News & Analysis as of

National Institute of Standards and Technology Comment Period

Wiley Rein LLP

Wireless Roundup (May 2024)

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FCC Solicits Comment on a Proposed New Framework for Licensing Space Stations Engaged in In-Space Servicing, Assembly, and Manufacturing: In this Notice of Proposed Rulemaking (NPRM) the Federal Communications Commission (FCC...more

Knobbe Martens

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

Knobbe Martens on

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more

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

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

Goodwin

CMMC 2.0: Defense Contractors Get Ready

Goodwin on

The US Department of Defense (DoD) has issued a proposed rule to implement its long-awaited Cybersecurity Maturity Model Certification program (CMMC 2.0). This proposed rule — released on December 26, 2023, and published in...more

WilmerHale

PTAB/USPTO Update - January 2024

WilmerHale on

On January 4, the USPTO announced the appointment of new leaders for the agency’s policy and communications teams. Sharon Israel will serve as the Chief Policy Officer and Director for International Affairs, and Jack...more

Bass, Berry & Sims PLC

Department of Defense Publishes Long-Awaited CMMC Proposed Rule

On December 26, the Department of Defense (DoD) published its long-awaited Cybersecurity Maturity Model Certification (CMMC) Program proposed rule, which places comprehensive cybersecurity and information security...more

Venable LLP

The New CMMC Rule: FAQs for Federal Contractors and Subcontractors

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The Department of Defense (DoD) delivered its proposed Cybersecurity Maturity Model Certification Program rule (CMMC) the day after Christmas this year, including several related guidance documents (listed here). The proposed...more

Wilson Sonsini Goodrich & Rosati

Draft Guidance Puts March-In Authority Pursuant to Bayh-Dole in the News Once Again

On December 8, 2023, the National Institute of Standards and Technology (NIST) released the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (guidance) to the public for comment. The...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

Sheppard Mullin Richter & Hampton LLP

Update: CISA Seeks Additional Input from Software Providers on Security Attestation Form

The Cybersecurity and Infrastructure Security Agency (“CISA”) recently revised its Secure Software Development Attestation Common Form (after receiving over 110 comments on the initial draft), and is seeking additional...more

Holland & Knight LLP

New Cybersecurity FAR Rules Poised to Have a Major Impact on Contractors

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The Federal Acquisition Regulatory (FAR) Council on Oct. 3, 2023, issued two proposed rules to partially implement President Biden's Executive Order on Improving the Nation's Cybersecurity. The first proposed rule imposes...more

Wiley Rein LLP

Wireless Roundup (September 2023)

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FCC Seeks Comment on Revising Spectrum Sharing Rules for Non-Geostationary Orbit, Fixed-Satellite Service Systems: In this proposed rule, the Federal Communications Commission (FCC or Commission) requests comment on revisions...more

Constangy, Brooks, Smith & Prophete, LLP

NIST Issues Cybersecurity Framework 2.0 for public comment

In early August, the National Institute of Standards and Technology released the initial public draft of its Cybersecurity Framework 2.0. The draft is a long-awaited update to a framework that’s been in place for almost 10...more

Orrick, Herrington & Sutcliffe LLP

NIST updates its Cybersecurity Framework

The National Institute of Standards and Technology (NIST) recently unveiled a proposed update to its Cybersecurity Framework, which was originally developed to provide information security guidelines for “critical...more

Morgan Lewis - Power & Pipes

Standard-Setting Agency Seeks Comment on Cybersecurity Framework for EV Charging

Electric vehicle (EV) charging relies on a complex ecosystem involving multiple entities, including utility operators, third-party data network providers, charging infrastructure owners, and the EVs themselves. The high...more

Manatt, Phelps & Phillips, LLP

FTC Seeks Comment on New Method to Obtain Parental Consent Under COPPA

The Federal Trade Commission (FTC or Commission) is seeking comment on an application from the Entertainment Software Rating Board (ESRB), Yoti and SuperAwesome for a new way to obtain parental consent under the Children’s...more

MoFo Life Sciences

FDA On Use Of AI/ML In Drug Development: Five Key Takeaways

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On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more

Wiley Rein LLP

NTIA Seeks Comment on AI Accountability

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Earlier this month, the National Telecommunications and Information Administration (NTIA) published its AI Accountability Policy Request for Comment (RFC). The RFC seeks comment on artificial intelligence (AI) system...more

Wiley Rein LLP

CISA Seeks Comments on New Security Attestation for Software Procurements

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On April 27, 2023, the Cybersecurity and Infrastructure Security Agency (CISA) of the U.S. Department of Homeland Security (DHS) issued a Notice of Agency Information Collection Activities to solicit public comments on a...more

Morgan Lewis

US Department of Commerce Details Proposed National Security Guardrails for CHIPS Incentives Program

Morgan Lewis on

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...more

Hogan Lovells

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more

Sheppard Mullin Richter & Hampton LLP

Third Time’s The Charm – FedRAMP Releases Draft Authorization Boundary Guidance Version 3 for Public Comment

The FedRAMP Program Management Office is seeking comments on its draft FedRAMP Authorization Boundary Guidance, Version 3.0, released on September 14, 2022. The public comment period currently is open and closes on October...more

BCLP

FERC NOPR seeks comment on proposed ratemaking incentives for transmission owner cybersecurity investments and expenses

BCLP on

On September 22, 2022, the Federal Energy Regulatory Commission (FERC or Commission) issued a Notice of Proposed Rulemaking (2022 NOPR) setting forth proposed utility incentives for expenses and investments relating to...more

Perkins Coie

FCC Seeks to Spark Space Innovation

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Earlier this month, the Federal Communications Commission (FCC) released a Notice of Inquiry (NOI) directed at advancing the space economy by examining in-space servicing, assembly, and manufacturing (ISAM) activities. The...more

Sheppard Mullin Richter & Hampton LLP

NIST Wants Your Input – Updating NIST’s Controlled Unclassified Information (CUI) Guidelines

On July 19, 2022, the National Institute of Standards and Technology (NIST) released a Pre-Draft Call for Comments, seeking feedback on improving its Controlled Unclassified Information (CUI) series of publications. The...more

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