(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 consider 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 consider 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.

S. 1387 — National Biotechnology Initiative Act of 2025