Removal of Regulations Regarding Certification of Antibiotic Drugs; Confirmation of Effective Date

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The direct final rule repealed FDA's regulations governing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