Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent

---
identifier: "/us/fr/2014-22089"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent"
title_number: 0
title_name: "Federal Register"
section_number: "2014-22089"
section_name: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent"
positive_law: false
currency: "2014-09-17"
last_updated: "2014-09-17"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2014-22089"
document_type: "notice"
publication_date: "2014-09-17"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "79 FR 55800"
fr_volume: 79
docket_ids:
  - "Docket No. FDA-2010-N-0062"
fr_action: "Notice."
---


#  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Exception From General Requirements for Informed Consent

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Medical Devices; Exception From General Requirements for Informed Consent” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).

**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 July 23, 2014, the Agency submitted a proposed collection of information entitled “Medical Devices; Exception From General Requirements for Informed Consent” 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 0910-0586. The approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at *http://www.reginfo.gov/public/do/PRAMain.*

Dated: September 11, 2014.

Leslie Kux,

Assistant Commissioner for Policy.