---
title: "FDASLA Act of 2022"
identifier: "117-S-4348"
congress: 117
bill_number: 4348
bill_type: "S"
version_code: "rs"
version_type: "Reported in Senate"
bill_url: "https://chamberzero.com/congresses/117/bills/s/4348"
source: "https://www.congress.gov/bill/117th-congress/senate-bill/4348"
other_versions:
  - { code: "is", type: "Introduced in Senate", date: "2022-05-26", url: "https://chamberzero.com/congresses/117/bills/s/4348/text.md?version=is" }
site: "Chamber Zero"
site_url: "https://chamberzero.com"
rendered_at: "2026-06-04T01:46:49.261Z"
---
# TITLE I — Fees relating to drugs

## SEC. 101 Short title; finding.

[Read Section 101 →](/congresses/117/bills/s/4348/sections/TI-101.md)

## SEC. 102 Definitions.

[Read Section 102 →](/congresses/117/bills/s/4348/sections/TI-102.md)

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

[Read Section 103 →](/congresses/117/bills/s/4348/sections/TI-103.md)

## SEC. 104 Reauthorization; reporting requirement.

[Read Section 104 →](/congresses/117/bills/s/4348/sections/TI-104.md)

## SEC. 105 Sunset dates.

[Read Section 105 →](/congresses/117/bills/s/4348/sections/TI-105.md)

## SEC. 106 Effective date.

[Read Section 106 →](/congresses/117/bills/s/4348/sections/TI-106.md)

## SEC. 107 Savings clause.

[Read Section 107 →](/congresses/117/bills/s/4348/sections/TI-107.md)

# TITLE II — Fees relating to devices

## SEC. 201 Short title; finding.

[Read Section 201 →](/congresses/117/bills/s/4348/sections/TII-201.md)

## SEC. 202 Definitions.

[Read Section 202 →](/congresses/117/bills/s/4348/sections/TII-202.md)

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

[Read Section 203 →](/congresses/117/bills/s/4348/sections/TII-203.md)

## SEC. 204 Reauthorization; reporting requirement.

[Read Section 204 →](/congresses/117/bills/s/4348/sections/TII-204.md)

## SEC. 205 Accreditation programs.

[Read Section 205 →](/congresses/117/bills/s/4348/sections/TII-205.md)

## SEC. 206 Sunset dates.

[Read Section 206 →](/congresses/117/bills/s/4348/sections/TII-206.md)

## SEC. 207 Effective date.

[Read Section 207 →](/congresses/117/bills/s/4348/sections/TII-207.md)

## SEC. 208 Savings clause.

[Read Section 208 →](/congresses/117/bills/s/4348/sections/TII-208.md)

# TITLE III — Fees relating to generic drugs

## SEC. 301 Short title; finding.

[Read Section 301 →](/congresses/117/bills/s/4348/sections/TIII-301.md)

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

[Read Section 302 →](/congresses/117/bills/s/4348/sections/TIII-302.md)

## SEC. 303 Reauthorization; reporting requirements.

[Read Section 303 →](/congresses/117/bills/s/4348/sections/TIII-303.md)

## SEC. 304 Sunset dates.

[Read Section 304 →](/congresses/117/bills/s/4348/sections/TIII-304.md)

## SEC. 305 Effective date.

[Read Section 305 →](/congresses/117/bills/s/4348/sections/TIII-305.md)

## SEC. 306 Savings clause.

[Read Section 306 →](/congresses/117/bills/s/4348/sections/TIII-306.md)

# TITLE IV — Fees relating to biosimilar biological products

## SEC. 401 Short title; finding.

[Read Section 401 →](/congresses/117/bills/s/4348/sections/TIV-401.md)

## SEC. 402 Definitions.

[Read Section 402 →](/congresses/117/bills/s/4348/sections/TIV-402.md)

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

[Read Section 403 →](/congresses/117/bills/s/4348/sections/TIV-403.md)

## SEC. 404 Reauthorization; reporting requirements.

[Read Section 404 →](/congresses/117/bills/s/4348/sections/TIV-404.md)

## SEC. 405 Sunset dates.

[Read Section 405 →](/congresses/117/bills/s/4348/sections/TIV-405.md)

## SEC. 406 Effective date.

[Read Section 406 →](/congresses/117/bills/s/4348/sections/TIV-406.md)

## SEC. 407 Savings clause.

[Read Section 407 →](/congresses/117/bills/s/4348/sections/TIV-407.md)

# TITLE V — Improving regulation of drugs and biological products

## SEC. 501 Alternatives to animal testing.

[Read Section 501 →](/congresses/117/bills/s/4348/sections/TV-501.md)

## SEC. 502 Safer disposal of opioids.

[Read Section 502 →](/congresses/117/bills/s/4348/sections/TV-502.md)

## SEC. 503 Clarifications to exclusivity provisions for first interchangeable biosimilar biological products.

[Read Section 503 →](/congresses/117/bills/s/4348/sections/TV-503.md)

## SEC. 504 Improvements to the Purple Book.

[Read Section 504 →](/congresses/117/bills/s/4348/sections/TV-504.md)

## SEC. 505 Therapeutic equivalence evaluations.

[Read Section 505 →](/congresses/117/bills/s/4348/sections/TV-505.md)

## SEC. 506 Modernizing accelerated approval.

[Read Section 506 →](/congresses/117/bills/s/4348/sections/TV-506.md)

## SEC. 507 Rare disease pilot program.

[Read Section 507 →](/congresses/117/bills/s/4348/sections/TV-507.md)

## SEC. 508 Supporting review and development of drugs to treat rare diseases.

[Read Section 508 →](/congresses/117/bills/s/4348/sections/TV-508.md)

## SEC. 509 Generic drug labeling changes.

[Read Section 509 →](/congresses/117/bills/s/4348/sections/TV-509.md)

## SEC. 510 Limitations on exclusive approval or licensure of orphan drugs.

[Read Section 510 →](/congresses/117/bills/s/4348/sections/TV-510.md)

## SEC. 511 Ensuring timely access to generics.

[Read Section 511 →](/congresses/117/bills/s/4348/sections/TV-511.md)

## SEC. 512 Increasing transparency in generic drug applications.

[Read Section 512 →](/congresses/117/bills/s/4348/sections/TV-512.md)

## SEC. 513 GAO report on nonprofit pharmaceutical organizations.

[Read Section 513 →](/congresses/117/bills/s/4348/sections/TV-513.md)

## SEC. 514 FDA public meeting on nonprofit prescription drug manufacturers.

[Read Section 514 →](/congresses/117/bills/s/4348/sections/TV-514.md)

## SEC. 515 180-day exclusivity period.

[Read Section 515 →](/congresses/117/bills/s/4348/sections/TV-515.md)

# TITLE VI — Other reauthorizations

## SEC. 601 Reauthorization of the critical path public-private partnership.

[Read Section 601 →](/congresses/117/bills/s/4348/sections/TVI-601.md)

## SEC. 602 Reauthorization of the best pharmaceuticals for children program.

[Read Section 602 →](/congresses/117/bills/s/4348/sections/TVI-602.md)

## SEC. 603 Reauthorization of the humanitarian device exemption incentive.

[Read Section 603 →](/congresses/117/bills/s/4348/sections/TVI-603.md)

## SEC. 604 Reauthorization of the pediatric device consortia program.

[Read Section 604 →](/congresses/117/bills/s/4348/sections/TVI-604.md)

## SEC. 605 Reauthorization of provision pertaining to drugs containing single enantiomers.

[Read Section 605 →](/congresses/117/bills/s/4348/sections/TVI-605.md)

## SEC. 606 Reauthorization of orphan drug grants.

[Read Section 606 →](/congresses/117/bills/s/4348/sections/TVI-606.md)

## SEC. 607 Reauthorization of certain device inspections.

[Read Section 607 →](/congresses/117/bills/s/4348/sections/TVI-607.md)

# TITLE VII — Enhancing FDA hiring authorities

## SEC. 701 Enhancing FDA hiring authority for scientific, technical, and professional personnel.

[Read Section 701 →](/congresses/117/bills/s/4348/sections/TVII-701.md)

## SEC. 702 Strategic workforce plan and report.

[Read Section 702 →](/congresses/117/bills/s/4348/sections/TVII-702.md)

# TITLE VIII — Advancing regulation of cosmetics, dietary supplements, and in vitro clinical tests

## Subtitle A — Cosmetics

## SEC. 801 Short title.

[Read Section 801 →](/congresses/117/bills/s/4348/sections/TVIII-801.md)

## SEC. 802 Amendments to cosmetic requirements.

[Read Section 802 →](/congresses/117/bills/s/4348/sections/TVIII-802.md)

## SEC. 803 Enforcement and conforming amendments.

[Read Section 803 →](/congresses/117/bills/s/4348/sections/TVIII-803.md)

## SEC. 804 Records inspection.

[Read Section 804 →](/congresses/117/bills/s/4348/sections/TVIII-804.md)

## SEC. 805 Talc-containing cosmetics.

[Read Section 805 →](/congresses/117/bills/s/4348/sections/TVIII-805.md)

## SEC. 806 PFAS in cosmetics.

[Read Section 806 →](/congresses/117/bills/s/4348/sections/TVIII-806.md)

## SEC. 807 Sense of the Senate on animal testing.

[Read Section 807 →](/congresses/117/bills/s/4348/sections/TVIII-807.md)

## SEC. 808 Funding.

[Read Section 808 →](/congresses/117/bills/s/4348/sections/TVIII-808.md)

## Subtitle B — Dietary supplements

## SEC. 811 Regulation of dietary supplements.

[Read Section 811 →](/congresses/117/bills/s/4348/sections/TVIII-811.md)

## Subtitle C — In vitro clinical tests

## SEC. 821 Short title.

[Read Section 821 →](/congresses/117/bills/s/4348/sections/TVIII-821.md)

## SEC. 822 Definitions.

[Read Section 822 →](/congresses/117/bills/s/4348/sections/TVIII-822.md)

## SEC. 823 Regulation of in vitro clinical tests.

[Read Section 823 →](/congresses/117/bills/s/4348/sections/TVIII-823.md)

## SEC. 824 Enforcement and other provisions.

[Read Section 824 →](/congresses/117/bills/s/4348/sections/TVIII-824.md)

## SEC. 825 Transition.

[Read Section 825 →](/congresses/117/bills/s/4348/sections/TVIII-825.md)

## SEC. 826 Emergency use authorization.

[Read Section 826 →](/congresses/117/bills/s/4348/sections/TVIII-826.md)

## SEC. 827 Antimicrobial susceptibility tests.

[Read Section 827 →](/congresses/117/bills/s/4348/sections/TVIII-827.md)

## SEC. 828 Combination products.

[Read Section 828 →](/congresses/117/bills/s/4348/sections/TVIII-828.md)

## SEC. 829 Resources.

[Read Section 829 →](/congresses/117/bills/s/4348/sections/TVIII-829.md)

## SEC. 830 Authorization of appropriations.

[Read Section 830 →](/congresses/117/bills/s/4348/sections/TVIII-830.md)

## SEC. 831 Guidance on Diagnostic Innovation.

[Read Section 831 →](/congresses/117/bills/s/4348/sections/TVIII-831.md)

## SEC. 832 GAO report on unique considerations.

[Read Section 832 →](/congresses/117/bills/s/4348/sections/TVIII-832.md)

# TITLE IX — Other provisions

## SEC. 901 Facilities management.

[Read Section 901 →](/congresses/117/bills/s/4348/sections/TIX-901.md)

## SEC. 902 User fee program transparency and accountability.

[Read Section 902 →](/congresses/117/bills/s/4348/sections/TIX-902.md)

## SEC. 903 OTC hearing aids final rule.

[Read Section 903 →](/congresses/117/bills/s/4348/sections/TIX-903.md)

## SEC. 904 Enhancing coordination and transparency on inspections.

[Read Section 904 →](/congresses/117/bills/s/4348/sections/TIX-904.md)

## SEC. 905 Certificates to foreign governments.

[Read Section 905 →](/congresses/117/bills/s/4348/sections/TIX-905.md)

## SEC. 906 Importation of drugs.

[Read Section 906 →](/congresses/117/bills/s/4348/sections/TIX-906.md)

## SEC. 907 Improving information technology systems of the Food and Drug Administration.

[Read Section 907 →](/congresses/117/bills/s/4348/sections/TIX-907.md)

## SEC. 908 Regulation of certain products as drugs.

[Read Section 908 →](/congresses/117/bills/s/4348/sections/TIX-908.md)

## SEC. 909 Reporting on mailroom and Office of the Executive Secretariat of the Food and Drug Administration.

[Read Section 909 →](/congresses/117/bills/s/4348/sections/TIX-909.md)

## SEC. 910 Protecting infants and improving formula supply.

[Read Section 910 →](/congresses/117/bills/s/4348/sections/TIX-910.md)

## SEC. 911 Predetermined change control plans for devices.

[Read Section 911 →](/congresses/117/bills/s/4348/sections/TIX-911.md)

## SEC. 912 Prohibition against food packaging containing intentionally added PFAS.

[Read Section 912 →](/congresses/117/bills/s/4348/sections/TIX-912.md)

## SEC. 913 Requirements regarding conflicts of interest.

[Read Section 913 →](/congresses/117/bills/s/4348/sections/TIX-913.md)

## SEC. 914 Third party data transparency.

[Read Section 914 →](/congresses/117/bills/s/4348/sections/TIX-914.md)

## SEC. 915 Banned devices.

[Read Section 915 →](/congresses/117/bills/s/4348/sections/TIX-915.md)

## SEC. 916 Device cybersecurity.

[Read Section 916 →](/congresses/117/bills/s/4348/sections/TIX-916.md)

## SEC. 917 Women's Health Research Roadmap.

[Read Section 917 →](/congresses/117/bills/s/4348/sections/TIX-917.md)

## SEC. 918 GAO report on deaths due to the cost of drugs in the United States.

[Read Section 918 →](/congresses/117/bills/s/4348/sections/TIX-918.md)