[Federal Register Volume 71, Number 25 (Tuesday, February 7, 2006)]
[Notices]
[Pages 6284-6285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Independent Evaluation of the Food and Drug Administration's 
First Cycle Review Performance--Retrospective Analysis Final Report; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Independent Evaluation of FDA's 
First Cycle Review Performance--Retrospective Analysis Final Report.'' 
This report describes an independent evaluation of the issues 
associated with FDA's conduct of first cycle reviews of new molecular 
entities for new drug applications (NMEs for NDAs), and biological 
license applications (BLAs). Applications covered by the report are 
those submitted to FDA in fiscal years 2002 to 2004. This independent 
study was conducted in relation to the Prescription Drug User Fee 
Amendments of 2002 (PDUFA III). This assessment includes a detailed 
evaluation of the events that occurred during the review process with a 
focus on identifying the best practices by FDA and industry that 
facilitated that process.

ADDRESSES: Submit written requests for single copies of this report to 
the 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. Submit 
electronic requests to [email protected]. This

[[Page 6285]]

report will be available on FDA's Web site at a later date.

FOR FURTHER INFORMATION CONTACT: Carolyn Staples, Office of Planning 
(HFP-10), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-5274, or William Hagan, Office of Planning (HFP-1), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-8816.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 12, 2002, the President signed into law the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002, which 
includes 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 NMEs for NDAs and BLAs (PDUFA Goals and Procedures, 
section 10). Related to this goal, FDA was 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 was to 
assess the following objectives: (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 awarded a contract to an independent expert to study these 
issues. The report referred to in this document covers the 
retrospective portion of objectives (1) and (2) listed previously.
    In accordance with the PDUFA goal, the report is being made 
available to the public.

    Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1605 Filed 2-6-06; 8:45 am]
BILLING CODE 4160-01-S