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 2014-10-07 article Notices D09002ee1c7f86b95 D09002ee1c7f86c2f 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States Government Agency or Subagency The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled "Informed Consent Information Sheet." A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information. 79 FR 57940 https://www.govinfo.gov/app/details/FR-2014-09-26/2014-22951 2014-22951 fr26se14-71 4164-01-P Docket No. FDA-2006-D-0031 https://www.govinfo.gov/app/details/FR-2014-09-26/2014-22951 https://www.govinfo.gov/content/pkg/FR-2014-09-26/html/2014-22951.htm https://www.govinfo.gov/content/pkg/FR-2014-09-26/pdf/2014-22951.pdf 1 p. 57940 57940 79 FR 57940 Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period; Federal Register Vol. 79, Issue NOTICE 2014-22951 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-10-27 Docket No. FDA-2006-D-0031 4164-01-P 2014-22951 Notice; reopening of the comment period.

The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled "Informed Consent Information Sheet." A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information.

Submit either electronic or written comments by October 27, 2014. Marsha Melvin, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Building 32, Silver Spring, MD 20993, marsha.melvin@fda.hhs.gov. Guidance for Industry and Staff: Institutional Review Boards, Clinical Investigators, and Sponsors , marsha.melvin@fda.hhs.gov http://www.regulations.gov Vol. 79, no. 187 Office of the Federal Register, National Archives and Records Administration 2014-09-26 continuing daily deposited born digital 550 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-09-26 P0b002ee189db152e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26se14 https://www.govinfo.gov/app/details/FR-2014-09-26 https://www.govinfo.gov/content/pkg/FR-2014-09-26/pdf/FR-2014-09-26.pdf https://www.govinfo.gov/content/pkg/FR-2014-09-26/xml/FR-2014-09-26.xml fdlp 57699 58240 DGPO 2014-10-07 2024-06-02 FR-2014-09-26 machine generated eng FR FR-2014-09-26 79 187