[Federal Register Volume 67, Number 61 (Friday, March 29, 2002)]
[Notices]
[Page 15210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0402]


Agency Information Collection Activities; Announcement of OMB 
Approval; Medical Devices; Third-Party Premarket Submission Review and 
Quality System Inspections Under 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 ``Medical Devices; Third-Party 
Premarket Submission Review and Quality System Inspections Under 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 Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 2002 
(67 FR 1770), 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 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: March 22, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7526 Filed 3-28-02; 8:45 am]
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