News & Analysis as of

Public Comment

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Troutman Pepper Locke

CFPB Introduces New Rule Banning Certain Contractual Provisions in Consumer Financial Agreements

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The Consumer Financial Protection Bureau (CFPB or Bureau) proposed a new rule aimed at banning certain contractual provisions in agreements for consumer financial products or services. The CFPB’s proposal targets certain...more

Husch Blackwell LLP

CBP Proposes Changes to the De Minimis Entry Process

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U.S. Customs and Border Protection (CBP) issued a Notice of Proposed Rulemaking on January 13, 2025, regarding an update to the rules governing de minimis shipments. The public can make comments on the proposed rule until...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

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On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

Alston & Bird

Updates to the Dietary Guidelines? HHS and USDA Request Public Input

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Our Food & Beverage Team discusses how looming changes to federal dietary guidelines and new Make America Healthy Again initiatives could impact the food and beverage industry in 2025....more

Fox Rothschild LLP

Minnesota Announces Intent to Adopt Expedited Cannabis Rules

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On Thursday, the Minnesota Office of Cannabis Management announced its intent to adopt expedited rules without a public hearing. According to the OCM, the expedited rules are “designed to regulate the adult-use cannabis,...more

Beveridge & Diamond PC

EPA Proposes Updated General Clean Water Act NPDES and Construction Permits

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2026 MSGP - EPA released its proposed 2026 MSGP, which authorizes stormwater discharges associated with industrial activities in jurisdictions where EPA is the NPDES permitting authority, including Massachusetts, New...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

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The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Fisher Phillips

PEOs Need to Prepare for Increased Cybersecurity Requirements Thanks to Proposed HIPAA Security Rule Revisions

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With the HIPAA Security Rule set to undergo a massive overhaul to boost cybersecurity protections, PEOs need to take note. After all, as stewards of worksite employee and client company data – and as sponsors of group health...more

Vinson & Elkins LLP

DOE Issues LNG Export Study; Public Comment Period Straddles the Upcoming Administration Change

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On December 17, 2024, the Office of Fossil and Carbon Management of the Department of Energy (“DOE”) released the long-awaited Liquefied Natural Gas (“LNG”) Export Study (“Study”). The Study was released 11 months after the...more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

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The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

Bergeson & Campbell, P.C.

EPA Proposes Plan to Track the Adoption of Bilingual End-Use Pesticide Labels

On December 27, 2024, the U.S. Environmental Protection Agency (EPA) released for comment a proposed plan to track the adoption of bilingual labeling of pesticide products. 90 Fed. Reg. 9. The Pesticide Registration...more

Allen Matkins

Federal Surface Transportation Agencies Issue Updated Guidance for Section 139 Environmental Review and Permitting Process

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The Federal Highway Administration (FHWA), Federal Transit Administration (FTA), and Federal Railroad Administration (FRA) (the Agencies) recently issued updated guidance for implementing 23 U.S.C. § 139 (Section 139)....more

ArentFox Schiff

CARB Relaxes Carbon Emission Reporting Requirements and Seeks Comment on Reporting and Risk Disclosure Requirements

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The California Air Resources Board (CARB) announced this month that it will use enforcement discretion for the first greenhouse gas (GHG) emission reports due in 2026 to allow regulated businesses (doing business in...more

Sheppard Mullin Richter & Hampton LLP

Draft Revision of China’s Anti-Unfair Competition Law Released

China’s Anti-Unfair Competition Law (“AUCL”) has been amended twice since its enactment in 1993, first in 2017 and another in 2019. On December 25, 2024, the Standing Committee of the National People’s Congress released a...more

Bowditch & Dewey

Executive Office of Housing and Livable Communities Will Close Public Comment on ADU Regulations on January 10, 2025

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The Executive Office of Housing and Livable Communities (EOHLC) posted its draft of 760 CMR 71:00 “PROTECTED USE ACCESSORY DWELLING UNITS” Regulations for comment in December 2024. The public comment period for the...more

Vorys, Sater, Seymour and Pease LLP

USEPA Releases Draft General Permit for Industrial Stormwater Discharges

On Friday, Dec. 13, 2024, the Environmental Protection Agency (EPA) released a proposed draft 2026 Multi-Sector General Permit for Industrial Stormwater Discharges (MSGP). The MSGP is a general permit that regulates...more

Morrison & Foerster LLP

California Climate Laws, CARB Opens Comment Period Seeking Industry Input by February

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On December 16, 2024, the California Air Resources Board (CARB) called for public comment on key issues related to the implementation of California’s two major climate disclosure bills, the Climate Corporate Data...more

Fox Rothschild LLP

Minnesota Seeks Comment on Rules Implementing Reporting Requirement for Products Containing Intentionally Added PFAS and...

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Following up on the rulemaking process presaged by Minnesota’s comprehensive statute (Amara’s Law) requiring phase outs of PFAS intentionally added to products, which we’ve previously discussed here and here, the Minnesota...more

Skadden, Arps, Slate, Meagher & Flom LLP

California Seeks Public Input on Climate Reporting Requirements

On December 16, 2024, the California Air Resources Board (CARB) issued a request to solicit feedback regarding Senate Bill 253, Climate Corporate Data Accountability Act (SB 253) and Senate Bill 261, Greenhouse Gases:...more

Vicente LLP

Massachusetts Cannabis Control Commission Releases Draft Social Consumption Establishment Regulations for Informal Public Comment

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The Massachusetts Cannabis Control Commission (the “Commission”) voted on December 17, 2024 to release its initial draft amendments to the Social Consumption Establishment regulations and accept informal public comments on...more

Akerman LLP

Office of the U.S. Trade Representative Initiates Section 301 Investigation on Nicaragua Relating to Labor and Human Rights

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On December 10, 2024, U.S. Trade Representative Katherine Tai initiated a Section 301 investigation on Nicaragua relating to labor rights, human rights, and the rule of law. Section 301 of the Trade Act of 1974 is designed to...more

Jenner & Block

California Issues First-of-its-kind Willful Heat Standard Violation

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On December 12, 2024, the California Division of Occupational Safety and Health (Cal/OSHA) announced a first-of-its-kind citation for a willful violation of California’s Heat Illness Prevention regulations. Per the Agency’s...more

Troutman Pepper Locke

CARB Solicits Public Input on Greenhouse Gas and Climate Risk Disclosure Laws

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On December 16, 2024, the California Air Resources Board (CARB) requested public feedback to “help inform its work to implement” the Climate Corporate Data Accountability Act (SB 253) and the Climate-Related Financial Risk...more

A&O Shearman

CFTC Issues Advisory Guidance For Anticipated Growth In Use Of Artificial Intelligence By Regulated Entities

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On December 5, 2024, the Divisions of Clearing and Risk, Data, Market Oversight, and Market Participants of the Commodity Futures Trading Commission (“CFTC”) issued an advisory on the use of artificial intelligence (“AI”) in...more

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