[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