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 2015_register executive 2015-10-30 article Proposed Rules D09002ee1c7f6f1c9 D09002ee1c7f6f25c 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) is reopening the comment period for the draft document entitled "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry" announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information. 80 FR 66847 https://www.govinfo.gov/app/details/FR-2015-10-30/2015-27707 2015-27707 fr30oc15-25 4164-01-P Docket No. FDA-2014-D-1584 https://www.govinfo.gov/app/details/FR-2015-10-30/2015-27707 https://www.govinfo.gov/content/pkg/FR-2015-10-30/html/2015-27707.htm https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/2015-27707.pdf 2 p. 66847 66848 80 FR 66847 Title 21 Part 1271 21 CFR Part 1271 Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period; Federal Register Vol. 80, Issue PRORULE 2015-27707 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-04-29 Docket No. FDA-2014-D-1584 4164-01-P 2015-27707 Notification; reopening of the comment period.

The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry" announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.

Submit either electronic or written comments on the draft guidance by April 29, 2016. Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Guidance for Industry and Staff: Same Surgical Procedure ExceptionQuestions and Answers Regarding the Scope of the Exception; Reopening Comment Period , http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 80, no. 210 Office of the Federal Register, National Archives and Records Administration 2015-10-30 continuing daily deposited born digital 488 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-10-30 P0b002ee18dd5b396 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30oc15 https://www.govinfo.gov/app/details/FR-2015-10-30 https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/FR-2015-10-30.pdf https://www.govinfo.gov/content/pkg/FR-2015-10-30/xml/FR-2015-10-30.xml fdlp 66781 67259 DGPO 2015-10-30 2024-06-02 FR-2015-10-30 machine generated eng FR FR-2015-10-30 80 210