Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45223 

application that are labeled on or after 

January 1, 2010), because the agency 

was still in the process of finalizing the 

guidance. The agency has now 

completed its review and evaluation of 

the comments received and has 

modified the guidance where 

appropriate. 

The document provides guidance to 

industry on the following topics: (1) The 

meaning of ‘‘domestic address’’ for 

purposes of the labeling requirements of 

section 502(x) of the act; (2) FDA’s 

recommendation for the use of an 

introductory statement before the 

domestic address or domestic telephone 

number that is required to appear on the 

product labeling under section 502(x) of 

the act (21 U.S.C. 352(x)); and (3) that 

FDA intends to begin enforcing the 

labeling requirements of section 502(x) 

of the act for products labeled on or 

after September 30, 2010. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. 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 requirement of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

this guidance were approved under 

OMB control no. 0190–0640. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments are available for public 

examination in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. 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. 

Dated: August 26, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21093 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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 on 

Alcohol Abuse and Alcoholism, Initial 

Review Group Biomedical Research Review 

Subcommittee. 

Date: October 26–27, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle, NW., Washington, DC 20005. 

Contact Person: Philippe Marmillot, PhD, 

Scientific Review Officer, National Institutes 

of Health, National Institute on Alcohol 

Abuse and Alcoholism, 5635 Fishers Lane, 

Rm. 2019, Bethesda, MD 20892. 301–443– 

2861. marmillotp@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271 Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 

Dated: August 24, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20860 Filed 8–31–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; 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 on 

Alcohol Abuse and Alcoholism Initial 

Review; Group Neuroscience Review 

Subcommittee. 

Date: November 16–17, 2009. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Hotel—Chevy Chase 

Pavilion, 4300 Military Road NW., 

Washington, DC 20015. 

Contact Person: Beata Buzas, PhD, 

Scientific Review Officer, National Institute 

on Alcohol Abuse and Alcoholism, National 

Institutes of Health, 5635 Fishers Lane, Rm 

2081, Rockville, MD 20852, 301–443–0800, 

bbuzas@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271 Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 

Dated: August 24, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20865 Filed 8–31–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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