[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 831-832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00028]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0529]
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 guidance for industry entitled ``Qualification
Process for Drug Development Tools.'' This guidance describes the
qualification process for drug development tools intended for potential
use, over time, in multiple drug development programs. The guidance
provides a framework for interactions between FDA and sponsors to
support work towards qualification of an identified drug development
tool and creates a mechanism for formal review of data to qualify the
tool and ensure that the evaluation is comprehensive and reliable.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the 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: Shaniece Bowens, 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 guidance for industry
entitled ``Qualification Process for Drug Development Tools.'' The
guidance describes the qualification process for drug development tools
(DDTs) intended for potential use, over time, in multiple drug
development programs.
In March 2006, FDA issued the ``Critical Path Opportunities Report
and List,'' in which FDA described six key areas along the critical
path to improved therapies and listed specific opportunities for
advancement within these topic areas. The report noted that a new
product 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 can help streamline
the drug development process, improve the chances for clinical trial
success, and yield more information about a treatment and/or disease.
DDTs include, but are not limited to, biomarkers and patient reported
outcome instruments. This guidance describes a formal
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process that FDA 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.
A draft version of this guidance was issued in the Federal Register
of October 25, 2010 (75 FR 65495). FDA received a number of comments,
most of which focused on clarifications and further illustration of the
qualification process. FDA reviewed all received comments carefully
during the finalization process of the guidance; the Agency has made
some clarifying changes in the final version of the guidance.
Specifically, FDA provided general guidance on the qualification
process, samples of what should be included in a qualification package,
and examples of drug development tools. A new DDT, Animal Models under
the Animal Rule, has been included and discussed in the final DDT
guidance.
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 the qualification process for drug
development tools. 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 an approach satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance contains an information collection that is 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 information collection
has been approved under the OMB control numbers 0910-0001 and 0910-
0014. The information requested in the guidance is currently submitted
to FDA to support medical product effectiveness (see 21 CFR 312.30, 21
CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).
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: December 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00028 Filed 1-6-14; 8:45 am]
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