Open Date (Earliest Submission Date)
Letter of Intent Due Date(s)
Application Due Date(s)
Any due dates on or after Jan 25, 2018 must use reissued FOA.
December 11, 2015 (New, Revision, and Resubmission
applications) followed by Standard
dates, 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.
Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.
AIDS Application Due Date(s)
Expiration Date
New Date January 24, 2018 per reissuance of FOA (Original Expiration Date: September 8, 2018)
Required Application Instructions
It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.
Table of Contents
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Part 2.
Full Text of Announcement
Section I. Funding Opportunity Description
The biggest risk factor for Alzheimer’s disease (AD) is age
and AD is the most common cause of dementia in those aged 65 and older. Because
of the aging of populations worldwide, this disorder will reach epidemic
proportions even in the best-case scenarios, with an enormous human and
economic burden. AD is one of the most persistent and devastating dementing disorders
of old age because it eventually leads to a complete loss of memory and of the
ability to function independently. It is estimated that over five million
people in the United States have AD in its various stages with an estimated
cost to society of over $200 billion per year. It is projected that 11 to 16
million people and their families could be affected by AD by the middle of this
century if no effective therapies are developed to prevent, slow or stop the
disease.
The vast majority of older adults will experience some
deterioration in cognitive function as they age. This age-related cognitive
decline may presage AD but even when it does not it can have substantial
influence on quality of life, character of personal relationships, and the
capacity for making informed decisions about health care, retirement, and other
issues faced daily by millions of adults.
Currently there are only a few interventions that have been
approved by the Food and Drug Administration for the treatment of AD and those
approved have demonstrated only modest effects in modifying the clinical
symptoms for relatively short periods. None has shown a clear therapeutic
effect on disease progression. The Alzheimer’s Association’s 2015 trajectory
report estimates that a treatment delaying onset by five years and beginning to
show its effect in 2025 would decrease the total number of older Americans with
Alzheimer’s from 8.2 million to 5.8 million in 2030. Moreover, a treatment
that even slowed disease progression would result in far fewer people with AD
in the severe stage that requires the highest level of care with the greatest
costs.
In response to this looming public-health crisis in the
United States and worldwide, a growing number of countries are increasing their
investment in all aspects of AD research. On January 4, 2011, President Obama
signed into law the National Alzheimer’s Project Act (NAPA). As part of the
Strategic Planning Process for the implementation of the National Alzheimer s
Project Act (see http://aspe.hhs.gov/daltcp/napa/ for more information) the National Institute on Aging (NIA) at the NIH with
support from the Foundation for the NIH (FNIH) organized and hosted two
Alzheimer’s Disease Research Summits entitled Path to Treatment and
Prevention, which were held on the NIH campus in May 2012 and February 2015.
The overarching goal of the summits was to formulate a strategy for a new
integrated, multidisciplinary research agenda to enable the development of effective
therapies (disease modifying and palliative) across the disease continuum for
the cognitive as well as neuropsychiatric symptoms of AD and to identify the
resources, infrastructure, and public private partnerships necessary to
successfully implement this translational agenda. This FOA is consistent with
the recommendations of these AD research summits, http://www.nia.nih.gov/newsroom/alzheimers-disease-research-summit-2012-recommendations; https://www.nia.nih.gov/research/recommendations-nih-ad-research-summit-2015.
Maintenance of cognitive health with age is a growing public
health imperative. The 2010 Cognitive Aging Summit, held by the NIA in
conjunction with the McKnight Brain Research Foundation (MBRF) and the
Foundation for NIH (FNIH) included recommendations to increase opportunities
at the interface of basic and clinical science to enhance the clinical trial
enterprise and encourage more integrative models of mechanisms for
age-related decline/maintenance/adaptation. In 2014, the NIA, in
collaboration with the MBRF and the FNIH, the National Center for Complementary
and Integrative Health (NCCIH), and the NIH Office of Behavioral and Social
Research (OBSSR), published a FOA to encourage the development of therapeutic
approaches that aim to drive beneficial plasticity of the aging brain and remediate
age-related cognitive decline. Recently, the Institute of Medicine completed a
study of the public health dimensions of cognitive aging, Cognitive Aging:
Progress in Understanding and Opportunities for Action (http://iom.nationalacademies.org/Reports/2015/Cognitive-Aging.aspx).
The study report included the recommendation for single- and multi-component
clinical trials of promising interventions to promote cognitive health and
prevent cognitive decline, testing for both cognitive status and functional
outcomes.
Research
Objectives
The goal of this FOA is to invite research grant
applications that enable the testing of promising pharmacological and
non-pharmacological interventions for cognitive and neuropsychiatric symptoms
in individuals with age-related cognitive decline and in individuals with AD
across the spectrum from pre-symptomatic to more severe stages of disease.
This funding opportunity will support Phase III clinical
trials testing pharmacological (small molecules and biologics) and
non-pharmacological interventions, using a combination of biomarkers (fluid and
imaging), cognitive, and functional measures as outcomes. These applications
may include trials testing combinations of interventions that may act
synergistically to produce a more robust and long-lasting response as well as
combinations of interventions that attempt to address multiple risk factors
simultaneously (e.g., obesity, hypertension, diabetes, physical inactivity,
anxiety, and depression). Investigators will be expected to collect DNA and
other biosamples from these studies to enable subsequent interrogation of
treatment responsiveness, as well as examination of predictors of decline in the
groups receiving placebo.
Phase III clinical trial applications, that are appropriate
for this FOA, will have established proof of mechanism or target engagement at
earlier stages of clinical development for the intervention(s) being tested.
The intervention(s) being tested in Phase III trials should also have adequate
safety data for the populations under study.
Studies designed to address heterogeneity of response are
strongly encouraged. This would include the identification of specific
individuals according to genetic profiles, behavioral factors, and/or
sociocultural or demographic factors who are more likely or less likely to benefit
from the intervention(s). Potential mediators of the therapeutic intervention,
such as continued educational opportunities, social network exposure and
engagement, continued engagement in driving or financial decision-making, may
facilitate effective real-life function and should be considered in
interpreting therapeutic outcomes.
Examples of interventions for evaluation include but are not
limited to: pharmacological interventions that target eradication or
progression of deposition of disease neuropathology; repurposed drugs that have
promise for AD treatment such as chemotherapeutic agents or drugs for insulin dysregulation/diabetes;
novel cognitive training or cognitive engagement approaches; aerobic exercise
and/or other movement therapies, such as Tai Chi; sleep enhancement;
mindfulness-based stress reduction; nutritional supplementation or adoption of
specific dietary programs; or combinations of interventions including the
mixture of pharmacological with non-pharmacological therapeutics.
Studies may also include substudies of cognitive decline
and/or dementia as part of existing/other Phase III trials for other diseases
of aging (e.g., age-related cardiovascular disease, arthritis, etc.).
Section II. Award Information
Funding Instrument
Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
New
Resubmission
Revision
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.
Funds Available and Anticipated Number of Awards
NIH intends to fund an estimate of 8 -10 awards,
corresponding to a total of $25 million for fiscal year 2016. Future year
amounts will depend on annual appropriations.
Award Budget
Application budgets are not limited but need to reflect the
actual needs of the proposed project.
Award Project Period
The scope of the proposed project should determine the
project period. The maximum project 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
-
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)
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.
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.
- 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.
Eligible Individuals (Program Director/Principal
Investigator)
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit
the Multiple Program Director/Principal Investigator Policy and submission
details in the Senior/Key Person Profile (Expanded) Component of the SF424
(R&R) Application Guide.
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.
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).
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, 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.
Letter of Intent
Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.
By the date listed in Part 1.
Overview Information, prospective applicants are asked to submit a letter
of intent that includes the following information:
-
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:
Laurie Ryan, Ph.D.
Telephone: 301-496-9350
Fax: 301-496-1494
Email: ryanl@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide
must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide
must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:
Protection
of Human Subjects: In order to protect the safety of
participants in intervention studies and assuring that trials are soundly
conducted and analyzed, as part of the data and safety monitoring plan (DSMP)
for Phase III clinical trials, NIA requires plans for an independent data and
safety monitoring board (DSMB).
Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.
Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.
Planned Enrollment Report
When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report
When conducting clinical research, follow all instructions
for completing Cumulative Inclusion Enrollment Report
as described in the SF424 (R&R) Application Guide.
Foreign Institutions
Foreign (non-U.S.) 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
See Part I. Section III.1 for information regarding the
requirements for obtaining a Dun and Bradstreet Universal Numbering System
(DUNS) Number and for completing and maintaining an active System for Award
Management (SAM) registration. Part I. Overview
Information contains information about Key Dates. Applicants are encouraged
to submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.
Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.
Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.
4. Intergovernmental Review
(E.O. 12372)
This initiative is not subject to intergovernmental
review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH
Grants Policy Statement.
6. Other Submission
Requirements and Information
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations
before the application due date. Section
III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.
The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant 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 a Scientific/ Research Contact 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 SF424
(R&R) Application Guide.
Post Submission Materials
Applicants are required to follow our Post Submission Application Materials policy.
Section V. Application Review Information
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.
Overall Impact
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.
Significance
Does the project address an
important problem or a critical barrier to progress in the field? If the aims
of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?
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?
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?
Environment
Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.
Protections for Human Subjects
For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.
Inclusion of Women, Minorities,
and Children
When the proposed project involves
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
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 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) Genomic Data Sharing Plan.
Budget and Period of Support
Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.
2. Review and Selection
Process
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National
Institute on Aging (NIA), 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.
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 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.
3. Anticipated Announcement
and Award Dates
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.
Information regarding the disposition of applications is
available in the NIH
Grants Policy Statement.
Section VI. Award
Administration Information
1. Award Notices
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be
subject to 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.
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 Research
Performance Progress Report (RPPR) annually and financial statements as
required in the NIH Grants
Policy Statement.
A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov
Scientific/Research Contact(s)
Laurie Ryan
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: ryanl@mail.nih.gov
Peer Review Contact(s)
Ramesh Vemuri
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: vemuri@mail.nih.gov
Financial/Grants Management Contact(s)
Katie Ellis
National Institute on Aging (NIA)
Telephone: 301-402-7734
Email: ellisk@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 Part 75.
Department of Health
and Human Services (HHS)
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