[Federal Register Volume 68, Number 78 (Wednesday, April 23, 2003)]
[Notices]
[Page 20015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9986]



[[Page 20015]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0163]


``Guidance for Industry: Recommendations for the Assessment of 
Donor Suitability and Blood Product Safety in Cases of Suspected Severe 
Acute Respiratory Syndrome (SARS) or Exposure to SARS;'' 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 the Assessment of Donor Suitability and Blood 
Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome 
(SARS) or Exposure to SARS'' dated April 2003. The guidance document 
provides our recommendations for assessing donor suitability and blood 
product safety with respect to SARS. The guidance applies to whole 
blood and blood components intended for transfusion and to blood 
components including recovered plasma, source leukocytes, and source 
plasma intended for use in further manufacturing into injectable or 
noninjectable 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 guidance document may also be obtained by 
mail by calling the CBER Voice Information System at 1-800-835-4709 or 
301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit written comments on the guidance 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: Stephen M. Ripley, 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 the Assessment of Donor 
Suitability and Blood Product Safety in Cases of Suspected Severe Acute 
Respiratory Syndrome (SARS) or Exposure to SARS'' dated April 2003. 
This guidance document provides our recommendations for assessing donor 
suitability and blood product safety with respect to SARS. This 
guidance applies to whole blood and blood components intended for 
transfusion and to blood components including recovered plasma, source 
leukocytes, and source plasma intended for use in further manufacturing 
into injectable or noninjectable products. FDA developed the 
recommendations in this guidance in consultation with other public 
health service agencies of the Department of Health and Human Services.

II. Comments

    The agency is soliciting public comment, but is implementing this 
guidance immediately because the agency has determined that prior 
public participation is not appropriate since SARS may pose immediate 
safety risks to the blood supply. Interested persons may submit to the 
Dockets Management Branch (see ADDRESSES) written or electronic 
comments regarding this guidance document. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments should be 
identified with the docket number found in the brackets in the heading 
of this document. A copy of the guidance document and received comments 
may be seen 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 guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9986 Filed 4-22-03; 8:45 am]
BILLING CODE 4160-01-S