[Federal Register Volume 66, Number 225 (Wednesday, November 21, 2001)]
[Notices]
[Pages 58503-58504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2405]


``Guidance for Industry: Information Request and Discipline 
Review Letters Under the Prescription Drug User Fee Act;'' 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 document entitled ``Guidance for Industry: 
Information Request and Discipline Review Letters Under the 
Prescription Drug User Fee Act'' dated November 2001. The guidance 
document provides guidance to industry on the use of certain types of 
letters by the Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) as part of the 
review of marketing applications for certain drug and biological 
products. The guidance document announced in this notice finalizes the 
draft guidance document entitled ``Guidance for Industry: Information 
Request and Discipline Review Letters Under the Prescription Drug User 
Fee Act'' dated August 1999.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist the office in 
processing your requests. The document may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX 
or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:
    Michael Anderson, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-6210; or
    Paul Varki, Center for Drug Evaluation and Research (HFD-7), 5600 
Fishers Lane, Rockville, MD 20852-1448, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Information Request and Discipline Review 
Letters Under the Prescription Drug User Fee Act'' dated November 2001. 
In a November 1997 letter to Congress regarding the reauthorization of 
the Prescription Drug User Fee Act (PDUFA) as part of the Food and Drug 
Administration Modernization Act of 1997 (Public Law 105-115), the 
Secretary of Health and Human Services (the Secretary) committed FDA to 
certain user fee performance goals and additional procedures related to 
the review of products in human drug applications as defined in section 
735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1) 
(PDUFA products)). The guidance document explains how the agency will 
issue and use information request letters and discipline review letters 
during the review of PDUFA products. The guidance document announced in 
this notice finalizes the draft guidance document entitled ``Guidance 
for Industry: Information Request and Discipline Review Letters Under 
the Prescription Drug User Fee Act'' dated August 1999 that was 
announced in the Federal Register of August 17, 1999 (64 FR 44741).
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance document represents 
the agency's current thinking on information request letters under 
PDUFA. 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 requirement of the applicable 
statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments should be identified with the 
docket number found in the brackets in the heading of this document. A 
copy of the document

[[Page 58504]]

and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cber/guidelines.htm.

    Dated: October 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-29004 Filed 11-20-01; 8:45 am]
BILLING CODE 4160-01-S