Part 1. Overview Information

Key Dates

All applications are due 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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

BACKGROUND

Rapidly evolving biomedical research coupled with emerging technologies has enabled translational research to fill the gap between basic and clinical research and facilitate the transfer of scientific discoveries into clinical practice. However, there remains significant knowledge gaps and unmet needs in effective prevention and treatment of many pregnancy complications and associated adverse outcomes (i.e., preeclampsia, preterm birth, stillbirth) as well as pediatric conditions at different development stages. The accumulation of biological samples and datasets from ongoing research networks has increased the need to create research resource platforms for translational research to advance safe and effective therapeutics in maternal and pediatric populations. There is also a need for tools to transform these data into usable knowledge, such as biomarkers, to advance precision therapeutics for maternal and pediatric diseases and conditions.

Biomarkers are essential components of translational research in identifying targeted therapies aiming to enable precision therapeutics. There are different types of biomarkers including, for example, molecular, imaging, physiologic, and digital biomarkers. Such biomarkers can have many applications such as serving as patient-specific measurable indicators of normal biological processes or responses to therapeutic interventions. Some examples of biomarker utility are facilitating the evaluation of therapeutic intervention on disease severity and progression, stratifying patients into risk categories, or improving clinical trial outcome measures. Moreover, biomarkers can serve as predictive indicators of drug safety and toxicity as well as provide guidance to drug dosing in individual patients. Biological samples and phenotypic data collected from clinical research and trials are rich resources for translational research to identify and validate novel and high-quality biomarkers that will accelerate the discovery of new drugs and targets, facilitate risk stratification for clinical trials, and provide predictive diagnostics and treatment responses for personalized medicine. For example, biological samples that were collected from pregnant women across pregnancy and linked to clinical data of the mothers and their newborns will be a valuable resource to discover novel preventive, diagnostic, and therapeutic biomarkers and could potentially advance the development of preventive strategies and novel drugs for precision therapeutics in maternal and pediatric populations.

The MPRINT Hub was recently established by NICHD and primarily focuses on aggregating, presenting, and expanding the available knowledge, tools and expertise in maternal and pediatric therapeutics research. This FOA, as part of the MPRINT program, aims to develop translational research resource platforms to advance maternal and pediatric therapeutics research through leveraging existing and prospective resources through collaborative multidisciplinary team science efforts. The TRRPs will work with the MPRINT Knowledge and Research Coordination Center on the implementation and dissemination of data and tools. The TRRP awardees are expected to attend the MPRINT Hub annual and other regular meetings.

RESEARCH OBJECTIVES AND SCOPE

For the purpose of this FOA, maternal and pediatric therapeutics is defined to encompass:

• Therapeutic treatment of obstetric and breastfeeding conditions;
• Physiological changes that occur in a person’s body during pregnancy, the post-partum period, and during lactation that impact the distribution or effects of administered therapeutics;
• Passage of drug from mother to fetus during pregnancy and to child during breastfeeding, including the effects of those drugs on the fetus or child;
• Therapeutic treatment of pediatric disease, particularly where there are unique pediatric conditions or pharmacodynamic differences from adult disease;
• Physiological changes that occur across the entire spectrum of pediatric development from birth through adolescence that impact the distribution or effects of administered therapeutics.

The objectives of this FOA are to support multidisciplinary groups of researchers to conduct collaborative, team-based science utilizing cutting-edge technologies and adapting innovative approaches to:

• Develop analytic tools and lab platforms to advance precision therapeutics in maternal and pediatric populations.
• Enable and accelerate the discovery of biomarkers with translational potential for therapeutic targets of maternal or pediatric conditions.
• Validate and support the qualification of biomarkers for maternal and pediatric conditions.

Each proposed study may employ one or more of the above approaches with an ultimate goal of delivering high quality biomarkers that have practical utilities for clinical applications.

Applicants are encouraged to form collaborations with NIH supported research networks that have a focus on maternal and pediatric conditions, such as, but not limited to, the Maternal Fetal Medicine Units Network (MFMU), Neonatal Research Network (NRN), Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (NuMoM2b), International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and Pediatric Trials Network (PTN), and leverage existing or newly established resources (e.g., biobanks, biospecimen repositories, omics data, tissue specific genomic/epigenomic atlases, imaging and clinical data repositories, and EHRs). Applicants are also encouraged to explore collaborations with groups that are experienced in the use of public-private partnerships (PPPs) to advance the qualification of drug development tools, such as the Foundation for the NIH’s Biomarker Consortium (https://fnih.org/our-programs/biomarkers-consortium).

Examples of translational resource platform-related activities suitable for this FOA, include, but are not limited to:

• Discover or validate novel biomarkers using real-world data (RWD) for patient stratification, targeted therapies, and/or drug safety prediction.
• Discover and validate biomarkers of novel therapeutic potentials or that can predict adverse pregnancy outcomes (e.g., pre-eclampsia, preterm birth).
• Develop informatics tools or utilize systems approaches, especially artificial intelligence tools, that integrate various types of data, including genomic, proteomic, metabolomic, or phenotypic data, to support the identification and validation of biomarkers in advancing precision medicine.
• Develop common analytic platforms and perform analysis of existing biological samples to address high priority questions and/or resource needs in translational and therapeutic research.
• Generate data and support filing for regulatory qualification of a biomarker with the FDA.
• Develop innovative strategies to identify and fill gaps in biological samples and data collections.
• Develop models/algorithms evaluating potential targets and toxicities of novel therapeutic strategies for pregnant, lactating, and pediatric populations

Applicants should reference the BEST (Biomarkers, EndpointS, and other Tools) resource for biomarker definitions (https://www.ncbi.nlm.nih.gov/books/NBK338448/).

Organization and Management of the TRRPs

A Steering Committee and a Subject Matter Experts will provide overall direction and guidance for the MPRINT TRRPs.

Steering Committee (SC)

• The SC consists of principal investigator(s) from each TRRP, and program staff from NICHD.
• The Chair of the SC will be selected by the NICHD from the PD/PI of the TRRP awardees.
• The SC will establish procedures for the function of the TRRPs, including regular SC teleconferences and in-person meetings, as necessary convene working groups for specific purposes (i.e., Biomarkers, Analytic Tools, and Data Integration and Implementation).
• The working groups of the SC should be composed of at least one PD/PI from a TRRP award, at least one senior/key personnel from each TRRP awardee, and NIH staff as well as other necessary TRRP members, external scientists, or experts, as needed.
• The SC is expected to hold two in-person meetings per year (or virtual equivalent) to review scientific progress and highlight TRRP’s key activities. At least one meeting should be held in conjunction with the MPRINT Hub annual meeting. The TRRP SC and other key personnel are expected to attend the TRRP in-person meeting as well as the MPRINT annual meeting.
• NIH staff from other NIH-funded networks may participate as ex officio members in the TRRP SC and/or its working groups.
• The SC will explore options for increased integration within the existing MPRINT Hub governance structure during the first year of award.

Subject Matter Experts (SMEs)

• The SMEs will review and evaluate the progress of the TRRPs and ensure the TRRPs are operating optimally and efficiently, and data and tools developed are accessible to the broader scientific community.
• The SMEs will be appointed by the NICHD on a yearly basis and may include, but is not limited to, persons with expertise in biomarker discovery, data sciences, bioinformatics, clinical pharmacology, pediatric subspecialties, maternal health, and regulatory sciences. The SMEs may include members of other Federal Agencies such as the Food and Drug Administration, or others as deemed necessary by the NICHD.
• The SMEs will meet at least once a year in conjunction with a meeting of the TRRP. The SMEs may individually confer with the NICHD program staff by phone or web at other times of the year, as needed.
• Annually, the SMEs will provide individual assessments to the NICHD of the progress of the TRRP and will present recommendations regarding any changes in the TRRP as necessary.
• The NICHD, after consulting with the SME may request modification to or re-prioritization of effort among research projects of the TRRPs.

Applications including the following types of studies will be considered non-responsive to this FOA and will not be reviewed

• Applications proposing to develop repositories or databases without an integrated plan for analysis of samples and dissemination of data during the award period.
• Applications proposing to solely study biomarkers for opioid use/addition or pediatric oncology.
• Applications proposing to develop diagnostic assay/technology for point-of-care use or evaluate existing diagnostic assays/platforms.
• Applications not focused on maternal and pediatric pharmacology and therapeutics research as defined above.
• Applications focused on medical devices that do not directly relate to therapeutics.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Government

• 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) 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 allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM)– 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. 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 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.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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.

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:

Zhaoxia Ren, M.D., Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-9340
Email: zren@mail.nih.gov

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

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.

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

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

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

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

R&R Budget

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

Applications proposing to utilize data and/or biological samples collected from newly awarded clinical studies/trials should budget for a total of $250,000 total costs for budget periods/years 3 and 4. A detailed plan for use of these funds should be submitted along with the year-2 Research Performance Progress Report (RPPR). These funds will be restricted from use until approved by the NICHD. This line item should be a Direct Cost amount such that when combined with its associated Indirect Costs the total is $250,000 in Total Costs.

The Program Directors/Principal Investigators (PD/PI) should have significant time commitment (3.0 person months) with each person having no less than 1.2 person months.

Budgeting should include travel and lodging for representatives of the MPRINT TRRP to attend:

• Annual meetings of the MPRINT TRRP and MPRINT Hub;
• Ad hoc meetings called by the MPRINT TRRP SC or the NICHD to discuss research findings and plan cooperative projects, to promulgate data sharing, and to discuss standardization of procedures and resource integration with the MPRINT KRCC.

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

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

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

Specific Aims: Address how the proposed research resource platform will address barriers to the conduct of maternal and/or pediatric therapeutics research and/or conduct of drug development projects in these populations. State the scientific objectives of the proposed research resource platform.

Research Strategy: Organize the Research Strategy by Significance, Innovation and Approach.

Significance:

• Define specific maternal and/or pediatric condition(s) to be addressed and the unmet need for safe and effective prevention and/or treatment.
• Describe how the proposed technology, reagents, analytical tools, and other resources proposed for the TRRP meet an important need for risk assessment, detection, diagnosis, and/or precision therapy.
• Describe the potential for the proposed studies to significantly advance precision therapeutics / medicine in the area(s) of maternal or pediatric conditions described.

Innovation:

• Describe how the proposed research seeks to shift current therapeutics research or clinical trial paradigms through enabling and accelerating the discovery, or validation, or qualification of high-quality biomarkers.
• Describe the leading edge and innovative attributes the application brings to the specific approaches to ulimately advance towards biomarker(s) .
• Describe the overall technical advances and innovative strengths of the proposed TRRP.

Approach: Applicants should address, at a minimum, the following aspects:

• Describe in detail the nature of the sample cohorts proposed to be collected (from biorepositories, biobanks or ongoing studies) for study in years 1 and 2 of the award.
• Provide a rationale and preliminary data demonstrating the technical approaches used to conduct the proposed research project.
• Describe the range of interdisciplinary expertise needed that will ensure the success of proposed project.
• Describe how the proposed approach(es) and technology will enable and accelerate the development of analytic tools and lab platforms to advance precision therapeutics in maternal and pediatric populations.
• Describe how the proposed approach(es) and technology will ultimately enable and accelerate the discovery, validation, or qualification of high-quality biomarkers with translational potential for therapeutic targets of maternal and pediatric conditions.
• Describe a plan for how samples will be identified for research activities to be performed in years 3 and 4 of the award.
• Describe how the proposed project(s) will interact with and leverage expertise and resources in establishing a TRRP.
• Describe the mechanisms for assessing and maximizing the utility and value of the resource platform to the translational research and clinical communities.

Milestones: The application must define and include the deliverable, timelines, and milestones in the approach section. The milestones must be well described, quantitative, and scientifically justified. NICHD program staff may negotiate changes to the proposed timelines and milestones as well as the process for their reprioritization as needed prior to the award.

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.

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

The plans should provide details for what will be shared, how it will be organized to enhance the user experience, and any limitation/restrictions on access to resources, data, and tools produced by the projects.

Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the MPRINT TRRP SC and approved by NICHD staff. These policies will remain consistent with NIH-wide and NICHD policies on data and resource sharing.

Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NICHD expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. For human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Where appropriate, applicants should identify such repositories and plans for deposition. For datatypes that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution that is consistent with achieving the goals of the program. Data should also be made available as appropriate via the MPRINT Hub Knowledge Base and Portal (https://mprint.org/) that will serve as the central access point for information regarding data, critical tools, and reagents being developed by the MPRINT initiative programs. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to it in the data sharing plan. If applicants are proposing research within Indian Country or tribal communities, they must propose a data sharing plan that respects and enforces principles and practices of Tribal data sovereignty and sovereignty-based data management and sharing requirements

Specific Plan for Protocol, Tool, and Reagent Sharing: In accomplishing the goals of the MPRINT TRRPs, it is likely that investigators will develop protocols, tools, and reagents that would be of broad use in the research community. The NICHD intends that protocols, tools, and reagents generated by the MPRINT TRRPs broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations in maternal and pediatric therapeutics. For all applications where applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, tools, and reagents.

Specific Plan for Sharing Software: A software dissemination plan is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. A dissemination plan guided by the following principles is thought to promote the largest impact:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of training, research institutions, and government laboratories.
• The terms should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• The software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
• The terms of software availability should include the ability of researchers outside of the MPRINT TRRP and its collaborating projects to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy https://sharing.nih.gov/other-sharing-policies/research-tools-policy) and other related NIH sharing policies at http://sharing.nih.gov).

Prior to funding, NICHD Program Staff may negotiate modifications to the Sharing Plan with the applicant.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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.

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.

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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 and responsiveness by NICHD , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission 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 proposed Center address the needs of the research resource that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing the proposed research? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research resource the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program/projects it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For resources 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 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 will receive a written critique.

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 and will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.
• Evidence that the applicant and investigators are committed to policies as established by the SC including confidentiality, sharing of information and resources, cooperative interaction, and functioning as a national resource.
• Evidence of previous productive, cooperative, collaborative interaction.
• Assurance that there is distribution of study between maternal pharmacology and pediatric pharmacology across all TRRP awards.

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 recipient's business official.

Recipients 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism (rather than an “acquisition” mechanism), in which substantial NIH programmatic involvement with the recipientss is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients’ activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Developing objectives, approaches, and goals for TRRP.
• Designating investigators to serve as members on a Steering Committee and other subcommittees, with NIH staff, as appropriate.
• Complying with Federal regulatory requirements, including but not limited to those relating to human subject protections.
• Attending monthly (or as needed) virtual Steering Committee meetings.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH.
• Agreeing to accept close coordination, cooperation, and management of the project with NICHD staff, including those outlined below in the “NIH Staff” section. The PD(s)/PI(s) will be expected to maintain close communications with the NICHD Project Scientist(s) and, where appropriate, the Program Officer(s). The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NICHD of the results and conclusions are to be developed by the PD(s)/PI(s) or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
• Attending an annual in-person (or virtual) meeting of all MPRINT TRRPs and Centers.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• NICHD will appoint a Steering Committee Chair for the first award year.
• NICHD will assign a Project Scientist(s) as the point of contact to work with the PD(s)/Pl(s) and participate in the Steering Committee to ensure the objectives of the program are being met. The primary responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH Project Scientist(s).
• NICHD will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for the award and will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
• NICHD may designate additional staff to provide advice to the recipient on specific scientific and/or administrative issues to optimize the conduct of TRRPs’ activities.
• NICHD will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
• NICHD staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and his/her staff.
• NICHD staff will provide input, expert advice, and suggestions in the design, development, and coordination and implementation of the study objectives.
• NICHD Program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• NICHD Program Officer will make recommendations for continued funding based on: a) overall TRRP progress; b) cooperation in carrying out the research; and/or c) maintenance of high quality of research in alignment with the goals of this RFA.

Areas of Joint Responsibility include:

• The primary responsibility for the program resides with the Recipients, although specific tasks and activities will be shared among the recipient and the NICHD Project Scientist(s).
• Close interactions of the MPRINT TRRP with the MPRINT Hub to assure data integration with MPRINT knowledge portal.
• Close interactions between the TRRP SC and the Hub SC to assure logistic coordination with any relevant collaborating networks that will bring samples to the MPRINT program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients 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 RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Zhaoxia Ren, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-9340
Email: zren@mail.nih.gov

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Sarah Lee
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-2101
Email: sara.lee@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.

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.