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 2014-02-06 article Notices D09002ee1c7fa7580 D09002ee1c7fa7604 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 reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications (INDs)--Determining whether Human Research Studies can be Conducted without an IND," published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements). 79 FR 7204 https://www.govinfo.gov/app/details/FR-2014-02-06/2014-02550 2014-02550 fr06fe14-68 4160-01-P Docket No. FDA-2010-D-0503 https://www.govinfo.gov/app/details/FR-2014-02-06/2014-02550 https://www.govinfo.gov/content/pkg/FR-2014-02-06/html/2014-02550.htm https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/2014-02550.pdf 1 p. 7204 7204 79 FR 7204 Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period; Federal Register Vol. 79, Issue NOTICE 2014-02550 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-04-07 Docket No. FDA-2010-D-0503 4160-01-P 2014-02550 Notice; reopening of the comment period.

The Food and Drug Administration (FDA or we) is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications (INDs)--Determining whether Human Research Studies can be Conducted without an IND," published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).

Submit either electronic or written comments by April 7, 2014. Paul L. Ferrari, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1722. Guidance for Industry: Determining whether Human Research Studies can be Conducted without an Investigational New Drug Application; Reopening of the Comment Period , http://www.regulations.gov Vol. 79, no. 25 Office of the Federal Register, National Archives and Records Administration 2014-02-06 continuing daily deposited born digital 326 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-02-06 P0b002ee186f97950 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06fe14 https://www.govinfo.gov/app/details/FR-2014-02-06 https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/FR-2014-02-06.pdf https://www.govinfo.gov/content/pkg/FR-2014-02-06/xml/FR-2014-02-06.xml fdlp 7047 7364 DGPO 2014-02-06 2024-06-03 FR-2014-02-06 machine generated eng FR FR-2014-02-06 79 25