[Federal Register Volume 74, Number 83 (Friday, May 1, 2009)]
[Notices]
[Pages 20322-20323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0181]


Draft Guidance for Industry on Label Comprehension Studies for 
Nonprescription Drug Products; 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availability of a draft guidance for industry entitled ``Label 
Comprehension Studies for Nonprescription Drug Products.'' The draft 
guidance provides recommendations on the design of label comprehension 
studies, which can be used to assess the extent to which consumers 
understand the information conveyed by proposed nonprescription drug 
product labeling and then apply that information when making 
hypothetical drug product use decisions.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by July 30, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:  Laura Shay, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5466, Silver Spring, MD 20993-0002, 301-
796-0994.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Label Comprehension Studies for Nonprescription Drug 
Products.'' This draft guidance is intended for individuals or 
organizations involved in the development of label comprehension 
studies for nonprescription drug products. This draft guidance 
discusses general concepts to be considered in the design and conduct 
of a label comprehension study. This draft guidance also incorporates 
advice obtained from the September 25, 2006, meeting of the 
Nonprescription Drug Advisory Committee that considered issues related 
to the analysis and interpretation of consumer behavior studies 
conducted to support marketing of nonprescription drug products.
    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 label 
comprehension studies for nonprescription drug products. It does not 
create or confer any rights for or on any person and does not operate 
to bind

[[Page 20323]]

FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information 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 21 CFR parts 312 and 314 have 
been approved under OMB Control Numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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 document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: April 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10005 Filed 4-30-09; 8:45 am]
BILLING CODE 4160-01-S