[Federal Register Volume 68, Number 181 (Thursday, September 18, 2003)]
[Notices]
[Pages 54734-54735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0163]


Guidance for Industry: Revised Recommendations for the Assessment 
of Donor Suitability and Blood Product Safety in Cases of Suspected 
Severe Acute Respiratory Syndrome or Exposure to Severe Acute 
Respiratory Syndrome; 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: Revised 
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 September 2003. The guidance 
provides revised recommendations to blood establishments for assessing 
donor suitability and blood product safety with respect to SARS. The 
guidance

[[Page 54735]]

document applies to Whole Blood and blood components intended for 
transfusion (including red blood cells for immunization) and blood 
components including recovered plasma, Source Leukocytes and Source 
Plasma intended for use in further manufacturing into injectable 
products or noninjectable products. The guidance announced in this 
document supersedes the 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.

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

ADDRESSES: Submit written requests for single copies of the 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 request. The guidance 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 Division of Dockets 
Management (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: Revised 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 
September 2003. The guidance provides revised recommendations to blood 
establishments for assessing donor suitability and blood product safety 
with respect to SARS. The guidance document applies to Whole Blood and 
blood components intended for transfusion (including red blood cells 
for immunization) and blood components including recovered plasma, 
Source Leukocytes and Source Plasma intended for use in further 
manufacturing into injectable products or noninjectable products. FDA 
developed the recommendations in the guidance in consultations with 
other public health service agencies of the Department of Health and 
Human Services. The guidance announced in this document supersedes the 
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 (68 FR 20015, April 23, 2003).
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance 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 statutes and regulations.

II. Comments

    The agency is soliciting public comment, but is implementing this 
guidance immediately. The agency has determined that prior public 
participation is not appropriate or feasible because there is an 
immediate need for clarification concerning whether FDA recommends that 
establishments continue to screen donors on the basis of travel to 
SARS-affected areas during time periods when the Centers for Disease 
Control has identified no areas as currently affected by SARS. 
Interested persons may, at any time, submit written or electronic 
comments to the Division of Dockets Management (see ADDRESSES) 
regarding this guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except individuals may submit 
one paper copy. Comments are to be identified with the docket number 
found in the brackets in the heading of this document. A copy of the 
guidance and received comments are available for public examination in 
the Division of Dockets Management 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: September 12, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23890 Filed 9-17-03; 8:45 am]
BILLING CODE 4160-01-S