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

Caenorhabditis Intervention Testing Program (CITP) – U01

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-13-010

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.866 

Funding Opportunity Purpose

The National Institute on Aging (NIA) invites applications for cooperative agreements (U01s) from investigators or groups of investigators (e.g., multiple PD(s)/PI(s) capable of, and interested in, participating in a Caenorhabditis Intervention Testing Program (CITP). The goal is to identify pharmacological interventions that increase lifespan and/or healthspan in a robust manner when tested using multiple species of the simple invertebrate Caenorhabditis and/or multiple strains of Caenorhabditis elegans. Human populations are genetically heterogeneous and thus, in order to work in humans, any intervention that extends lifespan/healthspan needs to do so within a variety of genetic backgrounds. Testing of promising compounds in a variety of genetic backgrounds within a species with a short, well-studied lifespan and healthspan, should accelerate the current rate of discovery.

Using as a model the NIA’s Intervention Testing Program (http://www.nia.nih.gov/ResearchInformation/ScientificResources/InterventionsTestingProgram.htm), the partners in this cooperative agreement will test compounds or combinations of compounds suggested by the research community and vetted through an Access Panel.  Compounds will be tested for longevity effects in at least 8-10 species of Caenorhabditis and/or independent strains of C. elegans, and at different doses. It is anticipated that positive results could be followed up with further testing under the current Intervention Testing Program in mice, though the two projects are independent of each other.

Key Dates
Posted Date

September  11, 2012

Open Date (Earliest Submission Date)

October  5, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

November 7, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 2013

Expiration Date

November 8, 2012

Due Dates for E.O. 12372

Not Applicable

 

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Lifespan is often used as a surrogate outcome to determine the effects of interventions on aging.  Lifespan determination in humans is technically challenging, and in mice it is costly. A major challenge in the field is to ascertain the role of the genetic background on the robustness of any given intervention or manipulation. Even apparently robust interventions such as caloric restriction (CR) appear to be susceptible to genetic background effects, both in mice and monkeys. Indeed, using a set of 41 Recombinant Inbred strains, Liao et al. (Aging Cell 9:92, 2010) reported that only approximately 1/3 of the strains tested responded positively to a 40% caloric restriction, with 1/3 showing no effect, and 1/3 actually showing decreased longevity. This study and additional published data suggest that the genetic background can strongly modulate the effect of CR. In addition, work by Harper et al. (Aging Cell 5:441, 2006) indicates that CR in wild mice results in a similar pattern, with a number of the mice dying early, but also extended longevity for others. Coming from a very different experimental paradigm, this observation is concordant with the study in the Recombinant Inbred strains, and reinforces the notion that CR does not work to the same extent in different genetic backgrounds. The fact that in a significant number of animals CR has a deleterious effect on lifespan is cause for concern in planning to extend this research (including CR mimetics) to the human population.

Translational research is fraught with false starts, and often it is found that manipulations and drugs that work in mice do not work in humans. Among other factors (age at testing, diet, exposure to pathogens, etc.), genetic heterogeneity is likely to play a role. Indeed, recent findings have demonstrated the effect of genetic background on several genetic manipulations that extend lifespan in invertebrate organisms. Burnett et al. recently published that the effect of sirtuin overexpression on longevity in both Caenorhabditis elegans and Drosophila melanogaster is highly dependent on the genetic background (Burnett et al., Nature 477:482, 2011), and similar observations have been reported for other lifespan-extending mutations. Establishing the robustness of these effects in genetically heterogeneous backgrounds is critical as we start attempting to apply our knowledge of the basic biology of aging to human populations.  Use of multiple strains in the testing protocol should increase the likelihood that positive findings in lower organisms will translate to mammalian species and decrease the risk of false negatives.

This FOA aims at identifying pharmacological interventions that are robust enough to work under a variety of different genetic backgrounds, at least in a simple model organism. Testing interventions in mice is expensive and slow, given the much longer lifespan of mice. For this reason, the present FOA focuses on a shorter-lived model which has nevertheless proved very informative about basic mechanisms of aging. The shorter time frame should allow for teams of researchers to rapidly test different modalities (time of initiation, dose, combinations of treatments, etc.), and the large numbers of individuals should allow for high statistical power to detect relatively small changes in longevity. It is realized that there are also many limitations, such as differences in drug absorption, metabolism and pharmacokinetics, as well as the limited repertoire of healthspan measurements available in C. elegans. For this reason, the NIA wishes to emphasize that the CITP is an independent program, not meant as an obligatory entry point to the current ITP using mice, or further testing in monkeys, dogs or other species with higher evolutionary proximity to humans.

RESEARCH OBJECTIVES

The objectives of this Program are:  1) to propose interventions for the first round of testing, compounds that have been shown in peer-reviewed reports to have some potential to extend life span and/or postpone age-related pathology or disability, or are promising candidates based on well-accepted hypotheses about aging mechanisms, 2) to perform survival analysis and limited health measurements in at least 8-10 species of Caenorhabditis and/or independent strains of C. elegans, with drugs administered at least at 3 different doses, potentially in conjunction with other promising candidates, and starting treatments at three different life stages (young, adult and old). Applicants should not apply as a pre-established consortium: while multiple PD(s)/PI(s) applications are encouraged, the NIA intends to select the best applications that combine appropriate expertise to form a new consortium. Whereas applicants are strongly encouraged to specify which species / strains they believe to be the best for the goal stated, all members of the consortium will use the same set of strains / species (selected by the Steering Committee from those proposed in the applications).

Applicants should indicate in the Specific Aims their willingness to perform the research in the strains / species chosen by this committee,and cooperate with others in the consortium to develop compatible approaches and procedures. . Applicants are strongly encouraged to present plans to make the data broadly available to the research community.

Detailed objectives include:

1.  Identifying interventions that increase mean and/or maximal life expectancy by at least 10% in at least a majority of the strains / species tested.  Applicants should include a power analysis to indicate how this will be achieved.  In addition, these studies should also be carried out in both hermaphrodites and in males, to detect whether the effects are gender-specific.

2. Interventions will be tested in at least 8-10 species of Caenorhabditis and/or independent strains of C. elegans. The specific species / strains to be used, and the rationale for each, should be included in the application, alongside survival data for each species / strain. Yet, the final set of species / strains will be chosen early in the process by the Steering Committee, and it might or might not include all the species / strains proposed by any given investigator. The descriptions present in the applications will inform the deliberations of the Steering Committee. Use of different mutants within a single genetic strain will not be considered responsive to this FOA.

3. For those compounds showing promise (as established by the Steering Committee), further analysis should include physiological measurements in at least two domains: 1) general physiology / biochemistry that assesses general health, and 2) specific molecular or physiological measures of parameters suspected to be affected by the treatment under study. The measurements of physiology/biochemistry that assess health span should be specified in the application. Measurements that are suspected to be treatment-specific do not need to be specified at this time. Examples of endpoints include, but are not limited to: measures of behavior, cognitive or sensory function, motor activity, indicators of stress and resistance to stress, protein oxidation or other protein modifications, and changes in gene expression.  The absence of actual validated biomarkers of aging requires that applicants rely on "best judgment" of informative age-sensitive traits to use as surrogate biomarkers.  Applicants should propose a variety of such endpoints and provide justification for the endpoints chosen to evaluate interventions, and details of the methodologies to be used, although consensus about the actual protocols to be used across sites will be developed by the Steering Committee early in the program.

4.  All results are expected to be published in peer-reviewed scientific journals, irrespective of whether the results are positive or negative.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NIH intends to fund an estimate of 3 awards, corresponding to a total of $1,500,000, for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to no more than $350,000 in direct costs per year. In addition, budgets need to reflect actual needs of the proposed project.

Award Project Period

 Three years  

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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:

Felipe Sierra, Ph.D.
7201 Wisconsin Ave-Suite 2C231
Bethesda MD 20892
Telephone: 301-496-6402
Email: sierraf@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Specific Aims

Applicants should state in the Specific Aims their willingness to perform the research in the strains / species chosen by the Steering Committee, and to cooperate with others in the consortium to develop compatible approaches and procedures. Applications lacking these statements will be considered nonresponsive.   Applicants are strongly encouraged to present plans to share the data broadly with the research community.

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 modifications:

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by 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-10-115.

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

Generally Not Applicable.  Reviewers should be any concerns to the attention of the Scientific Review Officer. 

Inclusion of Women, Minorities, and Children 

Generally Not Applicable.  Reviewers should be any concerns to the attention of the Scientific Review Officer. 

Vertebrate Animals

Generally Not Applicable.  Reviewers should be any concerns to the attention of the Scientific Review Officer. 

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

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).  As a condition of award, all results will be published in a peer reviewed scientific journal.

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 appropriate Scientific Review Groups convened by NIA in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 National Advisory Council on Aging. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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:

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 Scientific Officer for this award, and will be responsible for scientific involvement in the CITP. The NIA Project Scientist will:

Additionally, a separate Program Official from the NIA Division of Aging Biology will be responsible for the normal scientific and programmatic stewardship of the award.  The NIA Program Official will approve all major stages of the study and all new major additions/changes to content and methods.  Prior approval is required by the NIA Program Official for any replacements of key personnel.

Areas of Joint Responsibility include:

STEERING COMMITTEE: This Committee will be the main governing body of the Program. Its voting members will include the 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 PD(s)/PI(s) and the NIA Project Scientist. The NIA project Scientist will not chair the committee. At the outset, the Steering Committee will agree on the strains to be used and on a common set of procedures to be followed across sites. In addition, during the entire duration of the award, the primary roles of the Steering Committee are to prioritize the interventions recommended by the Access Panel, and develop consensus on testing protocols to be employed in the 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 the CITP; 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 Caenorhabditis. The Access Panel shall consist of one representative (not the 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Felipe Sierra, Ph. D.
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: sierraf@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
7201 Wisconsin Avenue, Ste. 2C-212
Bethesda, MD 20892-9205
(for courier use 20814)
301-402-7700 (phone)
301-402-0066 (fax)
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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH . . . Turning Discovery Into Health

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.