[Federal Register: May 1, 2009 (Volume 74, Number 83)]
[Notices]
[Page 20322-20323]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01my09-51]
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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Draft Guidance for Industry on Label Comprehension Studies for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availability of a draft guidance for industry entitled ``Label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 The draft
guidance provides recommendations on the design of label comprehension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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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INFORMATION section for electronic access to the draft guidance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FDA is announcing the availability of a draft guidance for industry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 This draft guidance is intended for individuals or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