[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: 98-24411]


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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.

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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