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

Background

Mobility disability (e.g., in walking, toileting, climbing stairs) is a major cause of loss of independence among older persons. It has many contributing factors (neurologic, cardiovascular, joint disorders, as well as muscular). Within muscular factors, a variety of muscular conditions may contribute to clinically meaningful impairments. Among these are low muscle mass and weakness, which are found in some, but not all patients with mobility disability.  Thus, in some patients with mobility disability, treating low muscle mass, weakness, or both, might reduce mobility disability and lower the severity or risk of other serious related outcomes.  However, it is still unknown to whom treatments might be beneficial.

Although the relations of muscle mass and strength to mobility disability are continuous functions, specific diagnostic cut-points to define low muscle mass and/or weakness are valuable to clinical decision-making and the evaluation of new interventions. As with other conditions based on continuous risk functions, practitioners need diagnostic cut-points to decide what level of the condition produces sufficiently adverse effects so that treatment would be warranted, if safe and effective.  Such cut-points could allow evidence-based definitions of conditions, e.g., sarcopenia (low muscle mass), or “dynapenia” (low muscle strength and/or power) as indications for treatments.

Potential criteria for the definition of low muscle mass have been published based solely on statistical distributions in healthy older populations. Potential criteria based on the proposed impact of low muscle mass on strength and function also have been proposed by several consensus groups essentially supported by professional opinion.  Recent analyses identified and proposed cut-points for clinically relevant low muscle mass and low muscle strength.  The proposed cut-points from these analyses were derived from community-dwelling older adults with limited representation of individuals with mobility disability.  Analyses of data containing larger numbers of older adults with mobility disability are needed for additional assessment and refinement of cut-points with regard to their clinical relevance and applicability.

Scope of Research Requested

NIA invites applications to conduct analyses of existing data (or ongoing data collection to be completed in one year from the date of publication of this FOA) from populations with high prevalence of mobility disability, and low muscle mass and strength, to generate and evaluate diagnostic criteria  or cut-points for low muscle mass and weakness.  Pooling data should be considered to increase power and strengthen study results.  The main goal is to develop and assess differing diagnostic cut-points with regard to properties such as sensitivity, specificity, and positive predictive value.

This FOA invites applications with datasets featuring the following elements:

A) Datasets including ALL of the following: Data from well-designed observational and interventional studies containing information on body composition (by dual-energy X-ray absorptiometry-DEXA), handgrip strength, gait speed, assessment of physical limitations and disability (e.g., Short Physical Performance tests), and self-reported functional status in populations of older adults ≥ 65 years of age with larger numbers of individuals with mobility disability.  Information on the variables and measurements mentioned above should be available at baseline and at least one subsequent multiple time point (e.g., 3, 6, 12 months).  Examples of such datasets include those of populations with hip fracture undergoing rehabilitation; with muscle-wasting conditions (e.g., congestive heart failure, end-stage renal disease, chronic obstructive pulmonary disease); with substantial mobility limitations participating in clinical trials of therapies targeting muscle mass or function; and with substantial levels of mobility limitation who live in the community or are institutionalized.  In view of potential limitations with sample size, pooling existent data whenever possible should be considered to increase power and strengthen study results.  Consortia or partnerships with foreign investigator(s) or institutions will be allowed.  To facilitate the development of such partnerships, applicants are encouraged to visit and search Clinicaltrials.gov (http://www.clinicaltrials.gov/) or other sources to identify completed or active ongoing studies for which data meeting the criteria described above are available.

B) Other Key Variables:

Other key variables include information on associated co-morbidities, medications, and other potential therapeutic approaches.  Data comprising multiple clinical populations with varying pathologies and co-morbidities are a strength to the FOA in that reassessment of the referred proposed criteria/cut-points in each of these populations will determine whether the criteria are broadly applicable to multiple subpopulations irrespective of comorbidities or whether there is a need to derive new morbidity-specific criteria that can be tested/validated in future prospective studies.

C) Gender analyses/comparison are strongly encouraged and should be reported/discussed to the extent possible. 

D) There is currently limited diversity of populations in existing datasets with the requisite combination of data on muscle mass, strength, and mobility disability.  This FOA encourages the identification of potential datasets that optimize the degree of diversity in the included population.  To the extent possible, data analysis across multiple diverse groups is encouraged, even if statistical power is limited, in order to provide preliminary analysis that may help guide future research and potential new data collection.

A variety of analytic methods may be applied to these datasets to calculate specificity, sensitivity, and related metrics for different cut points for muscle mass or strength based on their ability to distinguish between persons with and without mobility disability.  Applicants are encouraged to construct datasets that provide sufficient information to allow them to conduct analyses of:

1. Effects of using different metrics for muscle mass (e.g., adjustment for body mass index), muscle strength, or other physical performance measures on sensitivity/specificity estimates.

2. Effects of differing specific conditions or combinations of conditions on sensitivity and specificity of differing cut-points, and the possible utility of differing cut-points for persons with differing conditions.

3. Sensitivity and specificity of different cut-points as predictors of incident as well prevalent mobility disability.

4. Sensitivity and specificity of differing cut-points for measures of change in muscle mass or strength as predictors of mobility disability.

5. Sensitivity and specificity of very low levels of muscle mass or strength with sufficiently narrow confidence intervals.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education

• Private Institutions of Higher Education

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

• Hispanic-serving Institutions

• Historically Black Colleges and Universities (HBCUs)

• Tribally Controlled Colleges and Universities (TCCUs)

• Alaska Native and Native Hawaiian Serving Institutions

• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses

• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments

• County Governments

• City or Township Governments

• Special District Governments

• Indian/Native American Tribal Governments (Federally Recognized)

• Indian/Native American Tribal Governments (Other than Federally Recognized)

• Eligible Agencies of the Federal Government

• U.S. Territory or Possession

Other

• Independent School Districts

• Public Housing Authorities/Indian Housing Authorities

• Native American Tribal Organizations (other than Federally recognized tribal governments)

• Faith-based or Community-based Organizations

• Regional Organizations

• Non-domestic (non-U.S.) Entities (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 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

• System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 

• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

• Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

• Of an application with a changed grant activity code.

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.

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:

• Descriptive title of proposed activity

• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

• Names of other key personnel

• Participating institution(s)

• Number and title of this funding opportunity

The letter of intent should be sent to:

Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D.

National Institute on Aging (NIA)

Telephone: 301-496-6762

Fax: 301-402-1784

Email: rosaly.correa-de-araujo@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.  To achieve the study's goals, the research team should be comprised of the following experience and expertise:

Experience with studies of low muscle mass, low muscle strength, and function in older adults.

Experience with the relation between low muscle mass, weakness, and other aging-related skeletal muscle dysfunctions to mobility disability.

Geriatrics and Clinical Gerontology experts/practitioners and researchers.

Knowledge/experience with bone and mineral research.

Expertise in biostatistics of complex data or of older adults' population with chronic conditions/multimorbidity

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: 

Specific Aims: Describe the specific aims of the project in relation to the FOA's goals which are described in detail under Section I of the FOA. An overview of datasets proposed for inclusion in the study and significance to the goals to be accomplished toward clinical relevance and applicability of criteria/cut-points for low muscle mass and low muscle strength should be addressed in detail.

Research Strategy:

Significance: Justify the choice of the datasets with an overview of the study, including initial study eligibility, recruitment strategy and yield, duration of follow-up and loss to follow-up rates, and the availability of data requirements outlined previously. Include total sample size and distributions by age, gender, race/ethnicity, initial mobility status and range and distribution of key measures of strength and mass.  Show how the measurements of variables in the study appropriately address the aims of the FOA. The variables should include all measures of strength, mass, physical performance and mobility disability. For each provide details of methods used to collect the measurements. Provide a summary table of baseline characteristics of these measures. Describe how body fat is determined and include the distribution of this characteristic in the table. Provide a summary of additional potential covariates including body mass index, co-morbidities, medication use and other relevant therapeutic approaches. (5 to 6 pages recommended)

Approach:  Methods for data harmonization and pooling across studies should be described. Methods to generate sensitivity, specificity, and related metrics should be described, including a discussion of the range of confidence intervals for such metrics that the study sample would be expected to yield. Internal or external replication studies should be described if they are planned.  Provide a discussion on potential products likely to result from the data analyses and identify/propose strategic approaches to dissemination of results and potential for translation into clinical practice. It is desired that results of the data analyses can be used to facilitate clinical practice including the identification of patients likely to benefit from treatment options. (4 to 5 pages recommended)

Provide a timeline and milestones for the expected completion of work for the first and second years.

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

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

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.  

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.

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.

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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the National Institute on Aging's Scientific Review Branch by email at VemuriR@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.

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?

In addition:

Has the applicant demonstrated knowledge and ability to articulate the clinical implications and relevance of criteria/cut-points for low muscle mass and low muscle strength in the context of the population and/or conditions associated with datasets proposed for analyses?

Has the application demonstrated significant involvement of a variety of experience and expertise including the aspects below

Experience with studies of low muscle mass, low muscle strength, and function in older adults.

Experience with the relation between low muscle mass, weakness, and other aging-related skeletal muscle dysfunctions to mobility disability.

Geriatrics and clinical gerontology experts/practitioners and researchers.

Knowledge /experience with bone and mineral research.

Expertise in biostatistics of complex data or of older adults’ population with chronic conditions/multimorbidity.  

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 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?

In addition:

Regarding to sample size and influential power, does the application demonstrate a strong plan for data pooling and harmonization? Regarding the consortia or partnerships, does the application demonstrate the ability to work together with  national and/or foreign groups by sharing information, presenting results and planning for dissemination strategies? Does the application describe in sufficient detail the characteristics of each of the datasets  proposed to  be used?   Does the application provide clear information on measures of strength, mass, physical performance and mobility disability including availability of baseline information for datasets to be analyzed? Does the application address the availability of information on covariates such as co-morbidities and medication use including their implication to the methodological approach for the data analyses? Does the application provide  a clear description of  proposed analytic methods to calculate sensitivity, specificity and related metrics including expected range of confidence intervals  for low muscle mass and strength cut-points and their potential to identify  older adults  with and without mobility-disability? 

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?   

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 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

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.

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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

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. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.

• Availability of funds.

• Relevance of the proposed project to program priorities.

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.

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.

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:

• All aspects of their study, including any potential modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.  The awardee agrees to accept close coordination, cooperation, and participation of NIA staff in those aspects of scientific and technical management of the study.

• Upon implementation of the study, each participant organization/investigator, whether a single institution or a consortium of institutions, will follow the procedures required by the protocol regarding study conduct and monitoring, data collection and management.

• Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIA support; or special access to project results, data, findings, or resources--may be advantageous and appropriate.  However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by NIA Program Administrator to ensure objectivity of research.

• Obtaining prior written approval of the NIA Grants Management Specialist in consultation with the NIA Program Officer for a change in any of the key personnel identified in the Notice of Award.

• 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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIA Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee (s).

• NIA Project Scientist Officer will provide real-time oversight of data identification, sharing, follow-up, integrity, quality control.

• Have access to data generated under this Cooperative Agreement and will periodically review the data and progress reports. NIA may use the information obtained from the data for the preparation of reports on the activities of the study.

• NIA Project Scientist will also assist in the development and/or adjustment of study design and data pooling thereby increasing the likelihood of successfully completing this important study. 

• The NIA Project Scientist may also participate in data analyses, interpretations and ensuring the public availability of  findings and related resources originated from this U01 project; in  identifying and coordinating useful scientific interactions/exchange of data with relevant other ongoing research projects; and  in helping coordinate potential collaborations with organizations/industry in the development of translational research strategies.

• The NIA Project Scientist may serve as co-author in publications as appropriate (dependent on the amount of involvement in the study).

• In addition, NIA will designate additional staff as Program Official to provide advice to the awardee on administrative issues and will perform the normal stewardship functions of the award. 

Areas of Joint Responsibility include:

A Steering Committee (SC), composed of the principal investigator, as well as investigators of the potential various institutions contributing with data, and NIA Project Scientist.  The NIA Project Scientist will have voting membership on the SC and, as appropriate, and its subcommittees.  The SC will have primary responsibility for facilitating the conduct and monitoring of study and reporting study results.  Awardees will be required to accept and implement the common study protocol/procedures approved by the SC.  The SC should meet with at least monthly conference calls.  Each full member will have one vote.  Awardee members of the SC will be required to accept and implement all policies governing the study conduct approved by that committee.

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.   The Dispute Resolution Panel 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 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. 

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

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)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6762
Email: rosaly.correa-de-araujo@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@nia.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 Parts 74 and 92.