[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