[Federal Register Volume 65, Number 11 (Tuesday, January 18, 2000)]
[Notices]
[Page 2633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0237]


Agency Information Collection Activities; Announcement of OMB 
Approval; New Drug and Biological Drug Products; Evidence Needed to 
Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently 
Disabling Toxic Substances When Efficacy Studies in Humans Ethically 
Cannot Be Conducted

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``New Drug and Biological Drug 
Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use 
Against lethal or Permanently Disabling Toxic Substances When Efficacy 
Studies in Humans Ethically Cannot Be Conducted'' has been approved by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995.

FOR FURTHER INFORMATION CONTACT:  JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION:  In the Federal Register of October 5, 1999 
(64 FR 53960), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0423. 
The approval expires on December 31, 2002. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: January 10, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-991 Filed 1-14-00; 8:45 am]
BILLING CODE 4160-01-F