AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of public meeting.
SUMMARY: This is a notice to inform the public of the first meeting of the Secretary's Advisory Committee on Animal Health. The meeting is being organized by the Animal and Plant Health Inspection Service.
DATES: The meeting will be held January 20 and 21, 2011, from 9 a.m. to 5 p.m. each day.
ADDRESSES: The meeting will be held in the Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington, DC 20250, in rooms 104-A and 107-A.
FOR FURTHER INFORMATION CONTACT: Mr. Michael R. Doerrer, Chief Operating Officer, Veterinary Services, APHIS, USDA, 4700 River Road Unit 37, Riverdale, MD 20737; (301) 734-5034; e-mail: SACAH.Management@aphis.usda.gov.
AGENCY: U. S. Army Corps of Engineers, Department of Defense.
SUMMARY: The National Wetland Plant List (NWPL) is used to delineate wetlands for purposes of the Clean Water Act and the Wetland Conservation Provisions of the Food Security Act. Other applications of the list include wetland restoration, establishment, and enhancement projects. To update the NWPL, the U.S. Army Corps of Engineers (Corps), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS) and the U.S. Department of Agriculture, Natural Resources Conservation Service (NRCS), is announcing the availability of the draft National Wetland Plant List (NWPL) and its web address to solicit public comments. The public will now be provided the opportunity to comment and vote on the wetland indicator status ratings of the plants, species nomenclature changes and the revisions to the definition of indicator status ratings contained in the NWPL.
DATES: Written comments must be submitted on or before March 7, 2011.
ADDRESSES: You may submit comments on indicator status evaluations and general comments through the Web site identified below. Whenever possible, commenters should submit comments on-line at: http://wetland_plants.usace.army.mil/. For instructions on how to submit comments online, please go to the supplementary section below.
For those without internet access, comments may be sent to Ms. Karen Mulligan, U.S. Army Corps of Engineers, Regulatory Community of Practice, 441 G St., NW., Washington, DC 20314-1000.
FOR FURTHER INFORMATION CONTACT: Ms. Karen Mulligan, Headquarters, Regulatory Community of Practice, Washington, DC or Mr. Robert Lichvar, Director of the National Wetland Plant List, Engineer Research and Development Center, Cold Regions Research and Engineering Laboratory. Ms. Mulligan can be reached at (202) 761-4664 and Mr. Lichvar can be reached at (603) 646-4657.
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: An Exposure Modeling Public Meeting (EMPM) will be held for one day on January 11, 2011. This notice announces the location and time for the meeting and sets forth the tentative agenda topics.
DATES: The meeting will be held on January 11, 2011 from 9 a.m. to 12:30 p.m. To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATION CONTACT, preferably prior to the meeting, to give EPA as much time as possible to process your request.
ADDRESSES: The meeting will be held at the Environmental Protection Agency, Office of Pesticide Programs (OPP), One Potomac Yard (South Building), 4th Floor South Conference Room (S-4370/80), 2777 S. Crystal Drive, Arlington, VA 22202.
FOR FURTHER INFORMATION CONTACT: Chuck Peck, Environmental Fate and Effects Division (7507P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 347-8064; fax number: (703) 305-6309; e- mail address: 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 "Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA's recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection.
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by April 7, 2011.
ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Critical Path Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4173, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist the 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 on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Leonard Sacks, Office of Critical Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 32, rm. 4174, Silver Spring, MD 20993-0002, 301-796-8502.
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/ NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.
DATES: Effective date: This rule is effective March 7, 2011.
Compliance date: The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date. See section III of this document for an additional explanation of the compliance date and required implementation of this final rule.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Office of Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4248, Silver Spring, MD 20993-0002, 301- 796-4830.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the President's Cancer Panel.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Name of Committee: President's Cancer Panel.
Date: February 1, 2011.
Time: 8 a.m. to 4 p.m.
Agenda: The Future of Cancer Research: Accelerating Scientific Innovation.
Place: Grand Hyatt Atlanta, 3300 Peachtree Road, NE., Atlanta, GA 30305.
Contact Person: Abby B. Sandler, PhD, Executive Secretary, Chief, Institute Review Office, Office of the Director, 6116 Executive Blvd., Suite 220, MSC 8349, National Cancer Institute, NIH, Bethesda, MD 20892-8349, (301) 451-9399, firstname.lastname@example.org.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page: deainfo.nci.nih.gov/advisory/pcp/pcp.htm, where an agenda and any additional information for the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
AGENCY: Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking (NPRM).
SUMMARY: CDC is proposing to amend its regulations for the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of Macaca fascicularis (cynomolgus), Chlorocebus aethiops (African green), and Macaca mulatta (rhesus) monkeys to all NHPs. Filovirus testing will continue to be required only for Old World NHPs. CDC also is proposing to reduce the frequency at which importers of cynomolgus, African green, and rhesus monkeys are required to renew their registrations, (from every 180 days to every two years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address: NHPs imported as part of a trained animal act; NHPs imported or transferred by zoological societies; The transfer of NHPs from approved laboratories; and Non-live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located.
DATES: Submit written or electronic comments by March 7, 2011.
ADDRESSES: Written comments, identified by Docket No. xxx, may be submitted to the following address: Centers for Disease Control and Prevention, Division of Global Migration and Quarantine, ATTN: NHP Rule Comments, 1600 Clifton Road, NE., (E03), Atlanta, GA, 30333. Comments will be available for public inspection Monday through Friday, except for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600 Clifton Road, NE., Atlanta, GA 30333. Please call ahead to 1-866-694- 4867 and ask for a representative in the Division of Global Migration and Quarantine (DGMQ) to schedule your visit. Comments also may be viewed at http://www.cdc.gov/ncidod/dq. Written comments may be submitted electronically via the Internet at http://www.regulations.gov or via e-mail to NHPPublicComments@cdc.gov. All comments received will be posted publicly without change, including any personal or proprietary information provided. To download an electronic version of the rule, access http://www.regulations.gov.
Mail written comments on the proposed information collection requirements to the following address: Office of Information and Regulatory Affairs, OMB, New Executive Office Building, 725 17th Street, NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for CDC.
FOR FURTHER INFORMATION CONTACT: Ashley A. Marrone, J.D., U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Division of Global Migration and Quarantine, 1600 Clifton Road, NE., Mailstop E-03, Atlanta, GA 30333, Telephone, 404- 498-1600.