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H.R. 9635

BillFederalHouseIn Committee
To amend the Federal Food, Drug, and Cosmetic Act to establish special rules to provide for continued review of human drug and device submissions during a lapse of appropriations, and for other purposes.
About This Bill
Committee
Latest Action · July 9, 2026
Referred to the House Committee on Energy and Commerce.
Congress
119th (2025–2027)
Introduced
July 9, 2026
Cosponsors (0)
None
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Summary

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This bill allows the Food and Drug Administration to continue reviewing new drug and medical device applications during government shutdowns, even if companies have not yet paid their required FDA fees. Specifically, the FDA can accept applications and submissions that are otherwise complete but lack fee payment, and must give companies an additional seven days after the shutdown ends to pay those fees. If a company fails to pay the extended fee deadline, the FDA will reject the application and cannot approve it or any related submissions until payment is received. The legislation applies to both human drug applications and medical device submissions. By enabling the FDA to keep processing these applications during funding lapses, the bill aims to prevent delays in getting new medicines and medical devices to patients when government appropriations temporarily expire.

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