[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2756 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 2756
To authorize the National Biotechnology Initiative, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 9, 2025
Mrs. Bice (for herself and Mr. Khanna) introduced the following bill;
which was referred to the Committee on Science, Space, and Technology,
and in addition to the Committees on Foreign Affairs, Agriculture,
Energy and Commerce, and Education and Workforce, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To authorize the National Biotechnology Initiative, 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 ``National Biotechnology Initiative
Act of 2025''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Bioliteracy.--The term ``bioliteracy'' refers to the
concept of imbuing people, personnel, or teams with an
understanding of and ability to engage with biology and
biotechnology.
(2) Biological data.--The term ``biological data'' means
the information, including associated descriptors, derived from
the structure, function, or process of a biological system(s)
that is either measured, collected, or aggregated for analysis.
(3) Biomanufacturing.--The term ``biomanufacturing'' means
the application of biotechnology to manufacturing.
(4) Biotechnology.--The term ``biotechnology'' means the
application of science and engineering in the direct or
indirect use of living organisms, or parts or products of
living organisms, including modified forms.
(5) Director of the national biotechnology coordination
office.--The term ``Director of the National Biotechnology
Coordination Office'' means the individual appointed pursuant
to section 4(b)(2)(A).
(6) Initiative.--The term ``Initiative'' means the National
Biotechnology Initiative established under section 3.
(7) Interagency committee.--The term ``Interagency
Committee'' means the interagency committee designated pursuant
to section 10403(a)(1).
(8) Office.--The term ``Office'' means the National
Biotechnology Coordination Office established under section
4(b).
(9) Participating agency.--The term ``participating
agency'' means a department, office, or agency set forth under
section 3(b).
SEC. 3. AUTHORIZATION OF THE NATIONAL BIOTECHNOLOGY INITIATIVE.
(a) Initiative Required.--
(1) In general.--The President, acting through the
Executive Office of the President, shall implement an
initiative to advance national security, economic productivity,
and competitiveness through advancement and coordination of
Federal activities relating to biotechnology.
(2) Designation.--The initiative implemented pursuant to
paragraph (1) shall be known as the ``National Biotechnology
Initiative''.
(b) Participating Agencies.--The following shall be participants in
the Initiative:
(1) The Department of Agriculture.
(2) The Department of Commerce.
(3) The Department of Defense.
(4) The Department of Energy.
(5) The Department of Health and Human Services.
(6) The Department of Homeland Security.
(7) The Department of the Interior.
(8) The Department of State.
(9) The Environmental Protection Agency.
(10) The National Aeronautics and Space Administration.
(11) The National Science Foundation.
(12) The Office of the Director of National Intelligence.
(13) The Office of the United States Trade Representative.
(14) Such other Federal departments and agencies as the
Director of the National Biotechnology Coordination Office
considers appropriate.
(c) Activities.--Each head of a participating agency shall carry
out the Initiative, including by carrying out the activities required
by section 6 and by addressing and coordinating the following:
(1) Federal activities relating to biotechnology, including
to create and maintain a national strategy on biotechnology.
(2) National security implications of emerging
biotechnology.
(3) Sustained support for research and development that
accelerates scientific understanding and technological
innovation in biotechnology.
(4) Sustained support for biological data, databases, and
related tools as a strategic national resource.
(5) Private sector translation and commercialization of
products that are produced with biotechnology.
(6) Regulatory streamlining for products that are produced
with biotechnology.
(7) Biosafety and biosecurity issues associated with
emerging biotechnology.
(8) Development of a domestic workforce, including the
Federal workforce, to advance biotechnology across the United
States.
(9) Bioliteracy activities that provide clear, easy-to-find
information for policymakers, innovators, and the public.
(10) International partnerships, including regulatory and
commercial diplomacy.
(11) Such other activities relating to biotechnology as the
Director of the National Biotechnology Coordination Office and
the Interagency Committee jointly determine are needed to
advance national security, economic productivity, and
competitiveness relating to biotechnology.
SEC. 4. INITIATIVE COORDINATION.
(a) Interagency Committee.--
(1) Designation.--Not later than 180 days after the date of
the enactment of this Act, the President shall, acting through
the Executive Office of the President, designate an interagency
committee to coordinate activities of the Initiative.
(2) Duties.--Each member of the Interagency Committee
shall--
(A) work with the Director of the National
Biotechnology Coordination Office to oversee the
planning, management, and coordination of the
Initiative;
(B) ensure the department or agency of the member
supports the Initiative through relevant activities set
forth under section 6;
(C) keep the other members of the Interagency
Committee apprised of the activities described in
subparagraph (B); and
(D) communicate activities of the Interagency
Committee with relevant components of the Department or
agency of the member.
(3) Membership.--The Interagency Committee shall include 1
member at the Assistant Secretary level from each participating
agency selected by the head of the participating agency.
(4) Co-chairpersons.--
(A) In general.--The Interagency Committee shall
have 3 co-chairpersons, of whom--
(i) one co-chairperson shall be the
Director of the National Biotechnology
Coordination Office; and
(ii) two co-chairpersons shall be selected
by the members of the Interagency Committee
from among the members of the Interagency
Committee.
(B) Terms.--Each co-chairperson selected pursuant
to subparagraph (A)(ii) shall serve a term of 2 years,
except for the first term the Interagency Committee
shall select one co-chairperson to serve a term of 3
years, such that subsequent terms are staggered.
(C) Vacancies.--
(i) In general.--A vacancy under this
paragraph shall be filled in the manner in
which the original appointment was made and
shall be subject to any conditions that applied
with respect to the original appointment.
(ii) Filling unexpired term.--An individual
chosen to fill a vacancy shall be appointed for
the unexpired term of the co-chairperson
replaced.
(D) Quorum.--A majority of the members of the
Interagency Committee shall constitute a quorum for the
purposes of voting for co-chairpersons under clauses
(i)(II) and (ii)(II) of subparagraph (A), with co-
chairpersons selected by the member who receives the
highest plurality of votes.
(E) Limitation.--A member of the Interagency
Committee from a particular Federal department or
agency may not serve consecutive terms as co-
chairperson of the Interagency Committee.
(b) National Biotechnology Coordination Office.--
(1) Establishment of national biotechnology coordination
office.--
(A) In general.--Not later than 180 days after the
date of the enactment of this Act, the President shall
establish an office in the Executive Office of the
President to support the Initiative.
(B) Designation.--The office established pursuant
to subparagraph (A) shall be known as the ``National
Biotechnology Coordination Office''.
(2) Director of national biotechnology coordination
office.--
(A) Appointment.--Not later than 180 days after the
date of the enactment of this Act, the President shall
appoint an individual to serve as the Director of the
National Biotechnology Coordination Office.
(B) Duties.--The duties of the Director of the
National Biotechnology Coordination Office are as
follows:
(i) To serve as the principal advisor to
the President for biotechnology.
(ii) To administer the functions of the
Office set forth under paragraph (3).
(C) Authorities.--In support of the Initiative, the
Director may--
(i) advise the Director of the Office of
Management and Budget for the purposes of
tracking and adjusting agency spending relating
to biotechnology, including to ensure that
Federal efforts are complementary and not
duplicative;
(ii) convene members of the Interagency
Committee in order to advance and coordinate
Federal activities relating to biotechnology;
(iii) coordinate Federal regulation of
products that are produced with biotechnology;
(iv) select, appoint, employ, and fix the
compensation of such officers and employees as
are necessary and prescribe their duties;
(v) enter into and perform such contracts,
leases, cooperative agreements, or other
transactions, as appropriate, to the conduct of
the work of the Office;
(vi) utilize, with their consent, the
services, personnel, and facilities of other
Federal agencies; and
(vii) accept voluntary and uncompensated
services, notwithstanding the provisions of
section 1342 of title 31, United States Code.
(3) Functions of the office.--The functions of the Office
shall be, in support of the Initiative, the following:
(A) Planning and coordination.--Functions relating
to planning and coordination as follows:
(i) Working with the Interagency Committee
to oversee the planning, management, and
coordination of Federal activities relating to
biotechnology.
(ii) Providing technical and administrative
support to the Interagency Committee.
(iii) Assessing the landscape and gaps
associated with the different components of the
Initiative.
(iv) Coordinating a fellowship program in
which Federal employees are detailed to 1 or
more Federal agencies to gain greater
understanding of biotechnology activities
outside of their home agency.
(v) Building and maintaining a coordinated
website for Federal activities relating to
biotechnology pursuant to subsection (c).
(vi) Coordinating development of an annual
report under subsection (d) and a national
strategy as required by subsection (e).
(vii) Conducting such other activities to
support the Initiative as the Director
considers appropriate.
(B) National security.--Functions relating to
national security as follows:
(i) Assessing and addressing the national
security and economic security implications of
emerging biotechnology.
(ii) Identifying and remedying any major
needs or information gaps in current national
security assessments and activities, including
to conduct counterintelligence efforts to fill
gaps relating to biotechnology.
(iii) Providing coordination in addressing
foreign investments and acquisition from
adversarial countries.
(C) Research and development.--Functions relating
to research and development as follows:
(i) Coordinating sustained support for
research and development that accelerates
scientific understanding and technological
innovation in biotechnology.
(ii) Facilitating joint agency
solicitations for funding for individual
grants, collaborative grants, and
interdisciplinary research centers.
(iii) Developing and proposing focus areas
or challenges for research funding meant to
advance biotechnology, particularly relating to
convergence with other technologies such as
artificial intelligence.
(iv) Developing, standardizing, and
deploying robust mechanisms for documenting and
quantifying the outputs and economic benefits
of biotechnology.
(D) Data and databases.--Functions relating to data
and databases as follows:
(i) Coordinating sustained support for
biological data, databases, and related tools
as a strategic national resource to advance
human health and the understanding of animals,
plants, microbes, and other organisms.
(ii) Recommending actions to integrate
security into biological data access and
international reciprocity agreements.
(iii) Coordinating frameworks for
biological data standardization to create
datasets that are interoperable and usable by
advanced computation methods such as artificial
intelligence.
(E) Product commercialization.--Functions relating
to product commercialization as follows:
(i) Strategizing and coordinating on
private sector translation and
commercialization of products that are produced
with biotechnology.
(ii) Assisting in coordinating a national
network of testbeds to enable scale-up of
biotechnology research.
(F) Regulatory streamlining.--Functions relating to
regulatory streamlining as follows:
(i) Coordinating the easing of regulatory
burden for types of biotechnology products that
have become well-understood by regulators,
including products that could have occurred
naturally or been developed with conventional
means.
(ii) Negotiating interagency agreements
that describe clear regulatory pathways for
each type of biotechnology product, with
information about timelines, decision points,
expected data requirements, clear hand-offs
between agencies, and other information deemed
necessary by the Office to resolve regulatory
gaps, overlaps, and ambiguities for
biotechnology products.
(iii) Providing regular status updates to
the Office of Management and Budget as to the
development of clear regulatory pathways, and
in the event that the Office and the
Interagency Committee cannot reach timely
agreement on a clear regulatory pathway for any
product type, assisting the Director of the
Office of Management and Budget in carrying out
paragraph (5).
(iv) Not later than 1 year after the date
of the enactment of this Act, jointly with the
Interagency Committee developing and making
available to the public a plan for regulatory
streamlining.
(G) Biosafety and biosecurity.--Functions relating
to biosafety and biosecurity as follows:
(i) Developing strategies and coordinating
to address biosafety and biosecurity issues
associated with emerging biotechnology.
(ii) Coordinating on assessment and
mitigation of potential biosafety and
biosecurity threats relating to biotechnology
research, including through collaboration with
regulatory agencies and industry.
(H) Workforce development.--Functions relating to
workforce development as follows:
(i) Coordinating and developing strategies
to develop a domestic workforce for
biotechnology.
(ii) Coordinating with appropriate agencies
to establish a national biotechnology workforce
framework to define biotechnology jobs and
skills in public and private sectors.
(iii) Coordinating with appropriate
agencies to conduct an interagency assessment
of biotechnology workforce needs, and
subsequently developing and providing training
programs.
(I) Bioliteracy.--Functions relating to bioliteracy
as follows:
(i) Coordinating development of plain-
language materials about biotechnology.
(ii) Providing central locations, including
the website required by subsection (c), for
clear, easy-to-find information about
biotechnology for policymakers, innovators, and
the public.
(J) International partnerships.--Functions relating
to international partnerships as follows:
(i) Coordinating Federal regulatory and
commercial diplomacy activities.
(ii) Assessing the current regulatory and
commercial diplomacy activities carried out
across the Federal Government, identifying
gaps, and developing an outreach strategy to
improve the regulatory landscape and market
access for products of the United States.
(iii) Identifying non-regulatory solutions
for trade and market access concerns (such as
the use of identity preservation for certain
agricultural biotechnology products) and
working with relevant government agencies and
stakeholders to implement solutions.
(K) Other.--Such other activities as the Director
considers necessary to advance national security,
economic productivity, and competitiveness related to
biotechnology.
(4) Administrative support and authorization of
appropriations.--
(A) Administrative support.--The Director of the
National Science Foundation shall provide support for
the administration and implementation of the
Initiative, including--
(i) appointing and providing compensation
for employees of the Office, without regard to
any provision relating to appointment or
compensation under title 5, United States Code,
including--
(I) deputy directors as needed to
address the responsibilities in
paragraph (3), as determined necessary
by the Director of the Office; and
(II) other appropriate employees,
including experts in the science of
biotechnology, biotechnology policy,
regulatory policy, and science
communication, legal counsel, and
software designers and developers, as
determined necessary by the Director of
the Office;
(ii) fixing the compensation of employees
of the Office in an amount that does not exceed
the amount of annual compensation (excluding
expenses) specified in section 102 of title 3,
United States Code;
(iii) detailing employees of the National
Science Foundation to the Office and receiving
the detail of employees from other agencies to
the Office; and
(iv) assistance with other costs associated
with running the Initiative, including physical
space, other staff, and overhead support.
(B) Authorization of appropriations.--There are
authorized to be appropriated to the Director of the
National Science Foundation to carry out subparagraph
(A)--
(i) $22,000,000 for fiscal year 2026;
(ii) $35,000,000 for fiscal year 2027;
(iii) $25,000,000 for fiscal year 2028;
(iv) $25,000,000 for fiscal year 2029; and
(v) $25,000,000 for fiscal year 2030.
(5) Regulatory streamlining by office of management and
budget.--In the event that the Office and the Interagency
Committee cannot reach timely agreement on a clear regulatory
pathway for a product type, as described in paragraph
(3)(F)(iii), the Director of the Office of Management and
Budget shall--
(A) identify overlaps, gaps, or ambiguities in the
regulation for such product type;
(B) negotiate an interagency agreement that
describes a clear regulatory pathway for such product
type, with information about timelines, decision
points, expected data requirements, clear hand-offs
between agencies, and other information deemed
necessary by the Office of Management and Budget to
resolve regulatory gaps, overlaps, and ambiguities; and
(C) recommend and oversee rulemaking or changes to
guidance as needed to implement clear regulatory
pathways.
(6) Wind-down.--
(A) In general.--The Office shall wind-down its
activities on the date that is 20 years after the date
of the enactment of this Act, and transition to serving
as an executive secretariat for the Initiative.
(B) Wind-down activities.--The activities specified
in this clause are as follows:
(i) The transfer of authorities,
requirements, resources, personnel, and
obligations of the Office to the fullest extent
possible to the Interagency Committee and such
elements of the Federal Government as the
Director and the Interagency Committee
considers appropriate.
(ii) The Office shall maintain authorities,
requirements, resources, personnel, and
obligations necessary to serve as the executive
secretariat for the Initiative, including to
continue the coordination in subsection
(b)(3)(A), the website in subsection (c), and
any other activities that the Director and the
Interagency Committee considers appropriate.
(C) Treatment of transferred functions.--Commencing
on the date on which the Office is terminated under
subparagraph (A), any reference to a requirement or an
authority of the Office that has been transferred to
the Interagency Committee or an element of the Federal
Government shall be treated as a reference to the
Interagency Committee or the element of the Federal
Government to which such requirement or authority was
transferred pursuant to subparagraph (B).
(c) Website.--
(1) In general.--Not later than 540 days after the date of
the enactment of this Act, the Director of the National
Biotechnology Coordination Office and the Interagency Committee
shall jointly develop and publish for the public a single,
coordinated Federal website for biotechnology that adheres to
best practices for website design, development, and
maintenance.
(2) Contents.--The website developed and published pursuant
to paragraph (1) shall include the following:
(A) A dashboard of Federal Government activities
relating to biotechnology, including information about
open funding opportunities.
(B) Plain-language information about biotechnology,
including information for policymakers, innovators,
trading partners, and the public.
(C) A mechanism for stakeholders to ask a question
and receive a single, coordinated response.
(D) Mechanisms, which may be populated over time,
to provide consolidated information about biotechnology
product regulation, focusing on products that are
regulated by more than 1 Federal agency, with content
that includes the following:
(i) A repository of interagency agreements
that describe clear regulatory pathways, with
links to relevant regulations and guidance
documents for each type of biotechnology
product.
(ii) A repository of regulatory decision
documents for biotechnology products.
(iii) A digital portal that allows
submission of a single application and
information sharing between Federal agencies.
(3) Updates.--The Director and the Interagency Committee
shall jointly update the website required by paragraph (1)
periodically.
(d) Annual Reports.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, and not less frequently than once
each year thereafter, except in years in which a national
strategy for biotechnology is required under subsection (e),
the Director of National Biotechnology Coordination Office and
the Interagency Committee shall jointly submit to the Committee
on Commerce, Science, and Transportation of the Senate and the
Committee on Science, Space, and Technology of the House of
Representatives an annual report on the Initiative.
(2) Contents.--Each annual report submitted pursuant to
paragraph (1) shall include, for the period covered by the
report, the following:
(A) An inventory and accounting of Federal
Government activities and spending in support of the
Initiative.
(B) Actions that the Director and the Interagency
Committee plan to take in support of the Initiative in
the next fiscal year.
(e) National Strategy.--
(1) In general.--Not later than 2 years after the date of
the enactment of this Act, and not less frequently than once
every 5 years thereafter, the Director of National
Biotechnology Coordination Office and the Interagency Committee
shall jointly make available to the public and submit to the
Committee on Commerce, Science, and Transportation of the
Senate and the Committee on Science, Space, and Technology of
the House of Representatives a comprehensive national strategy
for biotechnology.
(2) Elements.--Each national strategy made available and
submitted pursuant to paragraph (1) shall cover the following:
(A) Actions, goals, and priorities to advance the
Initiative, including how each Federal department and
agency will address the requirements of section 6 and
how each Federal department and agency will integrate
biotechnology into their own strategies.
(B) Activities that are an urgent priority to
advance biotechnology in the United States but not
currently being conducted by Federal agencies, with an
estimated 5-year budget for those activities.
(C) Recommendations for legislative or
administrative action to advance biotechnology in the
United States.
(D) An inventory of all Federal Government
databases with biological data with an assessment that
identifies opportunities--
(i) to improve the utility of such
databases, in a manner that does not compromise
national security or the privacy and security
of information within such databases; and
(ii) to inform investment in such databases
as critical infrastructure for the
biotechnology research enterprise.
(E) An assessment of United States competitiveness
in biotechnology relative to peer countries,
including--
(i) contributions of biotechnology to
United States economic growth and other
societal indicators;
(ii) contributions of biotechnology to
economic growth in other countries, especially
peer-competitors; and
(iii) current barriers to commercialization
of biotechnology products, processes, and tools
in the United States.
(F) A national biological data strategy to ensure
biotechnology research fully leverages plant, animal,
and microbe biodiversity, as appropriate and in a
manner that does not compromise economic
competitiveness, national security, or the privacy or
security of human genetic information.
(G) The information that is required as a part of
the annual report required by subsection (d).
(f) Comptroller General Review.--The Comptroller General of the
United States shall--
(1) not later than 3 years after the date of the enactment
of this Act, begin a review to assess the efficacy of
interagency coordination and fulfillment of the activities
conducted by the Office and the Interagency Committee under the
Initiative;
(2) not later than 3.5 years after the date of the
enactment of this Act, provide Congress a briefing on the
initial findings of the Comptroller General with respect to the
activities described in paragraph (1);
(3) not later than 4 years after the date of the enactment
of this Act, submit to the Committee on Commerce, Science, and
Transportation of the Senate and the Committee on Science,
Space, and Technology of the House of Representatives a report
with recommendations to improve the Initiative; and
(4) repeat the process outlined in paragraphs (1), (2), and
(3) every 5 years thereafter until the date that is 20 years
after the date of the enactment of this Act.
SEC. 5. CONVENING OF EXPERTS ON BIOTECHNOLOGY RESEARCH AND DEVELOPMENT.
(a) In General.--The Director of the National Biotechnology
Coordination Office may, in consultation with the Interagency
Committee, convene experts to assess and inform the activities of the
Initiative in a time and manner as deemed appropriate and necessary by
the Director.
(b) Application of Federal Advisory Committee Act.--Section 1013 of
title 5, United States Code, shall not apply to the convening of
experts under this section.
SEC. 6. AGENCY ACTIVITIES.
Each head of a participating agency shall, in support of the
Initiative and in coordination with the Office, conduct or support, in
a manner consistent with the duties and mission of the respective
department or agency, the following activities to advance biotechnology
across defense, human health, food and agriculture, energy, space,
mining, environmental stewardship, and other sectors:
(1) Planning and coordination.--Activities relating to
planning and coordination as follows:
(A) Designating an individual within the respective
department or agency at the level of Assistant
Secretary to lead the biotechnology activities for the
department or agency, if such person is not already
designated, and to serve as the department or agency
liaison to the Initiative and member of the Interagency
Committee.
(B) Designating individuals within the respective
department or agency to serve as members of
subcommittees that may be established by the
Interagency Committee.
(C) Coordinating activities of the participating
agency that relate to biotechnology with the Office.
(D) Implementing applicable portions of the
national strategy required by section 4(e) in ways that
improve government efficiency and reduce redundancy.
(E) Providing insight and information about
biotechnology to the heads of other Federal departments
and agencies and to Congress.
(F) Leveraging horizon scanning and technology
foresight to ensure United States leadership in future
biotechnology advancements.
(2) National security.--Activities relating to national
security as follows:
(A) Analyzing ongoing and emerging threats from
foreign adversary development and application of
biotechnology, including foreign investments and
acquisition of United States capabilities,
technologies, and biological data.
(B) Providing expertise to address foreign
investments and acquisition from adversarial countries.
(C) Analyzing and identifying actions to mitigate
supply chain risks posed by foreign adversary
involvement in such supply chains.
(D) Coordinating and ensuring information sharing
with foreign service officers regarding threats to and
opportunities for biotechnology.
(E) Coordinating with industry on threat
information sharing, vulnerability disclosure, and risk
mitigation for cybersecurity and infrastructure risks,
including risks to biological data and related physical
and digital infrastructure and devices.
(F) Improving cybersecurity and stress-testing
related to sensitive biological data and to
biotechnology infrastructure, tools, and
instrumentation.
(3) Research and development.--Activities relating to
research and development as follows:
(A) Providing sustained support for research and
development that accelerates scientific understanding
and technological innovation in biotechnology.
(B) Conducting joint agency solicitation and
selection of applications for funding of individual
grants, collaborative grants, and interdisciplinary
research centers.
(C) Developing instrumentation, equipment, and
infrastructure for biotechnology, including to
optimize, standardize, scale, and deliver new products
and solutions.
(D) Developing standard reference materials and
measurements to promote interoperability between new
component technologies and processes for biotechnology
discovery, innovation, and production processes.
(E) Increasing understanding of the risks and
benefits of biotechnology, including how products
developed with biotechnology can affect or protect the
environment.
(F) Increasing understanding of the ethical, legal,
and social implications of biotechnology, including
research that contributes to public understanding of
biotechnology.
(4) Data and databases.--Activities relating to data and
databases as follows:
(A) Providing sustained support for biological
data, databases, and related tools to advance human
health and the understanding of animals, plants,
microbes, and other organisms.
(B) Establishing, curating, and maintaining
genomics, epigenomics, and other relevant omics and
biological data and databases, such as through a
centralized biological data access hub with appropriate
protections for the privacy or security of information
within such databases.
(C) Developing standards for biological data and
databases, including for curation, interoperability,
and protection of privacy and security.
(D) Developing computational tools, including
artificial intelligence tools, to accelerate research
and innovation using biological data and databases.
(E) Developing tools that use omics and associated
bioinformatic sciences to improve monitoring,
management, assessments, and forecasts.
(5) Product commercialization.--Activities relating to
product commercialization as follows:
(A) Providing sustained support for private sector
translation and commercialization of products that are
produced with biotechnology, including
biomanufacturing.
(B) Utilizing existing Federal programs, such as
the Small Business Innovation Research Program and the
Small Business Technology Transfer Program (as
described in section 9 of the Small Business Act (15
U.S.C. 638)), in support of biotechnology, including to
support proof of concept activities, and the formation
of startup companies.
(C) Accelerating the translation, scale-up, and
commercialization of new products, processes, and
technologies in order to transfer fundamental research
results to industry and accelerate commercial
applications.
(D) Facilitating public-private partnerships in
biotechnology research and development that address and
reduce barriers to scaling up biotechnology
innovations.
(E) Supporting a national network of testbeds based
on open standards, interfaces, and processes, including
by repurposing existing facilities, to enable scale-up
of biotechnology research.
(F) Providing incentives for retooling of
industrial sites across the United States to foster a
pivot to biotechnology.
(G) Providing access to user facilities with
advanced or unique equipment, services, materials, and
other resources, including secure access to high-
performance computing, as appropriate, to industry,
institutions of higher education, nonprofit
organizations, and government agencies to perform
research and testing.
(6) Regulatory streamlining.--Activities relating to
regulatory streamlining as follows:
(A) Conducting and coordinating regulatory
streamlining for products that are produced with
biotechnology.
(B) Easing regulatory burden for types of
biotechnology products that have become well-understood
by regulators, including products that could have
occurred naturally or been developed with conventional
means.
(C) Establishing clear regulatory pathways for
biotechnology products, including through short-term
regulatory trials to establish new or update existing
regulatory pathways.
(D) Ensuring consistent, risk-proportionate
regulation of biotechnology research and development
activities, including for release of products or
organisms into the environment.
(E) Conducting horizon scanning to identify novel
biotechnology products and develop clear regulatory
pathways for such products.
(7) Biosafety and biosecurity.--Activities relating to
biosafety and biosecurity as follows:
(A) Addressing biosafety, biosecurity, and
responsible biology issues associated with emerging
biotechnology.
(B) Developing an applied management plan to
address biological risks of biotechnology research.
(C) Creating an adaptable, evidence-based framework
to respond to emerging biosecurity challenges that
considers and informs updates of existing biosecurity
governance policies, guidance, and directives and
identifies necessary safeguards for new products,
processes, and systems of biotechnology.
(D) Conducting outreach to industry, institutions
of higher education, nonprofit organizations, and
government agencies to increase awareness of biosafety
and biosecurity implications of biotechnology research.
(8) Workforce development.--Activities relating to
workforce development as follows:
(A) Providing sustained support for development of
a domestic biotechnology workforce.
(B) Ensuring that Congress and Federal departments
and agencies have access to necessary expertise across
national security and emerging biotechnology issues.
(C) Supporting Federal biotechnology education and
workforce training programs and initiatives for
students and workers.
(D) Supporting education and training of
undergraduate and graduate students in biotechnology,
including biomanufacturing, bioprocess engineering, and
computational science applied to biotechnology.
(E) Connecting researchers, graduate students, and
postdoctoral fellows with entrepreneurship education
and training opportunities, including to award grants,
on a competitive basis, that enable institutions to
support graduate students, and postdoctoral fellows who
perform some of their biotechnology research in an
industry setting.
(F) Supporting professional development, continuing
education, and skills development (such as re-skilling
and upskilling) for veterans, industry workers, and
technology professionals.
(G) Supporting curriculum development and research
experiences for secondary, undergraduate, and graduate
students in biotechnology, including through support
for graduate fellowships and traineeships in
biotechnology to ensure that students are receiving up-
to-date training that keeps pace with biotechnologies
as they evolve and meets industry workforce needs so
students are qualified for employment.
(H) Supporting curriculum development and research
experiences in biotechnology and associated data and
information sciences across the Federal workforce,
including for the military education system.
(9) Bioliteracy.--Activities relating to bioliteracy as
follows:
(A) Providing clear, easy-to-find information about
biotechnology for policymakers, innovators, and the
public.
(B) Supporting greater evidence-based public
discourse about the benefits and risks of
biotechnology.
(C) Ensuring that public input and outreach are
integrated into Federal biotechnology activities
through regular and ongoing public discussions such as
workshops, consensus conferences, and educational
events, as may be appropriate.
(10) International partnerships.--Activities relating to
international partnerships as follows:
(A) Developing an internal international engagement
strategy for the respective department or agency, in
cooperation with relevant interagency partners.
(B) Strengthening and developing bilateral and
multilateral relationships to advance United States
priorities in biotechnology abroad.
(C) Providing sustained support and coordinating
interagency activities in international biotechnology
outreach and engagement with allies and partners.
(D) Engaging in coordinated regulatory and
commercial diplomacy to better align biotechnology
regulations and expand market access for biotechnology
products.
(E) Supporting the development of international
standards and norms for biotechnology, including to
define shared values and interests.
(F) Supporting biological data-sharing agreements
with partner countries.
(G) Supporting biotechnology talent exchanges with
partner countries, including through fellowships, work
authorization programs, and other mechanisms.
(H) Supporting harmonization of multilateral export
controls to protect against misuse of biotechnology.
(11) Other.--Such other activities as the head of the
participating agency determines may be needed to advance
national security, economic productivity, and competitiveness
relating to biotechnology.
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