[Federal Register: June 25, 2002 (Volume 67, Number 122)]
[Notices]               
[Page 42789-42790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn02-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0266]

 
Draft ``Guidance for Industry: Preventive Measures to Reduce the 
Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and 
Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps);'' 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: 
Preventive Measures to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease 
(vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products 
(HCT/Ps)'' dated June 2002. The draft guidance document provides 
information that would assist manufacturers of human cellular and 
tissue-based products in minimizing the possible risk of transmission 
of CJD/vCJD by HCT/Ps through deferral of donors with possible exposure 
to the agents of CJD and vCJD. Because there is no readily available 
demographic information about the HCT/P donor population, FDA 
encourages establishments to submit with their comments study data 
concerning the effect that implementation of these recommendations 
could have on the HCT/P supply.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by December 23, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 42790]]

SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.
    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: Nathaniel L. Geary, 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: Preventive Measures to Reduce the Possible 
Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant 
Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular 
and Tissue-Based Products (HCT/Ps)'' dated June 2002. The draft 
guidance document provides information that would help human cellular 
and tissue-based product manufacturers minimize the possible risk of 
transmission of CJD/vCJD by HCT/Ps through deferral of donors with 
possible exposure to the agents causing CJD and vCJD.
    The 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 statute, regulations, or both. As with 
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions 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

    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 (see ADDRESSES) 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 December 23, 2002. Two copies of 
any written 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: June 13, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15898 Filed 6-24-02; 8:45 am]
BILLING CODE 4160-01-S