H.R.9635

Getting Innovations to Patients During Shutdowns Act allows FDA to accept and review drug and device applications during funding lapses.

The Getting Innovations to Patients During Shutdowns Act amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration to accept and review human drug and device submissions during a lapse of appropriations. The Secretary may accept complete submissions without the required fees and extend the fee payment deadline by seven days. If the fees are not paid by the extended deadline, the submission will not be approved. This ensures continued review of critical applications during funding interruptions.