[Congressional Record Volume 171, Number 196 (Thursday, November 20, 2025)]
[Senate]
[Page S8270]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. DURBIN (for himself, Mr. Blumenthal, and Mr. Markey):
S. 3252. 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; to the Committee on Health,
Education , Labor, and Pensions.
Mr. DURBIN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 3252
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FSMA Fee Technical
Corrections Act''.
SEC. 2. 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;''; and
(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).''.
______
By Mr. DURBIN (for himself, Ms. Duckworth, and Mrs. Gillibrand):
S. 3253. A bill to amend the Servicemembers Civil Relief Act to
extend the interest rate limitation on debt entered into during
military service to debt incurred during military service to
consolidate or refinance student loans incurred before military
service, and for other purposes; to the Committee on Veterans' Affairs.
Mr. DURBIN. Mr. President, I ask unanimous consent that the text of
the bill be printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 3253
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Servicemember Student Loan
Affordability Act of 2025''.
SEC. 2. INTEREST RATE LIMITATION ON DEBT ENTERED INTO DURING
MILITARY SERVICE TO CONSOLIDATE OR REFINANCE
STUDENT LOANS INCURRED BEFORE MILITARY SERVICE.
(a) In General.--Subsection (a) of section 207 of the
Servicemembers Civil Relief Act (50 U.S.C. 3937) is amended--
(1) in paragraph (1), by inserting ``on debt incurred
before service'' after ``Limitation to 6 percent'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(3) by inserting after paragraph (1) the following new
paragraph (2):
``(2) Limitation to 6 percent on debt incurred during
military service to consolidate or refinance student loans
incurred before military service.--
``(A) In general.--Subject to subparagraph (B), an
obligation or liability bearing interest at a rate in excess
of 6 percent per year that is incurred by a servicemember, or
the servicemember and the servicemember's spouse jointly,
during military service to consolidate or refinance one or
more student loans incurred by the servicemember before such
military service shall not bear an interest at a rate in
excess of 6 percent during the period of military service.
``(B) Limitation.--Subparagraph (A) shall apply only to the
consolidation or refinancing of student loans described in
such subparagraph and shall not apply to the consolidation or
refinancing of any other obligation or liability.'';
(4) in paragraph (3), as redesignated by paragraph (2) of
this subsection, by inserting ``or (2)'' after ``paragraph
(1)''; and
(5) in paragraph (4), as so redesignated, by striking
``paragraph (2)'' and inserting ``paragraph (3)''.
(b) Implementation of Limitation.--Subsection (b) of such
section is amended--
(1) in paragraph (1)(A), by striking ``the interest rate
limitation in subsection (a)'' and inserting ``an interest
rate limitation in paragraph (1) or (2) of subsection (a)'';
and
(2) in paragraph (2)--
(A) in the paragraph heading, by striking ``effective as of
date of order to active duty'' and inserting ``effective
date''; and
(B) by inserting before the period at the end the
following: ``in the case of an obligation or liability
covered by subsection (a)(1), or as of the date the
servicemember (or servicemember and spouse jointly) incurs
the obligation or liability concerned under subsection
(a)(2)''.
(c) Student Loan Defined.--Subsection (d) of such section
is amended by adding at the end the following new paragraph:
``(3) Student loan.--The term `student loan' means--
``(A) a Federal student loan made, insured, or guaranteed
under title IV of the Higher Education Act of 1965 (20 U.S.C.
1070 et seq.); or
``(B) a private education loan as that term is defined in
section 140(a) of the Truth in Lending Act (15 U.S.C.
1650(a)).''.
______
By Ms. COLLINS (for herself, Ms. Cortez Masto, Mrs. Capito, and
Mr. Warner):
S. 3267. A bill to amend title XVIII of the Social Security Act to
provide for Medicare coverage of blood-based dementia screening tests;
to the Committee on Finance.
Ms. COLLINS. 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.
____________________