---
title: "FDASRA Act of 2022"
identifier: "117-S-4535"
congress: 117
bill_number: 4535
bill_type: "S"
version_code: "is"
version_type: "Introduced in Senate"
bill_url: "https://chamberzero.com/congresses/117/bills/s/4535"
source: "https://www.congress.gov/bill/117th-congress/senate-bill/4535"
site: "Chamber Zero"
site_url: "https://chamberzero.com"
rendered_at: "2026-06-04T00:45:39.019Z"
---
## SEC. 1 Short title; table of contents.

[Read Section 1 →](/congresses/117/bills/s/4535/sections/1-section-one.md)

# TITLE I — Fees relating to drugs

## SEC. 101 Short title; finding.

[Read Section 101 →](/congresses/117/bills/s/4535/sections/TI-101.md)

## SEC. 102 Definitions.

[Read Section 102 →](/congresses/117/bills/s/4535/sections/TI-102.md)

## SEC. 103 Authority to assess and use drug fees.

[Read Section 103 →](/congresses/117/bills/s/4535/sections/TI-103.md)

## SEC. 104 Reauthorization; reporting requirement.

[Read Section 104 →](/congresses/117/bills/s/4535/sections/TI-104.md)

## SEC. 105 Sunset dates.

[Read Section 105 →](/congresses/117/bills/s/4535/sections/TI-105.md)

## SEC. 106 Effective date.

[Read Section 106 →](/congresses/117/bills/s/4535/sections/TI-106.md)

## SEC. 107 Savings clause.

[Read Section 107 →](/congresses/117/bills/s/4535/sections/TI-107.md)

# TITLE II — Fees relating to devices

## SEC. 201 Short title; finding.

[Read Section 201 →](/congresses/117/bills/s/4535/sections/TII-201.md)

## SEC. 202 Definitions.

[Read Section 202 →](/congresses/117/bills/s/4535/sections/TII-202.md)

## SEC. 203 Authority to assess and use device fees.

[Read Section 203 →](/congresses/117/bills/s/4535/sections/TII-203.md)

## SEC. 204 Reauthorization; reporting requirement.

[Read Section 204 →](/congresses/117/bills/s/4535/sections/TII-204.md)

## SEC. 205 Accreditation programs.

[Read Section 205 →](/congresses/117/bills/s/4535/sections/TII-205.md)

## SEC. 206 Sunset dates.

[Read Section 206 →](/congresses/117/bills/s/4535/sections/TII-206.md)

## SEC. 207 Effective date.

[Read Section 207 →](/congresses/117/bills/s/4535/sections/TII-207.md)

## SEC. 208 Savings clause.

[Read Section 208 →](/congresses/117/bills/s/4535/sections/TII-208.md)

# TITLE III — Fees relating to generic drugs

## SEC. 301 Short title; finding.

[Read Section 301 →](/congresses/117/bills/s/4535/sections/TIII-301.md)

## SEC. 302 Authority to assess and use human generic drug fees.

[Read Section 302 →](/congresses/117/bills/s/4535/sections/TIII-302.md)

## SEC. 303 Reauthorization; reporting requirements.

[Read Section 303 →](/congresses/117/bills/s/4535/sections/TIII-303.md)

## SEC. 304 Sunset dates.

[Read Section 304 →](/congresses/117/bills/s/4535/sections/TIII-304.md)

## SEC. 305 Effective date.

[Read Section 305 →](/congresses/117/bills/s/4535/sections/TIII-305.md)

## SEC. 306 Savings clause.

[Read Section 306 →](/congresses/117/bills/s/4535/sections/TIII-306.md)

# TITLE IV — Fees relating to biosimilar biological products

## SEC. 401 Short title; finding.

[Read Section 401 →](/congresses/117/bills/s/4535/sections/TIV-401.md)

## SEC. 402 Definitions.

[Read Section 402 →](/congresses/117/bills/s/4535/sections/TIV-402.md)

## SEC. 403 Authority to assess and use biosimilar biological product fees.

[Read Section 403 →](/congresses/117/bills/s/4535/sections/TIV-403.md)

## SEC. 404 Reauthorization; reporting requirements.

[Read Section 404 →](/congresses/117/bills/s/4535/sections/TIV-404.md)

## SEC. 405 Sunset dates.

[Read Section 405 →](/congresses/117/bills/s/4535/sections/TIV-405.md)

## SEC. 406 Effective date.

[Read Section 406 →](/congresses/117/bills/s/4535/sections/TIV-406.md)

## SEC. 407 Savings clause.

[Read Section 407 →](/congresses/117/bills/s/4535/sections/TIV-407.md)

# TITLE V — Other reauthorizations

## SEC. 501 Reauthorization of the critical path public-private partnership.

[Read Section 501 →](/congresses/117/bills/s/4535/sections/TV-501.md)

## SEC. 502 Reauthorization of the best pharmaceuticals for children program.

[Read Section 502 →](/congresses/117/bills/s/4535/sections/TV-502.md)

## SEC. 503 Reauthorization of the humanitarian device exemption incentive.

[Read Section 503 →](/congresses/117/bills/s/4535/sections/TV-503.md)

## SEC. 504 Reauthorization of the pediatric device consortia program.

[Read Section 504 →](/congresses/117/bills/s/4535/sections/TV-504.md)

## SEC. 505 Reauthorization of provision pertaining to drugs containing single enantiomers.

[Read Section 505 →](/congresses/117/bills/s/4535/sections/TV-505.md)

## SEC. 506 Reauthorization of orphan drug grants.

[Read Section 506 →](/congresses/117/bills/s/4535/sections/TV-506.md)

## SEC. 507 Reauthorization of certain device inspections.

[Read Section 507 →](/congresses/117/bills/s/4535/sections/TV-507.md)