News & Analysis as of

Comment Period Regulatory Requirements

Sheppard Mullin Richter & Hampton LLP

FedRAMP Releases New Draft Authorization Boundary Guidance

Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

Troutman Pepper Locke

NYC DCWP Further Delays Effective Date of Amended Debt Collection Rules

Troutman Pepper Locke on

In our previous post, we discussed the New York City Department of Consumer and Worker Protection’s (NYC DCWP) decision to delay the enforcement of the amended debt collection rules from December 1, 2024, to April 1, 2025....more

DLA Piper

Maine DEP Proposes Currently Unavoidable Use Procedures for PFAS in Products Law

DLA Piper on

Maine’s Department of Environmental Protection (DEP) recently published a proposed rule prescribing procedures and criteria for determining Currently Unavoidable Uses (CUU) of intentionally added per- and polyfluoroalkyl...more

Troutman Pepper Locke

FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products

Troutman Pepper Locke on

On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more

Fenwick & West LLP

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

Fenwick & West LLP on

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more

Schwabe, Williamson & Wyatt PC

SBA Proposes Faster Payments and Simplified Reporting

On December 19, the Small Business Administration published proposed amendments to 13 CFR § 125.3 that would affect small business subcontracting. Their goal is to accelerate payments to small business subcontractors and...more

Maynard Nexsen

SBA Publishes Major Rule Change: Heeding Input, the Administration Clarifies and Refines M&A-Related Rules to Ease Concerns

Maynard Nexsen on

In August, the Small Business Administration ("SBA") issued a proposed rule that included significant and sweeping changes to its regulations, including to its rules on joint ventures, mentor-protégé, HUBZones, and others....more

Foley Hoag LLP - Security, Privacy and the...

HHS Office for Civil Rights Proposes Measures to Strengthen Cybersecurity in Health Care Under HIPAA

The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...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

A&O Shearman

European Securities and Markets Authority consults on the draft technical standards on open-ended loan-originating alternative...

A&O Shearman on

The European Securities and Markets Authority has published a consultation paper on draft regulatory technical standards on open-ended loan originating Alternative Investment Funds under the revised Alternative Investment...more

Ballard Spahr LLP

California’s DFPI seeks comments on additional products and services to be registered under the CCFPL

Ballard Spahr LLP on

In the wake of the Office of Administrative Law’s approval of its registration and reporting requirements for providers of income-based advances, private postsecondary education financing, debt settlement services, and...more

Bennett Jones LLP

CSA Seeks Comments on Proposed Access Model: Modernized Approach for Delivery of Continuous Disclosure

Bennett Jones LLP on

As an update to our previous blog posts, Greater Flexibility for Reporting Issuers: Access Equals Delivery and CSA Seeks Comments on “Access Equals Delivery” Model for Prospectuses, Financial Statements and MD&A, the Canadian...more

Sullivan & Worcester

EPA Proposes New Stormwater Regulations for Three Boston Area Watersheds

Sullivan & Worcester on

On October 31, 2024, Region 1 of the United States Environmental Protection Agency (“EPA”), which covers the New England states, proposed sweeping new requirements to regulate stormwater discharges from certain commercial,...more

A&O Shearman

Mansion House: UK Government Finalizes PISCES Policy

A&O Shearman on

In its consultation response, the government notes that the proposal to establish a PISCES Sandbox was well received as an appropriate way to develop and test this new regulatory regime. The government confirms that it will...more

Ballard Spahr LLP

California Finalizes Registration Requirements for Providers of Earned Wage Access, Other Financial Products and Services

Ballard Spahr LLP on

On October 11, California’s Office of Administrative Law (“OAL”) approved the Department of Financial Protection and Innovation’s (“DFPI’s”) registration rulemaking for providers of the following products...more

Shipkevich PLLC

California DFPI Seeks Greater Oversight Over Additional Consumer Financial Services: Seeks Comments on Who Should Be Regulated...

Shipkevich PLLC on

The ink is barely dry on the California Department of Financial Protection and Innovation’s (“DFPI” or the “Department”) newly approved regulation package PRO 01-21, and DFPI has already begun to take steps to implement...more

McDermott Will & Emery

Are We There Yet? DoD Issues Final Rule Establishing CMMC Program

McDermott Will & Emery on

The US Department of Defense (DoD) published a final rule codifying the Cybersecurity Maturity Model Certification (CMMC) Program. The final CMMC rule will apply to all DoD contractors and subcontractors that will process,...more

Maynard Nexsen

SBA Proposes Rule That Will Change M&A Landscape for Small Business, Recertifications to Impact Award Eligibility

Maynard Nexsen on

The Small Business Administration ("SBA") recently issued a proposed rule that changes the effect of a concern's size recertification following mergers and acquisitions ("M&A") activity. Notably, the proposed rule is...more

Schwabe, Williamson & Wyatt PC

SBA’s Proposed Rule: Affiliation and Negative Control

Comments are due by October 7, 2024. On Friday, August 23, the Small Business Administration issued a proposed rule that would significantly change the SBA’s HUBZone small business contracting program and other small...more

Bass, Berry & Sims PLC

HHS Proposed Rule Seeks to Align Health IT Procurement Standards to Leverage Interoperable Data

Bass, Berry & Sims PLC on

On August 9, the Department of Health and Human Services (HHS) published a proposed rule that seeks to amend and update the Health and Human Services Acquisition Regulation (HHSAR) to align health IT procurement requirements....more

Schwabe, Williamson & Wyatt PC

SBA’s Proposed Rule: Impact on HUBZone and 8(a) Programs

On Friday, August 23, the Small Business Administration issued a proposed rule that would make significant changes to the SBA’s HUBZone small business contracting program, as well as modifications to other small business...more

Sheppard Mullin Richter & Hampton LLP

The CMMC Rule To Update the DFARS is Here!

The proposed rule to implement the Cybersecurity Maturity Model Certification (“CMMC”) program in the Defense Federal Acquisition Regulation Supplement (“DFARS”) was published in the Federal Register on August 15, 2024 and...more

Perkins Coie

FCC Proposes New Rules for AI-Generated Content in Calls and Texts

Perkins Coie on

The Federal Communications Commission (FCC) has once again set its sights on artificial intelligence (AI), proposing consumer protections in the use of AI-generated content in robocalls and robotexts. Illegal robocalls and...more

Sheppard Mullin Richter & Hampton LLP

Soil and Security: The Broadening Scope of CFIUS in Real Estate Transactions

As the Committee on Foreign Investment in the United States (CFIUS) continues to expand its jurisdictional reach, investors, property owners, and landlords should be aware of a growing focus on real estate transactions....more

190 Results
 / 
View per page
Page: of 8

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide