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)

Funding Opportunity Title

Cardiovascular Risk Reduction in Underserved Rural Communities (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices
  • June 22, 2012 - Notice on Upcoming Webinars for RFA-HL-13-013. See Notice NOT-HL-12-146.
Funding Opportunity Announcement (FOA) Number

RFA-HL-13-013

Companion FOA

 None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.837 

FOA Purpose

The overall objective is to build the evidence base and accelerate the implementation and translation of evidence- or practice-based interventions into practice in rural communities.  To accomplish this objective, NHLBI invites applications that will plan and execute well-designed controlled trials that maximize the opportunities available in rural communities to reduce cardiovascular disease risk factors. The long-term goal is to foster sustainable interventions and scientific research that will lead to reduced cardiovascular morbidity and mortality in high-risk rural populations. 

Key Dates
Posted Date

March 21, 2012

Open Date (Earliest Submission Date)
Letter of Intent Due Date

December 11, 2012

Application Due Date(s)

January 11, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May/June 2013

Advisory Council Review

August 2013

Earliest Start Date(s)

September 2013

Expiration Date

January 12, 2013

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

Rural communities can be defined as “all territory, population, and housing units located outside of urbanized areas and urban clusters. Urbanized areas include populations of at least 50,000, and urban clusters include populations between 2,500 and 50,000.” (http://www.rupri.org/Forms/RuralDefinitionsBrief.pdf   Coburn AF, MacKinney AC, McBride TD, Mueller KJ, Slifkin RT, Wakefield MK. Choosing Rural Definitions: Implications for Health Policy. Rural Policy Research Institute Health Panel. 2007 (Issue Brief #2)). Using this definition, the most recent data indicate about 70 million rural residents in the United States. Rural communities are characterized by a high prevalence of and varying disparities in heart disease morbidity and mortality (Brown and O'Connor, http://www.nejm.org/doi/full/10.1056/NEJMp1003880), including obesity, Chronic Obstructive Pulmonary Disease (COPD), hypertension and diabetes. As noted by Murray et al. (http://www.sciencedirect.com/science/article/pii/S0749379705002898), "startling life expectancy gaps as high as 15 years are evident, and “tens of millions of Americans are experiencing levels of health that are more typical of middle-income or low-income developing countries.” Clearly, the burden of cardiovascular disease risk factors, the wide life-expectancy gaps, and the unique challenges (and opportunities) in rural communities call for targeted research. The prevention and management of cardiovascular disease risk factors such as hypertension, obesity, diabetes, and adverse health behaviors (e.g., physical inactivity, poor dietary habits, sleep disorders, and smoking) in rural settings are often stymied by many challenges including:

1. Limited use of appropriate study designs or failure of investigators to evaluate the likelihood of success in rural settings of controlled trials that have had demonstrable efficacy in other settings.

2.  Interventions that are not sustained in rural communities and are characterized by brief, superficial encounters of investigators with rural communities, frequently resulting in research findings that are inadequately communicated and of little use to participants.

3.  Failure to consider the financial and transportation constraints, cultural barriers, and limited educational attainment of rural populations or to form partnerships with community agencies, to engage community members and health workers in their interventions or to test strategies to improve policies and infrastructure that have the potential to reduce cardiovascular disease risk.

4.  Limited number of studies that adapt evidence- or practice-based interventions to rural settings and address multiple cardiovascular disease risk factors even though such multiple risk factors co-exist and are more prevalent in rural populations. In addition, to successfully translate and sustain evidence- or practice-based interventions into practice in rural settings will require longer times and often more than five years. 

To overcome these challenges, applicants must address in their applications the following two stages:

1. Stage 1 is a planning phase to develop partnerships among a multi-disciplinary team of investigators (e.g., community agencies, academic institutions, social workers, policy makers, anthropologists and economists) and rural community health promoters, including community health workers to: (a) assess the community's resources and cardiovascular risk reduction needs, (b) engage the community through, for example, community-based participatory approaches, and (c) identify appropriate study design, target audience, recruitment and retention strategies, intervention approaches and evaluation methods. This initiative encourages collaboration among organizations, including collaboration among a network of community health centers or hospitals for optimal care of patients (e.g., hypertensive patients or patients with acute MI).

2.  Stage 2 is a developmental phase of small-scale, feasibility controlled clinical trials to explore approaches for adapting efficacious, evidence- or practice-based interventions into rural community settings. Investigators may identify ongoing practice-based interventions that are open to research and implement evidence-based interventions that have been found efficacious in non-rural settings. Investigators may also test new intervention approaches. Interventions must be based on sound study designs (e.g., RCTs) and analytic methods. Justification and threats to internal and external validity must be addressed if non-randomized study designs are used. Stage 1 activities will be expanded and integrated into the intervention.

Stage 1 planning phase (about 18 months) activities may include the following:

1. Identifying community stakeholders and partners, including those in public or regional health departments and health care organizations.  Applicants are encouraged to collaborate with local agencies (e.g., USDA Cooperative Extension Service or community-based agencies located in the rural county).

2. Forming leadership teams and coalitions to advise on development and implementation of the intervention.

3.  Obtaining cardiovascular disease risk factor burden assessment; review and analyze data.

4.  Identifying community engagement opportunities and how to best facilitate community development, training and partnerships. Applicants may use geographic information systems (geo-spatial mapping) and other novel approaches to identify their rural communities.

5. Applicants must specify their rural community and must select and justify their definitions (see definitions in this URL http://www.rupri.org/Forms/RuralDefinitionsBrief.pdf Coburn AF, MacKinney AC, McBride TD, Mueller KJ, Slifkin RT, Wakefield MK. Choosing Rural Definitions: Implications for Health Policy. Rural Policy Research Institute Health Panel. 2007, Issue Brief #2 http://www.hrsa.gov/advisorycommittees/rural/2008secreport.pdf).  

6.  Determine the best study design that will be used in the preliminary/feasibility study in Stage 2, and recruitment and retention strategies.

7.  Conduct formative research (e.g., focus groups, in-depth interviews, ethnography, photovoice) and determine the scope of the intervention and the specific risk reduction applicable to the study population (e.g., behavioral, environmental, and/or policy focused).  

Stage 2 feasibility phase (about 18 months) activities may include:

1. Testing on a small scale the hypothesis that adults who participate in multi-component interventions in multiple settings compared to a single component intervention (e.g., economic development intervention) will prevent or reduce multiple cardiovascular disease risk factors.

2.  Exploring the utility of various technologies for cardiovascular disease prevention in rural communities (e.g., telemedicine, electronic health records).

3.  Piloting research strategies to improve policies and community infrastructure shown in epidemiologic studies to have the potential to reduce cardiovascular disease risk factors.

4.  Exploring innovative approaches for adapting efficacious studies into practice in rural communities.

Applicants must delineate performance milestones in both Stages 1 and 2 that would assure the likelihood and feasibility of a successful larger-scale trial. Applicants must provide study timelines to be completed in Stages 1 and 2, rationale for the clinical trial to be developed in Stage 3, potential sustainability plans, and evidence that the intervention to be tested in Stage 3 is based on sound research findings in Stage 2. Applicants will be evaluated at the end of Stage 2 by an External Advisory Group to assess whether identified performance milestones have been met.

Successful Stage 1 and 2 awardees as well as others who can show promise of completing required activities and milestones in Stages 1 and 2 or have demonstrated feasibility in adapting efficacious interventions in rural settings would be eligible to apply for Stage 3 (Issuance of Stage 3 FOA to be determined at a later date). A major goal is to build the evidence base for interventions in rural communities; to implement and translate research findings into community and public health practice; and to accelerate the diffusion, adoption, integration, and sustainability of tested intervention. Applicants must design their studies to be sustainable and cost-effective.

In June 2010, NHLBI convened a workshop, in collaboration with other federal agencies to identify research gaps and to provide recommendations for future research in the development, implementation and evaluation of community interventions to reduce cardiovascular disease risk factors in rural communities. Recommendations from the workshop are available at http://www.nhlbi.nih.gov/meetings/workshops/cvd_rural_workshop/report.htm

Applicants are encouraged to be familiar with CDC's Million Hearts Initiative http://millionhearts.hhs.gov/ and to incorporate the Million Hearts strategies in their interventions to reduce the prevalence of CVD risk factors.  

The National Heart, Lung, and Blood Institute and other NIH Institutes have supported studies that have demonstrable efficacy or effectiveness in the prevention of cardiovascular risk factors including hypertension (e.g., Dietary Approaches to Stop Hypertension [DASH], and DASH sodium, DASH for Kids), obesity (POUNDS Lost, PREMIER), physical activity (e.g., Trial of Activity for Adolescent Girls, Activity Counseling Trial), diabetes (e.g., Diabetes Prevention Program, Look Ahead), all of which can be implemented and tested in rural community settings.

For coordination among investigators, applicants are required to participate in biannual meetings to enable sharing and collaborative problems solving. Applicants should budget for key investigators to attend two-day biannual face-to-face meetings in the Bethesda/Washington, D.C. Metro area. NHLBI, CDC and other staff will participate in the biannual meetings to provide technical and scientific assistance.

For Frequently Asked Questions, see http://www.nhlbi.nih.gov/funding/inits/faq-hl-13-013.htm

Section II. Award Information
Funding Instrument

Grant

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 up to 4 awards, corresponding to a total of $800,000 for fiscal year 2013.  Future year amounts will depend on annual appropriations.

NHLBI intends to commit FY 2014, $2.4M; FY 2015, $2.4M; and FY 2016, $800,000 for 4 awards.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

4 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

Applicant institutions that have not been major recipients of NIH support are encouraged to apply for this FOA. Non-governmental organizations may collaborate with institutions of higher education.

ADDITIONAL INFORMATION: The eligible organization must select and define their rural community and are encouraged to select their definitions from those specified in the brief by http://www.rupri.org/Forms/RuralDefinitionsBrief.pdf Coburn AF, MacKinney AC, McBride TD, Mueller KJ, Slifkin RT, Wakefield MK. Choosing Rural Definitions: Implications for Health Policy. Rural Policy Research Institute Health Panel. 2007(Issue Brief #2).

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 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

ADDITIONAL INFORMATION:

A multidisciplinary team is encouraged. Such a team may consist of local community health workers, trained lay workers, social workers, policy makers, anthropologists and economists, investigators from academic institutions, community agencies, and non-governmental institutions.  Investigators must demonstrate how the team will function and implement the aims of the study.

Multiple PD(s)/PI(s) are strongly encouraged to state their areas of expertise and indicate how they complement one another. A community agency partner is encouraged as one of the PIs in a multiple PD(s)/PI(s) relationship.  A minimum of 2.4 person months distributed across the multiple PD(s)/PI(s) is encouraged.  

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 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.  

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@mail.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 submission of applications for this FOA. 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:

Data and Safety Monitoring Plans:

Data and safety monitoring plans are required, and must:

Identify the entity that will monitor the study. Monitoring may be conducted in various ways or by various individuals or groups. It may be performed by the Principal Investigator (PI), an independent monitoring group or a DSMB. (See: Data and Safety Monitoring Plan Checklist)

Certification of IRB approval(s) of a protocol with its data and safety monitoring plan must be sent (preferably electronically) to the NHLBI Grants Management Officer (GMO) before a proposed human subjects research project may begin at a site.

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 Institutions

Not Applicable

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(s)/PI(s) 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.  

Requirements

In order to be responsive to this FOA, the proposed study must be performed in a rural community. Applicants must define clearly the rural community in which the study will occur.

Post Submission Materials

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

Additional Submission Information

Applicants provide collaborative letters of support from rural community agencies and must demonstrate long-standing relationships with the rural community or agency(ies).  Include letters of support as an attachment in the “other research plan” section and not in the appendix.

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? Have the investigators provide evidence of the significance of their selected rural community? Have the investigators defined their rural community using definitions in  the article by Coburn AF, MacKinney AC, McBride TD, Mueller KJ, Slifkin RT, Wakefield MK. Choosing Rural Definitions: Implications for Health Policy. Rural Policy Research Institute Health Panel. 2007(Issue Brief #2)http://www.rupri.org/Forms/RuralDefinitionsBrief.pdf?   

Investigator(s)    

Are the PD(s)/PI(s), 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is there evidence of a multi-disciplinary team including community partner investigators? Do community partner investigators have significant effort in the study? Is there evidence of collaboration among team members?  Is there a clear description of the governance structure of the proposed relationship between the academic and community partners?

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? Are there innovative approaches to engaging the rural community? Is there evidence of potential sustainability of the proposed intervention?  Is the application using innovative methods to adapt efficacious, evidence- or practice-based interventions into rural community settings or are there new intervention approaches being tested in rural communities?

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? Are the performance milestones for Stages 1 and 2 adequate? Are study timelines for Stages 1 and 2 provided and adequate? Is there evidence to indicate potential success of the proposed intervention and the likelihood of its sustainability? Are evidence-based or practice-based approaches proposed for the intervention, or is the study testing novel approaches? Is there evidence of local capacity building? Is there evidence that the proposed research builds on community strengths and infrastructure? 

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? Is there a clear definition of the proposed rural community? Is the application targeting rural populations?      

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.

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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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 (an) appropriate Scientific Review Group(s), convened by the NHLBI, 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:

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 NHLBI National Advisory Council. 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(s)/PI(s) 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’s 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

Not Applicable

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)

Charlotte A. Pratt, PhD.
Program Director
Division of Cardiovascular Sciences
Prevention and Population Science Program
National Heart, Lung, and Blood Institute
Telephone: 301-435-0382
Email:prattc@mail.nih.gov

Cheryl Nelson, MSPH
Program Director
Division of Cardiovascular Sciences
Prevention and Population Science Program
National Heart, Lung and Blood Institute
Telephone: 301-435-0451
Email: nelsoncr@mail.nih.gov

Josephine Boyington, PhD, MPH
Program Director
Division of Cardiovascular Sciences
Prevention and Population Science Program
National Heart, Lung and Blood Institute
Telephone: 301-435-0446
Email: boyingtonje@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@mail.nih.gov

Financial/Grants Management Contact(s)

Ms. Tawana McKeither
Grants Management Specialist

Division of Extramural Research Administration (DERA)
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, Room 7159
Bethesda, MD 20892-7926
Telephone 301-435-0166
FAX: 301-451-5642
Email: mckeitherta@nhlbi.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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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