[Federal Register Volume 68, Number 15 (Thursday, January 23, 2003)]
[Notices]
[Pages 3261-3262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1401]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0400]


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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Regulations Requiring 
Manufacturers to Assess 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 (the PRA).

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 13, 2002 
(67 FR 52726), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 
section 3507 of the PRA (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 October 31, 2005. A 
copy of the supporting statement for this information collection is 
available on

[[Page 3262]]

the Internet at http://www.fda.gov/ohrms/dockets.

    Dated: January 14, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1401 Filed 1-22-03; 8:45 am]
BILLING CODE 4160-01-S