Comments on IND Application Paperwork Sought by FDA
Published Date: 8/17/2026
Notice
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 3 costs, 1 mixed.
Large Annual Reporting & Recordkeeping Burden
FDA estimates very large annual burden hours from IND reporting and recordkeeping: for human drugs, 23,016,423 reporting hours and 2,832,742 recordkeeping hours annually; for biologics, 6,694,050 reporting hours and 127,220 recordkeeping hours annually. These totals reflect the cumulative time respondents spend on the listed 21 CFR part 312 activities each year.
Electronic IND Submission & Web Interface
Information for INDs must be submitted electronically and FDA offers a new web-based interface (mobile or desktop) to help complete and electronically submit Form FDA 1571 and associated files. Individuals may request printed forms by email, but fees may apply for printed copies.
Form FDA 1571 Adds RWE/RWD Fields
If you file an IND using Form FDA 1571, the form was updated to include new real‑world evidence/real‑world data (RWE/RWD) tracking fields per the PDUFA VII commitment. FDA says these new fields will capture submissions that include RWE/RWD so the Agency can track and report on related performance.
Right to Try Annual Report Due March 31
Sponsors and manufacturers who provide an "eligible investigational drug" under the Right to Try Act must submit an annual report using Form FDA 5023 by March 31 each year covering the preceding calendar year. FDA lists this requirement under 21 CFR 300.200.
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Previous: 2026-16714, Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's third-party disclosure and recordkeeping requirements for reportable food.
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The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.