[Federal Register Volume 59, Number 111 (Friday, June 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14212]
[[Page Unknown]]
[Federal Register: June 10, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 1270
[Docket No. 93N-0453]
Public Workshop on Human Tissue Intended for Transplantation
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim rule; notification of public workshop.
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SUMMARY: The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research (CBER), is holding a public workshop to discuss
specific topics relating to an interim rule on human tissue intended
for transplantation that appeared in the Federal Register of December
14, 1993.
DATES: The public workshop will be held on Monday, June 20, 1994, 8:30
to 5 p.m. Submit comments and information on issues addressed at the
workshop by August 20, 1994.
ADDRESSES: The public workshop will be held at the Holiday Inn
Gaithersburg, 2 Montgomery Village Ave., Gaithersburg, MD. To register
for the workshop, contact April Wells, KRA Corp., 1010 Wayne Ave.,
suite 850, Silver Spring, MD 20910, 301-495-1591; or FAX 301-495-9410.
Registration will also be accepted at the workshop.
Submit written comments regarding the workshop to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 10857.
FOR FURTHER INFORMATION CONTACT: Joseph Wilczek, Center for Biologics
Evaluation and Research (HFM-300), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-594-6700.
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 immunodeficiency syndrome (AIDS) and hepatitis
through human tissue used in transplantation. The regulations set forth
in the interim rule became effective upon publication. Interested
persons were given until March 14, 1994, to comment on the interim
rule.
The objective of this public workshop is to discuss practical
concerns expressed in received public comments relating to the
implementation of the interim rule. The following topics will be
discussed:
1. Experience with the interim rule;
2. Management of testing relative to hemodilution;
3. Experience with test kit performance on cadaveric blood samples;
and
4. Management of current inventories in regard to testing for human
immunodeficiency virus (HIV) and hepatitis C virus (HCV).
Discussion of these topics will be considered by FDA in the development
of any future rulemaking.
FDA is reopening the comment period to the interim rule so that
interested persons may submit comments on the workshop. Persons who
wish to provide additional materials for consideration should file
these materials with the Dockets Management Branch (address above).
Interested persons may, on or before August 20, 1994, submit to the
Dockets Management Branch (address above), written comments regarding
this 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. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Dated: June 6, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-14212 Filed 6-7-94; 4:36 pm]
BILLING CODE 4160-01-F
