Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
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.)
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Small Business FDA User Fee Adjustment Act of 2021
USA117th CongressHR-4405| House
| Updated: 7/12/2021
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.)