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 Notices D09002ee1c7f6f1fb D09002ee1c7f6f28d 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 we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an IND." We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay. 80 FR 66907 https://www.govinfo.gov/app/details/FR-2015-10-30/2015-27729 2015-27729 fr30oc15-75 4164-01-P Docket No. FDA-2010-D-0503 https://www.govinfo.gov/app/details/FR-2015-10-30/2015-27729 https://www.govinfo.gov/content/pkg/FR-2015-10-30/html/2015-27729.htm https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/2015-27729.pdf 3 p. 66907 66909 80 FR 66907 Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance; Federal Register Vol. 80, Issue NOTICE 2015-27729 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-10-30 Docket No. FDA-2010-D-0503 4164-01-P 2015-27729 Notice of administrative stay of action.

The Food and Drug Administration (FDA or we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an IND." We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay.

This stay is effective October 30, 2015 Submit either electronic or written comments on FDA guidances at any time. Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: philip.chao@fda.hhs.gov; or Ebla Ali-Ibrahim, Center for Drug Evaluation and Research (HFD-160), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3691; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. Guidance for Industry and Staff: Investigational New Drug ApplicationsDetermining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application , philip.chao@fda.hhs.gov 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