Posted on May 01, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” Under the EO, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged 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 (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). OMB states that 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. To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023.
The Working Group, through OMB, seeks input on how to identify, classify, and measure best 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, according to OMB, input should include information on how particular industries or products are linked to the bioeconomy and, where appropriate and available, evidence should be provided. OMB states that this will afford the Working Group the opportunity to use existing evidence to inform its recommendations. The RFI includes the following questions:
- What information and what high-priority concerns should the Working Group consider in making these recommendations for potential revisions to the NAICS and NAPCS that would enable characterization of the economic value of the U.S. bioeconomy?
- 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? Please explain why.
- Which industries not currently measured as unique classifications in NAICS related to the bioeconomy should be considered? Similarly, which products not currently measured as unique classifications 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 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.
- 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?
- What role can the NAPCS fill in order to advance measurement of biomanufacturing and biotechnology?
- 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.
- 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?
Posted on March 03, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invites feedback on the recommendations as it continues to consider them, with these questions as a starting point:
- Which of the recommendations would most effectively broaden public engagement in the federal regulatory process, especially from members of underserved communities and those who do not typically participate in the regulatory process? Are there recommendations that are not helpful?
- Are there obstacles or barriers to greater public participation, especially for underserved communities, that are not addressed by these recommendations? If so, are there other recommendations that we should consider?
- Are there existing materials, such as guides or tools, that would be especially effective in revising and potentially implementing these recommendations? What new tools or guidance are needed?
- How can intermediaries -- such as trade associations or coalitions -- be helpful in reaching individuals and small organizations or businesses, where have they been successful in doing so, and where might they be insufficient?
Interested members of the public can submit their feedback to .(JavaScript must be enabled to view this email address) as written feedback or recorded audio and video submissions. OIRA will be actively reviewing any submissions received through 5:00 p.m. (EST) March 10, 2023. OIRA states that it is also planning an additional virtual listening session during which members of the public can provide their views on these recommendations, to be held 3:00 p.m. - 4:30 p.m. (EST) on Tuesday, March 7, 2023.
Posted on August 23, 2019 by Lynn L Bergeson
Posted on November 16, 2018 by Lynn L BergesonBy Lynn L. Bergeson
On November 13, 2018, the U.S. Environmental Protection Agency (EPA) announced the submission for review of an information collection request (ICR) on the Renewable Fuel Standard (RFS) Program to the Office of Management and Budget (OMB). 83 Fed. Reg. 56319. The Federal Register notice states that purpose of this submission is to obtain OMB approval of an ICR that consolidates some existing collections. By consolidating the existing collections and recordkeeping updates, EPA is aiming to create a new, consistent, and easily understandable format to report burden and cost estimates related to the RFS program. Additionally, the ICR requests approval of updates to the recordkeeping and reporting burden along with cost estimated in December 2017. EPA requested comments on this ICR for a 60-day period. The November 13, 2018, notice extends the request for public comments by an additional 30 days. Additional comments may be submitted on or before December 13, 2018. The estimated burden approximates 566,665 hours per year, with a total estimated cost of $57,457,330 per year. The cost estimate includes $0 of annualized capital or operation and maintenance costs.
Posted on November 09, 2018 by Lynn L BergesonBy Lynn L. Bergeson
On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition of Section 351(k). The BPCI Act also amended the Federal Food, Drug, and Cosmetic Act to include Section 351(k) under human drug applications for prescription drug user fees provisions. The Program is meant to “create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product.” In 2012, the Biosimilar User Fee Act (BsUFA) allowed FDA to assess and collect user fees for activities connected with biosimilar biological product development (BPD). Some of these activities include the submission and review of forms, as well as an annual survey of all BsUFA participants.
The information collection proposal estimates an annual reporting burden of 57 hours, based on the number of respondents, the number of responses per respondent, the total annual responses, and the average burden per response. OMB will be accepting comments on FDA’s collection of information proposal until December 5, 2018.
Posted on May 18, 2018 by Lynn L BergesonBy Lynn L. Bergeson
On May 11, 2018, the U.S. Environmental Protection Agency (EPA) sent a proposed renewable fuel standard (RFS) biofuel volumes rule for 2019 to the White House Office of Management and Budget (OMB) for pre-publication review. The proposed rule addresses 2019 renewable blending obligations for cellulosic biofuel, advanced biofuel, and total biofuel, with a proposed 2020 percentage standard for biomass-based diesel. The 2019 blending requirement for biomass-based diesel is 2.1 billion gallons and was included in a final rule from 2017.
Posted on March 23, 2018 by Lynn L BergesonBy Lynn L. Bergeson
On March 12, 2018, the U.S. Department of Agriculture (USDA) issued in the Federal Register a notice announcing the submission of an information collection request (ICR) on the guidelines for designating biobased products for federal procurement to the Office of Management and Budget (OMB). Pursuant to Section 9002 of the Farm Security and Rural Investment Act (FSRIA) of 2002, as amended by the Food, Conservation, and Energy Act (FCEA) of 2008, and the Agricultural Act of 2014, federal agencies are required to purchase biobased products under the preferred procurement program. Product categories for preferred procurement are established by rulemaking based on the availability of biobased products, the economic and technological feasibility of using such products, and the costs of using such products. Additionally, federal agencies are provided with information on the availability, price, performance, and environmental and public health benefits of such product categories, and, where appropriate, the recommended level of biobased material to be contained in the procured product. Such information is gathered under the ICR from biobased product manufacturers and vendors by the Office of Procurement and Property Management (OPPM) and its contractors. USDA is seeking comments on:
- Whether the collection of information is necessary for the proper performance of the functions of USDA, including whether the information will have practical utility;
- The accuracy of USDA’s estimate of burden, including the validity of the methodology and assumptions used;
- Ways to enhance the quality, utility, and clarity of the information to be collected; and
- Ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Posted on May 05, 2017 by Kathleen M RobertsBy Kathleen M. Roberts
On April 25, 2017, the U.S. Department of Agriculture’s (USDA) Rural Business-Cooperative Service published in the Federal Register a notice that it is requesting approval from the Office of Management and Budget (OMB) of a revision to a currently approved information collection for the Advanced Biofuel Payment Program, which provides funding to eligible advanced biofuel producers to support the production of biofuel products. The Rural Business-Cooperative Service is specifically seeking comments on the following topics:
- Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
- The accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used;
- Ways to enhance the quality, utility, and clarity of the information to be collected; and
- Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments on this notice, which are due by June 26, 2017, will be summarized and included in the request for OMB approval.
Posted on August 29, 2014 by Heidi
On August 22, 2014, the U.S. Environmental Protection Agency (EPA) sent the final 2014 Renewable Fuel Standard (RFS) rule to the Office of Management and Budget (OMB) for its review and formal publication in the Federal Register. This much anticipated review is the last step before public release. Nearly nine months behind schedule currently, it is unclear whether OMB will move quickly to release and publish the rule. Typically, OMB can take anywhere between 30 to 90 days to review a proposal, or significantly longer as has been the case with more controversial rules sent from EPA. As EPA received 340,000 comments on its proposed rulemaking, a speedy review seems unlikely. Current speculation suggests modest increases, at best, are expected from OMB review and that the rule will be issued in final shortly after, or possibly before, the mid-term elections in November.
More information is available online. The current status of the 2014 RFS rulemaking at the OMB is available online.
The Biobased and Renewable Products Advocacy Group (BRAG®) recently published a report describing EPA's actions delaying the final 2014 RFS rule, and the impact of the continuing delays on the RFS debate. A copy of that report is available online.
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