HR 4405 United States House · 117th Congress

Small Business FDA User Fee Adjustment Act of 2021

Summary
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.)
Bill status in committee 1 of 4 stages cleared
Introduction
Jul 2021
Committee Review
Floor Vote
President
Introduced Jul 9, 2021 Last action Jul 12, 2021
Floor votes

How they voted

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Full legislative history

Actions timeline

Total actions
3
Key actions
0
Committee
2
Jul 12, 2021
Committee
Referred to the Subcommittee on Health.
lower
Jul 9, 2021
Committee
Referred to the House Committee on Energy and Commerce.
lower
Jul 9, 2021
Introduced
Introduced in House
lower
1 primary · 0 co-sponsors

Sponsors

Role
Legislator
Party
State
District
P
Photo of W. Gregory Steube
W. Gregory Steube
RRepublican
FL
17