Administrative practice and procedure: Effective date,

[Federal Register: September 11, 1998 (Volume 63, Number 176)]

[Rules and Regulations]

[Page 48576]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11se98-6]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 3, 5, 10, 16, 25, 50, 56, 58, 71, 200, 201, 207, 210, 211, 310, 312, 314, 369, 429, 800, and 812

[Docket No. 98N-0210]

Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

SUMMARY: The Food and Drug Administration (FDA) published in the Federal Register of May 13, 1998, a direct final rule (63 FR 26694). The direct final rule amends the regulations regarding certification of drugs composed wholly or partly of insulin, and conforming and related amendments. 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 26694 is confirmed as September 25, 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 25, 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 and under authority delegated to the Commissioner of Food and Drugs, notice is given that no objections or requests for a hearing were filedin response to the May 13, 1998, final rule. Accordingly, the amendments issued thereby are effective September 25, 1998.

Dated: September 1, 1998. William B. Schultz, Deputy Commissioner for Policy.

[FR Doc. 98-24411Filed9-10-98; 8:45 am]

BILLING CODE 4160-01-F