[Federal Register Volume 62, Number 145 (Tuesday, July 29, 1997)]
[Notices]
[Pages 40536-40537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19821]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0453]


Guidance for Screening and Testing of Donors of Human Tissue 
Intended for Transplantation; 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 guidance document entitled ``Guidance for Screening 
and Testing of Donors of Human Tissue Intended for Transplantation.'' 
The purpose of the guidance document is to assist facilities involved 
in recovery, infectious disease testing, screening, processing, 
storing, or distributing human tissue intended for transplantation. The 
guidance document provides information on procedures and practices for 
donor screening and testing. FDA prepared the guidance document after 
receiving public input. The topics included in the guidance document 
were contained in a draft document ``Screening and Testing of Donors of 
Human Tissue Intended for Transplantation'' made available for 
discussion at a public workshop on human tissue held on June 20 and 21, 
1995.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the ``Guidance 
for Screening and Testing of Donors of Human Tissue Intended for 
Transplantation'' 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 that 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.
    Persons with access to the Internet may obtain the document using 
File Transfer Protocol (FTP), the World Wide Web (WWW), or bounce-back 
e-mail. For FTP access, connect to CBER at ``ftp://ftp.fda.gov/cber/''. 
For WWW access, connect to CBER at ``http://www.fda.gov/cber/
publications.htm''. To receive the document by bounce-back e-mail, send 
a message to ``[email protected]''.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments 
are to be submitted, except individuals may submit one copy. Requests 
and comments are to be identified with the docket number found in 
brackets in the heading of this document. The 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.

FOR FURTHER INFORMATION CONTACT:  Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 14, 1993 
(58 FR 65514), FDA published an interim rule on human tissue intended 
for transplantation to reduce the risk of transmission of human 
immunodeficiency virus (HIV) and hepatitis through human tissue 
intended for transplantation. The interim rule was issued under the 
authority of sections 215, 311, 361, and 368 of the Public Health 
Service Act (42 U.S.C. 216, 243, 264, 271) because of an immediate need 
to protect the public health from the transmission of communicable 
diseases through the transplantation of human tissue. The interim rule 
established requirements for the testing of donors of human tissue for 
HIV Type 1 virus, HIV Type 2 virus, hepatitis B virus, and hepatitis C 
virus. The interim rule also required that donors be screened for 
medical history, including behaviors that carry an increased risk of 
exposure to these viruses (behavioral and high risk information) and 
for signs and symptoms of infection with these viruses.
    In the Federal Register of June 20, 1995 (60 FR 32128), FDA 
announced the availability for public comment of a draft document 
entitled ``Screening and Testing of Donors of Human Tissue Intended for 
Transplantation.'' The availability of the draft document coincided 
with the workshop on Human Tissue for Transplantation and Human 
Reproductive Tissue: Scientific and Regulatory Issues and Perspectives 
which was held on June 20 and 21, 1995. Comments received on this draft 
document and the issues discussed at the workshop were considered in 
the development of the guidance document being announced in this 
notice.
    This guidance document provides general information on the 
following procedures: (1) Determination of donor suitability, (2) 
evaluation of screening test performance, (3) application of a plasma 
dilution algorithm to determine the acceptability of the blood specimen 
used for testing, (4) screening for behavioral and high risk 
information, and (5) evaluation of clinical and physical evidence of 
infection with HIV or hepatitis.
    As technical standards change over time due to an increased 
understanding of infectious diseases and improved technology for 
testing, FDA may issue future guidance to help ensure that the 
regulatory process reflects the current level of knowledge. The 
recommendations in this guidance document should be considered in 
addition to voluntary standards developed and used by human tissue 
organizations.
    This document is not being issued under the authority of 21 CFR 
10.90(b) because FDA is in the process of revising this section. As 
with other guidance documents, FDA does not intend this document to be 
all-inclusive. This document does not bind the agency and does not 
create or confer any rights, privileges, or benefits for or on any 
person. Tissue facilities may follow the guidance document or may 
choose to use alternative procedures not provided in the guidance 
document. If a tissue facility chooses to use alternative procedures, 
the facility may wish to discuss the matter further with the agency to 
prevent expenditure of resources on activities that may be unacceptable 
to FDA.
    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Continued comment by the human tissue industry is encouraged, and 
comments will be continuously accepted by the Dockets Management 
Branch.
    FDA periodically will review written comments on the guidance 
document to

[[Page 40537]]

determine whether future revisions to the guidance document are 
warranted.

    Dated: January 21, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-19821 Filed 7-28-97; 8:45 am]
BILLING CODE 4160-01-F