Currently, we do not have any broad guidance from the FDA.
9/24/2025: NIH released NOT-OD-25-160: NIH Policy on Enhancing Security Measures for Human Biospecimens regarding sharing human biospecimens with countries of concern.
9/12/2025: NIH released NOT-OD-25-155: New Application Structure for NIH-Funded International Collaborations to address foreign components/collaborations.
9/11/2025: NIH released NOT-OD-25-154: Implementation of NIH Research Security Policies outlining a series of requirements to strengthen transparency and accountability across NIH funded projects.
9/10/2025: The Substance Abuse and Mental Health Services Administration (SAMHSA) released its new strategic priorities, which can be viewed here.
9/9/25: NIH released a statement outlining a comprehensive effort to modernize the biosafety framework.
9/4/2025: NIH released NIH NOT-OD-25-152 Preview of NIH Common Forms for Biographical Sketch and Current and Pending (Other) Support Coming Soon to SciENcv regarding preview versions of NIH Common Forms being visible on SciEncv.
8/22/2025: NIH released its implementation plan for driving gold standard science. The plan outlines key accomplishments and presents the agency’s vision for the future.
8/7/2025: NIH has issued NOT-OD-25-142 Update: No-Cost Extension Functionality in eRA, which reinstates the first-time no-cost-extension (NCE) functionality in the eRA Commons.
7/24/25: NIH released NOT-OD-25-135: Notice to Applicants of Adjustments to Achieve Consistency in Peer Review Contacts and Processes. The notice confirms that that effective with the August/October Council round, all NIH peer review of contracts, grants, and cooperative agreements will be centralized within the Center for Scientific Review.
7/17/25: NIH published a new website containing status updates on recent changes impacting NIH grants administration and funding.
7/17/25: NIH released NOT-OD-25-132: Supporting Fairness and Originality in NIH Research Applications to provide guidance on the appropriate usage of artificial intelligence (AI) in grant applications.
7/17/25: NIH released NOT-OD-25-133: NIH Announces a New Policy Requirement to Train Senior/Key Personnel on Other Support Disclosure Requirements, which outlines new disclosure training requirements for senior/key grant personnel.
7/10/25: NIH announced that all new Notices of Funding Opportunity (NOFOs) that relate to animal model systems must now also support human-focused approaches such as clinical trials, real world data, or new approach methods. This announcement follows the 4/29/25 announcement of an NIH Initiative to Prioritize Human-based Research.
7/7/2025: NIH issued NOT-OD-25-128: Guidance on Enforcement of Closeout Requirements During the Appeals Process. This NOT provides guidance regarding compliance with closeout requirements for terminated grants that are still undergoing the appeals process.
06/04/2025: NIH has indicated through a direct correspondence with OSP the following two points regarding foreign subawards and foreign paid collaborations: 1) Applications submitted after May 1, 2025, that propose foreign subawards will not be accepted. 2) Applicants that plan to include monetary foreign collaborations in their applications should hold until the new NIH award structure is implemented in the coming months. This correspondence refers to NIH’s updated policy on foreign subawards NOT-OD-25-104.
5/22/2025: NIH released NOT-OD-25-114: Notice of Short-Term Extension to Early-Stage Investigator (ESI) Eligibility Period. This NOT grants an “automatic extension of Early-Stage Investigator (ESI) eligibility. This extension addresses delays impacting grant application submissions, peer review, or award processing timelines between January 1, 2025, and May 31, 2025, and seeks to mitigate their effects on the biomedical research community.”
5/16/2023: NIH released the Ruth L. Kirschstein National Research Service Award (NRSA) stipends, tuition/fees and other budgetary levels effective for fiscal year 2025. This notice (NOT-OD-25-105) supersedes NOT-OD-24-104.
05/16/2025: The U.S. District Court of Rhode Island issued a temporary injunction in favor of 23 states and the District of Columbia blocking the March 2025 HHS decision that, because the COVID-19 pandemic is over, numerous health programs and appropriations responsible for $11 billion of federal financial assistance were no longer necessary. The injunction can be viewed here.
5/7/2025: NIH released a notice (NOT-OD-25-110) that prior approval is now required for all no-cost extensions. View the notice here.
5/7/2025: NIH released a notice (NOT-OD-25-104) updating its policy on foreign subawards. View the notice here. Additional information on NIH foreign subawards can be found here.
5/7/25: NIH notice (NOT-OD-25-090) reaffirms that universities must comply with all Federal anti-discrimination laws, including, for example Title VI, Title IX, and the Americans with Disabilities Act (ADA). View the notice here.
5/2/2025: NIH announced a change (NOT-OD-25-102) in post-award reporting requirements for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) award recipients that did not undergo foreign risk assessment at the time of their original application submission. View the notice here.
5/1/2025: NIH released an updated policy on foreign subawards (NOT-OD-25-104). The policy states that NIH will not issue awards to domestic or foreign entities (new, renewal or non-competing continuation) that include a subaward to a foreign entity. NIH will not retroactively revise ongoing awards to remove foreign subawards at this time. View the notice here.
4/30/2025: NIH announced (NOT-OD-25-101) a new effective date of the 2024 NIH Public Access Policy (NOT-OD-25-047). The new effective date is July 1, 2025 (previously December 31, 2025). View the policy here.
4/25/2025: NIH released a notice (NOT-OD-25-098) reminding investigators of the requirement to disclose foreign activities and collaborations during the grant application process. View the notice here.
4/07/2025: A temporary restraining order (TRO) was granted by the U.S. District Court for the District of Rhode Island pertaining to HHS’s termination of public health grants. Twenty-three states, including Pennsylvania and the District of Columbia, are listed plaintiffs on the TRO. Review details of the TRO at this link.
3/27/2025: The U.S. Department of Health and Human Services (HHS) announced restructuring in accordance with the White House Executive Order, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative.” See fact sheet for more information.
3/27/2025: The NIH has provided information on the new NIH Simplified Review Framework and how it may impact already submitted applications. You can review that guidance and FAQs at this link.
3/25/2025: The NIH has launched a webpage on the Implementation of New Initiatives and Policies. You can learn more about the status of changes impacting NIH grants process and plans for implementing new initiatives and policies by visiting this link.
2/12/2025: NIH’s no-cost extension (NCE) button is now available again on the eRA Commons site.
2/11/2025: The CDC issued a rescission on stop work orders related to “DEI Activities” and “Activities Promoting Gender Ideology.” See rescission at this link.
2/10/2025: A federal judge ordered a nationwide temporary pause on the NIH’s Supplemental Guidance (NOT-OD-25-068) which imposed a standard indirect cost rate on all grants of 15%. Accordingly, until further notice, grant budgets submitted to the NIH should continue to include the University’s published negotiated indirect cost rate.
2/7/2025: The NIH posted “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates.” You can view the guidance at this link.
2/7/2025: NIH’s no-cost extension (NCE) button is unavailable on the eRA Commons site. As we understand, a guide notice will be posted by the NIH explaining next steps.
2/3/2025: The U.S. Department of Health and Human Services (HHS) has provided a notice of temporary restraining order (TRO) pursuant to a case pending in the U.S. District Court in the District of Rhode Island. Review the notice at this link.
2/3/2025: The U.S. Department of Health and Human Services (HHS)/Administration for Strategic Preparedness & Response (ASPR) has provided a notice of temporary restraining order (TRO) pursuant to a case pending in the U.S. District Court in the District of Rhode Island. Review the notice at this link.
2/3/2025: The U.S. Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC) has provided a notice of temporary restraining order (TRO) pursuant to a case pending in the U.S. District Court in the District of Rhode Island. Review the notice at this link.
2/3/2025: The U.S. Department of Health and Human Services (HHS)/National Institutes of Health (NIH) has provided a notice of temporary restraining order (TRO) pursuant to a case pending in the U.S. District Court in the District of Rhode Island. Review the notice at this link.
1/31/2025: The CDC has called for the termination of all programs, personnel, activities, or contracts promoting or inculcating gender ideology. Review the memorandum at this link.
1/29/2025: The CDC has issued an immediate termination of DEI activity for all programs, personnel, activities, or contracts. You can review the memorandum at this link.
If we receive additional guidance from a federal agency, the Office of Sponsored Programs will follow up with those impacted.
If you receive a notification from an agency or program officer, please contact the Office of Sponsored Programs immediately at OSP@pitt.edu.