H.R. 6572

[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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