S. 3252Senate119th Congress (2025-2027)In Committee

FSMA Fee Technical Corrections Act

AI-Generated Summary

Updated December 19, 2025 at 5:13 AM UTC

The FSMA Fee Technical Corrections Act updates the Food Safety Modernization Act’s fee rules so the FDA can more clearly assess and collect reinspection and recall fees. It sets a standard fee amount, provides discounts for small businesses, and clarifies how the fees may be used. The changes affect food facilities, importers, and the FDA’s fee‑collection processes.

Key Provisions

Sets the base fee for reinspection and recall activities at $15,000 (adjusted each fiscal year by a formula) for fiscal year 2026 and onward.
Provides a small‑business discount: eligible facilities or importers pay only one‑third of the standard fee.
Requires the FDA to publish guidance within 270 days on how small businesses can request fee reductions.
Limits the use of collected fees: oversight fees go only to supervising domestic and foreign facilities, while fees for the voluntary qualified importer program go only to that program.
Raises the overall fee‑collection caps from $20 million to $25 million and from $25 million to $30 million.
Adds clear definitions for “reinspection,” “importer,” and “small business” to determine fee applicability.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8277-8278)

Health, Education, Labor, and Pensions Committee

November 20, 2025

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SenateIntro Referral

Introduced in Senate

November 20, 2025

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8277-8278)

Health, Education, Labor, and Pensions Committee

November 20, 2025

Floor Debate

2 members

What members said about S. 3252 on the floor

1 Republican1 Democrat

Sen. Susan M. CollinsR-ME · Nov 20, 2025

Mr. President, I rise to introduce the Alzheimer's Screening and Prevention ASAP Act. This bill would require the Centers for Medicare & Medicaid Services to cover FDA-approved blood-based biomarker tests for Alzheimer's disease, expanding access to earlier and more accurate diagnoses for millions of Americans.

Alzheimer's disease is one of the greatest public health challenges of our time. It currently affects more than 7 million Americans, including an estimated 29,000 individuals in Maine. That number is expected to increase in the coming years as our population ages.

Alzheimer's is also the most expensive disease in America. The cost of caring for people with Alzheimer's and other dementia was an estimated $360 billion in 2024. Total costs are expected to exceed $1 trillion by 2050 unless we take meaningful action.

Early diagnosis of this disease is critical. It allows patients and their families to better plan for the future, access

care and support services, and take advantage of available treatments that are most effective in the early stages. Yet far too many individuals remain undiagnosed until their symptoms become severe.

I have had the privilege of meeting with Mainers from the Alzheimer's Association year after year when they come to Washington. One story stands out to me as an example of the importance of early diagnosis. Ten years ago, Ralph Carmona was diagnosed with mild cognitive impairment resulting from Alzheimer's disease. Because he was diagnosed in the very early stages of disease, Ralph was able to participate in a clinical trial for Leqembi. Leqembi is one of the first disease- modifying therapies approved by the FDA for early treatment of Alzheimer's. Ralph credits this drug with significantly slowing his symptoms. He has even run a marathon since his initial diagnosis.

Recent scientific advances have led to the development of blood-based biomarker tests that can detect Alzheimer's with increasing accuracy. These tests are far less invasive and significantly more affordable than current diagnostic methods, such as PET scans or spinal taps. Earlier this year, FDA approved the first blood test for clinical use. This approval will greatly increase the ability of primary care physicians to diagnose the disease in its very early stages while symptoms are still mild and potentially treatable. The only current treatments available for Alzheimer's disease are approved for patients in the early stages of disease.

An important next step is for CMS to cover this breakthrough. I pushed CMS to cover Leqembi and other early-stage disease-modifying therapies. If the FDA approves a treatment an innovative blood test such as this one, there is no reason why CMS should refuse to cover it.

The ASAP Act would address this gap by requiring CMS to cover FDA- approved blood tests for Alzheimer's once they are deemed safe and effective. The bill also supports the continued development and evaluation of screening practices that reflect the latest in medical science.

As the founder and cochair of the Congressional Alzheimer's Task Force, I have long believed that we must do more to detect Alzheimer's early and expand access to innovations in diagnosis and treatment. I want to thank the Alzheimer's Association for its continued advocacy and for developing this important legislation. Their partnership and dedication to improving the lives of those affected by Alzheimer's have been invaluable.

I look forward to working with my colleagues to ensure swift passage of this bill.

Sen. Richard J. DurbinD-IL · Nov 20, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Sen. Richard J. DurbinD-IL · Nov 20, 2025

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

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Introduced in SenateIssued November 20, 2025

119th CONGRESS

1st Session

S. 3252

IN THE SENATE OF THE UNITED STATES

November 20, 2025

Mr. Durbin (for himself, Mr. Blumenthal, and Mr. Markey) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To make technical corrections to amendments made by the FDA Food Safety Modernization Act to allow the Food and Drug Administration to assess and collect food-related reinspection fees and recall fees, and for other purposes.

Short title

This Act may be cited as the FSMA Fee Technical Corrections Act.

Food-related fees

(a)

In general

Paragraph (2) of section 743(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31(b)) is amended to read as follows:

(2)

Fee methodology; fee amounts

(A)

In general

Subject to adjustments made by the Secretary in accordance with subparagraph (B), fees established for a fiscal year—

(i)

under subsection (a)(1)(A) shall be in the amount equal to $15,000, multiplied, for fiscal year 2026 and each subsequent fiscal year, by the adjustment factor described in subsection (c)(3);

(ii)

under subsection (a)(1)(B) shall be in the amount equal to $15,000, multiplied, for fiscal year 2026 and each subsequent fiscal year, by the adjustment factor described in subsection (c)(3);

(iii)

under subsection (a)(1)(C) shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subsection for such fiscal year; and

(iv)

under subsection (a)(1)(D) shall be in the amount equal to $15,000, multiplied, for fiscal year 2026 and each subsequent fiscal year, by the adjustment factor described in subsection (c)(3).

(B)

Other considerations

(i)

Fee adjustment for small businesses

(I)

In general

In the case of a facility or importer that, at the time of the reinspection or recall order, is a small business as defined in subsection (a)(2)(E), the amount of the fee under subparagraph (A), (B), or (D) of subsection (a)(1), for a fiscal year, shall be adjusted to be equal to 1/3 of the amount of the fee calculated under clause (i), (ii), or (iv) of subparagraph (A), as applicable, for such fiscal year.

(II)

Publication of schedule

The schedule of such adjusted fee amounts shall be published annually with the user fee notice under subsection (e).

(III)

Guidance

Not later than 270 days after the date of enactment of the FSMA Fee Technical Corrections Act, the Secretary shall publish guidance to describe how a food facility or importer may request a fee reduction under this clause, which shall be issued for immediate implementation to facilitate timely fee reductions, as applicable.

(ii)

Voluntary qualified importer program

In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(c) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year.

(iii)

Crediting of carryover fees

In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting toward fee revenue of estimated carryover fee collections from the previous fiscal year if the Secretary overestimated the amount of fees needed to carry out activities described in paragraph (3) for such previous year, and shall account for any adjustment of fees under clause (i).

(b)

Use of fees

Paragraph (3) of section 743(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31(b)) is amended to read as follows:

(3)

Use of fees

(A)

Oversight of facilities and importers

Fees collected pursuant to subparagraphs (A), (B), and (D) of subsection (a)(1) shall be available solely for the costs of oversight of foreign and domestic facilities and importers.

(B)

Voluntary qualified importer program

Fees collected pursuant to subparagraph (C) of subsection (a)(1) shall be available solely for the costs of the voluntary qualified importer program under section 806.

(c)

Limitation on amount

Section 743(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31(c)(4)(A)) is amended—

(1)

in clause (i), by striking $20,000,000 and inserting $25,000,000; and

(2)

in clause (ii), by striking $25,000,000 and inserting $30,000,000.

(d)

Definition of reinspection

Section 743(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31(a)(2)) is amended—

(1)

by amending subparagraph (A) to read as follows:

(A)

the term reinspection means—

(i)

with respect to domestic and foreign facilities, 1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance resulting in a classification of official action indicated, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and

(ii)

with respect to importers, 1 or more inspections conducted under the foreign supplier verification program under section 805 subsequent to an inspection conducted under such provision which identified noncompliance resulting in a classification of official action indicated, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction;

;

(2)

in subparagraph (B)(ii), by striking ; and and inserting a semicolon;

(3)

in subparagraph (C), by striking the period and inserting a semicolon; and

(4)

by adding at the end the following:

(D)

the term importer means an importer of human or animal food that is subject to the foreign supplier verification program requirements under section 805; and

(E)

the term small business means—

(i)

with respect to a domestic or foreign facility, a business (including any subsidiaries or affiliates) employing fewer than 500 full-time equivalent employees;

(ii)

with respect to an importer of human food, an importer (including any subsidiaries and affiliates) averaging less than $1,000,000 per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of human food combined with the United States market value of human food imported, manufactured, processed, packed, or held without sale (such as food imported for a fee); and

(iii)

with respect to an importer of animal food, an importer (including any subsidiaries and affiliates) averaging less than $2,500,000 per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of animal food combined with the United States market value of animal food imported, manufactured, processed, packed, or held without sale (such as food imported for a fee).