NIH Announcements
This section contains pertinent notices of NIH Policy Changes regarding the administration and management of NIH-funded research. This is not meant to be a comprehensive list. For more information, please visit the following link: https://grants.nih.gov/policy-and-compliance/notice-of-policy-changes
Update of NIH Late Application Submission Policy and End of Continuous Submission | End of Continuous Submission NIH greatly appreciates the time and service of those who serve on our review and advisory groups. We intended the continuous submission policy to allow applications with PD/PIs providing review service to be submitted at any time. In practice, the Council assignment deadline became a de facto due date - sometimes as much as nine weeks after the submission deadline. The submission delays have led to inefficiencies in application referral and peer review. As a result, we are ending the Continuous Submission Policy and updating the Late Application Submission Policy to designate participation in a recent review or advisory group meeting as an acceptable reason for late submission. We will accept Continuous Submission applications through August 10, 2026 (the end of the continuous submission receipt period for the June/July standard due dates) for assignment to January 2027 Council. Updated Late Application Submission Policy The updated Late Application Submission Policy is effective for applications submitted for due dates on or after May 25, 2026. NIH only accepts late applications in limited situations and considers each late application for acceptance on a case-by-case basis. Decisions are based on the cover letter explanation, the funding opportunity, and the completed submission date. To be considered under the late policy, you must submit your application within two calendar weeks of the original due date, even if there is more than one reason for the delay. We consider those two calendar weeks the late application period. If an application due date extends to the next business day because it falls on a weekend or federal holiday, the late application period is calculated from that business day. You may submit during the late application period if all the following are true:
NIH Review Service You may also submit within the late application period, if within four calendar weeks before or after the due date, any PD/PI named on the application participates in
This specific review service is the only pre-authorized reason for a late submission (i.e., automatically accepted once review service information provided in the cover letter is confirmed). Other types of NIH activities and services for other federal agencies or private organizations are not acceptable reasons for late submission. No Advance Permission is Given to Submit Late We don't provide advance permission to submit late. No NIH staff member (including receipt and referral, review, grants management, and program staff) has the authority to evaluate or pre-approve reasons for late submission. Submitting a Late Application & Cover Letter Submit your application as soon as possible. We consider your submission time as a factor when evaluating your case. You must document your situation in the Cover Letter attachment on the SF424 R&R form submitted with your late application. Clearly explain the reason for the delay (including delays for qualifying NIH review service). NIH receipt and referral staff use the cover letter to evaluate whether your situation warrants late application acceptance. While the reasons for late application submission are sometimes personal in nature, specific information about the timing and cause of the delay should be provided so an informed, objective decision can be made. For example, in the case of sudden, acute, severe illness, the timing/onset and severity should be explained. Your cover letter is only seen by NIH staff who need the information for referral or review decisions. We do not share cover letters with peer reviewers or include them in the assembled e-Application seen by reviewers and general NIH staff. Examples of reasons we may or may not accept a late application can be found on our NIH Late Application Submission Policy page. |
Harmonizing the NIH Definition of “Intervention” with the Common Rule | In 2014, the NIH revised its definition of a clinical trial (NOT-OD-15-015) to increase transparency and accountability and enhance the precision of the information NIH collects, tracks, and reports on clinical trials. In the context of the NIH clinical trial definition, the NIH also defined an intervention as:
A manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. These efforts preceded the 2018 Common Rule (45 CFR 46, Subpart A [Protection of Human Subjects]), which defined an intervention as: Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. NIH adopted an implementation approach that operationalized these definitions in a similar manner. However, to ensure consistency and harmonize implementation of the Common Rule across federal agencies, effective with the publication of this Notice, NIH is adopting the definition of an intervention as defined in 45 CFR 46, Subpart A, above. The NIH will make revisions to its websites and forms, as needed, to reflect this change. Guidance on determining whether a research study with human subjects is considered by the NIH to be a clinical trial, a basic experimental study involving humans (BESH), or an observational study can be found on the Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving humans webpage. |
Publication of the Revised NIH Grants Policy Statement (Rev. March 2026) for Fiscal Year 2026 | This update incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated April 2024. This version of the NIHGPS includes policies and requirements that have been published via Guide Notices in effect as of March 17, 2026. The updates published in this version of the NIHGPS consolidate all such Guide Notices and supersede the April 2024 version of the NIHGPS.
The current version of the NIHGPS, in both HTML and PDF formats, as well as previous versions of the NIHGPS and documents summarizing significant changes implemented with each revision, are available on the NIH Grants Policy website. After the March 2026 NIHGPS is issued, NIH will continue to publish interim grants policy changes and/or clarifications through the issuance of NIH Guide Notices, available on the website, and Federal Register Notices as appropriate. |
Prior Approval requirement for Changes to Domestic Subawards | Effective June 1, 2026, all prime recipients are required to obtain NIH prior approval when adding a new domestic subaward to a project post-award, when the arrangement was not originally a part of the peer-reviewed and approved application. The new prior approval requirement is intended to ensure that NIH is aware of all subaward activities for each NIH project, so that NIH can monitor the prime recipient and ensure compliance with subaward monitoring and reporting requirements.
Requests must be submitted in the eRA Commons Prior Approval Module using the “Other Request” type. As a reminder, effective May 1, 2025, NIH no longer recognizes foreign subawards. Recipients seeking to initiate a new international collaboration must utilize the new application structure for NIH-funded international collaborations (PF5/UF5) |
NIH’s Implementation of Common Forms for Biographical Sketch and Current and Pending (Other) Support for Due Dates on or after January 25, 2026 Notice Number: NOT-OD-26-018 | In an effort to support strong collaboration between Federal research agencies, NIH is adopting the Common Forms for Biographical Sketch and Current and Pending (Other) Support as per the White House Office of Science and Technology Policy (OSTP) memorandum on Policy Regarding Use of Common Disclosure Forms. This Guide Notice provides details for the Common Forms, NIH Biographical Sketch Supplement, and instructions required for use for application due dates and Research Performance Progress Report (RPPR) submissions on or after January 25, 2026. An important reminder: institutions must maintain internal controls (e.g., policies and procedures) for disclosure, which must include training on these policies and procedures for senior/key personnel. Availability of Forms and Instructions: A preview of the Biographical Sketch Common Form, NIH Biographical Sketch Supplement, and Current and Pending (Other) Support Common Form and instructions are currently available in Science Experts Network Curriculum Vitae (SciENcv) (see Guide Notice NOT-OD-25-152). NIH anticipates finalizing the templates in SciENcv for Common Forms, the NIH Biographical Sketch Supplement and associated instructions the week of December 15, 2025. |
Research Security Training Requirements for NIH | This notice notifies the extramural community of the NIH implementation of the Research Security Training (RST) requirements outlined in the CHIPS and Science Act of 2022 (P.L. 117-167).
In accordance with Section 10634 of Act, each covered individual (for NIH this is defined as senior/key personnel) listed on an NIH grant application must certify that they have completed RST within 12 months of the date of application submission. NIH does not collect Current and Pending (Other) Support at the time of application based on our Just-in-Time policy. Therefore, NIH will collect the individual certification at the time of the application submission, through the Biographical Sketch in SciENcv. The Act also requires applicant institutions to certify that each covered individual who is employed by the institution and listed on the application has completed RST. The Authorized Organization Representative (AOR), via their signature on the face page of the application, will certify the applicant institution’s compliance with this requirement. Applicants and recipients may utilize any training that addresses cybersecurity, international collaboration, foreign interference, and rules for proper use of funds, disclosure, conflict of commitment, and conflict of interest. NSF, in partnership with the National Institutes of Health (NIH), the Department of Energy (DOE) and the Department of Defense (DOD), have provided four online RST modules as a resource to the extramural community. Subsequently, the SECURE Center developed an updated and condensed version of the four modules. The condensed RST module is designed to meet the government-wide RST requirement in Section 10634 of the CHIPS and Science Act of 2022 (42 U.S.C. § 19234). To that end, NIH also recognizes completion of the condensed module as compliant with the respective RST requirements. Effective Date: At this time, the research security training requirement is optional. Completion of RST and the individual and institutional certifications will be effective for applications submitted for due dates on or after May 25, 2026. |
Interim Guidance on Reopening of NIH Extramural Activities | NIH is working to reestablish dates for grant and contract submissions, determine how to communicate details related to missed review meetings, reschedule dates for training, and other activities that were scheduled to occur during and immediately following the period of the government shutdown.
As of today, we can confirm that we will be rescheduling all October and November grant application submission deadlines (specific dates to be announced in a future Notice). By delaying due dates that occurred both during the lapse in funding and in the week following, applicants will have access to NIH staff and the help desks as they develop their applications. Peer review meetings that were scheduled to take place between October 1 and November 14 have been cancelled and will be rescheduled, details to come. Additionally, council meetings that were scheduled to take place between October 1 and November 14 were cancelled and will be rescheduled, details to come. During the shutdown, the eRA system remained open and available to accept application submissions. As such, eRA is currently reviewing service desk ticket requests from entities and individuals that needed assistance with login and passwords. eRA staff will address the tickets on a first come, first serve basis. Please note that due to the volume the response time may be longer than usual. The eRA system was also available for recipients to submit Research Performance and Progress Reports, Federal Financial Reports, etc. The email reminders and submission confirmations were held and will be sent out in the coming weeks. If you submitted any reports during this time, no additional action is required unless you are contacted by NIH staff. NIH will provide additional information, including a Notice on NIH operations during a continuing resolution, as soon as it is available. |
| Information for the NIH Extramural Community During the Lapse of Federal Grant Funding
Notice Number: NOT-OD-26-004 | This notice provides guidance on available functions of NIH during the current government shutdown.
Federal grant submission deadlines are still in effect. As such, PAVIR continues to submit federal proposals. |
| RESCINDED – Implementation of NIH Research Security Policies
Notice Number: NOT-OD-25-154 | This notice rescinds the implementation of NIH Research Security Training for all Senior/Key personnel on NIH grants or cooperative agreements. PAVIR will continue to monitor this topic and will provide updates as they become available.
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| No-Cost Extension Functionality in eRA Notice Number: NOT-OD-25-142 Release Date: August 7, 2025 Source: NOT-OD-25-142: Update: No-Cost Extension Functionality in eRA | This notice provides an update on the guidance issued inNOT-OD-25-110. Effective with the issuance of this Guide Notice, NIH has re-enabled the No-Cost Extension functionality within eRA Commons. Recipients may resume initiating first no-cost extensions in eRA Commons, in accordance with the NIH Grants Policy Statement, Section 8.1.1.3. Requests that were previously submitted via the prior approval module will not be reviewed, and recipients will need to initiate the first no cost extension within the Status module by using the Extension action.
If you believe this affects your PAVIR-administered NIH-funded award, please contact your assigned Post-Award Contract and Grant Analyst for further details. |
| How Does the NIH Initiative to Prioritize Human-Based Research Affect Research Proposing the Use of Laboratory Animals?
July 18, 2025 | In July 2025,NIH announced it will no longer develop new funding opportunities focused exclusively on animal models of human disease. Rather, going forward, new funding opportunities will be designed more broadly with language that also encourages various approaches be considered. This means researchers may choose any model they deem appropriate – including a combination of approaches – to answer a research question when submitting applications seeking NIH support. This strategy is intended to open the possibilities of which types of models can be submitted in response to funding opportunities, not be restrictive or prescriptive.
Applicants may continue to propose research exclusively involving human participants (like clinical trials), particular laboratory animals, real-world data, in vitro methods, mathematical models, artificial intelligence, in silico approaches, other alternative approaches, or a combination of models. Peer reviewers will assess, through our fair and impartial review process, the merit of each approach proposed, its relevance to human disease, and if it is best suited to answering the research question that advances biomedical research and discovery. Our overarching goal is to accelerate progress, encourage innovation, and ultimately improve the quality and validation of new approach methodologies. We are also prioritizing human-based technologies and models, where scientifically valid and justified. Likewise, funding opportunities will indicate a special emphasis on human-based approaches. These steps should encourage investigators to choose the best models for their research without constraints. To reiterate, NIH will continue to support grants that use laboratory animal models if scientifically appropriate, justifiable, and with appropriate animal welfare oversight. Moreover, if laboratory animals are proposed, scientists must still continue to clearly explain why they are necessary for their research, that the minimal number needed to ensure rigorous and reproducible studies will be used, and why the study cannot be done using another model or approach (see more here). While traditional animal models continue to be important to advancing scientific knowledge, NIH recognizes that prioritizing new and emerging human-based technologies can offer unique strengths to expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions. It also moves us toward our continued long-term goal of reducing, refining, and replacing the use of laboratory animals in NIH-supported research. |
Updated Implementation Guidance on NIH Policy on Foreign Subawards for Active Projects | Taking into consideration concerns for patient safety risks for ongoing projects, NIH recognized the need to identify an alternative approach for removing the foreign subawards from existing grants and cooperative agreements involving human subjects research (e.g., clinical trials and clinical research) at the foreign site. As a result, NIH Institutes, Centers, and Offices (ICOs) will have the option to renegotiate the award structure with a recipient such that foreign subawards are financially removed from the primary award and awarded as administrative supplement (i.e., Type 3) awards. Each foreign supplement award will only include funds allocated for a single foreign entity, allowing NIH better ability to track obligations to foreign entities.
Please contact your assigned PAVIR Post-Award Contract and Grant Analyst (CGA) if you have further questions or concerns on how this affects your PAVIR-administered NIH award. |
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Supporting Fairness and Originality in NIH Research Applications | NIH will not consider applications that are either substantially developed by AI, or contain sections substantially developed by AI, to be original ideas of applicants.
NIH will only accept 6 new, renewal, resubmission, or revision applications from an individual Principal Investigator/Program Director or Multiple Principal Investigator for all council round sin a calendar year. This applies to all activity codes except T activity codes and R13 Conference Grant applications. PAVIR will be monitoring the number of submissions per PI to NIH to ensure that the maximum number of proposals to be submitted is not exceeded. |
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NIH Announces a New Policy Requirement to Train Senior/Key Personnel on Other Support Disclosure | This Guide Notice announces a new policy requirement that requires NIH recipients to provide training to all faculty and researchers identified asSenior/Key Personnel on the requirement to disclose all research activities and affiliations (active and pending) in Other Support (see Other Support form). The new requirement to train researchers to comply with other support disclosure requirements adds to the current policy (see NIH Grants Policy Statement (GPS), Section 2.5.1 "Just-in-Time Procedures") in order to provide a comprehensive plan in the area of disclosure requirements for recipients. This update will be included in the FY2026 version of the NIH GPS as part of NIH’s standard processes.
PAVIR is still in discussion on how it will implement this new requirement going forward. Communication to the PI community will be sent once this has been finalized. |
