[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4273 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 4273
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 HOUSE OF REPRESENTATIVES
July 2, 2025
Mr. Latta (for himself, Ms. DeGette, Mr. Crenshaw, and Mrs. Dingell)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Over-the-Counter Monograph Drug User
Fee Amendments''.
SEC. 2. FINDING.
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.
SEC. 3. DEFINITIONS.
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-71(9)(A)) is amended--
(1) in clause (v), by striking ``; or'' and inserting a
semicolon;
(2) in clause (vi)--
(A) by striking ``addition'' and inserting ``the
addition''; and
(B) by striking the period and inserting ``; or'';
and
(3) by adding at the end the following:
``(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--
``(I) established by a national or
international standards development
organization; and
``(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
agency website, which addresses voluntary
consensus standards for pharmaceutical
quality.''.
SEC. 4. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.
(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--
(1) in subparagraph (A)--
(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'';
(B) by striking ``Each person'' and inserting the
following:
``(i) Assessment of fees.--Each person'';
and
(C) by adding at the end the following:
``(ii) Applicable period.--For purposes of
clause (i), the applicable period is--
``(I) for fiscal year 2026, the 12-
month period ending on December 31,
2025;
``(II) for fiscal year 2027, the 9-
month period ending on September 30,
2026; and
``(III) for fiscal year 2028 and
each subsequent fiscal year, the 12-
month period ending on September 30 of
the preceding fiscal year.'';
(2) in subparagraph (B)(i), by amending subclause (I) to
read as follows:
``(I) has ceased all activities
related to OTC monograph drugs prior
to--
``(aa) for purposes of
fiscal year 2026, January 1,
2025;
``(bb) for purposes of
fiscal year 2027, January 1,
2026; and
``(cc) for purposes of
fiscal year 2028 and each
subsequent fiscal year, October
1 of the preceding fiscal year;
and''; and
(3) by amending subparagraph (D) to read as follows:
``(D) Due date.--
``(i) Fiscal year 2026.--For fiscal year
2026, the facility fees required under
subparagraph (A) shall be due on the later of--
``(I) the first business day of
June of such year; or
``(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.
``(ii) Fiscal year 2027.--For fiscal year
2027, the facility fees required under
subparagraph (A) shall be due--
``(I) in a first installment
representing 50 percent of such fee, on
the later of--
``(aa) October 1, 2026; or
``(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
``(II) in a second installment
representing the remaining 50 percent
of such fee, on--
``(aa) February 1, 2027; or
``(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.
``(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--
``(I) the first business day on or
after October 1 of the fiscal year; or
``(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.''.
(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:
``(b) Fee Revenue Amounts.--
``(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--
``(A) the annual base revenue for the fiscal year
(as determined under paragraph (2));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(2));
``(D) additional direct cost adjustments (as
determined under subsection (c)(3));
``(E) an additional dollar amount equal to--
``(i) $2,373,000 for fiscal year 2026;
``(ii) $1,233,000 for fiscal year 2027; and
``(iii) $854,000 for fiscal year 2028; and
``(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.
``(2) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(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
``(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).''.
(c) Adjustments; Annual Fee Setting.--Section 744M(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), in the matter preceding
clause (i)--
(i) by striking ``subsection (b)(2)(B)''
and inserting ``subsection (b)(1)(B)''; and
(ii) by striking ``fiscal year 2022 and
each subsequent fiscal year'' and inserting
``each fiscal year'';
(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--
``(i) for fiscal year 2026--
``(I) the fee for fiscal year 2025
under subsection (a)(2); and
``(II) the inflation adjustment
percentage under subparagraph (C); and
``(ii) for each of fiscal years 2027
through 2030--
``(I) the applicable fee under
subsection (a)(2) for the preceding
fiscal year; and
``(II) the inflation adjustment
percentage under subparagraph (C).'';
and
(C) in subparagraph (C)--
(i) in the matter preceding clause (i), by
inserting ``the sum of'' after ``is equal to'';
(ii) by striking clause (i);
(iii) by redesignating subclauses (I) and
(II) as clauses (i) and (ii), respectively, and
adjusting the margins accordingly;
(iv) by striking ``(ii) for each of fiscal
years 2024 and 2025, the sum of''; and
(v) in clause (ii), as so redesignated, by
striking ``Washington-Baltimore, DC-MD-VA-WV''
and inserting ``Washington-Arlington-
Alexandria-DC-VA-MD-WV'';
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``fiscal year 2021 and
subsequent fiscal years'' and inserting ``each
fiscal year'';
(ii) by striking ``subsections (b)(1)(B)
and (b)(2)(C)'' and inserting ``subsection
(b)(1)(C)''; and
(iii) by striking ``the number of weeks
specified in subparagraph (B)'' and inserting
``10 weeks'';
(B) by striking subparagraph (B);
(C) by redesignating subparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(D) in subparagraph (C), as so redesignated, by
striking ``paragraph (4) establishing'' and inserting
``paragraph (5) publishing'';
(3) in paragraph (3)--
(A) in the matter preceding subparagraph (A), by
striking ``subsection (b)(2)(D)'' and inserting
``subsection (b)(1)(D)''; and
(B) by striking subparagraphs (A) through (E) and
inserting the following:
``(A) $135,000 for fiscal year 2026;
``(B) $300,000 for fiscal year 2027;
``(C) $55,000 for fiscal year 2028;
``(D) $0 for fiscal year 2029; and
``(E) $30,000 for fiscal year 2030.''; and
(4) by striking paragraph (4) and inserting the following:
``(4) One-time facility fee workload adjustment.--
``(A) In general.--In addition to the adjustments
under paragraphs (1), (2), and (3), the Secretary may
further increase the fee revenues and fees through a
one-time adjustment made for fiscal year 2028, 2029, or
2030, in accordance with this paragraph.
``(B) Adjustment described.--
``(i) Conditions for adjustment.--An
adjustment under this paragraph may be made for
a fiscal year only if--
``(I) an adjustment under this
paragraph had not been made for any
prior fiscal year;
``(II) the average number of OTC
monograph drug facilities subject to a
facility fee under subsection (a)(1)
over the period of the preceding 3
fiscal years exceeds 1,625; and
``(III) with respect to facilities
described in subclause (II), the
average number of such facilities
(expressed as a percentage) that
appeared on the arrears lists pursuant
to subsection (e)(1)(A)(i) over the
period of the preceding 3 fiscal years
is less than 30 percent.
``(ii) Amount of adjustment.--An adjustment
under this paragraph for a fiscal year shall
equal the product of--
``(I) the total facility revenue
amount determined under subsection (b)
for the fiscal year, exclusive of the
adjustment under this paragraph for
such fiscal year; and
``(II) the excess facility
percentage described in clause (iii).
``(iii) Excess facility percentage.--The
excess facility percentage described in this
clause is--
``(I) the amount by which the
average number of OTC monograph drug
facilities subject to a facility fee
under subsection (a)(1) over the
preceding 3 fiscal years exceeds 1,625;
divided by
``(II) 1,625.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the first day of each fiscal year--
``(A) establish for such fiscal year, based on the
revenue amounts under subsection (b) and the
adjustments provided under this subsection--
``(i) OTC monograph drug facility fees
under subsection (a)(1); and
``(ii) OTC monograph order request fees
under subsection (a)(2); and
``(B) publish such fee revenue amounts, facility
fees, and OTC monograph order request fees in the
Federal Register.''.
(d) Crediting and Availability of Fees.--Section 744M(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(f)) is
amended--
(1) in paragraph (2)(D)--
(A) in the subparagraph heading, by striking ``in
subsequent years''; and
(B) by striking ``(after fiscal year 2021)''; and
(2) in paragraph (3), by striking ``2021 through 2025'' and
inserting ``2026 through 2030''.
SEC. 5. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-73) is ame