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# Comments Sought on Info Collection for INDs
- URL: https://www.fdaweb.com/comments-sought-on-info-collection-for-inds/
- Published: 2018-10-04T12:00:00.000Z
- Updated: 2026-09-15T00:35:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142515

*Federal Register* notice: FDA is seeking comments on an information collection extension entitled “Investigational New Drug Application—21 CFR Part 312.” Agency regulations establish reporting requirements that include an initial application as well as amendments to that application, reports on significant revisions of clinical investigation plans, and information on a drug’s safety or effectiveness. In addition, the sponsor is required to give FDA an annual summary of the previous year’s clinical experience. The regulations also include recordkeeping requirements pertaining to the disposition of drugs, records pertaining to individual case histories, and certain other documentation verifying the fulfillment of responsibilities by clinical investigators. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-04/pdf/2018-21610.pdf?ref=fdaweb.com).