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Statement of Work for the Evaluation of First Cycle Review Performance; Availability

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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.

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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.

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Dated: October 8, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-26446 Filed 10-20-03; 8:45 am]

BILLING CODE 4160-01-S