Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

National Centers for Translational Research in Reproduction and Infertility (P50 Clinical Trial Optional)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-HD-19-017

Related Notices

NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research.

Funding Opportunity Announcement (FOA) Number

RFA-HD-21-012

Companion Funding Opportunity

None

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

93.865

Funding Opportunity Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Fertility and Infertility (FI) Branch, provides funding for a limited number of research centers in the reproductive sciences.  These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs in these scientific areas.  The centers also serve as national resources for the training and career development of junior scientists electing to pursue biomedical research careers in reproductive health.  Finally, center investigators develop and participate in community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public.

The purpose of this FOA is to announce the re-competition of the National Centers for Translational Research in Reproduction and Infertility (NCTRI).  The NCTRI will be administered through the Specialized Research Center (P50) award mechanism.  These centers will form a national network that facilitates and accelerates bidirectional knowledge transfer between the laboratory and clinic with the ultimate goal of improving human reproductive health through research excellence and innovation.

For this FOA, applications that address the 'omic (e.g., genomic, epigenomic, proteomic, metabolomic) bases of reproductive health and fertility will be strongly encouraged.  Particular emphasis will be on applications that go beyond correlative studies to address possible causality and contributions of variants to inherited reproductive health.  Although applications that are responsive to the scientific mission areas of the FI Branch will be accepted, meritorious applications addressing the 'omic bases of reproductive health will receive priority in making funding decisions.  Additionally, only two renewals (15 years of total NCTRI support) investigating the same biological question will be allowed.  

Key Dates
Posted Date

December 4, 2019

Open Date (Earliest Submission Date)

February 29, 2020  

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 31, 2020

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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.  No late applications will accepted for this Funding Opportunity Announcement.

AIDS Application Due Date(s)

Not applicable  

Scientific Merit Review

July 2020  

Advisory Council Review

October 2020

Earliest Start Date

December 2020  

Expiration Date

April 1, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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

  3. Table of Contents

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

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


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

    The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Fertility and Infertility (FI) Branch, provides funding for a limited number of research centers in the reproductive sciences.  These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs in this scientific area.  The centers also serve as national resources for the training and career development of young scientists electing to pursue biomedical research careers in reproduction and infertility.  Finally, center investigators develop and participate in community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public.  Accordingly, the purpose of this FOA is to announce the re-competition of the National Centers for Translational Research in Reproduction and Infertility (NCTRI).  The NCTRI will be administered through the Specialized Research Center (P50) award mechanism.  These centers will form a national network that facilitates and accelerates bidirectional knowledge transfer between the laboratory and clinic with the goal of improving human reproductive health through research excellence and innovation.

    Background

    One of the most basic of human drives - reproduction - is frustrated or denied by the occurrence of infertility in couples desiring children.  According to data from the National Survey of Family Growth, between 2011-2015, 6.7 percent of married women between the ages of 15-44 were infertile (12 months or longer without birth control and without a pregnancy).  While this represents a decline from the prevalence of 7.4 percent reported in 2002, about 11% of married women had impaired fecundity, i.e., the biological capacity to reproduce, in 2010 compared to 8.5% of married women in 1982.  This trend likely is indicative of the delay in childbearing found in the couple population base in which significant age-related increases in infertility and subfecundity have been reported.

    Physician office visits for infertility services have markedly increased over four-fold between 1968 and 2015 in the U.S. (>2,000,000 visits annually).  It is estimated that 12 percent of American women aged 15-44 receive infertility services at some point during their lifetime.  Of the infertile couples seeking treatment for infertility, it has been estimated that up to one half will be unsuccessful in achieving their desired outcome.  This increase in medical assistance has led to a rise in infertility service costs to more than several billion dollars annually.

    In couples struggling with infertility, approximately one third of infertility is attributable to the male partner, one third is attributed to the female partner, and one third attributed to either both partners or unknown factors.  For male factor infertility, the pathophysiology is either not understood at all or, at best, poorly understood.  The prognosis for male infertility treatment outcomes is extremely poor at present.  Indeed, whereas 80 percent of infertile women can be successfully treated, male infertility can be treated in only 10-20 percent of cases.  While intracytoplasmic sperm injection and other assisted reproductive technologies have enabled otherwise infertile men (and women) to have children, these technologies do not address the underlying causes of infertility, which could be passed down to future generations, and may also be linked to other health problems that will negatively impact the life of the child.  Female infertility is more likely to be successfully treated, yet the sociologic and economic consequences of female infertility can still be devastating.  Uterine leiomyomatas, polycystic ovary syndrome (PCOS), premature ovarian insufficiency (POI), idiopathic hypogonadotropic hypogonadism (IHH) and endometriosis all can negatively impact infertility, but the pathogenesis and etiology of these debilitating conditions are poorly understood.

    Data now firmly support the contribution of genetics in both male and female infertility.  In males, there is considerable evidence from animal studies that mutations in over 100 separate genes result in infertility.  More limited studies in humans show that several inherited diseases associated with abnormal sperm morphology and function are likely polygenic.  Similarly, it is estimated that 15-20 percent of human pregnancies are chromosomally abnormal as a result of division errors during oocyte meiosis or early embryonic cleavage.  Such errors are not only the leading cause of birth defects but may be the most important factor contributing to human infertility.

    It is becoming increasing apparent that, in addition to genetic contributions, non-genetic factors are involved in infertility and diseases of reproductive health, e.g., PCOS, endometriosis, and male infertility.  These non-genetic factors, collectively referred to as epigenetic mechanisms, include DNA methylation, RNA modifications, post-translational histone modifications, and non-coding RNAs (microRNAs, long non-coding RNAs).  Unlike alterations to the DNA that are ‘fixed’, epigenetic mechanisms are bidirectional, e.g., a histone may alternate between being acetylated or not depending on the transcriptional state of its associated gene.  These epigenetic mechanisms are responsible for how the genome interacts with the environment and changes in the epigenome are sporadic and differ from cell-to-cell.  This heterogeneity makes analyses difficult, although techniques now exist that permit the epigenome to be interrogated at the single cell level.  

    Recent scientific breakthroughs have allowed for unprecedented access to researchers studying the complexities of biological systems.  The explosion of 'omics technologies has allowed for a better characterization and quantification of the biological molecules that translate into the structure and function of a cell, organ, system, or organism.  These advances have also allowed for many of these 'omics technologies to be more affordable, a necessary advancement for the advent of a more personalized approach to healthcare.  The rise of 'omics technologies has led to “single-cell 'omics” – that is, the use of these powerful technologies on individual cells.  The combination of genetic factors such as genomics, transcriptomics, and proteomics, along with non-genetic factors such as epigenomics, metabolomics, and microbiomics could conceivably be used to better understand reproductive health and disease.

    The advent of multiomic approaches also has the potential to elucidate the relationship between fertility and overall health.  Multiple studies suggest that infertility is not necessarily a unique disease of the reproductive axis, but is often physiologically and/or genetically linked with other diseases and conditions.  Although it is well-established that many chronic diseases and conditions can impair fertility, less is known about the extent to which fertility status can act as a biomarker for overall health.  Recent epidemiologic studies demonstrate a link between fertility status and various somatic diseases and disorders and suggest that fertility status can be a window into overall health. The findings include both male and female reproductive function, and their association with cancer, as well as conditions of the cardiovascular, metabolic, and the immune systems.  Validation of the premise that fertility status can be a window into overall health would provide a valuable opportunity to affect future health during fertility evaluation, allowing early intervention in serious, chronic somatic diseases and conditions.

    The FI Branch recognizes that the interactive needs of basic and clinical research necessary to address the above and related problems may be so complex that they cannot be solved by individual investigators working alone.  Therefore, it is the intention of the branch, contingent upon the availability of funds, to continue supporting multi-component reproduction and infertility research programs that focus on topics of high priority and significance that are critically important to the mission of the FI Branch and NICHD, and that address important reproductive health concerns of the American public.

    NICHD Strategic Plan

    The continuation of the NCTRI reproductive centers program directly aligns with the NICHD Strategic Plan.  In 2018, NICHD initiated a process to develop a new strategic plan that would provide a guide for the research NICHD supports over the next several years.  In September 2019, the Plan was announced and “focuses the institute’s research and training efforts to understand human development, improve reproductive health, enhance the lives of children and adolescents and optimize abilities for all.”  One of the five research themes announced is: Promoting Gynecology, Andrological and Reproductive Health with the goal to “enable women and men to manage fertility and minimize the impact of gynecologic and andrologic conditions in support of lifetime reproductive health.”  A focus on this topic is appropriate as NICHD accounts for almost one half (47%) of NIH spending on reproductive health and supports more research in this area that any other NIH institute or center.  One priority of this theme is to “identify biologic, social, and environmental factors that can lead or contribute to idiopathic female and male infertility and/or early pregnancy loss.”  Such understanding will likely lead to treatments for conditions that affect the male and female reproductive systems.  This research theme highlights the integration of ‘omics and novel model systems. 

    Another Strategic Plan research theme is: Understanding Early Human Development.  Further knowledge of development is critical for understanding various reproductive processes.  Here, the scientific opportunity is to capitalize on newly available technology with the role of various 'omics technologies particularly highlighted to identify developmental processes.  A third research theme is: Setting the Foundation for Healthy Pregnancies and Lifelong Wellness.  One scientific priority is the characterization of pre-pregnancy factors involved with gamete quality and parental health.  A fourth research theme that aligns with reproductive health is: Improving Health During the Transition from Adolescence to Adulthood.  Both male and female causes of infertility can arise due to mis-regulation during important developmental timepoints, such as the adolescent to adulthood transition.  In addition to the research themes is a series of cross-cutting topics integrated into a particular scientific area.  One such topic is nutrition and its role on reproductive health and fertility; ‘omic technogies, including metabolomics is highlighted. 

    Thus, the goals of this FOA work in synergy to directly address the scientific goals outlined in the NICHD Strategic Plan.  Additionally, the use of 'omics technologies in the pursuit of these research themes is also in agreement with the plan.

    Objectives

    A major objective of the NCTRI is to support specialized translational reproductive research programs of high quality, and to facilitate and accelerate bidirectional transfer of knowledge between the laboratory and clinic.  This process of translating research between the laboratory and clinic is a continuum that encompasses all aspects of knowledge transfer from non-human animal models to humans.  The ultimate goal of supporting translational research through the NCTRI is to improve human reproductive health.

    This FOA is specifically designed to stimulate the reproductive sciences research community to organize and maintain research-based centers of outstanding quality that, serving as national research resources, form a centers program that fosters communication, innovation and high-quality reproduction and infertility research.  To facilitate networking and collaboration, investigators will have opportunities to participate in various Research Focus Groups, comprised of investigators from multiple centers who have similar research interests in various aspects of reproductive health.

    Research Scope

    The NCTRI is comprised of research-based center grants designed to support interactive groups of research projects and supporting core service facilities.  The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the specific research topic areas discussed in this FOA.  These centers may have more than one focus or emphasis, but all the research projects involved must address one or more of the specific research areas of reproduction supported by the FIB.  Furthermore, the objectives of this Program require that at least one of the research projects be entirely or predominantly clinical, and that all basic science projects be linked to the clinical project (s) of the center. 

    These topics listed below identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to fertility regulation, as well as of diagnostic tools and procedures for the detection and effective management of reproductive disorders that impact on reproductive competence.

    • Reproductive Developmental Biology: origins and maintenance of male and female gametogenesis from fertilization to adulthood
    • Reproductive Tract Biology and Physiology: the proper formation and function of the male and female reproductive tracts
    • Reproductive Endocrinology and Neuroendocrinology: mechanisms of hormone synthesis, secretion, regulation, and action in the context of reproduction
    • Reproductive Medicine: etiology, pathophysiology, prevention, and management of male or female infertility (including fertility preservation)
    • Fertility Status as a Biomarker for Future Health: the linkage between fertility status and overall fitness

    Additionally, the use of 'omic methodologies, particularly multiomic approaches that combine and synthesize data from multiple 'omic datasets, are strongly encouraged to apply; meritorious applications incorporating these approaches will be given priority in making funding decisions.  These 'omics technologies would include, but are not limited to genomics, transcriptomics, proteomics, epigenomics, metabolomics, metallomics, and microbiomics.

    Because this list of topics is not meant to be all-inclusive, prospective applicants preparing either a new or renewal center grant application are encouraged to discuss program relevance issues with the Scientific/Research Contact indicated in Section VII. Agency Contacts.  However, applicants should note that the research scope of this FOA does not include studies in the areas of:

    • Gynecologic diseases, e.g., endometriosis, PCOS, except when the study directly relates to infertility
    • Reproductive oncology, reproductive toxicology, reproductive epidemiology, post-implantation pregnancy and parturition or other areas that are out-of-scope of research supported by the FI Branch

    Further, applications proposing research activities focused exclusively on basic research or applications or components thereof proposing large scale clinical trial research will not be considered responsive to this FOA.  Additionally, only two renewals (15 years of total NCTRI support) investigating the same biological question will be allowed.

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

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    Renewal (only two renewals are allowed)
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The NICHD  intends to commit $3.2 million in FY2021 to fund up to two awards.

    Award Budget

    Application budgets may request a budget for direct costs of no more than $1.0 million/year.

    Award Project Period

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

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)
    • 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 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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

    Stuart B. Moss, PhD
    Telephone: 301-435-6979
    Fax: 301-480-2389
    Email: mossstua@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    12

    Admin Core (use for Administrative Core)

    6

    Project (use for Research Project)

    12 (for each project)

    Educ Outreach Core (use for Education/Outreach Core)

    6

    Tech Service Core (use for Technical Services Core)

    6

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

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    Overall: required

    Administrative Core: required; maximum 1

    Research Projects: required; minimum 2, maximum 4.  At least one of the research projects must be entirely or predominantly clinical, and all basic science projects be linked to the clinical project(s) of the center. 

    Educ/Outreach Core: required; maximum 1

    Tech Service Core: optional; minimum 0, maximum 2

    Overall Component

    When preparing your application, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

    Specific Aims: Include Specific Aims for the overall P50 project  

    Research Strategy: Describe the major themes of the overall Center, its goals and objectives, background information and the overall importance of the research to the theme of this program.  Explain the strategy for achieving the goals defined for the overall program and how each Research Project and Core relate to that strategy.  Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, and how the combined resources create an overall program that is more than the sum of its parts.  Include all necessary tables, graphs, figures, diagrams and charts in this section.  In addition, provide the following information:

    • History, Purpose, and Objectives of the Program

    Discuss the overall program's objectives and general plans for the proposed grant period, including research grant history (as a P50 and/or U54 center) with yearly funding level, if appropriate. 

    • Administration, Organization, and Operation

    Include information on the support and commitment of the parent institution for the program, the authority and qualifications of the PD(s)/PI(s).  Describe organizational framework and provide an organizational chart.

    • Research Program>

    Discuss the proposed research program, highlighting its central theme.

    • Description of Assurances and Collaborative Agreements

    Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Letters of Support for these arrangements are included as described below.

    Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants.  Letters of support for the overall Center should be included with the Overall Component. Letters of support for individual Research Projects or Cores should be included with those components of the application. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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

    All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.  The Data Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.  It is expected that the results of NICHD-funded research will be shared with the wider scientific community in a timely manner. 

    Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype “dbGaP” (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub “DASH” (https://dash.nichd.nih.gov/) or other equivalent broad-sharing data and/or biospecimen repositories.”

    The following resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing: https://www.nlm.nih.gov/cde/

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.  For a given study, the PHS Human Subject and Clinical Trial study record form should only be completed once. The PHS Human Subjects and Clinical Trial study record form for each study should be placed in the most relevant section of the application, e.g., Research Project, Education and Outreach Core (if applicable).

    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

    PHS Assignment Request Form (Overall)

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

    Administrative Core

    When preparing your application, use Component Type ‘Admin Core.’

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Administrative Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Administrative Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
    Budget (Administrative Core)

    Budget forms appropriate for the specific component will be included in the application package.

    The budget for the Administrative Core must include $50,000 direct costs per year to support pilot studies.  Procedures should be in place to ensure that new faculty/senior trainees are provided with funds to develop projects, and that these projects are within the scope of the Center. 

    Funds should be allocated for the PD(s)/PI(s) of the center and the Leads of the Projects and Cores to attend up to two meetings a year, one a meeting of the most appropriate Research Focus Group (a group of investigators from multiple centers with similar research interests, e.g., male infertility), and one the Research Meeting or the Center Directors' meeting, occurring in alternative years.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Administrative Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Administrative Core.      

    Research Strategy: The Administrative Core will provide oversight for the Cores and Research Projects, and will promote coordination and collaboration within the program and with investigators and organizations outside the program.  The Research Strategy should describe the planning and coordination of research activities, the integration of cross-disciplinary research, allocation of funds, management of resources and quality control, the maintenance of ongoing communication, and plans for evaluation of the Center Project by internal or external advisory committees.  Indicate who will be responsible for each of these activities.  Include a description of the process by which pilot/collaborative projects will be selected and evaluated for potential funding.  For example, are the various advisory committees, both internal and external consulted during this process?  Are pilot projects from new investigators particularly encouraged? 

    For the Administrative Core, provide the following information:

    • Objectives of the Administrative Core
    • Staffing: Description of administrative, scientific, technical, and support staff who are not designated as Key Personnel.
    • Resources: Description of how Administrative Core resources will contribute to the objectives of the Research Projects.
    • Services provided: Description of the services provided to other Cores and Research Projects.
    • Administration: Description of the strategies and processes that will be used to manage the Center and achieve the overall goals.
    • Use of advisory committees; do not list specific members for any external advisory committees.  This list should only include the type of expertise needed to advise Key Personnel of the Program Project.  If the center is funded, the PD(s)/PI(s) will be asked to name an external advisory committee. 
    • Method of determining Core access and space assignments.

    Describe structures for day-to-day management of the Center, including arrangements for internal quality control of ongoing research.

    Letters of Support: Include Letters of Support specific to the Administrative Core.

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

    Do not include a Resource Sharing Plan for this component.  Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component..

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

    Education/Outreach Core

    When preparing your application, use Component Type ‘Educ Outreach Core.’

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

    SF424 (R&R) Cover (Education/Outreach Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Education/Outreach Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Education/Outreach Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Education/Outreach Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Education/Outreach Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Education/Outreach Core)

    Budget forms appropriate for the specific component will be included in the application package.

    This core must have a separate budget of $50,000 direct costs per year to support activities related to community outreach and dissemination.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Education/Outreach Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Education/Outreach Core.   

    Research Strategy: Provide the following information:

    • Objectives of the Core: This core provides funds to support activities related to community outreach and education. 
    • Staffing: Description of scientific, technical, and support staff who are not designated as Key Personnel.
    • Resources and Services provided: Investigators are required to describe a plan for disseminating information and providing awareness experiences for community members including students, families and other health-care professionals.  Examples of activities that would address this important aspect of the center include development of a web site for the public that includes tutorials, laboratory-based learning experiences, seminars and involvement of the community on external advisory boards.
    • Management: Description of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control.
    • Utilization of Core: Provide a description of the activities and target audiences for the required Education/Outreach Core.

    Letters of Support: Include Letters of Support specific to the Core.

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

    • Do not include a Resource Sharing Plan for this component.  Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. 

    PHS Human Subjects and Clinical Trials Information (Education/Outreach Core)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

    Technical Service Core

    When preparing your application, use Component Type ‘Tech Service Core.’

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

    SF424 (R&R) Cover (Technical Service Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Technical Service Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Technical Service Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Technical Service Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Technical Service Core)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Technical Service Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Technical Service Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims:  Include a brief list of Specific Aims outlining the objectives and functions of the Core.    

    Research Strategy: Provide the following information:

    • Objectives of the Core
    • Staffing: Description of scientific, technical, and support staff who are not designated as Key Personnel.
    • Resources and Services provided: Description of current and projected services to other Core and Research Components, as well as the process for prioritizing requests for use of Core facilities by the various Research Projects.  If a Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant developments.  Describe how the quality of services provided will allow investigators to achieve their research goals.
    • Management: Description of overall management of the Core, decision-making process for use of Core services, and plans for cost-effectiveness and quality control.
    • Utilization of Core: Provide a summary of past and/or projected usage of Core services (e.g., assays performed, animals supplied, etc.).  Include estimates of the percentage use of each Core unit by the affiliated Research Project components.  

    The applicant may choose one of two center structure options regarding access to Technical Service Core facilities:

    • Closed Access Structure:  In this center structure, administrative and all technical service cores will be utilized by budgeted center Research Projects only.  Consistent with NICHD guidelines for establishment of core facilities, utilization by at least two research projects is required to justify a Technical Service Core facility.  Percent utilization by any one of the two Research Projects justifying the core may not exceed 50 percent or be less than five percent.  The percent utilization of additional projects requiring core services may be less than five percent.  Costs necessary to use a particular core facility may be incorporated into the budget of the core unit, and not in the budgets of the Research Projects per se.  No internal charge-back system would be required.
    • Open Access Structure:  In this center structure, budgeted center research projects, as well as research projects external to the Center (e.g., R01, R03, R21, P01 subproject), may have access to technical service cores.  However, special consideration must be given to justification of a technical service core facility and the formal establishment of an effective charge-back system for all technical service cores.  For each core service facility, at least one of the projects used to justify a core must be a budgeted center Research Project, while the remaining project(s) used in justifying the core may be externally funded NICHD projects administered by the FI Branch.  Percent utilization by any internally budgeted Research Project or externally funded FI Branch project used to justify a particular core facility may not exceed 50 percent or be less than five percent.  Additional federally funded, peer reviewed external research projects addressing program relevant research areas of the FI Branch may access the core up to 100 percent of its service capacity.  Centers must establish an internal management policy for evaluating the acceptability of proposed FI Branch program relevant external projects to access the core facilities.  Approval of requests for core access privileges for external projects which would replace those described above must be made to FI Branch Program Staff who then will evaluate the extent to which the project is relevant to FI Branch mission research areas (see Research Scope), and render a decision accordingly.
    • If centers choose to operate in an open access format, the PD/PI must have in place, and adequately describe in the application, management policies that ensure that budgeted center Research Projects are given highest priority in receiving services provided by the core.  Costs necessary to utilize a particular core facility by budgeted center Research Projects must be incorporated into the budget of the project and not the core budget in order to accommodate participation in the required charge-back system.  Core budgets will be justified and evaluated based on access by budgeted center projects and external, program relevant research projects as described above.  Above and beyond this arrangement, technology based core units may offer services to additional external projects addressing any area of research regardless of funding source only on a full payback (fee for service or in-kind) basis.  However, additional funds necessary to provide services to these external projects (e.g., technical support, supplies, etc.) must come from sources other than the center funding, such as the supply budgets of the external projects wishing to access the core facilities.
    • Centers choosing to configure in an open access center format may propose one or more technical service cores that will be utilized exclusively by budgeted center Research Projects.  These centers may, therefore, have a mix of open and restricted access technical service cores.  On the other hand, the Administrative Core in open center structures may be accessed only by budgeted center projects.
    • Once an award is made, centers configured as a closed access center structure may, at a later time, choose to convert to an open access center structure by requesting such conversion in writing to the NICHD.  

    Letters of Support: Include Letters of Support specific to the Core.

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

    Do not include a Resource Sharing Plan for this component.  Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

    PHS Human Subjects and Clinical Trials Information (Technical Service Core)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

    Research Project

    When preparing your application, use Component Type 'Project.’

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

    SF424 (R&R) Cover (Research Project)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates

    PHS 398 Cover Page Supplement (Research Project)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Project)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Research Project)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Research Project)

    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

    Budget (Research Project)

    Budget forms appropriate for the specific component will be included in the application package.

    There should be at least 1.8 person months effort on the part of the Project Lead and at least a total of 2.4 person months effort for the PD/PI of the center.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Research Project)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: Include a brief list of Specific Aims outlining the objectives and functions of the Research Project.   

    Research Strategy:  Following the instructions in the SF424 (R&R) Application Guide, start each section with the appropriate section heading—Significance, Innovation, Approach. Cite published experimental details and provide the full reference in the Bibliography and References Cited section of the Other Project Information form. Clearly describe the project's objectives and explain its relevance to the overall program's theme.  Specify the underlying scientific premise and biomedical significance of the work proposed.  As part of the Research Strategy, include information on preliminary studies, data, and/or prior experience pertinent to this application. Discuss rigor and reproducibility of the study.  Provide a consideration of sex and other biological variables.  For renewal applications, provide a Progress Report.  Describe the Research Project's use of Core services, including why the services are needed and the advantages and cost effectiveness of Core usage for the Project.

    Letters of Support: Include Letters of Support specific to the Research Project.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.  As discussed, investigators are encouraged to utilize the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from NICHD-funded studies (https://dash.nichd.nih.gov/).  The website provides guidance for storing data in DASH.  Submission of data to the NICHD DASH is one way that grantees may meet the expectations of the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information (Research Project)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

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

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

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    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) and component Project Leads 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.

    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 (SAM). 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    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.

    In addition, for applications proposing clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center 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 center proposed).

    Center as an Integrated Effort

    The overall P50 Center will be evaluated as an integrated research effort focused on one or more research areas listed under Research Scope.  The relationship and contributions of each Research Project and Core to the overall objectives will be discussed and evaluated. Reviewers will assign an impact score based on assessment of the scientific and technical merit of the Center overall. The assessment will take into consideration all proposed Research Projects and Cores, including any with poor ratings. The review will assess the level of merit of the Center as an integrated effort, including the following criteria:

    • Will there be coordination, interrelationships, cohesiveness, and synergy among the research projects and core components as they relate to the common theme of the Center?
    • Are there clear advantages of conducting the proposed research as a program rather than through separate research efforts? Will the research efforts taken together have more impact on the field than each separate project conducted in isolation?  Will the research proposed in individual projects be enhanced by the Center?
    • Are mechanisms proposed for regular communication and coordination among investigators in the Center?
    • Are administrative structures in place for effective day-to-day management of the Center, including arrangements for internal quality control of ongoing research?
    Scored Review Criteria - Overall

    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 center that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the center 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?

    In addition, for applications involving clinical trials:

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

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

    In addition, for applications involving clinical trials:

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? 

    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?

    In addition, for applications involving clinical trials:

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?  

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the center? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the center 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?     

    In addition, for applications involving clinical trials:

    Does the application adequately address the following, if applicable?

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    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? 

    In addition, for applications proposing clinical trials:

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria - Overall

    As applicable for the center 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.

    Study Timeline

    Specific to applications proposing clinical trials:

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls

    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 centert 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 following:

    • Has sufficient progress been made in the last funding period relative to the original goals of the project?
    • Has the project contributed to the translational goals of the center, defined as knowledge transfer from non-human models to humans as well as humans to non-human models?
    Revisions

    Not applicable

    Additional Review Considerations - Overall

    As applicable for the center 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 .

    Authentication of Key Biological and/or Chemical Resources

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

    Budget and Period of Support

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

     
    Additional Review Criteria - Cores

    As applicable for each individual Core, reviewers will provide an assessment of its strengths and weaknesses. In particular, the following items should be evaluated while determining scientific and technical merit, and in providing an overall Impact Score for the core; however, separate scores will not be given for these items.

    For the Administrative Core:

    • Does the Core Lead have sufficient experience in research administration?
    • Is there a decision-making process within the proposed center for the evaluation of research productivity, for allocation of funds and for management of the resources? 
    • Is there a plan for center evaluation, including the use of any internal and external advisory groups? 
    • Is there an effective process by which pilot/collaborative projects will be selected and evaluated for potential funding?

    For the Education/Outreach Core:

    • Are the qualifications, experience, and commitment of the Core Lead and other core personnel appropriate?
    • Does the applicant describe an effective plan for outreach/education activities? 
    • Will the activities result in a better comprehension by the community of the objectives and goals of the NCTRI, a greater appreciation for research progress made as a result of funding and a better understanding of the implications of NCTRI-supported research for reproductive health? 
    • Are efforts made to include community representatives on advisory committees?

    For the Technical Service Cores:

    • Are the qualifications, experience, and commitment of the Core Lead and other core personnel appropriate?
    • Will the quality of services provided enable center investigators to achieve their research goals?
    • Is there cost effectiveness in the core; will quality control measures be taken for core procedures?
    • Is the use of core services by the budgeted center projects and, if applicable, by external projects appropriate?
    Scored Review Criteria - Research Projects

    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 center that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the research project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous?  If the aims of the center 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?

    In addition, for projects involving clinical trials:

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

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

    In addition, for applications involving clinical trials:

    With regard to the proposed leadership for the project, do the Project Lead(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? 

    Innovation

    Does the research project 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?

    In addition, for applications involving clinical trials:

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the research project? Have Project Lead(s) included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    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?     

    In addition, for research projects involving clinical trials:

    Does the research project adequately address the following, if applicable?

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    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 research project proposed? Will the research project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

    In addition, for research projects proposing clinical trials:

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the research project adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the research project adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria - Research Projects

    As applicable for the research 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.

    Study Timeline

    Specific to applications proposing clinical trials:

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls?

    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 centert 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 research project 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 following:

    • Has sufficient progress been made in the last funding period relative to the original goals of the project?
    • Has the project contributed to the translational goals of the center, defined as knowledge transfer from non-human models to humans as well as humans to non-human models?

    Revisions

    Not applicable

    Additional Review Considerations - Research Projects

    As applicable for the center 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 .

    Authentication of Key Biological and/or Chemical Resources

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

    Budget and Period of Support

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

    2. Review and Selection Process

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

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

    Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/. 

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

    Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

    Prior Approval of Pilot Projects

    Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. 

    2. Administrative and National Policy Requirements

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

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    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 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.

    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. 

    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.

    Application Submission Contacts

    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: 301-945-7573

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

    Scientific/Research Contact(s)

    Stuart B. Moss, PhD
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD))
    Telephone: 301435-6979
    Email: mossstua@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Margaret Young
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD))
    Telephone: 301-642-4552
    Email: margaret.young@nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.    

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