[Federal Register Volume 64, Number 250 (Thursday, December 30, 1999)]
[Notices]
[Pages 73562-73563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33940]
[[Page 73562]]
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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
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availability of a draft guidance document entitled ``Guidance for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 Contacts.'' The draft
guidance document is intended to provide recommendations to all
registered blood and plasma establishments, and establishments engaged
in manufacturing plasma derivatives. The draft guidance document
provides recommendations regarding donor deferral and the disposition
of blood products.
DATES: Submit written comments at any time, however, comments should be
submitted by February 28, 2000, to ensure their adequate consideration
in preparation of the final document.
ADDRESSES: Submit written requests for single copies of ``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 Contacts'' 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to the draft guidance document. Submit written comments on the draft
guidance document to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
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 draft guidance 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 Contacts.'' The
draft guidance document provides FDA's recommendations to all
registered blood and plasma establishments and establishments engaged
in manufacturing plasma derivatives regarding donor deferral. It also
provides recommendations on the disposition of blood products
manufactured from a donor who is retrospectively discovered to have
received a xenotransplantation product or to have been in close contact
with a recipient of a xenotransplantation product.
Concerns have arisen in the last few years about the potential
infectious disease and public health risks associated with
xenotransplantation. Zoonoses are infectious diseases of animals that
can be transmitted to humans through exposure to, or consumption of
animals. Because transplantation necessitates disruption of the
recipient's usual protective physical and immunologic barriers,
xenotransplantation may facilitate transmission of known or as yet
unrecognized infectious agents to humans.
The ``Draft Public Health Service (PHS) Guideline on Infectious
Disease Issues in Xenotransplantation'' published in the Federal
Register of September 23, 1996 (61 FR 49920). The draft guideline,
which includes outlines of health surveillance programs and principles
for screening candidate source animals for infectious agents of
concern, indicated that patient consent forms should state clearly that
xenotransplantation product recipients should never, subsequent to
receiving the transplant, donate Whole Blood, blood components, Source
Plasma, Source Leukocytes, tissues, breast milk, ova, sperm, or any
other body parts for use in humans.
In an open public meeting on December 17, 1997 (62 FR 62776,
November 25, 1997), the Xenotransplantation Subcommittee of the
Biological Response Modifiers Advisory Committee recommended that close
contacts of xenotransplantation product recipients, as well as the
recipients themselves, should not donate blood or tissue because these
individuals are theoretically at risk of acquiring zoonoses, and of
transmitting them through blood and tissue donations. At FDA's Blood
Products Advisory Committee open public meeting held on March 19, 1998
(63 FR 8461, February 19, 1998), donor deferral issues related to
xenotransplantation were also discussed.
The draft guidance document represents the agency's current
thinking with regard to 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 statute, regulations, or both. As with
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to
all situations. The document is intended to provide information and
does not set forth requirements.
II. Comments
The draft guidance document is being distributed for comment,
however, the recommendations may be implemented immediately without
prior approval by FDA. Interested persons may submit to the Dockets
Management Branch (address above) written comments regarding this draft
guidance document. Written comments may be submitted at any time,
however, comments should be submitted by February 28, 2000, to ensure
adequate consideration in preparation of the final 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 draft guidance
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.
[[Page 73563]]
Dated: December 22, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-33940 Filed 12-29-99; 8:45 am]
BILLING CODE 4160-01-F