2010-26927. Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Qualification Process for Drug Development Tools.” This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. The draft guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 24, 2011.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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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FDA is announcing the availability of a draft guidance for industry entitled “Qualification Process for Drug Development Tools.”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 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.