[Federal Register Volume 68, Number 88 (Wednesday, May 7, 2003)]
[Notices]
[Pages 24486-24487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0112]


Draft ``Guidance for Industry: Independent Consultants for 
Biotechnology Clinical Trial Protocols;'' 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 document entitled ``Guidance for Industry: 
Independent Consultants for Biotechnology Clinical Trial Protocols'' 
dated May 2003. This draft guidance document is intended to explain 
when and how sponsors of clinical trials for certain products can 
request that FDA engage an independent consultant to participate in the 
review of protocols for clinical studies intended to serve as the 
primary basis of claims of efficacy.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by August 5, 2003. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448; or the Division of Drug Information (HFD-240), Center 
for Drug Evaluation and Research (CDER), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed 
adhesive label to assist the office in processing your requests. The 
document may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800, or by calling the 
FAX Information System at 1-888-CBER-FAX or 301-827-3844. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Michael D. Anderson, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210; or John Jenkins, Center for Drug Evaluation and Research (HFD-
020), 1451 Rockville Pike, Rockville, MD 20852-1448, 301-594-5421.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Independent Consultants for Biotechnology 
Clinical Trial Protocols''

[[Page 24487]]

dated May 2003. 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). Secretary Thompson's letter to Congress concerning PDUFA III 
included an addendum containing the performance goals and programs 
intended to facilitate the development and review of human drugs to 
which FDA had committed. One commitment was the establishment of a 
program that allows the sponsor of clinical trials for certain products 
to request that FDA engage an independent consultant to participate in 
the review of protocols for clinical studies that are intended to serve 
as the primary basis of claims of efficacy. This draft guidance 
document is intended to explain when and how a sponsor may take 
advantage of this program.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft guidance 
document represents the agency's current thinking on this topic. 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 requirement of the applicable statutes 
and regulations.

II. Comments

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (see ADDRESSES) written or 
electronic comments regarding this draft guidance document. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final document. Two copies of mailed comments are to 
be submitted, except individuals may submit one copy. Comments should 
be identified with the docket number found in the brackets in the 
heading of this document. A copy of the document and received comments 
are available for public examination in the Dockets Management Branch 
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/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11214 Filed 5-6-03; 8:45 am]
BILLING CODE 4160-01-S