Guidance for Industry on Fast Track Drug Development Programs: Designation, Development, and Application Review; Availability; Collection of Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0813]

Guidance for Industry on Fast Track Drug Development Programs:

Designation, Development, and Application Review; Availability;

Collection of Information

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 ``Fast Track Drug

Development Programs: Designation, Development,

[[Page 64094]]

and Application Review.'' This document provides guidance to industry

on FDA's fast track program, which seeks to facilitate the development

and expedite the review of new drugs that are intended to treat serious

or life-threatening conditions and that have the potential to address

unmet medical needs for such conditions. The guidance document is also

intended to meet the requirement of section 112(b) of the Food and Drug

Administration Modernization Act of 1997 (the Modernization Act).

DATES: Written comments on the guidance document may be submitted by

February 16, 1999. General comments on the agency guidance documents

are welcome at any time.

ADDRESSES: Copies of this guidance for industry are available on the

Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://

www.fda.gov/cber/guidelines.htm''. Submit written requests for single

copies to the Drug Information Branch (HFD-210), Center for Drug

Evaluation and Research, Food and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, or the Office of Communication, Training,

and Manufacturers Assistance (HFM-540), Center for Biologics Evaluation

and Research, Food and Drug Administration, 1401 Rockville Pike,

Rockville, MD 20852. Send one self-addressed adhesive label to assist

that office in processing your requests. Submit written comments on

this guidance document to the Dockets Management Branch (HFD-305), Food

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. After the comment period, comments may be submitted to one of

the centers at the address below.

FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-2041; or Bette A. Goldman,

Center for Biologics Evaluation and Research (HFM-500), 1401 Rockville

Pike, Rockville, MD 20852-1448, 301-827-5098.

SUPPLEMENTARY INFORMATION:

FDA is announcing the availability of a guidance for industry

entitled ``Fast Track Drug Development Programs: Designation,

Development, and Application Review.'' This guidance document is

intended to meet the requirement of section 112(b) of the Modernization

Act (Pub. L. 105-115), which amends the Federal Food, Drug, and

Cosmetic Act (the act) by adding new section 506 (21 U.S.C. 356) and

directs FDA to issue guidance describing its policies and procedures

pertaining to fast track products.

FDA's fast track programs are designed to facilitate the

development and expedite the review of new drugs that are intended to

treat serious or life-threatening conditions and that demonstrate the

potential to address unmet medical needs (fast track products). In this

guidance document, FDA discusses the regulations, policies, and

procedures of the Center for Biologics Evaluation and Research (CBER)

and the Center for Drug Evaluation and Research (CDER) that are related

to fast track products. This guidance document describes and clarifies

the criteria and processes for designating a new drug as a product in a

fast track drug development program and describes the diverse

activities and programs that can facilitate the development and

expedite the review of drugs that demonstrate the potential to advance

the treatment of serious and life-threatening illnesses.

This guidance document is being issued as a Level 1 guidance

consistent with FDA's Good Guidance Practices (62 FR 8961, February 27,

1997). It is being implemented without prior public comment because the

guidance document is needed to implement the Modernization Act. The

agency understands the need for this document to be available

immediately in order for there to be clear guidance to industry, the

public, and agency reviewers about this very significant program.

However, FDA also understands that many interested persons may wish to

provide comments and suggest revisions to this guidance. FDA is,

therefore, emphasizing that it is soliciting comment from all

interested persons and is providing a 90-day comment period and

establishing a docket for receipt of comments. The agency will give

full consideration to all comments received and make any appropriate

changes to the guidance in a timely manner.

This guidance document represents the agency's current thinking on

its policies and procedures relating to products in fast track drug

development programs. 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 statute, regulations, or both.

This guidance document contains collections of information that

require clearance by the Office of Management and Budget (OMB) under

the Paperwork Reduction of 1995. In a notice published in the Federal

Register of October 21, 1998 (63 FR 56195), FDA announced that this

collection of information has been submitted to OMB for emergency

processing. The notice also solicited comments on the collection of

information. An agency may not conduct or sponsor, and a person is not

required to respond to, a collection of information unless a currently

valid OMB control number has been displayed.

Interested persons may, at any time, submit to the Dockets

Management Branch (address above) written comments on the guidance

document. Two copies of any comments are to be submitted, except that

individuals may submit one copy. Comments are to be identified with the

docket number found in brackets in the heading of this document. The

guidance document and received comments are available for public

examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: November 11, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-30811 Filed 11-17-98; 8:45 am]

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