Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

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 on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
Activity Code

R61/R33 Exploratory/Developmental  Phased Award

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-NS-22-037
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.853, 93.213, 93.350, 93.393, 93.866, 93.273, 93.846, 93.865, 93.279, 93.121, 93.307, 93.361, 93.313
Funding Opportunity Purpose

The purpose of this FOA is to solicit applications to develop, test, and implement novel, culturally-appropriate pain interventions and/or adapt, test and evaluate efficacy and effectiveness of existing pain interventions, in populations that disproportionately experience negative health outcomes. Desired outcomes of these interventions include reduction of pain and pain-related symptoms, and improvement in overall health outcomes, including function and quality of life. Interventions that target populations that experience health disparities with chronic pain in addition to at least one comorbid condition (OUD, mental health disorders and/or chronic health conditions) are of the highest priority.

Key Dates

Posted Date
January 20, 2022
Open Date (Earliest Submission Date)
February 22, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 22, 2022 Not Applicable Not Applicable July 2022 October 2022 December 2022

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.

Expiration Date
March 23, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The 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 HEAL Initiative is available at: https://heal.nih.gov/.

Populations that experience health disparities (HDPs), including, but not limited to, racial and ethnic groups and socioeconomically disadvantaged populations too often have higher rates of chronic pain and comorbid conditions, receive poorer pain care, and experience overall worse health outcomes resulting in decreased quality of life and shorter lifespan. Wide disparities in access to appropriate pain care may result in undertreatment of pain, leading to unnecessary suffering, or overreliance on opioids that carry an increased risk of addiction and overdose.

Due to the low representation of HDPs within clinical trials, many interventions for pain have not been tested rigorously in populations that experience health disparities. Furthermore, what works in one homogeneous population may not be as effective or efficacious in another population. Because there are differences across and within populations, there is a need to demonstrate that existing and emerging interventions for chronic pain are effective in HDPs. To optimize the likelihood that evidence-based interventions would be effective in HDPs, cultural and community influences, and other factors should be considered when developing and designing interventions. This allows for generalizability and ensures that health disparities are not exacerbated. There is a need for cultural and community-based adaptation and rigorous testing of existing evidence-based interventions for HDPs with acute and/or chronic pain.

Chronic pain often occurs within the context of comorbid conditions that may impact pain and modify the effectiveness of interventions necessitating consideration of the relationships between the comorbid conditions and pain. Multimorbidity (coexistence of two or more chronic health conditions) is more common in disadvantaged and older populations than in the general population. In the United States, complex, multisystem multimorbidity is more likely to affect Black individuals and those with Hispanic or Latino backgrounds compared to Non-Hispanic White Americans, and that accumulation of morbidity contributes to older adults from those groups living shorter lives than their White counterparts.

Common conditions that co-occur with chronic pain include opioid use disorder (OUD), mental health and substance use disorders and/or other chronic health conditions. It is estimated that anywhere between 3 – 48% of persons with chronic pain have co-occurring OUD. There is also evidence of higher prevalence of anxiety and depression in persons with chronic pain compared to the general population. Patients experiencing high impact chronic pain (HICP), which is more prevalent in HDPs, are more likely to have at least one other chronic health condition (e.g., depression, heart disease, obesity, diabetes). These comorbid conditions may have shared underlying biological, psychological, and social mechanisms that increase the likelihood of co-occurrence. For example, opioid misuse in persons with chronic pain has been shown to be associated with increased anxiety and depressive symptoms. Inadequate or inappropriate pain management may result in worsening or exacerbation of other comorbid conditions and lack of timely or appropriate treatment of comorbid conditions may exacerbate and worsen pain. There is a need to develop evidence-based interventions that target biological, psychological, and social factors that contribute to co-occurrence and exacerbation of chronic pain and comorbidities in HDPs.

Social determinants of health (SDOH) are major driving factors for health disparities in racial/ethnic and socioeconomically disadvantaged populations. Socioeconomic status, race-based discrimination and systems’ characteristics affect access and overall care, resulting in inadequately managed pain and other chronic conditions. Chronic pain prevalence rises as income levels decrease, and experiences of poverty and homelessness create stress and psychological burdens that can result in increased sensitivity to chronic pain. HDPs may lack access to care due to lack of insurance, geographical isolation, and neighborhood characteristics. Poor access increases the risk of pain and other health conditions going untreated, which increases the likelihood of disease chronicity and multimorbidity. There are overlaps between the social, psychological and structural factors that affect substance use and addiction, mental health and pain management. Therefore, studies that target these upstream SDOHs could have an impact on multiple conditions within individuals. There is a need to develop novel, evidence-based, SDOH-driven, culturally-tailored interventions that target chronic pain and comorbid conditions in HDPs.

Taken together, the complex array of multi-level factors influencing pain care may lead to overall poor health and decreased quality and length of life for HDPs. Single treatments and single interventions will likely not have lasting and sustainable changes in mitigating or eliminating health disparities in pain care. Rather, whole system changes from the top down are likely to have the greatest overall impact. Even for those who have access to healthcare, disparities within healthcare systems exist. Factors including provider bias and insurance quality affect the type, quality and length of care that HDPs may receive. A multidisciplinary approach offers the best solution for sustainable, lasting care that would improve the overall trajectory of an individual’s health. HDPs are not as likely to receive multidisciplinary pain care that focuses on whole-person health due to structural and systemic factors. There is a need for evidence-based interventions that improve multidisciplinary care for HDPs, who are at disproportionate risk of developing chronic pain and comorbid conditions.

Research objectives

Effective evidence-based interventions are needed for HDPs that suffer disproportionately from pain and other comorbid conditions including OUD, mental health and substance use disorders and other prevalent chronic health conditions. These interventions should account for the lived experience of these individuals as a more patient-centered, interpersonal approach can improve pain outcomes and satisfaction with treatment.

The scope of this initiative includes but is not limited to:

  • Adapting and testing existing evidence-based interventions for chronic pain to culturally-tailored interventions for specific HDPs.
  • Developing and testing culturally-tailored interventions that target biological, psychological and social stressors that exacerbate chronic pain and comorbidities in HDPs.
  • Developing interventions that target common underlying mechanisms between comorbid pain and other chronic conditions.
  • Developing and testing novel SDOH-driven, culturally-tailored interventions that target chronic pain and comorbid conditions.
  • Improving multidisciplinary care for populations at disproportionate risk of pain and comorbidities.

Applications submitted in response to this FOA are strongly encouraged to:

  • Propose a research plan designed to develop, test, and implement novel, culturally appropriate interventions and/or adapt, test and evaluate efficacy and effectiveness of existing interventions in NIH-designated populations that disproportionately experience negative health outcomes. Interventions that target HDPs with chronic pain in addition to at least one comorbid condition (OUD, mental health and substance use disorders and/or chronic health conditions) are of the highest priority. Desired outcomes of these interventions include reduction of pain and pain-related symptoms. Secondary outcomes may include decreased risk of OUD; improvement of mental health; improvement in patient satisfaction, and overall health outcomes, including function and quality of life and improvement in patient satisfaction, and overall health outcomes, including function and quality of life. Potential outcomes may reflect health status, disability, quality of life, mortality and morbidity, health behaviors, and access to, utilization of, or quality of health care.
  • Include collaborations with relevant organizations, groups or stakeholders, such as patients with lived experience, health service providers and systems, academic institutions, state and local public health agencies, Federally Qualified Health Centers (FQHCs), patient or consumer advocacy groups, community-based organizations, and faith-based organizations.
  • Include research teams with appropriate expertise in the fields of acute and/or chronic pain, pain comorbidities, and pain management as well as health disparities research. Multidisciplinary research teams that bring together ideas, theories, methods and approaches from different scientific and clinical disciplines to address underlying social, cultural, clinical, environmental or biological factors responsible for disparities in pain management are strongly encouraged.
  • Include a plan for involving persons with lived experience or representatives from patient organizations to capture their perspectives and serve as collaborators in the designing, conducting, and dissemination stages of the research projects. Additionally, non-patient stakeholders relevant to the project may also be included.
  • Consider interventions that address individual-level factors in addition to other levels of influence (e.g. organizational/institutional, community/neighborhood, societal) that contribute to health disparities in pain management. Consideration of models that hierarchically connect information at different levels of NIMHD's research framework and differentiate between individual and structural factors are encouraged where appropriate.
  • Proactively identify a theory or model that applies to the intervention proposed and the critical variables expected to result in change. Use an appropriate experimental design to test the proposed theory, identify the essential components of complex interventions, and/or elucidate the mechanism(s) by which an intervention exerts its effects.
  • Consider the potential for long-term sustainability and scalability of proposed interventions.
  • Incorporate efficiencies and utilize existing resources (e.g., NCATS CTSAs and the Trial Innovation Network including the Recruitment Innovation Center, practice-based research networks, electronic health records, administrative databases, and/or patient registries) to increase the efficiency of participant enrollment, retention and data collection.
  • Assess social determinants of health using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org) or other widely adopted measures, as appropriate.
  • Ensure sufficient power to demonstrate efficacy of the intervention in the population(s) of interest. Consider subpopulation analysis to determine which interventions work best for specific population groups (e.g. Hispanic or Latino subpopulations, Pacific Islander subpopulations), including medically underserved and under-represented groups with the intent to focus on reduction of health disparities.
  • Include translation services, as appropriate, in the research plan and the budget. Exclusion of non-English speaking participants without compelling scientific justification is discouraged.

Applications Not Responsive to the FOA include:

  • Observational/confirmatory studies solely focused on showing the existence of health disparities in HDPs.
  • Applications that do not include a focus on one or more NIH-designated populations that experience health disparities, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minorities, and underserved medically and under-represented groups (e.g. people with intellectual and physical disabilities).
  • Applications that do not include a milestones plan.
  • Applications that do not include a detailed recruitment and retention plan.
  • Projects that propose data collection or testing of interventions outside of the U.S.

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

Phases of Award

Utilization of milestones is a key characteristic of this FOA. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Plans must be guided by milestones that will be reached by the end of the R61 phase. Milestones are to be performance-based to achieve completion of the study on time and on budget. The individual milestones must be well-defined and quantifiable. A summary of the milestones will undergo an administrative review by the administering NIH Institute/Center (I/C) to ascertain if each milestone proposed was or was not met. Only R61 projects that have met milestones will be deemed eligible to transition to the R33 phase.

The R61 Phase

The primary objective of the R61 phase supported under this FOA is to perform the formative work necessary to prepare for a successful R33 phase. This may include adaptation and tailoring of interventions for the proposed R33, stakeholder interviews, focus groups, and tests of feasibility and validity. Applicants are expected to provide a detailed description of the intervention(s) they propose to study. Applicants are also expected to provide detailed descriptions of the measures and a strong rationale for choosing such measures.

Examples of R61 milestones include, but are not limited to:

  • Demonstration of intervention feasibility
  • Demonstration of successful engagement of HDP(s) of interest
  • Pilot data of intervention demonstrating improvement of pain-related health outcomes (e.g., pain, pain-related symptoms, comorbid condition-related symptoms) in population of interest

Funding for and transition to the R33 phase is contingent on the following: 1) meeting the milestones articulated in the R61 phase, 2) the availability of funds, 3) continued relevance/impact of the research to the NIH and HEAL missions, and 4) NIH and regulatory approval of the planned R33 activities (e.g., study documents, IRB).

Please note: To transition from the R61 phase to the R33 phase, grantees will submit a transition request 3 months prior to the proposed transition date. Successful achievement of milestones must be documented prior to submission of the transition package.

The R33 Phase

The R33 phase should be designed to conduct the effectiveness of the intervention using the study design developed or optimized in the R61 phase.The R33 phase will execute the evidence-based intervention at full scale and demonstrate improved outcomes (e.g., reduced pain, reduction in opioid use, reduction of comorbid condition symptoms, improved quality of life) for the population of interest. Applicants should address how this intervention can be implemented, scaled-up and/or sustained.

Diversity

In addition to scientific diversity, applicants should strive to enhance diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. (See Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details).

PD/PI Meeting Attendance

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

Information Relevant to Specific Institutes/Centers/Offices:

The National Institute of Neurological Disorders and Stroke (NINDS) commits to reducing the disproportionate burden of neurological diseases experienced by underserved groups of society, including racial and ethnic minorities, rural, and socioeconomically disadvantaged populations, by funding a spectrum of research from basic science through clinical studies and training the next generation of health equity investigators (https://www.ninds.nih.gov/Current-Research/Focus-Tools-Topics/Health-Disparities-Research).

NINDS is particularly interested in:

  • Modifying and implementing existing evidence-based chronic pain interventions, that are culturally-tailored, in specific HDPs
  • Developing and testing culturally-tailored interventions that target biological, psychological and social stressors that exacerbate chronic pain and comorbidities in HDPs.
  • Developing interventions that target common underlying mechanisms that impact comorbid pain and other chronic conditions.
  • Developing and testing culturally-tailed interventions for chronic pain and comorbid conditions that mitigate negative SDOH-mediators.
  • Improving multidisciplinary care of underserved populations at disproportionate risk for pain and comorbidities.

A letter of intent and communication with NINDS program staff prior to submission of an application are strongly encouraged.

National Center for Advancing Translational Sciences (NCATS)

NCATS’ mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of diseases and conditions. NCATS is interested in attainment of health equity for HDPs in the management of pain and comorbid conditions by getting more treatments to more patients more quickly through the use of translational science https://ncats.nih.gov/translation/spectrum. NCATS is interested in studies that accelerate development, testing and implementation of innovations that reduce, remove or bypass system-wide bottlenecks that increase the likelihood of pain chronicity and multimorbidity and diminish attainment of health equity for HDPs. Additionally, multi-level/multi-disciplinary innovations that catalyze translational efficiency and the development/adaption and delivery of interventions that address the bidirectional relationship (e.g., interruption of bidirectional exacerbation of disease, modification of intervention effectiveness, interplay of disease modifying factors, etc) between chronic pain and comorbid conditions to improve HDP outcomes are encouraged. Applications from the Clinical and Translational Science Award (CTSA) Program hub institutions that leverage CTSA resources including: existing partnerships/collaborations across institutions, stakeholders, and communities to address health disparities; the Trial Innovation Network including the Recruitment Innovation Center; and, the National Center for Data to Health (CD2H). Additionally, applications proposing collaborations between two or more CTSA Program hub institutions, that cannot be accomplished by a single hub, that extends the regional/national reach of the proposed intervention such that it has the potential to reach more patients more quickly are encouraged.

The National Institute of Dental and Craniofacial Research (NIDCR) is interested in multi-disciplinary research to develop and test interventions that target underlying mechanisms between chronic orofacial pain (such as chronic dental pain, chronic TMD pain, and burning mouth syndrome) and other pain or non-pain related conditions and comorbidities in populations that disproportionately experience negative health outcomes. The interventions supported by NIDCR are to improve comprehensiveness and patient-centeredness of orofacial pain management and its outcome in populations that disproportionately experience negative health outcomes by addressing social determinants of health and common risk factors for pain and comorbidities during the life-course.

The National Institute on Aging (NIA) is interested in applications relevant to health equity and pain with aging and in mid-life and older adults with pain and chronic comorbid conditions, including Alzheimer’s Disease and Alzheimer’s Disease Related Dementias. NIA intends to administer applications under this FOA that are consistent with NIA’s mission of improving the health and well-being of older adults through research. NIA encourages applicants to address priorities outlined in the NIA Health Disparities Research Framework (https://www.nia.nih.gov/research/osp/framework). NIA also encourages applicants to consider the NIH Stage Model for Behavioral Intervention Development (https://www.nia.nih.gov/research/dbsr/nih-stage-model-behavioral-intervention-development), including examination of mechanisms of behavior change at each stage of intervention development.

The National Institute on Drug Abuse (NIDA) is interested in research to evaluate pain management interventions that may reduce the severity of opioid use disorders (OUDs) and related comorbidities in health disparities populations. These efforts include the evaluation of existing or new medications,behavioral treatments, or other interventions for pain management that can reduce the need for opioids, e.g., opioid-sparing, to treat pain conditions (simplified drug design, vaccine adjuvants, medication delivery). Additionally, research is encouraged that has the potential to reduce abuse liability of addictive pain treatments, and studies of pain medications, psychostimulants, anxiolytics, sedative/hypnotics that focus on clinical measurement of vulnerability to substance use disorder (SUD). Research also is encouraged towards understanding the neurobiological bases (e.g., circuitry, neurochemical substrates) of the affective component of pain and how these overlap with neurobiological substrates of addiction. Understanding of acute and chronic pain processes; antinociceptive actions of opioids, cannabinoids, peptides; cellular processes of pain, analgesia, and tolerance (i.e., receptor internalization).

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in applications that address factors that contribute to disparities in pain assessment, treatment, and management in the NIAMS mission-relevant disease areas. Research in community health care settings is particularly encouraged. Note, applications focusing on chronic low back pain (cLBP) will be expected to align with the Back Pain Consortium (BACPAC) Research Program definition of cLBP and collect the BACPAC minimum data set as appropriate. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

The National Cancer Institute (NCI) leads, conducts, and supports cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. The NCI is interested in supporting intervention research for cancer patients and survivors with comorbid conditions in the following areas that include, but are not limited to:

  • Testing non-pharmacological, complementary, or integrative approaches to pain management
  • Developing and testing multilevel strategies to ensure effective pain management and targeted monitoring for those in underserved communities, particularly racial and ethnic minorities and those in rural areas
  • Testing pain reporting mechanisms that are culturally and linguistically tailored for individuals with limited English proficiency and
  • Identifying effective strategies to prevent or mitigate pain and co-occurring symptoms due to cancer treatment.
     

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is particularly interested in applications that address culturally appropriate-pain interventions and/or adapt existing pain applications relevant to (a) persistent pain of women with endometriosis, chronic pelvic pain, vulvodynia/vestibulodynia, dysmenorrhea, and other gynecologic pain syndromes with at least one comorbid condition or multimorbidity, and (b) pain conditions (acute and chronic) in children, women of reproductive age, pregnant and lactating individuals, people with intellectual and physical disabilities, and health disparity populations (i.e. racial/ethnic groups, sexual and gender minorities, underserved rural and socioeconomically disadvantaged populations) with at least one comorbid condition or multimorbidity.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) promotes the assessment of alcohol use and Alcohol Use Disorder (AUD) through instruments such as the Alcohol Use Disorders Identification Test (AUDIT; https://pubs.niaaa.nih.gov/publications/Audit.pdf) to evaluate alcohol’s influence on pain outcomes in vulnerable populations.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH intends to fund up to 7 awards

The number of awards is contingent upon NIH appropriations and submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. It is strongly recommended that applicants not request a budget of more than $500,000 in direct costs per year for the R61 phase and $1,000,000 in direct costs per year for the R33 phase.

Award Project Period

The scope of the project should determine the project period for each phase. The maximum period of the combined R61 and R33 phases is 5 years, with 1 to 2 years for the R61 phase and up to 4 years for the R33 phase.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

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 not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from minority Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Cheryse A. Sankar, PhD
Telephone: 301-318-2889
Email: cheryse.sankar@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims:

In the single page attachment allowed for the specific aims, applicants should include clearly marked headers for “R61 Specific Aims” and “R33 Specific Aims” with brief descriptions of key hypotheses.

Research Strategy:

The Research Strategy should be organized in a manner that will facilitate peer review. The body of the application should present an overview of the state of the science, current status and relevance of the trial, a discussion of the specific protocol, the approach to data collection, analysis, and dissemination as well as consideration of long-term sustainability and scalability of the proposed interventions. The application should contain separate Approach sections for the R61 and R33 phases.

Identify the HDPs that will be the focus of the project and describe the documented burden of pain and pain-related symptoms in this population. Describe the prevalence and burden of the comorbid condition(s) in the population of interest, as appropriate. Provide a data analytic plan that specifies how multi-level factors, intervention effects and interactions, or outcomes will be handled, as appropriate.

Include research teams with appropriate expertise in the fields of acute and/or chronic pain and health disparities research. Describe and specify the roles of collaborators.

The application must include a plan for involving persons with lived experience or representatives from patient organizations to capture their perspectives and serve as collaborators in the designing, conducting, and dissemination stages of the research projects. Additionally, non-patient stakeholders relevant to the project may also be included.

Separate Significance and Innovation sections may be included, but they could also be combined into a single section within the R61 section as appropriate. It is not necessary to repeat any information or details in the R33 section that are described in the R61 section.

The following criteria should be addressed:

Significance: The significance of the proposed study and importance of the question should be clearly stated.The application should make clear the need for and timeliness of the study with emphasis on how the results will address an evidence gap and therefore advance our knowledge of theory and practice in this area. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance. The applicant is expected to address the following questions: (1) Will the results provide evidence-based strategies to a) reduce pain and pain-related symptoms and/or improve function and quality of life in HDPs? (2) Are the proposed evidence-based interventions culturally-tailored and appropriate to the specific HDP of interest? (3) Are the study design and intervention informed by engagement of patients with lived experience relevant to the study?

Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms.

Approach: The research approach section should include a description of the supporting data, clinical trial experience, the experimental approach, and reference the Timeline and Milestone Plan.

Applicants are expected to proactively identify a theory or model that applies to the intervention proposed and the critical variables expected to result in change. Applications are required to use an appropriate experimental design and research framework to test the proposed theory, identify the essential components of complex interventions, and/or elucidate the mechanism(s) by which an intervention exerts its effects.

Supporting Data: Studies that led to the proposed project should be presented. Data from studies that show the need for and feasibility of the trial should also be presented. While an R61/R33 grant application need not have preliminary data, extensive background material or preliminary information, they should be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. The application should adequately frame and justify the initial planning/feasibility phase (R61), transition to the R33 phase and overall project. Applications should address the rationale for choosing the planned intervention. This may include public health impact if subsequent efficacy trials are conducted and demonstrated to be effective; ethical dimensions; and/or patient perspectives on acceptability of the proposed intervention. Characteristics of any preliminary research results provided in support of the proposed project, whether conducted by the applicant or others, should be described in the application.

Experimental Approach: The proposed experimental approach should clearly describe the study design and rationale for the approach chosen. The following elements should be included as part of the PHS Human Subjects/Clinical Trials Information forms as indicated or within the research strategy, but not in both sections. The experimental approach description should include:

  • A brief description of the project timeline referencing but not repeating the Timeline and Milestone Plan as appropriate.
  • A description and rationale for the research hypothesis(es) to be tested, methods of randomization if applicable, primary and secondary outcome measures, intervention(s), and participant follow-up procedures.
  • A description of the study population and why it is the most appropriate group to answer the research question, and how or if results will generalize to a broader population.
  • For the R33 phase, describe the methodology including: a) the scientific rationale for the measure(s) used to assess the impact of the intervention; b) the measure(s) proposed to assess the intervention's effect on reduction of pain and pain-related symptoms, improvement in adherence to the intervention and overall health outcomes, including function and quality of life. Information on measurement validity and reliability should be included in the application. Describe measurement schedules. The approach should be summarized clearly in the application.
  • Discussion of the challenges expected in implementing the research and how these might be overcome.
  • Adherence to strict principles of experimental design, appropriate statistical analysis, and scientific rigor. Please refer to https://grants.nih.gov/policy/reproducibility/guidance.htm for guidance on NIH policy on enhancing reproducibility through rigor and transparency. Please refer to https://grants.nih.gov/policy/reproducibility/resources.htm for resources on preparing a rigorous application.
  • The strategy for timely publication and dissemination of results.

Letters of Support: Letters of support from relevant organizations, groups, stakeholders (e.g. health service providers and/or systems, clinicians or clinical department chairs, etc) whose support are necessary to the successful conduct of the trial should be provided, if available.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Additional guidance on data related activities can be found at https://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

  • Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
  • Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
  • All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
  • NIH encourages researchers to explore the use of the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR® standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery.

Awardees conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Describe the following: 1) the planned recruitment methods including use of contact lists, databases or other pre-screening resources, advertisements, outreach, media / social media and referral networks or groups; 2) if there are known participant or study-related barriers to accrual or participation (based on literature or prior experience), please list these barriers and describe plans to address them to optimize success; 3) contingency plans for participant accrual if enrollment significantly lags behind accrual benchmarks; 4) participant retention and adherence strategies; 5) possible competition from other trials for study participants; 6) culturally and linguistically appropriate strategies for outreach, recruitment and retention of NIH-designated HDPs; and 7) stakeholder engagement that will play a critical role in recruitment and retention.

2.7 Study Timeline

A milestone plan must describe the key milestones that need to be met throughout the lifecycle of the project and the transition from R61 to R33 to ensure its success; the processes that will be used to reach the milestones. Include a table or graph of the overall study timeline. This is expected to be a visual representation (such as a Gantt Chart) of milestone plan and key project management activities. All applicants must use the following definition of a milestone in their application: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be relevant, achievable, and measurable. The research plan should include anticipated challenges to meeting milestones and propose potential mitigation or corrective actions strategies. Milestones should address overall recruitment and retention goals. The Terms and Conditions for an award under this FOA will include a milestone plan that is mutually agreed upon by the investigators and NIH.

Milestones of particular interest that should be described in the application may include, but are not limited to, the following:

  • Complete finalized clinical protocol approved by NIH and/or Protocol Review Committee/DSMB as appropriate
  • Final Informed Consent Form(s) and, if applicable, assent form(s)
  • Agreements in place for clinician/provider participation and/or product supply (if applicable)
  • Comprehensive laboratory plan (as applicable)
  • Pharmacy/Laboratories Identification (as applicable)
  • Contracts/Third Party Agreements (if applicable)
  • Protocol and procedural training plan for clinical site
  • Final Data and Safety Monitoring Plan
  • Site Performance Plan
  • Data Completeness and Quality Monitoring Reporting Plan
  • Completion of regulatory approvals
  • IRB approval for clinical site(s)
  • Collection of data related to primary and secondary endpoints and database lock
  • Submission of primary outcome(s) manuscript to peer-reviewed scientific journal
  • Submission of study results to ClinicalTrials.gov within 12 months of the primary completion date
  • Data sharing plan for study data and biospecimens (if applicable)

Investigators and NIH will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the grant, if awarded. During the award phase, achievement of each milestone will need to be communicated to the NIH Program Officer listed on the Notice of Award. Award continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below projections, or milestones mutually agreed upon by the PD/PI and the NIH, are not met, the NIH may consider ending support and negotiating an orderly phase-out of the award. The NIH retains, as an option, periodic external peer review of progress. NIH staff will closely monitor progress at all trial stages including milestones, accrual, and safety.

Please note: To transition from the R61 phase to the R33 phase, grantees will submit a transition request 3 months prior to the proposed transition date. Successful achievement of milestones must be documented prior to submission of the transition package.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

All applications are expected to include a detailed data and safety monitoring plan. Applicants should refer to NIH’s policy on data and safety monitoring (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-Related Attachments

Clinical Trial Experience.

Applicants must provide a detailed table listing the characteristics of trials that demonstrate experience in trial conduct and/or coordination in the last 5 years. The table must be provided as an attachment called "Clinical Trial Experience.pdf", appended with 1, 2, 3, etc. as needed, and must not exceed 3 pages. Applications that do not include this attachment or exceed the page limit will not be peer reviewed.

The table columns should include:

Column A: clinical trial title

Column B: applicant's role in the trial

Column C: a brief description of the trial design

Column D: planned enrollment

Column E: actual enrollment

Column F: number of sites

Column G: whether the trial(s) were completed on schedule or not

Column H: publication reference(s)

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R61/R33 phased innovation grant supports highly innovative studies as well as a rapid translation of such insights into clinically relevant optimization strategies. While highly innovative work often inherently carries a substantial scientific risk (i.e., the original hypothesis may not be proven), this risk can be substantially mitigated by properly designed milestones that would help determine whether at the end of the R61 phase the study is ready to move forward to the R33 phase. A well-planned R33 phase is only meaningful if the R61 phase is both innovative and well-designed. An R61/R33 grant application need not have preliminary data or extensive background material; however, they should be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the level of innovation, the potential to significantly optimize the proposed intervention, and the rigor of the proposed experimental designs. Reviewers will assign a single impact score for the entire application, which includes the R61 phase, the proposed R61-to-R33 transition milestones, and the R33 phase.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the population of interest experience acute and/or chronic pain in addition to at least one comorbid condition?

Is there adequate evidence of a significant health burden that impacts pain and/or pain-related outcomes in the population of interest?

How well does the project address the source of the health burden, assess the impact of the proposed intervention on pain and/or pain-related outcomes, and increase health equity in pain management for HDPs?

Does the proposed intervention have the potential to produce clinically meaningful changes to HDP pain-related patient outcomes and comorbid conditions (if applicable)? Does the project include consideration for long-term sustainability and scalability?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the team of research investigators demonstrate expertise in both health disparities research AND pain research? Does the investigative team have a track record of publishing the results of previously completed research?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the proposed research have the potential to advance the field even if the proposed study design, methods, and intervention are not innovative?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Does the research design include assessment of mechanisms through which the proposed intervention mitigates/eliminates a health burden and how these changes result in improvement in pain management outcomes? Are models that hierarchically connect information at different levels (e.g. NIMHD's research framework) and differentiate between individual and structural factors considered? Have investigators proposed methods to mitigate bias, error, and confounding? How well are the outcome measures, duration of intervention and follow up, appropriateness of inclusion/exclusion criteria, and sample size justified and explained? Are collaborations with relevant organizations, groups, and/or stakeholders included? How well does the Recruitment and Retention plan provide evidence that the accrual goals can be reached within the application? Is there a plan to collaborate and engage with HDP patients and relevant stakeholders? Is the intervention culturally and linguistically appropriate for the proposed HDP population/s? How appropriate is the plan to monitor accrual? Are there plans for adverse events to be appropriately captured and monitored? For the R61 phase will the proposed adaptions and tailoring provide the formative work to allow for a successful R33 phase? For the R33 phase will the chosen study design be appropriate for the stated goals of the project?

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the application document the availability of the requisite eligible participant pool in proposed recruitment site(s)? Is there documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel and facilities?

Does the application include a data management and sharing plan? Does the plan describe data types, file formats, submission timelines, and standards used in collecting or processing the data?

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

R61 to R33 Milestones
Do the milestones define clear assessment(s) that support the transition to the R33 phase? Are the proposed milestones relevant, achievable, and measurable? Does the research plan include anticipated challenges to meeting milestones and propose potential mitigation or corrective actions strategies? Do milestones address overall recruitment and retention goals?

Study Timeline


Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Cheryse A. Sankar
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-318-2889
Email: cheryse.sankar@nih.gov

Yolanda F Vallejo Ph.D.
National Center For Advancing Translational Sciences (NCATS)
Phone: (301) 827-4655
E-mail: yolanda.vallejo@nih.gov

Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-402-1272
Email: weberwj@mail.nih.gov

Alexis Bakos, Ph.D., M.P.H., R.N.
National Cancer Institute (NCI)
Telephone: 301-921-5970
Email: alexis.bakos@nih.gov

Houmam H Araj
National Eye Institute (NEI)
Phone: (301) 435-8166
E-mail: ha50c@nih.gov

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5899
Email: devon.oskvig@nih.gov

Mark Egli
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-594-6382
E-mail: megli@mail.nih.gov

Leslie K Derr, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: (301) 594-8174
E-mail: derrl@mail.nih.gov

Helena H. Ahn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-827-3207
E-mail: helena.ahn@nih.gov

Will Aklin
National Institute On Drug Abuse (NIDA)
Phone: 301-827-5909
E-mail: aklinwm@mail.nih.gov

Hiroko Iida, DDS, MPH
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-7404
E-mail: hiroko.iida@nih.gov

Priscah Mujuru
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-9765
E-mail: mujurup@mail.nih.gov

Lynn S. Adams, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-8911
Email: adamsls@mail.nih.gov

David A Thomas
Office Of Research On Women's Health (ORWH)
Phone: 301-435-1313
E-mail: david.thomas@nih.gov

Peer Review Contact(s)

Center for Scientific Review
Email: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov  

Katie Lynn Matthews
National Center For Advancing Translational Sciences (NCATS)
Phone: 301-827-7060
E-mail: katie.matthews@nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov

Sean Hine
National Cancer Institute (NCI)
Phone: 240-276-6291
Email: hines@mail.nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov

Jeni Smits
National Institute on Aging (NIA)
Phone: 301-827-4020
Email: jeni.smits@nih.gov 

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

Priscilla Grant
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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