[Federal Register Volume 64, Number 94 (Monday, May 17, 1999)]
[Rules and Regulations]
[Page 26657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12230]



[[Page 26657]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 2, 3, 5, 10, 12, 16, 20, 25, 50, 54, 56, 58, 60, 70, 
71, 200, 201, 202, 206, 207, 210, 211, 299, 300, 310, 312, 314, 
316, 320, 333, 369, 510, 514, 520, 522, 524, 529, 800, 801, 807, 
809, 812, and 860

[Docket No. 98N-0720]


Conforming Regulations Regarding Removal of Section 507 of the 
Federal Food, Drug, and Cosmetic Act; Confirmation of Effective Date

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) published in the 
Federal Register of January 5, 1999 (64 FR 396), a direct final rule. 
The direct final rule amended FDA's regulations by removing references 
to the repealed statutory provision of the Federal Food, Drug, and 
Cosmetic Act (the act) under which the agency certified antibiotic 
drugs. The direct final rule also removed references to the repealed 
antibiotic monograph regulations and to those regulations dealing with 
antibiotic applications. This document confirms the effective date of 
the direct final rule.

EFFECTIVE DATE:  The effective date of the direct final rule published 
at 64 FR 396 is confirmed as May 20, 1999.

FOR FURTHER INFORMATION CONTACT:  Christine F. Rogers, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:  FDA solicited comments concerning the 
direct final rule for a 75-day period ending March 22, 1999. FDA stated 
that the effective date of the direct final rule would be on May 20, 
1999, 60 days after the end of the comment period, unless any 
significant adverse comment was submitted to FDA during the comment 
period. FDA did not receive any significant adverse comments.
     Therefore, under the act, the FDA Modernization Act, and authority 
delegated to the Commissioner of Food and Drugs, notice is given that 
no objections were filed in response to the January 5, 1999, final 
rule. Accordingly, the amendments issued thereby are effective May 20, 
1999.

    Dated: May 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12230 Filed 5-14-99; 8:45 am]
BILLING CODE 4160-01-F