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# Info Collection Extension on Orphan Drugs
- URL: https://www.fdaweb.com/info-collection-extension-on-orphan-drugs/
- Published: 2023-12-01T12:00:00.000Z
- Updated: 2026-09-14T14:17:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155899

*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Orphan Drugs — 21 CFR Part 316.” The collection supports FDA regulations covering such products, such as recommendations on studies required for a product’s approval. It also supports the conditions under which a sponsor of an approved orphan drug can be granted seven years market exclusivity. To view the notice, click [here](https://public-inspection.federalregister.gov/2023-26544.pdf?ref=fdaweb.com).