[Federal Register Volume 65, Number 72 (Thursday, April 13, 2000)]
[Notices]
[Page 19914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-0595]


Agency Information Collection Activities; Announcement of OMB 
Approval; Reporting and Recordkeeping Requirements for Manufacturers, 
Importers, User Facilities, and Distributors of Medical Devices Under 
FDAMA

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 ``Reporting and Recordkeeping 
Requirements for Manufacturers, Importers, User Facilities, and 
Distributors of Medical Devices Under FDAMA'' 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 theFederal Register of January 26, 2000 
(65 FR 4249), 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 0910-0437. 
The approval expires on March 31, 2003. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: April 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-9130 Filed 4-12-00; 8:45 am]
BILLING CODE 4160-01-F