[Federal Register Volume 69, Number 170 (Thursday, September 2, 2004)]
[Notices]
[Pages 53729-53730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0320]


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 guidance for industry and clinical investigators 
entitled ``The Use of Clinical Holds Following Clinical Investigator 
Misconduct.'' This 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 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

[[Page 53730]]

we might take to protect human subjects from investigator misconduct.

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

ADDRESSES: Submit written requests for single copies of the 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 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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rachel Behrman, Center for Drug 
Evaluation and Research (HFD-40), Food and Drug Administration, 5515 
Security Lane, Rockville, MD 20852, 301-594-6758; or Patricia 
Holobaugh, Center for Biologics Evaluation and Research (HFM-664), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 
301-827-6347.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
clinical investigators entitled ``The Use of Clinical Holds Following 
Clinical Investigator Misconduct.'' The guidance provides information 
on one use of our authority to impose a clinical hold on a study or a 
study site if FDA finds that human subjects are or would be exposed to 
an unreasonable and significant risk of illness or injury. The guidance 
describes the circumstances in which FDA may impose clinical hold based 
on credible evidence 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 
required report. The 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.
    In the Federal Register of August 27, 2002 (67 FR 55025), FDA 
announced the availability of a draft version of the guidance entitled 
``The Use of Clinical Holds Following Clinical Investigator 
Misconduct.'' The August 2002 guidance gave interested persons an 
opportunity to submit comments through November 25, 2002. All comments 
received during the comment period have been carefully reviewed and, 
where appropriate, incorporated in the guidance. As a result of the 
public comments and editorial changes, the guidance is clearer than the 
draft version.
    The guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in the guidance were approved under OMB 
control number 0910-0014.
    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 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 FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes 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

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two paper copies of mailed comments are to be submitted, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The guidance and received comments may be seen 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 document at 
http://www.fda.gov/cber/guidelines.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/oc/gcp/guidance.html.

    Dated: August 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19983 Filed 9-1-04; 8:45 am]
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