[Federal Register: November 21, 2001 (Volume 66, Number 225)]
[Notices]
[Page 58503-58504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no01-105]
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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draft guidance document entitled ``Guidance for Industry: Information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