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 2014_register executive 2014-10-23 article Proposed Rules D09002ee1c7f852f2 D09002ee1c7f8536a 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 or Agency) is announcing the availability of a draft document entitled "Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception" dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements. 79 FR 63348 https://www.govinfo.gov/app/details/FR-2014-10-23/2014-25217 2014-25217 fr23oc14-21 4164-01-P Docket No. FDA-2014-D-1584 https://www.govinfo.gov/app/details/FR-2014-10-23/2014-25217 https://www.govinfo.gov/content/pkg/FR-2014-10-23/html/2014-25217.htm https://www.govinfo.gov/content/pkg/FR-2014-10-23/pdf/2014-25217.pdf 2 p. 63348 63349 79 FR 63348 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1271 21 CFR Part 1271 Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability; Federal Register Vol. 79, Issue PRORULE 2014-25217 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-1584 4164-01-P 2014-25217 Request for comment on draft guidance.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception" dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 22, 2014 Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.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: Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 205 Office of the Federal Register, National Archives and Records Administration 2014-10-23 continuing daily deposited born digital 217 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-10-23 P0b002ee189e95aa6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23oc14 https://www.govinfo.gov/app/details/FR-2014-10-23 https://www.govinfo.gov/content/pkg/FR-2014-10-23/pdf/FR-2014-10-23.pdf https://www.govinfo.gov/content/pkg/FR-2014-10-23/xml/FR-2014-10-23.xml fdlp 63287 63495 DGPO 2014-10-23 2024-06-02 FR-2014-10-23 machine generated eng FR FR-2014-10-23 79 205