[Federal Register: August 29, 2001 (Volume 66, Number 168)]
[Notices]
[Page 45683-45684]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au01-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0318]
Draft ``Guidance for Industry: Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease
(CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood
Products;'' 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 document entitled ``Guidance for Industry:
Revised Preventive Measures to Reduce the Possible Risk of Transmission
of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob
Disease (vCJD) by Blood and Blood Products'' dated August 2001. The
draft guidance document provides comprehensive current recommendations
to all registered blood and plasma establishments for deferral of
donors with possible exposure to the agent of vCJD. The new
recommendations are intended to minimize the possible risk of vCJD
transmission from blood products. When the draft guidance is finalized,
the guidance document entitled ``Revised Preventive Measures to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD)
and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood
Products'' dated November 1999 will be superseded.
DATES: Submit written or electronic comments on the draft guidance to
ensure their adequate consideration in preparation of the final
document by September 28, 2001. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), 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. The document may also be obtained
by mail by calling the CBER Voice Information System at 1-800-835-4709
or 301-827-1800, or by fax by calling the FAX Information System at 1-
888-CBER-FAX or 301-827-3844. See the
[[Page 45684]]
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit written comments on the document 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.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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 document entitled
``Guidance for Industry: Revised Preventive Measures to Reduce the
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''
dated August 2001. This guidance document contains comprehensive
revised recommendations based upon advisory committee discussions and
internal Public Health Service and FDA deliberations. We (FDA) have
developed recommendations for donor deferral, and product retrieval,
quarantine, and disposition based upon consideration of risk in the
donor and product, and the effect that withdrawals and deferrals might
have on the supply of life- and health-sustaining blood components and
plasma derivatives. The new recommendations are intended to minimize
the possible risk of vCJD transmission from blood products while
maintaining their availability. When the draft guidance is finalized,
the guidance document entitled ``Revised Preventive Measures to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD)
and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood
Products'' dated November 1999 (64 FR 65715, November 23, 1999) will be
superseded.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance
document represents the agency's current thinking on this topic. 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 requirement of the applicable statutes
and regulations.
II. Comments
This draft document is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Dockets Management Branch (address above) written or
electronic comments regarding this draft guidance document. Submit
written or electronic comments to ensure adequate consideration in
preparation of the final document by September 28, 2001. Two copies of
any comments are to be submitted, except individuals may submit one
copy. Comments should be identified with the docket number found in the
brackets in the heading of this document. A copy of the document 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
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/
ohrms/dockets/default.htm.
Dated: August 23, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21920 Filed 8-27-01; 11:39 am]
BILLING CODE 4160-01-S