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[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Rules and Regulations]
[Page 18440-18441]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap08-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 210 and 211
[Docket No. FDA-2008-N-0179] (formerly Docket No. 2007N-0280)
Amendment to the Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing a
[[Page 18441]]
direct final rule that published in the Federal Register of December 4,
2007 (72 FR 68064), to amend certain regulations as the first phase of
an incremental approach to modernize or clarify some of the current
good manufacturing practice (CGMP) regulations for finished
pharmaceuticals, as well as harmonize some of the CGMP requirements
with those of other foreign regulators and other FDA regulations. The
comment period closed February 19, 2008. FDA is withdrawing the direct
final rule because the agency received significant adverse comments.
FDA will consider the comments received under our usual procedures for
notice and comment in connection with the notice of proposed rulemaking
that was published in the Federal Register of December 4, 2007, as a
companion to the direct final rule (72 FR 68113).
DATES: The direct final rule published at 72 FR 68064 on December 4,
2007, is withdrawn as of April 4, 2008.
FOR FURTHER INFORMATION CONTACT:
Mary Malarkey, Center for Biologics Evaluation and Research (HFM-
600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-6190, or
Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8268, or
Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, 301-796-3279.
Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act,
and under authority delegated to the Commissioner of Food and Drugs,
the direct final rule published on December 4, 2007 (72 FR 68064) is
withdrawn.
Dated: March 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7107 Filed 4-3-08; 8:45 am]
BILLING CODE 4160-01-S