[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is withdrawn effective September 14, 2006.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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