Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Mental Health (NIMH)

Funding Opportunity Title
New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI): Clinical/Community Field Centers (UG3/UH3 - Clinical Trial Not Allowed)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices
  • July 15, 2022 - Notice of Technical Assistance Webinar for NHLBI New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI) Clinical/Community Field Centers (UG3/UH3) RFA-HL-23-015 and Coordinating Center (U24) RFA-HL-23-01.See Notice NOT-HL-22-034.
  • July 13, 2022 - Notice of Participation and Areas of Interest of NIMH in RFA-HL-23-015 and RFA-HL-23-016 "New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI) (UG3/UH3) (U24)". See Notice NOT-MH-22-175
Funding Opportunity Announcement (FOA) Number
RFA-HL-23-015
Companion Funding Opportunity
NOT-HL-22-027 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-HL-23-016 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.837, 93.839, 93.838, 93.233, 93.840, 93.172, 93.853, 93.307, 93.242
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for Clinical or Community Field Centers (CCFC) to establish a new population-based cohort study to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This epidemiological cohort study will enable the enrollment, initial examination, and follow-up activities of a cohort of approximately 10,000 participants from multiple immigrant generations of ancestral Asian subpopulations, as well as, Native Hawaiians, and Pacific Islander subpopulations. Specifically, this initiative will utilize a “populomics” perspective, i.e., examination of health influences across multiple levels (biological, lifestyle/behavioral, environmental, sociocultural) using multi-disciplinary methods to investigate the web of influences impacting the health of AsA-NHPI subpopulations.

This FOA uses the bi-phasic, milestone-driven cooperative agreement mechanism (UG3/UH3) and runs in parallel with a companion FOA (RFA-HL-23-016) that encourages applications for a Coordinating Center (CC). Awards made under this FOA will support a milestone driven planning phase including feasibility studies and pilot activities for up to two years (UG3), with possible transition to an implementation phase (UH3) for up to five additional years. Only UG3 cohorts that meet the scientific milestones and award requirements of the UG3 may transition to the UH3 phase. Applications submitted to this FOA must address both the UG3 and UH3 phases. Applications must also include plans for study participant recruitment and retention, scientific conduct of the study including a clinical examination, data collection, follow-up contacts, coordination with the CC and performance milestones for each phase.

Key Dates

Posted Date
July 06, 2022
Open Date (Earliest Submission Date)
September 13, 2022
Letter of Intent Due Date(s)

September 13, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 13, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

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
October 14, 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.

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

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) invites applications for Clinical or Community Field Centers to establish a new population-based cohort study to address key population research gaps in the health of Asian Americans (AsA), Native Hawaiians, and Pacific Islanders (NHPI). This epidemiological cohort study will enable the enrollment, initial examination, and follow-up activities of a cohort of participants from multiple immigrant generations of ancestral Asians living in the United States, as well as Native Hawaiians, and Pacific Islanders. Specifically, this initiative will utilize a “populomics” perspective, i.e., examination of health influences across multiple levels (biological, lifestyle/behavioral, environmental, sociocultural) using multi-disciplinary methods to investigate the web of influences impacting the health of AsA-NHPI subpopulations. The estimated number of total participants from all awards is about 10,000. This FOA uses a bi-phasic, milestone-driven, cooperative agreement mechanism (UG3/UH3).

Awards made under this FOA will support a milestone-driven planning phase, including feasibility studies and pilot activities for up to 2 years (UG3), with possible transition to an implementation phase (UH3) for up to five additional years. Only UG3 cohorts that meet the scientific milestones and award requirements of the UG3 phase may transition to the UH3 phase. Applicants are expected to be familiar with the requirements of the UG3/UH3 mechanism. Applications submitted in response to this FOA are expected to address both the UG3 and UH3 phases. Applications are also expected to include plans for project management, including participation in the development of a common protocol for the UH3 phase during the UG3 phase, study participant recruitment and retention, scientific conduct of the study including a clinical examination, data collection, follow-up contacts, and close coordination with the Coordinating Center (CC). Inclusion of performance-based milestones for each phase is a critical component of the application.

This FOA runs in parallel with a companion U24 FOA (RFA-HL-23-016), which seeks applications for a CC for this AsA-NHPI Cohort Study.

Background

Approximately 7% or 23 million Americans are of self-reported Asian ancestry. From 2010 to 2019, AsAs were the fastest growing subpopulation in the US, which increased by 34% compared to an overall US population growth of 6%. In the same period, growth of NHPIs increased 22%. Chinese (23%), Indian (20%), Filipino (19%), Vietnamese (10%), Korean (8%), and Japanese (7%) are six origin groups which make up 88% of all AsAs. Hawaiian (40%), Samoan (14%), Guamanian or Chamorro (10%), Tongan (4%), and Fijian (4%) are six origin groups that make up 72% of all NHPIs.

Despite the genetic and ethnic diversity of AsA-NHPI populations, these groups are frequently aggregated in population research, potentially masking important contributors to disease in these populations. For example, AsAs tend to be at higher risk for type 2 diabetes. Among adults 45-84 years of age, disaggregated prevalence estimates ranged from 18% in Chinese Americans to 35% for Filipino Americans and 38% for NHPIs. Hypertension rates also exhibit heterogeneity, with prevalence rates of approximately 33% in Chinese Americans, Korean Americans, and Southeast Asians to over 50% in Filipino Americans and Native Hawaiian and Pacific Islanders. Available data on disaggregated Asian Americans, Native Hawaiian, and Pacific Islander subpopulations is generally sparse, originating from electronic medical records (EMRs), smaller studies, or targeted surveys and may have inherent limitations such as referral biases, lack of objective data or biomarkers, and limited ability to control for important confounders or examine interactions across organ systems. Further, Social Determinants of Health (SDOH) remain an important risk factor in these communities as demonstrated by recent events, such as COVID outcomes and harassment and physical attacks. Another significant challenge in these populations is how genetic admixture might explain morbidity in these communities. Thus, a strong need exists to address the current gap in knowledge on how biological, social, lifestyle and behavioral factors interact to impact the health of AsA-NHPIs.

The NHLBI workshop “Identifying Research Opportunities for Asian American, Native Hawaiian, and Pacific Islander Health”, convened in March of 2021, has identified an urgent need to develop an innovative research infrastructure to support well-powered and representative prospective cohorts to understand mechanisms of disease with appropriate data disaggregation across AsA and NHPI subpopulations.

Research Scope/Objectives

Through this initiative, NHLBI will take the lead in establishing a new epidemiological cohort study to systematically investigate factors of risk and resilience and other potential factors impacting the health of AsA-NHPI subpopulations. The estimated number of target participants from all awards is approximately 10,000, which will include 4 to 5 major subpopulations of AsA-NHPI. To improve our understanding of human genetic variation, 25% of the total participant population should include AsA-NHPI subpopulations who are among the most understudied in biomedical research. A multi-generational design will be encouraged to further the understanding of how generation and nativity influence risk and health outcomes. An examination that will systematically collect standardized, high-quality phenotypic data from participants will be a key feature and will enable the opportunity to pursue multiple research hypotheses within a single research design.

The sampling design will support two analytical objectives:

  • to estimate the prevalence, mean values and distribution of key health and risk factors, with sufficient sample size to stratify by place of origin of major AsA-NHPI subpopulations and other relevant demographic characteristics that are clearly defined, consistently used and transparently presented (e.g., sex, gender, education, occupation, religiosity, income, self-identified race and ethnicity, etc.);
  • to evaluate relationships among baseline risk factors, and relationships of risk factors with health outcomes. Representative samples of participants will be drawn from census tracts in these defined communities and recruited from households using strategies that maximize participation rates, and minimize nonresponse and attrition during follow-up.

Expectations for the baseline exam include core elements such as questionnaires to assess acculturation, discrimination, social networks, residential history, medical and personal histories, smoking history, sleep, and respiratory questionnaires for history and current symptomology; assessment of body weight and height, blood pressure; ECG; spirometry; urine collection; and phlebotomy for lipids, glucose, and possibly other biomarkers (as funding permits), and biospecimen storage for future use including genomics and multi-omics. Additional questionnaires related to other sociocultural influences, environmental, lifestyle dimensions (e.g., diet, physical activity), psychological and cognitive health may be included. A cost-efficient in-person exam, utilizing home-visiting data collection, for example, is encouraged, along with innovative strategies for cost efficient data collection.

Applications considered nonresponsive to the FOA will not be reviewed. Examples of activities that are not appropriate for this FOA include, but are not limited to:

  • Applications that are considered NIH-defined clinical trials
  • Applications that include only one AsA-NHPI subpopulation
  • Applications that propose to recruit a non-AsA-NHPI subpopulation as a comparator group
  • Applications that do not involve human subjects

Specific Areas of Research

NIMH Area of Interest: NIMH is interested in research that can quantify the prevalence and characterize the clinical trajectories and outcomes of mental health disorders in Asian American, Native Hawaiian, and Pacific Islander subpopulations. Areas of high interest include, but are not limited to:

  • Research characterizing risk and trajectories of mood and anxiety disorders, disaggregated by sex, AsA-NHPI subgroup, and other social or structural factors potentially related to mental health.
  • Investigations that use rigorous measures of environmental and sociocultural factors like neighborhood effects, access to and quality of healthcare, food and resource security, intersectionality, and cultural beliefs to elucidate risk and course of mental health disorders.
  • Research examining the contribution of genetic and genomic factors to risk and resilience in mental health outcomes in AsA-NHPI cohorts, as well as interaction of genetic and familial risk with environmental factors in the development of mental illness.
  • Studies which identify how structural racism and discrimination impact trajectories of mental health disorders across the lifespan, particularly focusing on sequential and integrative relationships across neural, behavioral, and environmental factors that lead to disparities in mental health outcomes.

For more information, review the NIMH Strategic Plan.

Per NOT-MH-20-067, NIMH expects that grant applications involving human research participants will collect a minimum set of Common Data Elements. For research involving adults, the expected data collection instruments include demographic measures (age, sex at birth), the Self-Rated Level 1 Cross-Cutting Symptom Measure-Adult (DSM-5-TR), a measure of impairment (WHODAS), and measures related to anxiety and depression (PHQ-9, GAD-7).

Core questions that are expected to be addressed through the baseline exam include the following:

  • How does cardiovascular and lung health in first- and subsequent-generation immigrants differ from comparable cohorts in their countries of origin?
  • How do generational and neighborhood exposures impact health outcomes, including sleep quality, mental health, cardiopulmonary, and cognition among AsA-NHPI subpopulations?
  • What is the interrelationship between acculturation, discrimination, neighborhood factors, social networks and kinship structures and how do these factors intersect to impact health outcomes?
  • What is the relationship between sociocultural, environmental, behavioral, clinical and/or genetic risk factors with metabolic disorders (e.g., glucose intolerance, dyslipidemia) in AsA-NHPI subpopulations?
  • What are the health effects of tobacco and nicotine delivery products across populations and the potential impacts on incidence of pulmonary disease and cardiovascular diseases?
  • Why is there a need to develop and validate acculturation instruments for AsA-NHPI subpopulations that include items beyond those that are language-based?
  • How do protective factors, such as resilience or social support, contribute to health in AsA-NHPI subpopulations, including how such protective factors may differ across immigrant groups and/or generations?
  • What is the prevalence and incidence of neurological disease (e.g., stroke, dementia, cognitive impairment, multiple sclerosis, epilepsy, traumatic brain injury, pain syndromes, etc.) in the AsA-NHPI subpopulations?
  • What are the independent and combined contributions of genetics and other risk factors (e.g., clinical, family history, environmental, social determinants of health) to the incidence of diseases most severely impacting AsA-NHPI?

It is anticipated that future opportunities from NHLBI and other ICs will permit investigators to propose ancillary studies and use other funding mechanisms (such as investigator-initiated grants) to collect additional measures on the study participants that can address additional research questions.

Examples of Research Questions for Future Ancillary Studies

  • How do cardiovascular and stroke risk factors in the various immigrant generations impact the development of Alzheimer’s disease and Alzheimer’s disease related dementia, including vascular cognitive impairment?
  • How do pre-migration environmental exposures affect lung health trajectories in first-generation immigrants?
  • How does genetic/genomic variation heterogeneity and prediction accuracy contribute to disease risk found in AsA-NHPI subpopulations?
  • What models might help explain differences in genetic and genomic risk prediction related to health or disease in AsA-NHPI subpopulations?
  • How does the interplay of social, cultural, environmental, clinical, genetic and other biological factors affect health disparities and health advantages among AsA-NHPI subpopulations?
  • How do study factors mediating differences in access to and utilization of health care services among different AsA-NHPI, including recommended screening and preventive services? Study triggers to seek health care services by AsA-NHPI, including sex, gender, age, social determinants of health and others.

Phases of Award

UG3 Phase

This two-year phase of the FOA consists of support for the planning and establishment of clinical/community partnerships, development of the UG3 protocol, staff training, and feasibility and pilot studies. This phase will support the establishment of study infrastructure, development and approval of standardized study protocols (potentially across multiple study/field sites) and preparation of required consents and clinic forms (including translations as needed), activation of clinical/community sites; and enrollment of 5% of the targeted study participants before entering into the UH3 phase.

During this phase, multiple clinical/community sites that receive the UG3 awards will work together with the CC (RFA-HL-23-016) and NIH program office staff to develop one common protocol (including study design, analytic plan, sample size, data and biospecimen management) to be used across multiple sites in the UH3 phase. Toward that end, community/clinical sites are expected to conduct any needed pilot studies in Year 2 of this phase to refine the development of the common protocol. Applicants will be expected to submit proposals for the study design and analytic plan to be used in the UH3 to evaluate the user information gathered in the UG3 phase that would inform the analytic plan for the UH3 phase. Attention to key design features including sample size, effect size, and power related to subpopulations are expected in the applications.

Transition from UG3 to UH3

Award of the UG3 does not guarantee subsequent UH3 funding. An NHLBI-appointed Observational Study Monitoring Board (OSMB) and NIH program office staff will provide administrative review of the UG3 phase to ascertain the extent to which peer-reviewed milestones have been met in the UG3 phase. OSMB and NIH program staff recommendation to transition into the UH3 phase will be considered by the NHLBI prior to the issuance of the UH3 award and subject to NHLBI funding availability.

UH3 Phase

This phase consists of implementation of one common protocol across multiple sites/programs, with coordination and support provided by the CC. A common feasible protocol in the UH3 phase would allow for identification and recruitment of cohort participants, conduct of a detailed baseline assessment on all participants (e.g., questionnaires and exam).The UH3 phase will also ensure appropriate management of relevant databases and biospecimens for tracking, data cleaning, harmonization and analysis. Applicants must provide a detailed proposal for both the UG3 and UH3 phases of the study (including study aims, design, approach, etc.).

Milestones

A key characteristic of this FOA is completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the Program on time and on budget.

The research protocols underpinning the establishment of this new population-based cohort are expected to be conducted with a high degree of efficiency, with streamlined administrative procedures wherever possible. Applicants are strongly encouraged to employ project management principles as appropriate.

Applications that address contingency plans to proactively confront potential delays or disturbances in meeting the milestones are strongly encouraged.

Milestones and timelines for the UH3 phase may be revised and finalized at the time of the UG3 to UH3 transition. Slower than anticipated progress towards meeting milestones in the second phase will result in a re-evaluation of the award by NHLBI including whether the program objectives can be met on time and on budget. If milestones have not been satisfactorily met, subsequent funding years may not be approved and may lead to phasing out of the award.

Core milestones that are of particular interest in the UG3 Phase include, but are not limited to:

  • Organization and collaborative participation in the study infrastructure (steering committee and other appropriate study committees) to develop and implement a coordinated plan to achieve the study objectives
  • Development and approval of standardized study protocols (potentially across multiple study/field sites)
  • Preparation and finalization of required consents and clinic forms (including translations as needed)
  • Obtainment of IRB approval to conduct the study
  • Successful completion of collaborative pilot study
  • Recruitment of cohort participants and enrollment of 5% of the projected recruitment of the study site
  • Providing materials and attending meetings of the NHLBI-appointed OSMB
  • Working collaboratively with the other Clinical or Community Field Centers (CCFCs) and the Coordinating Center (CC) to develop the recruitment and retention strategies and materials, as well as communication plans to conduct regular community engagement activities and events, and to convene and maintain a Community Advisory Board (CAB)

Core milestones that are of particular interest in the UH3 Phase include, but are not limited to:

  • Enrollment of 100% of the projected recruitment of the study site
  • Successful conduct of a baseline assessment on study participants (e.g., questionnaires and exam) and the transfer of data to the Coordinating Center (CC)
  • Completion of quality control, quality assurance, and data harmonization activities
  • Working collaboratively with the CC and Steering Committee on post-exam activities including:
    • Participant (morbidity and mortality) surveillance
    • Analysis of data collected on cohort participants
    • Development and distribution of findings from the exam in the form of lay summaries for the study participants, manuscripts/publications, and a Data Book for the scientific community and stakeholders

NHLBI policies regarding milestones and relevant clinical research/studies policies are described in the following: NHLBI Accrual of Human Subjects (Milestones) Policy, NHLBI Policy for Inclusion of Women and Minorities in Clinical Research,NHLBI Policy for Data and Safety Monitoring of Extramural Clinical Studies,and NHLBI Data Sharing Policy.

Notice of NIH's Interest in Diversity

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. 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. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences. See NOT-OD-20-031 and NOT-OD-22-019 for details.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

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?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts:

NHLBI intends to fund 4 to 6 awards, corresponding to total costs of up to $2.3 million in Fiscal Year (FY) 2023, $2.4 million in FY2024, $2.5 million per year in FY2025, FY2026 and FY2027, and $2.1 million in FY2028 and FY2029 for a total contribution of $16.4 million for 7 years. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIMHD, NINDS, and NHGRI each intend to commit individually $500,000 per year for FY 2023-2029 to co-fund applications in response to RFA-HL-23-015 and RFA-HL-23-016. Other NIH Institutes/Centers who are interested in collaborating will have an opportunity to join at a later time.

Together, NHLBI and collaborating NIH ICs intend to commit an estimated total of $16.4 million from NHLBI for RFA-HL-23-015 and up to $10.5 million from collaborating ICs across RFA-HL-23-015 and RFA-HL-23-016 to fund 4-6 awards for the entire 7 years period.

NIMH intends to commit up to $500,000 per year for FY 2023-2029 to co-fund applications in response to RFA-HL-23-015 and RFA-HL-23-016.

Awards issued under this FOA are contingent upon the availability of funds.

Award Budget

The budget for each application may not exceed direct costs of up to $373,000 in Fiscal Year (FY) 2023, up to $390,000 in FY2024, up to $406,000 per year in FYs 2025 through 2027, and up to $341,000 per year in FY2028 and FY2029. Funding to perform the study-wide participants' examinations, follow-up, and events ascertainment will be part of the CC’s grant award and be distributed by the CC as a capitation to the CCFCs in accordance with budgets approved by the NIH Program Office.

Award Project Period

The maximum period of the combined UG3 and UH3 phases is 7 years, with up to 2 years for the UG3 phase, and up to 5 years for the UH3 phase. The scope of the proposed project should determine the project period. Only those UG3 projects that meet the scientific milestones and award requirements of the UG3 FOA may transition to the UH3 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 eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented 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:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung and Blood Institute (NHLBI)
Email: NHLBIChiefReviewBranch@nhlbi.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.

Facilities and Other Resources:

As appropriate, describe available resources such as clinical and laboratory facilities, geographic distribution of space and personnel, and resources relevant to the effective implementation of a baseline exam of cohort participants and, if applicable, the efficient operation of a multi-site study. Applicants must provide strong evidence of the availability of appropriate institutional resources and access to suitable participant populations. For multi-site applications, information must be provided for each participating site.

Other Attachments:

The attachments listed below must be completed and attached or the application will not be peer reviewed, with the exception of the "Biospecimen Plan" which must only be provided if applicable.

1. Work Plan for Baseline Assessment and Surveillance(3 pages)

A brief description of the data that will be collected, how the data will be collected, and how Personally identifiable information (PII) will be protected during the participant baseline exam must be provided as an attachment using the filename "Work Plan for Baseline Assessment and Surveillance.pdf" and may not exceed 3 pages. Examples of data that may be collected on participants include, but are not limited to the following:

  • Demographics (e.g., race/ethnicity, immigration status, education, residential and occupational history, existing genetic testing)
  • Genetic or genomic data
  • Clinical characteristics and basic diagnostic information (e.g., anthropometry, functional status, medication use, medical history, laboratory measurements)
  • Co-morbidities and risk factors (e.g., diabetes, hypertension, dyslipidemia, ectopic fat, environmental exposures, family history)
  • Lifestyle and psychosocial factors (e.g., diet, physical activity, smoking history, sleep habits, immigration pattern/status, acculturation, social support, mental health, social determinants of health, quality of life)
  • Participant- or patient-reported outcomes
  • Repeated or longitudinal measurements to support scientific hypotheses, if applicable (e.g., circadian fluctuations)
  • Surveillance: describe plans for active and/or passive participant follow-up or surveillance.

2. Community Engagement (3 pages)

A description of how the applicant proposes to engage the AsA-NHPI communities from which it plans to recruit study participants must be provided as an attachment using the filename "Community Engagement.pdf" and may not exceed 3 pages. Provide details to address the bullets below:

  • Describe strategy for community engagement and retention of participants (including activities) during the different phases of the study (i.e., planning; pre-recruitment; recruitment, retention, and data acquisition; analysis and dissemination of study results).
  • Develop a strategy and communication plan to conduct regular community engagement activities and events, convene and maintain a Community Advisory Board (CAB).
  • Discuss plans to provide content to the Coordinating Center for the participant newsletters and website.
  • Describe planned approach for providing a number of community members to receive formal and/or informal training related to basic epidemiology study, data analysis and reporting provided by the study. A description of the training must also be provided.
  • Describe planned activities to enhance the capacity of communities to sustain delivery of information and results from the study.(e.g., translation of materials into appropriate languages of AsA-NHPI subpopoulations in UG3 and UH3 phase)
  • Describe the plan to include engagement of community stakeholders throughout the research process. Examples of stakeholders could be derived from relevant AsA-NHPI organizations, patients with lived experience, patient or consumer advocacy groups, limited English proficiency advocacy groups, community champions, community-based organizations, faith-based organizations.

3. Biospecimen Plan (must be provided if applicable to the study proposed, 2 pages)

If applicable, a Biospecimen Plan should be provided as an attachment using the filename "Biospecimen Plan. pdf" and may not exceed 2 pages. Provide details for each bullet below:

  • Brief description how the biospecimens will be collected during the exam (eg. blood, urine, PAXgene, stool etc.), processed, and stored temporarily before shipping to the study laboratory (or laboratories) as directed by the NIH and the Steering Committee.
  • Plans for adherence to Good Laboratory Practices (GLP) and use of current best practices for biospecimen collection, management, and quality control.
SF424(R&R) Senior/Key Person Profile

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

All Key Personnel who are major contributors to the project must provide a NIH Biosketch, whether or not they are budgeted.

PD(s)/PI(s) must describe their experience with epidemiology cohort studies, specifically documenting their abilities to organize and manage a cohort study and its related activities. If a PD/PI has no prior experience with epidemiology cohort studies, then he/she must describe experience with large research consortia or multi-site studies. If applicable, note whether the study team has ever worked together. Include a management transition plan to account for the possibility of changes to leadership (e.g., due to the PI leaving the institution).

R&R Budget

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

A detailed budget for the AsA-NHPI CCFC must be presented for activities to be conducted under this FOA. The operational budget should include, but not be limited to the following items:

  • Management of day-to-day operations and oversight of professional activities, including administrative activities, data and research coordination, and relevant staff skills development program.
  • Recruitment of cohort participants and conduct of a baseline examination on targeted number of participants by the proposed CCFC. Please indicate the AsA-NHPI sub-populations that will primarily be targeted by the CCFC for recruitment.
  • Conduct of post-exam activities such as annual or bi-annual follow-up contact and participant surveillance and analysis of cohort baseline and interim-contact data.
  • Attendance for in-person or virtual steering committee/OSMB meetings, as well as an initial kick-off meeting of investigators and NHLBI program staff. These meetings will be held in the Washington, D.C area.
  • Sub-awards as needed. The application must include only its own budget, including any subcontract budgets associated with it. Separate itemized budgets must be prepared for each subcontract. The application must provide detailed annual budgets that will enable the CCFC to meet its milestones.
  • Community engagement activities such as community outreach, education, and dissemination.

The CC will collaborate with the CCFCs to propose preliminary baseline clinical examination protocols and associated budget for review by the Steering Committee and the NIH Program Office. Funding to perform the clinical examination of the participants will be part of the CC’s grant award and will be distributed by the CC as a capitation to the CCFCs in accordance with budgets for the protocol as determined and approved by the NIH Program Office and the Steering Committee. The capitation model to the CCFCs also apply for annual or bi-annual follow-up contact and for ascertainment of clinical events of interest (e.g., myocardial infarctions, cardiac injury, cerebrovascular events, chronic obstructive pulmonary disease, asthma, etc.)

For planning purposes, it is estimated that $350,000 in direct costs for year 2, $2,200,000 in direct costs for years 3-5, $1,500,000 in direct costs for year 6, and $1,500,000 in direct costs for year 7 will be available for these study-wide protocol(s) to be finalized and implemented across the AsA-NHPI cohort study team after funding. This would result in an average of $700 direct costs per participant for the overall period of years 2-7 for recruitment and follow-up.

Note: even if selected for award, subsequent budget reallocations may be needed in year 2 of the UG3 phase as a common protocol is being developed in order to facilitate any further refinement, pilot testing, and initial implementation of the common protocol by the CC and the clinical/community site grantees.

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:

Provide Specific Aims for the establishment of Clinical or Community Field Centers to launch a new population-based cohort study to address key population research gaps in the health of AsA-NHPI subpopulations. In parallel with the companion U24 FOA (RFA-HL-23-016), the CCFC FOA will enable the enrollment, initial examination and follow-up activities of a cohort of approximately 10,000 participants from multiple immigrant generations of ancestral Asian and NHPI subpopulations.

Research Strategy:

The Research Strategy must indicate the number of participants the proposed CCFC is aiming to recruit to undergo the baseline clinical examination. The application must also sufficiently indicate the proposed representation from targeted ancestral and NHPI subpopulation(s). Participants can be any generation of immigrants (age 25-64) from Asian countries or Native Hawaiians and Pacific Islanders. The proposed strategies must present an overview of the state of the science and relevance of the proposed cohort, a detailed discussion of the specific protocol, and the approach to data collection, analysis, and dissemination. Both the UG3 and the UH3 phases must specify the objectives and scope to be accomplished.

UG3 Phase

Each application must address the following:

  • Describe the anticipated specific duties and tasks of study personnel. Detail the planned feasibility studies and the roles of project staff. Include plans to work collaboratively with other awardees in other CCFCs and with the CC.
  • Describe the proposed study design to be used in the UH3 phase. Provide details on the baseline exams to be implemented.
  • Describe population descriptors that will be used to define the subpopulations and why there is an anticipated disease risk in the subpopulation that can be answered by this longitudinal study.
  • Describe plans to involve ESIs in the proposed project, including those underrepresented in biomedical research
  • Propose and justify milestones that will be subject to peer review. Core milestones that are of particular interest include, but are not limited to:
    • Develop study protocols for recruitment, clinical examination, events ascertainment, and retention of participants
    • Develop study protocols to ensure appropriate management of relevant databases for tracking and data capture
    • Complete and finalize protocol and informed consent documents
    • Conduct feasibility and pilot studies
    • OSMB approval by of a common protocol
    • IRB approval of final protocol and consent and/or assent
    • Initiate recruitment at the 4th quarter of 2nd year of UG3
    • Enroll 5% of the target participants per CCFC during the UG3 phase
      •  

The clinical/community sites that receive the UG3 awards will work together with the CC and NIH Program Office team to develop one protocol (including study design, analytic plan, sample sizes for specific research questions, etc.) to be used across multiple sites in the UH3 phase.

UH3 Phase

This phase consists of implementation of a Steering Committee-, OSMB-, and NIH-approved common protocol among all the grantees in this FOA and the FOA for the CC.

  • Describe how the full enrollment and retention of study participants will be supported
  • Describe planned processes to work collaboratively with other awarded CCFCs and with the Coordinating Center
  • Provide clearly defined milestones. Core milestones include, but are not limited to these examples:
    • Enrollment of 100% of the projected recruitment for all study participants
    • Full plan for maintaining retenton of study participants
    • Completion of baseline exam
    • Collection of data related to relevant clinical endpoints and data transfer to Coordinating Center (CC)
    • Submission of primary manuscript to peer-reviewed scientific journal(s) and dissemination of results

Applications should use the Research Strategy section to discuss the overall strategy, methodology, and analyses of the proposed research. Do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information Form.

In the Research Strategy section, applicants must specifically address the following:

  • Describe how the establishment of the proposed cohort study will permit research that will address multiple scientific hypotheses
  • Discuss how the proposed cohort study will fill the key population research gaps in the health of AsA-NHPI.
  • Explain how the proposed research will align with the NHLBI's Strategic Vision
  • Outline the short-, medium-, and long-term vision for the cohort
  • Describe how the participant baseline assessment will support:
    • The study's multiple research hypotheses
    • Investigation of endpoints of clinical significance and other health outcomes of interest
    • Surveillance or follow-up of participants over time

Letters of Support:

A statement of commitment from each participating institution or organization must be provided. If outside support for of the study will be provided by sources other than the NHLBI, provide Letter(s) of Support signed by an authorized representative.

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.

All applications, regardless of the amount of direct costs requested for any one year, are expected to include a Data Sharing Plan. Consistent with achieving the goals of the program, applications are expected to describe planned internal and external data and biospecimen sharing policies. Applicants may contact NHLBI staff listed in Section VII to discuss any concerns about sharing study data from their proposed cohort.

NHLBI expectations for data sharing:

Data collected under support from this FOA are expected to be widely shared through the NHLBI BioData Catalyst (https://biodatacatalyst.nhlbi.nih.gov/), BioLINCC (https://biolincc.nhlbi.nih.gov/home/), and/or other NIH-designated repositories. Metadata, protocols, manuals of procedures, algorithms for calculated data elements, and other documentation necessary to describe the study and resultant data to investigators not affiliated with the study are also expected to be widely available.

Genomic data sharing:

If proposing to generate large-scale human genomic data, applications are expected to also describe a genomic data sharing plan per the NIH Genomic Data Sharing (GDS) Policy (https://osp.od.nih.gov/wp-content/uploads/NIH_GDS_Policy.pdf). Even if applications do not propose to conduct genomic or other -omic analyses, these types of analyses may occur during future data collection cycles; as such, applicants may wish to anticipate the potential for these types of studies by incorporating relevant language regarding genomic data collection, analysis, and sharing into their informed consent process.

The NIH has developed several guidance documents to assist applicants with the NIH GDS Policy. Applicants are encouraged to review the following resources and to contact NHLBI staff to discuss any concerns about genomic data sharing:

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

2.4 Inclusion of Women and Minorities has the following additional instructions:

  • Justify the anticipated or projected sample size for the cohort proposed for recruitment and for the relevant targeted subpopulations (i.e., is the sample size sufficiently powered to address the study's aims?)
  • Ensure the inclusion of AsA and NHPI subpopulations between the age range of 25-64 years of age
  • Participants can be any generation of immigrants from Asian countries or Native Hawaiians and Pacific Islanders

2.5 Recruitment and Retention Plan has the following additional instructions:

  • Demonstrate that each recruitment site has access to sufficient numbers of potential participants to attain its target enrollment and includes plans for recruiting two or more subpopulations
  • Provide estimates or other data (e.g., pilot data) to demonstrate the feasibility of meeting proposed recruitment goals, broken down by enrollment site if applicable
  • Describe contingency plans to manage potential delays or barriers with participant recruitment in the overall cohort as well as in key subpopulations
  • Describe retention plan, expected attrition rate and how these might impact study design and plans to overcome the challenge

2.7 Study Timeline has the following additional instruction:

Include the following milestones in the study timeline, as applicable:

  • IRB approval
  • Establishment of study infrastructure, such as committees, biospecimen collection, temporary storage and shipping, and clinical examination sites (or home-visit data collections)
  • Finalized standard operating procedures (SOPs), data collection protocols, and informed consent/assent document(s)
  • Anticipated start and end dates for participant recruitment and data collection(s)
  • Data cleaning and quality control

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects has the following additional instruction:

When discussing potential benefits and risks to participants, include a description of whether any research data or findings might be returned to participants, and if so which type(s) of results would be returned (e.g., medically actionable genomic variation, clinically significant or incidental exam findings).

3.5 Overall Structure of Study Team is required for this FOA, and has the following additional instructions:

The Overall Structure of the Study Team attachment is required. In addition to describing the various study sites (e.g., administrative sites, data coordinating sites, enrollment/participating sites, laboratory or testing centers), applicants must also describe any committees, sub-committees, and/or working groups that will be used to coordinate and oversee study activities (e.g., steering committee, publications, community engagement).

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 provided on the application is the same identifier 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a "Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects NIH ICs strongly encourages investigators that plan to collect phenotype and/or environmental exposure data about their study participants to utilize standard protocols included in the PhenX Toolkit (http://www.phenxtoolkit.org).

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:

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?

Specific to this FOA

  • How well will the CCFC contribute to the establishment of the overall cohort and enable the study to address multiple scientific hypotheses?
  • How feasible are the short-, medium-, and long-term operational plans for the targeted cohort for which the CCFC proposes to recruit, perform an exam on, and retain?
  • How likely are the anticipated study results to help address key population research gaps in the health of AsA-NHPI?
  • How likely will the data and knowledge generated by the Cohort Study lead to a better understanding on how to tackle the challenges that this population faces?

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?

Specific to this FOA

  • How well does the experience of the PD(s)/PI(s) qualify him/her to lead a large epidemiology cohort study and its related activities (e.g., recruiting and retaining participants, community engagement, establishing study infrastructure, clinical data collection, data cleaning and quality control, overseeing multiple study sites (if proposed)?
  • How well developed is the team structure and how appropriate is the experience of the study personnel, including PDs/PIs in leading and building collaborative research? Have personnel been identified for specific tasks at UG3 and UH3 phases?
  • How adequate is the organizational plan in describing the project management staff, their roles and responsibilities and the percent efforts for each?
  • How well-described are the roles and responsibilities of study personnel and ESIs, including those underrepresented in biomedical research, within the organizational plan?
  • Does the composition of the research team have appropriate breadth and inclusiveness of expertise and disciplines in assessing and evaluating the health outcomes in AsA-NHPI populations? Does the research team have appropriate linguistic and cultural competence to assess and evaluating effects within populations that experience health disparities?

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?

Specific to this FOA

  • How well does the research team leverage novel approaches for new technology as part of the research protocol to generate new knowledge?
  • Does the design/research plan include innovative elements, as appropriate, that enhance its potential to collect the data and to help address key population research gaps in the health of AsA-NHPIs?
  • What are the strengths and weaknesses of the innovative approaches to the facilitation of data collection or data management of the cohort, if applicable to the proposed study?

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?

Specific to this FOA

  • How feasible are the plans to work collaboratively and share data with other clinical sites and with the coordinating center?
  • How appropriate is the process for obtaining informed consent or assent?
  • How achievable are the study's timeline and milestones?
  • How well will the participant baseline assessment support: (a) the study's multiple research hypotheses, (b) the investigation of endpoints of clinical significance and other health outcomes of interest, and (c) surveillance or follow-up of participants over time?
  • How rigorous are the plans for managing study data?
  • To what extent are the roles of all community partners clearly articulated?
  • Are appropriate linguistic and cultural competence strategies (i.e., research instruments, appropriate collaborators, team/partner training, accessibility measures etc.) incorporated into the engagement plan to reduce obstacles and enable recruitment and retention of diverse cohorts of participants, including AsA-NHPI populations?

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?

Specific to this FOA

  • To what extent will the facilities and other resources available to the applicant(s) enable the effective implementation of a detailed baseline assessment of cohort participants and, if applicable, the efficient operation of a multi-site study?
  • What are the strengths and weaknesses of the study team's overall structure?
  • How effectively will the proposed study sites, committees, sub-committees, and/or working groups be able to coordinate and oversee study activities?
  • If multi-sites/sub-centers are proposed, is there evidence of the ability of the individual site or sub-center to: (1) enroll the proposed numbers; (2) retain the participants; (3) adhere to the protocol; (4) collect and transmit data in an accurate and timely fashion; and, (5) 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.

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., 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

Not applicable

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) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  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 the National Heart, Lung, and Blood Institute, 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 National Heart, Lung, and Blood Advisory Council. 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

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 identity, 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, althoughspecific tasks and activities may be shared among the recipients and the NIH as defined below. All multi-year activity codes except R15 must get multi-year funding authorization from the OER and upload the approval into the FOAM with the FOA.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NHLBI for the performance and proper conduct of the research supported by the UG3/UH3 award in accordance with these terms and conditions of the award. As such, the recipient PD(s)/PI(s) will be responsible for all aspects of the study and cohort, as well as any modification(s), unless otherwise provided for in these terms or by action of the cohort Steering Committee.

Specific responsibilities include:

  • Defining objectives and approaches of the research
  • Defining the research plan and goals
  • Project design and protocol development
  • Obtaining all requisite study and protocol approvals
  • Participant recruitment, retention and follow-up
  • Data collection and quality control
  • Safety and data monitoring
  • Oversight of study activities, such as data analysis and interpretation, manuscript preparation, and dissemination of study results
  • Overseeing/performing other scientific activities of the research plan
  • Monitoring the completion of the supported activities and taking corrective actions if needed
  • Participating in the activities of the cohort Steering Committee
  • Accepting and implementing the decisions approved by the cohort Steering Committee to the extent consistent with applicable grant regulations
  • Cooperating with NHLBI programmatic, technical, and administrative staff
  • Administratively managing the cooperative agreement award
  • Developing collaborations with and making data accessible to external investigators
  • Ensuring submission of reports to the OSMB, if applicable

The recipient will be required to provide updated descriptive and meta-data to the NHLBI upon request, including cohort characteristics, study protocols, basic counts of study participants, enrollment progress, biospecimen availability, and study variable definitions. Recipients must also provide analytical data files (illustrative examples include: derived/calculated data variables; finalized questionnaire data; data from procedures, such as spirometry, echocardiography, ECG, exercise testing, polysomnography, etc.; participant follow-up data; clinical event outcomes data) to the NHLBI periodically based upon a mutually agreed schedule and format and at the end of the period of this award, along with documentation necessary for their use.

Recipients will be expected to evaluate and document compliance with NCI's Best Practices for Biospecimen Resources for collection, processing, and storage of future previously collected biospecimens (http://biospecimens.cancer.gov/bestpractices). Recipients will be required to explore, with NHLBI staff, the feasibility of data harmonization and pooling with other cohorts and studies. Awardees are encouraged to register the cohort through ClinicalTrials.gov (http://clinicaltrials.gov). Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Recipients agree to the governance of the study through a Steering Committee and to accept and implement decisions approved by the Steering Committee (see "Joint Responsibilities" section below).

Recipients are expected to make their data widely available to other investigators per NIH and NHLBI data sharing policies (https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_policies.html, https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing-from-clinical-trials-and-epidemiological-studies). If recipients propose to generate large-scale genomic data, they are expected to comply with the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/). Study investigators are strongly encouraged to publish and disseminate results, tools, resources, and other products of the study, in accordance with the study protocols and governance. It is expected that all methods, analyses, software, and algorithms will be made available in a timely manner to the scientific community.

Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party; involvement of study resources; citing the name of the study or NHLBI support; or special access to study results, data, findings, or resources requires notification of and concurrence by NHLBI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to and concurrence by NHLBI.

NHLBI staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A designated NHLBI Project Scientist(s) will have the following responsibilities:

  • Participating in the activities of the cohort's Steering Committee, as well as any subcommittees as appropriate, and helping to address issues that come before these committees
  • Facilitating collaborations between the recipients and other NHLBI-sponsored programs, investigators, or organizations that may contribute to the study's goals
  • Assisting in the interaction between the recipients and investigators at other institutions, as appropriate for the cohort
  • Promoting collaborative research efforts that involve interactions with other NIH-supported projects, programs, and centers and helping with the coordination of such efforts
  • Facilitating harmonization of data and biospecimen resource optimization
  • Participating in study meetings
  • Providing technical assistance and advice to the recipients as appropriate
  • Organizing and conducting regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the study investigators and centers
  • Assisting with the development of research protocols
  • Monitoring participant recruitment and study progress
  • Ensuring disclosure of conflicts of interest and adherence to NHLBI policies

At the discretion of the NHLBI, an independent Observational Study Monitoring Board (OSMB) may be appointed by the Director, NHLBI, to provide overall monitoring of data and safety issues in accordance with NHLBI DSMB/OSMB policy (https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-data-and-safety-monitoring-extramural-clinical-studies). Meetings of the OSMB will ordinarily be held in Bethesda, MD or via teleconference/videoconference. An NHLBI scientist other than the NHLBI Program Official or Project Scientist will serve as Executive Secretary to the Board. Because the OSMB serves as an independent group advisory to the NHLBI, study investigators shall not communicate with OSMB members regarding study issues, except as authorized by the Board's Executive Secretary.

In addition to the Project Scientist, a separate NHLBI Program Official will be responsible for the normal program stewardship of the cooperative agreement, and will be in the Notice of Award. However, the NHLBI may elect to have a dual-role approach where a single individual may act as both the NHLBI Project Scientist and Program Official. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist. The responsibility for final decision making may reside with Senior Institute management, separate organizational components, and/or oversight committees. Because it is anticipated that the Program Official will participate in activities that rise to a level of involvement (i.e., additional role as Project Scientist) that results in conflicts of interest (e.g., co-publication), other staff members such as direct line supervisor and/or other Senior NHLBI Program management staff may serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award. Additional NHLBI staff members may be designated to have substantial involvement in the study.

The NHLBI policy on authorship and manuscript review of NHLBI-sponsored extramural research protects against conflicts of interest with the Program Officer.

The NHLBI reserves the right to withhold funding or curtail the study in the event that any of the following occur:

  • Substantial shortfall in participant recruitment, or retention, data reporting, or quality control
  • Major breach of the protocol or substantive changes in the agreed-upon protocol, methodologies, and/or tools with which the NHLBI cannot concur
  • Failure to develop or implement a mutually agreeable protocol
  • Human participant ethical issues that may dictate a premature end of the award
  • Results that substantially diminish the scientific value of study continuation

Areas of Joint Responsibility:

Participate actively and collaboratively in a Steering Committee (SC), composed of the principal investigator of the coordinating center, as well as the principal investigators of the various field clinical centers, and NHLBI and other scientific staff from co-funding Institutes or offices. The SC will have primary responsibility for facilitating the conduct and monitoring of studies and reporting study results. As the components of the SC may be geographically dispersed, the SC should meet with at least monthly conference calls, supplemented as deemed necessary by face to face meetings. Each full member of the SC will have one vote, except NIH staff, who will have one collective vote. Recipient members of the Steering Committee will be required to accept and implement all policies governing the study conduct approved by the Steering Committee. Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members.? The Steering Committee may also form an Executive Committee (EC) and/or subcommittees as needed, such as the Design Committee, Recruitment Committee, Quality Control Committee, Publications and Presentations Committee, Ancillary Study Committee, and others. The NHLBI Project Scientist(s) may serve on the EC and on subcommittees as deemed appropriate.?The Chair of the Steering Committee will be selected by NHLBI.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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)

Yuling Hong, M.D.,M.Sc.,Ph.D.
National Heart, Lung, and Blood Institute
Division of Cardiovascular Sciences
Telephone: 301-827-3469
Email: yuling.hong@nih.gov

Ye Yan, Ph.D.
National Heart, Lung, and Blood Institute
Division of Cardiovascular Sciences
Telephone: 301-480-6779
Email: ye.yan@nih.gov

Lauren Hill, Ph.D.
National Institutes of Mental Health (NIMH)
Telephone: 301-443-2638
Email: hillla@mail.nih.gov

Richard T. Benson, MD, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Richard.benson@nih.gov

Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: dasr2@mail.nih.gov

Robb Rowley, MD
National Human Genome Research Institute
Robb.Rowley@nih.gov
(301) 827-9126 (office)

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email:?NHLBIChiefReviewBranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

Julie Delgado
National Heart, Lung, and Blood Institute
Telephone: 301-435-0833
Email: julie.delgado@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

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

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Ann Fitzpatrick
National Human Genome Research Institute (NHGRI)
Phone: 301-594-0628
Email: ann.fitzpatrick@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, 45 CFR Part 75, and 2 CFR Part 200.

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