Document ID: FDA-2008-N-0179-0001
Agency: fda
Document Type: Rule
Title: Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal [Re: FDA-2007-N-0379]
Posted Date: 2008-04-04T04:00Z

[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2007, is withdrawn as of April 4, 2008.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