[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2292 Reported in Senate (RS)]
<DOC>
Calendar No. 152
119th CONGRESS
1st Session
S. 2292
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user fee program for over-the-counter monograph drugs, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 15, 2025
Mr. Banks (for himself, Mr. Kaine, Mr. Kim, and Mr. Husted) introduced
the following bill; which was read twice and referred to the Committee
on Health, Education, Labor, and Pensions
September 8, 2025
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user fee program for over-the-counter monograph drugs, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Over-the-Counter Monograph
Drug User Fee Amendments''.</DELETED>
<DELETED>SEC. 2. FINDING.</DELETED>
<DELETED> Congress finds that the fees authorized by the amendments
made in this Act will be dedicated to OTC monograph drug activities, as
set forth in the goals identified for purposes of part 10 of subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-71 et seq.), in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Energy and Commerce of the
House of Representatives and the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate, as set forth in the
Congressional Record.</DELETED>
<DELETED>SEC. 3. DEFINITIONS.</DELETED>
<DELETED> Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-71(9)(A)) is amended--</DELETED>
<DELETED> (1) in clause (v), by striking ``; or'' and
inserting a semicolon;</DELETED>
<DELETED> (2) in clause (vi)--</DELETED>
<DELETED> (A) by striking ``addition'' and inserting
``the addition''; and</DELETED>
<DELETED> (B) by striking the period and inserting
``; or''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(vii) the addition or modification of a
testing procedure applicable to one or more OTC
monograph drugs, provided that such additional or
modified testing procedure reflects a voluntary
consensus standard with respect to pharmaceutical
quality that is--</DELETED>
<DELETED> ``(I) established by a national or
international standards development
organization; and</DELETED>
<DELETED> ``(II) recognized by the Secretary
through a process described in guidance for
industry, initially published in July 2023, or
any successor guidance, publicly available on
the website of the Food and Drug
Administration, which addresses voluntary
consensus standards for pharmaceutical
quality.''.</DELETED>
<DELETED>SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH
FEES.</DELETED>
<DELETED> (a) Types of Fees.--Section 744M(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(a)(1)) is amended--
</DELETED>
<DELETED> (1) in subparagraph (A)--</DELETED>
<DELETED> (A) by striking ``on December 31 of the
fiscal year or at any time during the preceding 12-
month period'' and inserting ``at any time during the
applicable period specified in clause (ii) for a fiscal
year'';</DELETED>
<DELETED> (B) by striking ``Each person'' and
inserting the following:</DELETED>
<DELETED> ``(i) Assessment of fees.--Each
person''; and</DELETED>
<DELETED> (C) by adding at the end the
following:</DELETED>
<DELETED> ``(ii) Applicable period.--For
purposes of clause (i), the applicable period
is--</DELETED>
<DELETED> ``(I) for fiscal year
2026, the 12-month period ending on
December 31, 2025;</DELETED>
<DELETED> ``(II) for fiscal year
2027, the 9-month period ending on
September 30, 2026; and</DELETED>
<DELETED> ``(III) for fiscal year
2028 and each subsequent fiscal year,
the 12-month period ending on September
30 of the preceding fiscal
year.'';</DELETED>
<DELETED> (2) in subparagraph (B)(i), by amending subclause
(I) to read as follows:</DELETED>
<DELETED> ``(I) has ceased all
activities related to OTC monograph
drugs prior to--</DELETED>
<DELETED> ``(aa) for
purposes of fiscal year 2026,
January 1, 2025;</DELETED>
<DELETED> ``(bb) for
purposes of fiscal year 2027,
January 1, 2026; and</DELETED>
<DELETED> ``(cc) for
purposes of fiscal year 2028
and each subsequent fiscal
year, October 1 of the
preceding fiscal year; and'';
and</DELETED>
<DELETED> (3) by amending subparagraph (D) to read as
follows:</DELETED>
<DELETED> ``(D) Due date.--</DELETED>
<DELETED> ``(i) Fiscal year 2026.--For
fiscal year 2026, the facility fees required
under subparagraph (A) shall be due on the
later of--</DELETED>
<DELETED> ``(I) the first business
day of June of such year; or</DELETED>
<DELETED> ``(II) the first business
day after the enactment of an
appropriations Act providing for the
collection and obligation of fees under
this section for such year.</DELETED>
<DELETED> ``(ii) Fiscal year 2027.--For
fiscal year 2027, the facility fees required
under subparagraph (A) shall be due--</DELETED>
<DELETED> ``(I) in a first
installment representing 50 percent of
such fee, on the later of--</DELETED>
<DELETED> ``(aa) October 1,
2026; or</DELETED>
<DELETED> ``(bb) the first
business day after the
enactment of an appropriations
Act providing for the
collection and obligation of
fees under this section for
such year; and</DELETED>
<DELETED> ``(II) in a second
installment representing the remaining
50 percent of such fee, on--</DELETED>
<DELETED> ``(aa) February 1,
2027; or</DELETED>
<DELETED> ``(bb) if an
appropriations Act described in
subclause (I)(bb) is not in
effect on February 1, 2027, the
first business day after
enactment of such an
appropriations Act.</DELETED>
<DELETED> ``(iii) Subsequent fiscal years.--
For fiscal year 2028 and each subsequent fiscal
year, the facility fees required under
subparagraph (A) shall be due on the later of--
</DELETED>
<DELETED> ``(I) the first business
day on or after October 1 of the fiscal
year; or</DELETED>
<DELETED> ``(II) the first business
day after the date of enactment of an
appropriations Act providing for the
collection and obligation of fees under
this section for the fiscal
year.''.</DELETED>
<DELETED> (b) Fee Revenue Amounts.--Section 744M(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(b)) is amended to read
as follows:</DELETED>
<DELETED> ``(b) Fee Revenue Amounts.--</DELETED>
<DELETED> ``(1) In general.--For each of the fiscal years
2026 through 2030, fees under subsection (a)(1) shall be
established to generate a total facility fee revenue amount
equal to the sum of--</DELETED>
<DELETED> ``(A) the annual base revenue for the
fiscal year (as determined under paragraph
(2));</DELETED>
<DELETED> ``(B) the dollar amount equal to the
inflation adjustment for the fiscal year (as determined
under subsection (c)(1));</DELETED>
<DELETED> ``(C) the dollar amount equal to the
operating reserve adjustment for the fiscal year, if
applicable (as determined under subsection
(c)(2));</DELETED>
<DELETED> ``(D) additional direct cost adjustments
(as determined under subsection (c)(3));</DELETED>
<DELETED> ``(E) an additional dollar amount equal
to--</DELETED>
<DELETED> ``(i) $2,373,000 for fiscal year
2026;</DELETED>
<DELETED> ``(ii) $1,233,000 for fiscal year
2027; and</DELETED>
<DELETED> ``(iii) $854,000 for fiscal year
2028; and</DELETED>
<DELETED> ``(F) in the case of a fiscal year for
which the Secretary applies the one-time facility fee
workload adjustment under subsection (c)(4), the dollar
amount equal to such adjustment.</DELETED>
<DELETED> ``(2) Annual base revenue.--For purposes of
paragraph (1), the dollar amount of the annual base revenue for
a fiscal year shall be--</DELETED>
<DELETED> ``(A) for fiscal year 2026, the dollar
amount of the total revenue amount established for
fiscal year 2025 under this subsection as in effect on
the day before the date of enactment of the Over-the-
Counter Monograph Drug User Fee Amendments, not
including any adjustments made for such fiscal year
2025 under subsection (c)(2), as so in effect;
and</DELETED>
<DELETED> ``(B) for fiscal years 2027 through 2030,
the dollar amount of the total revenue amount
established under this subsection for the previous
fiscal year, not including any adjustments made for
such previous fiscal year under subsection (c)(2) or
(c)(3).''.</DELETED>
<DELETED> (c) Adjustments; Annual Fee Setting.--Section 744M(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72) is
amended--</DELETED>
<DELETED> (1) in paragraph (1)--</DELETED>
<DELETED> (A) in subparagraph (A), in the matter
preceding clause (i)--</DELETED>
<DELETED> (i) by striking ``subsection
(b)(2)(B)'' and inserting ``subsection
(b)(1)(B)''; and</DELETED>
<DELETED> (ii) by striking ``fiscal year
2022 and each subsequent fiscal year'' and
inserting ``each fiscal year'';</DELETED>
<DELETED> (B) in subparagraph (B), by striking
``fiscal year 2022'' and all that follows through the
period at the end and inserting the following: ``a
fiscal year shall be equal to the product of--
</DELETED>
<DELETED> ``(i) for fiscal year 2026--
</DELETED>
<DELETED> ``(I) the fee for fiscal
year 2025 under subsection (a)(2);
and</DELETED>
<DELETED> ``(II) the inflation
adjustment percentage under
subparagraph (C); and</DELETED>
<DELETED> ``(ii) for each of fiscal years
2027 through 2030--</DELETED>
<DELETED> ``(I) the applicable fee
under subsection (a)(2) for the
preceding fiscal year; and</DELETED>
<DELETED> ``(II) the inflation
adjustment percentage under
subparagraph (C).''; and</DELETED>
<DELETED> (C) in subparagraph (C)--</DELETED>
<DELETED> (i) in the matter preceding clause
(i), by inserting ``the sum of'' after ``is
equal to'';</DELETED>
<DELETED> (ii) by striking clause
(i);</DELETED>
<DELETED> (iii) by redesignating subclauses
(I) and (II) of clause (ii) as clauses (i) and
(ii), respectively, and adjusting the margins
accordingly;</DELETED>
<DELETED> (iv) by striking ``(ii) for each
of fiscal years 2024 and 2025, the sum of--'';
and</DELETED>
<DELETED> (v) in clause (ii), as so
redesignated, by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting
``Washington-Arlington-Alexandria-DC-VA-MD-
WV'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) in subparagraph (A)--</DELETED>
<DELETED> (i) by striking ``fiscal year 2021
and subsequent fiscal years'' and inserting
``each fiscal year'';</DELETED>
<DELETED> (ii) by striking ``subsections
(b)(1)(B) and (b)(2)(C)'' and inserting
``subsection (b)(1)(C)''; and</DELETED>
<DELETED> (iii) by striking ``the number of
weeks specified in subparagraph (B)'' and
inserting ``10 weeks'';</DELETED>
<DELETED> (B) by striking subparagraph
(B);</DELETED>
<DELETED> (C) by redesignating subparagraphs (C) and
(D) as subparagraphs (B) and (C), respectively;
and</DELETED>
<DELETED> (D) in subparagraph (C), as so
redesignated, by striking ``paragraph (4)
establishing'' and inserting ``paragraph (5)
publishing'';</DELETED>
<DELETED> (3) in paragraph (3)--</DELETED>
<DELETED> (A) in the matter preceding subparagraph
(A), by striking ``subsection (b)(2)(D)'' and inserting
``subsection (b)(1)(D)''; and</DELETED>
<DELETED> (B) by striking subparagraphs (A) through
(E) and inserting the following:</DELETED>
<DELETED> ``(A) $135,000 for fiscal year
2026;</DELETED>
<DELETED> ``(B) $300,000 for fiscal year
2027;</DELETED>
<DELETED> ``(C) $55,000 for fiscal year
2028;</DELETED>
<DELETED> ``(D) $30,000 for fiscal year 2029;
and</DELETED>
<DELETED> ``(E) $0 for fiscal year 2030.'';
and</DELETED>
<DELETED> (4) by striking paragraph (4) and inserting the
following:</DELETED>
<DELETED> ``(4) One