[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
