[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Notices]
[Page 27820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0452]


Agency Information Collection Activities; Announcement of OMB 
Approval; New Drugs and Biological Drug Products; Evidence Needed to 
Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are 
Not Ethical or Feasible

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 Drugs and Biological Drug 
Products; Evidence Needed to Demonstrate Effectiveness of New Drugs 
When Human Efficacy Studies Are Not Ethical or Feasible'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 7, 2003 (68 
FR 11119), 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 May 31, 2006. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12723 Filed 5-20-03; 8:45 am]
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