[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]



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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availability of a draft guidance document entitled ``Guidance for 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 The draft 
guidance document is intended to provide recommendations to all 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 The draft guidance document 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to the draft guidance document. Submit written comments on the draft 
guidance document to the Dockets Management Branch (HFA-305), Food and 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.


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    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