Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices

---
identifier: "/us/fr/2011-1756"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices"
title_number: 0
title_name: "Federal Register"
section_number: "2011-1756"
section_name: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices"
positive_law: false
currency: "2011-01-27"
last_updated: "2011-01-27"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2011-1756"
document_type: "notice"
publication_date: "2011-01-27"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "76 FR 4917"
fr_volume: 76
docket_ids:
  - "Docket No. FDA-2010-N-0250"
fr_action: "Notice."
---


#  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of 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 “Premarket Approval of Medical Devices” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

**FOR FURTHER INFORMATION CONTACT:**

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

In the *Federal Register* of September 24, 2010  (75 FR 58396), 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 0910-0231. The approval expires on December 31, 2013. A copy of the supporting statement for this information collection is available on the Internet at *http://www.reginfo.gov/public/do/PRAMain.*

Dated: January 21, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.