H.R. 6089

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6089 Introduced in House (IH)]

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119th CONGRESS
1st Session
H. R. 6089

To establish a Biopharmaceutical Center of Excellence, and for other 
purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

November 18, 2025

Ms. Houlahan (for herself, Mr. Baird, Ms. Ross, and Mr. Rouzer) 
introduced the following bill; which was referred to the Committee on 
Science, Space, and Technology

_______________________________________________________________________

A BILL

To establish a Biopharmaceutical Center of Excellence, 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 ``Biomanufacturing Excellence Act of 
2025''.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

(a) Findings.--Congress finds the following:
(1) Biotechnology is the designing and engineering of 
biological systems. Biotechnology allows scientists to grow 
everything from medicines to crops to materials, enabling 
``biology by design''.
(2) Biotechnology holds the potential for the United States 
to transform its military capabilities, strengthen food 
security and agricultural resilience, and cure life-threatening 
diseases, but it holds that same potential for other countries. 
The countries that master biotechnology first will gain the 
ability to shape how those technologies are used for decades to 
come.
(3) Biotechnology unlocks the capabilities of producing 
medicines via biological systems, known as biopharmaceutical 
manufacturing. Biopharmaceutical manufacturing will enable 
better and less invasive treatments that extend and improve 
lives.
(4) By investing in biomanufacturing, the United States 
Government would reduce dependency on foreign supply chains.
(5) For United States manufacturers, the biggest roadblock 
to commercialization is proving that their products and 
processes can scale and produce a return on investment. 
Biomanufacturing requires flexible and affordable 
infrastructure for development, to ensure that innovative 
products can rapidly move from the lab to commercial-scale 
production.
(b) Sense of Congress.--It is the sense of Congress that--
(1) to realize the potential of biotechnology, the United 
States Government should establish a biopharmaceutical 
manufacturing center of excellence;
(2) the center should facilitate and accelerate 
manufacturing innovation, support good manufacturing practices, 
and provide for collaboration among public, private, and 
nonprofit institutions; and
(3) the center should also facilitate training for workers 
to operate biotechnology tools and equipment and to bolster 
talent throughout the biotechnology sector.

SEC. 3. ESTABLISHMENT OF NATIONAL BIOPHARMACEUTICAL CENTER OF 
EXCELLENCE.

The National Institute of Standards and Technology Act (15 U.S.C. 
271 et seq.) is amended--
(1) by redesignating section 36 as section 37; and
(2) by inserting after section 35 the following:

``SEC. 36. NATIONAL BIOPHARMACEUTICAL CENTER OF EXCELLENCE.

``(a) Establishment of Center of Excellence.--
``(1) In general.--The Director shall award a grant to or 
enter into an other transaction agreement with, on a 
competitive basis, an eligible entity to establish and operate 
a center of excellence to be known as the National 
Biopharmaceutical Manufacturing Center of Excellence (in this 
section referred to as the `Center of Excellence').
``(2) Objectives.--The objectives of the Center of 
Excellence include--
``(A) advancing the science of biopharmaceutical 
manufacturing, especially with respect to products of 
particular importance to the national security, health 
security, or economic security of the United States, 
including by--
``(i) developing and demonstrating flexible 
biopharmaceutical manufacturing technologies 
and systems;
``(ii) improving upstream and downstream 
processes for multiple biopharmaceutical 
manufacturing platforms or product modalities;
``(iii) improving biopharmaceutical 
manufacturing equipment and capabilities; and
``(iv) reducing supply bottlenecks and 
strengthening supply chain self-sufficiency 
through demonstration of innovative 
technologies;
``(B) supporting good manufacturing practices, 
quality by design, and standardization of chemistry, 
manufacturing, and controls to ensure effective and 
efficient manufacturing and to improve the regulation 
of innovative methods of manufacturing;
``(C) advancing workforce training and development 
by working with educational and community partners to 
bolster biotechnology talent;
``(D) developing the science of and deploying the 
infrastructure for innovative biopharmaceutical 
manufacturing by engaging with--
``(i) institutions of higher education;
``(ii) small, medium, and large 
pharmaceutical manufacturers;
``(iii) Federal, State, and local 
government agencies and institutes;
``(iv) non-profit organizations;
``(v) professional organizations; and
``(vi) any other entity the Director 
considers relevant;
``(E) sharing with the head of any Executive agency 
that oversees the planning, management, or coordination 
of Federal activities relating to biotechnology 
research generated by the Center of Excellence, 
including data regarding best practices for 
biopharmeceutical manufacturing; and
``(F) any other objective the Director considers 
relevant.
``(3) Funding.--The Director shall award the Center of 
Excellence funding for any of the following:
``(A) To facilitate the construction of facilities 
necessary to accomplish the objectives described in 
paragraph (2).
``(B) To conduct collaborative research on new 
technology for scaling biopharmaceutical manufacturing 
in the United States for commercial production.
``(C) To facilitate workforce training programs for 
biopharmaceutical manufacturing.
``(D) To fund relevant research and programs for 
the development of biopharmaceutical manufacturing.
``(b) Application; Award.--
``(1) In general.--Not later than 180 days after the date 
of the enactment of this section, the Director shall solicit 
applications from eligible entities specified in paragraph (2) 
and award to or enter into with one such entity a grant or 
other transaction agreement to establish the Center of 
Excellence.
``(2) Eligibility.--An entity is eligible to submit an 
application pursuant to paragraph (1) if--
``(A) the entity is--
``(i) a public-private partnership;
``(ii) an institution of higher education; 
or
``(iii) a consortia of entities specified 
in clauses (i) or (ii); and
``(B) the entity is not a Federal entity.
``(3) Content of application.--An application submitted by 
an entity pursuant to paragraph (1) shall include--
``(A) examples from the entity of previous 
research, development, implementation, and 
demonstration of innovative practices of 
biopharmaceutical manufacturing;
``(B) a description of the manner by which the 
entity plans to advance the science of 
biopharmaceutical manufacturing, especially with 
respect to products of particular importance to the 
national security, health security, or economic 
security of the United States;
``(C) a description of the manner by which the 
entity plans to incorporate good manufacturing 
practices, quality by design, and standardization of 
chemistry, manufacturing, and controls, and similar 
guidance to ensure effective and efficient 
manufacturing and to make innovative methods of 
manufacturing more understandable to Executive agencies 
that are tasked with regulating such methods;
``(D) examples of trainings facilitated by the 
entity that prepare workers for the biotechnology 
sector;
``(E) a description of any existing partnerships 
with educational or community partners that help 
facilitate workforce training for the biotechnology 
sector;
``(F) a description of any experience participating 
in or leading biopharmaceutical manufacturing 
partnerships, including those with institutions of 
higher education, pharmaceutical manufacturers, non-
profit organizations, and governmental agencies--
``(i) to organize and conduct research and 
development aimed at--
``(I) creating and standardizing 
new and more effective technology;
``(II) developing best practices 
and sharing knowledge about such 
technology;
``(III) creating intellectual 
property; and
``(IV) maintaining technological 
leadership in the United States;
``(ii) to support the deployment of 
innovative practices and infrastructure of 
biopharmaceutical manufacturing in the United 
States; and
``(iii) to support developing a skilled 
workforce ready to use innovations in the 
biopharmaceutical manufacturing sector; and
``(G) a description of how the entity intends to 
utilize any funds authorized under this section to 
build or expand facilities and infrastructure to 
achieve any of the objectives described in subsection 
(a)(2).
``(4) Selection criteria.--In selecting an applicant for a 
grant or other transaction agreement under paragraph (1), the 
Director shall consider the following:
``(A) The potential of the applicant to establish a 
Center of Excellence that would achieve the objectives 
set forth in subsection (a)(2).
``(B) The past performance of the applicant in 
biopharmaceutical manufacturing workforce development 
and the potential of the applicant to support workforce 
development activities in various regions throughout 
the United States.
``(C) The extent to which the applicant proposes to 
leverage the activities of other biopharmaceutical 
manufacturing innovation, development, and scaling 
initiatives.
``(D) Whether the proposed location for the Center 
of Excellence is proximate to other biomanufacturing 
infrastructure, training facilities, or industrial 
clusters.
``(E) The time the applicant estimates is needed 
for the Center of Excellence to be fully operational 
and to start delivering impact.
``(F) The amount of co-investment committed by 
Federal, State, private, and other sources to establish 
the Center of Excellence.
``(G) Any additional criteria that the Director 
considers relevant.
``(c) Annual Reports.--
``(1) Initial report.--Not later than one year after the 
date on which the Director awards to or enters into with an 
eligible entity a grant or other transaction agreement to 
establish the Center of Excellence under subsection (b)(1), the 
Director shall submit to Congress a report describing the 
progress on establishing the Center of Excellence, including--
``(A) the construction of facilities;
``(B) any activities, partnerships, and 
collaborations by the Center of Excellence; and
``(C) any other information regarding the formation 
of the Center of Excellence that the Director considers 
relevant.
``(2) Progress report.--Not later than one year after the 
date on which operations at the Center of Excellence officially 
begin, the Director shall submit to Congress a report 
describing--
``(A) the activities, partnerships, collaborations, 
and findings of the Center of Excellence; and
``(B) any other information regarding the Center of 
Excellence that the Director considers relevant.
``(3) Final report.--Not later than 5 years after the date 
on which operations at the Center of Excellence officially 
begin, the Director shall submit to Congress a report 
describing--
``(A) the activities, partnerships, collaborations, 
and findings of the Center of Excellence; and
``(B) any other information regarding the Center of 
Excellence that the Director considers relevant.
``(4) Publication.--The Director shall make the reports 
required by paragraphs (1), (2), and (3) available to the 
public in an easily accessible electronic format on a website 
of the Federal Government that includes information on 
biotechnology.
``(d) Intellectual Property.--The Director shall ensure that, prior 
to commencing operations, the Center of Excellence, in consultation 
with similar existing institutions, such as Manufacturing USA 
institutes (as defined in section 34(d)), establishes intellectual 
property guidelines for research conducted within or in collaboration 
with the Center of Excellence.
``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to the Director to carry out this section $120,000,000 for 
fiscal year 2026.
``(f) Definitions.--In this section:
``(1) Biomanufacturing.--The term `biomanufacturing' means 
the application of biotechnology to manufacturing.
``(2) Biopharmaceutical.--The term `biopharmaceutical' 
means a pharmaceutical drug product manufactured using, 
extracted from, or synthesized from living cells or biological 
organisms.
``(3) Biotechnology.--The term `biotechnology' means the 
application of science or engineering, directly or indirectly, 
to--
``(A) a living organism;
``(B) a part or product of a living organism; or
``(C) a modified form of subparagraph (A) or (B).
``(4) Executive agency.--The term `Executive agency'--
``(A) has the meaning given that term in section 
105 of title 5, United States Code; and
``(B) includes the Executive Office of the 
President and the Office of the Vice President.
``(5) Institution of higher education.--The term 
`institution of higher education' has the meaning given that 
term in section 101 of the Higher Education Act of 1965 (20 
U.S.C. 1001).''.
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