[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]



=======================================================================
-----------------------------------------------------------------------
[[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.

-----------------------------------------------------------------------

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