[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6572 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 6572
To direct the Director of the National Institutes of Health to carry
out a program, to be known as the ``X-Labs Initiative'', to support
breakthrough biomedical research at innovative research institutions,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 10, 2025
Mr. Harder of California (for himself and Mr. Obernolte) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To direct the Director of the National Institutes of Health to carry
out a program, to be known as the ``X-Labs Initiative'', to support
breakthrough biomedical research at innovative research institutions,
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 ``Launching X-Labs for Breakthrough
Science Act''.
SEC. 2. NIH INSTITUTIONAL AWARDS FOR BREAKTHROUGH BIOMEDICAL RESEARCH.
Part A of title IV of the Public Health Service Act (42 U.S.C. 281
et seq.) is amended by adding at the end the following:
``SEC. 404P. NIH INSTITUTIONAL AWARDS FOR BREAKTHROUGH BIOMEDICAL
RESEARCH.
``(a) In General.--The Director of NIH shall establish a program,
to be known as the `X-Labs Initiative', to provide long-term
institutional awards to eligible entities in accordance with the
requirements of this section.
``(b) Purposes.--The purposes of the program shall be--
``(1) to enable and catalyze innovative research
institutions to conduct breakthrough biomedical research; and
``(2) to assist such institutions in the acquisition of R&D
plant, as necessary, to complete such research.
``(c) Institutional Awards.--
``(1) In general.--In carrying out the program, the
Director of NIH shall, acting directly or through the head of
an NIH institute or center, make institutional awards to
eligible entities on a competitive basis.
``(2) XL-series activity code.--The Director of NIH shall
designate the `XL-series' as a distinct NIH activity code
available to all NIH institutes and centers making
institutional awards under the program.
``(3) Categories.--An institutional award under the program
shall be made within one of the following categories:
``(A) XL01 funding.--Awards of XL01 funding to
support basic science research institutions whose
principal activities, or proposed principal activities,
are directed toward advancing foundational scientific
discovery. The purpose of such awards shall be to
provide such institutions stable, long-term funding and
minimal budgetary reprogramming requirements.
``(B) XL02 funding.--Awards of XL02 funding to
support science institutions whose principal
activities, or proposed principal activities, are
directed toward developing new scientific resources,
including datasets or measurement tools or techniques,
with deliverables that are clearly defined at the
beginning of the award.
``(C) XL03 funding.--Awards of XL03 funding to
support nonprofit institutions that award focused
research organizations, individual researchers, or
research collaborations or centers funds to conduct
breakthrough biomedical research.
``(D) XL04 funding.--Awards of XL04 funding to
support the formation and planning of new scientific
institutions that will be eligible for XL01, XL02, or
XL03 funding.
``(4) Special rules applicable to xl03 funding.--
``(A) Regrants.--An eligible entity that receives
an award of XL03 funding described in paragraph (3)(C)
shall, subject to the terms of the award, make regrants
using funds from the award to support research teams,
early-stage projects, or innovative scientific
initiatives consistent with the purposes of this
section. Such teams, projects, and initiatives shall be
located in the United States.
``(B) Requirements.--An eligible entity that
receives an award of XL03 funding described in
paragraph (3)(C)--
``(i) shall use such funding to provide
assistance, through regrants described in
subparagraph (A), to organizations (in this
section referred to as `regrant recipients')
that the eligible entity determines are
unlikely to receive support through traditional
NIH grants despite the breakthrough potential
of the research to be conducted by the regrant
recipient;
``(ii) shall use innovative methods to
identify, fund, and evaluate the research to be
conducted using such assistance; and
``(iii) not later than one year after the
date on which the eligible entity provides such
assistance to a regrant recipient, shall make
available to the public a summary of the method
by which the eligible entity identified,
funded, and plans to evaluate the regrant
recipient.
``(5) Amounts.--
``(A) XL01, xl02, and xl03 funding.--
``(i) In general.--The Director of NIH
shall structure an award of XL01, XL02, or XL03
funding such that the award totals not less
than $5,000,000 and not more than $50,000,000
per fiscal year for a period of 7 consecutive
fiscal years. The amount of such an award shall
be determined based on institutional scope,
scientific ambition, and programmatic needs.
``(ii) Renewals.--The Director of NIH may
renew an award described in clause (i) for not
more than one additional period of 7
consecutive fiscal years, subject to--
``(I) a competitive review of
institutional performance and
scientific impact over the previous
period;
``(II) the availability of
appropriations; and
``(III) a programmatic cap on the
proportion of institutional awards
eligible for renewal, to be determined
by the Director of NIH, to ensure
regular entry of new institutions into
the program.
``(B) XL04 funding.--
``(i) In general.--The Director of NIH
shall structure an award of XL04 funding such
that the award totals not less than $1,000,000
and not more than $5,000,000 per fiscal year
for a period of 1, 2, or 3 consecutive fiscal
years, as determined by the Director of NIH.
``(ii) Prohibition on renewals.--The
Director of NIH may not renew an award
described in clause (i).
``(6) Applications.--An eligible entity seeking an award
under the program shall submit to the Director of NIH an
application at such time, in such form, and containing such
information as the Director of NIH may require.
``(7) Maintaining eligibility.--To remain eligible for an
institutional award under the program and remain in good
standing with respect to an award, an eligible entity shall not
compete for or receive any other Federal research funding in
the form of a research grant, excluding a training grant,
during the award period of the entity for XL01, XL02, or XL03
funding.
``(8) Early termination or suspension.--
``(A) In general.--The Director of NIH may
terminate or suspend an award made to an award
recipient under this section prior to the expiration of
the applicable period of the award described in
paragraph (5) if the Director determines that the award
recipient--
``(i) is not meeting the deliverables
referred to in paragraph (3)(B), if applicable;
``(ii) is no longer an eligible entity; or
``(iii) is otherwise failing to comply with
the terms and conditions of the award.
``(B) Revocation of funds; reallocation.--Upon a
determination to terminate or suspend an award under
subparagraph (A), the Director of NIH may revoke any
remaining funds from the award and reallocate such
funds to new awards under this section.
``(d) Administration.--
``(1) In general.--The program shall be administered by the
Director of NIH, in coordination with the heads of relevant
institutes and centers.
``(2) Institute participation.--Any institute or center
within the National Institutes of Health may utilize the
program to fund institutions within their areas of scientific
focus, subject to coordination with the Director of NIH and the
availability of funds.
``(3) Other transactions authorities.--Notwithstanding any
other provision of law, the Director of NIH may use the
authorities available under section 402(n)(1) or other
applicable transactions authorities to carry out this section.
``(e) Reporting Requirements.--
``(1) Initial reports.--Not later than 1 year after the
date of enactment of this Act, and annually thereafter for 2
additional years, the Director of NIH shall submit to the
appropriate committees of Congress a report describing--
``(A) the progress made in establishing the
program, including the development of application
processes, review criteria, and award categories;
``(B) the number and types of applications received
under the program;
``(C) the number, type, and amount of awards made
under the program; and
``(D) any challenges or barriers encountered in the
implementation of the program.
``(2) Periodic evaluation.--Not later than 5 years after
the date of the first award under the program, and once every 5
years thereafter during the term of the program, the Director
of NIH shall submit to the appropriate committees of Congress a
report evaluating--
``(A) the scientific impact and outcomes of
institutions receiving support under the program;
``(B) the effectiveness of the program in advancing
the purposes described in subsection (b);
``(C) lessons learned from implementation of the
program and recommendations for program improvement;
and
``(D) the extent to which the program has reduced
administrative burden and enabled research that is
high-risk and high-reward.
``(f) Definitions.--In this section:
``(1) Appropriate committees of congress.--The term
`appropriate committees of Congress' means--
``(A) the Committee on Energy and Commerce and the
Committee on Appropriations of the House of
Representatives; and
``(B) the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the
Senate.
``(2) Basic science research institution.--The term `basic
science research institution' means a research institution
conducting systematic study directed toward greater
understanding of fundamental principles or phenomena of nature
without specific applications in mind.
``(3) Breakthrough biomedical research.--The term
`breakthrough biomedical research' means scientific research
that has the potential to create substantial, field-defining
advances in knowledge, methods, or technologies that enable
significant improvements in human health or scientific
capability.
``(4) Eligible entity.--The term `eligible entity' means--
``(A) a nonprofit research organization;
``(B) an institution of higher education, as
defined in section 101 of the Higher Education Act of
1965;
``(C) a for-profit entity with nonprofit
subsidiaries dedicated to scientific research;
``(D) an individual with plans to establish a
nonprofit research organization; or
``(E) any other research organization that the
Director of NIH determines appropriate.
``(5) Focused research organization.--The term `focused
research organization' means a time-limited, goal-oriented
nonprofit entity that concentrates resources and talent on
achieving a defined scientific or technological objective not
sufficiently pursued within existing academic, corporate, or
government structures.
``(6) Foundational scientific discovery.--The term
`foundational scientific discovery' means research that
produces broadly enabling scientific knowledge, methods, or
tools that support subsequent applied or translational
advances.
``(7) Institutional award; award.--The term `institutional
award' or `award' means an award of funding made under the
program.
``(8) Institutional scope.--The term `institutional scope'
means the size and organizational capacity of an institution to
undertake research activities, including the breadth of its
scientific research, number of personnel supported, and
physical research infrastructure relevant to the proposed
award.
``(9) NIH.--The term `NIH' means the National Institutes of
Health.
``(10) Nonprofit research organization.--The term
`nonprofit research organization' means a domestic public or
private organization exempt from taxation under section
501(c)(3) of the Internal Revenue Code of 1986 that conducts or
supports scientific research as a primary purpose.
``(11) Program.--The term `program' means the program
authorized under subsection (a).
``(12) Programmatic needs.--The term `programmatic needs'
means the degree to which an award would advance the strategic
research priorities and unmet needs of NIH and its institutes
and centers, as determined by the Director of NIH.
``(13) R&D plant.--The term `R&D plant' means fixed assets
used primarily for research and development, including the
construction, expansion, leasing, or modernization of research
facilities and the acquisition of major movable research
equipment.
``(14) Regrant.--The term `regrant' means the provision of
a subaward or other financial assistance by an award recipient
under the program to carry out research activities consistent
with the purposes of the original award.
``(15) Scientific ambition.--The term `scientific ambition'
means the scale, novelty, and transformative potential of an
institution's proposed research agenda under an award, as
measured by the significance of the scientific questions
addressed and the potential to advance fundamental or
translational understanding.
``(16) United states.--The term `United States' means the
States and the District of Columbia.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section such sums as may be necessary
for each of fiscal years 2026 through 2031.''.
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