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Dec 20 -- The President's Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy launched a National Biotechnology and Biomanufacturing Initiative (NBBI) to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, and supply chain resilience, and to advance national and economic security. Biotechnology and biomanufacturing offer new opportunities to strengthen supply chains and lower prices, create more sustainable products through bio-based production, expand domestic production of goods and materials, create jobs across all of America, and spur new opportunities in agricultural communities, as some examples. This RFI seeks public input on how advances in biotechnology and biomanufacturing can help us achieve goals that were previously out of reach and what steps can be taken to ensure we have the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. Interested persons and organizations are invited to submit comments on or before 5 p.m. ET on January 20, 2023.

Through Executive Order 14081, the Federal Government will deliver reports to the President on how biotechnology and biomanufacturing can further societal goals related to health, climate change and energy, food and agricultural innovation, resilient supply chains, and cross-cutting scientific advances. The White House Office of Science and Technology Policy (OSTP) is tasked with developing a plan to implement the recommendations in the reports. Additionally, the Executive Office of the President and Federal agencies are tasked with the development of reports and recommendations related to the biotechnology and biomanufacturing workforce, data to support the bioeconomy, expanding domestic biomanufacturing capacity, and other components to support a strong bioeconomy. A separate request for information will be published regarding biotechnology regulation.

The Executive Order describes four categories where biotechnology and biomanufacturing can further societal goals:

(1) Health: biotechnology and biomanufacturing to achieve medical breakthroughs, improve health outcomes, or reduce the overall burden of disease.

(2) Climate and energy: biotechnology, biomanufacturing, bioenergy, and biobased products to address the causes of climate change and adapt to and mitigate the impacts of climate change, including by sequestering carbon and reducing greenhouse gas emissions.

(3) Food and agriculture: biotechnology and biomanufacturing for food and agricultural innovation, including by improving sustainability and land conservation; increasing food quality and nutrition; increasing agricultural yields; protecting against plant and animal pests and diseases; and cultivating alternative food sources.

(4) Supply chain resilience: biotechnology and biomanufacturing across economic sectors to strengthen the resilience of United States supply chains, such as addressing specific supply chain bottlenecks and developing new types of production methods.

OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations who work on biotechnology, biomanufacturing, or related topics; and members of the public.

OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing R&D To Further Societal Goals

1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):

a. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short-term (5 years) and long-term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:

i. Develop domestic bio-based routes of production, including the entire supply chain, for X% of active pharmaceutical ingredients.
ii. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y% of U.S. petroleum consumption.

b. What research and development (R&D) is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the Government support this R&D, including through existing Federal programs, creation of new areas of R&D, and/or development of new mechanisms?

c. How else can the Government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?

2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

3. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

4. How can the Federal Government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

5. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors and what are the limits of current practice?

6. What can the Federal Government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful and what incentive structures could be employed?

7. What are barriers that must be addressed in order to better enable domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

8. How can the Federal Government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

9. What are new, environmentally sustainable biobased products that the Federal Government could purchase through its BioPreferred Program? How can the Federal Government incentivize development of new categories of sustainable biobased products?

Biotechnology and Biomanufacturing Workforce

10. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or Federal level?

11. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs—including those involving Historically Black Colleges and Universities, Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

12. What can the Federal Government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing lifecycles?

13. How can Federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

Measuring the Bioeconomy

14. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

15. How should the North American Industry Classification System and the North American Product Classification System be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical bio-based and fossil fuel-based commodities?

International Engagement

16. What are opportunities for the U.S. Government to advance research and development, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely key to advance these priority areas?

17. What risks are associated with international biotechnology development and use, and how can the U.S. Government work with allies and partners to mitigate these risks?
RFI: https://www.federalregister.gov/d/2022-27600

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