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HR 4405 117th Congress House Health

Small Business FDA User Fee Adjustment Act of 2021

Introduced: July 9, 2021 Introduced by: Steube, W. Gregory Republican · Florida See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 12, 2021
Referred to the Subcommittee on Health.
Jul 9, 2021
Referred to the House Committee on Energy and Commerce.
Jul 9, 2021
Introduced in House
 Plain-English summary Congressional Research Service

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.)

What's happening now July 12, 2021

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2