Biden-Harris Administration’s Policies and Priorities

The US Environmental Protection Agency (EPA) recently lowered the recommended regional screening level (RSL) and regional removal management level (RML) for lead-contaminated soil in areas where children live and play from 400 parts per million (ppm) to 200 ppm. EPA recommends using an even lower RSL of 100 ppm in areas with other sources of lead exposure, including lead water service lines and lead-based paint, and areas identified as non-attainment areas for lead emissions under the Clean Air Act.

This report provides summaries of 44 FDA guidances and rulemakings issued in 2023 on premarket development, clinical trials, review standards, manufacturing, supply chain, promotion, and labeling considerations. Additionally, we provide insights into what some of these trends and rulemakings may mean for 2024 as their influence carries forward into the new year and beyond.

The Internal Revenue Service’s proposed Section 45X regulations, released on December 15, provide US-based manufacturers with much-anticipated guidance for a credit that has been available since the beginning of 2023.

The US Internal Revenue Service (IRS) and US Department of the Treasury (Treasury) released proposed regulations on November 17, 2023 addressing the investment tax credit (ITC) for renewable energy and energy storage facilities, expanding upon and clarifying prior guidance on applying the ITC following the enactment of the Inflation Reduction Act of 2022 (IRA).

The Biden administration issued a long-anticipated executive order on August 9 regarding US outbound investment in select technology and products with national security applications produced by “countries of concern.” Executive Order 14105 (EO) was released in conjunction with a corresponding Advanced Notice of Proposed Rulemaking (ANPRM) from the US Department of the Treasury (Treasury). Both these developments, while not yet effective, are critical to technology companies and investors, and the coming months will reveal the extent of the impact and the direction Treasury takes with its proposed regulations.

In the wake of the US Supreme Court’s recent decision striking down affirmative action in higher education in Students for Fair Admissions v. Harvard University and Students for Fair Admissions v. University of North Carolina (Harvard/UNC), corporations are being swept into a nationwide conflict over diversity, equity, and inclusion (DEI) initiatives. Corporate boards should consider taking preventive measures now to mitigate litigation risk.

A recently issued White House Fact Sheet, along with a regulatory package from the US Departments of the Treasury, Labor, and Health and Human Services (the Departments), provides some welcome clarity for plan sponsors and fiduciaries on the requirements imposed on group health plans by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), while also raising key questions for stakeholders.

Partner David Dziengowski and associate Megan Lipsky wrote an article for FEDweek on the implications of the US Supreme Court’s decisions in Students for Fair Admissions, Inc. v. University of North Carolina and Students for Fair Admissions, Inc. v. Harvard University on federal contractors covered by Executive Order 11246, an antidiscrimination directive that serves as the principle legal authority on which contractors’ equal employment opportunity plans and affirmative action programs are based.

The US Supreme Court issued a landmark decision on June 29, 2023 regarding challenges to race-conscious admissions programs at Harvard University and the University of North Carolina (UNC). In a 6–3 decision split along ideological lines (the vote was 6–3 in Students for Fair Admissions, Inc. v. University of North Carolina and 6–2 in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College with Justice Jackson recused), the Supreme Court held that Harvard and UNC’s race-conscious admissions policies fail strict scrutiny and thus violate the Equal Protection Clause of the Fourteenth Amendment to the US Constitution.

On June 14, 2023, the Internal Revenue Service and US Department of the Treasury released temporary regulations and proposed regulations (collectively, the Transferability Guidance) relating to the transfer of certain clean technology industry federal income tax credits pursuant to Section 6418 of the Internal Revenue Code of 1986, as amended, which was enacted under the Inflation Reduction Act of 2022.

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic. With the PHE coming to an end, organizations may need to make drastic changes as the regulatory enforcement returns to “normal.”

The US Department of Homeland Security (DHS) and US Immigration and Customs Enforcement (ICE) announced on May 4, 2023 that employers will have until August 30, 2023 to complete the physical inspection of identity and employment eligibility documents for any employee whose Form I-9 was completed virtually pursuant to COVID-19–era temporary flexibility provisions.

Concurrent with the termination of the COVID-19 Public Health Emergency, various regulatory flexibilities will also come to an end, including the blanket waivers to the Stark Law and related enforcement discretion under the Federal anti-kickback statute. Accordingly, healthcare providers should promptly assess the ongoing compliance of all financial arrangements with physicians relying on these regulatory flexibilities and remediate or terminate such arrangements as appropriate.

The proposed emissions requirements would be phased in over model years 2027 through 2032, drastically accelerating the nationwide transition to zero-emission vehicles (ZEVs) consistent with the Biden administration’s commitment to addressing global climate change and improving community air quality.

The Internal Revenue Service (IRS) recently issued proposed regulations that would require forfeitures in defined contribution plans—i.e., unvested benefits forfeited by terminating defined contribution plan participants—to be used to offset employer contributions or pay reasonable plan administrative expenses, or otherwise be allocated to participants, by the end of the year following the year of forfeiture.

The comment period has opened for the US Department of Commerce’s recently issued CHIPS for America incentive program notice of proposed rulemaking, which lays out funding requirements, incentives, and restrictions for potential funding recipients, with the aim of bolstering the US semiconductor industry.

The US Securities and Exchange Commission (SEC) issued a notice of proposed rulemaking (the Proposal) on March 15 that would require SEC-regulated investment advisers, investment companies, and broker dealers to provide notice to individuals affected by certain types of data breaches, along with other related requirements. The Proposal was part of a spate of privacy proposals issued by the SEC and follows other recent proposals.

National Labor Relations Board (NLRB or the Board) General Counsel (GC) Jennifer Abruzzo issued guidance on the Board’s recent decision regarding severance agreements. In McLaren Macomb, 372 NLRB No. 58, the Board found that confidentiality and nondisparagement restrictions in severance agreements violated the National Labor Relations Act (NLRA). The GC’s March 22, 2023 guidance, contained in GC Memorandum 23-05 (GC Memo), addresses many questions raised by the decision.

The US Department of Commerce has begun implementing the CHIPS and Sciences Act by introducing the first Notice of Funding Opportunity of its “CHIPS for America” incentive programs, which aim to support the construction, expansion, or modernization of commercial semiconductor manufacturing facilities in the United States. The program intends to increase domestic semiconductor production, reduce reliance on foreign suppliers, create new jobs in the semiconductor industry, and enhance national security by ensuring the availability of critical technologies for US government agencies and contractors.

Despite global economic headwinds, the US offshore wind industry has continued to slowly but steadily blossom, driven largely by enhanced vision and cooperation among federal government agencies under the Biden administration, coastal states and utilities looking to make good on renewable procurement and other climate change pledges, and private industry and capital seeking new opportunities for the next generation of large-scale clean power. Nevertheless, the United States lags far behind Europe when it comes to harnessing the abundant power of offshore wind.

Three hundred million tons of plastics are produced each year worldwide. Less than 10% of plastic waste in the United States is recycled each year. With projections showing that plastics production is expected to triple over the next 40 years, public concern over plastics pollution is coming to a head.

US governmental authorities, including the US Department of the Treasury, the Board of Governors of the Federal Reserve System, and the Federal Deposit Insurance Corporation, took actions to provide both insured and uninsured depositors of Silicon Valley Bank (SVB) (as well as Signature Bank) access to their deposits beginning Monday, March 13. However, despite these actions, many customers are still dealing with the aftermath of an uncertain weekend, and practical questions remain to be answered.

On October 26, 2022, the US Securities and Exchange Commission (SEC) announced the adoption of its new rules directing national securities exchanges, including the New York Stock Exchange (NYSE) and the Nasdaq Stock Market (Nasdaq), to establish listing standards for compensation recovery (clawback) policies. In accordance with the SEC’s clawback rule, both the NYSE and Nasdaq submitted their clawback proposals to the SEC on February 22, 2023. This blog post offers guidance on compliance and implementation deadlines pursuant to these proposals, as well as what public companies need to do in the coming months to ensure timely adoption.

Morgan Lewis lawyers lay out some important trends in the 2023 energy storage market.

In response to assertions that the Biden administration has not done enough to pursue pandemic-era fraud, on March 2, 2023, the White House proposed a framework for a “whole-of-government” anti-fraud effort with the US Department of Justice (DOJ) at the helm.

On March 2, the White House issued the National Cybersecurity Strategy (the Strategy), a broad vision to reinvigorate the federal government’s approach to cybersecurity and address a wide spectrum of long-term challenges. The Strategy reflects the latest significant cybersecurity-focused activity from the Biden administration and contains an ambitious set of goals and initiatives.

Both the US House of Representatives and the Senate passed a resolution to overturn the US Department of Labor’s so-called “ESG Rule” on February 28 and March 1, 2023, respectively. The ESG Rule has been a topic of debate as it sought to clarify the role that environmental, social, and governance (ESG) factors can play in fiduciary decision-making on behalf of retirement plans regulated by ERISA. This resolution is part of a larger effort to limit ESG investing at both federal and state levels.

Registered entities continued to be a significant focus of the US Securities and Exchange Commission’s (SEC’s) enforcement and rulemaking programs in 2022, and we expect similar attention this year. The SEC’s Division of Examinations recently issued its 2023 Examination Priorities Report, highlighting a number of areas that will draw increased scrutiny from the Examinations staff and are likely precursors to future enforcement sweeps and referrals. Similarly, the Financial Industry Regulatory Authority’s (FINRA’s) 2023 Report on Examination and Risk Monitoring Program identified many areas of focus for broker-dealers that will garner continued attention, including Regulation Best Interest, Consolidated Audit Trail, mobile apps, and cybersecurity.

The Federal Communications Commission (FCC) is considering rules to enable wireless communications for drones (or unmanned aircraft (UAS)) operating in the 5030-5091 MHz spectrum band and is seeking comment on whether the FCC should take other measures to facilitate drone use on a flexible use wireless network.

The National Labor Relations Board (NLRB or the Board) issued a decision on February 21 in McLaren Macomb (372 NLRB No. 58) overruling precedent to hold that employers may not offer employees severance agreements containing confidentiality or non-disparagement provisions. Employers, whether unionized or not, should take note of the NLRB’s new focus on restricting common language in severance agreements that the Board believes requires employees to waive their rights under the National Labor Relations Act.

The US Department of Labor’s final regulation on the investment duties of ERISA fiduciaries contains a special rule on proxy voting by ERISA pooled investment vehicles, which requires action by December 1, 2023.

The US Food and Drug Administration (FDA) recently issued a final guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The guidance finalizes a 2020 draft guidance outlining how sponsors and investigators can legally conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds such as cannabidiol (CBD).

The SECURE Act 2.0 makes changes to the US employer retirement plan system with respect to both single employer plans and to “applicable collectively bargained plans.” Applicable collectively bargained plans are defined in the statute as plans maintained pursuant to one or more collective bargaining agreements between employee representatives and one or more employers, i.e., multiemployer plans.

The Environmental Protection Agency’s (EPA’s) highly anticipated regulations governing per- and polyfluoroalkyl substances (PFAS) reporting, originally slated for final publication in January 2023, have been delayed to at least March. There have been concerns that the forthcoming rule may place an excessive burden on entities that are required to report, particularly from smaller businesses and others that may not have the infrastructure or resources to satisfy the reporting obligations.

While none of the recent environmental, social, and governance (ESG) developments with respect to organizations under some sort of regulatory oversight—including public companies and retirement plans—is directly relevant to tax-exempt organizations, these developments do reflect a steadily changing landscape that has relevance by analogy. Changes at both the federal and state levels, when finalized, may provide new information for ESG-minded tax-exempt investors to consider. They may also help inform tax-exempt organizations that are considering voluntarily adopting, or have adopted, intentional ESG practices about issues to consider with respect to such practices.

The US Food and Drug Administration (FDA) recently issued a notice clarifying the agency’s approach to determining the scope of orphan drug exclusivity. According to the FDA, it intends to continue applying its orphan drug regulations such that the scope of orphan drug exclusivity is tied to the specific orphan indication for which a drug is approved, not the indication for which it was designated. This approach, however, is in contrast with the 2021 Catalyst Pharmaceuticals Inc. v. Becerra ruling, and will likely position the agency for future challenges. The FDA’s approach also lends uncertainty to the ultimate scope of current and future periods of orphan drug exclusivity.

The US Department of Justice (DOJ) Antitrust Division is withdrawing three enforcement policy statements that provided important guidance on the exchange of competitively sensitive information through third parties. The guidance previously created a safe harbor for market benchmarking surveys that were (1) administered through a third party, (2) historical, and (3) anonymous. The withdrawal of this guidance creates uncertainty regarding how companies should approach market research and benchmarking activities and may signal increased scrutiny from federal enforcers going forward.

The US Department of Justice (DOJ) Antitrust Division is withdrawing three enforcement policy statements that provided important guidance on the exchange of competitively sensitive information through third parties. The guidance previously created a safe harbor for market benchmarking surveys that were (1) administered through a third party, (2) historical, and (3) anonymous. The withdrawal of this guidance creates uncertainty regarding how companies should approach market research and benchmarking activities and may signal increased scrutiny from federal enforcers going forward.

Environmental, social, and governance (ESG) matters are now the subject of significantly greater regulatory scrutiny and are becoming a more prominent part of public companies’ mandatory filings, shareholder proposals, and activist campaigns.

With the recent announcement from the Biden administration that the COVID-19 national and public health emergencies will end this May, the temporary US Department of Homeland Security guidance that permitted businesses operating remotely due to COVID-19 precautions to conduct remote Form I-9 document inspections will expire on July 31, 2023.

More than a decade after its initial proposal, the US Securities and Exchange Commission (SEC) has re-proposed a new rule under the Securities Act of 1933, as amended (the Securities Act), prohibiting material conflicts of interest in asset-backed securities (ABS) transactions, as required by Section 621 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (the Dodd-Frank Act).

The federal safety agency recently unveiled new initiatives aimed at “impactful enforcement . . . in the form of increased citations and penalties.” Changes to how the Occupational Safety and Health Administration (OSHA) uses subpoenas, issues instance-by-instance citations, and groups violations will directly impact employers.

The Federal Trade Commission (FTC) announced on January 23 that it will increase the Hart-­Scott-­Rodino Act (HSR Act) jurisdictional filing thresholds, which, along with the new HSR Act filing fee thresholds contemplated by the Merger Filing Fee Modernization Act of 2022, will go into effect 30 days after the pending publication in the Federal Register, which is expected in the upcoming days.

The US Department of Justice (DOJ) continues to try to dispel lingering skepticism over the benefits of corporate disclosure and cooperation. In remarks delivered on January 17, Assistant Attorney General (AAG) Kenneth A. Polite, Jr. announced the first significant changes to the DOJ Criminal Division’s Corporate Enforcement Policy (CEP) since the CEP was initially announced in 2017. The revised CEP provides guidance to prosecutors for how to assess and treat corporate offenders.

The SECURE 2.0 Act of 2022 makes far-ranging changes to the US employer-retirement plan system. This LawFlash—one in a series—more closely examines the act’s provisions that expand and encourage retirement plan participation.

The Internal Revenue Service (IRS) issued proposed regulations under Sections 892 and 897 of the Internal Revenue Code of 1986, as amended, on December 29, 2022. Final regulations  under Section 897 regarding the exemption for “qualified foreign pension funds” from taxation under the Foreign Investment in Real Property Tax Act of 1980 were issued the same day.

The Federal Trade Commission’s (FTC’s) January 5, 2023, notice of proposed rulemaking would ban businesses from entering into and maintaining noncompete clauses with workers. In this LawFlash, we answer several frequently asked questions related to the proposed rule’s applicability and anticipated impact, and discuss what businesses can do to prepare.

At its January 26 open meeting, the Federal Communications Commission (FCC) will consider an order and further notice of proposed rulemaking (FNPRM) to amend the rules of the Rural Health Care Program, which includes the Healthcare Connect Fund (HCF) Program and the Telecommunications (Telecom) Program. The most significant change in the final rules under consideration would reinstate the Telecom Program’s pre-2021 urban and rural rate rules, which have caused confusion and compliance failures for applicants and service providers in the past.

The SECURE 2.0 Act of 2022 makes far-ranging changes to the US employer-retirement plan system intended to expand access to retirement plans and encourage savings by US workers. This LawFlash—one in a series—examines provisions regarding expanded self-correction and new overpayment correction rules and relief.

The Federal Trade Commission (FTC) announced a notice of proposed rulemaking (NPRM) on January 5, 2023, that would ban employers from entering into and maintaining noncompete clauses with their workers. With this potential ability for workers to change jobs more freely, employers will become more focused on protecting their innovations by enforcing confidentiality clauses and trade secret laws.

Congress recently passed and sent to the president the Protecting American Intellectual Property Act of 2022. The act mandates sanctions on entities and individuals identified by the executive branch as having committed “significant thefts of trade secrets,” including those who facilitate or provide support for such thefts, where the trade secret theft is “reasonably likely to result in, or has materially contributed to, a significant threat to the national security, foreign policy, or economic health or financial stability of the United States.”

The US Congress passed the Pregnant Workers Fairness Act (PWFA) and Providing Urgent Maternal Protections for Nursing Mothers Act (PUMP Act) on December 23, 2022, as part of the omnibus spending bill for FY2023. President Joseph Biden signed the bills into law on December 29. The PWFA will take effect 180 days after the bill is signed. The PUMP Act’s expanded coverage provisions take effect 120 days after signature. The expanded remedies apply immediately.

Many people spent the last week of 2022 celebrating holidays or seeking travel adventures both far and near. However, a select group of personnel at the US Internal Revenue Service (IRS) and Department of the Treasury opted for a different path. On December 29, the IRS and Treasury issued a number of documents providing information and clarification on issues concerning tax credit eligibility for purchases of clean vehicles beginning in January 2023.

The US Citizenship and Immigration Services will use the Dates for Filing Chart in January 2023. Due to increased demand, an EB-1 cutoff date has been established for China and India. There are no other changes to the January 2023 Visa Bulletin.

On December 13, 2022, the Department of Energy’s Office of Fossil Energy and Carbon Management released a Funding Opportunity Announcement (FOA) to make available up to $1.236 billion of funding to promote the development of four Regional Direct Air Capture (DAC) Hubs. This FOA is intended to accelerate the commercialization of, and demonstrate the processing, transport, geologic storage, and conversion of carbon dioxide (CO2) captured from the atmosphere.

The SEC’s Division of Corporation Finance recently posted new compliance and disclosure interpretations concluding that any registered broker-dealer acting as an authorized participant (AP) for any ActiveShares exchange-traded fund (ETF) may rely on the Commission’s disaggregation guidance to separately report ownership of securities acquired in a confidential brokerage account (Confidential Account) with a nonaffiliated brokerage firm (AP Representative), for the benefit of the AP.

On December 14, 2022, the US Securities and Exchange Commission (SEC) proposed a fundamental restructuring of the US equity markets in the form of two rule amendments and one new rule proposal (the Equity Market Proposals). In addition, the SEC proposed new Regulation Best Execution (Proposed Regulation Best Ex) under the Securities Exchange Act of 1934 (Exchange Act). The comment period for each rule proposal will remain open until the later of March 31, 2023, or 60 days after the applicable proposing release is published in the Federal Register.

The New York Department of Financial Services (NYDFS) published its proposed amendment to its 23 NYCRR Part 500 (Cybersecurity Rules) on November 9, 2022, following the release of the draft version on July 29, 2022. The proposed amendments complement the efforts of the US government to further regulate cybersecurity practices pursuant to the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (CIRCIA). If adopted, the proposed amendment, among other things, establishes “Class A” companies, and requires covered entities (i.e., insurance companies, banks and other financial institutions regulated by the NYDFS) to, within 180 days, review their existing policies and procedures and ensure compliance with all applicable requirements of the Cybersecurity Rules.

The Internal Revenue Service (IRS) published Notice 2022-61 (the Notice) in the November 30 Federal Register to provide guidance on the key prevailing wage and apprenticeship labor standards (W&A Requirements) generally required to obtain the full expected credit amount for tax credits enacted, expanded, or extended under the Inflation Reduction Act of 2022 (IRA). The W&A Requirements must be satisfied with respect to the construction of qualified facilities, properties, projects, or equipment (collectively, facilities) and, to varying extents, the alteration and repair of facilities.

The House of Representatives and the Senate took the first steps in response to the collapse of FTX this week. The Senate Agriculture Committee has announced a hearing at which the chair of the Commodity Futures Trading Commission (CFTC) will testify, while the House Financial Services Committee announced its intention to hold bipartisan oversight hearings and to take testimony from companies and individuals involved, including Sam Bankman-Fried, Alameda Research, Binance, FTX, and related entities, among others. Separately, a spokesperson from the US Senate Committee on Banking, Housing, and Urban Affairs stated that the committee would also hold oversight hearings into the FTX bankruptcy.

The US Securities and Exchange Commission recently released its enforcement statistics for fiscal year 2022. In this LawFlash, we discuss trends and takeaways on what was an active year for the Division of Enforcement.

The US Securities and Exchange Commission (SEC) on November 2, 2022, by a 3-2 party line vote, proposed amendments (the Proposal) to the liquidity risk management programs rule (Rule 22e-4) under the Investment Company Act of 1940, as amended; and amendments that would require certain funds to implement “swing pricing” and impose a “hard close” on the acceptance of purchase and redemption orders. The SEC described the Proposal as intended to “better prepare open-end funds for stressed conditions,” citing systemic issues associated with the onset of the COVID-19 pandemic, as well as to “mitigate dilution of shareholders’ interests” and “enhance how funds manage their liquidity risks.”

The HHS Office of Inspector General (OIG) has, for the last several years, been actively auditing hospices regarding their Medicare regulatory and billing compliance, with a national hospice audit in the works. Recently, OIG has notified certain hospices that it is conducting an audit of hospices’ compliance with CARES Act Provider Relief Fund (PRF) requirements and whether the hospices complied with certain terms and conditions and federal requirements related to the use of those PRF grants that were furnished to Medicare providers as part of the COVID-19 relief efforts in 2020 and 2021.

The White House Office of Science and Technology recently published The Blueprint for an AI Bill of Rights: Making Automated Systems Work for the American People (the Blueprint), a set of five principles to help guide designers, developers, and deployers of AI in the design, use, and deployment of automated systems with the goal of protecting the public’s rights.

The US Securities and Exchange Commission (SEC) recently finalized rule and form amendments (Adopted Rules) that require mutual funds and most exchange-traded funds (ETFs) to provide shareholders with streamlined and “visually engaging” shareholder reports. The Adopted Rules include significant changes to both the content and the presentation of information in shareholder reports, summarizing certain key information and moving other information that is currently included in shareholder reports to other SEC filings (e.g., Form N-CSR) and to fund websites. These changes are part of the SEC’s investor experience initiative and its effort to modernize shareholder disclosures and implement layered disclosure approaches.

Hydrogen will play a key role in addressing the climate crisis, supporting a transition to net zero, and achieving a sustainable clean energy future. As a versatile energy carrier and chemical feedstock, hydrogen offers many advantages and an ability to leverage renewables, nuclear, and fossil fuels with carbon capture and storage. It can also be used as a fuel or feedstock for applications that do not have competitive and efficient clean alternatives.

The Commodity Futures Trading Commission (CFTC or the Commission) released its enforcement results for fiscal year 2022 on October 20, 2022. The enforcement results detail the 82 enforcement actions the CFTC filed in 2022 and show that orders secured by the Commission imposed more than $2.5 billion in restitution, disgorgement, and civil monetary penalties, either through settlement or litigation.

On October 12, 2022, the US Securities and Exchange Commission (SEC or Commission) adopted amendments (Final Rules) to the electronic recordkeeping requirements applicable to broker-dealers, security-based swap dealers, and major security-based swap participants under the Securities Exchange Act of 1934. The Final Rules are largely consistent with the Proposed Amendments with some modifications.

In response to confusion regarding the “10-Year Rule” that was added to the required minimum distribution (RMD) rules by the Setting Every Community Up for Retirement Enhancement Act of 2019 (SECURE Act), the US Internal Revenue Service (IRS) has provided relief to defined contribution plan beneficiaries and individual retirement account beneficiaries. In Notice 2022-53, the IRS provides two forms of relief: (1) the proposed RMD regulations, including the application of the 10-Year Rule, if finalized, will not apply earlier than 2023, and (2) the failure to distribute “Specified RMD” payments in 2021 and 2022 will not be treated as a plan qualification failure or trigger the 50% excise tax for the Specified RMDs.

On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and enforcing industry compliance. They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance.

The US Department of Labor published a Proposed Rule on October 13 seeking to return to applying a test that would make it more difficult for certain workers to qualify as independent contractors.

The US Department of State has released its November 2022 Visa Bulletin, outlining per-country priority date cutoffs that regulate immigrant visa availability and the flow of adjustment of status application and consular immigrant visa application filings and approvals. Notably, the State Department indicated that it may be necessary to establish a worldwide Final Action Date in the Employment-Based Second Preference (EB-2) category due to increased demand.

The Biden-Harris administration’s amendments to the domestic preference requirements in Federal Acquisition Regulation Part 25 become effective on October 25. The new requirements will increase the domestic content threshold for government purchases under the Buy American Act over a several-year period.

US Environmental Protection Agency Administrator Michael Regan announced on September 24 that the agency is establishing a new national office focused on advancing environmental justice and civil rights.

The Department of Defense issued a memorandum this month refining its guidance on inflation-related economic price adjustments for contractors with existing firm-fixed-price contracts. The updated guidance provides new hope for some contractors that continue to be ravaged by inflated-related cost increases.

The Federal Trade Commission’s September 15 policy statement is the latest in a series of actions signaling the Commission’s continued focus on competition and labor issues in the gig economy. The policy statement—and the FTC’s focus on the gig economy—are likely to have implications for companies that rely on nontraditional workers on a part-time, on-demand basis, regardless of whether those workers are classified as employees.

The US government took important steps this year to promote a growing hydrogen economy. On August 16, 2022, shortly after the US Department of Energy (DOE) announced a game-changing program to fund $8 billion for the development of regional hydrogen hubs in accordance with the provisions of the Infrastructure Investment and Jobs Act, President Joseph Biden signed the Inflation Reduction Act (IRA) into law, funding approximately $369 billion in new renewable and green energy projects across the country.

Since President Biden took office, companies have invested nearly $85 billion in the manufacturing of electric vehicles (EVs), batteries, and EV chargers in the United States. This is triple the investment made in domestic EV manufacturing in 2020 and more the 28 times the investment in batteries from two years ago, and the sale of EVs in the United States has tripled in the same period. The Biden-Harris administration is crediting the increase in the development and adoption of EV to an aggressive and holistic funding strategy driven by the White House.

In the last two weeks, South Carolina’s Senate failed to pass a near-total ban on abortion, California’s legislature passed a law prohibiting California corporations from assisting with certain investigations related to the provision of abortion services, and Oklahoma’s attorney general released guidance on enforcement of the state’s criminal laws prohibiting abortion. In addition, the US Department of Veterans Affairs issued an interim final rule that would permit abortion counseling as part of its medical benefits packages.

In a notice of proposed rulemaking (NPRM) published on September 7, 2022, the National Labor Relations Board (NLRB) proposes an initial regulation that would fundamentally change the definition of “joint employer,” replacing the prior legal standards with vastly broader ones and likely sweeping many more business relationships under its coverage.

Federal litigation was in the spotlight last week with two major decisions related to the Biden-Harris administration’s Emergency Medical Treatment and Labor Act (EMTALA) guidance on providing abortion services as emergency medical care. There was also a potentially significant federal class action filed against Texas that could test the ability of states to enforce abortion bans extraterritorially. Finally, we continued to see action on state-level litigation and state legislative efforts.

Is the COVID-19 pandemic making you feel a bit like Bill Murray in Groundhog Day? Although most parts of life have returned to the "new normal," the federal government remains in a seemingly endless cycle of regulatory uncertainty.

In the September 2022 Visa Bulletin, visa numbers in certain categories may become unavailable mid-month. Other Workers from All Chargeability Areas, Mexico, and the Philippines will retrogress to May 8, 2019. All other Final Action cutoff dates remain unchanged.

The Inflation Reduction Act of 2022 reflects a significant step toward meeting the United States’ greenhouse gas emission reduction targets from the Paris Convention and recognizes the indispensable role that nuclear power must play to achieve that commitment. The act contains several key provisions that bolster a broad spectrum of new and existing activities in the nuclear industry.

The Internal Revenue Service (IRS) provided a late summer gift to retirement plan sponsors by extending some year-end plan amendment deadlines. In Notice 2022-33, the IRS extended the remedial amendment deadlines for certain Setting Every Community Up for Retirement Enhancement Act (SECURE Act) provisions (including the MINERS Act provision lowering in-service retirement age for pension plans from age 62 to age 59½) and Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provisions. This extension is particularly helpful for retirement plan sponsors hoping for additional guidance before amending plans to reflect certain SECURE Act changes (for example, the mandatory long-term part-time employee participation provisions and the new age 72 required minimum distribution rules).

The Setting Every Community Up for Retirement Enhancement Act of 2019 (the SECURE Act) made sweeping changes affecting sponsors of defined contribution and defined benefit plans, retirement plan service providers, and providers of individual retirement accounts and annuities (IRAs). While many believed the SECURE Act went a long way toward expanding retirement savings opportunities and promoting retirement income security, some believed it could have gone further. There are currently several proposed retirement acts pending reconciliation in Congress.

FERC recently issued a notice of proposed rulemaking (NOPR) to expand the existing duty of candor rule by adding a requirement in 18 CFR Part 1 that any entity communicating with FERC or other specified organizations related to a matter that is subject to FERC’s jurisdiction must submit accurate and factual information and must not submit false or misleading information or omit material information. However, exercising due diligence to prevent the submission of false or inaccurate information would be an affirmative defense to violations of the requirement.

The Inflation Reduction Act of 2022 proposes significant changes and expansions to the existing federal income tax benefits for renewable energy, fuel production, and other green technologies.

US Senators Joe Manchin and Chuck Schumer announced on July 27 an agreement in principle on a legislative proposal, known as the Inflation Reduction Act of 2022, that includes a range of measures addressing consumer energy costs and carbon emissions, Medicare’s ability to negotiate drug prices, an extension of benefits under the Affordable Care Act, and federal deficit reduction—as well as significant federal income tax changes.

The staff of the US Securities and Exchange Commission division of Investment Management announced that it would allow its October 26, 2017 no-action letter to SIFMA to expire on July 3, 2023—raising questions about the possible investment adviser status of broker-dealers that, after that date, accept cash or “hard dollar” payments for research from investment managers subject to the EU Markets in Financial Instruments Directive II.

The recent increase in use of telehealth as a care modality has been important to patients and providers alike, with significant benefits for public health. However, with the growing mainstream acceptance of virtual care, the US Department of Health and Human Services Office of Inspector General (OIG), the Department of Justice (DOJ), and other federal regulators have likewise increased fraud enforcement in this area, including through the issuance of OIG’s recent Special Fraud Alert (SFA).

The weeks after the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization decision have seen an array of federal and state actions on the issue of access to abortion-related services, including new legislation, executive actions, and litigation. This Insight provides updates as of July 19, 2022.

The US Securities and Exchange Commission on July 13 proposed amendments to the shareholder proposal rule, which governs the process for including or excluding a shareholder proposal in a company’s proxy statement.

The US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization put the onus on states to define laws around access to abortion-related services. As expected, the two largest sources of action following the decision—beyond US President Joe Biden’s July 8 executive order on abortion access—have been state-level litigation challenging abortion restrictions and executive actions in states that support abortion access.

The Centers for Medicare & Medicaid Services on July 7 released its proposed rule for the Medicare physician fee schedule for Calendar Year 2023. Among other updates, the proposed rule contains significant programmatic changes to the Medicare Shared Savings Program.

The federal COVID-19 public health emergency’s (PHE) current expiration date is just one week away—July 14, 2022. While no official extension has been issued by the Biden-Harris administration yet, it is increasingly likely that the PHE will be extended for at least another 90 days. Previously, the federal government had pledged to states that it would announce an end to the PHE at least 60 days before its expiration. That 60-day time frame ended on May 16 with no indication from the US Department of Health and Human Services (HHS) that it was anticipating the end of the PHE.

The US House of Representatives recently passed HR 7694, the Strengthening Subcontracting for Small Businesses Act of 2022, which aims to amend the Small Business Act to require the federal government to consider prior compliance with a subcontracting plan when evaluating an offeror’s past performance. 

Another boost to the growing US offshore wind industry came on June 23, 2022, when the Biden-Harris administration and several cabinet secretaries announced new initiatives, including a partnership with 11 eastern states described as a “first-of-its-kind forum for collaboration between federal and state officials to accelerate offshore wind progress.”

The US Supreme Court released its opinion in Dobbs v. Jackson Women’s Health on June 24. The decision overturns prior Supreme Court decisions in Roe v. Wade and Planned Parenthood v. Casey, which held that the US Constitution prohibits states from banning abortion or unduly burdening access to abortion services in the initial phases of pregnancy. At least 24 states have laws that can now be enforced barring abortion or imposing conditions beyond those previously permitted by Roe and Casey. The decision may also open the door for further state regulation regarding reproductive rights.

The US Supreme Court’s June 21 order granting certiorari in Polansky v. Executive Health Resources signals the Court’s intention to settle a circuit court split on the procedure and standard by which the government can exercise its dismissal authority under 31 USC § 3730(c)(2)(A) of the False Claims Act in declined qui tam cases.

A new Morgan Lewis White Paper, Bipartisan Proposal Attempts to Provide Solutions for Comprehensive Regulation of Digital Assets, analyzes the proposed Responsible Financial Innovation Act (RFIA) in the United States from several different angles, including with respect to issues such as key definitions in this emerging space, jurisdiction, ancillary assets (which are not fully decentralized), stablecoin issuance, taxes, disclosures, and money transmission. 

On June 7, 2022, Senators Cynthia Lummis (R-WY) and Kirsten Gillibrand (D-NY) introduced the Responsible Financial Innovation Act (RFIA), a bipartisan effort to develop and provide greater regulatory clarity to the eclectic digital asset industry. Since releasing the text of the bill, Senators Lummis and Gillibrand launched a strong public lobbying campaign, discussing the bill at fundraisers, joint conference panel appearances, and other events as an opportunity for bipartisan cooperation and reassertion of US leadership in the distributed ledger technology fintech and investment space. The RFIA would create a more coherent and consistent regulatory framework for the digital asset industry, and encourage responsible financial innovation, flexibility, transparency, and robust consumer protection.

The Financial Industry Regulatory Authority recently filed two rule proposals—SR-FINRA-2022-011 and SR-FINRA-2022-013—with the US Securities and Exchange Commission and issued Regulatory Notice 22-12 in an effort to expand the TRACE reporting requirements for FINRA member firms in TRACE-eligible securities.

As the US Department of Labor (DOL) continues to contemplate the role of environmental, social, and governance (ESG) considerations in ERISA plan investing, ESG issues surrounding retirement plans are cropping up in another way: as a target for proxy vote proposals that seek to require companies to evaluate their ESG commitments in retirement plans.

The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.

The US Equal Employment Opportunity Commission (EEOC) released guidance on May 12 addressing the application of the Americans with Disabilities Act (ADA) to employer use of algorithms and artificial intelligence (AI) during the hiring process. Produced as part of the Artificial Intelligence and Algorithmic Fairness Initiative launched in October 2021, the guidance reflects the agency’s growing interest in employer use of AI, including machine learning, natural language processing, and other emerging technologies in employment decisions.

A lawsuit filed by 17 states challenges California’s authority to implement climate change–related vehicle emission standards and zero-emissions goals, prompting 20 states to seek to intervene in order to defend California’s role in reducing greenhouse gas emissions.

The NRC recently issued its Allegation Program Annual Trends Report, analyzing regional, national, and site-specific allegation trends for calendar year 2021. The report’s top-line numbers show that allegations increased approximately 40% from 2020. The broad-based increase spanned reactor and materials licensees, as well as their vendors.

After the US Securities and Exchange Commission spent several years focused on “Main Street” retail misconduct that left private funds largely out of the its crosshairs, Chairman Gary Gensler and the Divisions of Enforcement and Examinations are intent on shifting that focus in a way certain to affect hedge and private equity fund managers. As noted in the 2022 Examination Priorities, given the “size, complexity, and significant growth of this market,” private fund advisers will garner growing examinations resources, and that in turn will lead to more enforcement scrutiny in areas such as valuation, fees and expenses, insider trading, and special purpose acquisition company (SPAC) transactions.

The 2022 Examination Priorities for the US Securities and Exchange Commission’s Division of Examinations place continued emphasis on resilient compliance programs that are flexible enough to adjust to known variables and capable of adjusting to new issues. We expect that conflicts of interest and disclosure will again be an enforcement focus, while sweeps, investigations, and initiatives in areas such as environmental, social, and governance (ESG); robo-advisory services; cybersecurity; and best execution will likely lead to enforcement actions. Couple these trends with an aggressive rulemaking agenda, and the next several months promise to be full of developments for investment advisers.

The Consumer Financial Protection Bureau (CFPB or Bureau) recently released its Spring Supervisory Highlights summarizing findings from supervisory exams it conducted between July and December 2021.

The NRC staff recently provided the Commission with their annual Reactor Oversight Process (ROP) Self-Assessment for Calendar Year 2021 (SECY-22-0029). These annual self-assessments have been part of the ROP since the ROP was implemented in 2000 and are used by the Commission, the NRC staff, and stakeholders to monitor the performance of the ROP and identify areas for improvement.

Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By law, those allergens must be listed separately from other ingredients on food labels. As discussed in a prior blog post, sesame is set to become the ninth major food allergen on January 1, 2023.

Partner Levi McAllister and associate Maggie Curran authored an article for POWER magazine on how the Biden-Harris administration is utilizing the Defense Production Act to increase materials needed for electric vehicle batteries.

The NRC staff recently released its long-awaited policy paper on Environmental Justice (EJ) reform at the agency (SECY-22-0025, “Systematic Review of How Agency Programs, Policies, and Activities Address Environmental Justice”). The staff’s retrospective review found that current NRC EJ efforts are fully consistent with applicable law. Nevertheless, they provided a series of recommendations and commitments for Commission consideration.

A bipartisan group of US senators recently proposed legislation intended to broadly address electric vehicle (EV) fleet management, as both the federal government and the private sector continue adopting EV use at an unprecedented rate in the US market.

The US Securities and Exchange Commission recently proposed new rules and amendments relating to initial public offerings by special purpose acquisition companies and to business combinations involving shell companies and private operating companies. While the proposed rules would enhance investor protections, it is possible they could have a cooling effect on the volume of such transactions or materially increase the costs of deal execution.

National Labor Relations Board General Counsel Jennifer Abruzzo issued Memorandum 22-04 on April 7, taking the position that mandatory meetings held by employers addressing Section 7 activity are unlawful—including meetings in response to union organizing—and announced her intention to prosecute employers who hold these meetings during her tenure in office.

On March 24, FERC granted a public utility’s petition for declaratory order regarding the treatment of a master license agreement for communications equipment under the public utility’s previously approved revenue sharing mechanism (Revenue Sharing Mechanism).

US President Joseph Biden issued a directive to the secretary of defense on March 31, invoking the Defense Production Act (DPA) to spur the domestic production of critical minerals needed to produce large-capacity batteries for the automotive, emobility, and stationary electricity storage sectors.

In an order denying a request to waive filing requirements triggered by changes in ownership of qualifying facility (QF) projects, the Federal Energy Regulatory Commission reiterated the importance of ensuring QF filings, specifically Form 556, are up to date.

As part of a long-standing series of joint meetings, FERC and the Nuclear Regulatory Commission (NRC) will be hosting a joint meeting on March 31, 2022. The meeting will address electric system reliability and nuclear plants, and will include presentations.

US President Joseph Biden’s recent executive order outlines the administration’s first take on regulating the digital asset industry, which includes cryptocurrency and non-fungible tokens. The order lays out six policy objectives and calls on federal agencies to produce reports on how these objectives interact with the industry.

A group of four US senators introduced a bill on March 16 to ban imports of uranium products from the Russian Federation. If enacted, such a ban could complicate the refueling of existing commercial reactors in the United States that rely on Russian uranium products. A ban also could extend the schedule in the United States for deploying some advanced reactors, because Russia is a key source of the high-assay, low enriched uranium (HALEU) they plan to use. In a related development, Russia is considering a ban on uranium exports to the United States in retaliation for the most recent energy sanctions on Russia.

Cryptocurrency investing has experienced a tidal wave of popularity since the fabled genesis of Bitcoin in 2009. This growth has been fueled by “extreme” investment returns (despite “extreme” volatility) and innovative means of investing in cryptocurrency. As the wave of interest in cryptocurrency investing reaches the shores of 401(k) plans, including interest in cryptocurrency as a plan investment option or through plan brokerage windows, the US Department of Labor (DOL) warns 401(k) plan fiduciaries to exercise “extreme care” before providing plan participants with the opportunity to expose their retirement savings to cryptocurrency.

The Internal Revenue Service (IRS) is temporarily suspending the IRS Prototype Opinion Letter Program for individual retirement accounts and individual retirement annuities (IRAs) effective March 14, 2022. As noted in Announcement 2022-6, the IRS will not be accepting applications for opinion letters on prototype traditional, Roth, and SIMPLE IRAs or SEP (including SARSEP) and SIMPLE IRA plans until further notice.

In a Reuters article, partners Elizabeth Goldberg and Lance Dial and associate Rachel Mann wrote about recent rulemaking from the US Department of Labor (DOL) that may impact how fiduciaries and other stakeholders approach environmental, social, and governance (ESG)-related investments. The DOL’s proposed rule "Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights,” as well as the agency’s request for input on ways climate change may affect the retirement industry, could prompt the DOL to take additional action related to ESG investment.

In a move that was telegraphed at the outset of the Biden-Harris administration, the US Environmental Protection Agency announced March 9 that it is reversing a Trump-era decision to revoke California’s authority to set tailpipe emission standards more stringent than those established by the Agency. This action restores California’s role in setting more stringent emission and fuel efficiency standards that, in practice, tend to drive the US market as a whole.

The Centers for Disease Control and Prevention (CDC) announced a new framework on February 25 providing that mask wearing is optional in low- and moderate-risk settings.

On February 9, 2022, US Senators Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (D-WI) introduced bipartisan legislation designed to modernize health privacy laws, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and account for emerging healthcare technologies not addressed by existing law.

Cancelled and reissued qualified plan distribution checks, particularly to decedents, should be monitored for payment in light of the Internal Revenue Service’s repeated refusal to repay withholding to payor plans. If a Form 1099-R is filed reporting a distribution that was never received, employers could end up effectively paying twice the withholding amounts.

The US Securities and Exchange Commission recently proposed a comprehensive framework of cybersecurity-related rules and amendments for investment advisers and investment companies. Although advisers and funds may have already implemented many of the requirements, some, such as incident reporting, are likely to prove burdensome and make the landscape surrounding cybersecurity risk management and compliance even more complex.

The US Department of Labor (DOL) recently announced that it is seeking comment on the impact of climate change on retirement security and what actions, if any, the agency should take to protect retirement savings from such risks.

The US Department of Justice’s Criminal Division Fraud Section released its annual Year in Review report on February 15, covering 2021. Despite ongoing aftershocks associated with the global pandemic, this year’s report highlights the Department’s sustained aggressive enforcement efforts against individuals and, to cap off the calendar year, two corporate resolutions—both guilty pleas imposing independent monitors—likely serving as a harbinger for what’s to come in 2022.

The US Securities and Exchange Commission (SEC) has proposed a sweeping expansion in how it defines securities exchanges to capture digital asset platforms, request-for-quote platforms, indication-of-interest platforms (IOI), and other messaging platforms.

Partner Dan Savrin and associate Molly Maidman discussed antitrust law basics and what insurers should know about the increase of state and federal enforcement in PLUS Blog.

New York State lifted its mask mandate applicable to businesses on February 10, and the New York State Department of Labor subsequently issued new guidance that the New York HERO Act does not require employers to enforce mask requirements.

The US Departments of Labor, Health & Human Services, and Treasury issued new frequently asked questions on February 4, 2022, regarding coverage of over-the-counter, at-home COVID-19 tests at no cost sharing (i.e., deductibles, copayments, and coinsurance), prior authorization, or other medical management requirements during the public health emergency.

The new Civil Cyber-Fraud Initiative of the US Department of Justice’s use of the punitive False Claims Act (FCA) and its whistleblower provisions has some important legal and risk management considerations for the health industry. Because enforcement will initially occur largely through civil investigations applying the FCA in the broadest possible way, healthcare organizations should undertake a priority assessment of their cybersecurity status to ensure that their practices can withstand hacks, whistleblowers, and government scrutiny.

The automotive industry was awash in change in 2021, driven by investment trends, new goals set by the Biden-Harris administration, and international electric vehicle developments. Looking back, 2021 will be viewed as a transformational year for the ways in which automobiles were—and will be—designed, manufactured, powered, sold, and regulated.

The Federal Trade Commission announced on January 24 that it will increase the Hart­Scott­Rodino Act jurisdictional and filing fee thresholds. Any transaction closing on or after February 23, 2022 will be subject to the revised thresholds.

The Dates for Filing Chart for February 2022 saw minimal movement. The US Citizenship and Immigration Services continues to use the “Dates for Filing” chart for employment-based adjustment of status.

The US Nuclear Regulatory Commission (NRC) issued a final rule in the Federal Register on January 14 updating the maximum amounts of civil monetary penalties it can impose. Reflecting the price challenges in the larger US economy, the maximum civil monetary penalty amounts dramatically increased over the prior year as a result of the rise of inflation.

Certain individuals who have only signature authority over non-US financial accounts now have until April 15, 2023 to file the Report of Foreign Bank and Financial Accounts.

As we start 2022, as part of our Spotlight series, we connect with Reece Hirsch, the co-head of Morgan Lewis’s privacy and cybersecurity practice, to discuss the recent policy statement issued by the US Federal Trade Commission regarding the Health Breach Notification Rule and how it applies to health app developers that handle consumers’ sensitive health information. Our Tech & Sourcing @ Morgan Lewis blog also published a summary of the policy statement.

The Department of Labor (Department) issued Field Assistance Bulletin No. 2021-03 (FAB) on December 30, 2021, announcing a temporary enforcement policy for group health plan service provider disclosures under ERISA Section 408(b)(2)(B).

In recent US immigration developments, the Department of State has authorized consular offices to forgo the in-person interview requirement for some nonimmigrant visa applicants. Further, President Joseph Biden has revoked the travel ban that had been in place for noncitizens traveling as immigrants or nonimmigrants who were physically present in certain African countries.

The US Securities and Exchange Commission (SEC) recently proposed amendments (Amendments) to its rules governing money market funds. The Amendments are intended to incorporate lessons learned from the COVID-19-related market turbulence in March 2020.

The US Securities and Exchange Commission has proposed amendments to its rules regarding disclosure about issuer repurchases of its equity securities, often referred to as buybacks, including a new proposed Form SR to be filed with the SEC. As proposed, these new rules prescribe considerably greater disclosure relating to buybacks and, as with the proposed rules on 10b5-1 plans, have been met with strong statements of dissent by certain SEC Commissioners.

The Dates for Filing Chart for January 2022 remains unchanged. The US Citizenship and Immigration Services continues to use the “Dates for Filing” chart for employment-based adjustment of status.

The US Securities and Exchange Commission proposed amendments to Rule 10b5-1 that would mandate additional disclosure and establish new requirements relating to insider trading. If adopted as proposed, the rule could have substantial impact on the manner in which company executives purchase and sell securities, as well as on issuer repurchases of their securities.

The Cal/OSHA Standards Board on December 16 voted to approve the second readoption of the California COVID-19 Prevention Emergency Temporary Standards (ETS) during its monthly public meeting. The revised ETS will not adopt the federal OSHA ETS or include a mandatory vaccination requirement for employers, but will include stricter requirements for employers than the current version.

The US Securities and Exchange Commission’s proposed Rule 10c-1 would create a sweeping new reporting and disclosure regime for participants in the securities lending markets. Among other things, the proposal increases the Financial Industry Regulatory Authority’s ability to look into the activities of non-broker-dealers, including the potential for near-real-time access to a market participant’s entire portfolio holdings of securities.

The US Internal Revenue Service has extended its temporary approval of accepting electronic or digital signatures on certain IRS forms until October 31, 2023, and has expanded the list of forms that may be signed electronically or digitally to include Form 1042, Annual Withholding Tax Return for US Source Income of Foreign Persons.

In Energy Central, partner Daniel Skees and associate Arjun Ramadevanahalli write that the US Department of Energy’s notice of Request for Information seeking public input on energy supply-chain issues and related technologies will be significant to the nation’s efforts at meeting emissions goals—including the licensing and deployment of advanced nuclear reactors.

Several years ago, the US government embarked on a project to standardize federal agency programs—including the NRC’s—for managing unclassified-but-sensitive information. At the NRC, this government-wide Controlled Unclassified Information (CUI) program is intended to replace the agency’s Sensitive Unclassified Non-Safeguards Information (SUNSI) program.

The Federal Register recently published the US Department of Energy’s (DOE) notice of Request for Information (RFI) seeking public input on energy sector supply chains. The RFI requests that stakeholders provide comment on a wide variety of issues concerning supply chains of energy and related technologies.

The US Environmental Protection Agency (EPA) recently issued a proposed rule under the Clean Act intended to reduce emissions of greenhouse gases (GHGs) and air pollutants from crude oil and natural gas operations (production, processing, transmission, and storage segments).

The IRS recently issued FAQs to address workforce issues and labor shortages resulting from the COVID-19 pandemic. The guidance seems to be in response to well-publicized labor shortages affecting schools and the education industry, although it is not limited to that industry. The FAQs reaffirm prior IRS guidance, but may give comfort to employers who are contemplating rehiring retirees as they try to manage workforce issues “related to” the pandemic.

The fate of the Occupational Safety and Health Administration’s landmark Emergency Temporary Standard on COVID-19 vaccination is in the hands of the Sixth Circuit—for now. In this LawFlash, we walk businesses through the legal challenges to the Emergency Temporary Standard, how they may unfold, and what businesses may wish to do in the interim.

FINRA recently filed a proposed rule change with the US Securities and Exchange Commission (SEC) on November 12, 2021 that would seek to once again delay the effective date of changes to FINRA Rule 4210 that were previously implemented on December 15, 2016. The amendments were supposed to become effective on January 26, 2022 and the proposed changes would move the effective date to April 26, 2022.

Before 2020, the IRS had long taken the position that an employee stock ownership plan (ESOP), and any other retirement plan for that matter, must be adopted no later than the end of the first tax year in which the employer wished to claim a deduction for a contribution to the plan. As a reminder, effective December 31, 2019, Section 201 of the SECURE Act extended that deadline from the end of the applicable tax year to the due date, including extensions, of the plan sponsor’s income tax return for the applicable tax year. Accordingly, under the SECURE Act, if a plan is adopted by the extended due date, it will be treated as having been adopted as of the last day of that year.

National Labor Relations Board General Counsel Jennifer A. Abruzzo issued a memorandum explaining her view of employers’ bargaining obligations in response to the US Department of Labor Occupational Safety and Health Administration’s Emergency Temporary Standard to Protect Workers from Coronavirus. According to Abruzzo, any issue involving employer discretion is subject to decision bargaining. The Emergency Temporary Standard may also trigger effects bargaining obligations for non-discretionary issues.

A settlement has been reached in Shergill v. Mayorkas, a federal lawsuit seeking to compel US Citizenship and Immigration Services to follow its regulations by automatically granting work permit extensions to L-2 and H-4 nonimmigrant visa holders. Under the settlement agreement, the agency has agreed to change its policies regarding employment authorization documents for certain H-4 and L-2 nonimmigrant visa holders.

After long anticipation by US companies and their employees, the US Department of Labor’s Occupational Safety and Health Administration (OSHA) published its 490-page Emergency Temporary Standard (ETS) and preamble on COVID-19 vaccination. The ETS establishes binding requirements on large employers (i.e., those with 100 or more employees) to help protect employees from contracting COVID-19 in the workplace. Covered employees must have received their final dose of a vaccine series by January 4, 2022, or be subject to weekly COVID-19 testing. The ETS contains many other requirements, including implementing a written vaccine policy, verifying and maintaining records of the vaccination status of the workforce, offering paid time off for vaccination, and more. Employers must comply with all ETS provisions by December 5, 2021, with the exception of the January 4 vaccination or testing deadline. This milestone ETS is expected to cover 84 million employees.

The US Department of Health and Human Services, Office of Inspector General (OIG) recently transmitted a memorandum to the Center for Medicaid and CHIP Services detailing the findings of the Massachusetts state auditor's report on the commonwealth’s controls around dual-eligible hospice patients and weaknesses related to election statements and potential MassHealth overpayments for curative items and services related to hospice patients that should have been covered by the hospices.

US congressional Democrats released the latest version of H.R. 5376—better known as the Build Back Better Act—late last week, hoping to advance a $1.85 trillion spending package after months of deadlock.

The US Food and Drug Administration (FDA) has finally issued its final rule establishing requirements for the de novo classification process. The de novo process allows FDA to establish new product classifications for low- to moderate-risk medical devices that meet existing device classifications, thereby significantly easing the regulatory authorization pathway. Without establishment of the new product classification, the device would by default be deemed a Class III device and thus require submission of a pre-market approval (PMA) application.

US restrictions on international travel will be lifted November 8 for fully vaccinated international visitors and temporary workers, including those from nearly three dozen nations who have been barred from entering the country since the start of the pandemic. US citizens and permanent residents remain subject to current COVID-19 testing requirements.

The Consolidated Appropriations Act of 2021 mandates that employers offering medical/surgical and mental health/substance use disorder coverage provide comparative analyses and any supporting documentation demonstrating compliance with parity requirements to the Employee Benefits Security Administration of the Department of Labor upon request.

The US Securities and Exchange Commission (SEC) has adopted amendments that allow for new payment methods for filing fees, including Automated Clearing House (ACH) payments and debit and credit card payments; revise most forms and schedules that require the payment of filing fees so that the information necessary for filing fee calculations is presented in a structured format; and update the rules regarding the allocation of filing fees.

FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance previously issued in September 2007 and revised in June 2008.

National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo issued a memorandum stating that, in her prosecutorial view, college athletes are statutory employees under the National Labor Relations Act (NLRA)—affording them all rights and protections under federal labor laws.

According to recent guidance from the US Federal Trade Commission (FTC), providers of health apps and connected devices that collect consumers’ health information must comply with the FTC’s Health Breach Notification Rule, 16 CFR Part 318, and therefore are required to notify consumers and others when their health data is breached.

Hinting that the US Department of Labor (DOL) is currently working on guidance related to cryptocurrency, the Acting Assistant Secretary for the DOL’s Employee Benefits Security Administration recently commented that the DOL finds the prospect of cryptocurrency investments in 401(k) plan lineups “troubling.” This may be a sign of DOL focus on the increasing frequency of ERISA plan investments in cryptocurrency vehicles, including funds with cryptocurrency exposures.

The Internal Revenue Service (IRS) issued an important reminder of the unique application of the limit under Internal Revenue Code (IRC) Section 415(c) to 403(b) plans on August 20, 2021. The IRS’s “Issue Snapshot” highlighted a rule that has applied for decades, but with which 403(b) plan sponsors and administrators are often not familiar.

The Financial Industry Regulatory Authority (FINRA) published a regulatory notice (RN 21-32) on September 14, 2021 requesting comment on its policy relating to the assignment of OTC symbols to unlisted equity securities. FINRA is considering whether it should begin assigning OTC symbols to unlisted equity securities that do not have a valid CUSIP identifier, in the limited circumstance where a broker-dealer demonstrates its best efforts to obtain a CUSIP identifier and provides documentation to identify the security.

The Democrats of the House of Representatives have released a much-anticipated tax plan that would significantly impact the federal estate and gift tax system. Importantly, the House could still amend this legislation and the Senate is actively working on its own bill. Nevertheless, the time for estate planning is now.

August 2021 proved to be a busy month for stakeholders in the electric vehicle (EV) sector. Between US President Joseph Biden's August 5 executive order to encourage the development of EVs and $15 billion in funds earmarked for EV support in the Senate-approved infrastructure legislation, the growth outlook for EVs and other zero-emission transportation is strong.

The US Department of Health and Human Services (HHS) recently announced that it will make $25.5 billion available in new COVID-19 relief funds to providers through the Health Resources and Services Administration (HRSA). To that end, HRSA will disburse $17 billion in Phase 4 payments remaining from the CARES Act Provider Relief Fund (PRF) to a “broad range of providers” based on lost revenues and expenses between July 1, 2020 and March 31, 2021.

According to the proposed Nasdaq board diversity and disclosure rules, listed companies must disclose board-level diversity data and will be required to have two diverse directors—or explain why they don’t meet this requirement.

How to best address impacts from our rapidly changing climate is an issue that has permeated almost all sectors of the global economy, traversing industries and impacting all. Governments and businesses around the world are taking action to reduce greenhouse gas emissions and adapt to or mitigate anticipated climate change impacts. These initiatives promise to drive emerging market opportunities and public demand to accelerate existing trends toward energy efficiency, jump-start alternative technologies, and prod changes in financing and tax policy.

Substantial change is imminent for key labor law issues commonly affecting healthcare entities. Healthcare employers utilize handbooks and rules, implement property access controls, and engage in human resources investigations, for instance. All these areas, and more, are poised for change with the new Biden-Harris administration National Labor Relations Board (NLRB) general counsel memorandum, highlighting a swath of legal issues where the general counsel will litigate test cases to change the law.

Newly confirmed National Labor Relations Board General Counsel Jennifer Abruzzo announced her enforcement priorities in a lengthy memorandum released on August 12, 2021. The memorandum requires employers to rethink their policies and practices in a number of key labor law areas, or else be subject to potentially unfair labor practice litigation intended to reverse precedent or change the law.

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,” “product hopping,” and “sham” citizen petitioning. Versions of some of these bills had been under consideration by this subcommittee for years, but had not been voted out of committee until now.

In a move that the Biden-Harris administration is promoting as a partial fulfillment of a campaign promise to cut US greenhouse gas emissions (GHGs) at least in half by 2030, President Joseph Biden signed a new executive order last week setting a goal of 50% of all new passenger cars and light trucks to be zero emissions vehicles by 2030 and building on Environmental Protection Agency (EPA) proposed tailpipe emission standards that are set to begin with the 2023 car model year.

US President Joseph Biden signed an executive order on August 5 that underscores his stated commitment to encourage the development and deployment of electric vehicles (EVs) as part of the Biden-Harris administration’s clean energy agenda. The executive order, Strengthening American Leadership in Clean Cars and Trucks, aims to increase the production of zero-emission vehicles by 2030 and directs new pollution and fuel economy standards for light‑, medium-, and heavy-duty vehicles for model years 2027 and later. President Biden’s issuance of the executive order, combined with the EV-related implications of various provisions in the draft infrastructure bill currently pending in Congress, may well serve to facilitate increased deployment of EVs in US markets.

As we described in our August 31, 2020 LawFlash, the US Department of Labor (DOL) issued an Interim Final Rule (Rule) on August 18, 2020 outlining the requirement of the Setting Every Community Up for Retirement Enhancement Act of 2019 (SECURE Act) for employers to provide “lifetime income illustrations” to defined contribution plan (e.g. 401(k), 403(b), etc.) participants. The purpose of the Rule is to provide participants with disclosures that will help them understand how their defined contribution plan accounts may translate into an income stream in retirement.

The US Department of Labor (DOL) issued Information Letter 06-14-2021 last month to the attorney of a plan participant who requested a copy of an audio recording and transcript of a phone conversation he or she had with the plan’s insurer. The participant was requesting this information in relation to the participant’s denied claim under the plan.

The Internal Revenue Service (IRS) made important changes to the Employee Plans Compliance Resolution System (EPCRS) in Revenue Procedure 2021-30 that are helpful for plan sponsors as they expand the ability of plan sponsors to self-correct certain operational failures. The IRS also requested comments on Revenue Procedure 2021-30 so there may be more changes to come.

The Pension Benefit Guaranty Corporation has issued an interim final rule implementing the special financial assistance provisions of the American Rescue Plan Act to assist financially troubled multiemployer pension plans.

EB-2 China cutoff dates advance by four months, EB-3 India cutoff dates advance by six months, and EB-1 priority date cutoff dates remain “Current” for all classifications.

The still evolving US sanctions (as well as the EU and now also separate UK sanctions) continue to challenge Russia-related business. The sanctions frameworks are complex, changing, and, at times, inconsistent as well as overlapping. Navigating this complex global framework is made even more difficult by the ongoing unpredictable and reactionary geopolitical environment as the Biden Administration gets underway.

In keeping with the Biden-Harris administration’s commitments to strengthen federal regulation of per- and polyfluoroalkyl substances (PFAS), the US Environmental Protection Agency (EPA) announced three actions last week with respect to the agency’s regulation of the use, import, and manufacture of PFAS.

In a move that is expected to expand the reach of the Clean Water Act, the US Environmental Protection Agency and the Army Corps of Engineers announced their intent to revise the definition of “waters of the United States”—a key threshold for the Clean Water Act’s application.

In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The announcement is an abrupt—but not unexpected—reversal from a previously issued controversial decision by the Trump administration’s HHS to end the Unapproved Drugs Initiative in November 2020. The reinstatement means that companies that market unapproved drugs should reassess their risk under FDA’s preexisting enforcement priorities.

US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other ingredients used in dietary supplements, foods, and beverages.

The scope of commitments by corporations involving their own sustainability efforts around the globe has markedly accelerated this year. About 300 companies have signed on to the RE100 initiative, which brings together businesses committed to 100% renewable electricity. And recently, more than 400 businesses urged the Biden-Harris administration and the United States to set goals of cutting greenhouse gas emissions to at least 50% below 2005 levels by 2030.

The Internal Revenue Service issued Notice 2021-31, providing the much-anticipated guidance plan sponsors, multiemployer plans, and COBRA administrators have been waiting for related to the COBRA subsidy provisions under the American Rescue Plan Act.

Just over 100 Days into the Biden-Harris administration, the course being charted by the government for automobile emissions and emerging automotive mobility technologies is becoming clearer. It includes retooling the current approach toward emissions regulations, including the Corporate Average Fuel Economy (CAFE) standards and the California Waiver as well as revitalizing the federal government’s sustainability efforts to achieve or facilitate clean and zero emission vehicles for federal, state, local, and tribal government fleets. But with new and existing legal and regulatory pitstops along the way, companies attempting to leverage these developments should consider the updates below before shifting into gear.

The Biden-Harris administration on April 28 introduced the American Families Plan (AFP), a $1.8 trillion legislative framework including provisions to “grow the middle class, expand the benefits of economic growth to all Americans, and leave the United States more competitive.” The AFP would expand access to education, reduce the cost of child care, create a national comprehensive paid family and medical leave program, and extend or make permanent certain tax credits for families with children and low and middle-income households, such as the Child Tax Credit and the Child and Dependent Care Tax Credit.

During the Leaders Summit on Climate, hosted by the Biden-Harris administration on April 22 and 23 in Washington, DC, President Joseph Biden set aggressive goals for reducing greenhouse gas (GHG) emissions in the United States.

The pace of regulatory and legislative developments in climate change and renewable energy over the past few years has been dizzying. With a new US presidential administration now focused on energy issues, examples set from forward-thinking states, and recent lessons learned on the importance of grid stability, here are some of the expected federal actions aimed at achieving energy goals in the “new abnormal.”

The VATM Yearbook 2021 takes an honest look at the current broadband and regulatory situation, analyzes problem areas, and offers solutions on how to achieve what is feasible and how to get there. Clear political perspectives for the post-election period are presented by the general secretaries of the major parties in Germany.

As we described in our March 15, 2021 LawFlash, the American Rescue Plan Act of 2021 (ARPA) includes a 100% COBRA premium subsidy for any employee or dependent who is a COBRA qualified beneficiary (or will become one) resulting from an involuntary termination of employment or a reduction of hours (referred to as an Eligible Individual).

The Biden-Harris administration announced its American Jobs Plan, a legislative framework laying out an ambitious $2 trillion investment in physical and human infrastructure, on March 31. The bulk of the proposed spending is directed to rebuild US infrastructure in the form of physical improvements on roads, bridges, airports, and ports, with additional investment and tax credits to support clean energy generation and storage, electric vehicles, and energy efficiency.

The Biden-Harris administration has allowed Presidential Proclamation 10052 (PP 10052) to expire as of March 31. PP 10052, implemented by the previous administration in June 2020, had suspended the issuance of certain nonimmigrant or temporary visas in several categories.

Senator Chris Van Hollen (D-MD) introduced a Congressional Review Act (CRA) resolution of disapproval on March 26 that would invalidate the Office of the Comptroller of the Currency’s (OCC’s) true lender final rule.

The American Rescue Plan Act of 2021 (ARPA) provides $1.9 trillion in relief funding to address the COVID-19 pandemic, support the US economy, and provide relief for impacted Americans. Signed into law by President Joseph R. Biden on March 11, 2021, ARPA includes provisions affecting healthcare providers, who remain on the frontlines of the pandemic as the new law takes effect.

The American Rescue Plan Act of 2021 includes a COBRA premium subsidy and increases the dependent care flexible spending account (DCFSA) limits. While the availability of the COBRA premium subsidy is a requirement, the increase in the DCFSA limit is optional.

Morgan Lewis’s 15th annual 2020 Year in Review and a Look Forward provides a comprehensive overview and analysis of key 2020 US Securities and Exchange Commission (SEC) enforcement and examination developments, notable broker-dealer cases, and anticipated enforcement priorities for 2021, including under the potential leadership of SEC chair nominee Gary Gensler.

Following the enactment of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act in December 2020, the Biden administration announced several changes to the Paycheck Protection Program on February 22, 2021 aimed at providing greater access to funds for underserved businesses and communities. This LawFlash discusses these recent changes, highlighting key provisions and guidance for businesses seeking to participate in the program before it officially expires on March 31, 2021 (pending any additional legislation from Congress).

We previously reported on recent mortgage rulemakings that were finalized by the Consumer Financial Protection Bureau (CFPB or Bureau) late last year. Of the two final rules from the Bureau, one drastically simplifies the definition of a “qualified mortgage” (QM) (the General QM Final Rule), and the other provides an alternate pathway to QM safe harbor status for certain seasoned mortgage loans (the Seasoned QM Final Rule). Both of these final rules—with potentially major impacts on the housing market—were published in the Federal Register on December 29, 2020, with effective dates of March 1, 2021 (although the General QM Final Rule contains a mandatory compliance date of July 1, 2021).

Much of the attention in President Joseph Biden’s executive actions in his first 100 days has been focused on his numerous executive orders on topics ranging from climate and COVID-19 to race and gender. Although these executive orders will immediately alter certain policies, observers have overlooked one non-executive order that may have a more consequential impact during the remainder of President Biden’s term: his January 20, 2021 memorandum titled “Modernizing Regulatory Review” (MMR).

President Joe Biden has rescinded Presidential Proclamation 10014, the prior administration’s ban that suspended the issuance of certain green cards overseas and barred entry into the United States of certain groups of immigrants. Effective immediately, these individuals should be eligible to enter the United States as permanent residents, and US consular posts should begin issuing immigrant visas to these applicants.

President Joe Biden has been in office for 34 days and his nominee for Secretary of Labor, Marty Walsh, has not yet been confirmed. So far, Mr. Walsh has not publicly stated much regarding his views or intended priorities with respect to ERISA, although it is known that he has a background in labor organizing and the pension issues related to labor unions.

As part of President Joe Biden’s efforts to address the continuing impact of the COVID-19 pandemic on American families, on February 16, the US Department of Housing and Urban Development, US Department of Veterans Affairs, and US Department of Agriculture (together, the agencies) announced a coordinated extension and expansion of forbearance and foreclosure relief programs. This announcement extends and expands the agencies’ forbearance and foreclosure relief programs through June 30, 2021. The programs were due to expire in March.

Consumer Financial Protection Bureau (CFPB) Acting Director David Uejio has put a special focus on the manner in which responses are made to the CFPB’s consumer complaint system. Signaling the importance of this issue by undertaking it even before President Joe Biden’s nominee for director, Rohit Chopra, is confirmed to the position, Uejio has called out in a publicly released message to CFPB staff the possibility that some responses to complainants are incomplete—and vary by the complainant’s apparent demographic community.

The inauguration of US President Joe Biden on January 20, 2021, marked the beginning of what will surely be a major transition across the US legislative and regulatory landscape—including the laws and regulations governing financial services firms in the United States.

The Biden administration has vowed to invoke the Defense Production Act (DPA) to increase domestic production of essential supplies needed to respond to the COVID-19 pandemic. In this Insight, we address key features of the DPA, guidance for companies that may receive a rated order, financing incentives offered by the DPA, and how we anticipate the Biden administration will use the DPA over the next year.

Shortly after the inauguration of President Joe Biden on January 20, former Consumer Financial Protection Bureau (CFPB or Bureau) Director Kathleen Kraninger submitted her resignation. Soon after that, the president announced that he had appointed David Uejio, a veteran CFPB official who most recently served as the Bureau’s chief strategy officer, to serve as acting director until the Senate confirms Rohit Chopra, his nominee for director.

President Joe Biden signed three new executive orders relating to immigration on Tuesday. Along with the executive orders issued immediately after his inauguration and the immigration legislative proposal sent to Congress on Day 1 of the new administration, these orders mark a stark new direction in immigration policy to strike a more welcoming tone with respect to immigrants, and to move away from the more restrictive rules and guidelines implemented during the Trump administration.

US President Joe Biden’s focus on Buy American Act domestic preference regulations and agency practices of implementing regulations and issuing waivers is likely to lead to an increased focus on federal government contractors’ compliance with heightened requirements.

January 28 was designated as “health day” for President Joe Biden’s early push of executive orders, with two new executive actions added to a growing list. The Executive Order on Strengthening Medicaid and the Affordable Care Act and Memorandum on Protecting Women’s Health at Home and Abroad were described by President Biden as “restorative” of policies modified by the prior administration.

President Joe Biden has signed several executive orders and announced other directives that will impact employers in the first 100 days of his administration, including guidance on protecting worker health and safety, economic relief for families and businesses, and racial equity and support.

President Joe Biden’s first days in office have focused heavily on issues of diversity, inclusion, equity, and human rights as applied across federal agencies and programs. We anticipate that this pattern will continue and that the principles underlying his first actions will heavily influence policy, federal contracting, and eligibility to participate in federal programs, and may help businesses focus their approach to federal policymaking going forward.

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations.

Immediately following his inauguration on January 20, US President Joseph R. Biden, Jr. began taking executive action to enact many of his administration’s initial priorities, which included a number of executive orders, memoranda, and directives to cabinet agencies to address policies he detailed during his campaign, including the COVID-19 pandemic, climate change, equality, and the global economy. To help clients navigate potential changes from these actions, Morgan Lewis has provided a quick analysis of many of these orders and their impact. We will release more detailed pieces as the president unveils additional specifics of his First 100 Days plan.

As the 46th president of the United States, Joe Biden took significant steps on his first day in office to advance the energy and climate initiatives of his administration. This LawFlash provides a brief summary of several key actions, including the notice of the United States’ intention to rejoin the Paris Agreement, cancellation of the federal permit for the Keystone XL Pipeline Project, and directives by President Biden to certain federal agencies, as well as an overview of key members of his climate team who will be advancing administration policies.

Effective June 30, 2021, the US Department of Labor will determine the prevailing wage for permanent labor certifications and labor condition applications based on a new formula for computing prevailing wage levels, resulting in higher prevailing wage levels for all occupations in the Occupation Employment Statistics wage database.

Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health.

The Final Rule retains the “economic realities” test while focusing on two “core factors” in analyzing whether an individual is an employee or an independent contractor but given the upcoming change in administration, employers should not make any changes in reliance on the Final Rule.

Morgan Lewis antitrust partners, Richard Taffet, Ryan Kantor and Will Tom co-authored an article “Antitrust Enforcement in a Biden Administration,” for a special issue of Concurrences Competition Law Review focused on the topic The New US Antitrust Administration.

Morgan Lewis partners Susan Harthill, Jennifer Breen, and Kenneth Polite authored a Law360 article about the pace of personnel changes that could result in federal agencies under a Biden administration.

Morgan Lewis partners Sandra Moser and Kenneth Polite authored a Law360 article about what a Biden administration will likely mean for white collar enforcement actions under the US Department of Justice (DOJ).

There was a perception in 2017 when then President-elect Trump took office that white collar enforcement actions under the US Department of Justice (DOJ) might drop dramatically. Many expected the Republican administration to effect policy changes or resourcing decisions that would keep corporations out of the spotlight when it came to major investigations and massive penalties.

Last week’s state attorney general races brought little change on the surface, but change in Washington significantly increases the risk of enforcement and litigation by the states. If it seems counterintuitive, it is. But this Washington changeover heightens the complexity of the relationship between Washington and state capitols.

The US Securities and Exchange Commission’s (SEC’s) recently issued 2024 Exam Priorities report is largely focused on cryptocurrency and emerging financial technology.

Corporate Counsel quoted partner Kelly Gibson regarding the US Securities and Exchange Commission’s (SEC’s) approach to enforcement in recent years. In an interview following her appearance as a panelist at ALM Global’s General Counsel Conference East, Kelly discussed how the SEC has taken a harder line when issuing penalties.

Partner Celia Soehner spoke with The National Law Journal about the US Securities and Exchange Commission’s clawback rule, which recently took effect and requires publicly traded companies to have policies in place for recovering incentive-based compensation paid to executives due to a financial reporting error.

Partner John McGuire spoke with Ignites about the US Securities and Exchange Commission’s final amendment to its Names Rule, noting that the approved reforms improve upon the agency’s initial proposal.

Partners Christine Lombardo and Christine Schleppegrell are quoted in a Bloomberg Law article discussing potential impacts of a new private fund rule from the US Securities and Exchange Commission that, among other measures, includes new disclosure requirements.