[Federal Register: August 27, 2002 (Volume 67, Number 166)]
[Notices]
[Page 55025-55026]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au02-63]
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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Draft Guidance for Industry and Clinical Investigators on the Use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availability of a draft guidance for industry and clinical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 This draft guidance provides information on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 The draft
guidance is intended to inform interested persons of the circumstances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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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access to the draft guidance document.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]
BILLING CODE 4160-01-S