Document ID: FDA-2010-N-0308-0046
Agency: fda
Document Type: Notice
Title: Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program
Posted Date: 2013-12-18T05:00Z

[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76628-76629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29822]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0308]

Centers for Medicare and Medicaid Services

[CMS-3180-N3]

Pilot Program for Parallel Review of Medical Products; Extension 
of the Duration of the Program

AGENCIES: Food and Drug Administration, Centers for Medicare and 
Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) and the Centers for 
Medicare and Medicaid Services (CMS) (the Agencies) are announcing the 
extension of the ``Pilot Program for Parallel Review of Medical 
Products.''

[[Page 76629]]

The Agencies have decided to continue the program as currently designed 
for an additional period of 2 years from the date of publication of 
this notice.

DATES: This notice is effective December 18, 2013.

FOR FURTHER INFORMATION CONTACT: John Burke, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5460, Silver Spring, MD 20993-0002, 301-796-5738, 
John.Burke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2011 
(76 FR 62808), the Agencies announced the procedures and guiding 
principles for the Parallel Review Pilot Program and solicited 
nominations for the pilot. To date, there has been significant interest 
in the pilot and the Agencies are currently working through the 
parallel review process with the approved pilot program participants. 
We believe that interest in the pilot has also facilitated mutually 
informative discussions between additional sponsors and the Agencies.
    In the October 11, 2011 (76 FR 62808), Parallel Review Pilot 
Program notice, the Agencies stated their intent to accept requests for 
a 2-year period, followed by an announcement in the Federal Register as 
to the future of the pilot. The Agencies have decided to continue the 
program as currently designed for an additional 2 years from the date 
of publication of this notice.
    Once a representative group of participants have completed the 
pilot process the Agencies will formally evaluate the program for best 
practices and will announce any future revisions and/or enhancements in 
a future Federal Register notice.

    Dated: December 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: December 6, 2013.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2013-29822 Filed 12-17-13; 8:45 am]
BILLING CODE 4120-01-M; 4160-01-M