Request for Information; National Biotechnology and Biomanufacturing Initiative, 77901-77903 [2022-27600]
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Federal Register / Vol. 87, No. 243 / Tuesday, December 20, 2022 / Notices
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Background Information
In 1986, OSTP issued the Coordinated
Framework for the Regulation of
Biotechnology (51 FR 23302), which
outlined a comprehensive Federal
regulatory policy for ensuring the safety
of biotechnology products. The
Coordinated Framework sought to
achieve a balance between regulation
adequate to ensure the protection of
health and the environment while
maintaining sufficient regulatory
flexibility to avoid impeding
innovation.
In 1992, OSTP issued an update to the
Coordinated Framework that set forth a
risk-based, scientifically sound basis for
the oversight of activities that introduce
biotechnology products into the
environment (57 FR 6753). The update
affirmed that Federal oversight should
focus on the characteristics of the
product, the environment into which it
is being introduced, and the intended
use of the product, rather than the
process by which the product is created.
In 2015, the Executive Office of the
President (EOP) issued a memorandum
directing EPA, FDA, and USDA to
update the Coordinated Framework. The
Federal government subsequently
published a National Strategy for
Modernizing the Regulatory System for
Biotechnology in 2016; and in 2017,
OSTP issued another update to the
Coordinated Framework. This 2017
update clarifies current agency roles and
responsibilities for the regulation of
biotechnology products. It provides a
table of responsibilities that lists the
offices within each agency or agencies
that may have regulatory responsibility
for a given biotechnology product
category, and relevant coordination
across the agencies. In addition, it
describes memoranda of understanding
(MOUs) among the agencies and the
types of products and information that
are covered within the scope of each
MOU. In 2019, E.O. 13874 recognized
that advances in biotechnology have the
potential to revolutionize agriculture,
enhance rural prosperity, and improve
the quality of American lives. The E.O.
ordered additional steps to be taken to
further modernize the regulatory
framework.
For details on the current roles and
responsibilities of agencies under the
Coordinated Framework for the
Regulation of Biotechnology, refer to the
Unified website for Biotechnology
Regulation https://usbiotechnology
regulation.mrp.usda.gov/
biotechnologygov/home/.
On September 12, 2022, President
Biden issued Executive Order (E.O.)
14081, ‘‘Advancing Biomanufacturing
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and Biotechnology Innovation for a
Sustainable, Safe, and Secure
Bioeconomy,’’ with the goal of
accelerating biotechnology innovation
and growing America’s bioeconomy
across multiple sectors, including
health, agriculture, and energy. Among
other objectives, E.O. 14081 aims to
support the safe use of biotechnology by
clarifying and streamlining regulations
in service of a science- and risk-based,
predictable, efficient, and transparent
regulatory system to support the safe
use of products of biotechnology. E.O.
14081 directs the EPA, FDA, and USDA
to:
• identify any regulatory ambiguities,
gaps, or uncertainties in the
Coordinated Framework for the
Regulation of Biotechnology, through
engaging with developers and
stakeholders and through horizon
scanning for novel biotechnology
products;
• provide plain-language information
on the regulatory roles, responsibilities,
and processes of each agency;
• provide a plan with processes and
timelines to implement regulatory
reform; and build upon the Unified
website for Biotechnology Regulation.
As noted in the Executive Order,
‘‘biotechnology means technology that
applies to and/or is enabled by life
sciences innovation or product
development.’’ Biotechnology products
include, for example, organisms
(including plants, animals, and
microbes) developed through genetic
engineering or the targeted or in vitro
manipulation of genetic information,
some products derived from such
organisms, as well as products produced
via cell-free synthesis, as determined by
existing statutes and regulations.
Questions
Respondents are encouraged to
provide relevant data or information,
including case studies, regarding
regulatory ambiguities, gaps, or
uncertainties in the Coordinated
Framework, and regarding new and
emerging biotechnology products.
Respondents need not reply to all
questions listed. Please identify your
answers as responses to a specific
question.
1. Describe any ambiguities, gaps,
inefficiencies, or uncertainties regarding
statutory authorities and/or agency
roles, responsibilities, or processes for
different biotechnology product types,
particularly for product types within the
responsibility of multiple agencies.
a. Describe the impact, including
economic impact, of these ambiguities,
gaps, inefficiencies or uncertainties.
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77901
2. Provide any relevant data or
information, including case studies, that
could inform improvement in the clarity
or efficiency (including the
predictability, transparency, and
coordination) of the regulatory system
and processes for biotechnology
products.
3. Describe any specific topics the
agencies should address in plain
language on the regulatory roles,
responsibilities, and processes of the
agencies.
4. Describe any specific issues the
agencies should consider in developing
a plan to implement regulatory reform,
including any updated or new
regulations or guidance documents.
5. Describe any new or emerging
biotechnology products (e.g., microbial
amendments to promote plant growth;
food plants expressing non-food
substances or allergens from non-plant
sources) that, based on lessons learned
from past experiences or other
information, the agencies should pay
particular attention to in their
evaluation of ambiguities, gaps, or
uncertainties regarding statutory
authorities and/or agency roles or
processes.
6. Describe any new or emerging
categories of biotechnology products on
the horizon that the regulatory system
and processes for biotechnology
products should be preparing to
address. Describe any specific
recommendations for regulating these
new or emerging categories of
biotechnology products to guide agency
preparations.
7. What is the highest priority issue
for the agencies to address in the short
term (i.e., within the next year) and in
the long term?
Dated: December 15, 2022.
Rachel Wallace,
Deputy General Counsel.
[FR Doc. 2022–27599 Filed 12–19–22; 8:45 am]
BILLING CODE 3270–F1–P
OFFICE OF SCIENCE AND
TECHNOLOGY POLICY
Request for Information; National
Biotechnology and Biomanufacturing
Initiative
Office of Science and
Technology Policy (OSTP).
ACTION: Notice of request for
information (RFI).
AGENCY:
The President’s Executive
Order on Advancing Biotechnology and
Biomanufacturing Innovation for a
Sustainable, Safe, and Secure American
Bioeconomy launched a National
SUMMARY:
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lotter on DSK11XQN23PROD with NOTICES1
77902
Federal Register / Vol. 87, No. 243 / Tuesday, December 20, 2022 / Notices
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 biotech@ostp.eop.gov
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
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18:41 Dec 19, 2022
Jkt 259001
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 biotech@
ostp.eop.gov; 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
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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
E:\FR\FM\20DEN1.SGM
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Federal Register / Vol. 87, No. 243 / Tuesday, December 20, 2022 / Notices
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?
lotter on DSK11XQN23PROD with NOTICES1
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?
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18:41 Dec 19, 2022
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77903
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?
SECURITIES AND EXCHANGE
COMMISSION
Reducing Risk by Advancing Biosafety
and Biosecurity
Pursuant to section 19(b)(1) of the
Securities Exchange Act of 1934
(‘‘Act’’),1 and Rule 19b–4 thereunder,2
notice is hereby given that on December
12, 2022, The Nasdaq Stock Market LLC
(‘‘Nasdaq’’ or ‘‘Exchange’’) filed with the
Securities and Exchange Commission
(‘‘Commission’’) the proposed rule
change as described in Items I, II, and
III below, which Items have been
prepared by the Exchange. The
Commission is publishing this notice to
solicit comments on the proposed rule
change from interested persons.
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.
[Release No. 34–96500; File No. SR–
NASDAQ–2022–075]
Self-Regulatory Organizations; The
Nasdaq Stock Market LLC; Notice of
Filing and Immediate Effectiveness of
Proposed Rule Change To Amend
Listing Rules 5605 and 5606
December 14, 2022.
I. Self-Regulatory Organization’s
Statement of the Terms of Substance of
the Proposed Rule Change
The Exchange proposes to simplify
implementation and compliance
tracking of Listing Rules 5605 and 5606,
as described further below.
The text of the proposed rule change
is available on the Exchange’s website at
https://listingcenter.nasdaq.com/
rulebook/nasdaq/rules, at the principal
office of the Exchange, and at the
Commission’s Public Reference Room.
II. Self-Regulatory Organization’s
Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule
Change
In its filing with the Commission, the
Exchange included statements
concerning the purpose of and basis for
the proposed rule change and discussed
any comments it received on the
proposed rule change. The text of these
statements may be examined at the
places specified in Item IV below. The
Exchange has prepared summaries, set
forth in sections A, B, and C below, of
the most significant aspects of such
statements.
A. Self-Regulatory Organization’s
Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule
Change
1. Purpose
On December 1, 2020, the Exchange
filed with the Commission a proposed
rule change to adopt listing rules to
[FR Doc. 2022–27600 Filed 12–19–22; 8:45 am]
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U.S.C. 78s(b)(1).
CFR 240.19b–4.
20DEN1
]]>Agencies
[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
