EXPIRED
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Limited Competition: Renewal of the Caenorhabditis Intervention Testing Program (U01)
U01 Research Project Cooperative Agreements
Reissue of RFA-AG-13-010
RFA-AG-17-001
RFA-AG-17-007 U24 Resource-Related Research Projects Cooperative Agreements
93.866
The purpose of the Caenorhabditis Interventions Testing Program (CITP) is to test, under standardized conditions at a consortium of three sites, potential intervention strategies which may decelerate the rate of aging in 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. The CITP will continue to use life span as its primary outcome for an intervention on a currently defined set of Caenorhabditis species and strains. This FOA calls for renewal and expansion of the scientific scope of the CITP with the following goals: 1. Continue to test compounds for effects on lifespan; 2. Increase the number of strains examined in lifespan studies as described in RFA AG-13-010. 3. Incorporate a limited set of studies for health span on selected compounds; 4. Incorporate studies to establish optimal effective doses when an initial test indicates the compound may be robust for its effect on lifespan across numerous strains of Caenorhabditis.
May 2, 2016
June 26, 2016
June 26, 2016
July 26, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
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.
Not Applicable
November 2016
January 2017
March 2017
July 27, 2016
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
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
This FOA is for the renewal and expansion of the Caenorhabditis Interventions Testing Program (CITP). The purpose of the CITP is to test, under standardized conditions at multiple sites, potential intervention strategies which may decelerate the rate of aging in diverse species and strains of Caenorhabditis. The rate of aging is to be measured by lifespan extension and/or improvements in health at later ages due to the intervention. The CITP has used life span as its primary outcome for an intervention, with limited studies on optimizing effective doses and using a restricted set of species and strains in order to develop standard operating procedures and identify the parameters needed to optimize reproducibility (within and between laboratories). This FOA calls for renewal and expansion of the scientific aspects of the CITP with the following goals: 1. Continue to test compounds for effects on lifespan; 2. Increase the number of strains examined in lifespan studies as described in RFA AG-13-010. 3. Incorporate a limited set of studies for health span on selected compounds; 4. Incorporate studies to establish optimal effective doses when an initial test indicates the compound may be robust for its effect on lifespan across numerous strains of Caenorhabditis.
The CITP has developed a specific combination of coordinated research approaches, sharing of research data, and combining lifespan data with species and strain differences that should allow the CITP to produce an understanding of the variance in lifespan in response to interventions using laboratory animal models of biological aging. This collaborative network was developed under RFA-AG-13-010 by the design and testing of standard operating procedures to optimize replication across 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. The CITP is expected to determine the effects of selected biological or synthetic compounds on diverse species and strains of Caenorhabditis. 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 between-laboratory reproducibility of lifespan extension.
Pharmacodynamics. The CITP is expected to determine whether single versus multiple formulations of compounds may be used for the diverse species and strains of Caenorhabditis, as well as under different experimental conditions (e.g., manual versus automated experiments to determine lifespans in the presence versus absence of a compound). The CITP is also expected to address potential differences in metabolism of compounds among species (e.g., differential absorption).
Health span. The CITP is expected to examine health span using a panel of candidate outcome measurements that can be tested for selected interventions (compounds).
To achieve the continuing goals of this program, which include establishing rigorously the reproducibility of experimental outcomes from the above three 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. Instructions on how to show evidence of the collaboration are provided in Section IV below.
The compounds to be used in these experiments will be selected by an Access Panel, 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 span, and whether the effects are robust or not.
See Section VIII. Other Information for award authorities and regulations.
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.
Renewal
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NIA intends to commit $1.85 million as total costs in FY 2017 to fund three awards.
Direct costs for each application may not exceed $450,000 per year.
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 in response to this FOA.
Only the current awardees of the Caenorhabditis Intervention Testing Program, funded under RFA-AG-13-010, may apply to this Limited Competition FOA.
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.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Only the current awardees of the Caenorhabditis Intervention Testing Program, funded under RFA-AG-13-010, may apply to this Limited Competition FOA.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Ronald A. Kohanski
Division of Aging Biology
National Institute on Aging
Gateway Building, Suite 2C231
7201 Wisconsin Ave.
Bethesda, MD 20892-9206
Telephone: 301-496-6402
Fax: 301-402-0010
Email: kohanskir@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
Lifespan Studies. The objective of lifespan studies is to identify compounds that extend lifespan in multiple species and/or strains of Caenorhabditis. Lifespan measurements are to be made in diverse species and strains of Caenorhabditis. The applicants should describe the basis for species and strain selection, including justifications for the numbers of species and strains. Options for reducing (or expanding) the selection should be described as well. The standard operating procedures for lifespan measurement should be described as part of a report on progress made under the prior award.
Health span studies on selected compounds. Applicants should propose a limited set of assays and describe methods to assess age-sensitive health outcomes that might be affected by those interventions that increase lifespan. Procedures and outcomes for health span measurements should be described as part of a report on progress made under the prior award.
Pharmacodynamics. Applications should include plans for efficient development of formulations of agents for testing. Applications should also include studies for optimizing concentrations of compounds that extend lifespan in diverse species and strains (e.g., testing the hypothesis that the optimal dose will differ among species and strains). Data on pharmacodynamics established under the prior award should be described as part of a report on progress.
Coordination of the research among the three laboratories 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 contributes to achieving the objectives of the proposed studies including experimental design, bioinformatics, and pharmacodynamics and evaluation of lifespan, Healthspan, and pharmacodynamics in studies using Caenorhabditis. This should include how the applicant will employ the proposed standard operating procedures and automation technologies, and 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.
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.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
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
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 National Institute on Aging, 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 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
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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 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?
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 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?
Specific for this FOA:
How well have the applicants addressed issues of replicating results among the participating laboratories?
How well-justified are the choices of Caenorhabditis species and strains?
How well have the applicants addressed issues of pharmacodynamics in light of the diversity of species and strains to be employed?
How have the applicants addressed comparisons between manual and automated lifespan studies?
How useful are the candidate health and health-outcome measurements in terms of worm physiology and translational potential?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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
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.
Not Applicable
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the 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:
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.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Development, implementation and evaluation of the 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.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIA Project Scientist will exercise substantial scientific and programmatic involvement to assist, guide, coordinate and participate in the conduct of the Testing Program activities. The NIA Project Scientist will attend and participate in all meetings of the Steering Committee as a voting member, and will provide liaison between the Steering Committee and the NIA/NIH. The NIA Project Scientist will assist the Steering Committee in developing and drafting operating policies, and policies for dealing with recurring situations that require a coordinated action.
An NIA Health Scientist Administrator will be the NIA Project Scientist for this award, and will be responsible for scientific involvement in the 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; participate 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 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 in life span 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the 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 awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, 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)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov
GrantsInfo
(Questions regarding application instructions and process, finding NIH grant
resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
Ronald A. Kohanski, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9402
Email: kohanskir@mail.nih.gov
Ramesh Vemuri, Ph.D
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: vemuri@nia.nih.gov
Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: whippl@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.