[Federal Register: August 19, 2004 (Volume 69, Number 160)]
[Notices]               
[Page 51469-51470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au04-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0112]

 
Guidance for Industry on 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 document entitled ``Guidance for Industry: 
Independent Consultants for Biotechnology Clinical Trial Protocols,'' 
dated August 2004. The guidance document provides guidance to sponsors 
of clinical trials for certain products on when and how to request from 
FDA the engagement of an independent consultant to participate in the 
review of protocols for clinical studies intended to serve as the 
primary basis of claims of efficacy. This guidance document finalizes 
the draft guidance of the same title dated May 2003.

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

ADDRESSES: Submit written requests for single copies of the 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 guidance may also be 
obtained by mail by calling the CBER voice information system at 1-800-
835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    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. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.


FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210; or Susan S. Johnson, Center for Drug Evaluation and 
Research, Office of New Drugs (HFD-20), 5515 Security Lane, suite 7215, 
Rockville, MD 20852, 301-594-3937.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Independent Consultants for Biotechnology 
Clinical Trial Protocols'' dated August 2004. 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). A letter from the 
Secretary of Health and Human Services (June 4, 2002), to Congress 
concerning PDUFA III included an addendum containing the performance 
goals and programs to which FDA committed as a means of facilitating 
the development and review of products subject to PDUFA III. One 
commitment was for FDA to establish a program to allow sponsors 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 guidance document is intended to explain when 
and how a sponsor may take advantage of this program.
    This guidance document finalizes the draft guidance document of the 
same title dated May 2003 (68 FR 24486, May 7, 2003). The 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 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 requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Division of Dockets Management (see ADDRESSES) 
regarding this guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in the brackets in the heading of this document. A copy of 
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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, or http://www.fda.gov/cder/guidance/

index.htm.


[[Page 51470]]


    Dated: August 11, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18974 Filed 8-18-04; 8:45 am]

BILLING CODE 4160-01-S