[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1262 Engrossed in House (EH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1262
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to
molecularly targeted pediatric cancer investigations, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

673fef39d11bc16ff32bdd55f480c64ae3abd232af9843743fc92dc2a8205b82

(a) Short Title.--This Act may be cited as the ``Mikaela Naylon
Give Kids a Chance Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:

d6bbc350a0f1c78a2bc825ada59cc9f8f9d2102df490082118619e0a4c820982

of Food and Drug Administration regarding
molecularly targeted cancer drugs.

6fc6374304fb059920b743cf2d57ad97e5e31468b57fcae068017078aa34a390

encourage treatments for rare pediatric
diseases.

e5aa65f1e564eb1f7b2d4188092af694947cc26afc0085dcbbeab80d2a7c625b

4e811b980f5c82b4de55ad88f0416b1649b4c06de1811298183274083facdf0e

OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY
TARGETED CANCER DRUGS.
(a) In General.--
(1) Additional active ingredient for application drug;
limitation regarding novel-combination application drug.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)(3)) is amended--
(A) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively; and
(B) by striking subparagraph (A) and inserting the
following:
``(A) In general.--For purposes of paragraph
(1)(B), the investigation described in this paragraph
is a molecularly targeted pediatric cancer
investigation of--
``(i) the drug or biological product for
which the application referred to in such
paragraph is submitted; or
``(ii) such drug or biological product used
in combination with--
``(I) an active ingredient of a
drug or biological product--
``(aa) for which an
approved application under
section 505(j) under this Act
or under section 351(k) of the
Public Health Service Act is in
effect; and
``(bb) that is determined
by the Secretary, after
consultation with the
applicant, to be part of the
standard of care for treating a
pediatric cancer; or
``(II) an active ingredient of a
drug or biological product--
``(aa) for which an
approved application under
section 505(b) of this Act or
section 351(a) of the Public
Health Service Act to treat an
adult cancer is in effect and
is held by the same person
submitting the application
under paragraph (1)(B); and
``(bb) that is directed at
a molecular target that the
Secretary determines to be
substantially relevant to the
growth or progression of a
pediatric cancer.
``(B) Additional requirements.--
``(i) Design of investigation.--A
molecularly targeted pediatric cancer
investigation referred to in subparagraph (A)
shall be designed to yield clinically
meaningful pediatric study data that is
gathered using appropriate formulations for
each age group for which the study is required,
regarding dosing, safety, and preliminary
efficacy to inform potential pediatric
labeling.
``(ii) Limitation.--An investigation
described in subparagraph (A)(ii) may be
required only if the drug or biological product
for which the application referred to in
paragraph (1)(B) contains either--
``(I) a single new active
ingredient; or
``(II) more than one active
ingredient, if an application for the
combination of active ingredients has
not previously been approved but each
active ingredient is in a drug product
that has been previously approved to
treat an adult cancer.
``(iii) Results of already-completed
preclinical studies of application drug.--With
respect to an investigation required pursuant
to paragraph (1)(B), the Secretary may require
the results of any completed preclinical
studies relevant to the initial pediatric study
plan be submitted to the Secretary at the same
time that the initial pediatric study plan
required under subsection (e)(1) is submitted.
``(iv) Rule of construction regarding
inactive ingredients.--With respect to a
combination of active ingredients referred to
in subparagraph (A)(ii), such subparagraph
shall not be construed as addressing the use of
inactive ingredients with such combination.''.
(2) Determination of applicable requirements.--Section
505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(e)(1)) is amended by adding at the end the
following: ``The Secretary shall determine whether subparagraph
(A) or (B) of subsection (a)(1) applies with respect to an
application before the date on which the applicant is required
to submit the initial pediatric study plan under paragraph
(2)(A).''.
(3) Clarifying applicability.--Section 505B(a)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
amended by adding at the end the following:
``(C) Rule of construction.--No application that is
subject to the requirements of subparagraph (B) shall
be subject to the requirements of subparagraph (A), and
no application (or supplement to an application) that
is subject to the requirements of subparagraph (A)
shall be subject to the requirements of subparagraph
(B).''.
(4) Conforming amendments.--Section 505B(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
(A) in paragraph (3)(C), as redesignated by
paragraph (1)(A) of this subsection, by striking
``investigations described in this paragraph'' and
inserting ``investigations referred to in subparagraph
(A)''; and
(B) in paragraph (3)(D), as redesignated by
paragraph (1)(A) of this subsection, by striking ``the
assessments under paragraph (2)(B)'' and inserting
``the assessments required under paragraph (1)(A)''.
(b) Guidance.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance on the implementation of the
amendments made by subsection (a); and
(2) not later than 12 months after closing the comment
period on such draft guidance, finalize such guidance.
(c) Applicability.--The amendments made by this section apply with
respect to any application under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under
section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)),
that is submitted on or after the date that is 3 years after the date
of enactment of this Act.
(d) Reports to Congress.--
(1) Secretary of health and human services.--Not later than
6 years after the date of enactment of this Act, the Secretary
of Health and Human Services shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on the Secretary's efforts, in coordination
with industry, to ensure implementation of the amendments made
by subsection (a).
(2) GAO study and report.--
(A) Study.--Not later than 8 years after the date
of enactment of this Act, the Comptroller General of
the United States shall conduct a study of the
effectiveness of requiring assessments and
investigations described in section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as
amended by subsection (a), in the development of drugs
and biological products for pediatric cancer
indications, including consideration of any benefits
to, or burdens on, pediatric cancer drug development.
(B) Findings.--Not later than 10 years after the
date of enactment of this Act, the Comptroller General
shall submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a
report containing the findings of the study conducted
under subparagraph (A).

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(a) Equal Accountability for Pediatric Study Requirements.--Section
505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d))
is amended--
(1) in paragraph (1), by striking ``Beginning 270'' and
inserting ``Noncompliance letter.--Beginning 270'';
(2) in paragraph (2)--
(A) by striking ``The drug or'' and inserting
``Effect of noncompliance.--The drug or''; and
(B) by striking ``(except that the drug or
biological product shall not be subject to action under
section 303)'' and inserting ``(except that the drug or
biological product shall be subject to action under
section 303 only if such person demonstrated a lack of
due diligence in satisfying the applicable
requirement)''; and
(3) by adding at the end the following:
``(3) Limitation.--The Secretary shall not issue
enforcement actions under section 303 for failures under this
subsection in the case of a drug or biological product that is
no longer marketed.''.
(b) Due Diligence.--Section 505B(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection (a), is
further amended by adding at the end the following:
``(4) Due diligence.--Before the Secretary may conclude
that a person failed to submit or otherwise meet a requirement
as described in the matter preceding paragraph (1), the
Secretary shall--
``(A) issue a noncompliance letter pursuant to
paragraph (1);
``(B) provide such person with a 45-day period
beginning on the date of receipt of such noncompliance
letter to respond in writing as set forth in such
paragraph; and
``(C) after reviewing such written response,
determine whether the person demonstrated a lack of due
diligence in satisfying such requirement.''.
(c) Conforming Amendments.--Section 303(f)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by
striking ``or 505-1'' and inserting ``505-1, or 505B''.
(d) Transition Rule.--The Secretary of Health and Human Services
may take enforcement action under section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333) only for failures described in
section 505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after
the date that is 180 days after the date of enactment of this Act.

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Section 508(b) of the Food and Drug Administration Safety and
Innovation Act (21 U.S.C. 355c-1(b)) is amended--
(1) in paragraph (11), by striking the semicolon at the end
and inserting ``, including an evaluation of compliance with
deadlines provided for in deferrals and deferral extensions;'';
(2) in paragraph (15), by striking ``and'' at the end;
(3) in paragraph (16), by striking the period at the end
and inserting ``; and''; and
(4) by adding at the end the following:
``(17) a listing of penalties, settlements, or payments
under section 303 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353) for failure to comply with requirements under
such section 505B, including, for each penalty, settlement, or
payment, the name of the drug, the sponsor thereof, and the
amount of the penalty, settlement, or payment imposed.''.

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ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.
(a) Extension.--Paragraph (5) of section 529(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by
striking ``December 20, 2024, unless'' and all that follows through the
period at the end and inserting ``September 30, 2029.''.
(b) User Fee Payment.--Section 529(c)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff(c)(4)) is amended by striking
subparagraph (A) and inserting the following:
``(A) In general.--The priority review user fee
required by this subsection shall be due upon the
submission of a human drug application under section
505(b)(1) or section 351(a) of the Public Health
Service Act for which the priority review voucher is
used. All other user fees associated with the human
drug application shall be due as required by the
Secretary or under applicable law.''.
(c) GAO Report on Effectiveness of Rare Pediatric Disease Priority
Voucher Awards in Incentivizing Rare Pediatric Disease Drug
Development.--
(1) GAO study.--
(A) Study.--The Comptroller General of the United
States shall conduct a study of the effectiveness of
awarding rare pediatric disease priority vouchers under
section 529 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff), as amended by subsection (a), in the
development of human drug products that treat or
prevent rare pediatric diseases (as defined in such
section 529).
(B) Contents of study.--In conducting the study
under subparagraph (A), the Comptroller General shall
examine the following:
(i) The indications for each drug or
biological product that--
(I) is the subject of a rare
pediatric disease product application
(as defined in section 529 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff)) for which a priority
review voucher was awarded; and
(II) was approved under section 505
of the Federal Food, Drug, and Cosmetic
Act (42 U.S.C. 355) or licensed under
section 351 of the Public Health
Service Act (42 U.S.C. 262).
(ii) Whether, and to what extent, an unmet
need related to the treatment or prevention of
a rare pediatric disease was met through the
approval or licensure of such a drug or
biological product.
(iii) The size of the company to which a
priority review voucher was awarded under
section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff) for such a drug
or biological product.
(iv) The value of such priority review
voucher if transferred.
(v) Identification of each drug for which a
priority review voucher awarded under such
section 529 was used.
(vi) The size of the company using each
priority review voucher awarded under such
section 529.
(vii) The length of the period of time
between the date on which a priority review
voucher was awarded under such section 529 and
the date on which it was used.
(viii) Whether, and to what extent, an
unmet need related to the treatment or
prevention of a rare pediatric disease was met
through the approval under section 505 of the
Federal Food, Drug, and Cosmetic Act (42 U.S.C.
355) or licensure under section 351 of the
Public Health Service Act (42 U.S.C. 262) of a
drug for which a priority review voucher was
used.
(ix) Whether, and to what extent, companies
were motivated by the availability of priority
review vouchers under section 529 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff) to attempt to develop a drug for a rare
pediatric disease.
(x) Whether, and to what extent, pediatric
review vouchers awarded under such section were
successful in stimulating development and
expedited patient access to drug products for
treatment or prevention of a rare pediatric
disease that wouldn't otherwise take place
without the incentive provided by such
vouchers.
(xi) The impact of such priority review
vouchers on the workload, review process, and
public health prioritization efforts of the
Food and Drug Administration.
(xii) Any other incentives in Federal law
that exist for companies developing drugs or
biological products described in clause (i).
(2) Report on findings.--Not later than 5 years after the
date of the enactment of this Act, the Comptroller General of
the United States shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
containing the findings of the study conducted under paragraph
(1).

6744cd057bd9670831328faa22f741abe87780dc7c97040a43471e9dd9f16596

(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph
(2), by striking ``same disease or condition'' and inserting
``same approved use or indication within such rare disease or
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``same rare disease or condition'' and
inserting ``same approved use or indication for which
such 7-year period applies to such already approved or
licensed drug''; and
(B) in paragraph (1), by inserting ``, relating to
the approved use or indication,'' after ``the needs'';
(3) in subsection (c)(1), by striking ``same rare disease
or condition as the already approved drug'' and inserting
``same use or indication for which the already approved or
licensed drug was approved or licensed''; and
(4) by adding at the end the following:
``(f) Approved Use or Indication Defined.--In this section, the
term `approved use or indication' means the use or indication approved
under section 505 of this Act or licensed under section 351 of the
Public Health Service Act for a drug designated under section 526 for a
rare disease or condition.''.
(b) Application of Amendments.--The amendments made by subsection
(a) shall apply with respect to any drug designated under section 526
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb),
regardless of the date on which the drug was so designated, and
regardless of the date on which the drug was approved under section 505
of such Act (21 U.S.C. 355) or licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262).

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Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended by striking ``section,'' and all that follows
through the period at the end and inserting ``section, $25,000,000 for
each of fiscal years 2026 through 2028.''.

0e99c64d6bc52f88c9603b72c42a5705d47eafd0467e99e91fe357ad4d893379

Section 372 of the Public Health Service Act (42 U.S.C. 274) is
amended--
(1) in subsection (b)(2)--
(A) by moving the margins of subparagraphs (M)
through (O) 2 ems to the left;
(B) in subparagraph (A)--
(i) in clause (i), by striking ``, and''
and inserting ``; and''; and
(ii) in clause (ii), by striking the comma
at the end and inserting a semicolon;
(C) in subparagraph (C), by striking ``twenty-four-
hour telephone service'' and inserting ``24-hour
telephone or information technology service'';
(D) in each of subparagraphs (B) through (M), by
striking the comma at the end and inserting a
semicolon;
(E) in subparagraph (N), by striking
``transportation, and'' and inserting
``transportation;'';
(F) in subparagraph (O), by striking the period and
inserting a semicolon; and
(G) by adding at the end the following:
``(P) encourage the integration of electronic
health records systems through application programming
interfaces (or successor technologies) among hospitals,
organ procurement organizations, and transplant
centers, including the use of automated electronic
hospital referrals and the grant of remote, electronic
access to hospital electronic health records of
potential donors by organ procurement organizations, in
a manner that complies with the privacy regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996, at part 160 of title 45,
Code of Federal Regulations, and subparts A, C, and E
of part 164 of such title (or any successor
regulations); and
``(Q) consider establishing a dashboard to display
the number of transplants performed, the types of
transplants performed, the number and types of organs
that entered the Organ Procurement and Transplantation
Network system and failed to be transplanted, and other
appropriate statistics, which should be updated more
frequently than annually.''; and
(2) by adding at the end the following:
``(d) Registration Fees.--
``(1) In general.--The Secretary may collect registration
fees from any member of the Organ Procurement and
Transplantation Network for each transplant candidate such
member places on the list described in subsection (b)(2)(A)(i).
Such registration fees shall be collected and distributed only
to support the operation of the Organ Procurement and
Transplantation Network. Such registration fees are authorized
to remain available until expended.
``(2) Collection.--The Secretary may collect the
registration fees under paragraph (1) directly or through
awards made under subsection (b)(1)(A).
``(3) Distribution.--Any amounts collected under this
subsection shall--
``(A) be credited to the currently applicable
appropriation, account, or fund of the Department of
Health and Human Services as discretionary offsetting
collections; and
``(B) be available, only to the extent and in the
amounts provided in advance in appropriations Acts, to
distribute such fees among awardees described in
subsection (b)(1)(A).
``(4) Transparency.--The Secretary shall--
``(A) promptly post on the website of the Organ
Procurement and Transplantation Network--
``(i) the amount of registration fees
collected under this subsection from each
member of the Organ Procurement and
Transplantation Network; and
``(ii) a list of activities such fees are
used to support; and
``(B) update the information posted pursuant to
subparagraph (A), as applicable for each calendar
quarter for which fees are collected under paragraph
(1).
``(5) GAO review.--Not later than 2 years after the date of
enactment of this subsection, the Comptroller General of the
United States shall, to the extent data are available--
``(A) conduct a review concerning the activities
under this subsection; and
``(B) submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Finance of the
Senate and the Committee on Energy and Commerce of the
House of Representatives, a report on such review,
including related recommendations, as applicable.
``(6) Sunset.--The authority to collect registration fees
under paragraph (1) shall expire on the date that is 3 years
after the date of enactment of the Mikaela Naylon Give Kids a
Chance Act.''.

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ADMINISTRATION.
(a) In General.--Chapter X of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 1015. ABRAHAM ACCORDS OFFICE.
``(a) In General.--The Secretary, acting through the Commissioner
of Food and Drugs, shall establish within the Food and Drug
Administration an office, to be known as the Abraham Accords Office, to
be headed by a director.
``(b) Office.--Not later than two years after the date of enactment
of this section, the Secretary shall--
``(1) in consultation with the governments of Abraham
Accords countries, as well as appropriate United States
Government diplomatic and security personnel--
``(A) select the location of the Abraham Accords
Office in an Abraham Accords country; and
``(B) establish such office; and
``(2) assign to such office such personnel of the Food and
Drug Administration as the Secretary determines necessary to
carry out the functions of such office.
``(c) Duties.--The Secretary, acting through the Director of the
Abraham Accords Office, shall--
``(1) after the Abraham Accords Office is established--
``(A) as part of the Food and Drug Administration's
work to strengthen the international oversight of
regulated commodities, provide technical assistance to
regulatory partners in Abraham Accords countries on
strengthening regulatory oversight and converging
regulatory requirements for the oversight of regulated
products, including good manufacturing practices and
other issues relevant to manufacturing medical products
that are regulated by the Food and Drug Administration;
and
``(B) facilitate interactions between the Food and
Drug Administration and interested parties in Abraham
Accords countries, including by sharing relevant
information regarding United States regulatory pathways
with such parties, and facilitate feedback on the
research, development, and manufacturing of products
regulated in accordance with this Act; and
``(2) carry out other functions and activities as the
Secretary determines to be necessary to carry out this section.
``(d) Abraham Accords Country Defined.--In this section, the term
`Abraham Accords country' means a country identified by the Department
of State as having signed the Abraham Accords Declaration.
``(e) National Security.--Nothing in this section shall be
construed to require any action inconsistent with a national security
recommendation provided by the Federal Government.''.
(b) Report to Congress.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Congress a report on the Abraham
Accords Office, including--
(A) an evaluation of how the Office has advanced
progress toward conformance with Food and Drug
Administration regulatory requirements by manufacturers
in the Abraham Accords countries;
(B) a numerical count of parties that the Office
has helped facilitate interactions or feedback pursuant
to section 1015(c)(1)(B) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a));
(C) a summary of technical assistance provided to
regulatory partners in Abraham Accords countries
pursuant to subparagraph (A) of such section
1015(c)(1); and
(D) recommendations for increasing and improving
coordination between the Food and Drug Administration
and entities in Abraham Accords countries.
(2) Abraham accords country defined.--In this subsection,
the term ``Abraham Accords country'' has the meaning given such
term in section 1015(d) of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)).

5f7b17922cd99487f665bdfa24d3d4492092713d2a454884a29dce3b7a6ac36f

(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or an analogous
process) by a person that has submitted or intends to submit an
abbreviated application under this subsection for a drug that is
required by regulation to contain one or more of the same inactive
ingredients in the same concentrations as the listed drug referred to,
or for which the Secretary determines there is a scientific
justification for an approach that is in vitro, in whole or in part, to
be used to demonstrate bioequivalence for a drug if such a drug
contains one or more of the same inactive ingredients in the same
concentrations as the listed drug referred to, the Secretary shall
inform the person whether such drug is qualitatively and quantitatively
the same as the listed drug. The Secretary may also provide such
information to such a person on the Secretary's own initiative during
the review of an abbreviated application under this subsection for such
drug.
``(ii) Notwithstanding section 301(j), if the Secretary determines
that such drug is not qualitatively or quantitatively the same as the
listed drug, the Secretary shall identify and disclose to the person--
``(I) the ingredient or ingredients that cause such drug
not to be qualitatively or quantitatively the same as the
listed drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, the amount of such deviation.
``(iii) If the Secretary determines that such drug is qualitatively
and quantitatively the same as the listed drug, the Secretary shall not
change or rescind such determination after the submission of an
abbreviated application for such drug under this subsection unless--
``(I) the formulation of the listed drug has been changed
and the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) The disclosures authorized under clauses (i) and (ii) are
disclosures authorized by law, including for purposes of section 1905
of title 18, United States Code. This subparagraph shall not otherwise
be construed to authorize the disclosure of nonpublic qualitative or
quantitative information about the ingredients in a listed drug, or to
affect the status, if any, of such information as trade secret or
confidential commercial information for purposes of section 301(j) of
this Act, section 552 of title 5, United States Code, or section 1905
of title 18, United States Code.''.
(b) Guidance.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance, or update guidance,
describing how the Secretary will determine whether a drug is
qualitatively and quantitatively the same as the listed drug
(as such terms are used in section 505(j)(3)(H) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a)),
including with respect to assessing pH adjusters.
(2) Process.--In issuing guidance under this subsection,
the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for
comment on the draft guidance; and
(C) after considering any comments received and not
later than one year after the close of the comment
period on the draft guidance, publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.

d91e43c3804d224fd9f242dfdfce300b11d10940e193b9a2c0a44436e5b3db8c

Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``$1,403,000,000'' and inserting
``$2,622,000,000''.
Passed the House of Representatives December 1, 2025.
Attest:
Clerk.
119th CONGRESS
1st Session
H. R. 1262
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act with respect to
molecularly targeted pediatric cancer investigations, and for other
purposes.

a95f92bb0fe3c6c03c54a67fba0c5c983f4133dfc3f6fbe5fc461f5a7f8135a8

Mikaela Naylon Give Kids a Chance Act — HR. 1262

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