[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1387 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 1387
To authorize the National Biotechnology Initiative, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 9, 2025
Mr. Young (for himself and Mr. Padilla) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
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