Beating Others to the Punch, DHS Proposes CUI Changes to Acquisition Regulations
Client Alert | 1 min read | 02.07.17
On the last full day of the Obama Administration, the Department of Homeland Security (DHS) published a proposed rule that would make several amendments to the Homeland Security Acquisition Regulation (HSAR) regarding Controlled Unclassified Information (CUI). Despite recent developments, the proposed rule is open for comment until March 20, 2017, and seeks to impose several obligations, including: (1) contractors handling CUI under a contract must be in compliance with a bevy of DHS policies and procedures at the time of contract award; (2) contractors operating federal information systems must meet numerous information security obligations prior to handling CUI on those systems; (3) contractors must report known or suspected incidents affecting CUI within one to eight hours, depending on the type of CUI at issue; and (4) contractors must adhere to specific breach notification and credit monitoring requirements in response to incidents affecting personally identifiable information (PII), a subset of CUI.
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Client Alert | 2 min read | 05.09.25
FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization
On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization.
Client Alert | 2 min read | 05.09.25
New SF-328 for Foreign Ownership, Control, and Influence Assessments Approved, Publication Imminent
Client Alert | 4 min read | 05.08.25
Client Alert | 4 min read | 05.07.25
