81 FR 10870 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 41 (March 2, 2016)

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.

[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Page 10870]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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