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Small Business FDA User Fee Adjustment Act of 2021
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
59pct
3d open
vs 9,698 other HR bills in the 117th — cohort avg 63d
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.)
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (3)
2022 · second_quarter · Pharmacy
OTC switch process -- no bill number H.R. 6000 - 21st Century Cures 2.0 S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021 H.R. 7667 - Food and Drug Amendments of 2022 Dietary Supplement Reform -- no bill number Cosmetics Reform -- no bill number S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 Genus vs. FDA Circuit Court Lobby Activity
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $160,270 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
OTC switch process -- no bill number H.R. 6000 - 21st Century Cures 2.0 S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021 H.R. 7667 - Food and Drug Amendments of 2022 Dietary Supplement Reform -- no bill number Cosmetics Reform -- (Included in H.R. 2617, Consolidated Appropriations Act of 2023) S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 Genus vs. FDA Circuit Court Lobby Activity -- (Included in H.R. 2617, Consolidated Appropriations Act of 2023) S. 4535 - Food and Drug Administration Simple Reauthorization Act of 2022 or the "FDASRA Act of 2022" H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes H.R.2617 - Consolidated Appropriations Act, 2023 H.R.7776 - James M. Inhofe National Defense Authorization Act for Fiscal Year 2023
Client expense: $178,500 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Pharmacy
OTC switch process -- no bill number H.R. 6000 - 21st Century Cures 2.0 S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021 H.R. 7667 - Food and Drug Amendments of 2022 Dietary Supplement Reform -- no bill number Cosmetics Reform -- no bill number S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 Genus vs. FDA Circuit Court Lobby Activity S. 4535 - Food and Drug Administration Simple Reauthorization Act of 2022 or the "FDASRA Act of 2022" H.R.6833 - Making continuing appropriations for fiscal year 2023, and for other purposes
Client expense: $142,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Pharmacy
OTC switch process -- no bill number H.R. 6000 - 21st Century Cures 2.0 S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021 H.R. 7667 - Food and Drug Amendments of 2022 Dietary Supplement Reform -- no bill number Cosmetics Reform -- no bill number S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 or the FDASLA Act of 2022 Genus vs. FDA Circuit Court Lobby Activity
Client expense: $160,270 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Pharmacy
OTC switch process -- no bill number Cures 2.0 -- no bill number S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021 Prescription Drug User Fee Act (PDUFA) -- no bill number Dietary Supplement Reform -- no bill number Cosmetics Reform -- no bill number
Client expense: $156,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Taxation/Internal Revenue Code
Implementation of the Restoring Access to Medications Act included in PL 116-136 the Coronavirus Aid, Relief and Economic Security Act. Issues related to supplements. Issues related to the implementation and collection of User Fees for over the counter medicines regulated by monograph, including H.R. 4405, Small Business FDA User Fee Adjustment Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Pharmacy
OTC switch process -- no bill number Cures 2.0 -- no bill number S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021
Client expense: $184,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of
2021 · fourth_quarter · Aerospace
Launch services for the United States Government and other entities. H.R. 4350, S.1605, Fiscal Year 2022 National Defense Authorization Act; H.R. 4432, H.R. 4405, Fiscal Year 2022 appropriations for defense and NASA (Commerce, Justice, Science, and Related Agencies), respectively. S.3023, S.3042, Fiscal Year 2022 appropriations for defense and NASA (Commerce, Justice, Science, and Related Agencies), respectively.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Taxation/Internal Revenue Code
Implementation of the Restoring Access to Medications Act included in PL 116-136 the Coronavirus Aid, Relief and Economic Security Act. Issues related to supplements. Issues related to the implementation and collection of User Fees for over the counter medicines regulated by monograph, including H.R. 4405, Small Business FDA User Fee Adjustment Act of 2021.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Aerospace
Launch services for the United States Government and other entities. H.R. 4350, S.2792, Fiscal Year 2022 National Defense Authorization Act; H.R. 4432, H.R. 4405, Fiscal Year 2022 appropriations for defense and NASA, respectively (Senate bill numbers pending).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Pharmacy
OTC switch process -- no bill number Cures 2.0 -- no bill number S.1435/HR 2873 - Affordable Prescriptions for Patients Act of 2021 H.R.4405 - Small Business FDA User Fee Adjustment Act of 2021
Client expense: $133,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of