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:

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.