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

Grants for Early Medical/Surgical Specialists’ Transition to Aging Research (GEMSSTAR) (R03)

Activity Code

R03 Small Grant Program

Announcement Type

Reissue of RFA-AG-13-006

Related Notices

  • August 15, 2014 - This RFA has been reissued as RFA-AG-15-007.
  • October 30, 2013 - See Notice NOT-AG-13-021. Notice of Warning Message Regarding Budgetary Limit during Submission.
  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

Funding Opportunity Announcement (FOA) Number

RFA-AG-14-010

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

This program is intended for early career physicians trained in medical or surgical specialties to establish a research track record in aging-related aspects of their specialty. The award will provide an opportunity to gain skills and experience in aging research and help investigators establish an independent program of research in their clinical field relevant to geriatric or gerontologic science.

Key Dates
Posted Date

August 8, 2013

Open Date (Earliest Submission Date)

September 21, 2013

Letter of Intent Due Date(s)

September 21, 2013

Application Due Date(s)

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

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January-February 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

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

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The National Institute on Aging (NIA) offers this initiative to promote research conducted by early stage physicians trained in medical or surgical specialties who are entering careers as clinician-scientists in aging-related aspects of their specialty.

The 2008 Institute of Medicine report “Retooling for an Aging America: Building the Health Care Workforce” emphasized the emergent need for additional health care personnel to address the medical needs of a growing population of older Americans with complex medical problems. Effective approaches to this impending health care crisis involve not only increasing the number of practicing physicians trained in geriatrics and in specialty fields related to the health problems of elders, but also fostering the development of the next generation of physician-scientists whose clinical research will lead to improved care and more effective treatment options for older patients with complex medical conditions.

A pivotal point in the development of clinician-scientists is the completion of training in a medical or surgical specialty and the first faculty appointment.  At this early stage, limited research experience and publication record preclude competitiveness for many kinds of advanced research opportunities. This transition stage may be particularly difficult for a specialty-trained physician focusing on aging-related aspects of his/her specialty, as multidisciplinary research entails training that is rarely available in conventional programs.  Thus, mechanisms that allow these physicians to begin research projects and establish a research track record are a priority for cultivating the next generation of clinician-scientists, particularly at the interface of aging and medical/surgical specialties.

Program Description

The goal of the Grants for Early Medical/Surgical Specialists’ Transition to Aging Research (GEMSSTAR) program is to promote future leaders in clinical aging research across the range of medical and surgical specialties. To accomplish this goal, NIA will provide two years of support for small research projects to physicians trained in medical or surgical specialties who seek to become clinician-scientists in aging-related aspects of their specialty. Eligible applicants include, but are not limited to, physicians in traditional medical or surgical specialties, anesthesiologists, emergency medicine physicians, family medicine practitioners, general internists, general surgeons, geriatricians, hospitalists, neurologists, obstetricians/gynecologists, palliative care physicians, physiatrists, and psychiatrists. As described below, research support through this initiative will be contingent on applicants’ demonstration of acceptable professional development activities and related support. Applicants must have a faculty appointment by the start of the award.

The GEMSSTAR program is intended to support a physician's first independent research project in aging. Applicants are generally expected to have received no prior research funding as principal investigators, though they may have support through institutional awards, such as career development awards (K12), a Clinical and Translational Science Award (KL2), or Older Americans Independence Center Research Career Development Awards (OAIC RCDC). In unusual circumstances where an applicant with funding support in a non-aging-related field wishes to refocus his/her research efforts on aging-related issues, there should be a strong and clear explanation in both the R03 application and in the subsequently submitted Professional Development Plan (if requested) for how the proposed research will entail a meaningful shift towards aging-related science within the applicant’s clinical specialty. Merely supplementing the applicant’s current research efforts with aging-related science would not be considered a meaningful shift.

Through this initiative, physicians trained in medical and surgical specialties who seek to bridge aging and clinical specialty disciplines can receive research project support through this R03 FOA. Research projects responsive to this initiative will combine aging with specialty clinical areas to focus on questions relevant to aging and/or the aged. The application should emphasize an integration of gerontologic or geriatric research with the candidate’s clinical specialty. Research may involve pilot or feasibility studies, secondary analyses of existing data, development of research methodology, or development of new research technology. Projects may span the breadth of scientific approaches, including basic, translational, clinical, genetic, or epidemiologic science. Human subjects, animal models, and in vitro systems are all acceptable as appropriate to the research questions. Projects should be appropriate to the background and level of experience of the applicant. Potential research topics may include, but are not limited to:

R03 applicants must obtain additional support for a concurrent Professional Development Plan (PDP) to receive a GEMSSTAR award. The PDP should not be included in the R03 application; rather, candidates should submit PDPs to the NIH only after NIA staff has requested them following scientific peer review. Please see Section IV.6. Other Submission Requirements for a complete description of the PDP requirement.

It is expected that applicants will have expertise in their clinical specialty, but may be less experienced in geriatric or gerontologic science or other areas. As such, applications should include a senior collaborator with complementary expertise in aging-related research and, if needed, other collaborators and/or consultants in other areas appropriate to the proposed project. Such an individual could be, but not necessarily must be, a mentor named in the PDP. 

Frequently asked questions regarding the GEMSSTAR program can be found on the NIA website

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

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

Funds Available and Anticipated Number of Awards

NIA intends to commit $1.5 million in FY 2014 for approximately 13-15 awards.

Award Budget

Application budgets are limited to $75,000 in direct costs per year.

Award Project Period

Project period is limited to 2 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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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.

Awardees must be physicians (i.e., those with M.D., D.O., or equivalent degrees) who have completed training in their medical or surgical specialty. These specialties include, but are not limited to, the traditional medical and surgical specialties, anesthesiology, emergency medicine, family medicine, general internal medicine, general surgery, geriatrics, hospital medicine, neurology, obstetrics/gynecology, palliative medicine, physiatry/rehabilitation medicine, and psychiatry. This award is not intended for individuals with substantial experience in aging research. Moreover, it is generally expected that applicants will have not had prior research funding as Program Director/Principal Investigator (PD/PI) on an NIH grant, though they may have support through institutional awards, such as institutional career development awards (K12), Clinical and Translational Science Awards (KL2), or Older Americans Independence Center Research Career Development Awards (OAIC RCDC).

A candidate in their last year of specialty training is eligible to apply provided that the candidate’s institution has committed to appointing him/her to a faculty position no later than at the start of award funding (July - August, 2014). Faculty appointments that are contingent on receiving a GEMSSTAR award are not acceptable. Documentation of the institution’s commitment to make the faculty appointment must be included in the R03 application.

Except in unusual circumstances, it is expected that GEMSSTAR applications will have a single PD/PI, and that other personnel will be listed as collaborators or consultants. In multiple PD(s)/PI(s) applications, all PD(s)/PI(s) must be eligible for the GEMSSTAR program.

Frequently asked questions regarding GEMSSTAR eligibility can be found at the NIA website.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

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

The letter of intent should be sent to:

Ramesh Vemuri, Ph.D., Chief
Scientific Review Branch
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205 (Express Mail ZIP 20814)
Telephone: 301-496-9666
FAX: 301-402-0066
Email: VemuriR@nia.nih.gov

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. In accordance with the goals of the GEMSSTAR program, the Biographical Sketches should emphasize how the candidate's proposed research will advance the understanding of aging-related science in the candidate’s specialty, as well as facilitate the candidate’s transition specifically into aging research. If candidates have an established record of research, they must delineate in their Biographical Sketch how this project differs from their prior work and how the proposed project will assist them in refocusing their research specifically on aging aspects of their specialty.

Applications should include a senior collaborator with complementary expertise in aging-related or geriatric-focused research and, if needed, other collaborators and/or consultants in other areas appropriate to the proposed project. Such an individual could be, but not necessarily must be, a mentor named in the PDP. Senior/Key Persons with aging/geriatrics-focused research expertise should highlight their background in their Biographical Sketch as well as how they will contribute to the applicant's knowledge and skills in aging research and how their expertise will complement that of the PD(s)/PI(s) to achieve the aims of the R03 application.

It is not appropriate to discuss mentorship or the PDP in the R03 application. The R03 provides support only for activities related directly to research.

Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The budget limit for  GEMSSTAR R03 applications is now $75,000 in direct costs per year. Applicants should include in their budget requests support to travel to an annual GEMSSTAR grantees' meeting held in Bethesda, Maryland, during each year of the award. Except in unusual circumstances, only the Program Director/Principal Investigator may be supported by R03 funds to travel to the grantee's meeting. Applicants should budget for travel to and from Bethesda, Maryland, two nights’ lodging, and meals. There is no specific line item in which to list travel costs in the Modular Budget format; however, the proposed travel should be included in the budget justification section. Frequently asked questions regarding travel to the annual GEMSSTAR meeting can be found on the NIA website.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: In accordance with the goals of the GEMSSTAR program, the Research Strategy should emphasize how the candidate's proposed research will advance the understanding of aging-related science in the candidate’s specialty, as well as facilitate the candidate’s transition specifically into aging research. Address to what extent the proposed project introduces aging-related research questions to the applicant’s clinical specialty area as well as its potential contribution to new and meaningful knowledge of geriatric- or gerontologic science related to the applicant’s clinical specialty.

Letters of Support: Letters of Support from department or division chairs or other institutional leaders are encouraged where appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following exception:

No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Additional information about preparing the R03 application
Professional Development Plan (PDP)

A PDP should not be submitted with the R03 application. A PDP should be submitted only after NIA staff have requested it following peer review of the R03 research application. In the event that applicants are asked to submit a PDP, the following information is provided to help candidates plan ahead, including securing additional funding and/or institutional commitment for protected time.

Funding of this R03 award is contingent on having an NIA-approved PDP for the duration of the R03 award. The PDP consists of three components: 1) the written plan and 2) letters of support from mentor(s), including at least one with geriatrics or aging-focused expertise and 3) documentation of support for the plan through independent funding and/or institutional commitment for protected time as outlined below. The components of a PDP will differ for each applicant based on a variety of individual factors such as career stage, research experience, and institutional resources. The PDP should be tailored to meet the applicant’s individual professional development needs in relation to the R03 application. Moreover, the PDP should specifically describe activities that will augment the applicant’s skills in geriatrics and/or aging research to enable him/her to develop into an independent researcher in aging science.  The NIA GEMSSTAR website offers guidance, resources and answers to frequently asked questions regarding the PDP and potential funding sources. Although it is not possible to specify precisely what the parts of an individual PDP should be, inclusion of at least some of the following components is encouraged:

The above is not an exhaustive list; other appropriate activities not included above may be proposed.

In addition to a description of professional development activities, additional funding support should be obtained to provide protected time and resources to pursue the proposed professional development activities. Such support may be provided through a variety of sources, alone or in combination. These sources may include, but are not limited to, the following:

Acceptable and documented support for professional development activities must be in place prior to award of the R03 and must remain active during the entire R03 award period. The commitment of time and resources should be commensurate with activities outlined in the candidate's PDP. Professional Development Plans should include a description of the costs and level of professional effort associated with the proposed activities. Applicants for this initiative are strongly advised to communicate with possible funders for PDP support early in the process, even as early as the time of submission of the R03 application. Acquiring support for professional development is the responsibility of the R03 applicant. Applicants are encouraged to share their R03 applications and summary statements with all potential sources of PDP funding.

NIA staff will evaluate each PDP for the degree to which it supplements the applicant’s current knowledge and skills with geriatrics and/or aging research training, its likelihood to enable the applicant’s development into an independent researcher in the aging aspects of his/her clinical specialty, and the adequacy of committed support for protected time and other related expenses.

PDPs should be limited to 5 pages, not including letters of support.  Requests for PDP’s will be sent to selected applicants shortly after scientific peer review. It is expected that requested PDPs will be due in May, 2014.

Post-Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? To what extent does the proposed project introduce aging-related research questions to the applicant’s clinical specialty area? To what extent will the proposed research contribute new and meaningful knowledge in geriatric- or gerontologic science related to the applicant’s clinical specialty?

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? If established, how will this award assist in the investigator’s transition to aging research and how does the project differ from his/her prior work? To what extent will this award help to bridge the applicant’s clinical specialty with geriatric- or gerontologic research? Does the team of investigators have complementary and integrated expertise in aging and geriatrics appropriate for the project? Is the role of the collaborator(s) appropriate to advance the specific aims of the project and supplement the skills of the PD/PI, as well as their skills in aging/geriatrics research?

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 score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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 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).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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 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 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

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

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

Scientific/Research Contact(s)

Susan J. Zieman, MD, PhD
National Institute on Aging
Telephone: 301-496-6761
Email: niagemsstar@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging
Telephone: 301-496-9666
Email: VemuriR@nia.nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging
Telephone: 301-451-9802
Email: blakeneyr@nia.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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