIRS) at 800-877-8339.
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of public meeting and Webcast.
SUMMARY: We, the U.S. Fish and Wildlife Service (Service), will host a Wind Turbine Guidelines Advisory Committee (Committee) meeting in- person and via webcast. The meeting and webcast are open to the public. The meeting agenda will include a presentation and discussion of the Service's revised Draft Land-Based Wind Energy Guidelines. The revised Draft incorporates changes based on public comment and recommendations from the Committee.
DATES: The meeting and webcast will take place on September 20 and 21, from 8 a.m. to 5 p.m. If you are a member of the public wishing to attend in person or participate via webcast, you must register online no later than September 13, 2011 (see "Meeting Participation Information'' under SUPPLEMENTARY INFORMATION.)
ADDRESSES: Meeting Location: Savoy Suites Hotel, 2505 Wisconsin Ave., NW, Washington, DC 20007. (See "Meeting Location Information'' under SUPPLEMENTARY INFORMATION.) Instructions for webcast participants will be given via e-mail upon online registration.
FOR FURTHER INFORMATION CONTACT: Rachel London, Division of Habitat and Resource Conservation, U.S. Fish and Wildlife Service, U.S. Department of the Interior, (703) 358-2161.