[Federal Register Volume 67, Number 166 (Tuesday, August 27, 2002)]
[Notices]
[Pages 55025-55026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0320]


Draft Guidance for Industry and Clinical Investigators on the Use 
of Clinical Holds Following Clinical Investigator Misconduct; 
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availability of a draft guidance for industry and clinical 
investigators entitled ``The Use of Clinical Holds Following Clinical 
Investigator Misconduct.'' This draft guidance provides information on 
FDA's use of its authority to impose a clinical hold on a study if FDA 
finds that a clinical investigator conducting the study has committed 
serious violations of our regulations pertaining to clinical trials 
involving human drug or biological products or has submitted false 
information to FDA or to the study's sponsor in any report. The draft 
guidance is intended to inform interested persons of the circumstances 
in which we may impose a clinical hold following the discovery of a 
clinical investigator's misconduct and the steps we might take to 
protect human subjects from investigator misconduct.

DATES: Submit written or electronic comments on the draft guidance by 
November 25, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Rachel Behrman, Center for Drug Evaluation and Research (HFD-40), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-6758; or
    Stephen M. Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and clinical investigators entitled ``The Use of Clinical Holds 
Following Clinical Investigator Misconduct.'' The draft guidance 
provides information on our authority to impose a clinical hold on a 
study if we find that a clinical investigator conducting the study has 
committed serious violations of our regulations pertaining to clinical 
trials involving human drug or biological products or has submitted 
false information to us or to the study's sponsor in any report. The 
draft guidance is intended to inform interested persons of the 
circumstances in which we may impose a clinical hold following the 
discovery of a clinical investigator's misconduct and the steps we 
might take to protect human subjects from investigator misconduct.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the use of 
clinical holds to protect human subjects following clinical 
investigator misconduct in a clinical trial of a human drug or 
biological product. It does not create or confer any rights for or on 
any person and does not operate to bind us or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes

[[Page 55026]]

and regulations. As with other guidance documents, we do not intend 
this document to be all-inclusive, and we caution that not all 
information may be applicable to all situations. The document is 
intended to provide information and does not set forth requirements.

II. Comments

    We are distributing this draft document for comment purposes only, 
and do not intend to implement it at this time. Interested persons may 
submit to the Dockets Management Branch (see ADDRESSES) written 
comments regarding this draft guidance document. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
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 
http://www.fda.gov/cber/guidelines.htm.

    Dated: July 8, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-21697 Filed 8-26-02; 8:45 am]
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