[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Notices]
[Pages 44345-44346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0317]


Draft Guidance for Reviewers and Industry on Good Review 
Management Principles for Prescription Drug User Fee Act Products; 
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availability of a draft guidance for reviewers and industry entitled 
``Good Review Management Principles for PDUFA Products.'' This is one 
in a series of guidance documents that FDA agreed to draft and 
implement in conjunction with the June 2002 reauthorization of the 
Prescription Drug User Fee Act of 1992 (PDUFA). The good review 
management principles (GRMPs) are intended to promote efficient and 
consistent management of application reviews. The GRMPs focus on the 
role of both reviewers and industry, emphasizing effective 
communication to enhance the drug development and review processes.

DATES: Submit written or electronic comments on the draft guidance by 
September 11, 2003. General comments on agency guidance documents are 
welcome at any time.

[[Page 44346]]


ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communications, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), 1401 Rockville Pike, Food and Drug 
Administration, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: John Jenkins, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 1451 
Rockville Pike, Rockville, MD 20852, 301-594-3937; or Robert A. Yetter, 
Center for Biologics Evaluation and Research (HFM-25), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for 
reviewers and industry entitled ``Good Review Management Principles for 
PDUFA Products.'' This document is intended to provide guidance to 
industry and the review staff in CDER and CBER on GRMPs for the conduct 
of the first-cycle review of a new drug application (NDA), a biologics 
license application (BLA), or an efficacy supplement under PDUFA. The 
GRMPs in this guidance are based on the collective experience of CDER 
and CBER with review of applications for PDUFA products and are 
intended to promote efficient and consistent management of application 
reviews. A key aspect of GRMPs is their emphasis on effective 
communication between the agency and applicants throughout the drug and 
biologic product development and review processes.
    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 GRMPs for 
PDUFA products. 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two copies of mailed 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 
draft guidance and received comments are available for public 
examination in the Division of Dockets Management 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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: July 18, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19026 Filed 7-25-03; 8:45 am]
BILLING CODE 4160-01-S