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

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to the repealed statutory provision of the Federal Food, Drug, and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 The direct final rule also removed references to the repealed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