HEAL Initiative: Pain Research Enhancement Program (R15 clinical trial optional) is sponsored by NIH (HEAL Initiative). Supports basic and mechanistic pain research and interdisciplinary partnerships at R15‑eligible institutions, enhancing pain research environments.

RFA-AT-25-003: HEAL Initiative: Pain Research Enhancement Program (PREP) (R15 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Complementary and Integrative Health ( NCCIH ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Neurological Disorders and Funding Opportunity Title HEAL Initiative: Pain Research Enhancement Program (PREP) (R15 Clinical Trial Optional) R15 Academic Research Enhancement Award (AREA) March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 213, 93.

846, 93. 273, 93. 121, 93.

866, 93. 865, 93.

853 Funding Opportunity Purpose The purpose of this HEAL Initiative program is to: (1) support basic and mechanistic pain research from R15-eligible undergraduate-focused serving institutions, health professional schools or graduate schools; (2) promote integrated, interdisciplinary research partnerships between Principal Investigators (PIs) from R15-eligible institutions and investigators from U.S. domestic institutions; and (3) enhance the pain research environment at the R15-eligible institution for health professional students, undergraduate and/or graduate students through active engagement in pain research.

Applications in response to this notice of funding opportunity (NOFO) should include plans to accomplish these goals. Specifically, applications should include a rigorous plan for conducting basic and mechanistic pain research in the Research Strategy section of the application .

In addition, a research partnership between the PI’s institution and at least one investigator from a separate U.S. domestic institution that provides resources and/or expertise that will enhance the proposed pain research program must be included in a separate Team Management Plan. The proposed partnership will be a sub-award agreement(s) with at least one partnering institution, which does not need to be R15-eligible.

The budget of all sub-awards must not exceed one third of the total budget. Furthermore, applications must include a Facilities & Other Resources document that demonstrates active involvement of health professional students, undergraduate and/or graduate students from the R15-eligible institution(s) in the proposed pain research projects.

Funding Opportunity Announcement Goal(s) The National Center for Complementary and Integrative Health (NCCIH) provides funding for research into complementary and integrative health approaches. Eligible entities (including, but not limited to: research and academic institutions, private companies) may submit research grant applications using the Grants. gov website.

All applications undergo a rigorous, 2-stage, peer-review system, and funding decisions are made based on the review of applications that are most meritorious and responsive to the mission of NCCIH. Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The purpose of this HEAL Initiative program is to: (1) support basic and mechanistic pain research from R15-eligible undergraduate-focused serving institutions, health professional schools or graduate schools; (2) promote integrated, interdisciplinary research partnerships between Principal Investigators (PIs) from R15-eligible institutions and investigators from U.S. domestic institutions; and (3) enhance the pain research environment at the R15-eligible institution for health professional students, undergraduate and/or graduate students through active engagement in pain research.

Applications in response to this notice of funding opportunity (NOFO) should include plans to accomplish these goals. Specifically, applications should include a rigorous plan for conducting basic and mechanistic pain research projects in the Research Strategy section of the application.

In addition, a research partnership between the PI’s institution and at least one investigator from a separate U.S. domestic institution that provides resources and/or expertise that will enhance the proposed pain research program must be included in a separate Team Management Plan. The proposed partnership will be a sub-award agreement(s) with at least one partnering institution, which does not need to be R15-eligible.

The budget of all sub-awards must not exceed one third of the total budget. Furthermore, applications must include a Facilities & Other Resources document that demonstrates active involvement of health professional students or undergraduate and/or graduate students from the R15-eligible institution(s) in the proposed pain research projects.

The National Institutes of Health (NIH) Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® , bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the NIH HEAL Initiative is available at https://heal. nih.

gov/ . The initiative has funded multiple pain workforce enhancement programs that support early-career investigators. Despite these efforts, the NIH HEAL Initiative can benefit from additionally supporting R15-eligible institutions that involve undergraduate, graduate or health professional school/colleges students in pain research.

Since Fiscal Year (FY) 1985, NIH has made a special effort to stimulate research at educational institutions that provide baccalaureate and/or advanced degrees for a significant number of the nation’s research scientists who have not been major recipients of NIH support.

NIH has implemented two parent award programs, the Academic Research Enhancement Award (AREA) program ( PAR-21-155 ) and Research Enhancement Award Program (REAP) ( PAR-22-060 ), to provide research experiences to health professional or undergraduate and/or graduate students pursuing biomedical or behavioral research at U.S. higher education institutions. Utilizing these two programs will further promote a broad pain research workforce.

This Pain Research Enhancement Program (“PREP”) will further support meritorious collaborative pain research from designated educational levels in the NIH HEAL Initiative, using the NIH Research Enhancement Award programs as a guide.

Specifically, this NOFO aims to support new scientific solutions to the national opioid public health crisis by establishing new research partnerships that will lead to research experiences for undergraduate, graduate, and health professional students, to further enhance the pool of potential participants in the pain research pipeline.

The purpose of this HEAL Initiative program is to: (1) support basic and mechanistic pain research from R15-eligible undergraduate-focused serving institutions, health professional schools or graduate schools; (2) promote integrated, interdisciplinary research partnerships between Principal Investigators (PIs) from R15-eligible institutions and investigators from U.S. domestic institutions; and (3) enhance the pain research environment at the R15-eligible institution for health professional students, undergraduate and/or graduate students through active engagement in pain research.

Successful applications will include plans detailing how they intend to accomplish all three goals. Please refer to Section III for specific R15 eligibility information. Although preliminary data are not required for an R15 application, they may be included if available.

The scientific foundation for the proposed research should be based on published research and/or any available preliminary data. Objective 1: Develop Small-Scale Basic and Mechanistic Pain Research Projects Proposed research projects should be hypothesis driven and use a rigorous scientific design to generate research data/evidence and advance scientific knowledge.

Applications should include objectives that are attainable within the 3-year grant period.

Pain research projects may include, but are not limited to, the study of: nociception and/or pain processing in non-pain populations, acute pain, cancer pain, chemotherapy-induced neuropathy, chronic pain, diabetic neuropathy, eye pain, gynecologic pain, headache, musculoskeletal pain, myofascial pain, obstetric pain, osteoarthritis, pain conditions across the lifespan (including in the context of aging), pain co-occurring with substance use disorders (SUDs), painful disorders of the orofacial region, painful neuropathy, post-stroke pain, post-surgical pain, sickle cell pain, and/or visceral pain.

Innovative pain research topics that propose an interdisciplinary mechanistic pain research are considered high program priority under this initiative. Projects may focus on basic pain research with pre-clinical ( e.g., animal or in silico ) models or involve research participants ( e.g., observational studies, epidemiological studies, secondary data analyses, or device development).

Alternatively, investigators may propose a mechanistic and/or “Basic Experimental Studies involving Humans” (BESH) clinical trial as described below. Clinical trials designed primarily to determine the safety, tolerability, and/or clinical efficacy of an intervention will be considered non-responsive to this NOFO and withdrawn without review.

For this NOFO, only the following types of clinical trials will be supported: Basic Experimental Studies with Humans (BESH) , defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.

Mechanistic trials , defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., how an intervention works, but not if it works or is safe) NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes ( https://grants.

nih. gov/grants/guide/notice-files/NOT-OD-15-015. html ).

For further clarification on how NIH defines the different types of clinical trials, please refer to the following resources: NOT-OD-15-015: Notice of Revised NIH Definition of Clinical Trial NIH's Definition of a Clinical Trial Decision Tree for NIH Clinical Trial Definition Guidance for Basic Experimental Studies with Humans (BESH) Funding Opportunities NIH Definition of Clinical Trial Case Studies Objective 2: Promote Integrated, Interdisciplinary Research Partnerships A second key objective of this NOFO is to promote new research partnerships among investigators at R15-eligible institutions with separate (legally distinct) investigators at domestic research institutions.

Investigators can have a multitude of research expertise that aligns with the proposed research projects and/or resources that can be shared to enhance the proposed research. Applications must propose a collaboration with at least one sub-award holder from a separate U.S. domestic research institution and should include details of how the collaboration will enhance the R15-research program must be described.

Applications are permitted to have a subaward to a non-R15-eligible institution. However, it is expected that PD/PI(s) from R15-eligible institution(s) will lead the proposed project and complete most of the research at the R15-eligible institution. As such, PI(s) from R15-eligible institutions must serve as the contact program director (PD)/PI for the project.

Additionally, no more than one third of the total budget for the project may be used by the identified sub-award institution. Applications that propose new interdisciplinary are considered a high program priority under this NOFO.

Interdisciplinary partnership could include, but are not limited to, any two or more areas of research expertise from the following: Clinical pain management (e.g., nonpharmacologic or pharmacologic interventions) Preclinical/basic pain biology and modeling Specific disease and/or pathological conditions (either human or preclinical models) In addition, a Team Management Plan is required as part of Objective 2.

Studies of team science have highlighted the need for effective management structures to achieve program goals. Many resources exist to aid in developing effective team-based programs (e.g., the National Cancer Institute Collaboration and Team Science Field Guide ). The Team Management Plan focuses on management of the whole team/key personnel.

Because teams will likely include individuals from widely divergent scientific backgrounds, teams must have a shared vision and a defined plan for communication and management of shared responsibilities, interpersonal interactions, and professional credit. The Team Management Plan should be included as an attachment (three pages maximum) to this application.

It should address how the research team, including the PI from R15-eligible Instiution and collaborator(s), will work together to accomplish program objectives. See the application instructions for “Other Attachments” on the SF424(R&R) Other Project Information in Section IV. 2 Instructions for Application Submission for details.

The Team Management Plan should address the following points: Organizational structure and team composition and roles Shared leadership, contributions, and distributed responsibility for decision-making Resource sharing and allocation Credit assignment and/or intellectual property (IP) rights Coordination and communication plans Intra-team data sharing, archiving, and preservation Objective 3: Enhance the Research Environment by Engaging Students The third objective of this program is to enhance the pain research environment at the R15-eligible institution by engaging and providing research opportunities to health professional students or undergraduate and/or graduate students.

A Facilities & Other Resources document is required to describe how the proposed research will enhance the pain research environment at the R15-eligible institution. Two-thirds of the proposed research project team should comprise personnel from the R15-eligible institutions, including health professional students, or graduate students or undergraduate students from the primary R15-eligible institution.

Although the proposed research project must be led by the identified PD/PI, applications with strong and innovative student engagement are of high program priority. If participating students have not yet been identified, the number and academic stage of those to be involved should be provided. Applications should identify which aspects of the proposed research will include student participation.

Student involvement may include participation in the design of experiments, collection and analysis of data, execution and troubleshooting of experiments, participation in research meetings, and discussion of future research directions.

When applicable, it is highly desirable that student participation also include presentation of research at local and/or national meetings (including the HEAL Annual Scientific Meeting and "Positively Uniting Researchers of Pain to Opine, Synthesize, & Engage" {PURPOSE} meeting), publication of journal articles, and collaborative interactions.

By engaging in these activities and collaborating on pain-focused research projects at early stages of training, students will be better prepared and motivated to pursue careers in pain research. Please see Section III for a list of eligible students. This NOFO aims to support pain research grants, not training or fellowship program s.

As such, applications should not include training plans such as didactic training or non-research activities related to professional development. Likewise, applications should not include independent student research projects. For applications that propose a clinical trial, the PD/PI must be the responsible individual of record for oversight of the trial though students can take part in all components of a clinical trial.

Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the student can gain experience in all these components in conjunction with the individual leading the trial.

Applications submitted to this NOFO may include additional investigators to those outlined above, including additional collaborators or consultants, or other individuals such as high school students, post-baccalaureate participants, postdoctoral fellows, or clinical fellows.

However, involvement of such individuals does not fulfill the goal of enhancing the R15-eligible institutional environment and should account for less than one third of the overall proposed project team. Non-responsiveness Criteria: Applications deemed to be non-responsive will not proceed to review and will be withdrawn.

Applications with one or more of the following characteristics are considered non-responsive to this NOFO: Research that does not address the NIH HEAL Initiative mission to enhance pain management. Failure to describe a proposed Research plan and specific aims primarily led by a PI from a R15-eligible Institution.

Omission of a domestic research partnership and accompanying sub award(s), or that include sub-award(s) that account for more than one third of the total project budget.

Failure to include the required Facilities & Other Resources document and Other Attachments, including a Team Management Planand, letters of support, including a letter of support from the identified subaward holder(s) and a letter of support from the R15-eligible institution’s provost. Please see s ection IV. 2 “Instructions for Application Submission” for details.

Proposing a clinical trial addressing safety, tolerability, efficacy, and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or noninvasive) interventions. Contacting Program Officers Prior to Submission Applicants are strongly encouraged to consult with program staff as plans for an application are being developed.

Rigor and Reproducibility NIH strives for rigor and transparency in all research it funds. For this reason, the NIH HEAL Initiative explicitly emphasizes the NIH application instructions related to rigor and transparency ( https://grants. nih.

gov/policy/reproducibility/guidance. htm ) and provides additional guidance from individual NIH institutes and centers (ICs) to the scientific community. For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner.

If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

Proposed research projects should incorporate adequate methodological rigor where applicable, including but not limited to a clear rationale for the chosen model(s) and primary/secondary endpoint(s), clear descriptions of tools and parameters, blinding, randomization, adequate sample size, prespecified inclusion/exclusion criteria, appropriate handling of missing data and outliers, appropriate controls, pre-planned analyses, and appropriate quantitative techniques.

Applications should also clearly indicate the exploratory vs. confirmatory components of the study, consider study limitations, and plan for transparent reporting of all methods, analyses, and results so that other investigators can evaluate the quality of the work and potentially perform replications.

NIH intends to maximize the impact of NIH HEAL Initiative-supported projects through broad and rapid data sharing and immediate access to publications ( https://heal. nih. gov/about/public-access-data ).

Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal. nih. gov/data/complying-heal-data-sharing-policy .

More details about NIH HEAL Initiative data sharing are described in Section IV.

Clinical Trial Accrual Policy: For applications that are proposing to conduct a clinical trial, a series of clinical recruitment milestones detailing completion of the clinical trial and providing contingency plans to proactively confront potential delays or disturbances in attaining the clinical recruitment milestones must be included along with a study timeline in the PHS Human Subjects and Clinical Trials Information form.

Continuation of the award is conditional upon satisfactory progress, availability of funds, and scientific priorities of the NIH HEAL Initiative. If, at any time, recruitment falls significantly below the projected milestones for recruitment, NIH will consider ending support and negotiating an orderly phaseout of the award. NIH retains the option of periodic external peer review of progress.

NIH program staff will closely monitor progress at all stages for milestones, accrual, and safety. Expected Activities of Coordination NIH HEAL Initiative awardees are strongly encouraged to cooperate and coordinate their activities.

It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after post award by participating in PD/PI meetings, including: NIH HEAL Initiative Scientific Meeting Attendance Applicants and students are highly encouraged to attend the annual NIH HEAL Initiative Scientific Meetings.

The NIH HEAL Initiative hosts an annual meeting of more than 800 NIH HEAL Initiative-funded researchers across the initiative’s research portfolio and career stage spectrum, NIH staff, people with lived and living experience, community partners advising initiative-funded projects, advocacy groups, and other stakeholders to Share research advances and cutting-edge science Discover opportunities, challenges, and approaches to build on the initiative’s progress Connect and explore collaboration with other NIH HEAL Initiative-funded researchers and collaborators to enhance initiative-funded research.

Annual National Pain Scientists Career Development Program (PURPOSE) Meeting Applicants and students are also highly encouraged to enroll in the HEAL Initiative: Positively Uniting Researchers of Pain to Opine, Synthesize, and Engage (PURPOSE) network and attend its annual meetings. Details can be found at https://painresearchers. com .

The HEAL R24 Coordinating Center for National Pain Scientists works to improve the collaboration between basic, translational, and clinical researchers who do not regularly collaborate or work together. One function of the HEAL R24 Coordinating Center for National Pain Scientists is to organize an annual meeting for established scientists as well as early-career pain investigators.

This annual meeting facilitates the creation of a network of pain research mentors and mentees as well as fostering communication between scientists and clinicians of different disciplines and providing enhanced mentorship, leadership courses, and any additional training that might be helpful for early-career scientists. R15 recipients are encouraged to attend the annual PURPOSE meeting, either virtually or in person. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The NIH HEAL Initiative intends to commit an estimated total of $1. 25 million to fund up to three awards per year for FY 2026 and FY 2027.

Support for this funding opportunity is contingent upon annual NIH appropriations and the submission of a sufficient number of meritorious applications Applicants may request up to $375,000 in direct costs for the entire project period. No more than one third of total project costs may go to non-R15-eligible institutions. Annual inflationary increases are not allowed.

The scope of the proposed project should determine the project period. The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

In addition, applicant organizations must meet the following criteria at the time of submission: The applicant organization must be an accredited public or nonprofit private school that grants baccalaureate or advanced degrees in health professions (see section below for more details) or biomedical and behavioral sciences.

The application must be submitted by the eligible organization with a unique entity identifier (such as UEI or DUNS) and a unique NIH eRA Institutional Profile File (IPF) number. At the time of application submission, determination of eligibility will be based in part on NIH institutional support. A year is defined as a Federal fiscal year: from October 1 through September 30.

Note that collaborating subawardees do not need to adhere to the R15 eligibility criteria stated above. However, they must be separate legal entities that fulfill the terms of an eligible subaward agreement. For this particular NOFO, they must also be U.S. domestic institutions.

More details can be found at https://grants. nih. gov/policy/subawards .

Undergraduate Focused Institutions: At the time of application submission, all the non-health professional components of the institution combined must not have received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 years.

For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole. Note that all activity codes are included in this calculation except the following: C06, S10, and all activity codes starting with a G.

Help determining the Organization Funding Level can be found at https://grants. nih. gov/grants/funding/Determing-Organization-Funding-Levels-R15-Eligibility.

pdf An academic component is any school/college that is not a Health Professional School or College. A qualifying academic component (i.e., school/college) within an institution (e.g., School of Arts and Sciences) has greater undergraduate student enrollment than graduate student enrollment. All types of Health Professional Schools and Colleges are not eligible to apply and are not considered in this calculation.

For institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if separate UEIs and NIH IPF numbers are established for each campus. For institutions that use one UEI or NIH IPF number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) combined.

Health Professional and Graduate Schools At the time of application submission, all components of the institution combined must not have received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 years.

For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all of the schools and colleges within the institution as a whole. Note that all activity codes are included in this calculation except the following: C06, S10, and all activity codes starting with a G.

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P. H. Eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics and prosthetics, kinesiology, occupational therapy, and psychology.

Accreditation must be provided by a body approved for such purpose by the Secretary of Education. For institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if a unique identifier number and NIH IPF number are established for each campus.

For institutions that use one identifier number or NIH IPF number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) together.

Additional Eligibility Guidance A signed letter is required from the provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. See the application instructions for “Other Attachments” on the SF424(R&R) Other Project Information form in Section IV.

2 Instructions for Application Submission. Final eligibility will be validated by NIH prior to award. To assist in determining eligibility, organizations are encouraged to use the NIH RePORT website under NIH Awards by Location & Organization .

A PREP application must provide evidence of a subaward to a separate institution , and the grantee may partner with a non-R15-eligible institution. However, applicants should keep the goals of the PREP in mind when preparing the application, which include strengthening the research environment of eligible institutions and engaging students from eligible institutions in pain research.

It is expected that the project, and two-thirds of the total project budget, will be directed by the PD(s)/PI(s) at R15-eligible institution(s). A letter of support from each collaborator is required verifying the research collaboration at the time of application submission according to the eligibility criteria indicated above.

The Letter(s) should detail how the proposed research partnership will help to accomplish the proposed pain research project, enhance the R15-eligible institution’s research program, and promote synergy from an integrated, interdisciplinary research partnership(s) among the multiple proposed institutions. See the application instructions for “Other Attachments” on the SF424(R&R) Other Project Information form in Section IV.

2 Instructions for Application Submission. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications