[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Rules and Regulations]
[Page 25747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 210

[Docket No. 2005N-0285]


Current Good Manufacturing Practice Regulation and 
Investigational New Drugs; 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 the 
direct final rule that published in the Federal Register of January 17, 
2006, to amend its current good manufacturing practice (CGMP) 
regulations for human drugs, including biological products, to exempt 
most investigational ``Phase 1'' drugs from complying with the 
requirements in FDA's regulations. FDA is withdrawing the rule because 
significant adverse comments were received.

DATES: The revision of 21 CFR part 210, published at 71 FR 2458 
(January 17, 2006), is withdrawn as of May 2, 2006.

FOR FURTHER INFORMATION CONTACT:
    Monica Caphart, Center for Drug Evaluation and Research (HFD-320), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-9047, or
    Christopher Joneckis, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-1), 1401 Rockville Pike, 
Rockville, MD 20852, 301-435-5681.

SUPPLEMENTARY INFORMATION: FDA published a direct final rule on January 
17, 2006 (71 FR 2458), that was intended to revise the current good 
manufacturing practice (CGMP) regulations for human drugs, including 
biological products, to exempt most investigational ``Phase 1'' drugs 
from complying with the requirements in FDA's regulations. In response 
to the direct final rule, the agency received significant adverse 
comments about the proposed revisions to the rule.
    Under FDA's direct final rule procedures, the receipt of any 
significant adverse comment will result in the withdrawal of the direct 
final rule. Thus, this direct final rule is being withdrawn, effective 
immediately. Comments received by the agency regarding the withdrawn 
rule will be considered in developing a final rule using the usual 
Administrative Procedure Act notice-and-comment procedures.
    For the reasons set forth in the preamble of this notice, and under 
the authority of the Federal Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner of Food and Drugs, the revision 
of 21 CFR part 210, published at 71 FR 2458 (January 17, 2006), is 
withdrawn.

    Dated: April 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-4091 Filed 5-1-06; 8:45 am]
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