70880 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / 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noted above, this draft guidance informs 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This draft guidance is being issued 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The draft guidance, when finalized, will 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 

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. 

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. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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. 

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. 

(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) 

Dated: November 21, 2014. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–28073 Filed 11–26–14; 8:45 am] 

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 

AGENCY: Federal Emergency 

Management Agency, DHS. 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Announcement of eBond Test 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: 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 


tkelley on DSK3SPTVN1PROD with NOTICES