Except as expressly provided otherwise, any reference to contained in any division of this Act shall be treated as referring only to the provisions of that division.
Section 10503(b)(1) of the Patient Protection and Affordable Care Act () is amended— 42 U.S.C. 254b–2(b)(1)
in subparagraph (I), by striking at the end; and
$606,904,110 for the period beginning on October 1, 2025, and ending on November 21, 2025; and
by adding at the end the following:
(b) Extension for the National Health Service Corps
Section 10503(b)(2) of the Patient Protection and Affordable Care Act () is amended— 42 U.S.C. 254b–2(b)(2)
in subparagraph (J), by striking and at the end;
in subparagraph (K), by striking the period at the end and inserting ; and; and
$49,150,685 for the period beginning on October 1, 2025, and ending on November 21, 2025.
by adding at the end the following:
(c) Teaching health centers that operate graduate medical education programs
Section 340H(g)(1) of the Public Health Service Act () is amended— 42 U.S.C. 256h(g)(1)
in subparagraph (E), by striking and at the end;
in subparagraph (F), by striking the period at the end and inserting ; and; and
$24,931,507 for the period beginning on October 1, 2025, and ending on November 21, 2025.
by adding at the end the following:
(d) Application of provisions
Amounts appropriated pursuant to the amendments made by this section shall be subject to the requirements contained in for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (). Public Law 117–328; 42 U.S.C. 254b et seq.
(e) Conforming amendment
Section 3014(h)(4) of title 18, United States Code, is amended by striking and section 2101(d) of division B of the Full-Year Continuing Appropriations and Extensions Act, 2025and inserting section 2101(d) of division B of the Full-Year Continuing Appropriations and Extensions Act, 2025, and section 101(d) of title I of division C of the Continuing Appropriations and Extensions Act, 2026.
(a) Extension of special diabetes programs for type i diabetes
Section 330B(b)(2) of the Public Health Service Act () is amended— 42 U.S.C. 254c–2(b)(2)
in subparagraph (F), by striking and at the end;
in subparagraph (G), by striking the period at the end and inserting ; and; and
$22,652,055 for the period beginning on October 1, 2025, and ending on November 21, 2025, to remain available until expended.
Section 1886(d)(12) of the Social Security Act () is amended— 42 U.S.C. 1395ww(d)(12)
in subparagraph (B), by striking in fiscal year 2026and inserting during the portion of fiscal year 2026 beginning on November 22, 2025, and ending on September 30, 2026, and in fiscal year 2027;
in subparagraph (C)(i)—
in the matter preceding subclause (I)—
(i) by inserting after ; and
(ii) by inserting after ;
in subclause (III), by inserting after ; and
in subclause (IV), by striking fiscal year 2026and inserting the portion of fiscal year 2026 beginning on November 22, 2025, and ending on September 30, 2026, and fiscal year 2027; and
in subparagraph (D)—
in the matter preceding clause (i), by inserting after ; and
in clause (ii), by inserting after .
(b) Implementation
Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by this section by program instruction or otherwise.
(a) In general
Section 1886(d)(5)(G) of the Social Security Act () is amended— 42 U.S.C. 1395ww(d)(5)(G)
in clause (i), by striking October 1, 2025and inserting November 22, 2025; and
in clause (ii)(II), by striking October 1, 2025and inserting November 22, 2025.
(b) Conforming amendments
(1) In general
Section 1886(b)(3)(D) of the Social Security Act () is amended— 42 U.S.C. 1395ww(b)(3)(D)
in the matter preceding clause (i), by striking October 1, 2025and inserting November 22, 2025; and
in clause (iv), by inserting after .
(2) Permitting hospitals to decline reclassification
Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of 1993 ( note) is amended by inserting after . 42 U.S.C. 1395ww
Section 1834(l) of the Social Security Act () is amended— 42 U.S.C. 1395m(l)
in paragraph (12)(A), by striking October 1, 2025and inserting November 22, 2025; and
in paragraph (13), by striking each place it appears and inserting in each such place.
Section 1890(d)(2) of the Social Security Act () is amended— 42 U.S.C. 1395aaa(d)(2)
in the first sentence, by striking September 30, 2025and inserting November 21, 2025; and
in the third sentence, by striking and inserting .
Section 510 of the Social Security Act () is amended— 42 U.S.C. 710
in subsection (a)—
in paragraph (1)—
(i) by striking 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, for the period beginning on January 20, 2024, and ending on March 8, 2024, for the period beginning on March 9, 2024, and ending on September 30, 2024, and for fiscal year 2025and inserting 2025, and for the period beginning on October 1, 2025, and ending on November 21, 2025; and
(ii) by striking fiscal year 2024and inserting fiscal year 2026; and
in paragraph (2)—
(i) in subparagraph (A)—
by striking through 2023and inserting through 2025;
by striking fiscal year 2024 or 2025and inserting fiscal year 2026; and
by inserting after ; and
(ii) in subparagraph (B)(i), by striking and inserting ; and
in subsection (f)(1) by striking 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on January 20, 2024, and ending on March 8, 2024, an amount equal to the pro rata portion of the amount appropriated for the period at the end of the corresponding sentence for fiscal year 2023, for the period beginning on March 9, 2024, and ending on September 30, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, and for fiscal year 2025, an amount equal to the amount appropriated for fiscal year 2024and inserting 2025, and for the period beginning on October 1, 2025, and ending on November 21, 2025, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2025.
Section 513 of the Social Security Act () is amended— 42 U.S.C. 713
in subsection (a)(1)—
in subparagraph (A), in the matter preceding clause (i), by striking 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, for the period beginning on January 20, 2024, and ending on March 8, 2024, for the period beginning on March 9, 2024, and ending on September 30, 2024, and for fiscal year 2025and inserting 2025, and for the period beginning on October 1, 2025, and ending on November 21, 2025; and
Section 1923(f)(6)(A)(vi) of the Social Security Act () is amended— 42 U.S.C. 1396r–4(f)(6)(A)(vi)
in the heading, by inserting after ; and
by inserting before the period.
(b) Delaying DSH allotment reductions
Section 1923(f) of the Social Security Act () is amended— 42 U.S.C. 1396r–4(f)
in paragraph (7)(A)—
in clause (i)—
(i) in the matter preceding subclause (I), by striking For each of fiscal years 2026 through 2028and inserting For the period beginning November 22, 2025, and ending September 30, 2026, and for each of fiscal years 2027 and 2028;
(ii) in subclause (I), by inserting after ; and
(iii) in subclause (II), by inserting after ; and
in clause (ii), by striking for each of fiscal years 2026 through 2028and inserting for the period beginning November 22, 2025, and ending September 30, 2026, and for each of fiscal years 2027 and 2028; and
This title may be cited as the Over-the-Counter Monograph Drug User Fee Amendments.
Congress finds that the fees authorized by the amendments made in this title will be dedicated to over-the-counter (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 (), 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. 21 U.S.C. 379j–71 et seq.
Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–71(9)(A)
in clause (v), by striking and inserting a semicolon;
in clause (vi)—
by adding at the end the following:
(a) Types of fees
Section 744M(a)(1) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–72(a)(1)
Types of fees
in subparagraph (A)—
by striking on December 31 of the fiscal year or at any time during the preceding 12-month periodand inserting at any time during the applicable period specified in clause (ii) for a fiscal year;
by striking and inserting the following:
(i) Each person
(ii) For purposes of clause (i), the applicable period is—
for fiscal year 2026, the 12-month period ending on December 31, 2025;
for fiscal year 2027, the 9-month period ending on September 30, 2026; and
for fiscal year 2028 and each subsequent fiscal year, the 12-month period ending on September 30 of the preceding fiscal year.
by adding at the end the following:
has ceased all activities related to OTC monograph drugs prior to—
for purposes of fiscal year 2026, January 1, 2025;
for purposes of fiscal year 2027, January 1, 2026; and
for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and
in subparagraph (B)(i), by amending subclause (I) to read as follows:
(D) Due date
(i) For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of—
the first business day of June of such year; or
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) For fiscal year 2027, the facility fees required under subparagraph (A) shall be due—
in a first installment representing 50 percent of such fee, on the later of—
Section 118(a) of division BB of the Consolidated Appropriations Act, 2021 () is amended— Public Law 116–260
by striking and inserting the following:
otherwise appropriated—
to the Secretary of Health and Human Services
in paragraph (1), as so inserted, by striking September 30, 2025.and inserting November 21, 2025; and; and
to the Secretary of Health and Human Services, in addition to amounts otherwise appropriated under paragraph (1), $15,000,000 for the period beginning on October 1, 2025, and ending on November 21, 2025.
Section 1710(f)(2)(B) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
Section 1710A(d) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
Section 201(j) of the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019 (; note) is amended by striking the date that is three years after the date on which the first grant is awarded under this sectionand inserting November 21, 2025. Public Law 116–171; 38 U.S.C. 1720F
Section 2(d) of the Sgt. Ketchum Rural Veterans Mental Health Act of 2021 (; note) is amended by striking and inserting . Public Law 117–21; 38 U.S.C. 1712A
Section 202(b)(2) of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 () is amended by striking On a quarterly basis during the two-year period beginning on the date of the enactment of this Act,and inserting On a quarterly basis during the period beginning on the date of the enactment of this Act and ending on December 31, 2026,. Public Law 117–168
Section 3699(c)(2)(C) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
Section 2002(a)(4) of the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 (; note) is amended by striking five yearsand inserting six years. Public Law 116–315; 38 U.S.C. 5101
Section 315(b) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
Section 2021A(f)(1) of title 38, United States Code, is amended by striking and inserting .
(a) General treatment
Section 2031(b) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
(b) Additional services at certain locations
Section 2033(d) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
Of the amounts appropriated to the Department of Veterans Affairs for fiscal year 2026 for , $92,000,000 shall be available until November 21, 2025, to carry out subsections (a), (b), and (c) of section 2044 of title 38, United States Code. Medical Services
Of the amounts appropriated to the Department of Veterans Affairs for fiscal year 2026 for , $833,333 shall be available until November 21, 2025, for the purposes of the program under section 2061 of title 38, United States Code. Medical Services
Section 2102A(e) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
Section 2108(g) of title 38, United States Code, is amended by striking September 30, 2025and inserting November 21, 2025.
(a) Clarification of relationship to other powers of Secretary
Section 3720(h) of title 38, United States Code, is amended by striking of subsection (a)and all that follows through the period at the end and inserting of subsection (a) in conjunction with the purchase of a loan under section 3732(a)(2) of this title unless the Secretary determines the purchase would be made consistent with section 3732(d) of this title..
(b) Administration of Partial Claim Program
Section 3737 of such title is amended—
in subsection (b)(2), by striking first lien guaranteed loan for such propertyand inserting amount of indebtedness under the guaranteed loan that the Secretary does not purchase; and
in subsection (c)—
in paragraph (2)(B)(ii), by striking 120 daysand inserting 180 days; and
An amount paid to the holder of a loan as a partial claim—
shall not alter the guaranty calculation specified by section 3703 of this title;
shall be included, for the purpose of a liquidation sale, in the same manner as any other advance allowed by the Secretary; and
shall not be claimed under the guaranty or increase the Secretary’s cost of acquisition of the property securing the defaulted loan.
(b) Extending funding for special diabetes programs for Indians
Section 330C(c)(2) of the Public Health Service Act () is amended— 42 U.S.C. 254c–3(c)(2)
in subparagraph (F), by striking and at the end;
in subparagraph (G), by striking the period at the end and inserting ; and; and
$22,652,055 for the period beginning on October 1, 2025, and ending on November 21, 2025, to remain available until expended.
by adding at the end the following:
Section 319(e)(8) of the Public Health Service Act () is amended by striking September 30, 2025and inserting November 21, 2025. 42 U.S.C. 247d(e)(8)
Section 319L(e)(1)(D) of the Public Health Service Act (42 U.S.C. 247d–7e(e)(1)(D)) is amended by striking September 30, 2025and inserting November 21, 2025.
Section 319L–1(b) of the Public Health Service Act (42 U.S.C. 247d–7f(b)) is amended by striking September 30, 2025and inserting November 21, 2025.
(d)
Section 2811A(g) of the Public Health Service Act (42 U.S.C. 300hh–10b(g)) is amended by striking September 30, 2025and inserting November 21, 2025.
Section 2811B(g)(1) of the Public Health Service Act (42 U.S.C. 300hh–10c(g)(1)) is amended by striking September 30, 2025and inserting November 21, 2025.
Section 2811C(g)(1) of the Public Health Service Act (42 U.S.C. 300hh–10d(g)(1)) is amended by striking September 30, 2025and inserting November 21, 2025.
Section 2812(c)(4)(B) of the Public Health Service Act () is amended by striking September 30, 2025and inserting November 21, 2025. 42 U.S.C. 300hh–11(c)(4)(B)
September 30, 2025
November 21, 2025
(a) State health insurance assistance programs
Subsection (a)(1)(B)(xiv) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 ( note) is amended by striking September 30, 2025, $30,000,000and inserting November 21, 2025, $32,136,986. 42 U.S.C. 1395b–3
(b) Area agencies on aging
Subsection (b)(1)(B)(xiv) of such section 119 is amended by striking September 30, 2025, $30,000,000and inserting November 21, 2025, $32,136,986.
(c) Aging and disability resource centers
Subsection (c)(1)(B)(xiv) of such section 119 is amended by striking September 30, 2025, striking0,000,000and inserting November 21, 2025, inserting0,712,329.
(d) Coordination of efforts To inform older Americans about benefits available under Federal and State programs
Subsection (d)(2)(xiv) of such section 119 is amended by striking September 30, 2025, $30,000,000and inserting November 21, 2025, $32,136,986.
Section 1848(e)(1)(E) of the Social Security Act () is amended by striking October 1, 2025and inserting November 22, 2025. 42 U.S.C. 1395w–4(e)(1)(E)
(a) Removing geographic requirements and expanding originating sites for telehealth services
Section 1834(m) of the Social Security Act () is amended— 42 U.S.C. 1395m(m)
in paragraph (2)(B)(iii), by striking ending September 30, 2025and inserting ending November 21, 2025; and
in paragraph (4)(C)(iii), by striking ending on September 30, 2025and inserting ending on November 21, 2025.
(b) Expanding practitioners eligible To furnish telehealth services
Section 1834(m)(4)(E) of the Social Security Act () is amended by striking ending on September 30, 2025and inserting ending on November 21, 2025. 42 U.S.C. 1395m(m)(4)(E)
(c) Extending telehealth services for federally qualified health centers and rural health clinics
Section 1834(m)(8)(A) of the Social Security Act () is amended by striking ending on September 30, 2025and inserting ending on November 21, 2025. 42 U.S.C. 1395m(m)(8)(A)
(d) Delaying the in-Person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology
(1) Delay in requirements for mental health services furnished through telehealth
Section 1834(m)(7)(B)(i) of the Social Security Act () is amended, in the matter preceding subclause (I), by striking on or after October 1, 2025and inserting on or after November 22, 2025. 42 U.S.C. 1395m(m)(7)(B)(i)
(2) Mental health visits furnished by rural health clinics
Section 1834(y)(2) of the Social Security Act () is amended by striking October 1, 2025and inserting November 22, 2025. 42 U.S.C. 1395m(y)(2)
(3) Mental health visits furnished by Federally qualified health centers
Section 1834(o)(4)(B) of the Social Security Act () is amended by striking October 1, 2025and inserting November 22, 2025. 42 U.S.C. 1395m(o)(4)(B)
(e) Allowing for the furnishing of audio-Only telehealth services
Section 1834(m)(9) of the Social Security Act () is amended by striking ending on September 30, 2025and inserting ending on November 21, 2025. 42 U.S.C. 1395m(m)(9)
(f) Extending use of telehealth To conduct face-to-Face encounter prior to recertification of eligibility for hospice care
Section 1814(a)(7)(D)(i)(II) of the Social Security Act () is amended by striking ending on September 30, 2025and inserting ending on November 21, 2025. 42 U.S.C. 1395f(a)(7)(D)(i)(II)
(g) Program instruction authority
The Secretary of Health and Human Services may implement the amendments made by this section through program instruction or otherwise.
Section 1866G(a)(1) of the Social Security Act () is amended by striking September 30, 2025and inserting November 21, 2025. 42 U.S.C. 1395cc–7(a)(1)
Section 1860D–2(e)(1)(C) of the Social Security Act () is amended by striking September 30, 2025and inserting November 21, 2025. 42 U.S.C. 1395w–102(e)(1)(C)
Section 3(a)(2) of the IMPACT Act of 2014 () is amended— Public Law 113–185
in subparagraph (A), by striking and at the end;
in subparagraph (B), by striking the period at the end and inserting ; and; and
$6,000,000 for the period beginning on October 1, 2025, and ending on November 21, 2025.
by adding at the end the following new subparagraph:
Section 1898(b)(1) of the Social Security Act () is amended— 42 U.S.C. 1395iii(b)(1)
by striking fiscal year 2026and inserting fiscal year 2027; and
by striking striking,804,000,000and inserting $664,000,000.
in subparagraph (B)(i), by striking the period beginning on October 1, 2023, and ending on November 17, 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, for the period beginning on January 20, 2024, and ending on March 8, 2024, for the period beginning on March 9, 2024, and ending on September 30, 2024, and for fiscal year 2025and inserting fiscal years 2024 and 2025, and for the period beginning on October 1, 2025, and ending on November 21, 2025;
in subsection (c)(3), by striking and inserting ; and
in subsection (f), by striking 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on January 20, 2024, and ending on March 8, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on March 9, 2024, and ending on September 30, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, and for fiscal year 2025, an amount equal to the amount appropriated for fiscal year 2024 for fiscal year 2024and inserting 2025, and for the period beginning on October 1, 2025, and ending on November 21, 2025, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2025.
Section 501(c)(1)(A) of the Social Security Act () is amended— 42 U.S.C. 701(c)(1)(A)
in clause (vii), by striking and at the end;
in clause (viii), by adding at the end; and
(ix) $854,795 for the portion of fiscal year 2026 beginning on October 1, 2025, and ending on November 21, 2025.
by adding at the end the following new clause:
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
in a second installment representing the remaining 50 percent of such fee, on—
February 1, 2027; or
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) For fiscal year 2028 and each subsequent fiscal year, the facility fees required under subparagraph (A) shall be due on the later of—
the first business day on or after October 1 of the fiscal year; or
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.
by amending subparagraph (D) to read as follows:
(b) Fee revenue amounts
Section 744M(b) of the Federal Food, Drug, and Cosmetic Act () is amended to read as follows: 21 U.S.C. 379j–72(b)
(b) Fee revenue amounts
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—
the annual base revenue for the fiscal year (as determined under paragraph (2));
the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));
the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));
additional direct cost adjustments (as determined under subsection (c)(3));
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
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—
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 , not including any adjustments made for such fiscal year 2025 under subsection (c)(2), as so in effect; and
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 () is amended— 21 U.S.C. 379j–72(c)
in paragraph (1)—
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 yearand inserting each fiscal year;
in subparagraph (B), by striking 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—
the fee for fiscal year 2025 under subsection (a)(2); and
the inflation adjustment percentage under subparagraph (C); and
(ii) for each of fiscal years 2027 through 2030—
the applicable fee under subsection (a)(2) for the preceding fiscal year; and
the inflation adjustment percentage under subparagraph (C).
in subparagraph (C)—
(i) in the matter preceding clause (i), by inserting after ;
(ii) by striking clause (i);
(iii) by redesignating subclauses (I) and (II) of clause (ii) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;
(iv) by striking ; and
(v) in clause (ii), as so redesignated, by striking Washington-Baltimore, DC–MD–VA–WVand inserting Washington–Arlington–Alexandria–DC–VA–MD–WV;
in paragraph (2)—
in subparagraph (A)—
(i) by striking fiscal year 2021 and subsequent fiscal yearsand 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;
by striking subparagraph (B);
by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and
in subparagraph (C), as so redesignated, by striking paragraph (4) establishingand inserting paragraph (5) publishing;
in paragraph (3)—
in the matter preceding subparagraph (A), by striking subsection (b)(2)(D)and inserting subsection (b)(1)(D); and
$135,000 for fiscal year 2026;
$300,000 for fiscal year 2027;
$55,000 for fiscal year 2028;
$30,000 for fiscal year 2029; and
$0 for fiscal year 2030.
by striking subparagraphs (A) through (E) 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.
In general
(B) Adjustment described
(i) An adjustment under this paragraph may be made for a fiscal year only if—
an adjustment under this paragraph had not been made for any prior fiscal year;
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
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) An adjustment under this paragraph for a fiscal year shall equal the product of—
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
the excess facility percentage described in clause (iii).
(iii) The excess facility percentage described in this clause is—
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
1,625.
(5) Annual fee setting
The Secretary shall, not later than 60 days before the first day of each fiscal year—
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
publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
by striking paragraph (4) and inserting the following:
(d) Crediting and availability of fees
Section 744M(f) of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–72(f)
in paragraph (2)(D)—
in the subparagraph heading, by striking ; and
by striking ; and
in paragraph (3), by striking 2021 through 2025and inserting 2026 through 2030.
(a) Performance report
Section 744N of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 379j–73
Performance report
in subsection (a)—
by striking and inserting the following:
(1) In general
Not later than 120 calendar days after the end of each fiscal year
by striking and inserting ; and
(2) Additional information
Beginning with fiscal year 2026, the annual report under this subsection shall include—
the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(i) the number of Tier 1 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(ii) the number of Tier 2 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(iii) the number of specified safety OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(iv) the number of generally recognized as safe and effective finalization OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;
(v) the average timeline for processing OTC monograph order requests, in the aggregate and by submission type, in the previous fiscal year; and
(vi) postmarket safety activities with respect to OTC monograph drugs, including—
collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
developing and using improved analytical tools, adverse event data-collection systems, including information technology systems, to assess potential safety problems, including access to external databases; and
activities under section 760;
information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—
(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 510(c) or 510(i) in the fiscal year; and
(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 744M(a) in the fiscal year, whether the facility paid such fee;
the status of implementation of evidence and testing standards under section 505G(r) for nonprescription drugs intended for topical administration, including—
(i) the application of evidence or testing standards; and
(ii) the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section 505G(b); and
the progress of the Food and Drug Administration in allowing nonclinical testing alternatives to animal testing for the consideration of sunscreen active ingredients.
(3) Confidentiality
Nothing in paragraph (2) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.
by adding at the end the following:
in subsection (b), by striking fiscal year 2021 and each subsequent fiscal yearand inserting each fiscal year; and
in subsection (d)—
by striking each place it appears and inserting ; and
(4) Minutes of negotiation meetings
Minutes of negotiation meetings
(A) Public availability
The Secretary shall make publicly available, on the public website of the Food and Drug Administration, robust written minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
(B) Content
The robust written minutes described under subparagraph (A) shall contain, in detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
by adding at the end the following:
(b) GAO report
(1) In general
Not later than September 30, 2027, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the supply chain of over-the-counter monograph drugs.
(2) Contents
The report required under paragraph (1) shall include an assessment of—
the overall stability of the supply chain of over-the-counter monograph drugs;
what information is collected by the Food and Drug Administration with respect to the supply chain of over-the-counter monograph drugs;
how the Food and Drug Administration uses information collected on the supply chain of over-the-counter monograph drugs to inform regulatory decisions;
how the Food and Drug Administration coordinates with other Federal agencies to monitor and mitigate disruptions to the supply chain of over-the-counter monograph drugs; and
the unique characteristics of the over-the-counter monograph drug marketplace and what additional authorities or information the Food and Drug Administration may need to ensure the stability of the supply chain of over-the-counter monograph drugs.
(a) In general
Section 505G of the Federal Food, Drug, and Cosmetic Act () is amended by adding at the end the following: 21 U.S.C. 355h
In general
(r) Evidence and testing standards for active ingredients for topical administration
(1) Evidence and testing standards for active ingredients for topical administration
The Secretary shall—
in evaluating the generally recognized as safe and effective status of active ingredients used in nonprescription drugs intended for topical administration for purposes of subsection (a), utilize standards that allow for the use of real world evidence (as defined in section 505F(b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials, provided that such standards allow the Secretary to evaluate whether the benefits of such active ingredients outweigh the risks; and
apply subsection (b)(6)(C) to the regulation of active ingredients used in drugs intended for topical administration.
(2) Non-animal testing methods for topical active ingredients
(A) In general
The Secretary shall consider the types of nonclinical tests described in paragraphs (1) through (4) of the first subsection (z) of section 505 (as inserted by section 3209(a)(2) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of )), or any other alternative to animal testing that the Secretary determines appropriate, in the consideration of drugs intended for topical administration under this section. Public Law 117–328
(B) Guidance
Not later than 1 year after the date of enactment of this subsection, the Secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for drugs intended for topical administration.
(3) Clarification
Nothing in this subsection shall be construed to alter, supersede, or limit the standards for making determinations of whether a drug is generally recognized as safe and effective under section 201(p) or the standards set forth under section 505 for determining the safety and effectiveness of drugs.
(b) Sunscreen final administrative order
A final administrative order on nonprescription sunscreen active ingredients issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security Act (; note) shall— Public Law 116–136; 21 U.S.C. 360fff–3
account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States;
account for the role of broad spectrum sunscreens with a Sun Protection Factor of 15 or higher in effective skin cancer prevention; and
incorporate the evidence and testing standards for sunscreen active ingredients detailed in section 505G(r) of the Federal Food, Drug, and Cosmetic Act () (as added by subsection (a)). 21 U.S.C. 355h
(a) In general
Section 505(b) of the Federal Food, Drug, and Cosmetic Act () is amended by adding at the end the following: 21 U.S.C. 355(b)
(7) Rx-to-nonprescription switches
(A) Meetings
Any person planning to submit an application for an Rx-to-nonprescription switch may submit to the Secretary a written request for a meeting, for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application, including the design of any necessary studies, and the format and content of the planned application. The Secretary may grant such a meeting, as appropriate, consistent with established procedures for granting meetings with, and providing written responses to, applications under this section. Each such meeting shall be documented in meeting minutes.
Meetings
(B) Guidance
(i) Not later than 18 months after the date of enactment of this paragraph, the Secretary shall issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section, including in the case of applications for an Rx-to-nonprescription switch, especially with respect to prescription drugs with well-established safety profiles for which an applicant may seek approval for nonprescription use.
In general
(ii) The guidance under clause (i) shall—
describe how published reports in medical literature, any previous finding of safety or effectiveness for the drug under this section, the results of significant human experience with the drug, unpublished studies and other data, and other sources of information may be used to support an application for a nonprescription drug, including in the context of an application for an Rx-to-nonprescription switch;
set forth procedures for sponsors to request meetings described in subparagraph (A) and document the recommendations made in such meetings;
describe evidentiary expectations to support approval of an application for a nonprescription drug, including in the context of an application for an Rx-to-nonprescription switch, including how sponsors can demonstrate that consumers can appropriately self-select and use the drug and comprehend the nonprescription drug label; and
provide recommendations for how mechanisms, in addition to the required Drug Facts Label, such as mobile applications and decisions aids, can be incorporated into the information submitted in support of an application for an Rx-to-nonprescription switch.
(C) Plan to engage with stakeholders
Not later than 1 year after the date of enactment of this paragraph, the Secretary shall develop and make publicly available on the website of the Food and Drug Administration a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for an Rx-to-nonprescription switch.
(D) Definition
For purposes of this paragraph, the term Rx-to-nonprescription switch means the approval of an application, or supplemental application, as applicable, submitted under this section by the holder of an approved application for a prescription drug seeking approval to market such drug as a nonprescription drug, including for—
(i) a full Rx-to-nonprescription switch, under which a drug previously approved for prescription use only is—
approved for nonprescription use under the same conditions as applied to the drug when approved for prescription use; or
approved for nonprescription use subject to one or more additional conditions for nonprescription use; and
(ii) a partial Rx-to-nonprescription switch, under which the drug is approved for nonprescription use only under certain conditions described in the approved labeling, while the drug otherwise remains approved for prescription use only.
(E) Rule of construction
Nothing in this paragraph shall be construed to—
Rule of construction
(i) supersede or modify the authority of the Secretary under section 505G with respect to the regulation of OTC monograph drugs; or
(ii) authorize the disclosure by the Secretary of confidential commercial information or trade secrets.
(b) GAO Report
(1) In general
Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that evaluates—
the number of applications for an Rx-to-nonprescription switch approved during the period beginning on October 1, 2022, and ending on the date of the report;
the number of drugs for which an application for an Rx-to-nonprescription switch was approved during such period subject to an additional condition for nonprescription use;
among the drugs for which an application for a full or partial Rx-to-nonprescription switch was approved during such period, the average length of time from receipt by the Food and Drug Administration of the application to the approval of such application;
the number of partial Rx-to-nonprescription switch applications approved during such period, and the number of applications for such a partial switch not approved;
any barriers to timely and predictable review of applications for an Rx-to-nonprescription switch;
engagement by the Food and Drug Administration with public stakeholders, including public meetings or additional activities to support review of applications for an Rx-to-nonprescription switch; and
opportunities for collaboration between the Center for Drug Evaluation and Research and the Centers for Medicare & Medicaid Services for the purpose of analyzing health insurance claims data for commonly prescribed drugs that appear to be suitable for an Rx-to-nonprescription switch.
(2) Definition
In this subsection, the term Rx-to-nonprescription switch has the meaning given such term in paragraph (7) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (), as added by subsection (a). 21 U.S.C. 244(b)
(a) Development advice to sponsors or requestors
Section 505G(h) of the Federal Food, Drug, and Cosmetic Act () is amended by striking sponsors or requestorsand inserting sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding. 21 U.S.C. 355h(h)
(b) Technical correction
Section 505G(b)(2)(A)(iv)(III) of the Federal Food, Drug, and Cosmetic Act () is amended by striking requestorsand inserting sponsors or requestors. 21 U.S.C. 355h(b)(2)(A)(iv)(III)
(a) Authorization
Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (; 379j–72) shall cease to be effective October 1, 2030. 21 U.S.C. 379j–71
(b) Reporting requirements
Section 744N of the Federal Food, Drug, and Cosmetic Act () shall cease to be effective January 31, 2031. 21 U.S.C. 379j–73
The amendments made by this title shall take effect on October 1, 2025, or the date of the enactment of this Act, whichever is later, except that fees under part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act () shall be assessed beginning October 1, 2025, regardless of the date of the enactment of this Act. 21 U.S.C. 379j–71 et seq.
Notwithstanding the amendments made by this title, part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (), as in effect on the day before the date of enactment of this Act, shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2026. 21 U.S.C. 379j–71 et seq.
(c) Requirements of loan holder
Section (d)(1) of such section is amending by inserting after .
(d) Default and foreclosure
Subsection (e) of such section is amended—
in paragraph (1)—
in subparagraph (A), by striking an individual whoand all that follows through the period at the end and inserting the following: ; and
The Secretary may charge administrative costs, fees, and interest, as appropriate, with respect to any default under a partial claim in a manner similar to the interest and administrative costs charged under section 5315 of this title.
by amending subparagraph (B) to read as follows:
by amending paragraph (2) to read as follows:
Notwithstanding section 2410 of title 28, a nonjudicial sale of real property to satisfy a loan guaranteed under this chapter shall discharge the property from a partial claim interest held by the Secretary, provided that the holder of the guaranteed loan conducts the non-judicial sale and distributes the sale proceeds, if any, in accordance with the State or local law where such property is situated.
(e) Guidance in advance of regulations
(h) Guidance in advance of regulations
Notwithstanding any other provision of law, the Secretary may, before prescribing regulations, issue administrative guidance with respect to the Partial Claim Program under this section and the loss mitigation options prescribed under section 3732(d) of this title, including any additional terms, conditions, and requirements the Secretary determines necessary.
Subsection (h) of such section is amended to read as follows:
(a) Annual reports
(1) In general
Not later than one year after the date of the enactment of this Act, and every year thereafter until the Partial Claim Program terminates, the Comptroller General of the United States shall submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report.
(2) Elements
Each report required by paragraph (1) shall include, for the period covered by the report and disaggregated by quarter, the following:
Key data on the performance of the Partial Claim Program, including—
(i) the number of partial claims filed and approved; and
(ii) the redefault and foreclosure rates of loans for which a partial claim was made.
A comparison of the data described in subparagraph (A) with data on the performance of other loss mitigation options provided by the Department of Veterans Affairs.
The number of housing loans insured, guaranteed, or made by the Secretary of Veterans Affairs under of title 38, United States Code. chapter 37
The number of applications for housing loan benefits under such chapter denied.
The number of housing loans insured, guaranteed, or made by the Secretary under such chapter refinanced under section 3710(a)(8) or 3712 of title 38, United States Code.
The number of veterans who owe a payment on a mortgage associated with a loan insured, guaranteed, or made by the Secretary under such chapter that is at least—
(i) 60 days late; and
(ii) 90 days late.
(b) Assessment
(1) In general
Not later than one year before the Partial Claim Program terminates, the Comptroller General shall—
conduct an assessment of the benefits and challenges of the Partial Claim Program; and
submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report on the findings of the Comptroller General with respect to that assessment.
(2) Considerations
In conducting the assessment required by paragraph (1), the Comptroller General shall consider the following:
The characteristics of borrowers for whom a partial claim was made compared to the characteristics of borrowers provided other loss mitigation options by the Department of Veterans Affairs.
The performance of loans guaranteed under of title 38, United States Code, following various loss mitigation actions. chapter 37
The information the Department considered in determining whether a borrower would benefit from a partial claim compared to other loss mitigation options.
The costs to taxpayers of the Partial Claim Program compared to the costs of other loss mitigation options provided by the Department.
Any similarities and differences in the Department's administration and use of the Partial Claim Program compared to the Department's administration and use of the COVID–19 Veterans Assistance Partial Claim Payment program established under subpart F of part 36 of title 38, Code of Regulations.
The information the Department learned from the COVID–19 Veterans Assistance Partial Claim Payment program and the extent to which those lessons learned were applied to the Partial Claim Program.
The types of information the Department collected to monitor the performance and effectiveness of the Partial Claim Program and how the Department used that information to make any needed adjustments to the program.
How the use by the Department of partial claims compares to the use of partial claims by other Federal housing agencies, including, for each partial claim program—
(i) the volume of loans for which partial claims have been made;
(ii) the results for borrowers (including redefault and foreclosure rates); and
(iii) the costs to taxpayers.
(c) Partial Claim Program defined
In this section, the term Partial Claim Program means the Partial Claim Program of the Department of Veterans Affairs carried out under section 3737 of title 38, United States Code.
Continuing Appropriations and Extensions Act, 2026 · Engrossed in House (2025-09-19) · Congress.wiki