Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Withdrawal

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.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing a

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The direct final rule published at 72 FR 68064 on December 4, 2007, is withdrawn as of April 4, 2008.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delegated to the Commissioner of Food and Drugs, the direct final rule published on December 4, 2007 (72 FR 68064) is withdrawn.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