Advisory Committees; Filing of Closed Meeting Reports, 10814 [2014-04144]

Download as PDF 10814 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices Estimated Total Annual Burden Hours: 7,680. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, Email: OIRA_SUBMISSION@ OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–04192 Filed 2–25–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: Center for Biologics Evaluation and Research Blood Products Advisory Committee, Cellular, Tissue, and Gene Therapies Advisory Committee, Vaccines and Related Biological Products Advisory Committee. National Center for Toxicological Research Science Board to the National Center for Toxicological Research. Center for Tobacco Products Tobacco Products Scientific Advisory Committee. Annual reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday at the following locations: (1) The Library of Congress, 101 Independence Ave. SE., James Madison Memorial Bldg., Newspaper and Current Periodical Reading Room, Rm. 133, Washington, DC 20540; and (2) The Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: February 21, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–04144 Filed 2–25–14; 8:45 am] BILLING CODE 4160–01–P Notice The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2013. ADDRESSES: Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301–827– 6860. FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Committee Management Officer, Advisory Committee and Oversight Management Staff, Food and Drug Administration, 10903 New SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2012, through September 30, 2013: VerDate Mar<15>2010 17:24 Feb 25, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0811] Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 announcing the availability of a draft guidance for industry entitled ‘‘Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,’’ dated March 2014. This draft guidance informs members of the medical and scientific community and other interested persons that we intend to exercise enforcement discretion regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile infection not responding to standard therapies, provided the licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for use of the FMT products, the stool is obtained from a donor known to either the patient or the licensed health care provider treating the patient, and the donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product to treat his or her patient. This draft guidance, when finalized, is intended to supersede the guidance document entitled ‘‘Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,’’ dated July 2013 (July 2013 Guidance). 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 March 28, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Page 10814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Advisory Committees; Filing of Closed Meeting Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice

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SUMMARY: The Food and Drug Administration (FDA) is announcing that, as 
required by the Federal Advisory Committee Act, the Agency has filed 
with the Library of Congress the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2013.

ADDRESSES: Copies are available from the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 301-827-6860.

FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Committee Management 
Officer, Advisory Committee and Oversight Management Staff, Food and 
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-8220.

SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory 
Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with 
the Library of Congress the annual reports for the following FDA 
advisory committees that held closed meetings during the period October 
1, 2012, through September 30, 2013:

Center for Biologics Evaluation and Research

Blood Products Advisory Committee, Cellular, Tissue, and Gene Therapies 
Advisory Committee, Vaccines and Related Biological Products Advisory 
Committee.

National Center for Toxicological Research

Science Board to the National Center for Toxicological Research.

Center for Tobacco Products

Tobacco Products Scientific Advisory Committee.
    Annual reports are available for public inspections between 9 a.m. 
and 4 p.m., Monday through Friday at the following locations:
    (1) The Library of Congress, 101 Independence Ave. SE., James 
Madison Memorial Bldg., Newspaper and Current Periodical Reading Room, 
Rm. 133, Washington, DC 20540; and
    (2) The Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 21, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-04144 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P

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