National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 70880 [2014-28074]

Download as PDF 70880 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES drug products to include a warning statement on the product labels to address the risk of serious skin reactions and that it would request the same warning be added by manufacturers of OTC acetaminophen-containing drug products marketed under an approved application. In the fall of 2013, FDA sent letters to manufacturers holding new drug applications (NDA) and abbreviated new drug applications (ANDA) requiring in some cases and requesting in others that the language recommended below be included on the labeling for all products (both prescription and OTC) containing acetaminophen marketed under NDAs and ANDAs. At this time, most of the requested labeling changes have been made by the relevant manufacturers. FDA also indicated that it planned to encourage manufacturers of acetaminophen-containing drug products marketed under the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use, published in the Federal Register (53 FR 46204, November 16, 1988) to similarly add a warning about serious skin reactions to the product labels. As noted above, this draft guidance informs manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as OTC) drug products bearing a warning as described in the draft guidance alerting consumers that the use of acetaminophen may cause severe skin reactions. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the recommended warning for OTC acetaminophen-containing drug products and labeling statements regarding serious skin reactions. It does not create or confer any rights for or on any person and does 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. II. Comments Interested persons may submit either electronic comments regarding this document to https://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 VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 heading of this document. 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 https:// www.regulations.gov. III. Paperwork Reduction Act of 1995 Under the draft guidance, manufacturers may add to their drug product labeling a warning statement supplied by FDA that pertains to acetaminophen to address the risk of serious skin reactions. Inclusion of the warning statement on the labels for these drug products would be exempt from review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520) because the public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within the definition of ‘‘collection of information’’ (see 5 CFR 1320.3(c)(2)). IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: November 21, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28086 Filed 11–26–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Peer Review Meeting. Date: December 16, 2014. Time: 9:00 a.m. to 12:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Room 4F100, 5601 Fishers Lane, Rockville, MD (Telephone Conference Call). Contact Person: Vasundhara Varthakavi, DVM, Ph.D., Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/ DHHS, 5601 Fishers Lane, Rockville, MD, 301–496–2550, varthakaviv@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: November 21, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–28074 Filed 11–26–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIH Support for Conferences and Scientific Meetings (Parent R13/U13). Date: December 15–19, 2014. Time: 9:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3G62, 5601 Fishers Lane, Rockville, MD 20852, (Virtual Meeting). Contact Person: Travis J. Taylor, Ph.D., Scientific Review Program DEA/NIAID/NIH/ DHHS, 5601 Fishers Lane, Rockville, MD 20892, 240–669–5082, Travis.Taylor@ nih.gov. E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Page 70880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The contract proposals and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the contract proposals, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Peer Review Meeting.
    Date: December 16, 2014.
    Time: 9:00 a.m. to 12:30 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institutes of Health, Room 4F100, 5601 Fishers 
Lane, Rockville, MD (Telephone Conference Call).
    Contact Person: Vasundhara Varthakavi, DVM, Ph.D., Scientific 
Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 5601 
Fishers Lane, Rockville, MD, 301-496-2550, 
varthakaviv@niaid.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

     Dated: November 21, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-28074 Filed 11-26-14; 8:45 am]
BILLING CODE 4140-01-P

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