National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 70880-70881 [2014-28075]

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 As noted above, this draft guidance informs manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to object to the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nonprescription (commonly referred to as OTC) drug products bearing a warning as described in the draft guidance alerting consumers that the use of acetaminophen may cause severe skin reactions. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the recommended warning for OTC acetaminophen-containing drug products and labeling statements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 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 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 http:// 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 http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// 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 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (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) Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Carol Hamelink, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4192, MSC 7850, Bethesda, MD 20892, (301) 213– 9887, hamelinc@csr.nih.gov. Dated: November 21, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) [FR Doc. 2014–28075 Filed 11–26–14; 8:45 am] BILLING CODE 4140–01–P Dated: November 21, 2014. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2014–28073 Filed 11–26–14; 8:45 am] Center for Scientific Review; Notice of Closed Meetings tkelley on DSK3SPTVN1PROD with NOTICES 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 meetings. The meetings 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: Center for Scientific Review, Special Emphasis Panel, Cardiovascular and Respiratory Sciences, AREA Review. Date: December 10–11, 2014. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Kimm Hamann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301–435– 5575, hamannkj@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review, Special Emphasis Panel, Member Conflict: Molecular Neuroscience. Date: December 17, 2014. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. VerDate Sep<11>2014 16:58 Nov 26, 2014 Jkt 235001 BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2014–0033; OMB No. 1660–0132] Agency Information Collection Activities: Proposed Collection; Comment Request, Level 1 Assessment Form, Level 3 Evaluation Form for Students, and Level 3 Evaluation Form for Supervisors Federal Emergency Management Agency, DHS. AGENCY: ACTION: Notice; correction. On November 19, 2014, the Federal Emergency Management Agency (FEMA) published an agency information collection notice in the Federal Register at 79 FR 68896. In the ADDRESSES section, FEMA inadvertently listed the docket ID in (1) Online as FEMA–2014–XXXX. The correct Docket ID is FEMA 2014–0033. Dated: November 24, 2014. Charlene D. Myrthil, Director, Records Management Division, Mission Support Bureau, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. 2014–28129 Filed 11–26–14; 8:45 am] BILLING CODE 9111–53–P PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 70881 DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Announcement of eBond Test U.S. Customs and Border Protection, Department of Homeland Security. ACTION: General notice. AGENCY: This notice announces U.S. Customs and Border Protection’s (CBP’s) plan to conduct a voluntary National Customs Automation Program test concerning automation of CBP’s bond program (eBond test). The eBond test utilizes an automated system (eBond system) that provides for the transmission of electronic bond contracts (eBonds) between principals and sureties, with CBP as third-party beneficiary, in the Automated Commercial Environment (ACE) for the purpose of linking those eBonds to the transactions they are intended to secure. All eBonds transmitted pursuant to this test must be transmitted to ACE electronically, either via the CBPapproved Electronic Data Interchange (EDI) or emailed to CBP for manual input into ACE. The transmission of eBonds to CBP must be made by a surety or surety agent. The eBond system works with ACE to ensure that transactions secured by an eBond have the proper bond coverage to protect the revenue and secure legal compliance. The eBond system is intended to establish a single repository for the centralization of all eBonds within the Office of Administration’s Revenue Division, to harmonize and enhance CBP’s bond processes, and to eliminate flaws in the execution of customs bonds, which may lead to increased legal risk for CBP. It is anticipated that the eBond test will reduce paper processing, expedite cargo release, allow for bonds to be transmitted beyond regular CBP business hours, and enhance traceability for audit purposes. The eBond test is intended to evaluate the automation of CBP’s bond program, its impact on trade, and CBP’s ability to enforce applicable laws and protect the revenue. This notice invites public comment concerning any aspect of the test, describes the eligibility, procedural and documentation requirements for voluntary participation in the test, and outlines the development and evaluation methodology to be used in the test. DATES: The eBond test will commence on January 3, 2015, and will run for approximately two years, subject to any extension, modification, or early SUMMARY: E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70880-70881]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28075]


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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 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.


[[Page 70881]]


    This notice is being published less than 15 days prior to the 
meeting due to the timing limitations imposed by the review and 
funding cycle.

(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. 2014-28075 Filed 11-26-14; 8:45 am]
BILLING CODE 4140-01-P