Notice2023-08841
Executive Order 14081 Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy-Request for Information; National Biotechnology and Biomanufacturing Initiative-Measuring the Bioeconomy
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Published
April 27, 2023
Issuing agencies
Management and Budget Office
Abstract
The Chief Statistician of the United States (CSOTUS) in the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs, was charged in the Executive Order (E.O. 14081), ``Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,'' with improving and enhancing Federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS).\1\ The bioeconomy refers to a segment of the total economy utilizing or derived from biological resources, and includes manufacturing processes, technologies, products and services. These may encompass, wholly or in part, industries and products including fuel, food, medicine, chemicals, and technology. This Federal Register Notice (FRN) is a Request for Information (RFI) seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. ---------------------------------------------------------------------------
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<title>Federal Register, Volume 88 Issue 81 (Thursday, April 27, 2023)</title>
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[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25711-25715]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08841]
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OFFICE OF MANAGEMENT AND BUDGET
Executive Order 14081 Advancing Biotechnology and
Biomanufacturing Innovation for a Sustainable, Safe, and Secure
American Bioeconomy--Request for Information; National Biotechnology
and Biomanufacturing Initiative--Measuring the Bioeconomy
AGENCY: Office of Information and Regulatory Affairs, Office of
Management and Budget, Executive Office of the President.
ACTION: Request for information.
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SUMMARY: The Chief Statistician of the United States (CSOTUS) in the
Office of Management and Budget (OMB), Office of Information and
Regulatory Affairs, was charged in the Executive Order (E.O. 14081),
``Advancing Biotechnology and Biomanufacturing Innovation for a
Sustainable, Safe, and Secure American Bioeconomy,'' with improving and
enhancing Federal statistical data collection designed to characterize
and measure the economic value of the U.S. bioeconomy. The CSOTUS was
also charged with establishing an Interagency Technical Working Group
to recommend bioeconomy-related revisions for the North American
Industry Classification System (NAICS) and the North American Product
Classification System (NAPCS).\1\ The bioeconomy refers to a segment of
the total economy utilizing or derived from biological resources, and
includes manufacturing processes, technologies, products and services.
These may encompass, wholly or in part, industries and products
including fuel, food, medicine, chemicals, and technology. This Federal
Register Notice (FRN) is a Request for Information (RFI) seeking public
input on existing or potential bioeconomy-related industries and
products that are established, emerging, or currently embedded in
existing industry/manufacturing processes.
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\1\ Executive Order 14081 of September 12, 2022 (Advancing
Biotechnology and Biomanufacturing Innovation for a Sustainable,
Safe, and Secure American Bioeconomy)--See <a href="https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american">https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american</a>.
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DATES: To ensure consideration of comments on potential bioeconomy-
related industries and products solicited in this notice, please submit
all comments in writing as soon as possible, but no later than 45 days
from the publication date of this RFI. Send comments on or before June
12, 2023. Because of delays in the receipt of regular mail related to
security screening, respondents are encouraged to send comments
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electronically (see ADDRESSES section, below).
ADDRESSES: Submit comments through <a href="http://www.regulations.gov">www.regulations.gov</a>, a Federal E-
Government website that allows the public to find, review, and submit
comments on documents that agencies have published in the Federal
Register and that are open for comment. Enter ``OMB-2023-0012'' (in
quotes) in the Comment or Submission search box, click Go and follow
the instructions for submitting comments.
Comments received by the date specified above will be included as
part of the official record. Please include the Docket ID (OMB-2023-
0012) and the phrase ``National Biotechnology and Biomanufacturing
Initiative--Measuring the Bioeconomy'' at the beginning of your
comments. Due to time constraints, electronic submissions received
after the deadline cannot be ensured to be incorporated or taken into
consideration.
Please indicate which questions in the SUPPLEMENTARY INFORMATION
section you are responding to.
Privacy Notice: Information submitted in response to this RFI will
be maintained in the OMB Public Input System of Records, OMB/INPUT/01
88 FR 20913. OMB generally makes comments received from members of the
public available for public viewing on the Federal Rulemaking Portal at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. As such, commenters should not include
information that they do not wish to make publicly available, including
information of a confidential nature, such as sensitive personal
information or proprietary information. Please note that if you submit
your email address, it will be automatically captured and included as
part of the comment that is placed in the public docket; however,
<a href="http://www.regulations.gov">www.regulations.gov</a> does include the option of commenting anonymously.
For more detail about how OMB may maintain and disclose submitted
information, please review the System of Records Notice at 88 FR 20913.
Electronic Availability: Federal Register notices are available
electronically at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. The NAICS website at
<a href="http://www.census.gov/naics">www.census.gov/naics</a> contains NAICS United States Federal Register
notices, Economic Classification Policy Committee (ECPC) Issues Papers,
ECPC Reports, the structures, industry definitions, and related
documents for all versions of NAICS United States.
Public Review Procedure: All comments and proposals received in
response to this notice will be available for public inspection.
Instructions: Response to this RFI is voluntary. Respondents may
provide input on any aspects of this solicitation. OMB is particularly
interested in receiving comments on the questions posed by the
Bioeconomy Interagency Technical Working Group (Working Group) tasked
with developing recommendations for revisions to the NAICS, and/or the
NAPCS. OMB's established process for updating existing Statistical
Policy Directives includes technical evaluation of the current standard
by an interagency working group composed of career Federal subject
matter experts; additional technical research, testing, and analysis to
close identified gaps; and solicitation and consideration of public
comment on ways to improve the standard.
The final decisions regarding any changes to the standards are made
by OMB. To provide useful information to the Working Group in their
ongoing deliberations and ultimately to OMB in reviewing the Working
Group's final recommendations, responders should acquaint themselves
with current NAICS \2\ and NAPCS \3\ structure and current
classifications. A brief description of the NAICS and NAPCS
classification processes, structures and uses, as well as a description
of this Interagency Technical Working Group (ITWG) are included in the
SUPPLEMENTARY INFORMATION section.
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\2\ North American Industrial Classification System--See <a href="http://www.census.gov/naics">http://www.census.gov/naics</a>.
\3\ North American Product Classification System--See <a href="https://www.census.gov/naics/napcs">https://www.census.gov/naics/napcs</a>.
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An effective response should be concise, and if summarizing or
depending on published works, please include citations and electronic
links to reference materials, studies, research, and other empirical
data that are not widely available. Questions posed below are those the
Working Group deemed most significant and relevant to the its
recommendations. and do not necessarily reflect or represent the
positions of OMB or the agencies participating in the Working Group.
The questions have been sorted into broad categories for ease of
review.
Any information obtained from this RFI is intended to be used by
the Government on a non-attribution basis for planning and strategy
development. OMB 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.
FOR FURTHER INFORMATION CONTACT: For information about this request for
comments, contact Anthony Nerino, Office of Management and Budget, 9215
New Executive Office Building, 725 17th St. NW, Washington, DC 20503,
telephone (202) 395-1128.
SUPPLEMENTARY INFORMATION:
I. Background
The bioeconomy refers to a segment of the total economy utilizing
and/or derived from biological resources, and includes manufacturing
processes, technologies, products, and services. These may encompass,
wholly or in part, industries and products including fuel, food,
medicine, chemicals, and technology. Advances in biotechnology and
biomanufacturing play a substantial role in addressing a range of
issues including health, climate change, energy, food security,
agriculture, labor opportunities and economic growth.
E.O. 14081 directed Federal agencies to foster innovative solutions
in health, climate change, energy, food security, agriculture, supply
chain resilience, and national and economic security. A critical
component of this broad effort is an accurate measurement of the
bioeconomy. Accurate data on bioeconomic manufacturing, industrial, and
service activities may be used to assess growth across industrial
sectors, inform Federal investments in research and development, guide
private sector investments for scaling manufacturing efforts, assess
emerging national and international economic opportunities, and foster
the equitable distribution of health, food, and labor opportunities.
Measuring U.S. industrial outputs and products provides critical
information to a wide variety of private sector and Federal government
stakeholders and requires accurate, reliable, independent measures that
are also congruent with international measurements.
As part of its role as coordinator of the Federal statistical
system under the
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authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3504(e))
(PRA), OMB, through the Chief Statistician of the United States
(CSOTUS), must ensure the efficiency and effectiveness of the system as
well as the integrity, objectivity, impartiality, utility, and
confidentiality of information collected for statistical purposes.\4\
This statute also charges OMB with developing and overseeing the
implementation of Government-wide principles, policies, standards, and
guidelines concerning the development, presentation, and dissemination
of statistical information.\5\ OMB maintains a set of statistical
policy directives to implement these requirements and the NAICS is
required by Statistical Policy Directive #8, North American Industrial
Classification System: Classification of Establishments.\6\
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\4\ Paperwork Reduction Act 1995 44I.S.C. 3504(e)(1)--See
USCODE-2021-title44-chap35-subchapI-sec3504.pdf (<a href="http://govinfo.gov">govinfo.gov</a>).
\5\ Paperwork Reduction Act 1995 44I.S.C. 3504(e)(3)--See
USCODE-2021-title44-chap35-subchapI-sec3504.pdf (<a href="http://govinfo.gov">govinfo.gov</a>).
\6\ Statistical Policy Directive #8--See 2021-27536.pdf
(<a href="http://govinfo.gov">govinfo.gov</a>).
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II. NAICS and NAPCS
Recommendations to the Working Group on potential revisions to the
NAICS and NAPCS requires some insight into what these classification
systems are and how they are used. The NAICS is used to generate
statistics on the U.S. and North American Economy. Additional
information and updates for 2022 can be found in the Federal Register
Notice (86 FR 35350, pp 35350-35365, Doc# 2021-14249).\7\
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\7\ NAICS See--Federal Register: North American Industry
Classification System (NAICS) Updates for 2022; Update of
Statistical Policy Directive No. 8, Standard Industrial
Classification of Establishments; and Elimination of Statistical
Policy Directive No. 9, Standard Industrial Classification of
Enterprises.
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NAICS: NAICS is a system for classifying establishments (individual
business locations) by type of economic activity. Its purposes are: (1)
to facilitate the collection, tabulation, presentation, and analysis of
data relating to establishments, and (2) to promote uniformity and
comparability in the presentation and analysis of statistical data
describing the North American economy. Federal statistical agencies use
NAICS to collect and/or publish data by industry. It is also widely
used by State agencies, trade associations, private businesses, and
other organizations.
Mexico's Instituto Nacional de Estad[iacute]stica y
Geograf[iacute]a (INEGI), Statistics Canada, and the United States
Office of Management and Budget (OMB), through the ECPC, collaborated
on NAICS to make the industry statistics produced by the three
countries comparable. NAICS is the first industry classification system
developed in accordance with a single principle of aggregation (i.e.,
producing units that use similar production processes should be grouped
together in the classification). NAICS also reflects changes in
technology and in the growth and diversification of services in recent
decades. Industry statistics presented using NAICS are extensively
comparable with statistics compiled according to the latest revision of
the United Nation's International Standard Industrial Classification of
All Economic Activities (ISIC, Revision 4).
For these three North American countries, NAICS provides a
consistent framework for the collection, tabulation, presentation, and
analysis of industry statistics used by government policy analysts,
academics, researchers, the business community, and the public. Please
note that NAICS is designed and maintained solely for statistical
purposes to improve and keep current this Federal statistical standard.
Consequently, although the classification may also be used for various
nonstatistical purposes (e.g., for administrative, regulatory, or
taxation functions), the requirements of government agencies or private
users that choose to use NAICS for nonstatistical purposes play no role
in its development or revision.
Four principles that guide NAICS development are:
(1) NAICS is erected on a production-oriented conceptual framework.
This means that producing units that use the same or similar production
processes are grouped together in NAICS.
(2) NAICS gives special attention to developing production-oriented
classifications for: (a) new and emerging industries, (b) service
industries in general, and (c) industries engaged in the production of
advanced technologies.
(3) Time series continuity is maintained to the extent possible.
(4) The system strives for compatibility with the two-digit level
of the International Standard Industrial Classification of All Economic
Activities (ISIC, Revision 4) of the United Nations.
NAICS uses a hierarchical structure to classify establishments from
the broadest level to the most detailed level using the following
format:
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Sector............................... 2-digit................ Sectors represent the highest level of
aggregation. There are 20 sectors in NAICS.
Subsector............................ 3-digit................ Subsectors represent the next, more detailed
level of aggregation. There are 96 subsectors
in NAICS 2022.
Industry Group....................... 4-digit................ Industry groups are more detailed than
subsectors. There are 308 industry groups in
NAICS 2022.
NAICS Industry....................... 5-digit................ NAICS industries, in most cases, represent the
lowest level of three-country comparability.
There are 698 five-digit industries in NAICS
2022.
Sector............................... 2-digit................ Sectors represent the highest level of
aggregation. There are 20 sectors in NAICS.
National Industry.................... 6-digit................ National industries are the most detailed level
and represent the national level detail. There
are 1,012 national industries in NAICS United
States 2022.
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To ensure the accuracy, timeliness, and relevance of the
classification, NAICS is reviewed every five years to determine what,
if any, changes are required.
NAICS 2022 is the fifth revision since OMB adopted NAICS in 1997.
In response to public proposals during the NAICS 2022 revision process,
the ECPC considered the feasibility, value, and impact of including new
industries for the bioeconomy. In its final set of recommendations to
OMB, the ECPC did not include bioeconomy revisions in NAICS 2022, but
indicated that NAPCS 2022 could be used to identify new products of the
bioeconomy, such as biobased chemical inputs, and to inform future
revision cycles on significant emerging industries of the bioeconomy.
The ECPC cites concerns regarding the availability of data for
emerging bioeconomy industries due in part to disclosure
considerations. ``However, the ECPC recognized that economic,
statistical, and policy implications can arise when the industry
classification system does not identify and account for important
economic developments. The ECPC acknowledged that balancing the
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costs of change against the potential for more accurate and relevant
economic statistics will require significant input from data producers,
data providers, and data users.'' \8\ OMB accepted the recommendations
of the ECPC, and in its final decision, OMB noted the ``importance of
continued research and stakeholder engagement on [the bioeconomy]
toward maintaining a relevant and objective statistical classification
standard.'' \9\
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\8\ NAICS See--Federal Register: North American Industry
Classification System (NAICS) Updates for 2022; Update of
Statistical Policy Directive No. 8, Standard Industrial
Classification of Establishments; and Elimination of Statistical
Policy Directive No. 9, Standard Industrial Classification of
Enterprises.
\9\ Revision for 2022; Update of Statistical Policy Directive
No. 8, North American Industry Classification System--See <a href="https://www.govinfo.gov/content/pkg/FR-2021-12-21/pdf/2021-27536.pdf">https://www.govinfo.gov/content/pkg/FR-2021-12-21/pdf/2021-27536.pdf</a>.
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NAPCS: NAPCS is a comprehensive, market- or demand-based,
hierarchical classification system for products (goods and services)
that: (a) is not industry-of-origin based, but can be linked to the
NAICS industry structure, (b) is consistent across the three North
American countries, and (c) promotes improvements in the identification
and classification of service products across international
classification systems, such as the Central Product Classification
System of the United Nations.
NAPCS, a product classification system, and NAICS, an industry
classification system, are independent but complementary. A product
produced by multiple industries carries the same title, definition, and
code in NAPCS, regardless of its industries of origin. Products can be
linked to the industries that produce them, and industries can be
linked to the products they produce.
The NAPCS structure comprises six hierarchical levels. At the
highest level of the structure, there are 24 sections. Each section
consists of subsections, divisions, groups, subgroups, and trilateral
products.
NAPCS Level
Section--Two digits
Subsection--Three digits
Division--Five digits
Group--Seven digits
Subgroup--Nine digits
Trilateral Product--11 digits
NAPCS provides a comprehensive list of products adopted by the
U.S., Canada, and Mexico, and will be incrementally implemented into
economic statistics programs. These detailed product data will provide
policymakers and the business community with the information needed to
understand our ever-changing economies. NAPCS provides useful
information to industry analysts to estimate market share for their
firm or to investigate the growth of demand for the products of their
firm with: (a) those for the industry as a whole, or (b) those that
compete with or are closely associated with the products produced by
the firm.\10\
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\10\ North American Product Classification System--See <a href="https://www.census.gov/naics/napcs">https://www.census.gov/naics/napcs</a>.
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III. ECPC
The ECPC is a standing committee responsible for the maintenance of
NAICS and NAPCS. The ECPC follows a robust review process, inclusive of
public comment, trilateral negotiations among the U.S., Canada and
Mexico, and expert engagement across Federal agency staff.
The results of the ECPC's robust process are recommendations for
proposed revisions to NAICS and NAPCS to CSOTUS. CSOTUS holds the
responsibility of reviewing the recommendations and issuing final
decisions for any revisions to the NAICS and NAPCS, per statutory
authority in the PRA.
IV. Interagency Technical Working Group
The Office of the Chief Statistician of the United States (CSOTUS)
convened an Interagency Technical Working Group on the Bioeconomy
(Working Group) to provide recommendations on bioeconomy-related
revisions for NAICS and NAPCS to the ECPC. Agency participation was
solicited from the Interagency Council on Statistical Policy (ICSP).
The ICSP comprises 13 Principal Statistical Agencies,\11\ and 24 Chief
Financial Officer (CFO) agencies \12\ as well as agencies that are
NAICS data users/stakeholders. The Working Group members were nominated
by their agency Statistical Official. The Working Group is comprised of
career staff from Federal agencies representing OMB, Department of
Agriculture, Department of Energy, Small Business Administration,
Bureau of Census, Bureau of Economic Analysis, Environmental Protection
Agency, National Science Foundation, Bureau of Labor Statistics, and
the Department of Defense.
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\11\ Paperwork Reduction Act 1995 44I.S.C. 3504(e)(3) See 44
U.S.C. 3504--Authority and functions of Director (<a href="http://govregs.com">govregs.com</a>).
\12\ See 31 U.S.C. 901: Establishment of agency Chief Financial
Officers (<a href="http://house.gov">house.gov</a>).
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The Working Group is charged with developing bioeconomy-related
recommendations for revisions to NAICS and NAPCS that would promote
accurate and reliable measurement of the bioeconomy, and maintain the
integrity of federal statistical products. Upon completion, these
recommendations will be provided to OMB and the ECPC. The ECPC will
consider these recommendations in the development of proposed revisions
for the 2027 NAICS and NAPCS.
V. Considerations for the Working Group
The Working Group, through OMB, is seeking input on how to best
identify, classify, and measure bioeconomy manufacturing, technology,
and products, including those that are primarily or exclusively: (a)
biobased, (b) components of traditional manufacturing processes, and
(c) nascent biobased processes and products. Importantly, input should
include information on how particular industries or products are linked
to the bioeconomy, and where appropriate and available, evidence to
support your input should be provided. This will afford the Working
Group the opportunity to use existing evidence to inform its
recommendations.
To restate, the bioeconomy refers to a segment of the total economy
utilizing and/or derived from biological resources, and includes
manufacturing processes, technologies, products, and services. These
may encompass, wholly or in part, industries and products including
fuel, food, medicine, chemicals, and technology.\13\
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\13\ Executive Order 14081 of September 12, 2022 (Advancing
Biotechnology and Biomanufacturing Innovation for a Sustainable,
Safe, and Secure American Bioeconomy)--See <a href="https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american">https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american</a>.
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Examples within these domains include: Energy (fuel, biomass),
Agriculture (food, genetically modified plants), Health (medicine,
genetic products), Manufacturing (biomaterials/chemicals, biobased
industrial equipment), Technology (bio-related software, products) and
Services (bio-based research and development, production, bio-based
waste management, biobased resource management).
The Working Group will use these comments to inform their
recommendations to OMB and ECPC as describes earlier.
V. Questions
1. What information and what high priority concerns should the
Working Group consider in making these
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recommendations for potential revisions to the NAICS and NAPCS that
would enable characterization of the economic value of the U.S.
bioeconomy?
2. Which quantitative economic indicators and processes are
currently used to measure the contributions of the U.S. bioeconomy? Are
these indicators reasonably accurate measures of the product
components, scope, and value, of the bioeconomy; and, please explain
why?
3. Which industries not currently measured as a unique
classification in NAICS related to the bioeconomy should be considered?
Similarly, which products not currently measured as a unique
classification in NAPCS related to the bioeconomy should be considered?
Please describe how a unique classification for such industry or
product would meet the principles of NAICS and NAPCS. Please also
include a description of the industry or product, with specific
examples. Please also provide an explanation of how such industry or
product would advance understanding of measuring the bioeconomy.
4. How might potential changes to the NAICS impact existing
industry measurements, such as assessing changes in the economic output
across current industries, time series measures, or data accuracy?
5. What role can the NAPCS fill in order to advance measurement of
biomanufacturing and biotechnology?
6. Biobased processes and products that are embedded in traditional
industries pose challenges for differentiation and measurement. Are
there methodologies that can differentiate these bioeconomy processes
from current manufacturing processes to enable measurement? If yes,
please explain.
7. What potential bioeconomy measurement strategies might be
considered other than revisions to and inclusion in the NAICS or NAPCS?
For example, are there ways the Federal Government could better collect
information to provide better measurement on biobased processes or
products in current industries?
Karen A. Orvis,
Chief Statistician of the United States, Chief, Statistical and Science
Policy Branch, Office of Information and Regulatory Affairs.
[FR Doc. 2023-08841 Filed 4-26-23; 8:45 am]
BILLING CODE 3110-01-P
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