Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

On August 31, 2015, the Agency submitted a proposed collection of information entitled “Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting” 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 December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.