[Federal Register: September 2, 2004 (Volume 69, Number 170)]
[Notices]
[Page 53729-53730]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se04-73]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://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/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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