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Rulemaking Process › National Institute of Health (NIH)

Sunstein LLP

NIH Edict Slashing Funding of All Grant Awards Halted Nationwide for Now by Massachusetts Federal Court

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An edict issued without warning in February 2025 by the National Institutes of Health (NIH), having the effect of slashing funding by the NIH across the board, has been put on a nationwide hold for now by a federal court in...more

Holland & Knight LLP

HHS Publishes Notice About Policy on Adhering to Text of Administrative Procedure Act

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) on Feb. 28, 2025, issued a policy statement limiting the circumstances under which HHS agencies must publish proposed rules for public comment before the rules are...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Health Care Compliance Association (HCCA) on

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Epstein Becker & Green

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

Epstein Becker & Green on

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

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