[Federal Register Volume 68, Number 2 (Friday, January 3, 2003)]
[Notices]
[Pages 377-378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-113]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0362]
``Guidance for Industry: Recommendations for Deferral of Donors
and Quarantine and Retrieval of Blood and Blood Products in Recent
Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of
Smallpox Vaccine Recipients;'' 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 Deferral of Donors and Quarantine and Retrieval of
Blood and Blood Products in Recent Recipients of Smallpox Vaccine
(Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients,''
dated December 2002. The guidance document provides guidance on
quarantine of blood and blood products previously collected from such
donors. Because of the likelihood of vaccination of many people with
smallpox, these measures are intended to reduce the possibility of
vaccinia virus transmission by blood and blood products.
DATES: Submit written or electronic comments on agency guidance 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 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. See the SUPPLEMENTARY INFORMATION section for electronic access
to the guidance document. Submit written comments on the guidance
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: Michael D. Anderson, 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 Deferral of Donors and
Quarantine and Retrieval of Blood and Blood Products in Recent
Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of
Smallpox Vaccine Recipients,'' dated December 2002. The guidance
document provides information that would help in instances related to
the possible risk of vaccinia virus transmission by blood or blood
products. Although the presence of vaccinia virus in blood has rarely
been documented, this possibility has not been assessed using
laboratory techniques. Therefore, the risk of vaccinia transmission by
blood and blood products is uncertain. In addition, unlike many
vaccines, the smallpox vaccine causes a scab, which can contain
infectious vaccinia virus. It is prudent, therefore, to temporarily
defer donors for an appropriate period of time. This guidance applies
to collections of Whole Blood, blood components (including recovered
plasma), Source Leukocytes, and Source Plasma intended for use in
transfusion or for further manufacturing into injectable products. FDA
developed the recommendations in this guidance in consultation with
experts on vaccinia virus at the Centers for Disease Control and at the
Department of Defense. This document is intended to provide guidance
pertaining to pre-event, nonemergency, smallpox vaccination. In the
event of widespread emergency vaccination due to an actual or impending
smallpox outbreak, the risk-benefit situation may differ significantly,
and these recommendations for donor deferrals, and for product
quarantine and retrieval may need to be modified according to the
circumstances and available scientific information.
This guidance is being issued in accordance with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance document
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.
[[Page 378]]
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 feasible or appropriate. FDA made this
determination because vaccination programs may start soon, and blood
establishments need to clarify the suitability of donors who have been
recently vaccinated or who have been infected through close contact
with a recently vaccinated person. Interested persons may submit to the
Dockets Management Branch (see ADDRESSES) written or electronic
comments 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/ohrms/dockets/default.htm or www.fda.gov/cber/guidelines.htm.
Dated: August 13, 2002.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-113 Filed 1-2-03; 8:45 am]
BILLING CODE 4160-01-S