Bill Overview
Title: Small Business Establishment Registration Waiver Act
Description: This bill allows the Food and Drug Administration to waive annual establishment registration fees for small businesses for which such fees present a financial hardship.
Sponsors: Sen. Braun, Mike [R-IN]
Target Audience
Population: Small businesses in FDA-regulated sectors
Estimated Size: 1000000
- Small businesses often face financial constraints and high operational costs.
- The FDA charges annual establishment registration fees to businesses in certain sectors, such as the pharmaceutical and food industries.
- The waiver of these fees would directly benefit small businesses involved in sectors regulated by the FDA.
- Globally, industries involving pharmaceuticals, food manufacturing, and other FDA-regulated sectors include millions of small businesses.
Reasoning
- The policy targets small businesses that are under the regulation of the FDA and face financial challenges due to the fee structure.
- Not all small businesses fall under the FDA's purview, so the policy's direct impact is limited to those sectors.
- Given the budget, the policy can support multiple small businesses, relieving them from a financial burden and allowing more investment in other areas.
- The future benefits of such waivers could be substantial, leading to increased business growth and employment.
Simulated Interviews
Owner of a small organic snack company (San Diego, CA)
Age: 45 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The waiver would be a huge relief on our financial statement.
- With fewer fees, we can invest more in product development.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Co-founder of a biotech startup (Austin, TX)
Age: 34 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Our company could tremendously benefit from reduced fees.
- It's often tough making ends meet with so many regulatory costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 8 | 4 |
| Year 10 | 8 | 4 |
| Year 20 | 8 | 4 |
CEO of a small pharmaceutical company (New York, NY)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- Cutting down on fees can help us allocate resources to research.
- The policy is beneficial to sustainable operations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
Owner of a vegan bakery (Portland, OR)
Age: 29 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 3.0 years
Commonness: 6/20
Statement of Opinion:
- This waiver is a potential lifeline, easing our cost pressures.
- It's a positive step for small enterprises like ours.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
Managing director of a food distribution company (Miami, FL)
Age: 39 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Reducing fees is an incentive for innovation in small businesses.
- It supports the economy by fostering growth.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 6 |
Proprietor of a small pet food brand (Boston, MA)
Age: 55 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The waiver could improve our tight margins.
- We could allocate more for growth and staff welfare.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Founder of a fitness nutrition startup (Chicago, IL)
Age: 44 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Avoiding fees means we can hire more and expand faster.
- It's hard to keep up with the costs as a new company.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 7 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 8 | 4 |
| Year 20 | 8 | 4 |
Owner of a small dairy processing plant (Houston, TX)
Age: 31 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 5/20
Statement of Opinion:
- The policy makes us more competitive in the market.
- With lower fees, we can offer better prices.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 8 | 5 |
Owner of a seafood processing company (Seattle, WA)
Age: 62 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Reducing fees is beneficial but not a panacea for all challenges.
- We appreciate any help in reducing operational costs.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Co-owner of a gluten-free bakery (Phoenix, AZ)
Age: 47 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- This waiver means more money to reinvent our product line.
- The small business community can certainly benefit from fee reductions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Cost Estimates
Year 1: $1000000000 (Low: $800000000, High: $1200000000)
Year 2: $1050000000 (Low: $840000000, High: $1260000000)
Year 3: $1100000000 (Low: $880000000, High: $1320000000)
Year 5: $1200000000 (Low: $960000000, High: $1440000000)
Year 10: $1400000000 (Low: $1120000000, High: $1680000000)
Year 100: $5000000000 (Low: $4000000000, High: $6000000000)
Key Considerations
- Identifying and verifying businesses eligible for fee waivers may require additional FDA resources.
- The indirect economic benefits, derived from potential small business growth, need to be weighed against immediate fiscal impacts.
- The broader economic impact depends heavily on how small businesses reinvest the saved costs.