2013-00009. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Withdrawal of notice.

SUMMARY:

This document withdraws a Food and Drug Administration (FDA) notice that published in the Federal Register of December 11, 2012 (77 FR 73662).

DATES:

This notice is withdrawn on January 7, 2013.

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:

FDA published a notice in the Federal Register of December 11, 2012 (77 FR 73662), informing interested parties that the proposed collection of information entitled “Guidance on Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 and inviting the public to submit comments on the proposed study to OMB. As of the date of this notice, FDA has not finalized the policy document underlying this information collection request. Thus, FDA is withdrawing the proposed collection of information published on December 11, 2012, at this time.

Dated: December 31, 2012.

Leslie Kux,

Assistant Commissioner for Policy.