[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]               
[Page 22882]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0437]

 
Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Third-Party Review Under the Food 
and Drug Administration Modernization Act, Third-Party Premarket 
Submission Review, and Quality System Inspections Under the United 
States/European Community Mutual Recognition Agreement

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 ``Third Party Review Under the Food 
and Drug Administration Modernization Act, Third-Party Premarket 
Submission Review, and Quality System Inspections Under the United 
States/European Community Mutual Recognition Agreement'' has been 
approved by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 5, 2005 
(70 FR 821), 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 0910-0378. 
The approval expires on April 30, 2008. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8736 Filed 5-2-05; 8:45 am]

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