News & Analysis as of

Department of Health and Human Services (HHS) National Institute of Health (NIH) Government Agencies

Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

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On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Alston & Bird

Health Care Week in Review | HHS Blocks Access to Select Federal Health Programs for Undocumented Individuals; Senate HELP...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Ropes & Gray LLP

With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

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On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more

McDermott+

Filling in More Puzzle Pieces with HHS’s Newly Released Budget Documents

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. June 5, 2025 – On May 30, 2025, the US Department of Health and Human Services...more

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

Holland & Knight LLP

Holland & Knight Health Dose: May 6, 2025

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Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...more

Holland & Knight LLP

NIH Announces Significant Changes to Federal Grant Terms, Conditions on Civil Rights

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The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more

McDermott+

HHS’s Restructuring: What Happens Next?

McDermott+ on

Last week, the US Department of Health and Human Services (HHS) announced that it will undergo a major restructuring and plans to eliminate 10,000 employees on top of 10,000 HHS employees who have already departed (20,000...more

McDermott+

McDermott+ Check-Up: March 28, 2025

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Senate Confirms FDA, NIH Nominations, Advances CMS Nomination. On March 25, 2025, the Senate confirmed Martin Makary, MD, as the next FDA commissioner by a 56 – 44 vote. Sens. Durbin (D-IL), Hassan (D-NH), and Shaheen (D-NH)...more

ArentFox Schiff

Major Restructuring of the US Department of Health and Human Services

ArentFox Schiff on

On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government...more

McDermott Will & Schulte

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Latham & Watkins LLP

Update: The NIH Funding Cuts: Implications and Status of Lawsuits

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The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more

Cozen O'Connor

Democratic AGs Secure Order Blocking Cuts to NIH-Funded Research Grants

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A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more

Epstein Becker & Green

The NIH IDC – Where Are We Now

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On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more

Wiley Rein LLP

Capping It All Off: NIH Caps Indirect Rates for Grants

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SUMMARY: On February 7, 2025, the Office of the Director for the National Institutes of Health (NIH) issued a Notice (Notice No. NOT-OD-25-068) imposing a cap of 15% on the indirect cost rates that can be charged to the...more

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