Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Nursing Research (NINR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Funding Opportunity Title

Reducing Health Disparities Among Minority and Underserved Children (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PA-11-104

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PA-14-033

Companion Funding Opportunity

PA-14-034, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.361, 93.273, 93.173  

Funding Opportunity Purpose

This initiative encourages research that targets the reduction of health disparities among children. Specific targeted areas of research include biobehavioral studies that incorporate multiple factors that influence child health disparities such as biological (e.g., genetics, cellular, organ systems), lifestyle factors, environmental (e.g., physical and family environments) social (e.g., peers), economic, institutional, and cultural and family influences; studies that target the specific health promotion needs of children with a known health condition and/or disability; and studies that test and evaluate the comparative effectiveness of health promotion interventions conducted in traditional and nontraditional settings. 

Key Dates
Posted Date

December 12, 2013

Open Date (Earliest Submission Date)

January 5, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, 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)

Standard AIDS dates apply, 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

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

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.


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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


Purpose

This initiative is designed to stimulate research that targets the reduction of health disparities among children. For purposes of this initiative, "health disparities" applies to children who have limited access to resources and privileges that impact their health. As such, this initiative includes a focus on ethnic and racial minority children and populations of underserved children to include: children from low literacy, rural and low-income populations, geographically isolated children, hearing and visually impaired children, physically or mentally disabled children, children of migrant workers, children from immigrant and refugee families, and language minority children. The NIH defines children as individuals 0-21 years of age. The primary purpose of this initiative, therefore, is to encourage intervention studies targeting one of the aforementioned groups. Rather than a singular approach, interventions using a multilevel approach (individual, health system, community, societal) are encouraged. In addition, basic studies designed to further delineate mechanisms/pathways of disparities that lead to the development of interventions are also encouraged. Specific targeted areas of research include biobehavioral studies that incorporate multiple factors that influence child health disparities such as biological (e.g., genetics, cellular, organ systems), lifestyle factors, environmental (physical and family environments) social (e.g. peers), economic, institutional, and cultural and family influences; studies that target the specific health promotion needs of children with a known illness and/or disability; and studies that test and evaluate the comparative effectiveness of health promotion interventions conducted in traditional and nontraditional settings. Strategic Plans on Reducing Health Disparities are located at:

NINR:  http://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan/keythemes ,

NIAAA: http://www.niaaa.nih.gov/sites/default/files/20092013HealthDisparitiesStrategicPlan.doc

NIDCD: http://www.nidcd.nih.gov/about/plans/2012-2016/Pages/2012-2016-Strategic-Plan-Full.aspx

Background

Chronic diseases, defined as a disease lasting 3 or more months (National Center for Health Statistics, 2013), disproportionately affect racial and ethnic minorities, including individuals from lower socioeconomic classes, women and children, and may affect these individuals' ability to attain and maintain health. Children are especially vulnerable and often have multiple risk factors for poor health. Children represent 24 percent of the 2011 U.S. population and include 53.2% White, 14% African American, 4.7% Asian/Pacific Islander, 23.5% Hispanic, and 0.9% American Indian/Alaskan Native (US Census Bureau, 2011, ChildStats.gov)). Forty-four percent of all children live in low-income families and nearly one in every five live in poor families. Moreover, the population of children is becoming increasingly more ethnically and racially diverse.  The Census Bureau indicated that 50.4 percent of our nation's population younger than age 1 were minorities as of July 1, 2011.  Uninsured rates are among the highest for these groups,.  There are 8 million uninsured U.S. children ( 38.5% White, 16.2%  African American, 4.5% Asian/Pacific Islander, 37.1% Hispanic, 1.3% American Indian, and other (multi-racial) 1.6 %are uninsured. It is also recognized that older children, ages 13 through 18 (38.1%), are particularly at risk of being uninsured (Children’s Defense Fund). The association between poverty, health status, race, ethnicity, insurance status, geographic location, and access to good quality health care, or any health care, is well documented. For example, the U.S. infant mortality rate continues to decline by 12% to a rate of 6.05 per 1,000 live births in 2011. Infant mortality remains disproportionally higher for non-Hispanic Blacks (12.4%) than for non-Hispanic white infants (5.3%). Black and Hispanic children are less likely to have access to health care or to receive preventive services including dental care, emotional counseling and diet management; and, poverty and minority race/ethnicity are associated with increased risk for childhood chronic and disabling diseases. As a result, recent studies estimate the prevalence of child and adolescent chronic conditions, requiring ongoing specialized care, to be between 10-20%; experts note that these estimates substantially undercount some prevalent conditions such as obesity and mental health conditions.

Asthma, the leading chronic disorder in childhood, affects 14% or an estimated 7.1 million or 1 in 10 children under 18 years of age. Minority children and children living in poverty have a greater burden from asthma compared with non-Hispanic white not living in poverty; the same children are less likely to receive adequate treatment and are less likely to have family or community support for their asthma management. Hospitalization for asthma is 40-100% more likely for minority children compared to other children. Other chronic diseases are also becoming increasingly common among the nation’s children, but particularly so among minority and underserved children.

In 2010, more than one third of children and adolescents were overweight or obese (CDChttp://www.cdc.gov/healthyyouth/obesity/facts.htm).Obesity, a serious health concern for children and adolescents, is another example of the complex issue of health disparities among minority and underserved children. Although childhood obesity has been a longstanding public health problem, recent increases in obesity prevalence rates have raised the level to epidemic proportions among US children. Results from the 2009-2010 National Health and Nutrition Examination Survey (NHANES), using measured heights and weights, indicate that 18.4 percent of children and adolescents ages 2-19 years are obese. Among pre-school age children 2-5 years of age, obesity increased from 10.4 to 12.1% between 2007-2008 and 2009-2010 and decreased from 19.6 to 18% among 6-11 year olds.  Among adolescents aged 12-19, obesity increased from 18.1 to 18.4% during the same period. Most worrisome, however, is that these increases are more prominent among non-Hispanic black and Hispanic children. Despite recommendations for a healthier diet, recent data show that the usual diet of today's children includes foods high in saturated fat, high in calorie dense foods and drinks, and low in fruit and vegetable consumption. The 2011 Pediatric Nutrition Surveillance System states that 1 of 7 low-income preschool-aged children is obese.

Poor dietary patterns and sedentary behaviors are not only linked to obesity but to the development of a number of serious disabling and life threatening conditions associated with obesity including type II diabetes mellitus, cardiovascular disease, kidney failure, and blindness. In addition, overweight and obese children and adolescents are at risk of becoming overweight adults with problems of coronary artery disease, hypertension, stroke, respiratory problems, gallbladder disease, osteoarthritis, sleep apnea, some forms of cancer, and premature death. It is clear, that U.S. minority and underserved children and families are at risk for facing serious health consequences as well as a number of socioeconomic consequences (e.g., suboptimal school performance, social stigmatization, the potential for decreased productivity across the life course, and high health care costs) as a result of chronic diseases like obesity.

Congenital hearing loss affects two to three infants per 1,000 live births.  While nearly 95% of newborns are screened for hearing loss before leaving the hospital, the Center for Disease Control and Prevention reports that half of those who do not pass the screen lack a documented diagnosis, and more than one-third of those with permanent hearing loss did not receive early intervention services. Without early hearing loss intervention, these children often fall behind their peers in language, cognitive, and social-emotional development.   Barriers to follow-up include service-system capacity, lack of provider knowledge, challenges to families in obtaining services, and information gaps.  Access to hearing health care services for young children from low-income families is particularly challenging.  Financial problems in procuring hearing aids are also a significant problem for young children. Language minority children are often identified as having a language disability when they do not. Language- and culturally-appropriate measures are needed to avoid over- as well as under-identifying of these children.  

The 2011 Institute of Medicine (IOM) Report, Child and Adolescent Health and Health Care Quality suggests that progress in children and adolescent healthcare has improved since the 2010 IOM Report, Children’s Health the Nation’s Wealth: Assessing and Improving Child Health. However, continued improvement is required.  Recommendations from the 2011 report include childhood morbidity and mortality, chronic disease conditions, preventable common health conditions (especially mental and behavioral health and oral health), functional status, end-of-life conditions, health disparities, and social determinants of health.

Alcohol is the intoxicant most widely used among adolescents in the U.S.   Early onset of problematic alcohol use correlates strongly with the development of alcohol dependence later in life. Compared to those who delay until age 21 or later, youth who report beginning to drink at age 15 or younger are 4 times as likely to have a diagnosis of alcohol dependence at some point in their lives.  According to national surveys some minority youth begin drinking at a later age and levels of consumption vary by gender and group. For example, rates of alcohol use, binge drinking, and AUDs have been shown to be greater among some American Indian or Alaska Native adolescents, but lower among Asian Americans.  Whereas historically Hispanic women were unlikely to use alcohol, this pattern appears to be changing so that some high school girls are drinking at levels similar to their male counterparts. Lower levels of use are reported among African Americans during youth, but their trajectory predicts higher percentages of heavy and problematic use in adulthood, particularly among males.  While underage drinking is associated with substantial morbidity and mortality, age-related risk/protective factors and differential consequences throughout adolescence have not been fully explored. Youth residing in rural setting as well as low income, inner city, public housing developments appear to be extremely vulnerable to risk factors associated with alcohol use.

By the year 2060, current census predictions are that racial and ethnic minority groups will comprise the majority of the US population. This demographic is also predicted to change at a more rapid rate in the pediatric population. Thus, there is an urgent need for research studies focused on the elimination or reduction of health disparities among children to thwart potentially significant burdens on individuals, families, the healthcare system, and society as a whole. In for advances to occur in reducing health disparities among minority underserved children and adolescents it must include sensitivity to cultural norms, values and practices.

Research Objectives

Specific research areas of interest for this FOA include, but are not limited to, the following areas:

NIAAA is particularly interested in the following:

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
Renewal
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 are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.     

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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 (PD(s)/PI(s))

All PD(s)/PI(s) 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.

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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

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.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or 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? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

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

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

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:

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:

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)
Telephone: 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 CenterTelephone: 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)

Mary Roary, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-594-2154
Email: mary.roary@nih.gov

Judith A. Arroyo, PhD
National Institute on Alcohol Abuse, and Alcoholism (NIAAA)
Telephone: 301-402-0717
Email: jarroyo@mail.nih.gov

Amy M. Donahue, Ph.D. 
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: donahuea@nidcd.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2870
Email: wertzr@mail.nih.gov

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

Chris Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@nidcd.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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NIH Funding Opportunities and Notices



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