[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Page 45641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19043]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry on Label Comprehension Studies for 
Nonprescription Drug Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Label Comprehension 
Studies for Nonprescription Drug Products.'' The guidance provides 
recommendations on the design of label comprehension studies that can 
be used to assess the extent to which consumers understand the 
information conveyed by proposed nonprescription drug product labeling. 
This guidance finalizes the draft guidance published on May 1, 2009.

DATES: Submit either electronic or written comments on agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Murewa Oguntimein, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5475,Silver Spring, MD 20993-0002, 301-
796-4869.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Label Comprehension Studies for Nonprescription Drug 
Products.'' This guidance is intended for individuals or organizations 
involved in the development of label comprehension studies for 
nonprescription drug products. This guidance discusses general concepts 
that should be considered in the design and conduct of a label 
comprehension study. This 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 studies conducted to support marketing of 
nonprescription drug products, and comments submitted to the draft 
guidance published in the Federal Register of May 1, 2009 (74 FR 
20322).
    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 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 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19043 Filed 8-2-10; 8:45 am]
BILLING CODE 4160-01-S