[Federal Register Volume 63, Number 176 (Friday, September 11, 1998)]
[Rules and Regulations]
[Page 48576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 430, 431, 432, 433, 436, 440, 441, 442, 443, 444, 446, 
448, 449, 450, 452, 453, 455, and 460

[Docket No. 98N-0211]


Removal of Regulations Regarding Certification of Antibiotic 
Drugs; 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 May 12, 1998, a direct final rule (63 FR 26066). 
The direct final rule repealed FDA's regulations governing 
certification of antibiotic drugs. This document confirms the effective 
date of the direct final rule.

EFFECTIVE DATE: The effective date of the direct final rule published 
at 63 FR 26066 is confirmed as September 24, 1998.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, 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 July 27, 1998. FDA stated that 
the effective date of the direct final rule would be on September 24, 
1998, 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 Federal Food, Drug, and Cosmetic Act, the Food 
and Drug Administration Modernization Act, and under authority 
delegated to the Commissioner of Food and Drugs, notice is given that 
no objections or requests for a hearing were filed in response to the 
May 12, 1998, final rule. Accordingly, the amendments issued thereby 
are effective September 24, 1998.

    Dated: September 1, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-24413 Filed 9-10-98; 8:45 am]
BILLING CODE 4160-01-F