[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 tissue2@a1.cber.fda.gov''.
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
