Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Renal Function and Chronic Kidney Disease in Aging (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PA-09-166

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • 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

PA-12-210

Companion Funding Opportunity

PA-12-211, R01 Research Project Grant    

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) issued by the National Institute on Aging (NIA), National Institutes of Health, invites applications that propose basic, clinical, and translational research on chronic kidney disease (CKD) and its consequences in aging and in older persons. Applications should focus on the 1) biology and pathophysiology of CKD in animal models; 2) etiology and pathophysiology of CKD in older adults; 3) epidemiology and risk factors for the development of CKD with advancing age; and/or 4) diagnosis, medical management and clinical outcomes of CKD in this population. Research supported by this initiative should enhance knowledge of CKD and its consequences in older adults and provide evidence-based guidance in the diagnosis, prevention, and treatment of CKD in older persons.

Key Dates
Posted Date

June 13, 2012

Open Date (Earliest Submission Date)

September 16, 2012

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

January 8, 2016

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.


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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

Background

CKD is a growing problem among the aging population. According to United States Renal Data System (USRDS) data, the number of older patients with end-stage renal disease (ESRD) has almost doubled over the last 25 years. Thus CKD poses a considerable medical and public health challenge, particularly in the older population.

CKD is a decline in renal function defined by decreased glomerular filtration rate (GFR) and/or other evidence of renal damage (e.g., proteinuria). Age is a major risk factor for CKD, and age-related changes in renal function measured as GFR are well described. GFR appears to be stable until about 40 years of age and then declines at an average rate of 8-10 mL/min/ per decade in approximately 70% of adults. In addition to changes in GFR, renal regulation of fluid and electrolytes may decrease with increasing age, and renal endocrine function or responsiveness may change with aging. This decline in renal function is characterized pathologically by tubular atrophy, glomerulosclerosis, and interstitial fibrosis. Alterations in renal vasculature and vascular function may also contribute to the development of CKD and to susceptibility to acute kidney injury (AKI), which also is in itself a risk factor for development and/or progression of CKD, particularly in older patients.

Consequences of CKD include not only progression to kidney failure but also multisystem complications. These include accelerated atherosclerosis with increased risk for cardiovascular and peripheral vascular diseases; vitamin D deficiency, disorders of calcium and phosphate metabolism, and renal osteodystrophy; hematologic problems (anemia and thrombosis) and impaired immune function; and the development of frailty and cognitive impairment. Innovative approaches for prevention, early recognition, and effective management of these complications in older patients are needed.

CKD is commonly classified according to the degree of lowering of GFR. Moderate declines in GFR, sometimes termed pre-clinical CKD are often underrecognized due to absent or subtle symptoms, as well as unreliability of creatinine-based GFR estimates in this range, particularly in aged patients. Little is known about patterns of progression or adverse clinical events in early stage disease. Although declining GFR occurs in over two thirds of aging adults, it progresses to advanced disease in a much smaller proportion of the population. This observation suggests that CKD associated with gradual age-related decline of renal function may differ in mechanism and outcomes from more rapidly progressing CKD often observed in younger adults. While risk reduction is recommended as an intervention in early stage disease, the extent to which early detection and intervention improves the outcome of CKD in older patients has been largely unexplored.

Current GFR estimates (eGFR) are based on measurements of serum creatinine and have recognized limitations, particularly in aged populations. Recent research suggests that increased serum levels of cystatin-C are associated with early decline in renal function among older persons and may be a promising marker of CKD and cardiovascular disease (CVD) in older adults. However, whether the measurement of cystatin-C is an improvement over creatinine-based equations for estimating GFR in older persons remains to be determined. Improved methods for ascertaining renal function and new biomarkers for chronic (and acute) kidney damage in older persons are needed.

CKD occurs more frequently in older patients with multiple comorbidities. Diabetes and hypertension, highly prevalent in older patients, are major risk factors for development and progression of CKD. The high prevalence of comorbid conditions and related polypharmacy in older patients complicate the symptoms, diagnosis and clinical management in this population. Aggressive control of glucose and blood pressure may slow progression of CKD or stabilize renal function. However, approaches to balancing risks and benefits of aggressive therapy in complex older patients are largely unexplored, and contributions of aggressive management to preventing physical and cognitive decline associated with CKD in older patients require additional research. In fact, decline in cognitive function may complicate self-care and appropriate clinical management in individuals with CKD.

The NIA and NIDDK participated in a workshop aimed at reviewing current knowledge and identifying research opportunities on CKD in older adults. The outcomes of that workshop are summarized in Anderson et al. Journal of the American Society of Nephrology 2009; 20:1199-1209.

SCOPE OF RESEARCH

This FOA invites research applications in both animal models and in humans, addressing the etiology, pathophysiology, risk factors, consequences, prevention, or treatment of CKD in older patients. Areas of interest include, but are not limited to, the following areas:

Etiology and Pathophysiology

Contributions of age-related changes in renal vascular structure and function on the development of CKD (e.g., changes in renal blood flow, vascular resistance, and sensitivity to ischemia), and the mechanisms by which these changes occur.

Mechanisms of kidney fibrosis underlying CKD progression.

Contributions of cellular senescence and gene polymorphisms to CKD during aging and in older adults and their mechanisms of action.

Relationship of CKD to age-related changes in renal morphology, pathology, structure (e.g., tubular atrophy, glomerulosclerosis, interstitial fibrosis) and function (e.g., changes in renal hemodynamics, GFR, urine concentrating and diluting ability, secretion of renin and erythropoietin, and activation of vitamin D).

Roles of oxidative stress and endothelial dysfunction in the development of CKD during aging and in aged adults.

Possible differences in pathology and pathophysiology of CKD in younger vs. older patients or animals.

Complications and long-term consequences of CKD in older adults (e.g., development of osteoporosis, CVD, and anemia; impact on vitamin D metabolism and phosphate balance; effects on coagulation mechanisms; and modulation of secretion of renin and erythropoietin).

Role of CKD and its complications in functional impairment and disability among older patients.

Epidemiology, Risk Factors, and Comorbid Interactions

Natural history of age-related decline in kidney function, and progression from early stage CKD to ESRD in older adults.

Clinical consequences and long-term outcomes of different stages of CKD in older adults, including effects of mild decreases in GFR on long-term health outcomes.

Role of established CKD risk factors (e.g., hypertension, diabetes and acute kidney injury) and potential new risk factors (e.g., oxidative stress, age-related endothelial dysfunction) in development and progression of CKD in older adults.

Studies that distinguish risk factors for progression to different stages of CKD, and the extent to which risk factors are the same or differ across different stages of CKD. Studies on the relationships between acute kidney injury and CKD are encouraged.

Relationships of comorbidities to development of CKD in older adults and its progression to ESRD, and the interaction of coexisting diseases with CKD on morbidity and functional outcomes in older patients.

Relationships of CKD and/or its treatment to cognitive impairment in older adults.

Early Detection and Diagnosis

Development and validation of new methods or biomarkers to accurately, reliably, and efficiently measure renal function and identify early stages of declining function in older persons or animal models.

Studies to analyze and improve the performance of current GFR estimating equations in older patients.

Development and validation of new tests of age-related acute and chronic renal damage, including measures of age-related decline in kidney functions other than glomerular filtration, e.g., kidney endocrine functions.

Development and validation of screening algorithms for early detection of CKD in community-dwelling older adults, particularly older adults at increased risk for CKD, to optimize timing of screening, frequency of testing, sensitivity and specificity of screening tests, and cost/benefit ratios.

Prevention and Treatment

Efficacy of treatments for CKD risk factors (e.g., cardiovascular disease and diabetes) to prevent or delay onset of CKD in older persons.

Effects of various interventions applied at early stages of CKD in preventing or slowing further adverse effects in older patients (e.g., risk factor management, vitamin D, dietary regimen such as protein restriction, salt restriction and calorie restriction, and physical activity interventions).

Testing new treatment approaches in older adults CKD patients who have conditions contributing to its progression (e.g., diabetes/hypertension), e.g., angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers and aldosterone blockade; optimal targets for blood pressure and glucose control.

Testing of clinical strategies for the management of complications and long-term consequences of CKD in older patients (e.g., cardiovascular and peripheral vascular disease, Vitamin D deficiency, hyperphosphatemia, osteodystrophy and hematologic problems).

Studies evaluating whether interventions to slow progression in CKD are efficacious in preventing or slowing further functional loss when applied at earlier levels of decrease in GFR.

Development and testing of interventions to maintain functional status, cognitive function, and quality of life among older CKD patients.

Specific age ranges for older patients or aged animals are not specified for this FOA. Age ranges and groups should be selected to address the study hypotheses and effectively utilize the demographic composition of available patient groups, study cohorts, or data sets. Applications may address changes across a span of ages as appropriate for the study questions, and younger age groups may be included for comparison purposes.

Resources that may be useful for applicants include longitudinal datasets designed for the study of older populations, administrative datasets with medical information, and datasets from large observational or intervention studies in specific diseases or conditions. Datasets may be augmented through data linkage or by collection of additional information targeted toward specific study questions. Potential study populations that focus on aging are listed in NIA's Population Studies Database, at http://nihlibrary.ors.nih.gov/nia/ps/niadb.asp; large longitudinal and epidemiological studies that focus on factors related to cognitive and emotional health/impairment in the adult are listed in the NIH Cognitive and Emotional Health Project database at http://trans.nih.gov/cehp (specifically, http://trans.nih.gov/cehp/hbq/search.asp). Information on another potential study population, the Chronic Renal Insufficiency Cohort (CRIC) Study, can be accessed through the NIDDK website at http://www.niddk.nih.gov/patient/cric/cric.htm.

Applications that propose human studies should use standard assessment instruments and techniques that have been developed and/or validated in older populations when possible, or may propose to test and validate new instruments. Applicants proposing studies on disease or treatment outcomes are encouraged to consider including measures of overall health status, functional status, and quality of life, as well as specific measures related to study hypotheses. Applications proposing interventional clinical trials should address a Data Safety and Monitoring Plan, which must receive approval from the NIA before enrollment can begin. A multidisciplinary research approach, including expertise in nephrology, renal physiology, biology of aging, neurobiology of aging, and geriatrics is strongly encouraged.

Animal models may be used to address questions that cannot be easily addressed in humans. The choice of the animal model should be justified and its relevance to the study question should be explained clearly. NIA's Scientific Resources, including the Nonhuman Primate Tissue Bank and Rodent Resources, are described at http://www.nia.nih.gov/research/scientific-resources.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

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

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.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed two 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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 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 Directors/Principal Investigators (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 PDs/PIs, 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.

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 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.

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.

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

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions 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(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, 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.

For this particular announcement, note the following:

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.

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(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?   

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.

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

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.

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

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(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)

Susan Zieman, MD, PhD
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: Susan.Zieman@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).

Financial/Grants Management Contact(s)

Ryan Blakeney,
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: blakeneyr@mail.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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