[Federal Register Volume 67, Number 28 (Monday, February 11, 2002)]
[Notices]
[Page 6266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3200]



[[Page 6266]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-5347]


Draft ``Guidance for Industry: Precautionary Measures to Reduce 
the Possible Risk of Transmission of Zoonoses by Blood and Blood 
Products From Xenotransplantation Product Recipients and Their Intimate 
Contacts;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Precautionary Measures to Reduce the Possible Risk of Transmission of 
Zoonoses by Blood and Blood Products From Xenotransplantation Product 
Recipients and Their Intimate Contacts'' dated February 2002. The draft 
guidance document provides recommendations to all registered blood and 
plasma establishments, and establishments engaged in manufacturing 
plasma derivatives. The draft guidance document, when finalized, is 
intended to provide recommendations regarding the disposition of blood 
products manufactured from a donor who is retrospectively discovered to 
have received a xenotransplantation product or to have been an intimate 
contact of a xenotransplantation product recipient. This is the second 
draft guidance document and it incorporates revisions based on public 
comments received on the first draft guidance document by the same name 
announced in the Federal Register of December 30, 1999 (64 FR 73562).

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by May 13, 2002. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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, or by fax by calling the FAX Information System at 1-
888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit written comments on the 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 revised, second draft 
document entitled ``Guidance for Industry: Precautionary Measures to 
Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood 
Products From Xenotransplantation Product Recipients and Their Intimate 
Contacts'' dated February 2002. The draft guidance document provides 
FDA's recommendations to all registered blood and plasma 
establishments, and establishments engaged in manufacturing plasma 
derivatives. The draft guidance document, when finalized, is intended 
to provide recommendations regarding the disposition of blood products 
manufactured from a donor who is retrospectively discovered to have 
received a xenotransplantation product or to have been an intimate 
contact of a xenotransplantation product recipient. This second draft 
guidance document incorporates revisions based on public comments 
received on the first draft document by the same name announced in the 
Federal Register of December 30, 1999, due to the number of changes 
made to the previous version of the draft guidance.
    FDA issues this draft guidance consistent with the good guidance 
practices regulation (21 CFR 10.115). This draft guidance document 
represents the agency's current thinking on precautionary measures to 
reduce the possible risk of transmission of zoonoses by 
xenotransplantation product recipients and their contacts, through 
blood and blood products. 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

    FDA is distributing this draft document for comment purposes only 
and does not intend to implement the draft guidance at this time. To 
ensure adequate consideration in preparation of the final document, 
interested persons may submit written comments to the Dockets 
Management Branch (address above) by May 13, 2002. Submit two copies of 
any comments, 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 
http://www.fda.gov/cber/guidelines.htm.

    Dated: January 30, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-3200 Filed 2-8-02; 8:45 am]
BILLING CODE 4160-01-S