[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7784-7785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1145]


Draft Guidance for Industry on Enrichment Strategies for Clinical 
Trials To Support Approval of Human Drugs and Biological Products; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the draft guidance for industry entitled 
``Enrichment Strategies for Clinical Trials to Support Approval of 
Human Drugs and Biological Products'' that appeared in the Federal 
Register of December 17, 2012 (77 FR 74670). In the document, FDA 
announced the availability of this draft guidance and explained that 
the comment period would close on February 15, 2013. The Agency is 
taking this action to allow interested persons additional time to 
submit comments.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 18, 2013.

ADDRESSES: Submit electronic comments 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. Identify comments with the docket number

[[Page 7785]]

found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Robert Temple, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4212, Silver 
Spring, MD 20993-0003, 301-796 2270; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448, 301-827-6210; or
Robert L. Becker, Center for Device and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5674, 
Silver Spring, MD 20993-0003, 301-796-5450.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of December 17, 2012 (77 FR 74670), FDA 
announced the availability of this draft guidance and explained that 
the comment period would close on February 15, 2013. The Agency is 
extending the comment period to March 18, 2013, to allow more time for 
public comments.
    This document provides guidance to industry on enrichment 
strategies that can be used in clinical trials intended to support 
effectiveness and safety claims in new drug applications and biologics 
license applications. Similar approaches could be used in clinical 
trials in earlier phases of drug development. This draft guidance 
defines and discusses three enrichment strategies: Decreasing 
heterogeneity, predictive enrichment, and prognostic enrichment. The 
guidance also discusses general clinical trial design considerations, 
provides examples of potential clinical trial designs, and discusses 
regulatory considerations when using enrichment strategies.

II. Submission of 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.

    Dated: January 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02293 Filed 2-1-13; 8:45 am]
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