2013-09481. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational Device Exemptions Reports and Records

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Investigational Device Exemptions Reports and Records” 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, [e-mail].

SUPPLEMENTARY INFORMATION:

On January 3, 2013, the Agency submitted a proposed collection of information entitled “Investigational Device Exemptions Reports and Records” 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 0910-0078. The approval expires on March 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/​public/​do/​PRAMain.

Dated: April 15, 2013.

Leslie Kux,

Assistant Commissioner for Policy.