/Office for Research and Innovation
Offices of Sponsored Programs and Grants Management

Key Information & Guidance

Navigating the NIH

The NIH Center for Scientific Review developed this resource to help clarify the application process, highlighting institution- and investigator-specific information, including key actions that must be taken well in advance of application submission. (Posted April 20, 2023) 

Review the How To Apply  - Application Guide

The NIH Grants & Funding website hosts various guides to help Investigators and Administrators in preparing, writing and submitting their application.  Information and guidance covers such topics as understanding FOAs,  types of NIH Applications, learning how to write a strong application, developing your budget,  how to format attachments, and much more.  Be certain to bookmark and visit the NIH How to Apply Application Guide Website!

Watch the NIH How To Apply Video Tutorials

The NIH Grants & Funding website features a How to Apply video tutorial series on applications that will take you through  an overview of the process, preparing your application, writing your application and submitting. Whether you are a new Investigator/Department Administrator or simply want a refresher, be sure to watch the NIH How to Apply Video Tutorial series.

Understand NIH Notices of Funding Opportunities (NOFOs)

NIH advertises availability of grant support through notices of funding opportunities (NOFOs) - previously referred to as funding opportunity. Search for a funding opportunity specific to your area of interest or apply to a generic parent announcements.

  • Use the instructions in the funding opportunity in conjunction with the application guide to prepare your application. If instructions conflict, follow the funding opportunity.
  • Pay attention to notices posted in the NIH Guide for Grants and Contracts. Notices may highlight topics of special interest to NIH or update key aspects of funding opportunities. Guidance included in notices supersedes guidance in the funding opportunity and application guide.
  • There is not a generic application form package that can be downloaded and used for all grant application submissions. You must use the application form package associated with the funding opportunity to which you are applying. Access the opportunity-specific form package through your chosen submission method (ASSIST, institutional system-to-system solution, Workspace). Learn more Link to Non-U.S. Government Site - Click for Disclaimer
  • Make sure that the NIH Institute or Center that might be interested in your research is listed as a participating organization in the funding opportunity. Notices of special interest may identify NIH Institutes or Centers participating in the notice initiative that are not listed in the funding opportunity used for submission.
  • Return to the funding opportunity to check the Related Notices section before submission to ensure you are in line with the most recent guidance.
  • Pay particular attention to the review criteria and write your application keeping these review criteria in mind. 
  • Take a tour of an annotated opportunity for tips and key information.

All About Grants Podcasts

The Office of Extramural Research (OER) talks to NIH staff members about the ins and outs of NIH funding. Designed for investigators, fellows, students, research administrators, and others just curious about the application and award process, the NIH provides insights on grant topics from those who live and breathe the information. Episodes are available as mp3s for download here, via iTunes, or via RSS feed.   Topics include: Preparing to Apply, Developing a Successful Grant Application, Advice for New and Early Career Scientists, Submitting Your Application, Peer Review, Post-Award Activities and Requirements, and more!

Get guidance for addressing rigor and reproducibility in your application

NIH is committed to supporting the best and most rigorous science.

Learn what reviewers are looking for, and find out how to address rigor and reproducibility in your applicationThis link is external to nei.nih.gov and will open in a new browser window or tab.

NIH Extramural Nexus Articles

  • Spring Into Action: How to Find Help at NIH  Have questions about funding opportunities, developing an application, or managing a grant award? Unsure who to contact for help? Don’t be scared to reach out to NIH staff!
  • The ABCs of Authentication Plans  Are you proposing to use key biological and/or chemical resources like cell lines, specialty chemicals, antibodies, or other biologics in your application? Learn more about authentication plans.
  • Referring Study Sections Is a Work of “ART” (Assisted Referral Tool)  Did you know there’s a tool to help you find relevant study sections for your grant application? The Assisted Referral Tool (ART) was developed by the NIH Center for Scientific Review (CSR) to recommend potentially appropriate study sections using text from your application.
  • Revisit Funding Opportunity Announcements Within 30 Days of the Due Date  Many NIH funding opportunity announcements (FOAs) have multiple due dates each year for up to three years. A lot can change over three years, so revisit your FOA within 30 days of your due date (pay extra attention to the Related Notices section) and you can ensure you are aware of the latest requirements before finalizing and submitting your application.
  • Check for Fit, Before You Submit! It takes quite a bit of time to prepare and submit a grant application. Imagine spending that time only to find out later that you submitted to the wrong opportunity. Funding opportunity announcements (FOAs) contain a lot of information. Most applicants are very good at reading the FOA description to ensure a good topic fit, but let’s look at a few less obvious items that are often overlooked.

NIH prior approval is required for the transfer of the legal and administrative responsibility for a grant-supported project or activity from one legal entity to another before the expiration date of the approved project period.

With Change of Recipient Organization requests, timing is critical and NIH expects to be notified at least three months prior to the date of transfer. Any notification after this time could cause delays that could adversely impact research. Please also consider that transfer applications that come in close to the end of the Fiscal Year may be deferred for processing until after fiscal year close.

The first step in this process is to contact the Program Officer (PO) to discuss the feasibility of the transfer (NIH usually will not consider or approve transfers of a grant in a no-cost extension, except under an extraordinaty circumstance). If no concerns are raised by your PO, then the next step is to contact the Grants Management Specialist (GMS) assigned to the award. The GMS can assist with questions about the submission of required documentation, such as the relinquishing statement and transfer application.

NIH Award Transfers are not guaranteed. Once the transfer documentation is received, NIH grants management and program staff will conduct an administrative review of the request to determine if the transfer is appropriate, and to determine the level of NIH funding that will be awarded to the new recipient. The decision to authorize transfer of the grant will be based upon the following criteria:

  • The project has been relinquished by the original organization.

  • The facilities and resources at the new location allow for the successful performance of the project.

  • The investigator plans no significant changes in research objectives and level of expenditures from those described in the previously approved project.

After the PI discusses the transfer with NIH, the Office of Sponsored Programs, Office of Grants Management, and Intellectual Property Partners are expected to submit the following documentation:

  1.  Relinquishing Statement (PHS Form 3734) or signed letter in lieu of the form (only if transfer is taking place prior to award of competitive application). If applicable, include a list of equipment that is transferring to the new institution. This form gives information about the date the investigator proposes to leave the old institution and proposes to start at the new institution. It provides an estimated amount of funds to be relinquished in the current grant year. The relinquishment statement can be submitted electronically through eRA Commons.



    Important to Note: The Form 3734 requests “the unexpended balance on the termination date of _____calculated on the basis of the total amount awarded for the grant year.” A common error is to include the total balance from all grant years (including carryover); however, this estimate should come ONLY from funds awarded in the budget period being relinquished.



    Form 3734 should be completed as soon as possible and always before the PI moves. While some grantees will wait until all charges are cleared, this significantly delays the process. If there is an underestimation of expenditures, the awards will be revised.
  2.  Final Invention Statement (PHS Form 568).
  3.  A final Federal Financial Report (FFR) is required for grant closeout and is due 120 days after the end of the competitive segment.

Helpful Links

 Informational materials are required from both the original recipient Relinquishing Statement and the proposed new recipient Transfer Application.

Additional information on the Change of Recipient Organization is also available in the section entitled "Prior Approval Requirements" in the NIH Grants Policy Statement.

The 2023 NIH Data Management and Sharing (DMS) Policy applies to all research, funded or conducted in whole or in part by the NIH, that results in the generation of scientific data. The policy details expectations and requirements regarding data management and sharing of scientific data generated out of NIH funded projects as well as budgeting for the costs to do so. The policy is effective January 25th 2023, and applies to all awards with receipt dates on or after that date.

The  NIH Data management and Sharing Policy Webpage contains detail on the policy and related information.

See OSP Guidelines for Proposals that require a Data Management Sharing Plan (DMSP) for helpful recommendations and resources. 

Elements to Include in a Data Management and Sharing Plan 

As outlined in NIH Guide Notice Supplemental Policy Information: Elements of an NIH Data Management and Sharing Plan, DMS Plans should address the following recommended elements and are recommended to be two pages, but longer plans are allowed. As described in the Application Guide, the DMS Plan should be attached to the application as a PDF file. See NIH’s Format Attachments page.

NIH RECOMMENDED ELEMENTS

DETAILS TO INCLUDE
DATA TYPE

Briefly describe the scientific data to be managed and shared:

  • Summarize the types (for example, 256-channel EEG data and fMRI images) and amount (for example, from 50 research participants) of scientific data to be generated and/or used in the research. Descriptions may include the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing.
  • Describe which scientific data from the project will be preserved and shared. NIH does not anticipate that researchers will preserve and share all scientific data generated in a study. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors. The plan should provide the reasoning for these decisions.

  • A brief listing of the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data
RELATED TOOLS, SOFTWARE AND/OR CODE Indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software. If applicable, specify how needed tools can be accessed.
STANDARDS Describe what standards, if any, will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).
DATA PRESERVATION, ACCESS, AND ASSOCIATED TIMELINES

Give plans and timelines for data preservation and access, including:

  • The name of the repository(ies) where scientific data and metadata arising from the project will be archived. See Selecting a Data Repository for information on selecting an appropriate repository. 
  • How the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools.

  • When the scientific data will be made available to other users and for how long. Identify any differences in timelines for different subsets of scientific data to be shared.

    • Note that NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.
ACCESS, DISTRIBUTION, OR REUSE CONSIDERATIONS

Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to:

  • Informed consent
  • Privacy and confidentiality protections consistent with applicable federal, Tribal, state, and local laws, regulations, and policies
  • Whether access to scientific data derived from humans will be controlled 
  • Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements

  • Any other considerations that may limit the extent of data sharing. Any potential limitations on subsequent data use should be communicated to the individuals or entities (for example, data repository managers) that will preserve and share the scientific data. The NIH ICO will assess whether an applicant’s DMS plan appropriately considers and describes these factors. For more examples, see Frequently Asked Questions for examples of justifiable reasons for limiting sharing of data.
OVERSIGHT OF DATA MANAGEMENT AND SHARING

Indicate how compliance with the DMS Plan will be monitored and managed, the frequency of oversight, and by whom (e.g., title, roles). This element refers to oversight by the funded institution, rather than by NIH. The DMS Policy does not create any expectations about who will be responsible for Plan oversight at the institution.

Suggested language to include:

  • The award will be administered and managed through the Research Foundation for the State University of New York. Monitoring and execution of this Data Management and Sharing Plan will be the responsibility of the project’s Principal Investigator (PI). Compliance with the plan will be monitored by the PI routinely. Progress on data sharing and/or changes to the DMSP will be reported in the Research Performance Progress Report annually. The Office for Research and Innovation at Stony Brook University has created a data management and sharing plan compliance system as part of their process for review and submission of JIT requests, the annual NIH progress report, and the NIH final report.*

The OR&I data management and sharing plan compliance process includes coordination with the Office of Research Computing, Informatics, & Innovation (RCI2).  The  Assistant Vice President/Chief Research Information Officer (and/or a member of their team) conducts institutional compliance reviews of the PI's NIH DMSP at various stages of the proposal/award including at Just-in-Time (JIT) and Progress Report (if changes are proposed to the existing/approved DMSP).

Budgeting for Data Management and Sharing

Inclusion of DMS costs demonstrates to NIH that an Investigator has given thought to how much time is needed to achieve all aspects of the proposed research, including those aspects related to data management and sharing.

 

 
COST CONSIDERATIONS
  • What is the associated time/effort for collecting the data?
  • Anticipated repository fees?
  • What costs are likely to change during the course of the award?
  • Archival costs? During the project period and beyond?
ALLOWABLE COSTS

Reasonable, allowable costs may be included in NIH budget requests for:

  • Curating data
  • Developing supporting documentation
  • Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access
  • De-identifying data
  • Preparing metadata to foster discoverability, interpretation, and reuse
  • Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (for example, before deposit into an established repository).
  • Preserving and sharing data through established repositories, such as data deposit fees.
    • If the Data Management & Sharing (DMS) plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.

Note that all allowable costs submitted in budget requests must be incurred during the performance period, even for scientific data and metadata preserved and shared beyond the award period. 

For instance, if a DMS plan proposes preserving and sharing scientific data for 10 years in an established repository with a deposition fee, the cost for the entire 10-year period must be paid before the end of the period of performance.
UNALLOWABLE COSTS

Budget requests must NOT include:

    • Infrastructure costs that are included in institutional overhead (for instance, Facilities and Administrative costs) 
    • Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data. 
    • Costs that are double charged or inconsistently charged as both direct and indirect costs 
REQUESTING & JUSTIFYING COSTS FOR DMS

Costs to support the activities described in the Data Management and Sharing Plan must be requested in the appropriate cost category(ies), e.g., personnel, equipment, supplies, and other expenses.

Investigators must also include a justification of the activities proposed in the DMS Plan that will incur costs. This justification must be labeled as "Data Management and Sharing Justification" within the budget justification attachment, followed by the estimated dollar amount.

The justification should include a brief summary of type and amount of scientific data to be preserved and shared, and the name of the established repository(ies) to be used. It should also indicate general cost categories (such as curating data and developing supporting documentation, local data management activities, preserving and sharing data through established repositories, etc.); each category should include an amount and a brief explanation.

The recommended length of the justification should be no more than half a page and should be included as follows:
EXTERNAL TOOLS & RESOURCES TO HELP UNDERSTAND DMSP COSTS

SBU Resources

 

 
DMP TOOL

We encourage the use of the  DMPTool, a University-wide Resource for Creating Data Management Plans (DMP).The DMPTool is a free, open-source, online application that helps researchers create data management plans. It is highly recommended that Investigators utilize the DMPTool to develop and write their Data Management and Sharing Plans (DMSPs). The DMPTool provides a click-through wizard for creating a DMP that complies with funder requirements. It also has direct links to funder websites, help text for answering questions, and data management best practices resources.

  • Built-in Sponsor Specific DMS plan templates (NIH, NSF)
  • A click-through wizard for step-by-step plan creation
  • Sample language
  • Embedded guidance from the Sponsor (ie NIH), SBU, and the DMPTool
  • A process for requesting feedback on your plan from SBU Offices including Research Computing, Informatics, & Innovation (RCI) & University Libraries, as well as adding your collaborators, department administrators, and others!
  • A multi-format download function
University Libraries

SBU Libraries provide various resources and assistance with managing research data, including the following:

  • Workshops covering the many steps and importance of data management
  • Librarians that can review your data management and sharing plans, and provide consultations as needed (please send requests to dataservices@stonybrook.edu)
Web-based resources including research guides on various aspects of research data management
Research Computing, Informatics, & Innovation (RCI2)

The  Research Computing, Informatics, & Innovation (RCI2) team supports the research mission of the university by meeting the computing and informatics resource needs of researchers, and enabling the proficient and appropriate use of these resources.  The (RCI2) team is pleased to offer consultation and project review services. To request consultation, email SBMIT_Research_Services@stonybrookmedicine.edu. 
Office of Research Compliance

Human Subject Research (IRB)

    • The Human Research Protection Program has consent templates available in the myResearch IRB library that include language related to data sharing
    • A copy of the Data Management and Sharing Plan must be submitted with your IRB application. This plan can be uploaded into the myResearch IRB electronic submission system. Once the application is submitted the IRB will look for consistency between the Data Sharing Plan and other study related documents.

 
NIH Institutes/Centers Guidelines & Resources
Additional Tips & Resources

Selecting a Data Repository

NIH recommends the use of well-established data repositories to share your data.  In general, NIH does not endorse or require sharing data in any particular repository, although some initiatives and funding opportunities will have individual requirements. For a list of NIH-supported repositories, visit Repositories for Sharing Scientific Data. Overall, NIH encourages researchers to select the repository that is most appropriate for their data type and discipline. See Selecting a Data Repository. 

Stony Brook has an institutional data repository, called Dryad. This resource is freely available to SBU researchers. It requires an ORCiD ID in order to create an account and login. There is another repository available for publications and smaller datasets, called Academic Commons. 

FAQs About the NIH Data Management and Sharing Policy

See the NIH 2023 Data Management & Sharing Policy FAQs.

Do I Need to Authenticate Key Biological and/or Chemical Resources? If So, How?

NIH’s Rigor and Reproducibility FAQs have been updated with new questions and answers about authenticating key biological/chemical resources:

Have more questions on this topic? Check out the Authentication of Key Biological/Chemical Resources section, or visit the complete set of Rigor and Reproducibility FAQs.

How Do I Craft a Strong NIGMS Application?

You’ve determined that you’re conducting research related to the NIGMS mission and have found a notice of funding opportunity (NOFO) you’d like to apply to. Now it’s time to craft your application.

There are many resources providing guidance on what to include in an NIH funding application. NIGMS recommends reviewing their grant writing webinar series, which discusses faculty readiness and submission considerations, as well as determining whether a funding opportunity is right for you and writing a competitive application. NIH’s Write Your Application webpage also includes valuable guidance.

In this post, we offer additional pointers on timing and planning your application, soliciting feedback, and writing with your reviewers in mind.

News & Information

New Tool to Explore NIH Grant Opportunities

(9/24/25)

Familiarize yourself with the new Explore NIH Grant Opportunities tool. Use its NIH-specific filters, sort, and advanced search options to help you quickly identify funding opportunities posted on Grants.gov.

Starting in October 2025, Grants.gov is the single official source for NIH notices of funding opportunities (NOFOs). NIH will no longer post NOFOs in the NIH Guide for Grants and Contracts. The NIH Guide will continue as your primary source for policy and informational notices.

We encourage you to use Grants.gov Subscriptions to get email notifications of new opportunities and custom search results. Direct any questions about Grants.gov search or subscriptions to the Grants.gov Support Center.

Try the Search Tips for NIH Opportunities to learn more about the new Explore tool and Grants.gov searches.

Introducing Highlighted Topics: A Centralized and Simple Resource to Learn about Research Areas of Interest to NIH(8/29/25)

We are excited to announce a new centralized and simplified resource, called NIH Highlighted Topics, that informs the research community about particular areas of science of interest to NIH. Visiting this resource early and often when conceptualizing your research ideas will help ensure you are aware of some of NIH’s latest scientific interests. It also aims to help facilitate innovation and discovery through a strong focus on more investigator initiated driven research.  

Our Highlighted Topics resource represents scientific areas where NIH encourages applications from the community. These topics target areas within the NIH mission, including areas that may not be readily associated with the particular funding Institute or Center or may even be a new or emerging area that is not well known. Please understand that these are simply topical area descriptions, not funding opportunities.  For full text, visit https://grants.nih.gov/news-events/nih-extramural-nexus-news/2025/08/introducing-highlighted-topics-a-centralized-and-simple-resource-to-learn-about-research-areas-of-interest-to-nih 

Updates to NIH Inclusion Policy (8/27/25)

When you prepare inclusion plans for your next applications or data for progress reports, review the updated Revision: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research (NOT-OD-25-131), effective August 16, 2025 for both new and ongoing clinical research projects.

The policy remains substantially unchanged. As before:

The revisions focus on terminology updates to align with HHS Sex-Based Definitions and Executive Order 14168. Inclusion plans and data reporting must consider and report on sex, race and/or ethnicity, and age.

Of note, the policy also mentions the federal race and ethnicity categories in the OMB Statistical Policy Directive No. 15 revision announced March 28, 2024. As discussed in the December 2024 Extramural Nexus article, award recipients should continue to report inclusion data to NIH using the 1997 categories until further notice.

Apply Responsibly: Policy on AI Use in NIH Research Applications and Limiting Submissions per PI (7/31/25)

 

NIH has recently announced a new policy that will continue to support originality, creativity, and fairness in the research application process. NIH has noticed that some Principal Investigators (PIs) have been submitting a large number of research applications that far exceed the numbers we traditionally expect and may have been prepared using artificial intelligence (AI) tools. 

While AI may be a helpful tool in preparing applications, the rapid submission of large numbers of research applications from a single PI may undermine the fairness and originality of the research application process and unfairly strain NIH’s application review processes.  

As use of AI tools becomes more commonplace, it is important to remember that applicants may use AI in limited aspects to reduce administrative burden while preparing applications. However, applicants should be mindful of the concerns around research misconduct or lack of originality when using such tools. Remember, NIH peer reviewers are prohibited from using AI for their critiques.   

To address these issues, the new policy is effective for the September 25, 2025, receipt date and beyond: 

  • Applications that are either substantially developed by AI or containing sections substantially developed by AI are not considered the original ideas of applicants and will not be considered by NIH. 
  • NIH will also only accept up to six new, renewal, resubmission, or revision applications from an individual PD/PI (Program Director/Principal Investigator) or Multiple Principal Investigator for all council rounds in a calendar year.  For more details on applicability, investigator roles, and impacted application types, please see these new FAQs.  

Based on historical data, we expect this policy will impact a relatively small number of investigators. For example, in 2024 only 1.3% of applicants submitted more than 6 applications. 

We appreciate the research community’s continued interest in ensuring applications submitted to NIH remain representative of their original thought and creativity. This policy will allow NIH to continue to advance biomedical research and appropriately steward taxpayer dollars.  

Common Forms for Biographical Sketch and Current and Pending (Other) Support (NIH) (3/26/25)

To further support a successful transition to the Common Forms, NIH is postponing the May 25, 2025 implementation for all applications and Research Performance Progress Reports (RPPRs). NIH will issue future Guide Notices outlining the new effective date and additional implementation details as they are finalized. NIH applicants and recipients must continue to use the current NIH  Biosketch  and  Other Support  format pages for applications, Just-in-Time (JIT) and RPPRs.

Implementation of New Initiatives and Policies Webpage (3/26/25)

This page serves as a central location where you can learn more about the status of changes impacting NIH grants process and plans for implementing new initiatives and policies.  On this page you will find : NIH Grants and Funding Information Status; Upcoming Changes; Recent Changes

 

Updated NIH Grants Policy Statement for Fiscal Year 2024 (Posted 5/13/24)

The updated NIH Grants Policy Statement (NIHGPS) is here for fiscal year 2024! The NIHGPS provides the policy requirements that serve as NIH standard terms and conditions of award for all NIH grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants.

This revision incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies since the previous version of the NIHGPS dated December 2022. For an overview of key updates, see Significant Changes to the GPS for FY 2024. This update is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2023. This update supersedes, in its entirety, the NIHGPS dated December 2022. Previous versions of the NIHGPS remain applicable as standard terms and conditions of award for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2023.

For more details, see the full Guide Notice.

Reporting Data Management and Sharing (DMS) Plan Activities in the Research Performance Progress Report (RPPR) NOT-OD-24-123 (Posted 5/9/24)

This Notice informs the extramural research community of planned changes to the Research Performance Progress Report (RPPR) instructions to address the NIH Data Management and Sharing Policy. Upon receiving approval from the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA), NIH will issue new DMS RPPR questions that align with the NIH Final Policy on Data Management and Sharing, to include updates on the status of data sharing, repositories and unique identifiers for data that have been shared.

Availability of Additional Guidance

The updated NIH RPPR Instruction Guide will be posted to the Research Performance Progress Report (RPPR) page upon approval from OIRA. NIH plans to implement the new questions for RPPRs submitted on or after October 1, 2024. 

Resources

Notice to Extend Parent R01/R03/R21 Parent Notices of Funding Opportunities (posted 4/14/24)

The purpose of this notice is to extend the expiration date for following Notices of Funding Opportunities (NOFOs): 

  • NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) PA-20-185 
  • Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) PA-20-184 
  • Research Project Grant (Parent R01 Clinical Trial Required) PA-20-183 
  • NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed) PA-20-200 
  • NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) PA-20-195 
  • NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) PA-20-194 
  • NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required) PA-20-196 

Current Key Dates

Expiration Date: May 8, 2023 

Modified Key Dates

Expiration Date: January 8. 2025

All other aspects of these NOFOs remain the same.

 

Common Forms for Biographical Sketch and Current and Pending (Other) Support

NIH is adopting the Biographical Sketch Common Form and the Current and Pending (Other) Support Common Form in 2025 as per the White House Office of Science and Technology Policy (OSTP) memorandum on Policy Regarding Use of Common Disclosure Forms for applications and Research Performance Progress Reports (RPPRs) submitted on or after May 2025.

The Common Forms represent a collaborative effort between Federal research agencies to ensure standard disclosure requirements as outlined in the National Security Presidential Memorandum - 33.

Resources:
New NIH "FORMS-I" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2025

This notice informs the applicant and recipient communities of changes to grant application forms and application guide instructions for due dates on or after January 25, 2025.

The following application forms include substantive form changes (i.e., new/deleted/modified fields). All other forms include only an OMB expiration date change.

  • PHS 398 Research Training Program Plan
  • PHS Fellowship Supplemental Form
  • PHS Assignment Request Form
  • PHS 398 Cover Page Supplement Form

Key Changes:

  • A new attachment field for the Recruitment Plan to Enhance Diversity on the PHS 398 Research Training Program Plan. Additional changes for institutional training grants will be detailed via NIH Guide notice by late spring 2024.
  • As part of NIH efforts to improve the peer review process for NRSA Fellowship applications, there will be modifications to some sections of the PHS Fellowship Supplement Form. Additional details will be provided via an NIH Guide notice by late spring 2024.
  • NIH adoption and required use of the Common Forms for Biographical Sketch and Current and Pending (Other) Support by May 2025. Additional details will be communicated via NIH Guide notice by summer 2024. 

See High-level Summary of Form Changes in FORMS-I Application Packages for a full list of known form changes. These changes will be implemented with application form packages identified with a Competition ID of "FORMS-I" and associated application guide instructions. Additional guidance and confirmation of implementation plans will be provided in fall 2024.

Effective Date

Applicants must use FORMS-I application packages for due dates on or after January 25, 2025, and must use FORMS-H application packages for due dates on or before January 24, 2025. Applications submitted using an incorrect forms package for their intended due date will be withdrawn and removed from funding consideration.

Availability of FORMS-I Application Guides

Application guides for FORMS-I application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2024.

Availability of FORMS-I Application Packages

FORMS-I application packages will be posted as follows:

  • New Notices of Funding Opportunities (NOFOs) will be posted with FORMS-H and/or FORMS-I application packages, as appropriate, beginning October 25, 2024.
  • New NOFOs posted before October 25, 2024, with initial due dates on or after January 25, 2025, will be posted without application forms until updated forms are available. Application packages will be added to these NOFOs between October 25, 2024, and November 25, 2024, with all application forms packages posted 30 calendar days or more prior to receipt dates.
  • All active Parent and IC-issued NOFOs with due dates on or after January 25, 2025, will be reissued or updated to add FORMS-I application packages between October 25, 2024, and November 25, 2024, with all application forms packages posted 30 calendar days or more prior to receipt dates.

For a transition period, both FORMS-H and FORMS-I application packages will be active simultaneously. Applicants must choose the appropriate application package for their due date when presented with both FORMS-H and FORMS-I application packages on the same NOFO (see table below).

Reminder: When an application due date falls on a weekend, Federal holiday, or Washington, DC area Federal office closure, the application deadline is automatically extended to the next business day.
Updates to NIH Training Grant Applications (Posted 4/5/2024)

The NIH National Research Service Award (NRSA) Training Program applications are undergoing changes that take effect for submissions due on or after January 25, 2025.

These modifications impact the PHS 398 Research Training Program Plan Form (the Recruitment Plan to Enhance Diversity will become its own attachment instead of part of the 25-page program plan) and the NRSA Training Tables. These changes will impact NRSA training grant applications and other applications that use the T forms (such as K12s) submitted for due dates on or after January 25, 2025.

Goals

  • Update the NRSA Data Tables to reduce applicant and reviewer burden.
  • Include training in the Responsible Conduct of Research and Recruitment Plan to Enhance Diversity as items that contribute to the overall impact score. 
  • Enhance research training programs by further defining expectations for mentor training and clarifying positive outcomes related to preparing trainees for the breadth of research and related careers relevant to the NIH mission.

Learn More

 
Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024

This Notice provides information regarding the salary limitation for NIH grant and cooperative agreement awards and extramural research and development contract awards.

Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards (referred to here as a grant). The mandate appears in the annual appropriation act that provides authority for NIH to incur obligations for a given Fiscal Year (FY). At this time, NIH has not received an FY 2024 appropriation and is operating under a Continuing Resolution, the "Further Continuing Appropriations and Other Extensions Act, 2024 (Public Law 118-22)”, that applies the terms and conditions of the Consolidated Appropriations Act, 2023.

The Consolidated Appropriations Act, 2023 restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. The Office of Personnel Management recently released new salary levels for the Executive Pay Scale. Effective January 1, 2024, the salary limitation for Executive Level II is $221,900.

For active awards, including awards that have been issued in FY 2024 (continuation and new) that were restricted to Executive Level II, if adequate funds are available, and if the salary cap increase is consistent with the institutional base salary, recipients may rebudget funds to accommodate the current Executive Level II salary level.

Once the Department of Health and Human Services Appropriation for FY 2024 is enacted, NIH will publish the annual Notice of legislative mandates to provide information on any statutory provisions that limit the use of NIH grant funds in FY 2024.
Use The New NIH Workflow to Check If The Single IRB Requirements Apply

If your next new or competing renewal application includes human subjects research, take advantage of NIH’s new Single IRB (sIRB) Requirement Determination Workflow (PDF) to help determine whether your project is subject to the single institutional review board (IRB) requirements. Follow the steps in the Workflow PDF to ascertain whether your research falls under the NIH sIRB Policy or the revised Common Rule Cooperative Research sIRB mandate.

Learn more about Single IRB for Multi-Site or Cooperative Research requirements.

Please note that if sIRB applies to your application, kindly outreach to SBU ORC and visit the ORC sIRB page for more information.
NIH Application Instruction Updates - Data Management & Sharing (DMS) Costs

NOT-OD-23-161: This notice updates the NIH application instructions for submitting requests for Data Management and Sharing costs in a single line item. As outlined in the Final NIH Policy on Data Management and Sharing (DMS), costs associated with data management and data sharing may be allowable under the budget for the proposed project. Currently, the NIH How to Apply - Application Guide states that costs to support activities described in the DMS plan, including personnel costs, must be noted on the R&R Budget Form as a single line item titled “Data Management and Sharing Costs.” The line item must be used only for DMS costs and cannot be combined with any “Other” costs. If no costs will be incurred, the applicant must enter “0” in the funds requested column. These previous instructions will be rescinded effective October for due dates on or after October 5, 2023.

Effective for applications submitted for due dates on or after October 5, 2023, NIH will no longer require the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories. Therefore, in line with our standard budget instructions, DMS costs must be requested in the appropriate cost category, e.g., personnel, equipment, supplies, and other expenses, following the instructions for the R&R Budget Form or PHS 398 Modular Budget Form, as applicable. While the single cost line item is no longer required, NIH will require applicants to specify estimated DMS cost details within the “Budget Justification” attachment of the R&R Budget Form or “Additional Narrative Justification” attachment of the PHS 398 Modular Budget Form, pursuant to the instructions.

Updates to the NIH How to Apply – Application Guide will be published prior to the October 5, 2023, effective date. 
NHLBI Supplement to the NIH Policy on Data Management and Sharing (effective May 25, 2023)

NHLBI Supplement to the NIH Policy for Data Management and Sharing, NOT-HL-23-070, the purpose of this Notice is to announce that the National Heart, Lung, and Blood Institute Supplement to the NIH Policy for Data Management and Sharing (NHLBI Supplement) is effective May 25, 2023, and replaces the previous NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies. The NHLBI Supplement harmonizes with the National Institutes of Health (NIH) Final NIH Policy for Data Management and Sharing (NIH DMS Policy), the latter which became effective on January 25, 2023, and applies to research funded or conducted by NIH that results in the generation of scientific data. The NHLBI Supplement also establishes additional expectations for NHLBI-supported researchers subject to the NIH DMS Policy, including for special compliance timelines, data repositories, and ancillary studies.  
FORMS-H: Instructions, Forms and a Handy Checklist

Investigators must use FORMS-H forms for grant application due dates on or after January 25, 2023.  The FORMS-H application instructions are posted and FORMS-H application packages are starting to show up on active opportunities.  The link provided here to the NIH Forms H checklist will help you navigate the changes.  Please do not hesitate to contact your OSP Pre-Award Grants Specialist for additional guidance. 
NIH Grants Policy Statement

The National Institutes of Health (NIH) announces publication of the updated NIH Grants Policy Statement (NIHGPS, rev. December 2022). The NIHGPS provides both up-to-date policy guidance that serves as NIH standard terms and conditions of award for all NIH grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants.  See Significant Changes to the GPS for FY 2023 
Data Management & Sharing Plan

The NIH Data Management & Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. This includes all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements.

 

NIH Post-Award Monitoring and Reporting

The information provided below is a brief overview of selected monitoring and reporting requirements. For full details on any of these topics, see the NIH Grants Policy Statement. For specific questions, consult first with your  OSP Post-Award Grants Specialist . The assigned NIH program officials and NIH grants management specialists are also available to answer any remaining questions.  Their contact information can be found on your Notice of Award and in your eRA Commons Award file.

Prior Approval Requests

National Institutes of Health (NIH) Policy allows grantees (recipients) a level of discretion when making changes to budgeting or grant-related activities to meet unanticipated needs. Some changes may be made at the recipient’s discretion as long as they are within the limits established by NIH and the relevant Institute/Center; others will require written prior approval as defined in the Grants Policy Statement (GPS) and the terms and conditions in the Notice of Award (NoA).

The eRA Commons Prior Approval module is available for electronic submission of several prior approval requests (e.g., Withdrawal of an application, $500K or More Direct Costs, Change of Principal Investigator (PI), No Cost Extension beyond 12 months, and Carryover). Recipients may submit other requests by email via an Authorized Organization Representative or Institutional Signing Official (AOR/SO).  To identify your AOR/SO, please contact your OSP Post-Award Grants Specialist.

Once submitted, the awarding Institute/Center (IC) Grants Management Specialist (GMS) and Program Officer (PO) will review the request and a response will be sent to the AOR/SO with copies to the Principal Investigator (PI) or Program Director (PD).

Failure to receive Prior Approval may result in enforcement action such as the disallowance of costs or termination of award or other actions within NIH agency authority.

See the NIH Grants Policy Statement on Prior Approval Requirements that describes the activities and/or expenditures that require NIH prior approval.

Common Prior Approval Requests

    • No Cost Extension (Extending the Project Period)
    • Change of the Principal Investigator (PI) or Program Director (PD); or Key Personnel; or from single to multiple PIs (or vice versa) named in the NoA requires prior approval from the awarding NIH IC.
    • Change in the effort of the PI/PD or other Key Personnel named in the NoA requires prior approval from the awarding NIH IC when the effort level devoted to the project changes by 25 percent or more from what was approved in the initial competing year award; or if the PI/PD is absent for any continuous period of 3 months or more. 
    • Change of Institution
    • Carryover Funds to Current Budget Period: Carryover is the process by which recipients carry forward unobligated funds to cover allowable costs in the current budget period. Most grants have automatic carryover authority, and recipients do not have to request approval from the IC to carryover funds from one budget period to the next.
    • Rebudgeting
Research Performance Progress Report (RPPR)

The RPPR is required for all annual non-competing (Type 5) NIH awards and final progress reports (Final-RPPR), including SBIR/STTR awards.  NIH requires the submission of an “Interim-RPPR” if the recipient organization has submitted a renewal application (Type 2) on or before the due date by which a Final-RPPR would be required for the current competitive segment.

Progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. NIH has implemented the Final and Interim-RPPR for final progress reporting here: https://grants.nih.gov/grants/funding/finalprogressreport.pdf.

RPPR Related Resources:

RPPR Online Help (screenshots and step-by-step instructions)

NIH RPPR Instruction Guide (PDF) (MS Word)

Screen Shots of the R01-like RPPR (PDF)

NIH Public Access Policy

Guide to Categorizing Products in RPPR's Sec. C (PDF)

Sample Project Outcomes Summary - RPPR

Interim and Final RPPR webinar

NIH Samples: Applications, Attachments and other Documents

Forms-I Instructions, Forms and Checklist

SBU Resources & Templates