Guidance for Screening and Testing of Donors of Human Tissue Intended for Transplantation; Availability

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