[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77901-77903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27600]


-----------------------------------------------------------------------

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).

-----------------------------------------------------------------------

SUMMARY: The President's Executive Order on Advancing Biotechnology and 
Biomanufacturing Innovation for a Sustainable, Safe, and Secure 
American Bioeconomy launched a National

[[Page 77902]]

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 [email protected] 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 
[email protected]; 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

[[Page 77903]]

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