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

Limited Competition: Renewal of the Aging Intervention Testing Program (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of RFA-AG-09-013

Related Notices

  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

RFA-AG-14-011

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed, as defined in  Section III. 3. Additional Information on Eligibility.

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

93.866 

Funding Opportunity Purpose

The purpose of the Aging Interventions Testing Program (ITP) is to test, under standardized conditions in multiple sites, potential intervention strategies which may decelerate the rate of aging in mammals. The rate of aging is to be measured by lifespan extension and/or improvements in health at later ages due to the intervention. The ITP has used life span as its primary outcome for an intervention, with limited studies on end-of-life pathologies and selected tests of health across the lifespan (health span). This FOA calls for renewal and expansion of the ITP with the following goals: 1. Continue to test compounds for effects on lifespan; 2. Increase analysis of pharmacodynamics and pharmacokinetics of compounds proposed for lifespan studies, including studies of optimal effective dose; 3. Increase histology and pathophysiology analyses at time-of-death; 4. Increase focused studies of health span on selected compounds; 5. Establish a data coordinating center. 

Key Dates
Posted Date

August 2, 2013

Open Date (Earliest Submission Date)

September 21, 2013

Letter of Intent Due Date(s)

September 21, 2013

Application Due Date(s)

(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 21, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

(Extended to November 2, 2013 per NOT-OD-14-003), Originally October 22, 2013

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.

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

This FOA is for the renewal and expansion of the Interventions Testing Program. The purpose of the Aging Interventions Testing Program (ITP) is to test, under standardized conditions in multiple sites, potential intervention strategies which may decelerate the rate of aging in mammals. The rate of aging is to be measured by lifespan extension and/or improvements in health at later ages due to the intervention. The ITP has used life span as its primary outcome for an intervention, with limited studies on end-of-life pathologies and selected tests of health across the lifespan (health span). The current ITP is described in greater detail at this site (http://www.nia.nih.gov/research/dab/interventions-testing-program-itp). This FOA calls for renewal and expansion of the ITP with the following goals: 1. Continue to test compounds for effects on lifespan; 2. Increase analysis of pharmacodynamics and pharmacokinetics of compounds proposed for lifespan studies, including studies of optimal effective dose; 3. Increase histology and pathophysiology analyses at time-of-death; 4. Increase focused studies of health span on selected compounds; 5. Establish a data coordinating center. The animal model of choice for these studies has been – the “four-way cross” mice described for ITP studies (http://www.nia.nih.gov/research/dab/interventions-testing-program-itp), 

The already established two-tier review process for selecting compounds for testing (by the Access Panel and the Steering Committee) should remain in place and continue to be used by the ITP. A description of this process can be accessed at the NIA website (see above). It need not be described as part of the submission for renewal under this FOA. However, if any changes are proposed then those must be included in the application. 

The Standard Operating Procedures (SOP) for lifespan measurements in the ITP were developed and refined during the first two cycles of funding of the program. The renewal applications should utilize these SOPs.  A Core for Statistical Procedures should be described with sufficient detail to be evaluated by an independent review. This includes approaches for blinding and randomization (where appropriate, such as for histology), and discussion of issues such as power analysis, sample size estimates based on anticipated variability in primary or secondary outcome(s) of interest, potential inclusion of interim analyses, and criteria for accounting for “losses of animals to follow-up” during the course of intervention studies. This Core might be at a single site, could include statistical expertise at each site or be established through a subcontract, depending on which option is cost-efficient while best supporting the original and expanded goals of the ITP.

Coordination among applications. Because this is a consortium the applications may be coordinated.

Some procedures and/or "core activities" will be performed at only one site, and those should be described and the use of a single site should be justified. In contrast, some assays and protocols will be used at two or three sites. It will not be necessary to include the descriptions in all three applications but they may appear in only one application and be cross-referenced by the other(s).

The primary research activities relevant to the current renewal of the ITP include:

Lifespan Studies. The details of protocols for lifespan studies have been evaluated in the review of applications submitted in response to the original and first renewal of the ITP. Several publications detailing the protocols and various results have been published. These methods will NOT be re-evaluated in this renewal and therefore the applicants should NOT restate these protocols in the current submission for renewal unless there are changes to the protocols.

Health span studies on selected compounds. Applicants should propose a limited set of assays and describe methods to assess age-sensitive health outcomes that might be affected by those interventions that increase lifespan. 

Pharmacodynamics (PD) and pharmacokinetics (PK) of compounds proposed for lifespan and healthspan studies, including studies of likely optimal effective initial dose. Applications should include proposals for efficient development of formulations of agents for testing. 

Histology and pathophysiology.  One (or more) of the applications should propose protocols for the collection of biospecimens and for histopathological assessments, and should discuss potential grading systems that could be used by veterinary pathologist(s) and plans for archiving the results. 

Data coordinating center. One of the applications should propose to develop a data coordinating center (DCC) that will house and maintain a public-access website and data repository. This will provide archival and current information concerning design, protocols, analytic methods and annotated data from the ITP studies.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIA intends to commit $ 4.8M total costs in FY2014 to fund 3 awards.

Award Budget

Direct costs for awards may not exceed $3.0 M per year for the consortium.

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

Only the current awardees of Intervention Testing Program (ITP) funded under RFA-AG-09-013 are eligible to apply under this Limited Competition FOA.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

Only the current awardees of the Intervention Testing Program funded under RFA-AG-09-013 are eligible to apply under this Limited Competition FOA.


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.

Letter of Intent

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

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

The letter of intent should be sent to:

Dr. Rebecca A. Fuldner
Division of Aging Biology
National Institute on Aging
Gateway Building, Suite 2C231
7201 Wisconsin Ave.
Bethesda, MD 20892-9206
Telephone: 301-496-6402
Email: fuldnerr@nia.nih.gov

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed Applicants should detail all of the unique and specialized facilities, equipment, research expertise and core resources and services that are available to evaluate the effect of interventions on age-related pathology.  If facilities and expertise other than those at the applicant(s) institutions are required for performing Phase 1 and/or Phase 2 studies, applicants should thoroughly describe them and obtain appropriate assurances.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. The application proposing a data coordinating center should include appropriate expertise and personnel (e.g., bioinformatics, data curation) for the activities described in the Resource Sharing Plan, below.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants may propose allocation of funding resources for preliminary pharmacodynamics and pharmacokinetics testing for proposed Phase 1 and Phase 2 interventions if needed.  In the budget justification, the applicants should describe how resources will be distributed to maintain a balance among lifespan, healthspan, histology and pharmacology studies. 

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

Lifespan Studies. Applicants should provide a general description of planned lifespan studies. The details of protocols for lifespan studies have been evaluated in the review of applications submitted in response to the original and first renewal of the ITP. Several publications detailing the protocols and various results have been published. Therefore these protocols will NOT be re-evaluated in this renewal and therefore the applicants should NOT restate these protocols in the current submission for renewal unless changes to the protocols are being proposed.

The progress reports of the applications should summarize compounds proposed by the research community, making clear why some compounds were chosen, and summarize results of lifespan studies (published and ongoing).  Not all elements of the progress report need to be present in all applications, but applicants should cross-reference each other in order to allow a meaningful overview of progress by the three sites. 

Pharmacodynamics (PD) and pharmacokinetics (PK): The extent of PD/PK data required to inform Phase 1 lifespan studies and Phase 2 healthspan studies will vary depending on the nature of the intervention being tested.  The research strategy should describe the additional PK/PD data that will be generated to develop the formulations of agents for testing and optimize the lifespan and healthspan studies as appropriate. Sufficient PK/PD studies should be performed to determine oral bioavailability and support selection of initial dosage.    

Studies of health span on selected compounds: Applicants should propose a panel of candidate health span outcome measurements that will be used to evaluate the interventions chosen. Since there may be little consensus on healthspan measures in model organisms, and the selected outcome measurements could reflect independent or interdependent underlying physiology, the applicants should focus carefully on the process by which measurements will be chosen.  Applicants should identify collaborators and/or subcontractors, if needed.

Histology and pathophysiology: One (or more) of the applications should describe standardized procedures for assessment of pathology at time of death.  The applicant(s) should provide details regarding collection of biospecimens (e.g., collection of tissues and blood samples) and histopathological assessment of treated mice used in lifespan or health span studies (as appropriate)  Applicant(s) should propose procedures for histopathology including number of mice evaluated, tissue collection, staining and field sampling methods, grading system used by veterinary pathologist and archiving of results. 

Statistical Procedures:   Applicants should describe in detail plans for the design of Phase 1 and Phase 2 studies, as well as plans for data analyses.  This includes approaches for blinding and randomization, and discussion of issues such as power analysis, sample size estimates based on anticipated variability in primary or secondary outcome(s) of interest, potential inclusion of interim analyses, and losses of animals to follow-up during the course of intervention studies. Information on the statistical experts and their involvement in the conduct of the studies and data analysis within the ITP should be included in the renewal applications. Applicants may choose to include statistical expertise at each site or to establish a common, statistical core for the ITP program, depending on which option best supports the ITP organizational structure and is cost-efficient.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in 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 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.

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. 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 NIA, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

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

Post-Submission Materials

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

Section V. Application Review Information


1. Criteria

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

The ITP requires coordination among the three sites and therefore a single score will also be given for the application in aggregate

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? 

Specific for this FOA:

Pharmacodynamics/pharmacokinetics:  How adequate are the methods proposed to support the selection of the optimal dose of an intervention for Phase 1/Phase 2 studies?

Healthspan studies: How appropriate are the selection of proposed healthspan outcome measures for Phase 2 testing?  Are the design and statistical methods for evaluating intervention effects adequate?

Histology and pathophysiology:  How appropriate are the plans for collection of biospecimens and pathological analysis of animals at time of death?  Are the grading systems proposed for evaluation of pathology and archiving of results adequate?

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 Guidelines for the Review of Human Subjects.

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 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

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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS) For the Data Coordinating Center reviewers will also comment on: Adequacy of plans for public data access, including scope of information, data quality control procedures and quality of informatics processes as well as the timeline for making information available to the public.

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 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:

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. 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

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 programmatic involvement with the awardees is anticipated during the performance of the activities. 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. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

Development, implementation and evaluation of the Aging Interventions Testing Program (ITP). The PDs/PIs will:  attend meetings of, and serve as a voting members of, the Steering Committee; participate in monthly teleconferences with the NIA representative; be responsible for accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee, and for close coordination and cooperation with the other components of the Testing Program, the Steering Committee, the application sponsors, and NIA staff; implement testing protocols of compounds approved by the steering committee; participate in the analysis and publication (preparation of manuscripts) of all results from the ITP testing; and

nominate individuals to serve on the Access Panel. Members of Access Panel will be selected by the Steering Committee.

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 exercise substantial scientific and programmatic involvement to assist, guide, coordinate and participate in the conduct of the Testing Program activities. The NIA Project Scientist will attend and participate in all meetings of the Steering Committee as a voting member, and will provide liaison between the Steering Committee and the NIA/NIH. The NIA Project Scientist

will assist the Steering Committee in developing and drafting operating policies, and policies for dealing with recurring situations that require a coordinated action.

An NIA Health Scientist Administrator will be the NIA Project Scientist for this award, and will be responsible for scientific involvement in the ITP. The NIA Project Scientist will:  coordinate monthly teleconferences with the PDs/PIs; coordinate with the Access Panel for the review of applications; participate in design, implementation, and evaluation of the program; participate analysis and publication of the results of testing in the ITP. 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.

Areas of Joint Responsibility include:

STEERING COMMITTEE: This Committee will be the main governing body of the Program. Its voting members will include the PD/PI of each award, at least four biogerontologists covering a broad range of gerontological expertise who are not affiliated with the Testing Program, and the NIA Project Scientist. These additional members will be chosen by the PDs/PIs and the NIA Project Scientist. The NIA project Scientist will not chair the committee. The primary roles of the Steering Committee are to prioritize the interventions recommended by the Access Panel; develop consensus on testing protocols to be employed in phase II studies, and decide which phase I studies will proceed to phase II studies. In carrying out these responsibilities, the Steering Committee should seek advice from outside experts as needed, and is encouraged to include the investigator(s) who either discovered or developed the potential intervention in their discussions as appropriate. These individuals, when present at Committee meetings, will be temporary non-voting members of the Committee. In addition, the Steering Committee will also review manuscripts to be submitted for publication. The Steering Committee will meet twice a year, or as needed, by teleconference.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

ACCESS PANEL: The function of the Access Panel is to review promising interventions to be tested in Phase 1 trials; these nominations may be made by anyone either within or outside of the Testing Program. Nominations should be accompanied by sufficient information, either published or unpublished, to permit the Access Panel to evaluate the potential efficacy of the intervention

in mice.

The Access Panel shall consist of one representative (not the PD/PI) from each testing site, and at least three other scientists nominated by the steering committee from the biogerontology research community and appointed by the NIA Director. The NIA Project Scientist will be a non-voting representative on this Panel. An intervention to be recommended for testing would require a majority vote of this panel. In evaluating the merit of a proposed intervention, the Access Panel should solicit relevant information from a wide range of experts, and use both published and unpublished data. Where appropriate, the Panel is encouraged to consult with the investigator(s) who discovered or developed a potential intervention. Recommendations from this panel will be prioritized by the Steering Committee. The Panel will meet twice a year by telephone conference calls and email amongst the panel members as needed. Proceedings of the Access Panel's meetings will be forwarded to the Steering Committee in writing, accompanied by appropriate supporting materials, and a priority rating.

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.

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

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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Rebecca A. Fuldner, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-4906-6402
Email: fuldnerr@nia.nih.gov)

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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