All Knowledge & Insights By Date

By 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...

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...

By 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...

On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping...

On February 8, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): “Notification of Substantial Risk of Injury to Health and the Environment under the Toxic Substances Control Act (TSCA),” identified by EPA ICR No. 0794.17 and OMB Control No. 2070-0046. 87 Fed. Reg. 7173. The ICR represents the renewal...

On January 20, 2022, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) concerning the procedures for submitting information subject to business confidentiality claims under the Toxic Substances Control Act (TSCA). According to an item in the fall 2021 Unified Agenda, EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential...

The U.S. Environmental Protection Agency (EPA) announced on August 27, 2020, that it submitted an information collection request (ICR), “Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials” to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA).  85 Fed. Reg. 52995.  The ICR covers reporting and recordkeeping requirements for persons who manufacture or...

On June 3, 2020, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances.  On March 3, 2020, EPA published a proposed supplemental SNUR for LCPFAC chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface...

As reported in our October 1, 2019, blog item, on September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  According to OMB’s website, OMB completed its review on February 14, 2020.  EPA has not yet publicly released the proposed rule. According...

On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC...

The Centers for Disease Control and Prevention (CDC) published a Federal Register notice on September 11, 2019, to provide an additional 30-day comment period on its proposed information collection project entitled “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.”  84 Fed. Reg. 47957.  As reported in our April 24, 2019, blog item, on April 23, 2019, CDC published a Federal Register notice inviting comment on the proposed...

By Lynn L. Bergeson On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which...

By 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...

By 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...

On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA).  As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical...

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA)...

By 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...

On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory.  The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements...

On April 30, 2018, the U.S. Environmental Protection Agency (EPA) will publish in the Federal Register a proposed rule entitled “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.”  EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of...

By 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...