H.R. 4405 · 117th Congress
Small Business FDA User Fee Adjustment Act of 2021
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
SteubeSponsorNo cosponsors.
This bill reduces and waives certain fees related to marketing certain over-the-counter (OTC) drugs for businesses with fewer than 500 employees, including employees of affiliates.
What it does: CRS summary · Introduced in House · Jul 9, 2021
Small Business FDA User Fee Adjustment Act of 2021
This bill reduces and waives certain fees related to marketing certain over-the-counter (OTC) drugs for businesses with fewer than 500 employees, including employees of affiliates.
Starting in FY2022, the Food and Drug Administration (FDA) must waive the fee for the first OTC monograph order request from such a business. (Generally, an OTC monograph order request is a request for the FDA to evaluate whether a nonprescription drug meets certain standards.)
The fee for each subsequent OTC monograph order request for such a business shall be 25% of the amount otherwise owed.
For such a business, the FDA must also reduce the annual OTC monograph drug facility fee to 25% of the amount otherwise owed. (Generally, such a facility is engaged in the manufacturing or processing of an OTC monograph drug.)
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Small Business FDA User Fee Adjustment Act of 2021
Latest action (Jul 12, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jul 9, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.