United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-09-16 article Notices D09002ee1c7f3e8b5 D09002ee1c7f3e986 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) has determined the regulatory review period for RESQCPR SYSTEM 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 medical device. 81 FR 63771 https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22343 2016-22343 fr16se16-72 4164-01-P Docket No. FDA-2015-E-2084 https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22343 https://www.govinfo.gov/content/pkg/FR-2016-09-16/html/2016-22343.htm https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/2016-22343.pdf 3 p. 63771 63773 81 FR 63771 Determination of Regulatory Review Period for Purposes of Patent Extension; RESQCPR SYSTEM; Federal Register Vol. 81, Issue NOTICE 2016-22343 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-03-15 Docket No. FDA-2015-E-2084 4164-01-P 2016-22343 Notice.

The Food and Drug Administration (FDA) has determined the regulatory review period for RESQCPR SYSTEM 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 medical device.

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 November 15, 2016. 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 March 15, 2017. 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. Patent Extension Regulatory Review Periods: RESQCPR System , http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 180 Office of the Federal Register, National Archives and Records Administration 2016-09-16 continuing daily deposited born digital 389 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-09-16 P0b002ee191308d9d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16se16 https://www.govinfo.gov/app/details/FR-2016-09-16 https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/FR-2016-09-16.pdf https://www.govinfo.gov/content/pkg/FR-2016-09-16/xml/FR-2016-09-16.xml fdlp 63671 64047 DGPO 2016-09-16 2024-06-01 FR-2016-09-16 machine generated eng FR FR-2016-09-16 81 180