Reports and guidance documents; availability, etc.: Clinical Holds Use Following Clinical Investigator Misconduct,

[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]

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Draft Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct; Availability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.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and clinical investigators entitled ``The Use of Clinical Holds Following Clinical Investigator Misconduct.'' This draft guidance provides information on FDA's use of its authority to impose a clinical hold on a study if FDA finds that a clinical investigator conducting the study has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 The draft guidance is intended to inform interested persons of the circumstances in which we may impose a clinical hold following the discovery of a clinical investigator's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DATES: Submit written or electronic comments on the draft guidance by November 25, 2002.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ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,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 Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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:

1. 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

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   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.

2. 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.

3. 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. 02-21697Filed8-26-02; 8:45 am]

   BILLING CODE 4160-01-S