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Regulatory Information
2019_register
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2019-12-03
article
Determination of Regulatory Review Period for Purposes of Patent Extension; AIMOVIG
Notices
D09002ee1bdb68e30
D09002ee1bdb68e9d
United States
Department of Health and Human Services
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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 AIMOVIG and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
84 FR 66201
https://www.govinfo.gov/app/details/FR-2019-12-03/2019-26081
2019-26081
fr03de19-55
4164-01-P
Docket No. FDA-2018-E-4403
https://www.govinfo.gov/app/details/FR-2019-12-03/2019-26081
https://www.govinfo.gov/content/pkg/FR-2019-12-03/html/2019-26081.htm
https://www.govinfo.gov/content/pkg/FR-2019-12-03/pdf/2019-26081.pdf
2 p.
66201
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84 FR 66201
Determination of Regulatory Review Period for Purposes of Patent Extension; AIMOVIG; Federal Register Vol. 84, Issue
NOTICE
2019-26081
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-02-03
Docket No. FDA-2018-E-4403
4164-01-P
2019-26081
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AIMOVIG and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 3, 2020. 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 June 1, 2020. 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.
Determination of Regulatory Review Period for Purposes of Patent Extension:
AIMOVIG,
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 232
Office of the Federal Register, National Archives and Records Administration
2019-12-03
continuing
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226 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-12-03
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0097-6326
0042-1219
0364-1406
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000582072
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https://www.govinfo.gov/app/details/FR-2019-12-03
https://www.govinfo.gov/content/pkg/FR-2019-12-03/pdf/FR-2019-12-03.pdf
https://www.govinfo.gov/content/pkg/FR-2019-12-03/xml/FR-2019-12-03.xml
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FR-2019-12-03
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FR-2019-12-03
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