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Fee Waivers and Reductions for Small OTC Drug Businesses

This act aims to ease financial burdens for small businesses that produce over-the-counter (OTC) drugs. By reducing or waiving certain fees, these companies can more easily introduce new products, potentially increasing drug availability and supporting small business growth in the pharmaceutical sector.
Key points
Small businesses (under 500 employees) will have their first OTC monograph order request fee waived.
Other applicable fees for small businesses producing OTC drugs will be reduced to 25% of the original amount.
These changes are set to take effect starting from fiscal year 2022.
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Additional Information
Print number: 117_HR_4405
Sponsor: Rep. Steube, W. Gregory [R-FL-17]
Process start date: 2021-07-09
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Small Business FDA User Fee Adjustment Act of 2021

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_HR_4405.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2021-07-09.

What are the main provisions?

Key points include:

  • Small businesses (under 500 employees) will have their first OTC monograph order request fee waived.
  • Other applicable fees for small businesses producing OTC drugs will be reduced to 25% of the original amount.
  • These changes are set to take effect starting from fiscal year 2022.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Steube, W. Gregory [R-FL-17].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-28.

CATEGORIES

Health Economy