Advisory Committees; Filing of Closed Meeting Reports, 78448 [2014-30460]

Download as PDF 78448 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices TABLE 2—REVISED DRAFT PRODUCT- DEPARTMENT OF HEALTH AND SPECIFIC BE RECOMMENDATIONS HUMAN SERVICES FOR DRUG PRODUCTS—Continued Food and Drug Administration Sevelamer hydrochloride. [Docket No. FDA–2014–N–0001] For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to http:// www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft and revised draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These guidances represent the Agency’s current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. IV. Comments Interested persons may submit either electronic comments on any of the specific BE recommendations posted on FDA’s Web site to http:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. The guidances, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http://www. regulations.gov. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: December 23, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30514 Filed 12–29–14; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 21:42 Dec 29, 2014 Jkt 235001 Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: 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 2014. ADDRESSES: Copies are available at the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You also may access the docket at http:// www.regulations.gov for the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2014. Insert the docket number found in brackets in the heading of this document at http:// www.regulations.gov into the ‘‘Search’’ box, clear filter under Document Type (left side of screen), and check ‘‘Supporting and Related Material,’’ then Sort By Best Match (from the dropdown menu; top right side of screen), ‘‘ID Number (Z–A)’’ or Sort By Best Match (from the drop-down menu) ‘‘Title (A–Z),’’ also found in the heading of this document. 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, 2013, through September 30, 2014: 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: SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Science Board to the National Center for Toxicological Research 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, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE., Rm. 133, Washington, DC; and (2) The Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 22, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30460 Filed 12–29–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–2065] Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Radiation Biodosimetry Devices.’’ This draft guidance provides recommendations to assist industry in designing studies to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. This draft guidance is not final nor is it in effect at this time. 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 of 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 30, 2015. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Radiation Biodosimetry Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Page 78448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30460]


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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 2014.

ADDRESSES: Copies are available at the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500. You also may access the docket at 
http://www.regulations.gov for the annual reports of those FDA advisory 
committees that held closed meetings during fiscal year 2014. Insert 
the docket number found in brackets in the heading of this document at 
http://www.regulations.gov into the ``Search'' box, clear filter under 
Document Type (left side of screen), and check ``Supporting and Related 
Material,'' then Sort By Best Match (from the drop-down menu; top right 
side of screen), ``ID Number (Z-A)'' or Sort By Best Match (from the 
drop-down menu) ``Title (A-Z),'' also found in the heading of this 
document.

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, 2013, through September 30, 2014:
    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

    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, Madison Bldg., Newspaper and Current 
Periodical Reading Room, 101 Independence Ave. SE., Rm. 133, 
Washington, DC; and
    (2) The Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30460 Filed 12-29-14; 8:45 am]
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