[Federal Register Volume 67, Number 11 (Wednesday, January 16, 2002)]
[Notices]
[Pages 2226-2227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1026]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0318]


``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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a 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 January 2002. The new 
recommendations are intended to minimize the possible risk of CJD and 
vCJD transmission from blood and blood products. The 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 guidance document announced in this notice 
finalizes the draft guidance of the same title, dated August 2001, and 
supersedes 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.

DATES: Submit written or electronic comments on agency guidance 
documents at any time.

[[Page 2227]]


ADDRESSES: Submit written requests for single copies of this 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 SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit written comments on the guidance 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 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 January 2002. This guidance document contains comprehensive 
revised recommendations based upon advisory committee discussions, 
internal Public Health Service and FDA deliberations, and public 
comments. FDA has 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 CJD and vCJD transmission from blood 
products while maintaining their availability. The guidance document 
announced in this notice finalizes the draft guidance of the same 
title, dated August 2001, announced in the Federal Register of August 
29, 2001 (66 FR 45683). The guidance document also supersedes 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).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This 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

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. 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: January 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-1026 Filed 1-15-02; 8:45 am]
BILLING CODE 4160-01-S