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 2026_register executive 2026-07-21 article Notices D09002ee1e571a96f D09002ee1e571a9ce 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 the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 24, 2026, to open a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants. 91 FR 45820 https://www.govinfo.gov/app/details/FR-2026-07-21/2026-14672 2026-14672 fr21jy26-57 4164-01-P Docket No. FDA-2026-N-4699 https://www.govinfo.gov/app/details/FR-2026-07-21/2026-14672 https://www.govinfo.gov/content/pkg/FR-2026-07-21/html/2026-14672.htm https://www.govinfo.gov/content/pkg/FR-2026-07-21/pdf/2026-14672.pdf 2 p. 45820 45821 91 FR 45820 Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period; Federal Register Vol. 91, Issue NOTICE 2026-14672 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-08-24 Docket No. FDA-2026-N-4699 4164-01-P 2026-14672 Notice; request for information; establishment of a public docket; extension of the comment period.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 24, 2026, to open a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH) study, while protecting clinical trial participants.

FDA is extending the comment period on the notice published on June 24, 2026 (91 FR 37996). Either electronic or written comments, data, or information must be received by August 24, 2026. Benjamin Cook, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 2, Rm. 2114, Silver Spring, MD 20993-0002, 240-338-4685, ExpeditedINDPilot@fda.hhs.gov. Request for Information Expedited Investigational New Drug Pilot Program; Extension of the Comment Period, ExpeditedINDPilot@fda.hhs.gov https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 91, no. 138 Office of the Federal Register, National Archives and Records Administration 2026-07-21 continuing daily deposited born digital 363 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-07-21 P0b002ee1e5716bff 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21jy26 https://www.govinfo.gov/app/details/FR-2026-07-21 https://www.govinfo.gov/content/pkg/FR-2026-07-21/pdf/FR-2026-07-21.pdf https://www.govinfo.gov/content/pkg/FR-2026-07-21/xml/FR-2026-07-21.xml fdlp 45637 45989 DGPO 2026-07-21 2026-07-21 FR-2026-07-21 machine generated eng FR FR-2026-07-21 91 138