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.

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

Age is the major risk factor for most chronic diseases and degenerative conditions in adults. Reaching an understanding of why aging is such a risk factor is a primary goal of studies in geroscience. The goal of this FOA is to assemble a multidisciplinary team of investigators to develop and plan collaborative strategies that aim to identify epigenetic changes during aging that collectively underlie aging as a risk factor for chronic diseases and degenerative conditions (referred to as “aging as a risk factor”). The intended outcome would be an evaluation of the technical requirements, types of epigenetic data, clinical parameters and candidate human subjects cohorts that would lead to identification of aging-specific epigenetic features that contribute to the increased risk of developing diverse aging-related diseases and degenerative conditions. Development of likely standard operating procedures and data resource management should be important outcomes of this planning and evaluation process. Ultimately, the epigenetic “aging-risk-factors” might be distinct from the disease- or condition-specific factors that contribute to any one aging phenotype. To address this possibility, applicants are expected to propose use of at least three diseases (or degenerative conditions) for future study, to justify their selections and to discuss the known or possible relatedness of these selections. Epigenetic features are not likely to be the only factors to explain the basis on which age is the major risk factor for chronic diseases and degenerative conditions. However, epigenetic and related data (sequence data, gene expression and epigenetic marks) can be obtained that are of sufficient quality and reproducibility that the epigenetic contribution of age-specific factors could be identified, distinguished from disease- and condition-specific factors, and then tested experimentally. Our current knowledge obtained from the studies of numerous diseases suggests strongly that an integrated approach would be an effective way to accomplish the goal of this FOA.

There are many cohorts and populations for the study of human aging, and also for the study of specific diseases. Each has potentially useful features and potential drawbacks, and determining balances among those would be a primary task of the planning grant. These cohorts and populations are potential resources for these studies, whether in the United States or abroad. Some cohorts also have specimen repositories that might prove useful in addressing the larger question of aging as a risk factor. An essential determinant for establishing the utility of a particular study population will be access to properly quantifiable data on the diseases or degenerative conditions. Uniformity in the diagnostic criteria and quantitation of aging phenotypes will be essential. With recent and emerging technological advancements in epigenetics and so many on-going and completed studies on chronic diseases and degenerative conditions, we believe that this is the time to evaluate the feasibility and develop strategies to study the epigenetic basis underlying aging as a risk factor.

This Funding Opportunity Announcement (FOA) will support planning cooperative agreements (U34) in anticipation of future research applications. The  planning grant is designed to permit the necessary planning, design, and small-scale pilot projects to circumscribe the scope of a complex question in geroscience (described below). Consultation with NIA staff is strongly encouraged prior to the submission of an application.

Applicants should assemble a team of investigators with expertise from the appropriate disciplines.  The planning team will consider, for example, whether: the existing technologies are in place; there are appropriate populations for such a large undertaking; there are existing epigenetic data of suitable quality or those data should be collected de novo; what would be the best strategies to distinguish aging factors from disease-specific factors. Other factors should be proposed by the planning team. The multidisciplinary team should include expertise in the following fields: aging biology; epigenetics;  human genetics; quantitative genetics; bioinformatics; statistics; systems biology; epidemiology; clinical diagnosis; and geriatrics. 

Applications should consider specific diseases that may be suitable for this planning grant. Applications that propose to use mortality or age-related risk of mortality will be considered outside the scope of this FOA. Research using model organisms is also outside the scope of this FOA. Cohorts relying on self-reported conditions should not be proposed for this study.

The activities proposed in the planning grant will depend on the type and complexity of the study design. Activities supported by the planning grant include, but are not limited to, the following examples:

Identify the epigenetic parameters that would be used in a study of aging as a risk factor.

Identify and justify the choice of three or more diseases and/or degenerative conditions that can be used together or separately to identify epigenetic features that correlate with – or possibly are causal for – aging as a risk factor.

The planning team will need to consider whether comorbidities are significant, and the potential interrelatedness of selected diseases and/or degenerative conditions.

Identify suitable human populations and/or studies that have been characterized clinically for one or more diseases or conditions associated with aging.

Determine how clinical characterization (diagnosis) of diseases or conditions has been established, and whether these need further adjudication in a study of “aging as a risk factor.”

The team of investigators would also identify important variables such as sex and ethnicity.

Assess suitable tissues and design strategies to obtain these materials.

If applicable, develop consent form(s) and assent form(s), and the need for IRB approval.

If new sampling will be required, develop a safety monitoring plan to address how risk to subjects will be minimized and the process for collecting and reporting of adverse events to the appropriate regulatory bodies

Develop a detailed project timeline and budget for conduct and completion of the research that would identify epigenetic features that are associated with aging as a risk factor.

Meetings and workshops to develop the above strategies may be included. A written report and its presentation at a symposium at NIA will occur at the end of the funding period.

Small-scale pilot projects may be proposed. These may be useful, for example, to test data quality, methods suitability, or utility of a type of sample or a population. These are not expected to produce an answer to the underlying question of epigenetic features that constitute aging as a risk factor.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education

• Private Institutions of Higher Education

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

• Hispanic-serving Institutions

• Historically Black Colleges and Universities (HBCUs)

• Tribally Controlled Colleges and Universities (TCCUs)

• Alaska Native and Native Hawaiian Serving Institutions

• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses

• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments

• County Governments

• City or Township Governments

• Special District Governments

• Indian/Native American Tribal Governments (Federally Recognized)

• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

Other

• Independent School Districts

• Public Housing Authorities/Indian Housing Authorities

• Native American Tribal Organizations (other than Federally recognized tribal governments)

• Faith-based or Community-based Organizations

• Regional Organizations

• Non-domestic (non-U.S.) Entities (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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

• System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 

• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

• Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

• Of an application with a changed grant activity code.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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

• Descriptive title of proposed activity

• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

• Names of other key personnel

• Participating institution(s)

• Number and title of this funding opportunity

The letter of intent should be sent to:

Ronald A. Kohanski, Ph.D.
National Institute on Aging (NIA)
7201 Wisconsin Avenue, Suite 2C231
Bethesda, MD 20892
Telephone: 301-496-6402
Email: kohanskir@mail.nih.gov

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.  

All instructions in the SF424 (R&R) Application Guide must be followed.  

All instructions in the SF424 (R&R) Application Guide must be followed.  

All instructions in the SF424 (R&R) Application Guide must be followed. 

All instructions in the SF424 (R&R) Application Guide must be followed.  Funds should be included for publication of a report and travel to a symposium at the NIA during the final year of the award, in addition to travel funds for other meetings needed to accomplish the aims of a planning grant.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.  

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

This is a planning grant and not a hypothesis-driven research grant. However, there is a hypothesis which can be stated as "epigenetic changes during aging collectively underlie aging as a risk factor for chronic diseases and degenerative conditions." The planning grant is intended to organize an approach to address this hypothesis, and possibly generate preliminary data that could be used to justify – or show the feasibility of – that approach. 

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. More precisely, the specific aims of an application  should be organized around three broad areas: First, approaches that could be taken to select suitable human populations for a future study that would seek to identify those epigenetic changes; second, approaches to select suitable epigenetic technologies and measurements that could be employed in a such a future study; third, estimates of a timeline, infrastructure and support that would be required to undertake such a study.

Research Strategy: The Research Strategy should address the following:

Under the first broad area, the application should propose and justify the choice of three or more diseases, and/or degenerative conditions, that can be used together or separately to identify epigenetic features that correlate with – or possibly are causal for – aging as a risk factor. There should be consideration given to comorbidities and whether they are significant, and the whether interrelatedness of selected diseases and/or degenerative conditions may be a confounding factor in the study. The application should also offer ways to evaluate clinical criteria and diagnoses by which existing cohorts for human studies would be suitable, including appropriate age ranges; if adjudication of these clinical criteria would be needed, indicate how an adjudication board will be set up and how it will function. The application should also address ways to handle important variables such as sex and ethnicity. Other factors deemed appropriate by the applicant should be included. An application to study the epigenetic basis of risk for a single disease or degenerative condition would not be responsive to this FOA.

Under the second broad area, the application should consider various categories of “epigenetic information,” based on the measurements and technologies available or emerging, and discuss the strengths and weaknesses of these for a study of epigenetics of aging as a risk factor. A discussion of tissue samples – whether they are currently available or should be (re)sampled – will be an important part of the planning application. If (re)sampling would be proposed, development of consent forms will be an important element of the application. Small-scale pilot experiments may be proposed to the extent that they might generate “preliminary data” for a specific set of epigenetic measurements or to demonstrate the utility of one or more tissue samples. These may be useful, for example, to test data quality, methods suitability, or utility of a type of sample or a population. However, if pilot studies are proposed they should not be attempts to actually determine the epigenetics of aging as a risk factor since that would be beyond the scope and budget of a planning grant.

Under the third broad area, the application should propose meetings and workshops to develop the above strategies may be included. It would be appropriate to identify possible areas of expertise for these meetings and possible participants, although their agreement to participate will not be required as part of this application. An outcome of these meetings and workshops should be a detailed project timeline and budget for the conduct and completion of a subsequent research effort that could identify epigenetic features that are associated with aging as a risk factor for multiple chronic diseases and/or degenerative conditions. A written report and its presentation at a symposium at NIA will occur at the end of the funding period,.

Letters of Support: The application should include letter(s) of support from partnering organization(s), if any, and for demonstrating access to any databases or other resources proposed for use as outlined in the application.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

This initiative is not subject to intergovernmental review.

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.

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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute on Aging, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applications that propose to use mortality or age-related risk of mortality will be considered not responsive to this FOA. Research using model organisms are also not responsive to this FOA. Cohorts relying on self-reported conditions should not be proposed for this study; they will be considered not responsive to this FOA.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at vemuri@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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).

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?   

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened b{the NIA 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 NIA Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.

• Availability of funds.

• Relevance of the proposed project to program priorities.

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.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH-NIA programmatic involvement with the awardees is anticipated during the performance of the activities, particularly in the selection of relevant human populations, clinical parameters and emerging technologies in epigenetics, data access, and coordination of meetings and study committees.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Leadership and primary responsibility for successful completion of the project will rest with the Principal Investigator(s).

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

The PD(s)/PI(s) will have the primary responsibility for carrying out the planning, organizing and implementation of research activities, day-to-day administrative functions and overall development of the U34 program.

The PD(s)/PI(s) should establish a Coordinating Committee comprised of members of the collaborative research team, and may include investigators not actively engaged in this research program but who have appropriate knowledge or expertise. The Coordinating Committee will be responsible for retaining focus on the goals of the FOA during the funding period.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The NIA Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee(s). The NIA Project Scientist may also participate in data analyses, interpretations and ensure the public availability of data, findings and related resources developed during the course of the U34 project.

The NIA Project Scientist will serve on the Coordinating Committee and also be responsible for attendance at meetings of this committee.

The NIA Project Scientist may serve as co-author in publications as appropriate (dependent on the extent of involvement in the study) and subject to agreement by vote of the Coordinating Committee..

NIA will designate additional NIA staff as a program official to provide advice to the awardee on administrative issues and will perform the normal stewardship functions of the award.

The application must also include a statement indicating the applicant’s willingness to abide by the Cooperative Agreement Terms and Conditions of the Award.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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Areas of Joint Responsibility include:

The Coordinating Committee will serve as the governing body for the U24 project.

This committee will have responsibility to approve planned analyses and/or pilot studies, establish study policies, help resolve issues and policy decisions, and provide direction and guidance to the project.

This committee will also act as liaison to potential industry collaborators, if any.

This committee will meet regularly (bi-monthly) via teleconference, ad hoc when appropriate, and annually in person.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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. 

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Ronald A. Kohanski, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: kohanksir@mail.nih.gov

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: venuri@nia.nih.gov

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: whippl@nia.nih.gov

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.

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.