EXPIRED
National Institutes of Health (NIH)
Biobehavioral and Technological Interventions to Attenuate Cognitive Decline in Individuals with Cognitive Impairment or Dementia (R15)
R15 Academic Research Enhancement Award
New
PA-15-016
93.361; 93.866
The purpose of this funding opportunity announcement (FOA) is to stimulate clinical research focused on biobehavioral or technological interventions to attenuate cognitive decline in individuals with dementia (such as Alzheimer’s disease, Lewy body dementia, vascular dementia), mild cognitive impairment (MCI), or disease- or age-related cognitive decline. There is particular interest in interventions that can be implemented in community settings by the affected individual, informal caregivers, or others in the community. Research to inform the development of such interventions is also of interest, as well as research examining underlying mechanisms and biomarkers associated with response to interventions. It is anticipated that the results of this research will help affected individuals maintain independence and quality of life, improve their ability to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs), and additionally help to reduce stress, burden, and other poor outcomes in their caregivers.
October 15, 2014
January 25, 2015
Not Applicable
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. The first standard due date for this FOA is February 25, 2015.
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.
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard dates apply
Standard dates apply
Standard dates apply
New Date December 18, 2017 per issuance of PA-18-473. (Original Expiration Date: January 8, 2018)
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The goal of this funding opportunity announcement (FOA) is to stimulate clinical research in order to 1) develop and test biobehavioral or technological interventions designed to attenuate cognitive decline in individuals with Alzheimer’s or other dementias (e.g., Lewy body dementia, vascular dementia), mild cognitive impairment (MCI), or disease- or age-related cognitive decline, 2) inform the development of such interventions, and 3) elucidate the underlying mechanisms and biomarkers associated with response to interventions. Intervention strategies include those that restore or enhance cognitive functioning, prevent or delay the progression of cognitive impairment, or enable individuals to compensate for, or work around their cognitive deficits. This FOA is particularly interested in interventions that can be delivered in community settings by individuals, caregivers, or others in the community.
Approximately 13.9 percent of people age 71 and older in the United States have dementia. Alzheimer’s disease is the most common form of dementia, and in 2014, the number of Americans with Alzheimer s disease is estimated to reach 5.2 million (http://www.alz.org/downloads/facts_figures_2014.pdf). The number of new cases of Alzheimer’s disease increases dramatically with age; in 2014, there will be approximately 59,000 new cases among people age 65 to 74, 172,000 new cases among people age 75 to 84, and 238,000 new cases among people 85 years and older. Because of the increase in the number of people over 65 in the United States, the annual total number of new cases of Alzheimer’s disease is projected to double by 2050. Other types of dementia include vascular dementia, which results from interrupted blood flow to the brain, Lewy body dementia, which is associated with abnormal deposits of alpha-synuclein in the brain, and fronto-temporal lobar degeneration dementia, which is caused by damage to neurons in the frontal and temporal lobes. Mild cognitive impairment (MCI) is thought to be a transitional stage to Alzheimer’s disease; however, not all patients with MCI will develop Alzheimer’s disease. Cognitive decline has also been associated with disease (such as heart failure and Parkinson’s disease), treatment (such as chemotherapy), and aging.
The National Alzheimer’s Project Act (NAPA) was signed into law in 2011; this was followed by the development of the National Plan to Address Alzheimer’s Disease (National Plan). A goal of the National Plan is to expand clinical trials on pharmacologic and non-pharmacologic approaches to prevent Alzheimer’s disease and manage and treat its symptoms, including conducting clinical trials to test the effectiveness of lifestyle interventions and risk factor reductions. While there are numerous ongoing efforts focused on pharmacological agents for treating or preventing dementia, non-pharmacological approaches, including biobehavioral and technology-based interventions, have received less overall attention. However, several studies have demonstrated potential for non-pharmacological approaches. For example, physical activity has been reported to confer a neuroprotective effect that can prevent or attenuate cognitive decline. Cognitive interventions have shown promise in improving memory and executive functions in individuals with dementia and in the older population. These interventions include cognitive training, which focuses on tasks designed to increase specific cognitive functions (such as attention and problem solving), cognitive rehabilitation, which focuses on improving performance in everyday life as a way to compensate for impairment, and cognitive stimulation, which involves engagement in activities targeting enhancement of cognitive and social functioning. The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study, a clinical trial involving 2,832 persons living independently and followed for 10 years (mean age at baseline 73.6 years), demonstrated that cognitive training has beneficial effects on cognitive abilities and on self-reported instrumental activities of daily living (IADL) function. Technology-based interventions have been shown to improve episodic memory in individuals with MCI and Alzheimer’s disease; technology can also provide a means to help individuals with dementia maintain independence, or to deliver/promote adherence to biobehavioral or other non-pharmacological interventions. Interventions that focus on health behaviors or modifiable environmental or lifestyle factors have the additional advantage of being implementable in community settings, and there are published reports demonstrating that informal caregivers can successfully deliver interventions that reduced symptoms in people with dementia.
Research projects of interest include, but are not limited to, those that address:
Interdisciplinary collaborations that include nurse scientists in the project team are strongly encouraged. Additionally, applicants should consider engaging the resources and expertise of nearby or otherwise available Clinical and Translational Science Award grant sites (CTSAs) and/or federally funded research centers where possible.
Academic Research Enhancement Award (AREA) grants are intended to create a research opportunity for scientists at institutions that have not previously been major recipients of NIH grant awards. It is anticipated that investigators supported under the AREA program will benefit from the opportunity to conduct independent research; that the grantee institution will benefit from a research environment strengthened through AREA grants and furthered by participation in the diverse extramural programs of the NIH; and that students at recipient institutions will benefit from exposure to and participation in scientific research in the biomedical and behavioral sciences.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applicants may request up to $300,000 in direct costs plus applicable Facilities & Administrative (F&A)/indirect costs for the entire project period of up to 3 years. Note when a consortium is involved, the $300,000 direct cost limit is exclusive of consortium F&A costs. These can be requested in addition to the $300,000 direct costs limit.
The scope of the proposed project should determine the project period. The maximum project period is 3 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.
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:
In addition, all organizations must meet the following two criteria:
1. The applicant organization must offer baccalaureate or advanced degrees in biomedical or behavioral sciences
2. The applicant organization may not receive research support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in each of 4 of the last 7 years.
Note that the following activity codes are excluded: C06, S10, and all activity codes starting with a G.
Institutions with Multiple Schools or Colleges
For institutions composed of multiple schools or colleges, the criterion of financial eligibility is based on the amount of NIH research grant monies received, not by the institution (university or college) as a whole, but by the individual school/college or aggregation of "other academic components" (as defined in this section) where the PD/PI has a primary appointment (e.g., School of Medicine, College of Nursing, etc.). Thus, each of the following should be considered independently when determining the financial eligibility of the applicant organization.
Additional Eligibility Guidance
To determine the eligibility of an institution, applicants should consult the list of ineligible institutions on the AREA program website. If the name of the institution does not appear on the list, it is likely eligible to apply for AREA grants. Applicants should check with their own institutions if unsure.
An AREA grant is permitted to have a subcontract to a non-AREA-eligible institution. However, applicants should keep the goals of the AREA program in mind when preparing the application, which include strengthening the research environment of the institution and exposing students to research.
Although foreign institutions are not eligible, applications may include a foreign collaboration, component, or consortium.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged to
apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
To be eligible for an AREA grant, the PD(s)/PI(s) must meet the following additional criteria.
Note: These eligibility criteria only apply to the PD(s)/PI(s) of the application, not to other key personnel such as collaborators and consultants.
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:
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:
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.
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, with the following additional instructions:
Facilities and Other Resources: Include the following information:
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketch: The PD(s)/PI(s) should include a summary of his or her previous and/or current experience in supervising students in research in the Personal Statement. The PD(s)/PI(s) also should indicate which peer-reviewed publications involved students under his or her supervision.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The total budget for all years of the proposed project must be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application.
Complete only Budget Period 1 of either the PHS398 Modular Budget form or the R&R Budget form.
Follow all instructions in the SF 424 (R&R) Application Guide, noting the following specifications for R15 applications.
Budget Period 1: Direct Costs
Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number must not exceed $250,000.
Consortium F&A: If applicable, enter the actual consortium F&A (e.g., $3,271).
Total Direct Costs: This field auto-calculates so no data entry is required.
Budget Period 1: Indirect Costs
If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs.
If the F&A rate has not been established, enter None-will negotiate and include information for a proposed rate. Use the budget justification if additional space is needed.
Budget Justification: Attach the Personnel Justification and Consortium Justification. If the requested budget requires any additional justification, attach an Additional Narrative Justification.
Personnel Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PDs/PIs should include undergraduate (preferably, if available) and/or graduate students in the proposed research to the extent practical. If students are available and will be involved in the research, indicate aspects of the proposed research in which they will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Consultants for the project, provide their names, organizational affiliations, and the services they will perform.
Consortium Justification: Follow all instructions in the SF424 (R&R) Application Guide, but note that the Letter of Intent to establish a consortium must also be included in the Consortium Justification attachment.
Follow all instructions in the SF424 (R&R) Application Guide, noting the following specifications for R15 applications.
Budget Period 1: Direct Costs
Total Direct Costs less Consortium F&A: This number must not exceed $300,000.
Budget Period 1: Indirect Costs
If the F&A rate agreement has been established, indicate the type of agreement. All appropriate exclusions must be applied in the calculation of the F&A costs.
If the F&A rate has not been established, enter None-will negotiate and include information for a proposed rate. Use the budget justification if additional space is needed.
Budget Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a primary objective of the AREA program is to expose students to meritorious research, PD(s)/PI(s) should include undergraduate (preferably, if available) and/or graduate students in the proposed research to the extent practical. Indicate aspects of the proposed research in which students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.
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:
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:
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, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow our Post Submission Application Materials policy.
Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
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 objectives of the R15 program are to (1) provide support for meritorious research, (2) strengthen the research environment of schools that have not been major recipients of NIH support, and (3) expose available undergraduate and graduate students in such environments to meritorious research. Preliminary data are not required for an R15 application; however, they may be included if available.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to make an important scientific contribution to the research field(s) involved, to provide research opportunities to students, and to strengthen the research environment of the institution, 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 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? If funded, will the AREA award have a substantial effect on the school/academic component in terms of strengthening the research environment and exposing students to research?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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? Do the PD(s)/PI(s) have suitable experience in supervising students in 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? Does the application provide sufficient evidence that the project
can stimulate the interests of students so that they consider a career in the
biomedical or behavioral sciences?
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
Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the application demonstrate the likely availability of well-qualified students to participate in the research project? Does the application provide sufficient evidence that students have in the past or are likely to pursue careers in the biomedical or behavioral sciences?
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
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
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 Center for Scientific Review,, 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:
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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
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
Not Applicable
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 Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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application packages)
Contact Center Telephone: 800-518-4726
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Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-945-7573
Email: GrantsInfo@nih.gov
Lois A. Tully, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
Email: tullyla@mail.nih.gov
Nina Silverberg
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: Freundlichr@mail.nih.gov
Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: laneyr@mail.nih.gov?
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.