#WorkforceWednesday: Guidance for Critical Infrastructure Workers; OSHA Reporting Guidance; EEOC Update - Employment Law This Week®
Under SECURE 2.0, plan sponsors were granted discretion to determine whether or not the plan would recoup "inadvertent benefit overpayments." However, SECURE 2.0, did not define the term, leaving implementation of the new...more
After rescinding the June 2022 guidance regarding Fintiv, the PTAB issued updates to how they will consider discretionary denial issues under Section 314(a) on Monday. ...more
In Pfizer Inc., v. Sanofi Pasteur Inc., SK Chems Co. Ltd., v. Vidal, 2019-1871 (March 5, 2024), the Federal Circuit affirmed the Board’s conclusions that claims 1–45 of U.S. Patent No. 9,492,559 were unpatentable due to...more
The NPRM proposals align with interim guidance on requesting director review for key AIA trial decisions. Following the Arthrex v. Smith & Nephew ruling, director review by the USPTO Director remains crucial for addressing...more
On April 8, the US Environmental Protection Agency (EPA) issued interim guidance for public comment regarding the destruction and disposal of per- and polyfluoroalkyl substances (PFAS). Below, we discuss the guidance and...more
The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
A federal judge recently exposed weaknesses in the U.S. Department of Justice's (DOJ) criminal healthcare fraud enforcement efforts by vacating a jury's conviction of a prominent Maryland doctor. On Aug. 4, 2023, a federal...more
The Internal Revenue Service (IRS) recently announced in Notice 2023-63 (notice) that proposed regulations regarding specified research or experimental (SRE) expenditures would be forthcoming. Until then, taxpayers may rely...more
As previously reported, the Patented Medicine Prices Review Board (PMPRB) proposed amendments in June 2023 to its Interim Guidance (“Amended Interim Guidance”) for reviewing the prices of patented medicines pending the...more
The July 19 Ultima ruling threw the 8(a) program into tumult after the U.S. District Court for the Eastern District of Tennessee found the program’s rebuttable presumption mechanism, used to find social disadvantage, in...more
The long wait for substantive guidance under Section 174 ended late last week with the release by the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) of Notice 2023-63 (Notice). Taxpayers may rely...more
The changes come in response to a court injunction declaring rebuttable presumption for social disadvantage unconstitutional. All pending SBA 8(a) program applications are currently suspended due to an injunction issued by...more
On July 19, the U.S. District Court for the Eastern District of Tennessee ruled in favor of Ultima Services Corporation, prompting the pause of new 8(a) applications and necessitating a reorganization of the program’s...more
As announced by U.S. Small Business Administration (SBA) Associate General Counsel for Procurement Law John Klein in an Aug. 17, 2023, webinar, SBA has issued a press release and interim guidance regarding its implementation...more
The interim administrative measures, which are the first comprehensive AI regulations in the People’s Republic of China (PRC or China), apply only to using generative AI technology to provide services to the public within the...more
There has never been a better time for plan sponsors to prioritize reviewing and self-correcting eligible plan failures. SECURE 2.0, attached to the 2022 year-end Consolidated Appropriations Act, expands retirement savings...more
The National Collegiate Athletics Association (NCAA) released its interim policy regarding name, image, and likeness (NIL) for NCAA student-athletes in July 2021. Since then, the NCAA has released several clarifying guidance...more
On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). The Guideline organizes parallel...more
On June 29, 2023, the Internal Revenue Service (IRS) issued Announcement 2023-18 (the Announcement), which provides transitional guidance with respect to the stock repurchase excise tax under section 4501 (the Buyback Tax)....more
Beginning with the PFAS Action Plan of 2019, it became clear to industry observers and environmental professionals that EPA intends to regulate PFAS compounds in industrial wastewater permits. The Action Plan identified an...more
The IRS recently issued Notice 2023-43 (Notice) to provide interim guidance on Section 305 of SECURE 2.0 Act of 2022 (SECURE 2.0), which significantly expanded self-correction under the Employee Plans Compliance Resolution...more
On June 20, 2023, the Patented Medicine Prices Review Board (PMPRB) released a proposal to amend the Interim Guidance, which sets out the approach for reviewing the prices of patented medicines under the July 1, 2022...more
The U.S. Bureau of Reclamation has initiated the Environmental Impact Statement (“EIS”) process for post-2026 operational guidelines and strategies of Lake Powell and Lake Mead. This process is in addition to the Draft...more
The IRS recently issued Notice 2023-43 providing new interim guidance for self-correction of plan errors. This guidance applies to corrections made prior to the anticipated issuance of revisions to the Employee Plans...more
Recently issued Notice 2023-43 provides interim guidance on certain changes to the Employee Plans Compliance Resolution System (EPCRS) made by the SECURE 2.0 Act of 2022. In particular, the notice addresses how plan sponsors...more