[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Notices]
[Page 58176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21750]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0017]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget 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 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 June 14, 2004 (69 
FR 33034), 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 September 30, 2007. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.fda.gov/ohrms/dockets.

    Dated: September 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21750 Filed 9-28-04; 8:45 am]
BILLING CODE 4160-01-S