[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76628-76629]
From the Federal Register Online via the Government Publishing 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,
[email protected].
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