[Federal Register: April 20, 1999 (Volume 64, Number 75)]
[Rules and Regulations]               
[Page 19269]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap99-18]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. 98N-0979]
RIN 0910-AA84

 
Investigational New Drug Applications; Clinical Holds; 
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 December 14, 1998 (63 FR 68676), a direct final 
rule. The direct final rule amends FDA's regulations governing 
investigational new drug applications (IND's) for human drug and 
biological products. This action amends the IND clinical hold 
requirements to state that the agency will respond in writing to a 
sponsor's request that a clinical hold be removed from an investigation 
within 30-calendar days of the agency's receipt of the request and the 
sponsor's complete response to the issue(s) that led to the clinical 
hold. 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 68676 is confirmed as April 28, 1999.

FOR FURTHER INFORMATION CONTACT:
    Murray M. Lumpkin, Center for Drug Evaluation and Research (HFD-2), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-5400, or
    Rebecca A. Devine, Center for Biologics Evaluation and Research 
(HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct 
final rule for a 75-day period ending March 1, 1999. FDA stated that 
the effective date of the direct final rule would be on April 28, 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 Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, notice 
is given that no objections were filed in response to the December 14, 
1998, final rule. Accordingly, the amendments issued thereby are 
effective April 28, 1999.

    Dated: April 13, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-9768 Filed 4-19-99; 8:45 am]
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