[Federal Register Volume 70, Number 61 (Thursday, March 31, 2005)]
[Notices]
[Pages 16507-16508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0317] (formerly Docket No. 03D-0317)


Guidance for Review Staff and Industry on Good Review Management 
Principles and Practices 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 guidance for review staff and industry entitled 
``Good Review Management Principles and Practices 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).

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

ADDRESSES:  Submit written requests for single copies of this 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 guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. The guidance may also be obtained from 
CBER by mail by calling 1-800-835-4709, or 301-827-1800. Submit 
electronic comments to http://www.fda.gov/dockets/ecomments. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT:  John Jenkins, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, suite 
7215, 5515 Security Lane, Rockville, MD 20852, 301-594-3937; or Robert 
A. Yetter, Center for Biologics Evaluation and Research (HFM-25), Food 
and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-
827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for review staff 
and industry entitled ``Good Review Management Principles and Practices 
for PDUFA Products.'' In conjunction with the June 2002 reauthorization 
of PDUFA, FDA agreed to meet specific performance goals (PDUFA Goals). 
The PDUFA Goals include providing guidance to industry and review staff 
in CDER and CBER on the good review management principles and practices 
(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. The GRMPs also clarify roles and responsibilities of review 
staff in managing the review process and identify ways in which NDA and 
BLA applicants may further the effectiveness and efficiency of the 
review process.
    In the Federal Register of July 28, 2003 (68 FR 44345), FDA 
published a notice announcing the availability of a draft version of 
this guidance. FDA received a number of comments when it issued the 
draft version of this guidance. We have considered the comments on the 
draft guidance carefully and have made some changes to address those 
comments. The guidance has been revised to clarify the principles on 
which our current and developing practices are based. We have also 
added general internal timelines for important milestones associated 
with the review process.
    The GRMPs also include the agency's current best practices, as well 
as goals for review management improvements. The GRMPs are an important 
foundational component of FDA's program to more fully implement a 
quality systems approach for the new drug and biologics review and 
approval process.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance at any 
time. 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 
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.

[[Page 16508]]

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6404 Filed 3-30-05; 8:45 am]
BILLING CODE 4160-01-S