[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Pages 64093-64094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30811]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-F