[Federal Register Volume 66, Number 141 (Monday, July 23, 2001)]
[Notices]
[Page 38290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18345]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0051]


Agency Information Collection Activities; Announcement of OMB 
Approval; Adverse Event Pilot Program for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Adverse Event Pilot Program for 
Medical Devices'' 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 June 20, 2001 (66 
FR 33099), 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 0910-0471. 
The approval expires on July 31, 2004. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: July 17, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18345 Filed 7-20-01; 8:45 am]
BILLING CODE 4160-01-S