Title 42, The Public Health and WelfareRelease 119-110

§19133 Initiative Coordination

Title 42 › CHAPTER 163 — RESEARCH AND DEVELOPMENT, COMPETITION, AND INNOVATION › SUBCHAPTER IV — BIOECONOMY RESEARCH AND DEVELOPMENT › § 19133

Last updated Sep 22, 2026|Official source

Summary

The President must create an interagency committee through the Office of Science and Technology Policy (OSTP) to plan, manage, and coordinate the Initiative. OSTP will co-chair the committee and the OSTP Director will pick a second co-chair. The committee must coordinate federal engineering biology work, set and update goals, and, not later than 12 months after August 9, 2022 and every five years after that, write a strategic plan for certain House and Senate committees. The plan must guide the Initiative and explain support for long-term funding, education and outreach, and research on ethical, legal, environmental, safety, security, and other societal issues. That includes an applied biorisk research plan, advice on data access and international reciprocity, manufacturing recommendations, a review of biosecurity rules, ways to move lab results into real-world use, and methods to measure engineering biology’s economic and social impact. The committee must also make a national genomic sequencing strategy that protects competitiveness, security, and human genetic privacy, and a plan to use Federal small-business programs to help the Initiative. It must consider advice from the Initiative’s advisory committee, a workshop, and other expert views. Starting with fiscal year 2023 and every five years for ten years, the committee must send reports to specific House and Senate committees with an agency budget summary (including facilities and instruments), and an assessment of how agencies are carrying out the strategic plan, including SBIR/STTR award amounts and counts, jointly funded projects by two or more agencies, and effects of new projects. The President must set up an Initiative Coordination Office with a full-time Director and staff to support the committees, act as a public contact, help coordinate funding solicitations, do outreach, gather societal input, and share technologies with agencies and industry. OSTP will work with agencies each year to estimate needed funds and include that estimate and agency contributions in the President’s budget. The Coordination Office will end 10 years after August 9, 2022. Nothing here changes any agency’s biomedical research rules or how they handle outside research proposals as they were the day before August 9, 2022.

Full Legal Text

Title 42, §19133

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Interagency committee

The President, acting through the Office of Science and Technology Policy, shall designate an interagency committee to coordinate activities of the Initiative as appropriate, which shall be co-chaired by the Office of Science and Technology Policy. The Director of the Office of Science and Technology Policy shall select an additional co-chairperson from among the members of the interagency committee. The interagency committee shall oversee the planning, management, and coordination of the Initiative. The interagency committee shall carry out the following:

(1)Provide for interagency coordination of Federal engineering biology research, development, and other activities undertaken pursuant to the Initiative.

(2)Establish and periodically update goals and priorities for the Initiative.

(3)Develop, not later than 12 months after August 9, 2022, and update every five years thereafter, a strategic plan submitted to the Committee on Science, Space, and Technology, the Committee on Agriculture, and the Committee on Energy and Commerce of the House of Representatives and the Committee on Commerce, Science, and Transportation, the Committee on Agriculture, Nutrition, and Forestry, the Committee on Small Business and Entrepreneurship, and the Committee on Health, Education, Labor, and Pensions of the Senate that—

(A)guides the activities of the Initiative for purposes of meeting the goals and priorities established under (and updated pursuant to) paragraph (2); and

(B)describes—

(i)the Initiative’s support for long-term funding for interdisciplinary engineering biology research and development;

(ii)the Initiative’s support for education and public outreach activities;

(iii)the Initiative’s support for research and other activities on ethical, legal, environmental, safety, security, and other appropriate societal issues related to engineering biology, including—

(I)an applied biorisk management research plan;

(II)recommendations for integrating security into biological data access and international reciprocity agreements;

(III)recommendations for manufacturing restructuring to support engineering biology research, development, and scaling-up initiatives; and

(IV)an evaluation of existing biosecurity governance policies, guidance, and directives for the purposes of creating an adaptable, evidence-based framework to respond to emerging biosecurity challenges created by advances in engineering biology;

(iv)how the Initiative will contribute to moving results out of the laboratory and into application for the benefit of society and United States competitiveness; and

(v)how the Initiative will measure and track the contributions of engineering biology to United States economic growth and other societal indicators.

(4)Develop a national genomic sequencing strategy to ensure engineering biology 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, to enhance long-term innovation and competitiveness in engineering biology in the United States.

(5)Develop a plan to utilize Federal programs, such as the Small Business Innovation Research Program and the Small Business Technology Transfer Program (as described in section 638 of title 15), in support of the activities described in section 19132(b)(3) of this title.

(6)In carrying out this section, take into consideration the recommendations of the advisory committee established under section 19134 of this title, the results of the workshop convened under section 19132 of this title, existing reports on related topics, and the views of academic, State, industry, and other appropriate groups.

(b)Quinquennial report

Beginning with fiscal year 2023 and every five years thereafter for ten years, the interagency committee shall prepare and submit to the Committee on Science, Space, and Technology, the Committee on Energy and Commerce, and the Committee on Agriculture of the House of Representatives and the Committee on Commerce, Science, and Transportation, the Committee on Health, Education, Labor, and Pensions, the Committee on Small Business and Entrepreneurship, and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that includes the following:

(1)A summarized agency budget in support of the Initiative for the current fiscal year, including a breakout of spending for each agency participating in the Program, and for the development and acquisition of any research facilities and instrumentation.

(2)An assessment of how Federal agencies are implementing the plan described in subsection (a)(3), including the following:

(A)A description of the amount and number of awards made under the Small Business Innovation Research Program and the Small Business Technology Transfer Program (as described in section 638 of title 15) in support of the Initiative.

(B)A description of the amount and number of projects funded under joint solicitations by a collaboration of not fewer than two agencies participating in the Initiative.

(C)A description of effects of newly-funded projects by the Initiative.

(c)Initiative Coordination Office

(1)In general

The President shall establish an Initiative Coordination Office, with a Director and full-time staff, which shall—

(A)provide technical and administrative support to the interagency committee and the advisory committee established under subsection (a) and section 19134 of this title;

(B)serve as the point of contact on Federal engineering biology activities for government organizations, academia, industry, professional societies, State governments, interested citizen groups, and others to exchange technical and programmatic information;

(C)oversee interagency coordination of the Initiative, including by encouraging and supporting joint agency solicitation and selection of applications for funding of activities under the Initiative, as appropriate;

(D)conduct public outreach, including dissemination of findings and recommendations of the advisory committee, as appropriate;

(E)serve as the coordinator of ethical, legal, environmental, safety, security, and other appropriate societal input; and

(F)promote access to, and early application of, the technologies, innovations, and expertise derived from Initiative activities to agency missions and systems across the Federal Government, and to United States industry, including startup companies.

(2)Funding

The Director of the Office of Science and Technology Policy, in coordination with each participating Federal department and agency, as appropriate, shall develop and annually update an estimate of the funds necessary to carry out the activities of the Initiative Coordination Office and submit such estimate with an agreed summary of contributions from each agency to Congress as part of the President’s annual budget request to Congress.

(3)Termination

The Initiative Coordination Office established under this subsection shall terminate on the date that is 10 years after August 9, 2022.

(d)Rule of construction

Nothing in this section may be construed to alter the policies, processes, or practices of individual Federal agencies in effect on the day before August 9, 2022, relating to the conduct of biomedical research and advanced development, including the solicitation and review of extramural research proposals.

Reference

Citations & Metadata

Citation

42 U.S.C. § 19133

Title 42, The Public Health and Welfare

Last Updated

Sep 22, 2026

Release point: 119-110