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 Caenorhabditis Intervention Testing Program (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
Reissue of RFA-AG-17-001
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AG-22-029
Companion Funding Opportunity
RFA-AG-22-028 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

The purpose of the Caenorhabditis Interventions Testing Program (CITP) is to test, under standardized conditions at a consortium of three sites, potential intervention strategies that may moderate/alleviate health declines associated with aging across genetically diverse species and strains of Caenorhabditis. All three laboratories in the CITP use identical standard operating procedures to test the same compounds (interventions) at the same concentrations and under the same conditions, allowing both reproducibility and robustness of compound interventions to be systematically assessed. The CITP will continue to use lifespan and indicators of locomotory health as criteria for efficacious impact by targeting mechanisms likely to be conserved across phyla, but will combine compound sets derived from multiple sources, including those proposed by the community. This Funding Opportunity Announcement (FOA) calls for the renewal and expansion of the scientific scope of the CITP, with the following goals: 1) increase the capacity to screen compounds with a high standard of rigor and reproducibility; 2) evaluate and, if warranted, implement new technologies and protocols to enhance the throughput and depth of the CITP; 3) measure transcriptomic profiles to provide additional information on compounds that are effective in multiple species and/or strains, or on compounds that are effective in only a subset of species or strains; 4) develop reporters of various aging hallmarks of aging in genetically diverse Caenorhabditis strains; and 5) use the reporters to develop phenotypic screens against hallmarks of aging as a novel paradigm for anti-aging compounds which can have multiple uses in basic research as well as generate unique platforms for translational research.

Key Dates

Posted Date
September 23, 2021
Open Date (Earliest Submission Date)
September 27, 2021
Letter of Intent Due Date(s)

September 27,2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable October 27, 2021 Not Applicable February 2022 May 2022 July 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date
October 28, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

This Funding Opportunity Announcement (FOA) is for the renewal and expansion of the Caenorhabditis Interventions Testing Program (CITP). The purpose of the Caenorhabditis Interventions Testing Program (CITP) is to test, under standardized conditions at a consortium of three sites, potential intervention strategies that may moderate/alleviate health declines associated with aging across genetically diverse species and strains of Caenorhabditis. Testing across different genetic backgrounds is a central required element of the program because it is hypothesized that shared responses across broad genetic diversity is likely to reveal interventions that target conserved pathways. All three laboratories in the CITP use identical standard operating procedures to test the same compounds (interventions) at the same concentrations and under the same conditions, allowing both reproducibility and robustness of compound interventions to be systematically assessed. Previous cycles of the CITP have revealed a need for even more comprehensive assessments of potentially gero-positive compound sets, and multiple strains have been engineered to allow more precise analysis of specific aging-related disease models. We hope that the next phase of the CITP will build on the past success of the CITP and provide more value to the broader scientific community by a) contributing broad-spectrum testing of interventions across a genetically diverse test set for impact on longevity and healthy aging; b) leading in scientific rigor and best practices in generating reproducible outcomes on health and longevity interventions; c) interfacing with the scientific community to evaluate efficacy of both novel and clinically engaged candidate anti-aging compounds; d) generating and distributing models of human aging-related diseases and associated genetic susceptibilities in a test set that features genetic differences greater than those between mice and humans; and e) adapting technologies for increased automation of lifespan, middle-age health, and resilience evaluation for both CITP and community studies.

Moving forward, the CITP will continue to use lifespan and indicators of locomotory health as criteria for efficacious impact by targeting mechanisms likely to be conserved across phyla, but will combine compound sets derived from multiple sources, including community-proposed CITP Access Panel recommendations, clinical trials for aging-associated diseases or anti-aging treatments, FDA-approved drugs under testing for repurposing, and novel compound sets with pro-longevity indications that pass prescreening within CITP. The next phase of the CITP will continue to put an emphasis on reproducibility and rigor in testing longevity and health indicators across a genetically diverse population. It will test and, if warranted, implement new technologies and protocols to enhance throughput as needed. The CITP compound screening will go beyond the lifespan and health metrics, and the “positive hits” from lifespan assays will be further characterized at the molecular level by measuring their transcriptomic profiles and also testing their impact on the reporter strains of various aging hallmarks.

This FOA calls for the renewal and expansion of the scientific scope of the CITP with the following goals:

  1. Increase the capacity to screen compounds likely to have positive influences on longevity and health indicators across genetically diverse strains, with a high standard of rigor and reproducibility.
  2. Evaluate and, if warranted, implement new technologies, protocols, and genetic technologies to enhance throughput within CITP.
  3. Measure transcriptomic profiles to provide additional information on compounds that are effective in multiple species and/or strains, or on compounds that are effective in only a subset of species or strains.
  4. Develop reporters of various aging hallmarks in genetically diverse Caenorhabditis strains and develop these for use in compound screens based on those reporters.

Research Objectives

The CITP has developed a specific combination of coordinated research approaches, data sharing, and multivariate computational analysis tools that enable the evaluation of lifespan data with species and strain differences. The unique CITP program can thereby evaluate variance in lifespan and additional health indicators in response to interventions using laboratory animal models of biological aging. The collaborative CITP network was developed under RFA-AG-13-010 by the design and testing of standard operating procedures to optimize replication across different sites. The CITP utilizes state-of-the-art automation and standardized workflows and protocols for lifespan measurements to study the effects of selected compounds on diverse species and strains of Caenorhabditis. Based on these paradigms, the research objectives of this FOA include:

  • Lifespan Studies and Midlife Health Indicators. The CITP is expected to determine the effects of selected compounds on diverse species and strains of Caenorhabditis. In addition, the CITP is expected to screen selected compound libraries of human relevance for lifespan extension and health benefits. After an initial pre-screen phase that evaluates dose and efficacy, each participating laboratory will perform lifespan studies on the same species and strains, using the same compounds and standard operating procedures. A key feature of these experiments is to determine the within-laboratory and among-laboratory reproducibility of lifespan extension. The CITP is also expected to examine midlife heath quality using outcome measurements of locomotion. Complementary measures of stress resistance and/or resilience may be used for selected interventions. In some instances, a focus on healthy functionality rather than longevity may be used.
  • Reporters of Aging Hallmarks. The CITP is expected to measure transcriptomic profiles to provide additional information on compounds that are effective in multiple species and/or strains, or on compounds that are effective in only a subset of species or strains. The CITP is also expected to develop reporters of selected aging hallmarks in genetically diverse Caenorhabditis strains. These reporter strains are expected to be used to develop compound screens affecting those hallmarks. Due to budget limitations, the measurement of transcriptomic profiles by bulk RNASeq or other affordable approaches would be acceptable. All transcriptomic profiling will be annotated and made publicly available through the data coordinating center to permit secondary analysis by other investigators (those not affiliated with the CITP).

The compounds to be used in these experiments will be derived from multiple candidate groups that include, but are not limited to: community-proposed CITP Access Panel recommendations, clinical trials for aging-related diseases or anti-aging treatments, FDA-approved drugs under testing for repurposing, and novel compound sets with pro-longevity indications that pass prescreening within CITP. The Access Panel interface will be as defined in Section VI. 2 Cooperative Agreement Terms and Conditions of Award.

All results are expected to be published in peer-reviewed scientific journals, irrespective of whether the effects increase, decrease, or have no impact on lifespan or health, and whether or not the effects are robust.

To achieve the continuing goals of this program, which include rigorously establishing the reproducibility of experimental outcomes from the above research objectives, identical protocols must be used at each of the three participating sites. Because of this, applicants may choose to collaborate in preparing applications and are expected to employ a central Data Coordinating Center for data collection, coordination, storage, analysis, and public access. Instructions on how to show evidence of the collaboration are provided in Section IV.

See Section VIII. Other Information for award authorities and regulations.

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. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIA intends to commit $1,250,000 million in direct costs in FY 2022 to fund 3 awards.

Award Budget

Direct costs for each application may not exceed $600,000 per year.

Award Project Period

The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only the current awardees of the Caenorhabditis Intervention Testing Program, funded under RFA-AG-17-001, "Limited Competition: Renewal of the Caenorhabditis Intervention Testing Program (U01)," may apply to 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.

  • 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) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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.

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:

  • 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:

Max Guo, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7747
Email: Max.Guo@nih.gov

Page Limitations

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

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.

SF424(R&R) Senior/Key Person Profile

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

In describing their respective expertise relevant to this application, applicants should also describe the contributions of key personnel to the coordination of research activities among the sites of this consortium.

R&R or Modular Budget

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

R&R Subaward Budget

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

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:

Lifespan Studies and Midlife Health Indicators. The CITP is expected to determine the effects of selected compounds on diverse species and strains of Caenorhabditis. In addition, the CITP is expected to screen selected compound libraries of human relevance for lifespan extension and health benefits. After an initial pre-screen phase that evaluates dose and efficacy, each participating laboratory will perform lifespan studies on the same species and strains, using the same compounds and standard operating procedures. A key feature of these experiments is to determine the within-laboratory and among-laboratory reproducibility of lifespan extension. The CITP is also expected to examine midlife heath quality using outcome measurements of locomotion. Complementary measures of stress resistance and or resilience may be used for selected interventions. In some instances, a focus on healthy functionality rather than longevity may be used. In the Research Plan, applicants are expected to provide standard operating procedures for lifespan assays. They are also expected to provide types of health indicators to be considered or measured, the rationale behind these choices, and plans on how to select and measure them.

Reporters of Aging Hallmarks. The CITP is expected to measure transcriptomic profiles and develop reporters of key aging hallmarks in genetically diverse Caenorhabditis strains. These reporter strains are expected to be used to develop compound screens affecting those hallmarks. Due to budget limitation, the measurement of transcriptomic profiles by bulk RNASeq or other affordable approaches would be acceptable. If any interesting features are discovered by these transcriptomic profiles, the aging research community can follow up with more detailed and comprehensive approaches, such as single cell RNASeq. In the Research Plan, applicants are expected to provide a proposed exterimental design for the transcriptomic profiling. For the reporter strains, applicants must propose the aging hallmarks to be selected for these reporters and the rationale behind these selection. The experimental design should be also described.

Coordination of the research among the three laboratories and the Data Coordinating Center (DCC) of the CITP is integral to success of this program. Therefore, applicants should provide details on collaborative aspects of the research. For example, outline the site at the applicant institution that contributes to achieving the objectives of the proposed studies including experimental design, bioinformatics, reporter development of aging hallmarks, evaluation of lifespan and healthspan, transcriptomic profiles, and molecular aging hallmarks in studies using Caenorhabditis. This should include how the applicant will employ the proposed standard operating procedures and automation technologies, identifying the expected strengths and possible weaknesses of the measurements (including quality control and assurance), and understanding how the characteristics and shortcomings of the collected data affect the interpretation of the results. The applicants must also describe how they interact with the DCC for data collection coordination, integration, analysis, statistical calculation, and the public access of the CITP data.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the 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.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute on Aging (NIA), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@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 the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission 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.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

Are the experience and qualifications of key personnel who are in charge of the coordination of research activities among all sites, including the DCC, appropriate for the proposed project?

 

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

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA:

Have the applicants provided justifications for the candidate health and health-outcome measurements in terms of worm physiology?

Have the applicants provided justifications for their selection of hallmarks of aging, for which reporters will be generated?

How well will the information from transcriptomic profiles and reporters of aging hallmarks be compared and integrated?

How well will the interaction and collaboration among all sites (including the DCC) be organized and facilitated?

 

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.

   

For research that involves human subjects but does not involve one of the  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  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.

 

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 individuals of all ages (including children and older adults) 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.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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

 

Not Applicable

 

 

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

 

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.

 

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.

 

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).

 

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) Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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 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 will receive a written critique.

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.

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

Applications will be assigned to the National Institute on Aging. 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:

  • 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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2 CFR Part 200, 45 CFR Parts 75, 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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

The development, implementation, and evaluation of the Caenorhabditis Interventions Testing Program (CITP). 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 CITP testing; and
  • Nominate individuals to serve on the Access Panel. Members of Access Panel will be selected by the Steering Committee.

Recipients 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 CITP. 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; and
  • Participate in the analysis and publication of the results of testing in the CITP.

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, including at least four biogerontologists covering a broad range of gerontologic 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 role of the Steering Committee is to prioritize the interventions recommended by the Access Panel. In carrying out these responsibilities, the Steering Committee may seek advice from outside experts as needed, and is encouraged to include the investigator(s) who either discovered or developed the potential intervention in relevant 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. Recipient 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 lifespan studies; 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 worms.

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 recipient. This special dispute resolution procedure does not alter the recipient'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, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.

A final RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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 Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Max Guo, Ph. D.
National Institute on Aging (NIA)
Telephone: 301-402-7747
Email: Max.Guo@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: jessi.perez@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 Part 75 and 2 CFR Part 200.


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