Small Business FDA User Fee Adjustment Act of 2021

Hozzl · 2022-12-31T05:07:17Z

Explore the details of House Bill 4405 Small Business FDA User Fee Adjustment Act of 2021 currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

12/31/2022, 5:07 AM

Summary of Bill HR 4405

Bill 117 HR 4405, also known as the Small Business FDA User Fee Adjustment Act of 2021, is a piece of legislation currently being considered by the US Congress. The main purpose of this bill is to make adjustments to the user fees that small businesses are required to pay to the Food and Drug Administration (FDA) for certain services.

The bill aims to provide relief to small businesses by reducing the fees they are required to pay for FDA services, such as the review of new drug applications or the inspection of manufacturing facilities. This is intended to help small businesses, which may not have the same financial resources as larger companies, to bring their products to market more easily and affordably.

In addition to reducing fees for small businesses, the bill also includes provisions to ensure that the FDA continues to have the necessary resources to carry out its regulatory responsibilities. This includes increasing fees for larger companies to offset the reduction in fees for small businesses. Overall, the Small Business FDA User Fee Adjustment Act of 2021 aims to strike a balance between supporting small businesses and ensuring that the FDA can effectively regulate the products it oversees. It is currently being debated in Congress and may undergo further revisions before potentially being signed into law.

Congressional Summary of HR 4405

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.)

Read the Full Bill

Formatted Text PDF Formatted XML

Current Status of Bill HR 4405

Bill HR 4405 is currently in the status of Bill Introduced since July 9, 2021. Bill HR 4405 was introduced during Congress 117 and was introduced to the House on July 9, 2021. Bill HR 4405's most recent activity was Referred to the Subcommittee on Health. as of July 12, 2021

Bipartisan Support of Bill HR 4405

Total Number of Sponsors

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill HR 4405

Primary Policy Focus

Health

Alternate Title(s) of Bill HR 4405

To amend the Federal Food, Drug, and Cosmetic Act to waive or reduce the amount of over-the-counter monograph fees applicable to small businesses, and for other purposes.

Small Business FDA User Fee Adjustment Act of 2021