[Federal Register Volume 75, Number 205 (Monday, October 25, 2010)]
[Notices]
[Pages 65495-65496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]


Draft Guidance for Industry on Qualification Process for Drug 
Development Tools; 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availability of a draft guidance for industry entitled ``Qualification 
Process for Drug Development Tools.'' This draft guidance describes the 
qualification process for drug development tools (DDTs) intended for 
potential use, over time, in multiple drug development programs. The 
draft guidance provides a framework for interactions between the Center 
for Drug Evaluation and Research (CDER) and DDT sponsors to support 
work towards qualification of an identified DDT and creates a mechanism 
for formal review of data by CDER to qualify the DDT and ensure that 
the evaluation is comprehensive and reliable.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 24, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Shaniece Gathers, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, rm. 4555, Silver Spring, MD 20993-0002, 301-
796-2600.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Qualification Process for Drug Development Tools.'' In March 
2006, FDA issued the ``Critical Path Opportunities Report'' and the 
``Critical Path Opportunities List.'' In these reports, FDA described 
six key areas along the critical path to improved therapies, and a list 
of specific opportunities for advancement within these topic areas. The 
opportunities report noted that a new product

[[Page 65496]]

development toolkit containing new scientific and technical methods was 
needed to improve the efficiency of drug development. Too often, 
attention to a needed DDT is delayed until the time when the 
registration study protocols are under development and the available 
DDTs are inadequate. Innovative and improved DDTs are among the methods 
that can help streamline the drug development process, improve the 
chances for clinical trial success, and yield more information about 
the treatment and/or disease. DDTs include, but are not limited to 
biomarkers and patient reported outcome instruments. This draft 
guidance describes a formal process that CDER will use in working with 
sponsors of these tools to guide them as they refine the tools and 
rigorously evaluate them for use in the regulatory process.
    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 the 
qualification process for DDTs . 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 draft 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 312.30, 21 CFR 314.50(d)(5), and 
21 CFR 314.126(b)(6) have been approved under OMB control numbers 0910-
0001 and 0910-0014.

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: October 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26927 Filed 10-22-10; 8:45 am]
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