Notice2022-27600
Request for Information; National Biotechnology and Biomanufacturing Initiative
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 20, 2022
Issuing agencies
Science and Technology Policy Office
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 243 (Tuesday, December 20, 2022)</title>
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[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77901-77903]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27600]
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OFFICE OF SCIENCE AND TECHNOLOGY POLICY
Request for Information; National Biotechnology and
Biomanufacturing Initiative
AGENCY: Office of Science and Technology Policy (OSTP).
ACTION: Notice of request for information (RFI).
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SUMMARY: The President's Executive Order on Advancing Biotechnology and
Biomanufacturing Innovation for a Sustainable, Safe, and Secure
American Bioeconomy launched a National
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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.
DATES: Interested persons and organizations are invited to submit
comments on or before 5 p.m. ET on January 20, 2023.
ADDRESSES: Interested individuals and organizations should submit
comments electronically to <a href="/cdn-cgi/l/email-protection#afcdc6c0dbcaccc7efc0dcdbdf81cac0df81c8c0d9"><span class="__cf_email__" data-cfemail="690b00061d0c0a0129061a1d19470c0619470e061f">[email protected]</span></a> and include ``RFI
Response: Biotechnology and Biomanufacturing Initiative'' in the
subject line of the email. Due to time constraints, mailed paper
submissions will not be accepted, and electronic submissions received
after the deadline may not be taken into consideration.
Instructions: Response to this RFI is voluntary. Respondents may
answer as many or as few questions as they wish. Each individual or
institution is requested to submit only one response. Electronic
responses must be provided as attachments to an email rather than a
link. Please identify your answers by referring to a specific question
number and/or letter within the response. Comments of seven pages or
fewer (3,500 words) are requested; longer responses will not be
considered. Responses should include the name of the person(s) or
organization(s) filing the response. Responses containing references,
studies, research, and other empirical data that are not widely
published should include copies of or electronic links to the
referenced materials. Responses containing profanity, vulgarity,
threats, or other inappropriate language or content will not be
considered.
Any information obtained from this RFI is intended to be used by
the Government on a non-attribution basis for planning and strategy
development. OSTP will not respond to individual submissions. A
response to this RFI will not be viewed as a binding commitment to
develop or pursue the project or ideas discussed. This RFI is not
accepting applications for financial assistance or financial
incentives.
Comments submitted in response to this notice are subject to the
Freedom of Information Act (FOIA). No business proprietary information,
copyrighted information, or personally identifiable information should
be submitted in response to this RFI. Please be aware that comments
submitted in response to this RFI, including the submitter's
identification (as noted above), may be posted, without change, on
OSTP's or another Federal website or otherwise released publicly.
FOR FURTHER INFORMATION CONTACT: Georgia Lagoudas at
<a href="/cdn-cgi/l/email-protection#06646f697263656e46697572762863697628616970"><span class="__cf_email__" data-cfemail="c2a0abadb6a7a1aa82adb1b6b2eca7adb2eca5adb4">[email protected]</span></a>; tel: 202-456-4444.
SUPPLEMENTARY INFORMATION:
Background: 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.
Information Requested: 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
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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?
Dated: December 15, 2022.
Rachel Wallace,
Deputy General Counsel.
[FR Doc. 2022-27600 Filed 12-19-22; 8:45 am]
BILLING CODE 3270-F1-P
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