[Federal Register: September 14, 2006 (Volume 71, Number 178)]
[Rules and Regulations]
[Page 54198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14se06-3]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. 2006N-0051]
Health Resources and Services Administration
42 CFR Part 121
Blood Vessels Recovered With Organs and Intended for Use in Organ
Transplantation; Withdrawal
AGENCIES: Food and Drug Administration, Health Resources and Services
Administration, HHS.
ACTION: Direct final rule; withdrawal.
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SUMMARY: The Health Resources and Services Administration (HRSA) and
the Food and Drug Administration (FDA) published in the Federal
Register of May 12, 2006 (71 FR 27606), a direct final rule to amend
the regulations to consider as part of an organ those blood vessels
recovered with the organ that are intended for use in organ
transplantation; and to exclude such blood vessels from the definition
of human cells, tissues, and cellular and tissue-based products. The
comment period closed July 26, 2006. HRSA and FDA are withdrawing the
direct final rule because FDA received significant adverse comment. The
agencies will consider the comments received under our usual procedures
for notice and comment in connection with the notice of proposed
rulemaking that was published as a companion to the direct final rule
(71 FR 27649).
DATES: The direct final rule published on May 12, 2006 (71 FR 27606),
is withdrawn effective September 14, 2006.
FOR FURTHER INFORMATION CONTACT:
For information regarding FDA's rule: Pamela Pope, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
For information regarding HRSA's rule: Jim Burdick, Division of
Transplantation, Healthcare Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane, room 12C-06, Rockville, MD
20857, 301-443-7577.
SUPPLEMENTARY INFORMATION: HRSA and FDA published a direct final rule
in the Federal Register of May 12, 2006 (71 FR 27606), to amend the
regulations to consider as part of an organ those blood vessels
recovered with the organ that are intended for use in organ
transplantation (HRSA regulation); and to exclude such blood vessels
from the definition of human cells, tissues, and cellular and tissue-
based products (FDA regulation).
HRSA and FDA received significant adverse comment in response to
the direct final rule. Therefore, the direct final rule is being
withdrawn. HRSA and FDA intend to finalize the proposed rule after
considering comments.
Authority: Therefore, under the Public Health Service Act and under
authority delegated to the Commissioner of Food and Drugs and to the
Administrator, Health Resources and Services Administration, the direct
final rule published on May 12, 2006 (71 FR 27606), is withdrawn.
Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7644 Filed 9-13-06; 8:45 am]
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