[Federal Register Volume 73, Number 239 (Thursday, December 11, 2008)]
[Notices]
[Pages 75436-75438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0429] (formerly Docket No. 2007D-0496)


Draft Guidance for Industry on Questions and Answers Regarding 
the Labeling of Nonprescription Human Drug Products Marketed Without an 
Approved Application as Required by the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act: Revision 1; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance entitled ``Questions and 
Answers Regarding the Labeling of Nonprescription Human Drug Products 
Marketed Without an Approved Application as Required by the Dietary 
Supplement and Nonprescription Drug

[[Page 75437]]

Consumer Protection Act: Revision 1.'' This revised draft guidance is 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. The revision of the 
draft guidance changes the date on which FDA intends to begin enforcing 
these labeling requirements. 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:  You can submit written or electronic comments on this revised 
draft guidance, or any guidance, at any time (see 21 CFR 10.115(g)(5)).

ADDRESSES:  Submit written requests for single copies of the revised 
draft guidance to the Division of Drug Information (HFD-240), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your requests. Submit written 
comments on the revised draft guidance to the Division of Dockets 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 revised draft 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, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance 
entitled ``Questions and Answers Regarding the Labeling of 
Nonprescription Human Drug Products Marketed Without an Approved 
Application as Required by the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act: Revision 1.'' On December 22, 2006, the 
President signed into law the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act (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 issued 
a draft guidance document containing questions and answers relating to 
the new labeling requirements under Public Law 109-462 for OTC drugs 
marketed without an approved application. Although interested parties 
can comment on any guidance at any time, to ensure that the agency 
considered 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. FDA is still working to finalize the 
guidance.
    Because the agency is still in the process of finalizing the 
guidance, FDA is issuing this revised draft guidance to notify industry 
that it intends to exercise enforcement discretion with regard to these 
labeling requirements for an additional 1-year period. The draft 
guidance issued on January 2, 2008, stated that FDA intended to begin 
enforcing the requirements of section 502(x) of the act for OTC drug 
products marketed without an approved application that are labeled on 
or after January 1, 2009. The revised draft guidance remains identical 
to the draft guidance issued on January 2, 2008, with respect to all 
topics except that it states that FDA intends to begin enforcing the 
labeling requirements of section 502(x) of the act for OTC drug 
products marketed without an approved application that are labeled on 
or after January 1, 2010.
    This revised 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 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

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval.
    To comply with this requirement, FDA's notice in the Federal 
Register announcing the availability of the draft guidance gave notice 
of the proposed collections of information in the draft guidance. The 
notice included an analysis and burden estimate for these proposed 
collections of information and provided 60 days for public comment 
under the PRA. Because this revised draft guidance makes no change, 
other than to change the date on which FDA intends to begin enforcing 
the labeling requirements of section 502(x) of the act for OTC drug 
products marketed without an approved application, FDA is not providing 
a revised PRA analysis and burden estimate in this notice.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the revised 
draft 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm.


[[Page 75438]]


    Dated: December 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29301 Filed 12-8-08; 11:15 am]
BILLING CODE 4160-01-S