Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute on Drug Abuse (NIDA)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Neurological Disorders and Stroke (NINDS)

Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03)  

Activity Code

R03 Small Grant Program

Announcement Type

New

Related Notices
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
Funding Opportunity Announcement (FOA) Number

PAR-16-323

Companion Funding Opportunity

None  

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

93.865, 93.273, 93.279, 93.121, 93.113, 93.853, 93.351  

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to promote initial establishment of basic science-clinical collaborations by providing small grants to teams of basic scientists, physician scientists, and/or clinicians.  These interdisciplinary teams may include but are not limited to the following:  developmental biologists, cell biologists, geneticists, genomicists, physician scientists including individuals with DVM/VMD degrees, clinicians, epidemiologists, biostatisticians, and/or bioinformaticists. 

In order to be eligible for this FOA, applications must include at least one scientist with expertise from the basic science side of the spectrum as well as one from the clinical side.  The multiple PD/PI model is strongly encouraged but not required. The goal is to facilitate the gathering of preliminary data to support future, larger research grant applications that will combine expertise and integrate basic, translational, and/or clinical approaches to understanding the developmental biology, genetics, and/or environmental basis of structural birth defects.    

Key Dates

 

Posted Date

June 10, 2016

Open Date (Earliest Submission Date)

September 16, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

The first standard application due date for this FOA is October 16, 2016.

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)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

The first AIDS application due date for this FOA is January 7, 2017.

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
Advisory Council Review
Earliest Start Date
Expiration Date

September 8, 2019

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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background

According to the Centers for Disease Control (CDC), in 2013 there were 3.93 million births in the United States.  Of these, approximately 1 in 33, almost 120,000 infants, was born with a structural birth defect.   Often overlooked are the untold number of miscarriages and fetal deaths potentially attributable to birth defects.  Most states only report fetal deaths at 20 weeks gestation or more, and in 2013 a total of 23,595 fetal deaths were reported in the United States.  While surgical interventions have improved the survival rate of children born with birth defects, during the first year of life birth defects are the leading cause of pediatric hospitalizations, medical expenses, and death.  Despite the devastating impact of birth defects on the affected children and/or families, we still understand little of their etiology.  Throughout childhood, they continue to rank among the top 10 causes of death and hospitalization among children of all ages.  Thus, structural birth defects have a great impact on family life, the affected individual over the lifespan, public health, and socioeconomics.

From the perspective of developmental biology, over the past decade or so, the ability to detect spatial and temporal patterns of gene expression and to test gene function by targeted disruption or misexpression of specific genes has enhanced our understanding of the roles of genes during the development of organs and organ systems in animal models.  Events like specification of organ primordia, inductive signaling, outgrowth, and patterning are routinely investigated at the level of molecular genetic mechanisms.  An emergent theme from these studies is the conserved role of growth factors, signaling molecules, and signaling pathways across vastly different animal species in all organ systems.  An outstanding question being addressed more recently relates to how these genetic processes are linked to tissue level organization and key cellular processes in order to modulate morphogenesis.  This work is truly expanding our conceptual framework for understanding morphogenesis in animals and has implications for the translation of basic developmental biology research findings to the clinical setting, potentially improving diagnosis and clinical management of and therapeutics for human structural birth defects.

From the clinical perspective, the identification of specific patient populations, careful phenotyping of affected individuals, and sequencing of patient cohorts place the field of structural birth defects research on the verge of major advances.  Currently, most birth defects are lumped into categories despite the fact that many phenotypically similar patients can have dramatically different outcomes.  The role of genetic variation and the ability to improve our functional understanding of sequence variation may allow stratification of diagnoses and better predictions of outcomes.  Identification of birth defect-specific genetic variations feeds back to the development biology arena and the ability to perform functional analyses in animal models.  Challenges persist in efforts to bridge clinical and research arenas and in fostering true collaborative endeavors.

Addressing the problem of structural birth defects has been a high priority goal of NICHD's since the Institute was established in 1962.  In 2000, this priority was emphasized by the establishment of the NICHD Structural Birth Defects Initiative.  Recognizing the wide range of organ systems that can be affected by structural birth defects, the NIH established, in 2014, the Trans-NIH Structural Birth Defects Working Group, bringing together Extramural staff from ten Institutes under the leadership of NICHD.  This working group leverages existing resources and fosters collaborations with the ultimate goal of accelerating the translation of basic research findings in developmental biology into better diagnoses, prevention, treatment and cures for structural birth defects.  It is clear that this goal will only be reached when more basic scientists are working alongside clinical scientists in synergistic collaborations tackling problems related to structural birth defects.

Scope

The intent of this FOA is to support basic scientists, physician scientists (including individuals with DVM/VMD degrees), and/or clinicians in a collaborative effort to develop a multi-pronged research program focused on the etiology of a structural birth defect.  The R03 funding will specifically support formulation of the overall collaborative experimental approaches as well as the collection of preliminary data to support a future, larger grant application such as an R01.

The first aspect of developing an interdisciplinary collaboration is often time spent breaking down barriers between differing disciplines and establishing effective lines of communication.  For example, it is anticipated that pediatricians might need to learn more about developmental biology and genomics while developmental biologists might need to learn more about human genetics or epidemiology.  Therefore, part of the R03 should be devoted to the cross-disciplinary discussions necessary to build the foundation for the experimental approaches to tackle the problem at hand.

Depending on the combination of experimental approaches to be undertaken, the areas of expertise required are expected to vary.  For birth defects research to succeed in the long run, it is clear that interdisciplinary teams including but not limited to the following are necessary:  developmental biologists, cell biologists, geneticists, genomicists, clinicians, veterinarians with animal modeling and comparative medicine expertise, epidemiologists, biostatisticians, and/or bioinformaticists.  Therefore, the collaborative R03 should minimally include at least two PD/PIs with differing expertise.  Expertise from both the basic science side of the spectrum as well as the clinical side should be engaged in the R03 research.  The multiple PD/PI model is strongly encouraged but not required.

The scope of the research proposed is expected to vary as well.  The proposed studies should develop, adapt, and use approaches to identify genetic contributions as well as environmental interactions and other non-genetic determinants that contribute to various structural birth defects.  It is clear that genetic factors can be the primary cause of structural birth defects and/or may act in concert with environmental exposures.  Genetic and epigenetic factors provide a basis for functional studies in animal models or cell culture systems such as patient-derived induced pluripotent stem cells.  Introducing genetic variants into animal model systems can bolster the causative role of the variant as well as provide insight into the embryological mechanisms underlying structural birth defects.  Depending on the birth defect in question, the most appropriate model(s) will vary.  Examples of research areas that are appropriate for this FOA are described below.  This is not intended to be all-inclusive, but is designed merely to provide guidance and direction for applicants.

Research Interests of Participating Institutes

NICHD

Of particular interest to the NICHD are applications to study developmental defects of generalized body patterning and localized dysmorphic anomalies of various systems, such as the skeletal, nervous (e.g., neural tube defects), and visceral systems, that lead to clinically significant and major congenital structural malformations. In particular, studies that focus on the role of quantitative aspects of development, such as gene dosage or copy number variation and the role of modifier genes as well as environmental factors that cause teratogenesis are of interest.

While applications focusing on developmental disorders that result in intellectual disabilities and related neurobehavioral disabilities are of interest to the NICHD, they are outside the scope of this FOA. However, syndromic conditions, which exhibit intellectual disability as part of the phenotype, are acceptable as long as the focus of the project is on associated structural anomalies (e.g. Cornelia de Lange syndrome).

NIAAA

Alcohol is a known teratogen capable of causing fetal alcohol spectrum disorders (FASD), a collection of birth defects and developmental disabilities that occur in individuals whose mothers drank alcohol during pregnancy.  Of particular interest to the NIAAA are multidisciplinary research applications into the etiology of brain and craniofacial abnormalities associated with prenatal alcohol exposure as well as structural birth defects not considered necessary for the diagnosis of fetal alcohol syndrome (FAS).  Examples include, but are not limited to, congenital abnormalities of the heart, kidney, bone, eye and ear.  Studies in which genetic susceptibility to alcohol related birth defects is examined in both animal models and in humans with FAS/FASD are encouraged.

NIDA

NIDA supports research to understand, prevent, and treat substance use disorders and mitigate their consequences to improve the public’s health. For the purposes of this FOA, NIDA encourages basic-clinical collaborations to promote understanding of the etiology, mechanisms, epidemiology, prevention, and treatment of structural birth defects related to drugs of abuse.  These collaborations may focus on research to uncover mechanisms underlying tolerance, sensitization, and addiction to drugs of abuse such as nicotine, amphetamine, cocaine, opiates, barbiturates, cannabinoids, and hallucinogens.  The identification of genetic suppressors and enhancers of effects of drugs of abuse on the development and function of the nervous system and behavior, clinical outcomes and human development are additional areas of interest.  Novel approaches to elucidate processes and genetic mechanisms involved in the development of brain regions, neural circuits, and neurotransmitter systems mediating the addictive properties of drugs of abuse to inform future prevention and treatment of birth defects are encouraged.

NIDCR

The NIDCR will accept applications proposing studies of developmental defects of craniofacial structures, particularly those developing new animal models of human gene-environment interactions; novel, clinically relevant animal models of human craniofacial dysmorphologies; and investigations of understudied craniofacial developmental disorders.  Priority will be given to applications from teams effectively combining clinical and bench science expertise.

NIEHS

NIEHS will support applications to engage both basic scientists and clinical researchers to test or develop relevant animal models or even computational models to integrate different types of extant data to identify possible chemical causes of structural birth defects and possible pathogenesis.  For the purposes of this FOA, the environmental risk factors or exposures that NIEHS will consider can include chemical toxicants, such as metals and solvents, and biological agents, such as toxins and endogenous or exogenous hormonally related exposures.

NINDS

Of particular interest to the NINDS are applications which study developmental processes in the central nervous system that, when perturbed, lead to clinically significant congenital structural malformations (e.g., hydrocephalus, Joubert Syndrome, etc.).  All forms of developmental brain and/or spinal disorders that are within the NINDS mission which present a clear morphological defect at birth are of potential interest. For this funding opportunity, structural malformations are defined as those that can be observed at birth either by visual examination or imaging.  Related basic studies that focus on the mechanistic aspects of development, such as identifying the genetic, epigenetic and/or environmental causes that drive the underlying basic mechanisms of pathogenesis of the brain and/or spine are of particular interest.

While applications focusing on developmental disorders that result in intellectual disabilities and related neurobehavioral disabilities without overt structural defects at birth continue to be of interest to the NINDS, they are outside the scope of this FOA.  In contrast, conditions which exhibit intellectual disability and/or epilepsy in conjunction with a structural phenotype are acceptable as long as the focus of the project is on the role of the associated structural anomalies in the disorder’s etiology (e.g., focal cortical dysplasia, lissencephaly).

Finally, NINDS will not support interventional studies in humans including clinical or device trials through this mechanism (Phase I, Phase II, or Phase III). Applications proposing a clinical trial must be submitted to one of the following NINDS FOAs specifically designed for clinical trials:

NINDS Exploratory Clinical Trials (R01) PAR 13-281

NINDS PHASE III Investigator-Initiated Efficacy Multi-Site Clinical Trials (U01) PAR 13-278

ORIP

The Office of Research Infrastructure Programs (ORIP) in the Office of the Director (OD) has a particular interest in model systems applications related to animal based research. This will include the development and characterization of natural and induced animal models to further understand the pathogenesis of structural birth defects.  ORIP/OD will support applications that (1) use animal models, and (2) engage veterinarian scientists as part of the interdisciplinary research team.  Veterinarian scientists are individuals with a DVM/VMD degree who are engaged in biomedical research.

See Section VIII. Other Information for award authorities and regulations.
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
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 for up to $75,000 direct costs per year are allowed but should reflect the actual needs of the proposed project    .     

Award Project Period

The maximum project period is two 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:

o    Hispanic-serving Institutions

o    Historically Black Colleges and Universities (HBCUs)

o    Tribally Controlled Colleges and Universities (TCCUs)

o    Alaska Native and Native Hawaiian Serving Institutions

o    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.

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.

  • 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • 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.

Since the intent of this FOA is to foster collaborative efforts between basic and clinical scientists, the multiple PD/PI format is strongly encouraged but not required as a means to clearly demonstrate the intent to establish a successful collaboration that will carry over into the development of further grant applications.  Applications must include at least one scientist with expertise from the basic science side of the spectrum as well as one from the clinical side. These two individuals must serve as Multiple PD(s)/PI(s) or one must serve as PD/PI with the other serving as Senior/Key Personnel. 

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 obtain 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.

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.

Other Attachment: The following attachment should be included  (2 pages maximum).

Collaboration Plan

Applications must include a proposed Collaboration Plan, describing how the proposed collaboration will be maintained throughout the duration of the award.  The following areas should be addressed:

  • Organizational structure;
  • Management plan detailing how existing resources will be utilized;
  • Planned interaction and responsibilities of key personnel other than PD(s)/PI(s);
  • Description of how the research team will communicate (e.g., in person, videocast, web meeting, etc.).

The filename "Collaboration Plan-PI-NAME.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  Since the intent of this FOA is to foster collaborative efforts across the spectrum of basic to clinical science, expertise from both the basic science side of the spectrum as well as the clinical side should be engaged in the R03 research.

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:

Research Strategy: Applicants are encouraged to clearly present the collaborative nature of the proposed research.  Research spanning the spectrum from basic to translational/clinical science should be evident in keeping with the purpose of this FOA.  

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, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed. 

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. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.

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 R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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? Is there a strong scientific premise for the project? 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? Does the expertise of the PD/PIs come from at least two different scientific areas spanning the spectrum from basic to translational/clinical science supporting the development of a synergistic, collaborative approach to future investigations of the structural birth defect of interest?   

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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Is the Collaboration Plan well defined with identifiable responsibilities for the PD/PIs? Is a plan for management of the collaboration clearly presented, with well-defined descriptions of what each participant proposes to provide to the collaborative partnership?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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 (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 (CSR), 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 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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)
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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)   

Lorette C. Javois, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6890
Email: javoisl@mail.nih.gov

Bill Dunty, Ph.D
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7351
Email: duntyw@mail.nih.gov

Dale Hereld, M.D., Ph.D 
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0912
Email: hereldd@mail.nih.gov

Da-Yu-Wu, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-4649
Email: wudy@mail.nih.gov

Cheryl Boyce, PhD
National Institute on Drug Abuse (NIDA)
Telephone:  301-435-1070
Email:  cboyce@mail.nih.gov

Steven Scholnick, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-3977
Email: scholnis@mail.nih.gov

Kimberly A. McAllister, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-4528
Email: mcallis2@niehs.nih.gov

Robert Riddle, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email: eiddlerr@nih.gov

Manuel Moro, D.V.M., Ph.D.
Office of Research Infrastructure Programs (ORIP)
Division of Comparative Medicine
Telephone:  301-435-0960
Email: morom@mail.nih.gov

Peer Review Contact(s)

Jonathan Arias, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2406
Email: ariasj@csr.nih.gov

Financial/Grants Management Contact(s)

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

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov

Edith Davis
National Institute on Drug Abuse (NIDA)
Telephone: 410-360-4734
Email: davised@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Molly Puente, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@mail.nih.gov

Tijuanna DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Julie Shriner
Office of Research Infrastructure Programs (ORIP)
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0853
Email:  Julia.shriner@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.

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