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Regulatory Information
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2018-10-26
article
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE
Notices
D09002ee1bdb95e50
D09002ee1bdb95ee8
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
83 FR 4224
https://www.govinfo.gov/app/details/FR-2018-01-30/2018-01655
2018-01655
fr30ja18-68
4164-01-P
Docket Nos. FDA-2016-E-1279 and FDA-2016-E-1282
https://www.govinfo.gov/app/details/FR-2018-01-30/2018-01655
https://www.govinfo.gov/content/pkg/FR-2018-01-30/html/2018-01655.htm
https://www.govinfo.gov/content/pkg/FR-2018-01-30/pdf/2018-01655.pdf
3 p.
4224
4226
83 FR 4224
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE; Federal Register Vol. 83, Issue
NOTICE
2018-01655
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-07-30
Docket Nos. FDA-2016-E-1279 and FDA-2016-E-1282
4164-01-P
2018-01655
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 2, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 30, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
Determinations of Regulatory Review Periods for Purposes of Patent Extensions:
SAPIEN 3 TRANSCATHETER HEART VALVE
,
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 20
Office of the Federal Register, National Archives and Records Administration
2018-01-30
continuing
daily
deposited
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292 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-01-30
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr30ja18
https://www.govinfo.gov/app/details/FR-2018-01-30
https://www.govinfo.gov/content/pkg/FR-2018-01-30/pdf/FR-2018-01-30.pdf
https://www.govinfo.gov/content/pkg/FR-2018-01-30/xml/FR-2018-01-30.xml
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2018-10-26
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FR-2018-01-30
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FR
FR-2018-01-30
83
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