[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