[Federal Register Volume 67, Number 9 (Monday, January 14, 2002)]
[Notices]
[Page 1774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0545]


``Guidance for Industry: Recommendations for Assessment of Donor 
Suitability and Blood and Blood Product Safety in Cases of Possible 
Exposure to Anthrax;'' 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 document entitled ``Guidance for Industry: 
Recommendations for Assessment of Donor Suitability and Blood and Blood 
Product Safety in Cases of Possible Exposure to Anthrax'' dated October 
2001. The guidance document provides the current recommendations for 
assessment of donor suitability and product safety for donors 
potentially exposed to anthrax. The guidance document applies to Whole 
Blood, blood components (including recovered plasma) and Source Plasma 
collections intended for use in transfusion or for further 
manufacturing into injectable products.

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

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 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: Recommendations for Assessment of Donor 
Suitability and Blood and Blood Product Safety in Cases of Possible 
Exposure to Anthrax'' dated October 2001. The guidance document 
provides the current recommendations for assessment of donor 
suitability and product safety for donors potentially exposed to 
Bacillus anthracis, the agent of anthrax. The guidance document applies 
to Whole Blood, blood components (including recovered plasma) and 
Source Plasma collections intended for use in transfusion or for 
further manufacturing into injectable products. FDA developed the 
recommendations in the guidance document in consultation with other 
Public Health Service agencies and with the Blood Safety Committee of 
the Department of Health and Human Services. Recommendations addressed 
in the guidance include: Donor deferral, product quarantine and 
retrieval, and notification of prior transfusion recipients.
    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 recommendations for assessment of 
donor suitability and product safety for donors potentially exposed to 
anthrax. 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

    The agency is soliciting public comment, but is implementing this 
guidance document immediately because of public health concerns. 
Interested persons may, at any time, submit written or electronic 
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: December 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-791 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-02-S