[Federal Register Volume 66, Number 168 (Wednesday, August 29, 2001)]
[Notices]
[Pages 45683-45684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21920]


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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draft guidance document provides comprehensive current recommendations 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 When the draft guidance is finalized, 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Products'' dated November 1999 will be superseded.

DATES: Submit written or electronic comments on the draft guidance to 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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