[Federal Register Volume 74, Number 168 (Tuesday, September 1, 2009)]
[Notices]
[Pages 45222-45223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21093]


-----------------------------------------------------------------------

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

[[Page 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/GuidanceComplianceRegulatoryInformation/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