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)
National Cancer Institute (NCI)

Funding Opportunity Title

Potential Effects of Metformin on Aging and Age-Related Conditions:  Small-Scale Clinical Studies and Secondary Analysis of Controlled Clinical Studies (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • September 6, 2012 - See Notice NOT-CA-12-015. NCI is Participating.

Funding Opportunity Announcement (FOA) Number

PA-12-271

Companion Funding Opportunity

NoneNone

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.866,93.393 

Funding Opportunity Purpose

Emerging data from clinical studies of metformin in a variety of patient populations suggest that it may have other effects, besides being an antihyperglycemic agent, which warrant further attention in translational aging research. The objective of this FOA is to support research projects (R01) that include small-scale physiologic studies in humans or secondary analyses of data and/or stored biospecimens from controlled clinical intervention studies, to increase our understanding about the clinical translational potential of metformin to delay deleterious aging changes or to extend healthy human life span.  This includes identification of specific populations particularly likely to benefit, and/or to obtain information on metformin’s human physiologic and cellular effects that would be useful in identifying novel molecular targets.

Key Dates
Posted Date

August 24, 2012

Open Date (Earliest Submission Date)

January 5, 2013

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

Standard dates apply , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply.

Advisory Council Review

Standard dates apply.

Earliest Start Date(s)

Standard dates apply.

Expiration Date

January 8, 2016

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

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


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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

An important goal of translational research in aging is the development of new therapeutic options to prevent or delay the onset of deleterious aging changes that contribute to morbidity and mortality among older adults. New opportunities in clinical translation could arise from the discovery of potential new therapeutic effects of already-approved drugs.  The current scientific literature suggests that metformin may have additional, previously unrecognized therapeutic effects against age-related conditions and warrants further attention in translational aging research. Initially approved for treatment of Type 2 diabetes, it has now been shown to be effective in Type 2 diabetes prevention.  Emerging data from clinical studies of metformin in a variety of patient populations suggest that it may have other effects, besides being an antihyperglycemic agent.  For example, there is some clinical evidence that metformin may have cardioprotective effects (e.g., reduce proinflammatory factors, improve lipid profiles, improve endothelial cell function, slow progression of coronary artery calcification). There is also evidence that it may contribute to prevention of some forms of human cancer (e.g., breast, prostate, colon). However, additional studies are necessary to determine if the potential cardioprotective and antineoplastic effects of metformin are direct (glucose or insulin-independent) or secondary effects through restoration of glucose and insulin levels.  

Evidence from animal models and in vitro studies suggest that metformin may also influence metabolic and cellular processes associated with the development of chronic conditions of old age, including inflammation, oxidative damage, increased glycation of proteins, diminished autophagy, cell senescence and apoptosis. However, many of these effects of metformin have been observed in pre-clinical studies using doses/concentrations of metformin which far exceed therapeutic levels in humans.  Further investigations of metformin at clinically relevant doses/levels will be needed to better understand the translational potential of metformin for the prevention or treatment of chronic conditions of old age.

Though not fully understood, the pleiotropic effects of metformin are thought to be mediated primarily through inhibition of mitochondrial complex 1 (i.e., effects on mitochondrial oxidative phosphorylation and cellular energy charge) and in part, through regulation of the activity of 5’adenosine monophosphate (AMP)-activated protein kinase (AMPK) and the mammalian target of rapamycin (mTOR).  Thus metformin has been of interest in experimental aging research because these pathways have been implicated in the modulation of life span and health span in animal models, as well as risk or progression of specific age-related conditions in animal models.  Furthermore, metformin has been noted to have some effects similar to those of caloric restriction, which extends life span and health span in many, but not all, experimental animal models. Thus drugs that affect several processes or outcomes are of particular interest in clinical translational research in aging since they may exert their effects by influencing fundamental aging factors that underlie multiple age-related conditions.  Information on this range of effects of metformin could have translational value either by directly suggesting alternative, new clinical uses for preventing or ameliorating age-related diseases, or leading to the identification of potential new therapeutic targets for which new compounds could be developed.

Insight into alternative, clinical effects of metformin on a broader range of age-related changes in disease risk factors and incidence of clinical outcomes can be gained through the conduct of small-scale physiological studies (including ancillary projects to ongoing clinical trials) and/or through secondary analyses of data and biospecimens generated from existing controlled clinical studies of metformin. Numerous controlled clinical trials and other controlled human studies of metformin monotherapy (i.e., placebo-controlled versus metformin-only treatment) have been completed or are in progress to examine effects on specific outcomes in a variety of patient populations. Data and stored samples from these studies could be leveraged to address factors contributing to heterogeneity of responses to metformin treatment within a given patient population, as well as questions regarding the effects of metformin and their mechanisms of action(s) under various conditions (e.g., hyperglycemia, hyperinsulinemia, proinflammatory conditions). Moreover, some of the existing clinical studies are prevention or risk factor studies, rather than treatment studies, thus providing an opportunity to assess such effects in persons free of potential complicating effects of conditions that are themselves potential targets of metformin.  It is also worth noting that clinical trials of metformin have included individuals of varying age ranges, including children. This allows analyses to explore possible age-related differences in the effects of metformin on aging changes and risk factors at different stages of the life span. 

RESEARCH OBJECTIVES

The objective of this FOA is to support research projects (R01) that include small-scale physiologic studies in humans or utilize secondary analyses to increase our understanding about the clinical translational potential of metformin to delay deleterious aging changes or to extend healthy human life span.  This includes identification of specific populations particularly likely to benefit (i.e., in diabetic, as well non-diabetic populations), and/or to obtain information on metformin’s human physiologic and cellular effects that would be useful in identifying novel molecular targets.

For those proposing projects utilizing secondary analyses, the principal focus of this FOA is on analyses of data sets and/or stored samples from controlled clinical studies of metformin monotherapy (i.e., placebo-controlled versus metformin-only treatment). Potential applicants may wish to review the following links to identify controlled human intervention studies/trials from which valuable data and/or biospecimens may be analyzed to better understand the effects of metformin on aging and age-related conditions:

NIH Research Portfolio Online Reporting Tools (RePORT):  http://projectreporter.nih.gov/reporter.cfm

NIH Clinical Trials.gov:  http://clinicaltrials.gov/

Central NIDDK Repository for Biosamples and Data : http://www.niddkrepository.org 

The NCI Cooperative Group Banks Associated with Large Clinical Trials:  http://cgb.cancer.gov/

Applicants are responsible for adhering to the individual study policies governing ancillary projects and access to clinical trials data and/or biorepository samples. The application should include a letter of support from the relevant study committee indicating approval of proposed ancillary study or granting access to data sets and/or repository (if proposal involves analysis of stored samples) and study approval for the proposed analyses.

This FOA invites small-scale physiological studies in humans or secondary analyses of data and/or stored samples from controlled clinical trials or other controlled human intervention studies of metformin. These studies may: 1) involve small-scale physiologic studies in humans (including ancillary studies to ongoing trials), 2) employ data mining techniques (e.g., data from a single trial or pooled analyses) and/or 2) utilize in vitro experimental models such as cells or tissues from intervention and control groups and/or 3) measure and compare factors in blood/plasma samples from intervention and controlled groups.  For proposed projects employing secondary analyses, this FOA will allow limited collection of new data (including collection of samples) if necessary to fully address the specific aims.

As appropriate, proposed studies of mechanism of action of metformin should consider a range of doses, especially the testing of metformin concentrations which are clinically relevant. Experiments to distinguish between direct effects of metformin (glucose or insulin-independent) from those effects mediated via reductions in hepatic gluconeogenesis and improvements in insulin sensitivity are especially encouraged.

Examples of potential research topics relevant to this FOA include but are not limited to:

Comparisons of treatment and control groups in single or merged multiple clinical trials data sets to investigate the effects of metformin on multiple risk factors for multiple age-related conditions (e.g., blood pressure, lipids, proinflammatory factors, prothrombotic factors, visceral obesity).  Analyses of both beneficial and potential adverse effects are of interest.  

Analyses of data from individual or pooled trials to identify potential populations who may be particularly likely to benefit (or be harmed) by broader uses of metformin.  It is suggested that relationships of covariates such as age (e.g., children vs. adults, middle-age vs. old age), genotype, gender, or presence of specific conditions or risk factors be considered in the proposed analyses.

Analyses of data and stored biospecimens to identify factors, including genetic factors, which contribute to heterogeneity of responses to metformin treatment.

Small-scale physiological studies or secondary analyses of data sets and/or assays of stored samples to probe metformin effects on physiologic processes that may influence aging (e.g., oxidative damage, inflammation, protein glycation, autophagy).  Approaches to distinguish direct effects of metformin on these processes versus effects which are secondary to and mediated via improvements in glucose metabolism are of interest.  

Small-scale physiological studies to further elucidate effect(s) of metformin on mitochondrial function and its impact on aging processes (e.g., ROS production, oxidative damage).  Such studies may employ non-invasive methods to assess mitochondrial function in vivo, as well as in vitro studies of isolated mitochondria from biopsy samples. In vitro studies of metformin effects on mitochondrial function are encouraged to evaluate concentrations of metformin within therapeutic levels.

In vitro studies comparing cells, cell lines, tissue samples, serum, or plasma from metformin-treated and control-group individuals, to determine effects of  metformin treatment on cellular or circulating factors that may influence protective or deleterious cellular or physiologic processes (e.g., responses to stressors and other stimuli, stress resistance,  autophagy, apoptosis) and mechanism(s) of action by which metformin exerts such effects. Analyses of dose-effect relationships are of particular interest.

Gene expression studies (e.g., comparisons of peripheral blood cells from metformin-treated and control group individuals) to identify possible mediators of effects of metformin.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

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

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum period is 5 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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

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.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)    

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

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

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 Human Subjects Protection and Inclusion Guidelines.

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

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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) in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines 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 appropriate national Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Chhanda Dutta, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-435-3048
Email:duttac@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: whipp@mail.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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