Document ID: FDA-2012-N-0110-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Medical Device Reporting:  Manufacturer, Importer, User Facility, and Distributor Reporting
Posted Date: 2016-03-02T05:00Z

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Page 10870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04576]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0110]

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.

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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.

    Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04576 Filed 3-1-16; 8:45 am]
 BILLING CODE 4164-01-P