[Federal Register Volume 60, Number 118 (Tuesday, June 20, 1995)]
[Proposed Rules]
[Pages 32128-32129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15084]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1270
[Docket No. 93N-0453]
Screening and Testing of Donors of Human Tissue Intended for
Transplantation; Draft Document; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Screening and Testing of
Donors of Human Tissue Intended for Transplantation.'' This draft
document is intended to provide additional opportunity for individuals
to submit comments on screening and testing of donors of human tissue
for transplantation. The availability of the draft document is to
coincide with the workshop on Human Tissue for Transplantation and
Human Reproductive Tissue: Scientific and Regulatory Issues and
Perspectives to be held June 20 and 21, 1995, in Bethesda, MD. The
workshop was announced in the Federal Register of May 24, 1995.
DATES: Written comments on the draft document should be submitted by
July 20, 1995.
ADDRESSES: Single copies of the draft document will be made available
to those attending the workshop. Persons not attending the workshop who
would like to receive a copy of the draft document should submit a
written request for single copies to the Congressional and Consumer
Affairs Branch (HFM-12), Food and Drug Administration, 1401 Rockville
Pike, suite 200 North, Rockville, MD 20852-1448. Send two self-
addressed adhesive labels to assist that office in processing your
requests.-
Persons with access to the INTERNET may request the draft document
be sent by return E-mail by sending a message to
``[email protected]''. The draft document may also be obtained
through INTERNET via File Transfer Protocol (FTP). Requestors should
connect to the Center for Drug Evaluation and Research (CDER) using the
FTP. The Center for Biologics Evaluation and Research (CBER) documents
are maintained in a subdirectory called CBER on the server,
``CDV2.CBER.FDA.GOV''. The ``READ.ME'' file in that subdirectory
describes the available documents, [[Page 32129]] which may be
available as an ASCII text file (*.TXT), or a WordPerfect 5.1 document
(*.w51), or both. A sample dialogue for obtaining the READ.ME file with
a test based FTP program would be:
FTP CDV2.CBER.FDA.GOV
LOGIN ANONYMOUS
BINARY
CD CBER
GET READ.ME
EXIT
The draft document may also be obtained by calling the CBER FAX
Information System (FAX-ON-DEMAND) at 301-594-1939 from a FAX machine
with a touch tone phone attached or built-in.
Submit written comments on the draft document to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Two copies of any comments are
to be submitted, except that individuals may submit one copy. Requests
and comments should be identified with the docket number found in
brackets in the heading of this document. The draft document and
received comments are available for public examination in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Martha A. Wells, Center for Biologics
Evaluation and Research (HFM-305), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0967.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 24, 1995 (60
FR 27406), FDA published a notice announcing a public workshop on Human
Tissue for Transplantation and Human Reproductive Tissue: Scientific
and Regulatory Issues and Perspectives to be held on June 20 and 21,
1995, from 8:30 a.m. to 5:30 p.m., at the National Institutes of
Health, Bldg. 45, Natcher Auditorium, 9000 Rockville Pike, Bethesda,
MD. The purpose of the workshop is to provide an opportunity for
continued discussion of FDA's interim rule on human tissue for
transplantation published in the Federal Register of December 14, 1993
(58 FR 65514). The workshop will include discussions of other related
issues, including possible regulation of reproductive tissue. The
notice stated that one of the objectives of the public workshop is to
provide an opportunity for discussion of current screening and testing
practices for donors of human tissue for transplantation and human
reproductive tissue.
The draft document, developed by a task force composed of FDA staff
from CBER, is designed to focus discussion towards specific points on
testing and screening donors of human tissue intended for
transplantation. The document includes the following topics: Required
donor testing, donor suitability and screening test performance, plasma
dilution, testing algorithm, sources of information for donor
screening, behavioral risk information, clinical evidence of human
immunodeficiency virus and hepatitis, and suitable autopsy.
Copies of the draft document will be available at the workshop. A
copy of the draft document will be placed on file with the Dockets
Management Branch (address above) under the docket number found in
brackets in the heading of this notice. To accommodate interested
persons who do not attend the workshop, as well as those who will be
attending the workshop, FDA is making the draft document available for
public comment and will consider such comments in any future rulemaking
and in the development of regulatory policies. Comments should be
submitted to the Dockets Management Branch (address above) by July 20,
1995.
FDA does not intend this draft document to be all-inclusive. This
document does not bind FDA and does not create or confer any rights,
privileges, or benefits on or for any private person, but is intended
merely for discussion.
Dated: June 14, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-15084 Filed 6-15-95; 4:43 pm]
BILLING CODE 4160-01-F
