Department of Health and Human Services

Part 1. Overview Information

Key Dates

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

1. Part 1. Overview Information
2. Part 2. Full Text of the Announcement
   1. Section I. Funding Opportunity Description
   2. Section II. Award Information
   3. Section III. Eligibility Information
   4. Section IV. Application and Submission Information
   5. Section V. Application Review Information
   6. Section VI. Award Administration Information
   7. Section VII. Agency Contacts
   8. Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) encourages Small Research Project Grant (R03) applications to support community-based participatory research (CBPR) projects planned and developed by recipients of the Phase I Academic-Community Partnerships Conference Series awards under PAR-09-092 and PAR-12-102. Only one CBPR project will be supported per Phase 1 grant award. The areas of research emphasis include: preterm birth; infant mortality; sudden infant death syndrome (SIDS); maternal mortality; reproductive health; uterine fibroid tumors; childhood, adolescent, and/or adult obesity; violence prevention; perinatal HBV and HIV/AIDS prevention; HIV/AIDS prevention; asthma; intellectual and developmental disabilities; pediatric injury prevention; and medical rehabilitation.

The purpose of the Phase II initiative "Addressing Health Disparities in Maternal and Child Health through Community-Based Participatory Research" is to use the CBPR methodology to conduct small research projects that (1) strengthen partnerships between academic and community partners established in Phase 1; (2) address a community health concern; and (3) increase our understanding of the causes of and solutions to maternal and child health disparities.

Support will be provided for formative research; pilot or feasibility studies; development, adaptation, and/or testing of methodologies; and development and/or testing of technology for the purpose of reducing maternal and child health disparities through the use of CBPR.

Background

The NIH recognizes the value of supporting academic and community partnerships which are relevant to one of the overarching goals of Healthy People 2020 "to achieve health equity, eliminate disparities, and improve the health of all groups." Advances in research to improve diagnosis, treatment, and prevention have led to significant declines in disability, morbidity, and mortality from numerous diseases and conditions. As a result, the population can expect to live longer, be more productive and enjoy a higher quality of life. However, these gains have not affected all segments of the population equally. The Phase I: Academic-Community Partnership Conference Series Initiative was designed to bring together academic institutions/organizations and community organizations to identify opportunities for addressing health disparities through the use of CBPR. The objectives of the Phase 1 award are to: (1) establish and/or enhance academic-community partnerships; (2) identify community-driven research priorities, and (3) develop long-term collaborative CBPR research agendas.

CBPR is a collaborative process of research involving researchers and community representatives at all phases of this process including conceptualization, implementation, evaluation, and dissemination. Through the Phase I and II awards, it is intended that key stakeholders, including persons affected by disparate health outcomes, will become full participants in research. Full engagement of community partners in research provides opportunities to generate better-informed hypotheses, develop more effective and sustainable interventions, and enhance the translation of research results into practice.

Program Scope

The purpose of the current Phase II initiative "Addressing Health Disparities in Maternal and Child Health through Community-Based Participatory Research (R03)" is to use the CBPR methodology to conduct small research projects that (1) strengthen partnerships between academic and community partners established in Phase 1; (2) address a community health concern; and (3) increase our understanding of the causes of and solutions to maternal and child health disparities.

Phase II awards should include shared leadership by academic and community partners, and all activities proposed in the application must include substantial input from the targeted community using the principles of CBPR. While multiple Program Director/Principal Investigator (PD/PI) applications comprised of academic and community organization PD/PIs are strongly encouraged, all applications should include, at a minimum, one academic partner and one community organization partner as part of the key research project team. At least one individual with expertise in CBPR should also be included as part of the research project team.

Applicants should outline the roles of the community in all phases of the current project and how the impact of the community partnership in regard to accomplishing the partnership processes and outcomes will be evaluated. Phase II awards should demonstrate support for implementation from the community through letters of support from relevant community organizations (e.g., public health department, public schools, church or youth organizations).

Phase II CBPR grant awards will support meritorious small-scale, new projects, developed for the purpose of reducing maternal and child health disparities, including, but not limited to the following:

• Formative research
• Pilot or feasibility studies
• Development, adaptation, and/or testing of methodologies
• Development and/or testing of technology

Additionally for planning purposes, keep in mind that the small research grant mechanism (R03) provides limited, short-term funding support for discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Preliminary data are not required for R03 applications.

Specific Areas of Research Interest

The proposed Phase II CBPR project should focus on the original area(s) of research emphasis identified in the Phase I Academic-Community Partnership Conference Series award. Support will be provided for projects focused on reducing disparities in the following NICHD mission areas:

• Preterm birth
• Infant mortality
• Sudden Infant Death Syndrome (SIDS)
• Maternal mortality
• Reproductive health
• Uterine fibroid tumors
• Childhood, adolescent, and/or adult obesity
• Violence prevention
• Perinatal HBV and HIV/AIDS prevention
• HIV/AIDS prevention
• Asthma
• Intellectual and developmental disabilities
• Pediatric injury prevention
• Medical rehabilitation (e.g., spinal cord injury, TBI, stroke)

More than one area of research focus should be addressed only when scientifically appropriate and related to the Phase I area of research emphasis. Health literacy and techniques for outreach and information dissemination should only be addressed in conjunction with one of the identified areas of research focus.

An application for Phase II awards could include CBPR projects in areas including, but not limited to, the following:

• Studies that develop and/or test evidence-based interventions to reduce disparities in maternal and child health outcomes
• Studies that adapt existing interventions developed for the general population or for use in a specified population as a strategy to reduce disparities in maternal and child health outcomes.
• Studies that develop and/or test culturally appropriate assessment tools to identify determinants important for reducing disparities in maternal and child health outcomes
• Studies that develop and/or test innovations in technology to reduce disparities in maternal and child health outcomes

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

• 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 eligible individual(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.

Special Criteria for Limited Competition

For this FOA, any individual with the skills, knowledge, and necessary resources may submit an application if the following additional criteria are met:

• You are/were the PD/PI on the Academic-Community Partnership Conference Series Phase I grant under PAR-09-092 and PAR-12-102 previously awarded to your institution.
• You are/were the PD/PI from a collaborating institution on a multi-PD/PI Academic-Community Partnership Conference Series Phase I award.
• In cases where a PD/PI on the Phase I Academic-Community Partnership Series Conference award is unable to participate in this limited competition, you are designated by your institution as the PD(s)/PI(s) in this "limited competition" FOA, with the approval of the academic and community partners from the Phase I Academic-Community Partnership Series initiative. The key academic and community partners should provide a letter of support for a newly designated PD/PI.
• Only one CBPR project will be supported per Phase 1 grant award.

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

Only one application per institution, usually defined as having a unique DUNS number or NIH IPF number, is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Regina Smith James, MD
Telephone: 301-435-2692
Fax: 301-480-0393
Email: [email protected]

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities & Other Resources: Describe the research environment, including the facilities, laboratories, core or multiple user research resources that will be used in the CBPR project.

SF424(R&R) Senior/Key Person Profile

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

Special Requirements for Academic-Community Partnerships:

The application should include individuals from one or more of the following types of institutions/organizations in the Senior/Key Person Profile of the grant application:

• Community partner: community organization located or working directly with the participating community (e.g., faith-based organizations, community health centers, schools, community associations, health departments, etc.)
• Scientific research partner: institutions or organizations having research scientists
• At least one individual with expertise in CBPR should also be included as part of the research project team if that expertise is not held by one of the designated PD/PIs.

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

Significance

• Define the relevant community or communities of interest using a set of tangible and explicit criteria. The criteria can include a common interest, identity, characteristic, or condition (e.g., a common interest, identity, characteristic, or health condition).
• Document evidence of the health disparity condition in the defined community and how this project will improve our understanding of how to reduce disparities in similar communities. The applicant should discuss how the proposed CBPR project will improve scientific knowledge, technical capability, and/or address the identified health inequity through increased knowledge, behavior, and/or social change resulting from the community partnership.
• Describe the partnership among academic and community partners established in Phase I. This should include a summary of activities conducted to obtain input from community members in planning of the current CBPR project.

Approach

• Describe the function of an Advisory Board or similar entity (i.e., Steering Committee, Community Coalition Board, etc.) in planning, education, outreach, dissemination, and evaluation efforts. The Advisory Board should be comprised of both community and academic partners and plans should outline qualifications for membership to the Advisory Board.
• Describe the roles of the community in all phases of the project and how the impact and outcomes of the community partnership will be evaluated.
• Describe plans for keeping the community informed as well as for disseminating research outcomes within the community.
• Timetable: Conclude the Approach section by providing a timetable for completing the proposed studies and describing future directions.

Letters of Support: Applicants should provide letters of institutional and community support and/or Memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) to document evidence of an existing academic-community partnership(s). The MOU/letter of agreement should identify the role of each partner, describe the health concerns to be addressed, and identify the research objectives which may include, for example, the intent to collaborate on the design, implementation, and evaluation of a pilot intervention aimed at reducing one of the NICHD maternal and child disparities areas of emphasis. In cases where a PD/PI on the Phase I Academic-Community Partnership Series Conference award is unable to participate in this limited competition, the key academic and community partners should provide a letter of support for a newly designated PD/PI.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

• No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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? 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?

What is the potential significance of the proposed study for reducing health inequities through increased knowledge, behavioral, and/or social change resulting from the community partnership? What are the perceived importance and relevance of the proposed study to community partners and thus the likelihood for increased buy-in and participation?

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?

Does the applicant provide information indicating that the training, qualifications, experience and commitment of the investigators are appropriate and well suited to the project? Do the investigators have prior CBPR training and experience? Does the applicant indicate the degree to which and in what way university and community partners have collaborated in the past?

Does the applicant describe the role of community partners in the leadership of the project? Does the applicant describe the specific expertise and strengths to be contributed by the community partners? Does the applicant adequately describe the community advisory board which has guided the design and conduct of the study?

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?

Does the applicant adequately describe how innovative ideas resulted from community participation in developing the research questions, methods, and/or intervention approaches?

Does the applicant adequately discuss how community input generated innovative approaches to overcoming research challenges?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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

Does the applicant describe how the community will be involved in all phases of the research effort (conceptualization, design, methods and analysis)? Does the applicant present strong arguments for the proposed study design as the best possible balance of scientific rigor, implementation constraints and ethical treatment of community partners? Does the applicant present the design of a rigorous process and outcome evaluation? Does the applicant provide a convincing rationale and adequate plan for how the community partnership is expected to enhance recruitment, retention, measurement design, data collection, and analysis/interpretation? Is there an adequate plan for facilitating dissemination and translation of study findings through the CBPR process? Are the potential limitations of the study design and CBPR approach adequately addressed?

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?

Does the proposed study take advantage of unique features of the scientific, institutional, or community environment or employ useful collaborative arrangements? Is there evidence of institutional and community support through letters and/or a MOU/letter of agreement? Does the PD/PI provide an effective framework for evaluating the partnership?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Scientific/Research Contact(s)

Della Brown White, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-2712
Email: [email protected]

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: [email protected]

Financial/Grants Management Contact(s)

Bonnie Jackson
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5482
Email: [email protected]

Section VIII. Other Information

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

Authority and Regulations

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