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)
National Institute of Nursing Research (NINR)

Funding Opportunity Title

Solid Organ Transplantation: Older Donors and Recipients (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • June 4, 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.
  • January 4, 2013 - See Notice NOT-NR-13-005. Notice of NINR's Participation.

Funding Opportunity Announcement (FOA) Number

PA-13-030

Companion Funding Opportunity

PA-13-037, R03 Small Grant Program
PA-13-038, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866, 93.361

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, translational, epidemiological and outcomes research on solid organ transplant (SOT) in older persons. Research may focus on, but is not limited to 1) appropriate selection of older SOT donors and recipients; 2) improved management of older SOT recipients; 3) immunology and immunosuppression pertaining to older SOT patients; and 4) healthcare disparities, utilization and costs of SOT in older patients. Research supported by this initiative is expected to enhance knowledge of immunobiology in aging and transplantation, and to provide evidence-based guidance to improve access to transplantation, organ allocation and utilization, graft survival, and short- and long-term outcomes of SOT in older persons.

Key Dates
Posted Date

December 6, 2012

Open Date (Earliest Submission Date)

January 4, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates

Advisory Council Review

Standard dates

Earliest Start Date

Standard dates

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 SF424 (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

Over the past decade, both the numbers of patients age 65 years and older referred for solid organ transplantation (SOT; kidney, liver, heart or lung) and donating organs, have been increasing.  As the proportion of older individuals in the population expands, these trends will likely continue.  However, despite similarly favorable long-term outcomes in older and younger SOT recipients, older patients are placed on the waiting list far less frequently than younger patients. Once listed, the proportion of older compared with younger SOT recipients is organ-specific, with the highest percentage of lungs going to older recipients (due to higher idiopathic pulmonary fibrosis incidence in seniors), followed by kidney (old and young roughly equal), while livers and hearts are transplanted far less frequently in older patients. To improve organ allocation and short- and long-term outcomes, and to better understand the complexities of the SOT selection, management and compatibility in the older host, specific research is needed.

Although seemingly beneficial, the increase in organs donated from older adults currently has drawbacks, as older organs have a higher rate of graft failure and worse outcomes than organs from younger donors. Factors shown to impair function of older donated organs include long harvest and ischemic time, organs from deceased versus live donors (kidney, liver), comorbidities and chronic infections (cytomegalovirus) of the older donor, and age-related decline in organ function.  Accurate functional assessment of potential donated organs remains limited, resulting in discard of approximately 65% of donated kidneys and livers from donors 65 years or older.  Usage of expanded criteria donors (ECD) organs, which are often donated by older individuals, may reduce this high discard rate, but target ECD recipient criteria need further refinement. Development of age-specific screening and assessment tools to evaluate older donors and their organ function and viability may increase the number and outcomes of available organs for transplant.

Multiple factors complicate the selection of potential older recipients for SOT that, in turn, further challenges organ allocation, which is currently based on illness severity. Advanced age often limits organ transplant referral, listing, and transplantation, yet chronologic age is likely a surrogate for more specific outcome predictors including functional status vs. frailty, comorbidities and/or body composition. Advanced criteria based on these factors plus those common in older adults (chronic infection, cancer risk, aging of other organs) require additional assessment for predictive value.  Equally important, the ability to predict outcomes focused on the overall transplant goals for the older patient, such as improvement in physical function/independence, health-related quality of life (HRQOL), cognitive function and QOL on alternative palliation or end-stage therapies may provide key insight into recipient selection and organ allocation in addition to those which can predict graft survival.

Racial and ethnic disparities exist in both the accessibility to and outcomes of transplantation. Despite a four-fold higher incidence of end-stage renal disease in minorities, Hispanic patients are less likely to receive SOT and African-Americans are less likely to be listed or receive SOT compared with Caucasians. Regarding patient and graft long-term survival, Asians and Hispanics have the most favorable outcomes followed by Caucasians, then African-Americans for all transplanted organs. The factors contributing to SOT access and outcome disparities between racial and ethnic groups are not well characterized.

Numerous age-related alterations in the immune system occur that may have important implications for the older transplant recipient. Cell-mediated immunity is most affected by aging, with a decline in naïve T cells and clonally expanded CD8 T cells resulting in less T cell diversity, diminished host defense, and accumulated ‘exhausted’ and ‘senescent’ T cells lacking CD28 expression. Accompanying these changes are increases in cytokine production and chronic inflammation and diminished reliance on T cell co-stimulation. These immune age-associated changes may be further altered by chronic host viral infection such as cytomegalovirus.  As acute graft rejection is more profound and long-term graft failure is more common and more severe in older recipients, the impact of aging altered immunobiology on immunosuppressive therapy in older transplant patients requires further understanding.  Age-related changes in immunity also increase vulnerability of the older adult to infections, which remain the most common cause of mortality in the first year after transplant in the older patient.  Research is needed to evaluate the balancing of efficacy and toxicity of immunosuppressive therapy, and the intensity and breadth of infectious prophylaxis and treatment, including immunizations, in the older transplant recipient. Additionally, biologic methods to assess immune function in the older SOT candidate and recipient might assist these therapeutic decisions.

The management of older SOT recipients is complex and requires a multidisciplinary approach.  Multimorbidities, polypharmacy and aging changes of other organ systems occur commonly in older patients, and may be additionally compounded by cognitive or functional decline, osteoporosis and glucose intolerance. Strategies to minimize or eliminate peri-operative and post-operative vulnerabilities of older donors and recipients including infections, delirium, pain and prolonged hospitalization need development.  The potential role of strength training and exercise prior to surgery, or ‘pre-hab’, and post-operative rehabilitation to improve outcomes in older SOT donors and recipients requires further investigation. Additionally, elucidation of mechanisms underlying the increased incidence of infections, acute rejection, and malignancies in older compared to younger SOT recipients may guide appropriate surveillance protocols. These important health aspects also deserve attention in younger transplant patients as they age.

A workshop reviewing the current state of knowledge and identifying research opportunities in solid organ (kidney, lung, liver and heart) transplantation in older adults was held in Washington, D.C. in January 2012 and was sponsored by the NIA, NIDDK, NIAID, NHLBI, the American for Academic Internal Medicine, the Hartford Foundation and the American Society of Geriatrics. Key points of this workshop including an extensive list of proposed research topics are summarized in Abecassis et al. American Journal of Transplantation 2012;12:2608-2622.

Scope of Research

The FOA invites research applications addressing the selection of older solid organ transplant donors and recipients, the management of older solid organ transplant patients, immunology and immunosuppression pertaining to older transplant patients, and healthcare disparities, utilization and cost of older transplant patients. Both animal models and human subjects are appropriate for this FOA. Areas of interest include, but are not limited to the following:

Selection of Older Solid Organ Transplant Donors and Recipients

 Management of Older Solid Organ Transplant Recipients

Immunology and Immunosuppression Pertaining to Older Transplant Patients

Healthcare Disparities, Utilization and Costs of Older Transplant Patients

Additional Guidance

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 researchers developing applications for this FOA 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. NIH-sponsored longitudinal aging cohorts that may be particularly relevant for questions regarding immunity and aging include:

Health and Retirement Survey (HRS)

Baltimore Longitudinal Study on Aging (BLSA)

Lifestyle Intervention for Elders (LIFE) study

Cardiovascular Health Study (CHS)

Multi-Ethnic Study of Atherosclerosis (MESA)

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 beyond those mentioned above are listed in NIA's Population Studies Database (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 adults are listed in the NIH Cognitive and Emotional Health Project database (http://trans.nih.gov/cehp/hbq/search.asp).

In addition, multiple organ transplant databases are available for research opportunities including:

Applicants studying human subjects are encouraged to use standard assessment instruments and techniques that have been developed and validated in older populations when possible, or may propose to test and validate such new instruments. Applicants proposing studies on 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. A multidisciplinary research approach, including expertise in nephrology/gastroenterology/pulmonary/cardiology, transplant surgery, anesthesiology, immunology, infectious diseases, physiology, biology of aging, neurobiology of aging, ethics, rehabilitation, psychiatry/psychology, transplant nursing, 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: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (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

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

Award Project Period

The maximum project period is 5 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, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (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 6 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(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/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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, with the following modification:

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-U.S.) 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 applications before 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 before the deadline 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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit 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 SF424(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 System for Award Management (SAM). 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

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) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. 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’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, SAM 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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
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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