[Federal Register Volume 64, Number 38 (Friday, February 26, 1999)]
[Notices]
[Page 9515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0165]


Agency Information Collection Activities; Announcement of OMB 
Approval; Regulations Requiring Manufacturers to Assess the Safety and 
Effectiveness of New Drugs and Biological Products in Pediatric 
Patients

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 ``Regulations Requiring 
Manufacturers to Asses the Safety and Effectiveness of New Drugs and 
Biological Products in Pediatric Patients'' 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 August 15, 1997 
(62 FR 43903), 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 0910-0392. 
The approval expires on January 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: February 19, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-4766 Filed 2-25-99; 8:45 am]
BILLING CODE 4160-01-F