Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Basic Behavioral & Social Science Opportunity Network (OppNet) on behalf of its constituent organizations:

Fogarty International Center (FIC)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Research on the Role of Epigenetics in Social, Behavioral, Environmental and Biological Relationships, throughout the Life-Span and across Generations (R21)

Activity Code

R21 Exploratory/Developmental Research Grant  

Announcement Type

New

Related Notices

  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

RFA-TW-13-002

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.113, 93.121, 93.142, 93.143, 93.172,93.173, 93.213, 93.233, 93.242, 93.273 ,93.279 ,93.286 ,93.307, 93.350,  93.361, 93.389,93.393, 93.394, 93.395,93.396, 93.399, 93.837, 93.838, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.989, 93.393, 93.859, 93.838, 93.837, 93.233, 93.856, 93.855, 93.113

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages exploratory and developmental grant applications to lay the foundation for innovative and collaborative basic research on the role of epigenetics in social, behavioral, environmental and biological relationships, throughout the life-span and across generations. Research plans that are responsive to this FOA will use existing bio-psycho-social and environmental data from human cohorts or animal studies that have biospecimens available for epigenetic profiling. The one year exploratory/developmental awards are expected to generate preliminary data for comprehensive basic research applications to study interactions between epigenetics and social/behavioral/biological/environmental factors in both normal function and pathophysiology throughout life and across generations. The results may ultimately inform research to develop clinical decision/diagnostic tools and prevention/treatment strategies.   

Key Dates
Posted Date

May 17, 2013

Open Date (Earliest Submission Date)

October 13, 2013

Letter of Intent Due Date(s)

October 13, 2013

Application Due Date(s)

November 13, 2013, by 5:00 PM local time of applicant organization.

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)

November 13, 2013, by 5:00 PM local time of applicant organization.

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.

Scientific Merit Review

February 2014

Advisory Council Review

May 2014

Earliest Start Date

September 30, 2014

Expiration Date

November 14, 2013

Due Dates for E.O. 12372

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.

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


About OppNet

OppNet is a trans-NIH initiative that funds activities to 1) build the collective body of knowledge about the nature of behavior and social systems, and 2) deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research. Applicants should understand that the NIH Institute or Center (IC) that made this FOA available to the public is not necessarily the NIH IC that ultimately will manage a funded OppNet project. For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov.

OppNet uses the NIH definition of b-BSSR (http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx) to determine application responsiveness. Consequently, OppNet strongly encourages prospective applicants to consult this definition, in addition to OppNet’s answers to frequently asked questions (FAQs) about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and FAQs regarding this specific FOA (http://oppnet.nih.gov/pdf/FAQsRFA-DA-14-002.pdf). Prospective applicants are encouraged to reach out to the NIH Scientific/Research Contacts listed under Section VII. Agency Contacts for additional guidance about this FOA.

Background

The purpose of this FOA is to support development of basic research to elucidate the role of social (including cultural and socio-economic context) and behavioral, influences on the epigenome, and vice versa,  and their relationship to external and internal, environmental and biological, factors throughout the life-span and across generations. Epigenetic mechanisms allow for alteration in gene expression without change in nucleotide sequence, allowing for multiple phenotypes from the same genetic code. Currently known epigenetic changes include acetylation, methylation of DNA, histone modifications, changes in noncoding RNAs, chromatin condensation and imprinting.  Epigenetic influences on gene expression profiles are associated with patterns of epigenetic marks (also known as chromatin states) which carry epigenetic memory through the life of the cell or organism, subject to variable epigenetic reversibility. For example variations in DNA methylation in the same genomic region in different cell types of an organism, under different endogenous or exogenous stimuli, may allow expression of diverse phenotypes at the same time. Similarly, differential methylation of a stable genotype over time may enable a given genomic region in a single cell, to produce different adaptive phenotypes with varying degrees of functionality at different time points and under different environmental conditions.

Complex behavioral issues in humans, such as learning, memory, stress response and mood disorders, involve interactions between genetic and epigenetic components. An individual’s underlying genetic sequence is acted upon by epigenetic tags, which may be affected by external cues to change in ways that create stable – but reversible – behavioral patterns. Both animal and human studies suggest that great epigenetic flux occurs during intrauterine life and there is evidence that specific exposures (including maternal, physical and mental health, diet, chemical exposure, trauma etc)  in utero can epigenetically influence developmental pathways. Similarly, epigenetic status underlying behavioral programming of an organism after birth may be changed by the direct action of the same and additional  early influences, both positive and negative,  such as diet, gut microbiota, physical and psychological illness and trauma, chemical exposures, maternal/caretaker stress etc. Such experiences in the developing organism may set the epigenetic basis for a trajectory of physiological and psychosocial function, upon which other influences (such as diet and exercise along with  physical and psychosocial stressors such as pollutant exposure, infections, physical and psychological trauma, disease, etc.) act via epigenetic mechanisms throughout the lifespan, and which may also extend across generations. In addition to the contribution of the maternal environment on transgenerational epigenetic influences, there is evidence of pre-conception, epigenetic-mediated contributions of paternal behavior, life experiences, and environment on offspring characteristics and susceptibility to chronic disease over multiple generations.

Alterations in the epigenetic programming of sex differences in the brain may underlie sexually dimorphic normal and disordered behavior and neurodevelopment. Sex differences in epigenetic factors may not only contribute to sexual differentiation of the brain and social behavior, but may confer sexually dimorphic risk and resilience for developing neurological and mental health disorders later in life.

Cognitive function across the lifespan is also determined by the interaction of genes and environment through epigenetic mechanisms. Epigenetic mechanisms most clearly mediate the development of cognitive function but may also mediate cognitive decline which is a debilitating feature of aging and most neurodegenerative diseases of the central nervous system. The causes leading to such impairment are only poorly understood. Some evidence exists to show that cognitive capacities in the neurodegenerating brain are constrained by an epigenetic blockade of gene transcription that is potentially reversible. Further elucidation of epigenetic mechanisms underlying cognitive decline have important implications for preservation of cognitive function.

Changes in gene expression mediated by epigenetic marks which respond to both internal and external environment may lead to varying physiological and bio-behavioral outcomes. Socioeconomic factors, social hierarchy and social and cultural attitudes such as stigmas may provide the context for, and mediate the impact of, other factors on epigenetic mechanisms associated with the development or expression of interpersonal attitudes and behaviors. Understanding how postnatal behavioral, sensory and psychosocial constructs arise from early experiences/exposures, and are subsequently modified in response to experiences throughout life by the dynamic changes in epigenetic processes, will illuminate basic mechanisms of an organism’s social- bio-behavioral adaptation to the internal and external environment and help unravel the epigenetic origins of psycho-social constructs and bio-behavioral function and  health  as well as disease susceptibility.

Leveraging existing studies involving the diversity of U.S. and foreign populations (particularly in low-middle income country environments) can be used to understand how unique genetic and epigenetic profiles contribute to varying psycho-social-bio-behavioral outcomes.  

Some other NIH resources on epigenetics in general as well as epigenetics and behavior across the lifespan are listed at the end of Section I. “Specific Areas of Research Interest.”

Scope and Specific Requirements

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. The R21 mechanism is intended to encourage new exploratory and developmental research projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area.  By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical, behavioral, or clinical research. 

An integrated approach is needed to understand the role of interactions among social/behavioral/genetic/biological/environmental factors with dynamic changes in the epigenome and to explain individual variability in behavioral traits as well as mechanisms underlying psycho-social and normal/diseased/disordered phenotypes throughout life and across generations.

For this initiative, applications may focus on behavioral epigenetics using the existing biological, psychological, clinical pathologic and/or epidemiologic data sets from experimental human or animal studies with archived or new biospecimens available for epigenetic analysis. Existing data sets with exposure information such as measures of maternal, paternal & child behavioral/social and environmental exposures, diet, anthropometrics, infections, medications as well as other measures of outcomes and function (cognitive, emotional, sensory, motor, social etc.) may be used. Either the exposure or outcome/function data, or both, must be in the behavioral/ social/ cultural realm.  Physical specimens for epigenetic analysis might include an array of biological samples and measures (e.g. gut microbial markers, mother’s blood and placenta; cord blood; blood or buccal cells at later ages).

Applicants may propose short-term pilot studies using archived biospecimens from past or ongoing human cohort or animal studies for epigenetic analysis, and integrate the information on epigenetic signatures with the existing data resources. Studies may for example propose secondary analyses on existing data sets to examine the effects of the pre-/perinatal period social/ behavioral/ biological/ environmental exposures on later life outcomes and launch both association and mechanistic epigenetic studies of early-life exposures on behavioral development later in life. Such studies could leverage exposure and outcome data from existing foreign or domestic large-scale prospective studies and/or birth cohort databases.

Researchers should 1) include milestones for the short-term project: deliverables including but not limited to pilot analyses of new and existing resources, establishment of baseline data and databases to support later research, development of measures and identification of research questions and new  research hypotheses; 2) show agreements among researchers to share existing data; 3) build on existing research to  explore understudied questions from multi-disciplinary perspectives; 4) identify challenges and opportunities to be addressed in follow up studies; and 5) be poised to apply for a follow-up project using appropriate funding mechanism(s) from NIH or other sources.

Specific Areas of Research Interest

Analysis at both the individual and population levels will be considered. Topics that take into account sex/gender differences and variation by age and/or developmental stage are encouraged. Relevant research topics and areas of specific interest include but are not limited to exploration or examination of the following at any point in the lifespan as long as there are existing samples, and data associated with those samples and related to BBSS characteristics and outcomes:

Mutual interactions between the epigenome and social/behavioral process.

Effects of the physical/social/cultural environment through social/behavioral processes on the epigenome.

Effects of the epigenome or epigenetic changes on behavioral outcomes and social processes in interpersonal interactions.

Methodological issues needed to advance epigenetics and bBSSR research.

Because this FOA targets basic behavioral and social science research approaches to understanding behavioral epigenetics, examples of  research activities that will NOT be considered responsive to the FOA include, but are not limited to:

Other Resources on Epigenomics Associated with NIH

The following initiatives emphasize developing tools, techniques and maps for epigenomic studies but do not focus on research at the intersection of epigenetics and behavior. However, results of these initiatives may be useful adjuncts to research responsive to this FOA.

Common Fund General Epigenomic Resources

The NIH Roadmap epigenomics page includes links to datasets available for analysis:

·    Introductory page on Common Fund Programs

Generate a comprehensive set of reference epigenome maps from a variety of tissues using a set of marks: (http://commonfund.nih.gov/epigenomics/overview.aspx)  

·    NIH Roadmap Epigenomics Mapping Consortium and Project

Developing tools and technologies for epigenetic data acquisition and processing

The NIH Roadmap epigenomics site includes links to datasets available for analysis and an epigenome atlas that is updated on an ongoing basis:

http://www.roadmapepigenomics.org/

http://www.roadmapepigenomics.org/participants

http://www.genboree.org/epigenomeatlas/index.rhtml

Epigenomics in NIH Strategic Plans:

NICHD Strategic Plan (pg. 20, biobehavioral development):

http://www.nichd.nih.gov/publications/pubs/Documents/strategicplan.pdf

Also of interest see: (the Eunice Kennedy Shriver National Institute of Child Health and Human Development Scientific Vision Workshop on Developmental Origins of Health and Disease February 14–15, 2011 Bethesda, Maryland Workshop White Paper) (page 4) and

http://www.nichd.nih.gov/vision/vision_themes/behavior/Documents/Behavior_White_Paper.pdf

http://www.nichd.nih.gov/vision/vision_themes/developmental_origins/Documents/Vision_DevOrig_WP_04212011.pdf

NIMH Strategic Plan (page 14):

http://www.nimh.nih.gov/about/strategic-planning-reports/nimh-strategic-plan-2008.pdf

NIDA Strategic Plan:

http://www.drugabuse.gov/sites/default/files/stratplan.pdf

NIAAA Strategic Plan (pg. 6,):

http://search2.google.cit.nih.gov/search?q=cache:Ij3madIy58gJ:www.niaaa.nih.gov/sites/default/files/StrategicPlan.doc+NIAAA+strategic+plan+%2B+epigenetics&site=NIH_Master&client=NIHNEW_frontend&proxystylesheet=NIHNEW_frontend&output=xml_no_dtd&ie=UTF-8&access=p&oe=UTF-8

NIEHS Strategic Plan (Goal 1b)

http://www.niehs.nih.gov/about/strategicplan/strategicplan2012_508.pdf

NCI Strategic Plan (Strategy 3.1)

http://strategicplan.nci.nih.gov/pdf/nci_2007_strategic_plan.pdf

ORWH (page 7)

http://orwh.od.nih.gov/research/strategicplan/ORWH_StrategicPlan2020_Vol1.pdf

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

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.

OppNet intends to fund an estimated 6-7 awards, corresponding to a total of approximately $1.0 million in fiscal year 2014.

Award Budget

Direct costs requested for the exploratory/developmental research applications may not exceed $150,000, not including consortia F&A.  

Award Project Period

This FOA provides funding support for one year.   

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant Organizations

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 (PDs/PIs)

All PDs/PIs must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

The letter of intent should be sent to:

Oppnet Epigenetics
Fax: 301-402-0779
Electronic Communication is preferred Email: OPPNET-EPIGEN2014@nih.gov
The subject line should begin with “OppNet Epigenetics R21 FOA”

Page Limitations

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

Required and Optional Components

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

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.

PHS 398 Cover Letter

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.

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-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.

5. Funding Restrictions

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

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

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, this must be stated in Section VI.1.

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.

Important reminders:
All PDs/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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 project lay out the foundation for further research at the intersection of epigenetics and basic behavioral and social sciences?

Investigator(s)    

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

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 proposed research encompass basic behavioral and social science research approaches to understanding behavioral epigenetics?  Does the application propose pilot studies to address, or lay the foundation for, future studies on epigenetics and basic behavioral/social science research questions?  Does the proposed study build on existing studies or cohorts that have available the appropriate exposure and/or outcome measures and biological samples for epigenetic assays? 

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

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications 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:

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the 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. 

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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Kathleen M. Michels, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: michelsk@nih.gov

Jonathan W. King, Ph.D.
National Institute on Aging
Phone: 301-402-4156
Email: kingjo@nia.nih.gov

Matthew Reilly, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6228
Email: reillymt@mail.nih.gov

Rosalind B. King, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6986
Email: rozking@mail.nih.gov

Rao Divi, PhD
National Cancer Institute (NCI)
Telephone: 301-443-5539
Email: divir@mail.nih.gov

Tanya Agurs-Collins, PhD
National Cancer Institute (NCI)
Telephone: 301-594-6637
Email: collinsta@mail.nih.gov

Frederick L. Tyson, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0176
Email: tyson2@niehs.nih.gov

Enid Light, Ph.D.
Fogarty International Center (FIC)/ National Institute of Mental Health (NIMH)
Telephone: 301-443-3599
Email: elight@mail.nih.gov

Robert Riddle
National Institute on Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email: RiddleR@nih.gov

Lois A. Tully, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
Email: tullyla@mail.nih.gov

Erica L. Spotts, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-402-1146
Email: spottse@mail.nih.gov

Peer Review Contact(s)

Valerie Durrant, Ph.D.
Center for Scientific Review (CSR)
Telephone:  301-827-6390
Email: durrantv@csr.nih.gov

Financial/Grants Management Contact(s)

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: Bruce.Butrum@nih.gov

Lesa McQueen
National Institute on Aging
Ph: 301-496-1472
Email: Lesa_McQueen@nih.gov

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov

Michelle Victalino
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4666
Email: victalinom@niehs.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rclaycam@mail.nih.gov

Judy Fox
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Tina DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decoster@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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