45222 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

labeling requirements of section 403(y) 

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 label under 

section 403(y) of the act; and (3) that 

FDA intends to begin enforcing the 

labeling requirements of section 403(y) 

of the act for products labeled on or 

after September 30, 2010. 

FDA is issuing this guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the labeling of 

dietary supplements as required by the 

DSNDCPA. 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. 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. 0910–0642. 

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 may be seen 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 guidance at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: August 26, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21094 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0429] (formerly 

Docket No. 2007D–0496] 

Guidance for Industry on Labeling of 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act: Questions 

and Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act: Questions and 

Answers.’’ This guidance is intended to 

assist industry in complying with the 

labeling requirements for 

nonprescription (over-the-counter 

(OTC)) human drugs marketed without 

an approved application established by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (DSNDCPA). Separate 

guidance, issued by the Center for Food 

Safety and Applied Nutrition on 

complying with the labeling 

requirements for dietary supplements, is 

announced elsewhere in this issue of 

the Federal Register. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, rm. 2201, 

Rockville, MD 20993–0002. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Walter Ellenberg, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5488, 

Silver Spring, MD 20993–0002, 301– 

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act: Questions and 

Answers.’’ On December 22, 2006, the 

President signed into law DSNDCPA 

(Public Law 109–462, 120 Stat. 3469). 

This law amends the Federal Food, 

Drug, and Cosmetic Act (the act) with 

respect to serious adverse event 

reporting for dietary supplements and 

nonprescription drugs marketed without 

an approved application. The law also 

amended the act to add section 502(x) 

(21 U.S.C. 352(x)), which requires the 

label of an OTC drug product marketed 

in the United States without an 

approved application to include a 

domestic address or domestic telephone 

number through which the product’s 

manufacturer, packer, or distributor may 

receive reports of serious adverse events 

associated with its use. 

In the Federal Register of January 2, 

2008 (73 FR 196), FDA announced the 

availability of a draft version of the 

guidance containing questions and 

answers relating to the new labeling 

requirements under Public Law 109–462 

for OTC drugs marketed without an 

approved application. In addition to 

providing guidance for industry on how 

to comply with the labeling 

requirements in section 502(x) of the 

act, the draft guidance stated that FDA 

intended to begin enforcing the 

requirements of section 502(x) for OTC 

human drugs marketed without an 

approved application labeled on or after 

January 1, 2009. Although interested 

parties can comment on any guidance at 

any time, to ensure that the agency 

would have the opportunity to consider 

comments on the draft guidance before 

beginning work on the final version of 

the guidance, FDA requested that 

interested parties submit comments by 

March 3, 2008. On December 11, 2008 

(73 FR 75436), FDA announced the 

availability of a revised draft guidance 

to notify industry and other members of 

the public that it intended to exercise 

enforcement discretion with regard to 

the labeling requirements of section 

502(x) of the act for an additional 1-year 

period (i.e., for OTC drug products 

marketed without an approved 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES