Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-4699] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information; establishment of a public docket; extension of the comment period. SUMMARY: 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. DATES: 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. ADDRESSES: You may submit comments, data, and information as follows. Please note that late, untimely filed comments ( printed page 45821) will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 24, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instr…
Other Federal Register documents from the same docket.
Citation: 91 FR 45820
