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# Comments Sought on Info Collection for Expedited Product Programs
- URL: https://www.fdaweb.com/comments-sought-on-info-collection-for-expedited-product-programs/
- Published: 2017-11-08T12:00:00.000Z
- Updated: 2026-09-14T23:00:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140085

*Federal Register* notice: FDA is seeking comments on an information collection revision for its “Guidance for Industry on Expedited Programs for Serious Conditions — Drugs and Biologics OMB Control Number 0910 – 0765.” The guidance provides a single resource for information on FDA’s policies and procedures related to the following expedited programs for serious conditions: (**1**) Fast track designation, (**2**) breakthrough therapy designation, (**3**) accelerated approval, and (**4**) priority review designation. The guidance describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. It also addresses the information that must be submitted to qualify for and receive such designations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-08/pdf/2017-24296.pdf?ref=fdaweb.com).