[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Draft Guidance for Industry on Qualification Process for Drug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availability of a draft guidance for industry entitled ``Qualification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 This draft guidance describes the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draft guidance provides a framework for interactions between the Center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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 24, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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