[Federal Register Volume 60, Number 100 (Wednesday, May 24, 1995)]
[Rules and Regulations]
[Pages 27405-27406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12763]
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[[Page 27406]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 1270
[Docket No. 93N-0453]
Human Tissue for Transplantation and Human Reproductive Tissue:
Scientific and Regulatory Issues and Perspectives; Notice of Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Human Tissue for Transplantation and Human
Reproductive Tissue: Scientific and Regulatory Issues and
Perspectives.'' The purpose of this workshop is to provide an
opportunity for continued discussion of the regulation of human tissue
for transplantation as outlined by FDA in an interim rule that
published in the Federal Register of December 14, 1993. The workshop
will include discussions of other related issues, including regulating
reproductive tissue.
DATES: The public workshop will be held on Tuesday and Wednesday, June
20 and 21, 1995, 8:30 a.m. to 5:30 p.m. Preregistration is requested by
Friday, June 9, 1995.
ADDRESSES: The public workshop will be held at the National Institutes
of Health, Bldg. 45, Natcher Auditorium, 9000 Rockville Pike, Bethesda,
MD. There is no registration fee.
.FOR FURTHER INFORMATION CONTACT:
Regarding information on registration: Julie Furman, KRA Corp.,
1010 Wayne Ave., suite 850, Silver Spring, MD 20910, 301-495-1591, or
FAX 301-495-9410.
Regarding information on this document: Marty 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 December 14, 1993
(58 FR 65514), FDA published an interim rule on human tissue intended
for transplantation. This interim rule requires certain infectious
disease testing, donor screening, and recordkeeping to help prevent the
transmission of acquired immune deficiency syndrome (AIDS) and
hepatitis through human tissue used in transplantation. The regulations
in the interim rule became effective upon publication.
The objectives of the public workshop are to: (1) Promote an
understanding of related public health issues based on scientific
knowledge; (2) provide an opportunity for discussion of current donor
screening and testing practices for human tissue for transplantation
and human reproductive tissue; (3) identify the practices and
procedures of the procurer, processor, distributor, and user of human
tissue for transplantation and human reproductive tissue and their
interactions; and (4) examine the existing state and industry
approaches to the regulation of human tissue for transplantation and
human reproductive tissue.
The workshop will consist of plenary and breakout sessions that
will include the following topics: (1) Donor screening; (2) infectious
disease testing and inactivation methods; (3) voluntary standards; (4)
assessment of industry practices related to tracking; (5) interactions
with organ procurement organizations and procurement coordination
practices; and (6) state regulatory approaches and industry practices.
Dated: May 19, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-12763 Filed 5-19-95; 3:29 pm]
BILLING CODE 4160-01-F
