[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7784-7785]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Enrichment Strategies for Clinical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comment period for the draft guidance for industry entitled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announced the availability of this draft guidance and explained that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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 18, 2013.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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