05-23676. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch: Food and Drug Administration Medical Products Reporting Program

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “MedWatch: Food and Drug Administration Medical Products Reporting Program” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

In the Federal Register of December 27, 2004 (69 FR 77256), 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 0910-0291.

As requested by the agency, in addition to the approval of the revised forms, the existing forms are approved for continued use for the next 12 months to allow for the industry to make necessary changes to their computerized systems.

The approval expires on October 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/​ohrms/​dockets.

Dated: November 30, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.