[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Notices]
[Pages 49394-49395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24161]


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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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) previously requested 
that comments on the draft 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 be submitted by 
September 28, 2001, to ensure their adequate consideration in 
preparation of the final document (66 FR 45683, August 29, 2001). The 
agency has determined that it will have adequate time to consider, in 
preparation of the final guidance, comments received by October 28, 
2001. FDA is taking this action in response to a request that the 
agency allow interested parties additional time to review and to submit 
comments.

DATES:  Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by October 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit written comments on the draft 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

    In the Federal Register of August 29, 2001 (66 FR 45683), FDA 
published a notice announcing the availability of a draft guidance 
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.'' 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 agency asked interested persons to submit written or 
electronic comments on the draft guidance to ensure their adequate 
consideration in preparation of the final document by September 28, 
2001.
    On September 19, 2001, a comment from America's Blood Centers was 
submitted to the docket requesting that FDA consider comments received 
after September 28, 2001. The comment stated that blood establishment 
obligations related to the recent terrorist attack has delayed the 
review of the guidance by a number of blood establishments. The agency 
has determined that it will have adequate time to consider comments 
received by October 28, 2001.

II. Comments

    Interested persons should submit to the Dockets Management Branch 
(address above) written or electronic comments regarding the draft 
guidance document by October 28, 2001, to

[[Page 49395]]

ensure consideration of comments in FDA's preparation of a final 
guidance. 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: September 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24161 Filed 9-26-01; 8:45 am]
BILLING CODE 4160-01-S