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 Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Reducing the Impact of Hypertension in Low and Middle Income Countries (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • August 3, 2011 - See Notice NOT-HL-11-155. Frequently Asked Questions posted.

Funding Opportunity Announcement (FOA) Number

RFA-HL-12-027

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.837, 93.853

FOA Purpose

The National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Neurological Disorders and Stroke (NINDS) invite research grant applications focusing on effective interventions that will provide sound scientific evidence for expanding sustainable blood pressure prevention and control programs in low and middle income countries (LMICs) at the local, regional, and national level.  

Key Dates
Posted Date

June 2, 2011

Open Date (Earliest Submission Date)

July 10, 2011

Letter of Intent Due Date

July 10, 2011

Application Due Date(s)

August 10, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 1, 2012

Expiration Date

August 11, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

 Research Objectives

The National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Neurological Disorders and Stroke (NINDS) invite research grant applications focusing on effective interventions that will provide sound scientific evidence for expanding sustainable blood pressure prevention and control programs in low and middle income countries (LMICs) (See http://data.worldbank.org/about/country-classifications for LMIC definitions) at the local, regional and national level.

This FOA is being issued in cooperation with the Global Alliance for Chronic Diseases (GACD) (http://www.ga-cd.org/). Members of the GACD include the Medical Research Councils of the United Kingdom and South Africa; The Australian Health and Medical Research Council (NHMRC); the Canadian Institutes of Health Research (CIHR); the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health in the United States; and the Chinese Academy of Medical Sciences. Each member will issue their own solicitation, but funded projects will be part of a Consortium.

The following Principles of the GACD are reflected in this FOA: 1) A commitment to improving health gains while reducing health disparities in LMICs and among Aboriginal populations in higher income countries; 2) A focus on research topics where the need for evidence to inform policy, programs, and practice is most urgent; 3) The translation of research findings and the  exchange of (clinical) approaches that are designed to maximize public health benefits; 4) The identification of common approaches for the implementation, integration, and scaling-up of health service delivery systems.

Learning from individual projects is expected to provide evidence that will support local decision making. Cumulative learning across funded projects is expected to provide a basis for evidence-informed recommendations for national and international organizations.

Outcomes expected from this FOA across participating countries include: 1) Established networks of teams involved in implementation research for chronic disease prevention and management; 2) Advances in the field of implementation science with applicability to other settings and other health issues; 3) Common protocols for implementation science initiatives developed and refined, including protocols for systems analysis; and 4) Strengthened capacity for implementation research in chronic disease.

The long term goal is for the results of projects supported by this announcement to provide healthcare providers and decision-makers with the scientific evidence to implement effective programs that will: 1) reduce the prevalence of cardiovascular disease (heart disease and stroke) developing as a consequence of high blood pressure and 2) inform implementation and enable scale-up of larger programs (including related policies in health and other sectors) at local, national and regional levels.

This NHLBI FOA is calling for applications from US domestic institutions, in partnership with one or more institutions in a LMIC, where the majority of the implementation work is being conducted in the LMIC.

Background

Hypertension is a major contributor to the growing global pandemic of cardiovascular disease and stroke. This FOA seeks research projects which will emphasize implementation science and will focus on hypertension prevention and control in Low and Middle Income Countries (LMICs) (See http://data.worldbank.org/about/country-classifications for LMIC definitions).  Poor control rates for hypertension and a lack of strategies to maintain normal blood pressure, particularly in LMICs, reflect the challenges of effective and affordable implementation in health care and other systems.  This program seeks to improve the implementation of existing approaches to prevention and control rather than to develop new treatments.  Developing novel and effective means of controlling blood pressure in persons who have suffered stroke or transient ischemic attack is of particular interest to NINDS. 

The GACD Members will encourage research from a variety of settings in LMICs.  Research involving the active engagement of Aboriginal communities in Canada and Australia will also be considered by CIHR and NHMRC respectively, but not by NHLBI. 

The overall aims of this program are: 1) to develop a better understanding of key barriers and facilitators at local and national levels that affect hypertension control and to consider how these implementation challenges can be overcome; 2) to understand how innovations for hypertension control can be introduced and scaled-up across a range of settings; 3) to identify what elements of systems most need to be strengthened to prevent hypertension and its consequences (e.g., stroke); and 4) to improve hypertension control rates while reducing disparities in hypertension control across population sub-groups.

This FOA is designed to optimize cumulative learning across individual projects, and to ensure that results are interpretable and can be generalized across locations.  These include standard metrics and/or protocols for examining outcomes and for assessing features of the health care system and the broader context.  The development of these standard metrics and/or protocols will be undertaken in consultation with national and international investigators, decision-makers, and policy-makers. Funded teams will come together as a consortium to develop approaches to standardize data collection and are expected to use these standardized approaches in their respective projects. This will allow the sharing of outcome data across projects.  A scientific standards and data-sharing technical advisory group will be established for this program by the GACD consortium.  

There are expected to be important differences across the settings of funded study teams.  These differences include variations in: social, economic and cultural contexts; population health disparities and disease burdens; health care delivery models including the mix of formal and informal health care providers; financing models for chronic disease prevention and control; private and non-governmental organization (NGO) sector engagement in chronic disease; and regulatory structures. These differences will provide an important basis for programmatic learning about the implementation and scale-up of hypertension prevention and control programs. 

Program Structure

This FOA is inviting applications from US domestic institutions where a significant part of the work is conducted in a LMIC, however, it is required that the applicant institution's Principal investigator has a substantial involvement in the direction of the research program. This includes being able to provide appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.

One of the goals of this FOA is to develop a highly interactive and synergetic Consortium of Investigators across the world who will share ideas, data, and resources to improve high blood pressure prevention and control in LMICs. The Consortium will consist of projects funded through this FOA and other projects funded through the GACD independent solicitations.  Collaboration and interaction among Consortium investigators will be requirements of the program and will be facilitated with teleconferences and meetings of the investigators organized by the GACD. Two investigators per project (one from the US and one from the partner LMIC) should agree to be active participants in Consortium-wide activities as deemed necessary by appropriate oversight committees. Such activities may include development and standardization of tools such as common data collection instruments and training materials, among others.

Steering Committee: The Consortium will have a Steering Committee that will be responsible for overall scientific direction, coordination, and oversight. The Steering Committee will be composed of two investigators per project (one from the US and one from the partner LMIC), and the NHLBI Project scientist. The role of the NHLBI Project scientist is described under Cooperative Agreement Terms and Conditions of Award Section V1.2. The Steering Committee will meet in person for an implementation meeting at the start of the project period, by conference call at least quarterly, and in person once a year in a LMIC throughout the project period (Annual Grantees meeting- see below). Participation in Steering Committee Activities is a requirement for the two investigators of each project (one from the US and one from the partner LMIC). Funds should be requested in the application's budget to attend Steering Committee meetings. 

Annual Grantee Meeting: The GACD will arrange annual meetings to encourage the exchange of information for the Consortium and potentially with other stakeholders. In the preparation of the budget for the grant application, applicants should include travel funds for one meeting each year to be held in a LMIC, for the principal investigator from the US, investigator from the LMIC partner, key collaborators, and trainees. A major goal of these meetings is to facilitate progress by providing a forum that will lead to sharing skills, ideas, technology, and data. At the meetings, participants will discuss coordination, sharing and a means of informing the community and policy makers about the progress made by the Consortium.

Research Applications

Research projects should include a focus on one or more of the following components that are crucial for the prevention and control of high blood pressure:

All Applications should describe as applicable:

Programs proposed can be new or linked to existing programs. Innovative approaches, including those that draw on successful local experience and those that lend themselves to adaptation to other environments, will be encouraged through this funding mechanism.

Applications in response to this announcement may utilize a variety of approaches such as experimental and quasi-experimental study designs, mixed methods studies, comparative case studies, economic and mathematical modeling, and combined approaches.

Selected Examples of innovative approaches include but are not limited to:

1.  The use of electronic and cell phone information and communication technologies.

2.  The involvement of industry and non-governmental organizations in health or other sectors.

3.  The participation of community workers and community leaders.

4.  The use of electronic and cell phone information and communication technologies to monitor adherence and control of blood pressure in survivors of recent stroke or TIA.

5.  The development of low cost and sustainable tools such as check lists for persons who have survived stroke and TIA as well as providers.

6.  The integration of community workers and community leaders in controlling blood pressure for stroke and TIA survivors.

Selected Research Examples include but are not limited to:

1. Implementation of an intervention program targeting environmental supports and policies that make healthy eating and a lower sodium diet an easier choice.  This might include:

2. Implementation of a comprehensive screening and high blood pressure control program, which:

3. Implementation of a stroke and TIA screening and diagnosis program, which:

4. Initiation of interventions to improve prevention treatment(s) for patients with stroke and TIA through a program which:

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, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

NHLBI intends to fund 2-3 awards.

NHLBI intends to commit a total of $1M for fiscal year 2012.

NHLBI intends to commit a total of $2M for each of fiscal years 2013, 2014, and 2015

NHLBI intends to commit a total of $1.5M for fiscal year 2016

NINDS has assigned funds to support one project focused on the prevention of secondary stroke, contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications proposing projects relevant to the programmatic priorities of the NINDS. Direct costs are limited to $230,000 in year 1, to $450,000 in years 2-4, and to $250,000 in year 5 of the project period. 

Award Budget

Direct costs are limited to $230,000 in year 1, to $450,000 in years 2-4, and to $250,000 in year 5 of the project period.  Applicants must submit non-modular budgets using the non-modular format. Direct Costs for the domestic component are limited to 30% of the total direct costs per year.

Award Project Period

Five years  

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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 SF 424 (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.

NIH will not accept or award any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.   

Eligible studies

High priority will be given to work in non-GACD member low and middle income countries. For the purpose of this solicitation, a GACD member is defined as a public funder of research in a country that has committed or communicated to the leadership of the GACD its intention to join the GACD.

Given the implementation focus of this FOA, the following types of studies will be considered non-responsive:

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel in US and LMIC institutions
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730
Email:nhlbichiefreviewbranch@nhlbi.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:  

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. 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.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)    

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

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/priority score, but will not give separate scores for these items.

Quality of the Team

Does the application demonstrate the active participation of decision makers? (Letter(s) of support from relevant decision-maker(s) should be included in the application.)

Implementation Plans

Are the proposed intervention strategies relevant to the social, cultural and economic context? Have inequities and equity gaps, including gender, been taken into account in the design of the proposed implementation strategy?

Have objective measures of evaluation of the effectiveness of hypertension prevention and control been included? Does the application include consideration of the potential for scaling-up intervention strategies in the local environment, such as addressing affordability for users, financial implications for implementing organizations and funders, etc? Does the application propose a training and implementation science capacity-building component?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Applications from Foreign organizations will not be accepted for this FOA.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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 NHLBI Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned  on the basis of established PHS referral guidelines to the NHLBI or NINDS. 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 NHLBI and NINDS Advisory Councils. The following will be considered in making funding decisions:

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

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 grantee business official.

Awardees 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.

Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the principal investigators (i.e., cooperative agreement awardees),  and the NHLBI Project Scientist.  The Steering Committee will meet in person for an implementation meeting at the start of the project period, by conference call at least quarterly, and in person once a year in a LMIC throughout the project period.

Encouraging study investigators to publish and to release publicly and disseminate results and other products of their study, in accordance with study protocols and governance. Within three years of the end of the period of NHLBI support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance.  In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the three year period following the end of the period of NHLBI support.

Ensuring that upon completion of the project, awardees put their intervention materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NHLBI, for the conduct of research at no charge other than the costs of reproduction and distribution.

Asking Awardees to share data and tools with the Consortium members as resources are being developed when deemed appropriate and discussed and approved by the Steering Committee. Awardees 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 DHHS, PHS, and NIH policies.  The NHLBI Project Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee

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

The NHLBI Project Scientist will serve on the Steering Committee; he/she or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and other NHLBI scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., data sharing and database development, quality control, adherence to protocol, core establishment.

The NHLBI reserves the right to withhold funding or curtail the study (or an individual award) in the event of (a) substantive changes in the agreed-upon work scope with which NHLBI cannot concur, (b) human subject ethical issues that may dictate a premature termination.

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

Additionally, an agency program official or NIH program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The assigned program director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

Awardees agree to the governance of the Consortium through the Steering Committee.    The Steering Committee Chair will be appointed by NHLBI.  Additional members may be added by majority vote of the Steering Committee.

Awardee members of the Steering Committee agree to accept and implement policies approved by the Steering Committee, and recommendations from the External Advisory Committee if one is constituted.

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 awardee. This special dispute resolution procedure does not alter the awardee'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, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.  

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Lawrence J. Fine, MD, DrPH
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10213
Bethesda, MD 20892-7936
Telephone: 301-435-0305
Email: finel@nhlbi.nih.gov

Cristina Rabadan-Diehl, Ph.D., M.P.H.
Office of Global Health
National Heart, Lung, and Blood Institute
31 Center Drive, Suite 5A06C
Bethesda, MD 20892
Telephone: 301-496-3620
Email:rabadanc@mail.nih.gov

Salina Waddy, MD
Program Director
National Institute of Neurological Disorders and Stroke (NINDS)
6001 Executive Boulevard, Room 2153 
Bethesda, Maryland 20892
Phone: 301- 496-9135
Email: waddysp@ninds.nih.gov

Peer Review Contact(s)

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Financial/Grants Management Contact(s)

David Ruane
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7134
Bethesda, MD 20892-7926
Bethesda, MD 20817 (express/courier zip service)
Telephone: 301-435-0166
Fax: 301-451-5462
Email: ruaned@nhlbi.nih.gov

Terri Jarosik
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7156
Bethesda, MD 20892-7926
Bethesda, MD 20817 (express/courier zip service)
Telephone: 301-435-1498
Fax: 301-435-0166
Email: tjarosik@mail.nih.gov

Tijuanna DeCoster, MPA
Grants Management Officer, Grants Management Branch
National Institutes of Neurological Disorders and Stroke
6001 Executive Blvd
Room 3258, MSC 9537
Bethesda MD 20892-9537
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9231
E-mail: decostert@ninds.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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