[Federal Register Volume 68, Number 203 (Tuesday, October 21, 2003)]
[Notices]
[Pages 60108-60109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0472]


Statement of Work for the Evaluation of First Cycle Review 
Performance; 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 ``Statement of Work for the 
Evaluation of First Cycle Review Performance.'' FDA requests comment on 
the document, which describes a study to evaluate issues associated 
with FDA's conduct of first cycle reviews of new drug applications 
(NDAs), biological license applications (BLAs), and efficacy 
supplements. FDA intends to award a contract to an independent expert 
consultant that would include, among other tasks, the performance of 
such a study. The document, as currently written, will be included in 
the Request for Proposal (RFP) as a sample statement of work. However, 
prior to actually assigning the task under the contract, FDA intends to 
finalize the statement of work after considering all received comments.

DATES: Submit written comments on the document by November 20, 2003.

[[Page 60109]]


ADDRESSES: Submit written requests for single copies of the document to 
First Cycle Review, Office of Planning (HFP-10), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
requests. Persons with access to the Internet may obtain the document 
at http://www.fda.gov/cder/pdufa/default.htm. Submit written comments 
on the document to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Carolyn L. Staples, Office of Planning 
(HFP-10), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-5274.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Statement of Work for the Evaluation of First Cycle Review 
Performance.'' FDA requests comment on the document, which describes a 
study to evaluate issues associated with FDA's performance of first 
cycle reviews of NDAs, BLAs, and efficacy supplements.
    On June 12, 2002, the President signed the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002, which includes 
the Prescription Drug User Fee Amendments of 2002 (PDUFA III). In 
conjunction with the passage of PDUFA III, FDA agreed to certain 
performance goals and procedures that were described in an enclosure to 
a June 4, 2002, letter from the Secretary of Health and Human Services, 
Tommy Thompson, to Congress entitled ``PDUFA Reauthorization 
Performance Goals and Procedures'' (PDUFA Goals and Procedures). One of 
the goals relates to FDA's performance of first cycle reviews of 
original NDAs, BLAs, and efficacy supplements (PDUFA Goals and 
Procedures, section 10). Specifically, FDA agreed to retain an 
independent expert consultant to undertake a study to evaluate issues 
associated with the agency's conduct of first cycle reviews. The study 
is intended to assess the following: (1) Current first cycle review 
performance and any changes that occur after FDA publishes guidance on 
Good Review Management Principles (GRMPs), (2) the first cycle review 
history of all NDAs for new molecular entities and all BLAs during 
PDUFA III, and (3) the effectiveness of FDA's staff training regarding 
GRMPs. FDA agreed to develop a statement of work for the study and to 
provide the public with an opportunity to review and comment on the 
statement of work before the study is implemented.
    In accordance with one of the PDUFA goals, the document being made 
available for public comment today is the statement of work developed 
by FDA. FDA intends to award a contract that would include, among other 
tasks, the performance of the study. The document, as currently 
written, will be included in the RFP as a sample statement of work. 
However, the statement of work is not yet final. FDA will consider all 
comments received in finalizing the statement of work prior to 
assigning the task under the contract.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written comments on the 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 document made available 
today and the received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26446 Filed 10-20-03; 8:45 am]
BILLING CODE 4160-01-S