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, 25711-25715 [2023-08841]

Agencies

• Management and Budget Office

[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25711-25715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american.

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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 www.regulations.gov, 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 
https://www.regulations.gov. 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, 
www.regulations.gov 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 https://www.regulations.gov. The NAICS website at 
www.census.gov/naics 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 https://www.census.gov/naics.
    \3\ North American Product Classification System--See https://www.census.gov/naics/napcs.
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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 (govinfo.gov).
    \5\ Paperwork Reduction Act 1995 44I.S.C. 3504(e)(3)--See 
USCODE-2021-title44-chap35-subchapI-sec3504.pdf (govinfo.gov).
    \6\ Statistical Policy Directive #8--See 2021-27536.pdf 
(govinfo.gov).
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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 https://www.govinfo.gov/content/pkg/FR-2021-12-21/pdf/2021-27536.pdf.
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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 https://www.census.gov/naics/napcs.
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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 (govregs.com).
    \12\ See 31 U.S.C. 901: Establishment of agency Chief Financial 
Officers (house.gov).
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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 https://www.federalregister.gov/documents/2022/09/15/2022-20167/advancing-biotechnology-and-biomanufacturing-innovation-for-a-sustainable-safe-and-secure-american.
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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