
[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Page 21611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0620]


Guidance for Industry on Self-Selection 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 guidance for industry entitled ``Self-Selection 
Studies for Nonprescription Drug Products.'' This guidance is intended 
to provide recommendations to industry involved in developing and 
conducting self-selection studies to support an application for 
nonprescription drug products. A self-selection study assesses the 
ability of consumers to apply drug labeling information to their 
personal health situation to make correct decisions about whether or 
not it is appropriate for them to use a drug product. This guidance 
finalizes the draft guidance issued on September 19, 2011.

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: Barbara R. Cohen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5437, Silver Spring, MD 20993-0002, 301-
796-2060.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Self-Selection Studies for Nonprescription Drug Products.'' 
A self-selection study assesses the ability of consumers to apply drug 
labeling information to their personal health situation to make correct 
decisions about whether or not it is appropriate for them to use a drug 
product. The guidance provides recommendations to industry involved in 
developing and conducting self-selection studies to support an 
application for nonprescription drug products.
    The guidance includes recommendations regarding study design, study 
conduct, and final reporting of self-selection studies. The guidance 
should not be considered a substitute for an FDA review of specific 
protocols. This guidance finalizes the draft guidance issued on 
September 19, 2011 (76 FR 58018). FDA has reviewed the docket comments 
submitted in response to the draft guidance and the guidance was 
revised based on that review. The guidance also incorporates advice 
obtained from the Nonprescription Drugs Advisory Committee at a meeting 
on September 25, 2006, at which the committee considered issues related 
to analysis and interpretation of consumer studies conducted to support 
marketing of nonprescription drug products.
    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 self-selection 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 found in FDA regulations. These collections of information 
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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

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: April 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08443 Filed 4-10-13; 8:45 am]
BILLING CODE 4160-01-P


