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 on Aging (NIA)
Office of Dietary Supplements (ODS), NIH

Funding Opportunity Title

Nutrition and Diet in the Causation, Prevention, and Management of Heart Failure (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PA-06-136

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number


Companion FOA

PA-11-165,  Nutrition and Diet in the Causation, Prevention, and Management of Heart Failure, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.837, 93.866

FOA Purpose

This initiative issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), and
Office of Dietary Supplements (ODS), NIH, will renew a Funding Opportunity Announcements (FOA) (R21) to encourage submission of exploratory or developmental research applications on the role of nutrition and diet in the causation, prevention, and treatment of cardiomyopathies and heart failure. Mechanistic, translational, and applied interdisciplinary research applications in humans or animals are of interest. The overall goal is to develop a satisfactory science base for rational nutritional management of patients in various stages of heart failure and for preventive approaches in high-risk individuals.  

Key Dates
Posted Date

March 17,  2011

Open Date (Earliest Submission Date)

May 16, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

May 8, 2014

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  

1. Research Objectives

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NHLBI, NIA and ODS seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance research on nutrition and diet in the causation, prevention and management of heart failure.

Public Health Need

Heart failure (HF) is typically a chronic disease, with progressive deterioration occurring over a period of years or even decades. Patients may become incapable of performing even the simplest activities of daily living and are at very high risk of medical complications and death.  Heart failure poses an especially large public health burden. 5.8 million American adults live with heart failure. 670,000 new cases are diagnosed yearly in adults older than 45 years of age, and the average duration of disease is 8.5 years.  Lifetime risk of an HF diagnosis is 20% in adults over 40.  In 2006, heart failure accounted for 283,000 deaths.  There were 1.1 million hospitalizations for congestive heart failure in 2004, representing $29 billion in hospital costs.  It is estimated that total costs due to heart failure in 2010 will reach $39.1.  Improved survival after myocardial infarction, an ever-aging population, and the rising prevalence of obesity, diabetes, and hypertension predict an increasing societal experience of heart failure that demands more effective low-cost management approaches.  The influence of nutrition on HF phenotypes is poorly understood, although epidemiologic and mechanistic evidence suggests that dietary factors and alterations in myocardial nutrient metabolism may play a critical role in the development and progression of the disease.  This implies that dietary modifications might reduce risk of developing HF or might delay progression to more severe forms.  In addition, patients with advanced cardiomyopathies, heart muscle disorders, or congestive heart failure typically suffer from severe nutritional debilitation. Little guidance is available at present regarding optimal nutritional approaches for advanced cases, but dietary management represents a means of improving clinical outcomes for these patients.

Nutrition in the Causation and Prevention of Heart Failure

Nutritional factors have long been implicated in the development of cardiomyopathies, particularly in animals; the veterinary and agricultural literature thoroughly documents multiple types of nutritional cardiomyopathies in species as diverse as swine, cats, dogs, foxes, rodents, and herbivores.  These primarily reflect dietary deficiencies or excesses of micronutrients such as vitamins or trace elements.  Nutritional deficiencies are known to cause heart failure in humans as well; the best known examples are beri-beri heart failure and Keshan cardiomyopathy, due to an interaction between Coxsackie virus and selenium/vitamin E deficiency.  Other causes include viruses, genetic factors, and agents that directly promote myocardial toxicity (e.g. alcohol, cocaine, or cancer chemotherapeutic agents). Most cases of HF, however, are linked to well-known risk factors for coronary artery disease.  The most striking of these is pre-existing hypertension, which appears to be both indirectly and directly linked to HF, as it is a risk factor for coronary artery disease and also is considered to result directly in the development of diastolic HF.

For relatively weak causal contributors such as diet or nutrition, a good way to obtain unbiased estimates of long-term risk is through the use of prospective cohort studies that enroll groups of healthy individuals and then track the development of disease over time. In fact, recent evidence from large, long-term follow-up studies has suggested that dietary and nutritional factors can act as effect modifiers for risk factors such as hypertension, but also may have independent and possible causal effects on HF risk.  The strongest evidence to date implicates elevated body mass index, high sodium intake, and possibly elevated homocysteine levels as causal or facilitative in raising risk of HF.  However, it is difficult to extrapolate cohort study findings to patient treatment approaches.  For example, heart failure patients are known to have poor vitamin D status, but it is not clear whether supplementation would produce benefit. Also, relatively modest intakes of alcohol may be protective, but the mechanisms for such an effect are not defined.  Improved understanding of the etiologic role of nutrition in HF, derived from hypothesis-testing research that can illuminate causal mechanisms, can be expected to lead to preventive approaches as well.

Nutrition in the Management of Heart Failure

Nutrition guidance for heart failure patients is minimal, in contrast with other serious clinical cardiovascular conditions and their predisposing risk factors.  Patients, families, and care providers alike seek well-integrated, robust information that accounts for specific therapeutic needs at various stages of disease, but also places them in a complete dietary context.  Overall, there is a dearth of both observational and mechanistic studies related to nutrition in adult and pediatric HF patients at all stages of the disease.  Thus more information is needed in various HF patient populations regarding dietary macronutrient composition, overall dietary patterns (such as the DASH diet), and the appropriate use of dietary supplements. Information particularly is needed regarding appropriate weight loss modalities for HF patients who are obese or overweight.  Conversely, research is needed to better understand energy balance and nutrient metabolism and requirements in children with heart failure, who often have suboptimal growth and development patterns.  Better data also are needed regarding the effects of heart failure medications on nutrient requirements and nutrient metabolism, as well as the impact of dietary modification on medication regimens.  Given recent recommendations that most HF patients should engage in therapeutic exercise regimens, a better understanding is needed of the role of nutrition in exercise tolerance. For example, glycogen-sparing diets may be able to enhance exercise capacity in HF, but have not been tested widely in different patient subgroups, such as those with concurrent diabetes.  Most striking, there is no evidence base at all for sodium intake recommendations for various subgroups of heart failure patients.

Advanced-stage HF patients, regardless of the original cause of disease, have unique nutritional problems that to date have been only minimally addressed.  These patients typically are suffering from severe nutritional debilitation, including loss of lean body mass and energy and micronutrient reserves.  Nutritional concerns among patients receiving left ventricular assist devices include a high frequency of impaired gastrointestinal function and poor nutrient absorption.  Similarly, the optimal nutritional management of cardiac transplant patients is not well developed; problems include pre-transplant debilitation and post-transplant drug-nutrient interactions, which can lead to obesity, hyperhomocysteinemia, and hyperlipidemia.  Better approaches are needed for characterizing nutritional status and managing nutritional support in such patients.  There also is a need for a more precise definition of cardiac cachexia (based on objective endpoints), as well as research to evaluate the causes of this condition, its effects on whole body metabolism and cardiac function, and potentially useful treatments.

Investigations into delivery of nutrition-related health services are needed.  Such studies could generate data that can help in decisions related to design of health care systems, effectiveness of behavioral interventions, and cost effectiveness of various treatment paradigms.  Although dietary guidance often is a component of multi-disciplinary team management of HF patients, it usually is difficult to identify the specific benefits and cost effectiveness of medical nutrition therapy services compared with other treatment modalities. This is particularly important for HF patients, given that many hospitalizations are ascribed to deviations from diet and medication.  Outpatients and hospitalized patients with HF need to be studied in terms of how to achieve good adherence to their prescribed treatments, and how to separate adherence vs. efficacy effects for dietary modifications. Research also is needed on cognitive, educational, behavioral, economic, psychosocial, family support, and other factors that affect the ability of HF patients to adhere to dietary recommendations.

The Exploratory/Developmental Approach

The R21 mechanism is intended to encourage new exploratory and developmental research projects. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted in response to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

A diverse array of investigator-initiated projects could effectively broaden the knowledge base on nutrition and HF. Studies are needed to develop and characterize novel and existing veterinary, agricultural, and laboratory small and large animal models of HF, to use in for research ranging from fundamental mechanisms to whole organism functions.  Approaches that include transcriptional profiling, metabolomics, proteomics and transgenic animal models could be used to evaluate the role of alterations in nutrient metabolism on cardiac function and might shed light on the role of gene-nutrient interactions in understanding individual risk of developing heart failure, as well as predicting individual response to treatment.

Epidemiologic and population science approaches could be useful in clarifying interactions between diet, nutritional status, and risk of cardiac dysfunction/HF, and in assessing diet-disease risk relationships in patient subsets (e.g., obesity, diabetes mellitus, metabolic syndrome, anorexia nervosa, sarcopenic elderly).  Use of established cohorts or existing data sets could provide an efficient research approach; taking advantage of longitudinal designs or hypothesis-generating analyses could provide descriptive data that might be the basis for power calculations for more focused studies.

The greatest impact is expected to derive from focused, mechanistically-oriented studies in humans. Such studies should be designed by multidisciplinary teams of investigators including cardiologists, nurses, and nutritionists. Most intervention trials in nutrition and HF to date have been short-term, small, and underpowered; the results have been hard to interpret, especially in the context of concurrent pharmacologic therapy, and the cardiac and nutritional endpoints often have been inadequate, preventing robust conclusions.

Appropriate designs for studies in humans would address: statistical power; effect size of

the intervention; appropriate homogeneity or heterogeneity of patient populations for testing the hypotheses of interest; potential confounding factors; time course of treatment; drop-out rates; dietary intake and nutritional status assessment; treatment compliance methodology; and intermediate measurements and surrogate endpoints relevant to HF research, including biological, clinical, and behavioral responses to specific interventions.

Selected Research Examples

Suitable topics for research include, but are not limited to, the following:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information
Funding Instrument


Application Types Allowed


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.

Award Budget

Although the size of award may vary with the scope of research proposed, it is expected that direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

Award Project Period

 Scope of the proposed project should determine the project period. The maximum period is 2 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



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 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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.  

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

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.

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.


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, 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, NIH. Applications that are incomplete 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.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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.


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?  


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?   


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 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?  


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.   

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.


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.


For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.


Not Applicable.


For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

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

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 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 Customer Support (Questions regarding registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936

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

Scientific/Research Contact(s)

Abby G. Ershow, Sc.D., FAHA
Program Director (Nutrition)
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8160, MSC 7956
Bethesda MD 20892-7956 (Express 20817)
Phone: 301-435-0550
Fax: 301-480-3667

Basil A. Eldadah, MD, PhD
Program Officer, Geriatrics Branch
Division of Geriatrics and Clinical Gerontology
National Institute on Aging
Gateway Building, Suite 3C-307
7201 Wisconsin Avenue
Bethesda, MD 20892-9205 (for FedEx use 20814)
Phone: (301) 496-6761
Fax: (301) 402-1784

Rebecca B. Costello, Ph.D., F.A.C.N.
Director of Grants and Extramural Activities
Office of Dietary Supplements
National Institutes of Health
6100 Executive Blvd., Room 3B01, MSC 7517
Bethesda, MD 20892-7517
Phone: (301) 435-2920
Fax: (301) 480-1845

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Anthony Agresti
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7158
Bethesda, MD 20892-7926
Telephone: (301) 435-0186
Fax: (301) 480-3310

John Bladen
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 402-7730
Fax: (301) 402-3672

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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