II
119THCONGRESS
1
STSESSION S. 1387
To authorize the National Biotechnology Initiative, and for other purposes.
IN THE SENATE OF THE UNITED STATES
APRIL9, 2025
Mr. Y
OUNG(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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘National Biotechnology 4
Initiative Act of 2025’’. 5
SEC. 2. DEFINITIONS. 6
In this Act: 7
(1) B
IOLITERACY.—The term ‘‘bioliteracy’’ re-8
fers to the concept of imbuing people, personnel, or 9
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teams with an understanding of and ability to en-1
gage with biology and biotechnology. 2
(2) B
IOLOGICAL DATA.—The term ‘‘biological 3
data’’ means the information, including associated 4
descriptors, derived from the structure, function, or 5
process of a biological system(s) that is either meas-6
ured, collected, or aggregated for analysis. 7
(3) B
IOMANUFACTURING.—The term ‘‘bio-8
manufacturing’’ means the application of bio-9
technology to manufacturing. 10
(4) B
IOTECHNOLOGY.—The term ‘‘bio-11
technology’’ means the application of science and en-12
gineering in the direct or indirect use of living orga-13
nisms, or parts or products of living organisms, in-14
cluding modified forms. 15
(5) D
IRECTOR OF THE NATIONAL BIO -16
TECHNOLOGY COORDINATION OFFICE .—The term 17
‘‘Director of the National Biotechnology Coordina-18
tion Office’’ means the individual appointed pursu-19
ant to section 4(b)(2)(A). 20
(6) I
NITIATIVE.—The term ‘‘Initiative’’ means 21
the National Biotechnology Initiative established 22
under section 3. 23
(7) I
NTERAGENCY COMMITTEE .—The term 24
‘‘Interagency Committee’’ means the interagency 25
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committee designated pursuant to section 1
10403(a)(1). 2
(8) O
FFICE.—The term ‘‘Office’’ means the 3
National Biotechnology Coordination Office estab-4
lished under section 4(b). 5
(9) P
ARTICIPATING AGENCY.—The term ‘‘par-6
ticipating agency’’ means a department, office, or 7
agency set forth under section 3(b). 8
SEC. 3. AUTHORIZATION OF THE NATIONAL BIO-9
TECHNOLOGY INITIATIVE. 10
(a) I
NITIATIVEREQUIRED.— 11
(1) I
N GENERAL.—The President, acting 12
through the Executive Office of the President, shall 13
implement an initiative to advance national security, 14
economic productivity, and competitiveness through 15
advancement and coordination of Federal activities 16
relating to biotechnology. 17
(2) D
ESIGNATION.—The initiative implemented 18
pursuant to paragraph (1) shall be known as the 19
‘‘National Biotechnology Initiative’’. 20
(b) P
ARTICIPATINGAGENCIES.—The following shall 21
be participants in the Initiative: 22
(1) The Department of Agriculture. 23
(2) The Department of Commerce. 24
(3) The Department of Defense. 25
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(4) The Department of Energy. 1
(5) The Department of Health and Human 2
Services. 3
(6) The Department of Homeland Security. 4
(7) The Department of the Interior. 5
(8) The Department of State. 6
(9) The Environmental Protection Agency. 7
(10) The National Aeronautics and Space Ad-8
ministration. 9
(11) The National Science Foundation. 10
(12) The Office of the Director of National In-11
telligence. 12
(13) The Office of the United States Trade 13
Representative. 14
(14) Such other Federal departments and agen-15
cies as the Director of the National Biotechnology 16
Coordination Office considers appropriate. 17
(c) A
CTIVITIES.—Each head of a participating agen-18
cy shall carry out the Initiative, including by carrying out 19
the activities required by section 6 and by addressing and 20
coordinating the following: 21
(1) Federal activities relating to biotechnology, 22
including to create and maintain a national strategy 23
on biotechnology. 24
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(2) National security implications of emerging 1
biotechnology. 2
(3) Sustained support for research and develop-3
ment that accelerates scientific understanding and 4
technological innovation in biotechnology. 5
(4) Sustained support for biological data, data-6
bases, and related tools as a strategic national re-7
source. 8
(5) Private sector translation and commer-9
cialization of products that are produced with bio-10
technology. 11
(6) Regulatory streamlining for products that 12
are produced with biotechnology. 13
(7) Biosafety and biosecurity issues associated 14
with emerging biotechnology. 15
(8) Development of a domestic workforce, in-16
cluding the Federal workforce, to advance bio-17
technology across the United States. 18
(9) Bioliteracy activities that provide clear, 19
easy-to-find information for policymakers, 20
innovators, and the public. 21
(10) International partnerships, including regu-22
latory and commercial diplomacy. 23
(11) Such other activities relating to bio-24
technology as the Director of the National Bio-25
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technology Coordination Office and the Interagency 1
Committee jointly determine are needed to advance 2
national security, economic productivity, and com-3
petitiveness relating to biotechnology. 4
SEC. 4. INITIATIVE COORDINATION. 5
(a) I
NTERAGENCYCOMMITTEE.— 6
(1) D
ESIGNATION.—Not later than 180 days 7
after the date of the enactment of this Act, the 8
President shall, acting through the Executive Office 9
of the President, designate an interagency committee 10
to coordinate activities of the Initiative. 11
(2) D
UTIES.—Each member of the Interagency 12
Committee shall— 13
(A) work with the Director of the National 14
Biotechnology Coordination Office to oversee 15
the planning, management, and coordination of 16
the Initiative; 17
(B) ensure the department or agency of 18
the member supports the Initiative through rel-19
evant activities set forth under section 6; 20
(C) keep the other members of the Inter-21
agency Committee apprised of the activities de-22
scribed in subparagraph (B); and 23
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(D) communicate activities of the Inter-1
agency Committee with relevant components of 2
the Department or agency of the member. 3
(3) M
EMBERSHIP.—The Interagency Com-4
mittee shall include 1 member at the Assistant Sec-5
retary level from each participating agency selected 6
by the head of the participating agency. 7
(4) C
O-CHAIRPERSONS.— 8
(A) I
N GENERAL.—The Interagency Com-9
mittee shall have 3 co-chairpersons, of whom— 10
(i) one co-chairperson shall be the Di-11
rector of the National Biotechnology Co-12
ordination Office; and 13
(ii) two co-chairpersons shall be se-14
lected by the members of the Interagency 15
Committee from among the members of 16
the Interagency Committee. 17
(B) T
ERMS.—Each co-chairperson selected 18
pursuant to subparagraph (A)(ii) shall serve a 19
term of 2 years, except for the first term the 20
Interagency Committee shall select one co- 21
chairperson to serve a term of 3 years, such 22
that subsequent terms are staggered. 23
(C) V
ACANCIES.— 24
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(i) IN GENERAL.—A vacancy under 1
this paragraph shall be filled in the man-2
ner in which the original appointment was 3
made and shall be subject to any condi-4
tions that applied with respect to the origi-5
nal appointment. 6
(ii) F
ILLING UNEXPIRED TERM .—An 7
individual chosen to fill a vacancy shall be 8
appointed for the unexpired term of the co- 9
chairperson replaced. 10
(D) Q
UORUM.—A majority of the members 11
of the Interagency Committee shall constitute a 12
quorum for the purposes of voting for co-chair-13
persons under clauses (i)(II) and (ii)(II) of sub-14
paragraph (A), with co-chairpersons selected by 15
the member who receives the highest plurality 16
of votes. 17
(E) L
IMITATION.—A member of the Inter-18
agency Committee from a particular Federal 19
department or agency may not serve consecu-20
tive terms as co-chairperson of the Interagency 21
Committee. 22
(b) N
ATIONALBIOTECHNOLOGYCOORDINATIONOF-23
FICE.— 24
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(1) ESTABLISHMENT OF NATIONAL BIO -1
TECHNOLOGY COORDINATION OFFICE .— 2
(A) I
N GENERAL.—Not later than 180 3
days after the date of the enactment of this 4
Act, the President shall establish an office in 5
the Executive Office of the President to support 6
the Initiative. 7
(B) D
ESIGNATION.—The office established 8
pursuant to subparagraph (A) shall be known 9
as the ‘‘National Biotechnology Coordination 10
Office’’. 11
(2) D
IRECTOR OF NATIONAL BIOTECHNOLOGY 12
COORDINATION OFFICE.— 13
(A) A
PPOINTMENT.—Not later than 180 14
days after the date of the enactment of this 15
Act, the President shall appoint an individual to 16
serve as the Director of the National Bio-17
technology Coordination Office. 18
(B) D
UTIES.—The duties of the Director 19
of the National Biotechnology Coordination Of-20
fice are as follows: 21
(i) To serve as the principal advisor to 22
the President for biotechnology. 23
(ii) To administer the functions of the 24
Office set forth under paragraph (3). 25
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(C) AUTHORITIES.—In support of the Ini-1
tiative, the Director may— 2
(i) advise the Director of the Office of 3
Management and Budget for the purposes 4
of tracking and adjusting agency spending 5
relating to biotechnology, including to en-6
sure that Federal efforts are complemen-7
tary and not duplicative; 8
(ii) convene members of the Inter-9
agency Committee in order to advance and 10
coordinate Federal activities relating to 11
biotechnology; 12
(iii) coordinate Federal regulation of 13
products that are produced with bio-14
technology; 15
(iv) select, appoint, employ, and fix 16
the compensation of such officers and em-17
ployees as are necessary and prescribe 18
their duties; 19
(v) enter into and perform such con-20
tracts, leases, cooperative agreements, or 21
other transactions, as appropriate, to the 22
conduct of the work of the Office; 23
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(vi) utilize, with their consent, the 1
services, personnel, and facilities of other 2
Federal agencies; and 3
(vii) accept voluntary and uncompen-4
sated services, notwithstanding the provi-5
sions of section 1342 of title 31, United 6
States Code. 7
(3) F
UNCTIONS OF THE OFFICE .—The func-8
tions of the Office shall be, in support of the Initia-9
tive, the following: 10
(A) P
LANNING AND COORDINATION .— 11
Functions relating to planning and coordination 12
as follows: 13
(i) Working with the Interagency 14
Committee to oversee the planning, man-15
agement, and coordination of Federal ac-16
tivities relating to biotechnology. 17
(ii) Providing technical and adminis-18
trative support to the Interagency Com-19
mittee. 20
(iii) Assessing the landscape and gaps 21
associated with the different components of 22
the Initiative. 23
(iv) Coordinating a fellowship pro-24
gram in which Federal employees are de-25
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tailed to 1 or more Federal agencies to 1
gain greater understanding of bio-2
technology activities outside of their home 3
agency. 4
(v) Building and maintaining a co-5
ordinated website for Federal activities re-6
lating to biotechnology pursuant to sub-7
section (c). 8
(vi) Coordinating development of an 9
annual report under subsection (d) and a 10
national strategy as required by subsection 11
(e). 12
(vii) Conducting such other activities 13
to support the Initiative as the Director 14
considers appropriate. 15
(B) N
ATIONAL SECURITY.—Functions re-16
lating to national security as follows: 17
(i) Assessing and addressing the na-18
tional security and economic security impli-19
cations of emerging biotechnology. 20
(ii) Identifying and remedying any 21
major needs or information gaps in current 22
national security assessments and activi-23
ties, including to conduct counterintel-24
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ligence efforts to fill gaps relating to bio-1
technology. 2
(iii) Providing coordination in ad-3
dressing foreign investments and acquisi-4
tion from adversarial countries. 5
(C) R
ESEARCH AND DEVELOPMENT .— 6
Functions relating to research and development 7
as follows: 8
(i) Coordinating sustained support for 9
research and development that accelerates 10
scientific understanding and technological 11
innovation in biotechnology. 12
(ii) Facilitating joint agency solicita-13
tions for funding for individual grants, col-14
laborative grants, and interdisciplinary re-15
search centers. 16
(iii) Developing and proposing focus 17
areas or challenges for research funding 18
meant to advance biotechnology, particu-19
larly relating to convergence with other 20
technologies such as artificial intelligence. 21
(iv) Developing, standardizing, and 22
deploying robust mechanisms for docu-23
menting and quantifying the outputs and 24
economic benefits of biotechnology. 25
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(D) DATA AND DATABASES .—Functions 1
relating to data and databases as follows: 2
(i) Coordinating sustained support for 3
biological data, databases, and related 4
tools as a strategic national resource to ad-5
vance human health and the understanding 6
of animals, plants, microbes, and other or-7
ganisms. 8
(ii) Recommending actions to inte-9
grate security into biological data access 10
and international reciprocity agreements. 11
(iii) Coordinating frameworks for bio-12
logical data standardization to create 13
datasets that are interoperable and usable 14
by advanced computation methods such as 15
artificial intelligence. 16
(E) P
RODUCT COMMERCIALIZATION .— 17
Functions relating to product commercialization 18
as follows: 19
(i) Strategizing and coordinating on 20
private sector translation and commer-21
cialization of products that are produced 22
with biotechnology. 23
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(ii) Assisting in coordinating a na-1
tional network of testbeds to enable scale- 2
up of biotechnology research. 3
(F) R
EGULATORY STREAMLINING .—Func-4
tions relating to regulatory streamlining as fol-5
lows: 6
(i) Coordinating the easing of regu-7
latory burden for types of biotechnology 8
products that have become well-understood 9
by regulators, including products that 10
could have occurred naturally or been de-11
veloped with conventional means. 12
(ii) Negotiating interagency agree-13
ments that describe clear regulatory path-14
ways for each type of biotechnology prod-15
uct, with information about timelines, deci-16
sion points, expected data requirements, 17
clear hand-offs between agencies, and 18
other information deemed necessary by the 19
Office to resolve regulatory gaps, overlaps, 20
and ambiguities for biotechnology prod-21
ucts. 22
(iii) Providing regular status updates 23
to the Office of Management and Budget 24
as to the development of clear regulatory 25
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pathways, and in the event that the Office 1
and the Interagency Committee cannot 2
reach timely agreement on a clear regu-3
latory pathway for any product type, as-4
sisting the Director of the Office of Man-5
agement and Budget in carrying out para-6
graph (5). 7
(iv) Not later than 1 year after the 8
date of the enactment of this Act, jointly 9
with the Interagency Committee developing 10
and making available to the public a plan 11
for regulatory streamlining. 12
(G) B
IOSAFETY AND BIOSECURITY .—Func-13
tions relating to biosafety and biosecurity as 14
follows: 15
(i) Developing strategies and coordi-16
nating to address biosafety and biosecurity 17
issues associated with emerging bio-18
technology. 19
(ii) Coordinating on assessment and 20
mitigation of potential biosafety and bio-21
security threats relating to biotechnology 22
research, including through collaboration 23
with regulatory agencies and industry. 24
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(H) WORKFORCE DEVELOPMENT .—Func-1
tions relating to workforce development as fol-2
lows: 3
(i) Coordinating and developing strat-4
egies to develop a domestic workforce for 5
biotechnology. 6
(ii) Coordinating with appropriate 7
agencies to establish a national bio-8
technology workforce framework to define 9
biotechnology jobs and skills in public and 10
private sectors. 11
(iii) Coordinating with appropriate 12
agencies to conduct an interagency assess-13
ment of biotechnology workforce needs, 14
and subsequently developing and providing 15
training programs. 16
(I) B
IOLITERACY.—Functions relating to 17
bioliteracy as follows: 18
(i) Coordinating development of plain- 19
language materials about biotechnology. 20
(ii) Providing central locations, includ-21
ing the website required by subsection (c), 22
for clear, easy-to-find information about 23
biotechnology for policymakers, innovators, 24
and the public. 25
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(J) INTERNATIONAL PARTNERSHIPS .— 1
Functions relating to international partnerships 2
as follows: 3
(i) Coordinating Federal regulatory 4
and commercial diplomacy activities. 5
(ii) Assessing the current regulatory 6
and commercial diplomacy activities car-7
ried out across the Federal Government, 8
identifying gaps, and developing an out-9
reach strategy to improve the regulatory 10
landscape and market access for products 11
of the United States. 12
(iii) Identifying non-regulatory solu-13
tions for trade and market access concerns 14
(such as the use of identity preservation 15
for certain agricultural biotechnology prod-16
ucts) and working with relevant govern-17
ment agencies and stakeholders to imple-18
ment solutions. 19
(K) O
THER.—Such other activities as the 20
Director considers necessary to advance na-21
tional security, economic productivity, and com-22
petitiveness related to biotechnology. 23
(4) A
DMINISTRATIVE SUPPORT AND AUTHOR -24
IZATION OF APPROPRIATIONS .— 25
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(A) ADMINISTRATIVE SUPPORT .—The Di-1
rector of the National Science Foundation shall 2
provide support for the administration and im-3
plementation of the Initiative, including— 4
(i) appointing and providing com-5
pensation for employees of the Office, with-6
out regard to any provision relating to ap-7
pointment or compensation under title 5, 8
United States Code, including— 9
(I) deputy directors as needed to 10
address the responsibilities in para-11
graph (3), as determined necessary by 12
the Director of the Office; and 13
(II) other appropriate employees, 14
including experts in the science of bio-15
technology, biotechnology policy, regu-16
latory policy, and science communica-17
tion, legal counsel, and software de-18
signers and developers, as determined 19
necessary by the Director of the Of-20
fice; 21
(ii) fixing the compensation of employ-22
ees of the Office in an amount that does 23
not exceed the amount of annual com-24
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pensation (excluding expenses) specified in 1
section 102 of title 3, United States Code; 2
(iii) detailing employees of the Na-3
tional Science Foundation to the Office 4
and receiving the detail of employees from 5
other agencies to the Office; and 6
(iv) assistance with other costs associ-7
ated with running the Initiative, including 8
physical space, other staff, and overhead 9
support. 10
(B) A
UTHORIZATION OF APPROPRIA -11
TIONS.—There are authorized to be appro-12
priated to the Director of the National Science 13
Foundation to carry out subparagraph (A)— 14
(i) $22,000,000 for fiscal year 2026; 15
(ii) $35,000,000 for fiscal year 2027; 16
(iii) $25,000,000 for fiscal year 2028; 17
(iv) $25,000,000 for fiscal year 2029; 18
and 19
(v) $25,000,000 for fiscal year 2030. 20
(5) R
EGULATORY STREAMLINING BY OFFICE OF 21
MANAGEMENT AND BUDGET .—In the event that the 22
Office and the Interagency Committee cannot reach 23
timely agreement on a clear regulatory pathway for 24
a product type, as described in paragraph 25
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(3)(F)(iii), the Director of the Office of Management 1
and Budget shall— 2
(A) identify overlaps, gaps, or ambiguities 3
in the regulation for such product type; 4
(B) negotiate an interagency agreement 5
that describes a clear regulatory pathway for 6
such product type, with information about 7
timelines, decision points, expected data re-8
quirements, clear hand-offs between agencies, 9
and other information deemed necessary by the 10
Office of Management and Budget to resolve 11
regulatory gaps, overlaps, and ambiguities; and 12
(C) recommend and oversee rulemaking or 13
changes to guidance as needed to implement 14
clear regulatory pathways. 15
(6) W
IND-DOWN.— 16
(A) I
N GENERAL.—The Office shall wind- 17
down its activities on the date that is 20 years 18
after the date of the enactment of this Act, and 19
transition to serving as an executive secretariat 20
for the Initiative. 21
(B) W
IND-DOWN ACTIVITIES.—The activi-22
ties specified in this clause are as follows: 23
(i) The transfer of authorities, re-24
quirements, resources, personnel, and obli-25
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gations of the Office to the fullest extent 1
possible to the Interagency Committee and 2
such elements of the Federal Government 3
as the Director and the Interagency Com-4
mittee consider appropriate. 5
(ii) The Office shall maintain authori-6
ties, requirements, resources, personnel, 7
and obligations necessary to serve as the 8
executive secretariat for the Initiative, in-9
cluding to continue the coordination in 10
subsection (b)(3)(A), the website in sub-11
section (c), and any other activities that 12
the Director and the Interagency Com-13
mittee consider appropriate. 14
(C) T
REATMENT OF TRANSFERRED FUNC -15
TIONS.—Commencing on the date on which the 16
Office is terminated under subparagraph (A), 17
any reference to a requirement or an authority 18
of the Office that has been transferred to the 19
Interagency Committee or an element of the 20
Federal Government shall be treated as a ref-21
erence to the Interagency Committee or the ele-22
ment of the Federal Government to which such 23
requirement or authority was transferred pursu-24
ant to subparagraph (B). 25
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(c) WEBSITE.— 1
(1) I
N GENERAL.—Not later than 540 days 2
after the date of the enactment of this Act, the Di-3
rector of the National Biotechnology Coordination 4
Office and the Interagency Committee shall jointly 5
develop and publish for the public a single, coordi-6
nated Federal website for biotechnology that adheres 7
to best practices for website design, development, 8
and maintenance. 9
(2) C
ONTENTS.—The website developed and 10
published pursuant to paragraph (1) shall include 11
the following: 12
(A) A dashboard of Federal Government 13
activities relating to biotechnology, including in-14
formation about open funding opportunities. 15
(B) Plain-language information about bio-16
technology, including information for policy-17
makers, innovators, trading partners, and the 18
public. 19
(C) A mechanism for stakeholders to ask a 20
question and receive a single, coordinated re-21
sponse. 22
(D) Mechanisms, which may be populated 23
over time, to provide consolidated information 24
about biotechnology product regulation, focus-25
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ing on products that are regulated by more 1
than 1 Federal agency, with content that in-2
cludes the following: 3
(i) A repository of interagency agree-4
ments that describe clear regulatory path-5
ways, with links to relevant regulations 6
and guidance documents for each type of 7
biotechnology product. 8
(ii) A repository of regulatory decision 9
documents for biotechnology products. 10
(iii) A digital portal that allows sub-11
mission of a single application and infor-12
mation sharing between Federal agencies. 13
(3) U
PDATES.—The Director and the Inter-14
agency Committee shall jointly update the website 15
required by paragraph (1) periodically. 16
(d) A
NNUALREPORTS.— 17
(1) I
N GENERAL.—Not later than 1 year after 18
the date of the enactment of this Act, and not less 19
frequently than once each year thereafter, except in 20
years in which a national strategy for biotechnology 21
is required under subsection (e), the Director of Na-22
tional Biotechnology Coordination Office and the 23
Interagency Committee shall jointly submit to the 24
Committee on Commerce, Science, and Transpor-25
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tation of the Senate and the Committee on Science, 1
Space, and Technology of the House of Representa-2
tives an annual report on the Initiative. 3
(2) C
ONTENTS.—Each annual report submitted 4
pursuant to paragraph (1) shall include, for the pe-5
riod covered by the report, the following: 6
(A) An inventory and accounting of Fed-7
eral Government activities and spending in sup-8
port of the Initiative. 9
(B) Actions that the Director and the 10
Interagency Committee plan to take in support 11
of the Initiative in the next fiscal year. 12
(e) N
ATIONALSTRATEGY.— 13
(1) I
N GENERAL.—Not later than 2 years after 14
the date of the enactment of this Act, and not less 15
frequently than once every 5 years thereafter, the 16
Director of National Biotechnology Coordination Of-17
fice and the Interagency Committee shall jointly 18
make available to the public and submit to the Com-19
mittee on Commerce, Science, and Transportation of 20
the Senate and the Committee on Science, Space, 21
and Technology of the House of Representatives a 22
comprehensive national strategy for biotechnology. 23
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(2) ELEMENTS.—Each national strategy made 1
available and submitted pursuant to paragraph (1) 2
shall cover the following: 3
(A) Actions, goals, and priorities to ad-4
vance the Initiative, including how each Federal 5
department and agency will address the require-6
ments of section 6 and how each Federal de-7
partment and agency will integrate bio-8
technology into their own strategies. 9
(B) Activities that are an urgent priority 10
to advance biotechnology in the United States 11
but not currently being conducted by Federal 12
agencies, with an estimated 5-year budget for 13
those activities. 14
(C) Recommendations for legislative or ad-15
ministrative action to advance biotechnology in 16
the United States. 17
(D) An inventory of all Federal Govern-18
ment databases with biological data with an as-19
sessment that identifies opportunities— 20
(i) to improve the utility of such data-21
bases, in a manner that does not com-22
promise national security or the privacy 23
and security of information within such 24
databases; and 25
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(ii) to inform investment in such data-1
bases as critical infrastructure for the bio-2
technology research enterprise. 3
(E) An assessment of United States com-4
petitiveness in biotechnology relative to peer 5
countries, including— 6
(i) contributions of biotechnology to 7
United States economic growth and other 8
societal indicators; 9
(ii) contributions of biotechnology to 10
economic growth in other countries, espe-11
cially peer-competitors; and 12
(iii) current barriers to commercializa-13
tion of biotechnology products, processes, 14
and tools in the United States. 15
(F) A national biological data strategy to 16
ensure biotechnology research fully leverages 17
plant, animal, and microbe biodiversity, as ap-18
propriate and in a manner that does not com-19
promise economic competitiveness, national se-20
curity, or the privacy or security of human ge-21
netic information. 22
(G) The information that is required as a 23
part of the annual report required by subsection 24
(d). 25
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(f) COMPTROLLER GENERALREVIEW.—The Comp-1
troller General of the United States shall— 2
(1) not later than 3 years after the date of the 3
enactment of this Act, begin a review to assess the 4
efficacy of interagency coordination and fulfillment 5
of the activities conducted by the Office and the 6
Interagency Committee under the Initiative; 7
(2) not later than 3.5 years after the date of 8
the enactment of this Act, provide Congress a brief-9
ing on the initial findings of the Comptroller General 10
with respect to the activities described in paragraph 11
(1); 12
(3) not later than 4 years after the date of the 13
enactment of this Act, submit to the Committee on 14
Commerce, Science, and Transportation of the Sen-15
ate and the Committee on Science, Space, and Tech-16
nology of the House of Representatives a report with 17
recommendations to improve the Initiative; and 18
(4) repeat the process outlined in paragraphs 19
(1), (2), and (3) every 5 years thereafter until the 20
date that is 20 years after the date of the enactment 21
of this Act. 22
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SEC. 5. CONVENING OF EXPERTS ON BIOTECHNOLOGY RE-1
SEARCH AND DEVELOPMENT. 2
(a) I
NGENERAL.—The Director of the National Bio-3
technology Coordination Office may, in consultation with 4
the Interagency Committee, convene experts to assess and 5
inform the activities of the Initiative in a time and manner 6
as deemed appropriate and necessary by the Director. 7
(b) A
PPLICATION OF FEDERALADVISORYCOM-8
MITTEEACT.—Section 1013 of title 5, United States 9
Code, shall not apply to the convening of experts under 10
this section. 11
SEC. 6. AGENCY ACTIVITIES. 12
Each head of a participating agency shall, in support 13
of the Initiative and in coordination with the Office, con-14
duct or support, in a manner consistent with the duties 15
and mission of the respective department or agency, the 16
following activities to advance biotechnology across de-17
fense, human health, food and agriculture, energy, space, 18
mining, environmental stewardship, and other sectors: 19
(1) P
LANNING AND COORDINATION .—Activities 20
relating to planning and coordination as follows: 21
(A) Designating an individual within the 22
respective department or agency at the level of 23
Assistant Secretary to lead the biotechnology 24
activities for the department or agency, if such 25
person is not already designated, and to serve 26
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as the department or agency liaison to the Ini-1
tiative and member of the Interagency Com-2
mittee. 3
(B) Designating individuals within the re-4
spective department or agency to serve as mem-5
bers of subcommittees that may be established 6
by the Interagency Committee. 7
(C) Coordinating activities of the partici-8
pating agency that relate to biotechnology with 9
the Office. 10
(D) Implementing applicable portions of 11
the national strategy required by section 4(e) in 12
ways that improve government efficiency and 13
reduce redundancy. 14
(E) Providing insight and information 15
about biotechnology to the heads of other Fed-16
eral departments and agencies and to Congress. 17
(F) Leveraging horizon scanning and tech-18
nology foresight to ensure United States leader-19
ship in future biotechnology advancements. 20
(2) N
ATIONAL SECURITY.—Activities relating to 21
national security as follows: 22
(A) Analyzing ongoing and emerging 23
threats from foreign adversary development and 24
application of biotechnology, including foreign 25
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investments and acquisition of United States 1
capabilities, technologies, and biological data. 2
(B) Providing expertise to address foreign 3
investments and acquisition from adversarial 4
countries. 5
(C) Analyzing and identifying actions to 6
mitigate supply chain risks posed by foreign ad-7
versary involvement in such supply chains. 8
(D) Coordinating and ensuring information 9
sharing with foreign service officers regarding 10
threats to and opportunities for biotechnology. 11
(E) Coordinating with industry on threat 12
information sharing, vulnerability disclosure, 13
and risk mitigation for cybersecurity and infra-14
structure risks, including risks to biological 15
data and related physical and digital infrastruc-16
ture and devices. 17
(F) Improving cybersecurity and stress- 18
testing related to sensitive biological data and 19
to biotechnology infrastructure, tools, and in-20
strumentation. 21
(3) R
ESEARCH AND DEVELOPMENT .—Activities 22
relating to research and development as follows: 23
(A) Providing sustained support for re-24
search and development that accelerates sci-25
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entific understanding and technological innova-1
tion in biotechnology. 2
(B) Conducting joint agency solicitation 3
and selection of applications for funding of indi-4
vidual grants, collaborative grants, and inter-5
disciplinary research centers. 6
(C) Developing instrumentation, equip-7
ment, and infrastructure for biotechnology, in-8
cluding to optimize, standardize, scale, and de-9
liver new products and solutions. 10
(D) Developing standard reference mate-11
rials and measurements to promote interoper-12
ability between new component technologies and 13
processes for biotechnology discovery, innova-14
tion, and production processes. 15
(E) Increasing understanding of the risks 16
and benefits of biotechnology, including how 17
products developed with biotechnology can af-18
fect or protect the environment. 19
(F) Increasing understanding of the eth-20
ical, legal, and social implications of bio-21
technology, including research that contributes 22
to public understanding of biotechnology. 23
(4) D
ATA AND DATABASES .—Activities relating 24
to data and databases as follows: 25
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(A) Providing sustained support for bio-1
logical data, databases, and related tools to ad-2
vance human health and the understanding of 3
animals, plants, microbes, and other organisms. 4
(B) Establishing, curating, and maintain-5
ing genomics, epigenomics, and other relevant 6
omics and biological data and databases, such 7
as through a centralized biological data access 8
hub with appropriate protections for the privacy 9
or security of information within such data-10
bases. 11
(C) Developing standards for biological 12
data and databases, including for curation, 13
interoperability, and protection of privacy and 14
security. 15
(D) Developing computational tools, in-16
cluding artificial intelligence tools, to accelerate 17
research and innovation using biological data 18
and databases. 19
(E) Developing tools that use omics and 20
associated bioinformatic sciences to improve 21
monitoring, management, assessments, and 22
forecasts. 23
(5) P
RODUCT COMMERCIALIZATION .—Activities 24
relating to product commercialization as follows: 25
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(A) Providing sustained support for private 1
sector translation and commercialization of 2
products that are produced with biotechnology, 3
including biomanufacturing. 4
(B) Utilizing existing Federal programs, 5
such as the Small Business Innovation Re-6
search Program and the Small Business Tech-7
nology Transfer Program (as described in sec-8
tion 9 of the Small Business Act (15 U.S.C. 9
638)), in support of biotechnology, including to 10
support proof of concept activities, and the for-11
mation of startup companies. 12
(C) Accelerating the translation, scale-up, 13
and commercialization of new products, proc-14
esses, and technologies in order to transfer fun-15
damental research results to industry and accel-16
erate commercial applications. 17
(D) Facilitating public-private partnerships 18
in biotechnology research and development that 19
address and reduce barriers to scaling up bio-20
technology innovations. 21
(E) Supporting a national network of 22
testbeds based on open standards, interfaces, 23
and processes, including by repurposing existing 24
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facilities, to enable scale-up of biotechnology re-1
search. 2
(F) Providing incentives for retooling of in-3
dustrial sites across the United States to foster 4
a pivot to biotechnology. 5
(G) Providing access to user facilities with 6
advanced or unique equipment, services, mate-7
rials, and other resources, including secure ac-8
cess to high-performance computing, as appro-9
priate, to industry, institutions of higher edu-10
cation, nonprofit organizations, and government 11
agencies to perform research and testing. 12
(6) R
EGULATORY STREAMLINING .—Activities 13
relating to regulatory streamlining as follows: 14
(A) Conducting and coordinating regu-15
latory streamlining for products that are pro-16
duced with biotechnology. 17
(B) Easing regulatory burden for types of 18
biotechnology products that have become well- 19
understood by regulators, including products 20
that could have occurred naturally or been de-21
veloped with conventional means. 22
(C) Establishing clear regulatory pathways 23
for biotechnology products, including through 24
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short-term regulatory trials to establish new or 1
update existing regulatory pathways. 2
(D) Ensuring consistent, risk-propor-3
tionate regulation of biotechnology research and 4
development activities, including for release of 5
products or organisms into the environment. 6
(E) Conducting horizon scanning to iden-7
tify novel biotechnology products and develop 8
clear regulatory pathways for such products. 9
(7) B
IOSAFETY AND BIOSECURITY .—Activities 10
relating to biosafety and biosecurity as follows: 11
(A) Addressing biosafety, biosecurity, and 12
responsible biology issues associated with 13
emerging biotechnology. 14
(B) Developing an applied management 15
plan to address biological risks of biotechnology 16
research. 17
(C) Creating an adaptable, evidence-based 18
framework to respond to emerging biosecurity 19
challenges that considers and informs updates 20
of existing biosecurity governance policies, guid-21
ance, and directives and identifies necessary 22
safeguards for new products, processes, and 23
systems of biotechnology. 24
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(D) Conducting outreach to industry, insti-1
tutions of higher education, nonprofit organiza-2
tions, and government agencies to increase 3
awareness of biosafety and biosecurity implica-4
tions of biotechnology research. 5
(8) W
ORKFORCE DEVELOPMENT .—Activities re-6
lating to workforce development as follows: 7
(A) Providing sustained support for devel-8
opment of a domestic biotechnology workforce. 9
(B) Ensuring that Congress and Federal 10
departments and agencies have access to nec-11
essary expertise across national security and 12
emerging biotechnology issues. 13
(C) Supporting Federal biotechnology edu-14
cation and workforce training programs and ini-15
tiatives for students and workers. 16
(D) Supporting education and training of 17
undergraduate and graduate students in bio-18
technology, including biomanufacturing, bio-19
process engineering, and computational science 20
applied to biotechnology. 21
(E) Connecting researchers, graduate stu-22
dents, and postdoctoral fellows with entrepre-23
neurship education and training opportunities, 24
including to award grants, on a competitive 25
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basis, that enable institutions to support grad-1
uate students, and postdoctoral fellows who per-2
form some of their biotechnology research in an 3
industry setting. 4
(F) Supporting professional development, 5
continuing education, and skills development 6
(such as re-skilling and upskilling) for veterans, 7
industry workers, and technology professionals. 8
(G) Supporting curriculum development 9
and research experiences for secondary, under-10
graduate, and graduate students in bio-11
technology, including through support for grad-12
uate fellowships and traineeships in bio-13
technology to ensure that students are receiving 14
up-to-date training that keeps pace with bio-15
technologies as they evolve and meets industry 16
workforce needs so students are qualified for 17
employment. 18
(H) Supporting curriculum development 19
and research experiences in biotechnology and 20
associated data and information sciences across 21
the Federal workforce, including for the mili-22
tary education system. 23
(9) B
IOLITERACY.—Activities relating to biolit-24
eracy as follows: 25
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(A) Providing clear, easy-to-find informa-1
tion about biotechnology for policymakers, 2
innovators, and the public. 3
(B) Supporting greater evidence-based 4
public discourse about the benefits and risks of 5
biotechnology. 6
(C) Ensuring that public input and out-7
reach are integrated into Federal biotechnology 8
activities through regular and ongoing public 9
discussions such as workshops, consensus con-10
ferences, and educational events, as may be ap-11
propriate. 12
(10) I
NTERNATIONAL PARTNERSHIPS .—Activi-13
ties relating to international partnerships as follows: 14
(A) Developing an internal international 15
engagement strategy for the respective depart-16
ment or agency, in cooperation with relevant 17
interagency partners. 18
(B) Strengthening and developing bilateral 19
and multilateral relationships to advance United 20
States priorities in biotechnology abroad. 21
(C) Providing sustained support and co-22
ordinating interagency activities in international 23
biotechnology outreach and engagement with al-24
lies and partners. 25
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(D) Engaging in coordinated regulatory 1
and commercial diplomacy to better align bio-2
technology regulations and expand market ac-3
cess for biotechnology products. 4
(E) Supporting the development of inter-5
national standards and norms for bio-6
technology, including to define shared values 7
and interests. 8
(F) Supporting biological data-sharing 9
agreements with partner countries. 10
(G) Supporting biotechnology talent ex-11
changes with partner countries, including 12
through fellowships, work authorization pro-13
grams, and other mechanisms. 14
(H) Supporting harmonization of multilat-15
eral export controls to protect against misuse of 16
biotechnology. 17
(11) O
THER.—Such other activities as the head 18
of the participating agency determines may be need-19
ed to advance national security, economic produc-20
tivity, and competitiveness relating to biotechnology. 21
Æ
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