[Federal Register Volume 64, Number 75 (Tuesday, April 20, 1999)]
[Rules and Regulations]
[Page 19269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9768]
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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]
BILLING CODE 4160-01-F
