Document ID: FDA-2013-N-1504-0003
Agency: fda
Document Type: Notice
Title: Independent Assessment of the Process for the Review of Device
Submissions; Final Comprehensive Findings and Recommendations and
First Implementation Plan; Correction
Posted Date: 2014-06-12T04:00Z

[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33759-33760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13758]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1504]

Independent Assessment of the Process for the Review of Device 
Submissions; Final Comprehensive Findings and Recommendations and First 
Implementation Plan; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Independent Assessment of the Process for the Review of 
Device Submissions; Final Comprehensive Findings and Recommendations 
and First Implementation Plan'' that appeared in the Federal Register 
of May 29, 2014 (79 FR 30853). The document announced Booz Allen 
Hamilton's final comprehensive findings and recommendations submitted 
as part of their independent assessment of the process for the review 
of medical device submissions as well as FDA's first implementation 
plan based on Booz Allen Hamilton's high priority recommendations 
issued December 11, 2013. The notice was issued earlier than intended. 
The documents will be available on June 11, 2014, as required by the 
Medical Device User Fee Amendments of 2012 (MDUFA) III Performance 
Goals and Procedures Commitment Letter.

FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3291, 
Silver Spring, MD 20993-0002, 301-796-9384, Amber.Sligar@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, May 29, 
2014, in FR Doc. 2014-12403, on pages 30853-30854, the following 
correction is made:
    The notice implied that Booz Allen Hamilton's final comprehensive 
findings and recommendations and FDA's first implementation plan are 
available as of May 29, 2014. In fact, the

[[Page 33760]]

documents will be available Wednesday, June 11, 2014, at the following 
Web site: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm314036.htm.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13758 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P