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

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 filed in

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. 98-24411 Filed 9-10-98; 8:45 am]

BILLING CODE 4160-01-F