[Federal Register Volume 68, Number 15 (Thursday, January 23, 2003)]
[Notices]
[Page 3262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0393]


Agency Information Collection Activities; Announcement of OMB 
Approval; Prescription Drug Product Labeling; Medication Guide 
Requirements

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 ``Prescription Drug Product 
Labeling; Medication Guide Requirements'' 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 December 14, 2001 
(66 FR 64840), 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 0910-0393. 
The approval expires on March 31, 2005. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: January 14, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1402 Filed 1-22-03; 8:45 am]
BILLING CODE 4160-01-S