[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