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Small Business FDA User Fee Adjustment Act of 2021

USA117th CongressHR-4405| House 
| Updated: 7/12/2021
W. Gregory Steube

W. Gregory Steube

Republican Representative

Florida

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
Jul 9, 2021
Introduced in House
Jul 9, 2021
Referred to the House Committee on Energy and Commerce.
Jul 12, 2021
Referred to the Subcommittee on Health.
  • July 9, 2021
    Introduced in House


  • July 9, 2021
    Referred to the House Committee on Energy and Commerce.


  • July 12, 2021
    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.)
View Full Text

Suggested Questions

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Timeline
Jul 9, 2021
Introduced in House
Jul 9, 2021
Referred to the House Committee on Energy and Commerce.
Jul 12, 2021
Referred to the Subcommittee on Health.
  • July 9, 2021
    Introduced in House


  • July 9, 2021
    Referred to the House Committee on Energy and Commerce.


  • July 12, 2021
    Referred to the Subcommittee on Health.
W. Gregory Steube

W. Gregory Steube

Republican Representative

Florida

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted