[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Notices]
[Pages 47330-47331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002N-0417]


Agency Information Collection Activities; Announcement of OMB 
Approval; Applications for FDA Approval to Market a New Drug: Patent 
Submission and Listing Requirements and Application of 30-Month Stays 
on Approval of Abbreviated New Drug Applications Certifying That a 
Patent Claiming a Drug Is Invalid or Will Not Be Infringed

AGENCY: Food and Drug Administration, HHS.

[[Page 47331]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Applications for FDA Approval to 
Market a New Drug: Patent Submission and Listing Requirements and 
Application of 30-Month Stays on Approval of Abbreviated New Drug 
Applications Certifying That a Patent Claiming a Drug Is Invalid or 
Will Not Be Infringed'' 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 June 18, 2003 (68 
FR 36676), 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 0910-0513. 
The approval expires on July 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: August 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20199 Filed 8-7-03; 8:45 am]
BILLING CODE 4160-01-S