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): Coordinating Center (U24 - Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

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-23-016
Companion Funding Opportunity
NOT-HL-22-027 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
RFA-HL-23-015 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
Assistance Listing Number(s)
93.837, 93.233, 93.839, 93.840, 93.838, 93.172, 93.853, 93.307, 93.242
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), utilizing the U24 grant funding mechanism, invites applications for a Coordinating Center (CC) 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 U24 cooperative agreement is administered by the National Heart, Lung, and Blood Institute (NHLBI), but includes extensive participation and funding contributions from a coalition of institutes at the National Institutes of Health (NIH). This FOA aims to systematically investigate factors of risk and resilience and potential mediators impacting the health of AsA-NHPI subpopulations in parallel with a companion FOA (RFA-HL-23-015) that encourages applications for Clinical or Community Field Centers (CCFCs). Applications submitted to this FOA are expected to propose a detailed approach on how the applicant plans to serve as the Coordinating Center to achieve the necessary goals required for the entire duration of the award.

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

Purpose

This Funding Opportunity Announcement (FOA), utilizing the U24 grant funding mechanism, invites applications for a Coordinating Center (CC) 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 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.

This U24 cooperative agreement is administered by the National Heart, Lung, and Blood Institute (NHLBI), but includes extensive participation and funding contributions from a coalition of institutes at the National Institutes of Health (NIH). This FOA aims to establish a coordinating center to facilitate the systematic investigation of factors of risk and resilience and potential mediators impacting the health of AsA-NHPI subpopulations in parallel with a companion UG3/UH3 FOA (RFA-HL-23-015) that encourages applications for Clinical or Community Field Centers (CCFCs) for the AsA-NHPI Cohort Study. Applications submitted to this FOA are expected to propose a detailed approach describing  plans to serve as the Coordinating Center to achieve the required milestones for the entire duration of the award.

Background

Approximately 7% or 23 million Americans are of self-reported Asian ancestry. From 2010 to 2019, AsAs were the fastest growing population 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 current gaps 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, identified a need for 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 potential other factors impacting the health of AsA-NHPI subpopulations. The primary role of the CC will be to provide overall management, coordination, communication, and relevant support of the AsA-NHPI Cohort Study across all subsections and cores of the program.

The following are details envisioned for the AsA-NHPI cohort as described on the companion FOA for the CCFCs (RFA-HL-23-015).

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 allow 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 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 a home-visiting data collector, for example, is encouraged, along with innovative strategies for cost efficient data collection.

Applicants will be expected to propose activities that include the following:

  1. Plan and support study coordinating substructure and functions of the AsA-NHPI Cohort Study. This includes, but is not limited to:
    • Developing a coordinating structure to include Steering Committee and subcommittees, composed of investigators from the CCFCs and NIH Program Office staff. Examples of potential subcommittees include Design Committee, Recruitment Committee, Quality Control Committee, Publications and Presentations Committee, and Ancillary Study Committee
    • Coordinating community engagement activities across awarded CCFCs
    • Developing and maintaining AsA-NHPI Cohort Study public-facing and secure website to include relevant resources for both participants and study investigators
    • Coordinating and providing overall management of subawards, including a Biorepository and Central Lab
    • Promoting communication and collaborations among AsA-NHPI Cohort Study investigators, including coordinating and providing relevant support for the CCFCs
    • Training staff on study protocols
    • Tracking manuscript proposals and publications that stem from the AsA-NHPI Cohort Study
    • Preparing materials and reports for the NHLBI-appointed Observational and Safety Monitoring Board (OSMB)
    • Collecting and evaluating the data collected from the CCFCs
    • Developing a Data Book designed for the AsA-NHPI participant community as a digital and/or print resource outlining the estimates and distributions of key risk factors from the baseline assessment
    • Coordinating the review of ancillary study proposals that leverage the AsA-NHPI Cohort Study platform, as well as facilitating the integration of any approved and funded ancillary studies into the study. [Note: Although not funded under this FOA, it is anticipated that future opportunities will permit investigators to propose ancillary studies using other funding mechanisms, such as investigator-initiated grants, to perform additional assessments, as well as collect genetic and biological markers on AsA-NHPI study participants.]
  1. Facilitate the development of a common protocol in collaboration with the CCFCs during the UG3 phase of the CCFCs, including the study design, analytic plan, sample size, and use of common data elements and measures across the AsA-NHPI CCFCs, to be reviewed by the NHLBI-appointed OSMB and approved by the NHLBI and collaborating institutes prior to UH3 phase for the CCFCs. [Note: The CC will work closely with the CCFCs and NIH Program Office to develop the uniform protocol (including study design, analytic plan, same size, etc.) to be adapted across multiple sites in the UH3 phase].
  1. Develop and implement data collection procedures, facilitate the collection of biomedical data, establish a central database, provide additional biostatistical expertise, and conduct analysis of data across study sites.
  1. Manage a capitation reimbursement model for the recruitment, retention, and events ascertainment of cohort participants by the CCFCs. Specifically, in addition to the funds awarded directly to the CC for conducting CC responsibilities, funds for the following three broad areas of activities will be part of the CC’s grant award and will be distributed by the CC as capitation to the CCFCs in accordance with the budgets for the protocol (see RFA-HL-23-015) as determined and approved by the NIH Program Office and the study Steering Committee:

(1) Initial examination of participants

(2) Annual or bi-annual follow-up contact

(3) Ascertainment of events of clinical significance (e.g., myocardial infarctions, cardiac injury, cerebrovascular events, chronic obstructive pulmonary disease, asthma, etc.)

  1. Coordinate the development of data files to be made available in an NIH data repository as designated by the NHLBI.

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 do 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?
  • What is the interrelationship between acculturation, discrimination, neighborhood factors, social networks and kinship structures and how do these factors intersect to impact healthoutcomes?

Study Timeline

Awards made under this FOA and RFA-HL-23-015 are permitted to propose a project period of up to 7 years in order to accommodate community engagement activities, recruitment and sampling plans, and to pursue additional exam components through ancillary studies leveraging the research infrastructure.

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 one award for this U24, corresponding to total costs of up to $2.2 million in Fiscal Year (FY) 2023, $3.6 million in FY 2024, $6.7 million in FY 2025, $6.7 million in FY 2026, $6.7 million in FY 2027, $4.0 million in FY 2028, and $3.4 million in FY 2029 for a total contribution of $33.3 million for 7 years.

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

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

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

Other NIH Institutes/Centers who are interested in collaborating will have an opportunity to join at a later time.

Together, NHLBI and collaborating NIH Institutes/Centers intend to commit an estimated total of $33.3 million from NHLBI and up to $10.5 million from collaborating ICs across RFA-HL-23-016 and RFA-HL-23-015 for the entire 7 year 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

Application budgets are not limited but must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period of award is expected to be 7 years.

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, Notice of NIH's Interest in Diversity, NOT-OD-20-031 and 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 details.

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.

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.

Other Attachments:

The attachment listed below must be completed and attached or the application will not be peer reviewed.

  1. Biospecimen Plan (5 pages)
  • A biospecimen plan must be provided as an attachment using the filename “Biospecimen Plan.pdf” and may not exceed 5 pages. Provide details on which biospecimens will be collected (e.g. blood, urine, PAXgene, stool, etc.)
  • Describe activities and plan (e.g., collection, management, tracking) to support an integrated biorepository resource to analyze and house biological specimens. Explain how linkages and coordination to one or more of these resources will be leveraged to provide an integrated resource to the investigator community
  • Plans for adherence to Good Laboratory Practices and use of current best practices for biospecimen management and quality control (e.g., the National Cancer Institute’s Best Practices for Biospecimen Resources, https://biospecimens.cancer.gov/bestpractices/)
  • Briefly describe prior experience in the operation and management of a biorepository and central lab
  1. Cohort Management (8 pages)
  • Plans for developing a collaborative organizational structure with awarded CCFCs including key cross-study committees (Steering Committee, Community Engagement, Recruitment and Retention, Ancillary Study, Quality Control, Publications and Presentations, etc.), processes for leading scientific direction, and resolving conflicts
  • Training/monitoring: Describe how training and monitoring of study sites and staff will be managed
  • Data management: Describe how study data will be managed, including data cleaning, quality control, and database management approaches. Describe how clinical events will be adjudicated
  • Data harmonization: Describe plans for data harmonization, metadata generation, and adoption/use of data standards or common data elements. If these activities are not possible or feasible for the proposed study, applications must explain why.
  • Plan for tracking and providing reimbursement to the CCFCs on their process in cohort participant recruitment, retention, and events ascertainment
  • Innovative approaches: If applicable, describe the planned use of innovative approaches to data management/standards, data collection, and/or participant follow-up/surveillance
  • Plans for developing participant newsletter and website
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 an NIH Biosketch, whether or not they are budgeted.

The experience of each PD/PI and all Key Personnel must be carefully documented, and roles and responsibilities must be well-defined. Applications must provide evidence that Senior/Key Personnel have:

  • Experience working with and/or leading multidisciplinary research team including level of expertise in coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), regulatory support, and biostatistical/analytical support.
  • Any special expertise or unique strengths that will be brought to the CC (e.g., experience in large research consortia or multi-site studies, non-government organizations, data analytic skills, cardiovascular disease prevention research, etc.).
  • Experience in the planning, implementation, project coordination and administration/management and monitoring of multi-site research including success in meeting milestones and timelines.
  • Expertise in coordinating collaborative, multi-site studies in low-resource and/or diverse settings (e.g., rural, urban, suburban, other geographically or otherwise diverse settings across the U.S.) or among underrepresented populations and with vulnerable and diverse populations.
  • Documented experience and expertise in project management of recent research project and/or multi-site consortia, with a description of the collaborative leadership structure used.

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 CC must be presented for activities related to coordinating functions for the AsA-NHPI CCFCs. The operational budget should include, but not be limited to the following items:

  • Management of day-to-day operations and oversight of the professional activities including proposed administrative activities, data and research coordination, and skills development program
  • Development and maintenance of AsA-NHPI Cohort Study public-facing and secure websites
  • Planning, coordinating, and facilitating in-person and virtual AsA-NHPI Cohort Study meetings, including the start-up meeting, monthly Steering Committee meetings, subcommittee meetings, webinars, conference calls, the meetings with the OSMB and other PD/PI meetings including NIH Program Office , as needed. This includes any site visits at the CC and CCFCs as needed
  • Coordination of support for one in-person or virtual OSMB meeting per year and any site visits at the CC and CCFCs as needed
  • Participation in awardee meetings, the Steering Committee or appropriate subcommittees, and other leadership committee functions; and communication, documentation, and reporting
  • Plan for an independent overall study chair to lead the Steering Committee including honorarium and travel cost. The overall study chair would be selected with input from the PI’s of the CC, CCFCs, and NIH
  • Coordination and delivery of skills development and training in the common protocol among AsA-NHPI Cohort Study awardees
  • Costs associated with data transfer to the CC, statistical analysis of common data, and publication of primary outcome and other papers (e.g., Open Access)
  • Costs for data transfer from CCFCs to CC and other monthly teleconferences and/or webinars
  • Development of public access data files, and close-out phase activities, if applicable
  • Costs associated with budget support for publication, data sharing, and broad dissemination of results
  • Costs associated with the development of the data book as a digital and/or hard copy resource
  • Sub-awards as needed. The application must include only its own budget, including any subcontract budgets (e.g., biorepository) associated with it. Separate itemized budgets must be prepared for each subcontract. The application must provide detailed annual budgets that will enable the CC to meet its milestones
  • The CC will collaborate with CCFCs to propose preliminary baseline assessment and examination protocols and budget. As aforementioned in this FOA, the protocol funds to perform the study-wide participant examinations, annual or bi-annual follow-up, and events ascertainment will be awarded to the CC and be distributed by the CC to the CCFCs on a capitation basis in accordance with budgets approved by the NIH Program Office

For planning purposes, it is estimated that $350,000 direct costs for year 2, $2,200,000 direct costs for years 3-5, $1,500,000 direct costs for year 6, and $1,500,000 direct costs for year 7 will be distributed to CCFCs from the CC’s award 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 2-5 for recruitment and follow-up. The amount for years 6-7 is largely for participant follow-up and retention.

Start-up and Annual Meetings

Budgets must include funds for the PD/PI and two additional key personnel from the CC for start-up and future meetings. These meetings will typically be held in the Washington, D.C.

OSMB

Include all costs associated with up to a seven-member NHLBI-appointed OSMB activities, which will consist annually of a one-day in-person or virtual meeting in the Washington, DC area and one or more conference call meetings. The study leadership is required to attend this meeting. An OSMB meeting could be held in conjunction with one of the in-person Steering Committee meetings. Travel cost and honorarium for the OSMB should also be included as should the costs for preparing reports for the OSMB and meeting requirements for the OSMB members.

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

This FOA aims to establish a coordinating center to facilitate the systematic investigation of factors of risk and resilience and potential mediators impacting the health of AsA-NHPI subpopulations in parallel with a companion UG3/UH3 FOA (RFA-HL-23-015) that encourages applications for Clinical or Community Field Centers (CCFCs) for the AsA-NHPI Cohort Study.

Indicate key infrastructure aims and how these aims will ensure the successful enrollment, initial examination, and follow-up activities of a cohort of participants representative of multiple immigrant generations of Asians Americans as well as Native Hawaiians and Pacific Islanders.

Research Strategy

Applications for the CC should demonstrate expertise in performing study coordinating structure and functions, facilitating the AsA-NHPI cohort study team on the development of the common protocol, leadership in developing a collaborative environment to achieve scientific objectives, calculate sample size and power estimations, and use of common elements and measures across CCFCs. In addition, the research strategy should present an overview of how the CC could serve as a leader or facilitator in working with the CCFCs and the Steering Committee to develop and propose the approach to collect baseline assessments to answer the core research questions. The applicants should consider innovative approaches to primary data collection methods such as, but not limited to the use of mobile technology, wearable devices, and remote monitoring. To that end, the following items described below mustbe addressed by the applicant.

Significance

Present a clear statement of the way in which the CC relates to the goals of the overall AsA-NHPI Cohort Study. Explain why the proposed coordinating center framework is optimal.

Approach and Innovation

Applicants must describe the following:

  • The management, administration, and operational needs of the CC. Discuss how the overall administration and coordination strategies, and operational plan are appropriate for the population of interest
  • The process for leading the establishment of a unified research protocol to address key research questions and plans for implementing the protocol across awarded CCFCs
  • The process for leading and coordinating community engagement activities across the recruitment sites
  • The proposed schedule and work-flow plan
  • Present plans to identify and solve problems, determine alternative strategies and milestones to be accomplished as well as benchmarks for success
  • Discuss processes to be used to facilitate and foster the recruitment and retention of study subjects by the CCFCs, and central training of study staff
  • Detailed plans for coordinating the functions of the CCFCs
  • Describe how data will be transmitted in an accurate, efficient, and timely fashion from the CCFCs to the CC, and how the CC will establish accessible and secure methods of communication and data transfer
  • Plans to provide biostatistics expertise for study design and data analysis in collaboration with CCFCs
  • Plans to track and review manuscript proposals and publications (e.g., establishment of an AsA-NHPI cohort study publications and presentations committee)

Letters of Support

A statement of commitment from each participating institution or organization, specific to the CC, shouldbe provided. Include letters of resource support, including support provided by the applicant institution and partner organizations that will enhance the potential for success. Examples of such support would include, but are not limited to, institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, web space, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as the assurances that partner organizations are committed to providing these resources to the CC should be included in this section.

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.

NHLBI expectations for data sharing:

Data collected under this FOA are expected to be widely shared through the NHLBIBioData 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 made widely available. ?

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.

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

2.7 Study Timeline has the following additional instruction:

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

  • Single IRB approval
  • Development of a coordinated study protocol including an initial examination of the cohort and follow-up activities and surveillance for events of clinical significance
  • Establishment of study infrastructure, such as committees, biospecimen assays and storage, and study sites
  • 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:

In addition to describing the various study sites (e.g., administrative sites, data coordinating sites, enrollment/participating sites, laboratory or testing centers), applicantions 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 field of 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

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 proposed Coordinating Center address the needs of the collaborating Clinical/Community Field Centers (RFA-HL-23-015) that it will serve? Is the scope of activities proposed for the Coordinating Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Clinical/Community Field Centers?

Specific to this FOA:

  • How will this CC make a significant contribution to the overall goals and objectives to help address key population research gaps in the health of AsA-NHPIs?
  • To what extent will the proposed approach to the research core questions lead to a better understanding on how to tackle the challenges that this population faces?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center Field Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in epidemiological cohort studies? Do the investigators demonstrate significant experience with coordinating collaborative epidemiological research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; is their leadership approach to developing a collaborative environment appropriate for the Coordinating Center Field Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

  • How strong are the investigators in having the necessary qualifications and experience in conducting coordinating functions and in facilitating and leading multidisciplinary teams?
  • How strong is the application regarding past and/or ongoing experience with coordinating collaborative, multi-site research in diverse settings?
  • How strong is the evidence that the applicant(s) have experience in clinical studies management, and/or home visit data-collection experience in working with diverse populations in rural, urban, suburban, other geographically or otherwise diverse settings across the U.S.?
  • If the CC is multi-PD/PI, how complementary and integrated are the investigators' expertise and skills?
  • To what extent does the application demonstrate experience that supports the ability to build partnerships and collaborative research and support CCFCs?
  • How strong is the organizational structure of the CC and project management expertise represented among the key personnel?
  • To what extent does the documented experience of the Key Personnel support the proposed coordinating functions including coordination and administration, logistics, communications, data management (including quality control), data capture and transfer from the CCFCs to coordinating center, data security and IT infrastructure (including development of public and secure study websites), regulatory support, clinical study and site monitoring, and biostatistical/analytical support?
  • Does the application demonstrate that proposed study personnel have the ability to analyze data across multiple sites? Do the proposed study personnel have sufficient expertise and experience in coordinating CCFCs from across the United States?

With regard to the proposed leadership for the project:

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

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research that the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Specific to this FOA:

  • How strong are the proposed plans to utilize novel organizational concepts and management strategies in coordinating the functions across CCFCs for the AsA-NHPI Cohort Study?
  • To what extent does the design/research plan include innovative elements, as appropriate, that enhance its potential to help address key population research gaps in the health of AsA-NHPIs?
  • To what extent do the innovative approaches positively contribute to the facilitation of data collection or data management of the cohort?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the collaborating Clinical/Community Field Centers, appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the collaborating Clinical/Community Field Centers? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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 realistically and well do the proposed contingency plans manage potential delays or barriers with participant recruitment in the overall cohort as well as in key AsA-NHPI subpopulations?
  • How achievable are the study's timeline and milestones?
  • How appropriate are the plans for collecting, processing, analyzing, managing and tracking, and storing study biospecimens?
  • How rigorous are the proposed plans for managing and analyzing study data?
  • How feasible are the plans for active and/or passive participant follow-up or surveillance?
  • How reasonable and adequate are the Data Sharing Plan and the Genomic Data Sharing Plan?

Environment

Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Center proposed? Will the Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this FOA:

  • To what extent does the application demonstrate sufficient infrastructure to implement the proposed coordinating center functions?
  • Are technical and information technology resources sufficient to house and securely share resources and/or data, as well as build and manage the AsA-NHPI Cohort Study’s public-facing and secure websites?
  • How 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?

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 elements that could help the CCFCs 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: Sharing Model Organisms  .

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] 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 on the basis of established PHS referral guidelines 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 recipient 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 recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

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 U24 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 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. Recipients 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 include:

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 clinical or community field 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)

Stephanie Marquez, M.P.H.
National Heart, Lung, and Blood Institute
Division of Cardiovascular Sciences
Telephone: 301-402-0965
Email: stephanie.marquez@nih.gov

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

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 (NHLBI)
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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