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NASA Proposes Cyber Lock-Down On Contractors

Client Alert | 1 min read | 08.11.06

Following an outbreak of highly publicized information security breaches ripping through the federal government and prompting new OMB "get-tough" directives, NASA is proposing a new crackdown on contractors that "(1) have physical or electronic access to NASA's computer systems, networks, or IT infrastructure; or (2) use information systems to generate, store, or exchange data with NASA or on behalf of NASA." 71 Fed. Reg. 43408 (Aug. 1, 2006). Under these proposed rules, NASA contractors face a variety of new and expanded cyber requirements that generally add cost and risk to contract performance, including: (1) submitting IT "Security Plans" compliant with National Institute of Standards and Technology (NIST) SP 800-18; (2) performing "Risk Assessments" consistent with Federal Information Processing Standards Publication (FIPS) 199; (3) preparing contingency plans per NIST SP 800-34; (4) conducting annual IT security training; and (5) assuring that contractor personnel with access to NASA IT systems have National Agency Check with Inquiries (NACI) screening.

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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....