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.