[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]]
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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.
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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 The draft
guidance document provides recommendations to all registered blood and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 The draft guidance document, when finalized, is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draft guidance document and it incorporates revisions based on public
comments received on the first draft guidance document by the same name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DATES: Submit written or electronic comments on the draft guidance to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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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]
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