This FOA encourages R01 applications that apply system
science approaches such as system dynamic modeling, agent-based modeling,
social network analysis, discrete event analysis, and Markov modeling to better
understand complex and dynamic behavioral and social sciences processes and
problems relevant to health. Research projects applicable to this FOA are those
that are either applied or basic in nature (including methodological
development), have a human behavioral and/or social science focus, and employ
systems science methodologies, a suite of methods suited to addressing the
complexity inherent in behavioral and social phenomena. This FOA will utilize
the R01 funding mechanism. A companion FOA entitled, Systems Science and Health
in the Behavioral and Social Sciences (R21) will be issued in parallel and will
utilize the R21 funding mechanism (See PAR-15-047).
This FOA is intended to increase the breadth and scope of
topics that can be addressed with systems science methodologies. This FOA calls
for research projects that are applied and/or basic in nature (including
methodological and measurement development), have a human behavioral and/or
social science focus, and employ methodologies suited to addressing the
complexity inherent in behavioral and social phenomena, referred to as systems
science methodologies. Additionally, this FOA seeks to promote
interdisciplinary collaboration among health researchers and experts in computational
approaches to further the development of modeling- and simulation-based systems
science methodologies and their application to important public health
challenges.
Systems science methodologies are specific methodological
approaches that have been developed to understand connections between a
system’s structure and its behavior over time. Systems science methodologies
is an umbrella term that refers to a variety of such methodologies including,
but not limited to, agent-based modeling, microsimulation, system dynamics
modeling, network analysis, discrete event analysis, Markov modeling, control
systems engineering and related engineering methods, and a variety of other
dynamic and computational modeling and simulation approaches.
A system, in this context, refers to the particular
configuration of all relevant entities, resources, and processes that together
adequately characterize the problem space under study (i.e., a system is
defined by the boundaries that stakeholders use to determine which acts/observations
are relevant for their inquiry as well as the interpretations/judgments that
they use to guide decisions or actions). Systems science methodologies are
valued for their ability to address the complexity inherent in behavioral and
social phenomena. For example, these approaches excel at identifying non-linear
relationships, bi-directional feedback loops, time delayed effects, emergent
properties of the system, and oscillating system behavior.
There has been rapidly growing interest in systems science
methodologies among the behavioral and social science research community in the
past few years. For example, in 2010 the Institute of Medicine (IOM) released a
report, For the Public’s Health: The Role of Measurement in Action and
Accountability (December 2010, available at: http://www.nap.edu/catalog.php?record_id=13005).
The report gives specific recommendations on what the U.S. Department of Health
and Human Services should do to improve population health data collection,
analysis, and reporting. Relevant to systems science is recommendation #6 in
this report: The pathways between the social, economic, and environmental
causes of poor health are complex and interconnected. Models and other novel
analytic tools can elucidate these pathways and relationships and be used to
assess the benefits and harms of policy and intervention options. These tools
are needed to support policy-making, including resource allocation. Therefore,
the committee recommends that the Department of Health and Human Services (HHS)
coordinate the development and evaluation and advance the use of predictive and
system-based simulation models to understand the health consequences of
underlying determinants of health. HHS should also use modeling to assess
intended and unintended outcomes associated with policy, funding, investment,
and resource options.
Moreover, another recent IOM report, Bridging the Evidence
Gap in Obesity Prevention: A Framework to Inform Decision Making (April 2010,
available at: http://books.nap.edu/openbook.php?record_id=12847), included
the recommendation that to address the obesity problem successfully, a systems
perspective will be needed. The report elaborated on this as an approach that
encompasses the whole picture, highlighting the broader context and
interactions among levels, to capture the complexity of obesity prevention and
other multifactorial public health challenges.
The Department of Health and Human Services has been heeding
this call. Several NIH Funding Opportunity Announcements now include language
encouraging systems science approaches and the Office of Behavioral and Social
Sciences includes Systems Thinking Approaches to Health as one of four
primary themes in its strategic prospectus (available at: http://obssr.od.nih.gov/about_obssr/strategic_planning/strategicPlanning.aspx).
Moreover, in late 2010, the Department released a report
entitled, "Ending The Tobacco Epidemic: A Tobacco Control Strategic Action
Plan for the U.S. Department of Health and Human Services" (available at: http://www.hhs.gov/ash/initiatives/tobacco/tobaccostrategicplan2010.pdf).
The specific strategic actions recommended in the report were based on policy
relevant to modeling and simulation.
Therefore, the Institutes, Centers, and Offices of NIH that
are listed as participating in this FOA issue this announcement in response to
the above developments, to encourage basic and applied research projects that
address behavioral and social aspects of health and utilize systems science
methodologies.
Examples of research topics encouraged under this FOA
include, but are not limited to, those listed below.
Example projects that would be appropriate to this FOA and
of interest to the NCI include, but are not limited to:
Specific topics that would be appropriate to this FOA and of
interest to NIBIB include, but are not limited to, projects that utilize
systems science methodologies to:
Specific topics that would be appropriate to this FOA and of
interest to the NINR include, but are not limited to projects that utilize
systems science methodologies to:
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
Renewal
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
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 the
actual needs of the proposed project.
Award 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).
In addition, the NIH will not accept a resubmission (A1)
application that is submitted later than 37 months after submission of the new
(A0) application that it follows. The NIH will accept submission:
- To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
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:
Elizabeth M. Ginexi, Ph.D.
Health Scientist Administrator
Office of Behavioral and Social Sciences Research
National Institutes of Health
Telephone: 301-594-4574
Fax: 301-402-1150
Email: [email protected]
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:
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, with the following modification:
- All applications submitted for the January 25, 2015, due date or
after are expected to comply with the NIH Genomic Data Sharing Policy as
detailed in NOT-OD-14-111,
as applicable.
- All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.
Software Sharing Plan: If software is developed within the
project, a software dissemination plan, with appropriate timelines, is expected
to be included in the application. This should be included in a separate
heading in the Resource Sharing Plan(s). There is no prescribed single license
for software produced through grants responding to this announcement. However,
NIH does have goals for software dissemination, and reviewers will be
instructed to evaluate the dissemination plan relative to these goals:
1. The software should be freely available to
biomedical researchers and educators in the non-profit sector, such as
institutions of education, research institutions, and government laboratories.
2. The terms of software availability should permit
the dissemination and commercialization of enhanced or customized versions of
the software, or incorporation of the software or pieces of it into other
software packages.
3. To preserve utility to the community, the software
should be transferable such that another individual or team can continue
development in the event that the original investigators are unwilling or
unable to do so.
4. The terms of software availability should include
the ability of researchers to modify the source code and to share modifications
with other colleagues. An applicant should take responsibility for creating the
original and subsequent official versions of a piece of software.
5. To further enhance the potential impact of their
software, applicants may consider proposing a plan to manage and disseminate
the improvements or customizations of their tools and resources by others. This
proposal may include a plan to incorporate the enhancements into the official
core software, may involve the creation of an infrastructure for plug-ins, or
may describe some other solution.
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
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 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 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? Will the proposed research contribute
significantly to the existing body of behavioral and social sciences research
while addressing an important health topic?
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? ? Does
the investigative team have sufficient expertise in the proposed systems
science methodology? Does the investigative team have appropriate behavioral
and/or social science expertise? Does the investigative team have appropriate
content area expertise in the relevant health domain(s)?
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?
Does the project propose to utilize
systems science methodologies? Are the methodologies proposed appropriate for
the research question being addressed? Is there a strong rationale for use of
the selected methodologies over non-systems science methods?
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
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 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 Wide Association Studies
(GWAS) /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), 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 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 or Board. 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 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 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: [email protected]
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-945-7573
Email: [email protected]
Scientific/Research Contact(s)
Stephen E. Marcus, PhD
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7934
Email: [email protected]
Kara Hall, P.h.D.
National Cancer Institute (NCI)
Telephone: 240-276-6831
Email: [email protected]
John W. R. Phillips, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: [email protected]
Gregory Bloss
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: [email protected]
Grace C.Y. Peng, PhD
National Institute of Biomedical Imaging & Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: [email protected]
Regina M. Bures, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
Telephone: 301-496-9485
Email: [email protected]
David B. Clark, Dr PH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: [email protected]
Bonnie Joubert, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone:919-541-7667
Email: [email protected]
Agnes Rupp, PhD
Senior Research Economist
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email: [email protected]
Augie Diana, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: (301) 402-6423
Email: [email protected]
Elizabeth M. Ginexi, Ph.D.
Office of Behavioral and Social Sciences Research
Telephone: 301-594-4574
Email: [email protected]
Peer Review Contact(s)
Gabriel Fosu, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: [email protected]
Financial/Grants Management Contact(s)
Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: [email protected]
Carol A. Perry
National Cancer Institute (NCI)
Telephone: 301-496-7205
Email: [email protected]
John Bladen
The National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]
James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: [email protected]
Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]
Diana Rutberg
National Institute of Dental and Craniofacial Research
(NIDCR)
Telephone: 301-594-4798
Email: [email protected]
Bryann Benton
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4259
Email: [email protected]
Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]
Judy Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]
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.
Department of Health
and Human Services (HHS)
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