NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

Part 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

The purpose of this funding opportunity announcement (FOA) is to announce a re-competition of the Research in Pediatric Developmental Pharmacology (RPDP) Centers Program.  Applications are sought from investigators to collaborate with the NICHD under a cooperative agreement in a translational multidisciplinary research program. Individual investigators will be expected to work with NICHD staff and other investigators to facilitate research collaborations.  This cooperative program is unique in the sense that it will form a national network that facilitates and accelerates bidirectional knowledge transfer between the laboratory and clinic with the ultimate goal of improving the use of pediatric medicines through enhanced communication, innovation and research excellence. The Centers also will serve as a national resource to educate junior scientists electing to pursue careers in the conduct of research in this area.

Children have been termed the therapeutic orphans of medicinal products due to the lack of adequate dosing, efficacy and safety information and age appropriate formulations. During the past two decades, the Federal government has implemented several initiatives to address this issue. Among the initiatives were the establishment of the Pediatric Pharmacology Research Units (PPRU) Network by the NICHD in the National Institutes of Health, and the enactment of several laws and regulations intended to mandate or offer incentives to develop essential information and products for pediatric use. Despite several years of experience with these multiple initiatives, the knowledge gaps in this field remain.

NICHD has recognized that among the reasons for these gaps are the limited number of experts in pediatric pharmacology and the lack of tools and knowledge to reach the public health goal of equality for children. Essential information such as developmental changes in metabolism, clinical research outcome assessments, assay and analytic techniques calibrated for pediatric use and predictive non-clinical models is lacking for most pediatric populations.

In an organized effort to address the future of pediatric developmental pharmacology, the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB) funded the first four RPDP Centers in 2011. The currently funded Centers have been very productive and remarkable progress has been made over the past few years. However, significant knowledge gaps remain in the field.

NICHD now seeks to establish the next cycle of RPDP Centers.  By issuance of this FOA, NICHD seeks to continue exploring and extending the frontiers of methods and knowledge in the field of pediatric developmental pharmacology. Specifically, NICHD seeks knowledge relating to such topics as the mechanistic basis for developmental changes in drug disposition and effect, suitable laboratory assays, age-appropriate clinical research outcome assessments, and new product delivery paradigms.

OPPTB recognizes that the interactive needs of basic and clinical research necessary to address these challenges may be so complex that they cannot be solved by individual investigators working alone.  Therefore, contingent upon the availability of funds, OPPTB seeks to establish and maintain organized, multi-component pediatric pharmacology research programs of high quality that focus on topics that are critically important to the mission of OPPTB, and also will address important health concerns of the American public.

A major objective of the RPDP is to support specialized translational pharmacology research programs of high quality, and to facilitate and accelerate the 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.  For example, the application of information from rodent species to non-human primates is considered part of the translational continuum.  However, the ultimate goal of supporting translational research through the RPDP is to improve the understanding and utilization of medicinal products in children. 

This FOA is specifically designed to stimulate the pediatric pharmacology research community to organize and maintain research-based Centers of outstanding quality that, serving as national research resources, form a cooperative network with NICHD that fosters communication, innovation and high quality pediatric developmental pharmacology research.  Such networking as afforded by the cooperative nature of this Centers Program will ensure that the pediatric pharmacology research community remains in the forefront of the development and utilization of new technologies that can be used to understand developmental pharmacology.

The RPDP will be comprised of research-based cooperative agreements designed to support interactive groups of research projects and core service facilities.  The research activities included in these Center awards must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the specific research topic areas announced in this FOA (see below).  These Centers may have more than one theme, focus or emphasis, but all of the subprojects involved must be responsive to one or more of the specific research areas of pediatric pharmacology supported by OPPTB.  Furthermore, the objectives of this Program require that one of the projects be entirely or predominantly clinical and that all basic science projects be linked to the clinical component(s) of the Center.

Topics that are considered to be responsive to the research mission areas of OPTPB include but are not limited to those bulleted below.  Additionally, these topics identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to pharmacology research, as well as of diagnostic tools and procedures for the detection, treatment and effective management of pediatric disorders.

• Establish predictive non-clinical models including animal studies, cell, tissue and organ-based systems, computational and systems modeling, and integration of signals and information from multiple systems to evaluate response- and age-specific toxicity, particularly neurologic and behavioral effects.
• Establish interdisciplinary approaches that utilize non-clinical approaches integrated with clinical approaches to understand developmentally specific responses and toxicities. An example may include non-clinical studies used to understand observations from a clinical study that would not be feasible or ethical to perform in clinical settings.
• Perform non-clinical and clinical research to understand mechanisms of age- and developmentally- related changes in metabolism and response to medicinal products.
• Pursue research into developmental changes in metabolism in different pediatric populations which would be clinically significant.
• Develop outcome measures and PD assessments that are age-appropriate to determine response or toxicity. Of particular interest are assays or assessments that can be performed across age groups and can also be performed in a non-clinical setting, and calibrated for each population.
• Establish assays and analytic procedures that have the sensitivity, reproducibility and value to inform pediatric medicinal product development and use.
• Incorporate the use of medicinal products as tools to understand developmental metabolism and pharmacology.
• Develop new techniques that provide greater precision or information about pediatric developmental pharmacology methods or outcomes.

Applications proposing research activities focused exclusively on basic research, applied research in the support or performance of known and established pharmacologic assays, or analysis in support of ongoing clinical trials or applications or components thereof, or proposing epidemiological or large-scale clinical trial research, will not be considered responsive to this FOA.

Minimal requirements:

Minimal requirements for a Center described in this FOA are as follows:

• A research plan that is responsive to the objectives of the Centers Program set forth in this FOA (see Objectives and Research Scope).
• At least two research projects that thematically address one or more research areas listed under Research Scope.  It is required that one project is entirely or predominantly clinical in nature, and that all basic science projects be linked to the clinical component(s) of the center.  For purposes of this FOA and consistent with the NIH definition, clinical research must be conducted with human subjects (or on material of human origin such as tissues and specimens) for which an investigator (or colleague) directly interacts with human subjects.  Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to living individuals.
• An Administrative Core that provides oversight to the Center, located at the applicant institution and accessed only by budgeted Center projects and cores.

The Administrative Core will have funds to support collaborative projects with investigators supported by other RPDP Centers and/or pilot studies.  In the case of pilot projects, it is encouraged that the center use the funds to support New Investigators. Centers are encouraged to also utilize these funds for conduct of clinical research studies that could form the basis for large scale clinical trials through other NIH funded clinical research programs.  A center can use these funds to support pilot studies even if a separate pilot project(s) was approved in the funded application (see below under Optional Components).  These funds will be requested as part of the Administrative Core budget, and will be restricted for use to support collaborative and/or pilot projects. Support for a particular collaborative research activity or pilot project is limited to two years.

This Core will also have funds to provide translational research experiences for students, postdoctoral fellows or residents from other Centers, post-residency scholars supported under institutional K12 awards such as the CTSA, and other training programs.  These funds will be requested as part of the Administrative Core budget, and will be restricted for cross-center research experiences.  Funds can be used for research expenses or travel.  Center investigators are particularly encouraged to provide experiences for under-represented minority groups, those with disabilities and those who wish to re-enter an active research career after taking time to care for children or attend to other family responsibilities. 

As part of the Administrative Core, Center investigators may optionally conduct community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public.

Optional Components:

Optional Components of the Center organization include the following:

• Pilot Projects: Funds may be requested in the original application to provide support for one or more pilot projects in Years 1 and 2 relevant to the center’s goals.  Pilot projects may be used to generate preliminary data for submission of an R01 or center project, to develop new technologies that further enhance the research efforts of the center or to support clinical research studies that could form the basis for conduct of large scale clinical trials through other networks or programs.  Support for a pilot project is limited to a two-year period.  Funding may not exceed $50,000 per year.  With NICHD staff approval, the period of support may be extended one additional year.  The proposed research plan must be described in sufficient detail, comparable to the other projects submitted in the application, to permit evaluation of the project using the review criteria listed under Section V Application Review Information with the exception that little or no preliminary data are required for a pilot project.  If a pilot project is favorably recommended for an initial two-year period, funds will be included each year for the full five years.  Funds in Years 3-5 will be contingent upon review and approval of additional pilot projects by the Steering Committee. Funding levels in these out-years will be based on the level of funding for this purpose in Years 1 and 2.

Program Coordination and Management Structure:

Overall coordination of the RPDP, consistent with the stated objectives set forth in this FOA (see Objectives), will be done by a Steering Committee consisting of all Center Program Directors/Principal Investigators (PD(s)/PI(s)) and an NICHD Project Scientist from the OPPTB, NICHD.  The Steering Committee will employ a consensus decision process to guide the RPDP in evaluating the progress of member Center programs, their proposed new research initiatives within the general scope of the approved program, the need to provide the entire RPDP network of Centers with access to new technologies, the need for collaborations either within or outside the RPDP network, and the need to redirect certain efforts of member Centers due to either sufficient data acquisition to permit conclusion, the acquisition of data supporting an alternative study initiative or experience proving that the proposed research is no longer feasible, or, in the case of RPDP-wide resources, lack of utilization. Collaborative and/or pilot projects will be proposed by the center PD(s)/PI(s) and reviewed and selected for funding by the Steering Committee.

In addition to the Steering Committee, smaller cooperative groups will be formed that consist of research components of member Centers having common research interests addressing a specific basic and/or clinical research problem.  These Research Focus Groups will perform coordinated research activities as recommended by the RPDP Steering Committee, subject to peer review.  In turn, progress of the Research Focus Groups will further guide the Steering Committee in decision-making regarding changes in specific research directions, translational activities, collaborative research projects and support of new resources.  The Research Focus Group will consist of an NICHD Staff liaison from OPPTB, NICHD, and relevant Project Leads or Core Leads. Further details of the guidance and management structures and processes may be found under Section VI.2. Cooperative Agreement Terms and Conditions of Award .

Travel to Meetings:

PD(s)/PI(s), Project Leads, and Core Leads are expected to participate in the annual Steering Committee Meeting as well as two research focus group meetings. 

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

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

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).

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

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise 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.

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

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:

Ekaterini Tsilou, MD
Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD)
6100 Executive Blvd, Rm 4A01H, MSC 7510,
Bethesda, MD 20892-7510
Telephone: 301-496-6287
Fax: 301-480-2897
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core (use for Administrative Core)	12 pages
Research Project (use for Research Project - Clinical Project; and Research Project - Basic/Translational Project)	12 pages
Pilot Project	6 pages

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Project - Clinical Project: one required
• Research Project(s) - Basic/Translational Project: one required, two maximum
• Pilot Project(s): optional, 2 maximum

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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.

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.

Specific Aims: State the overall goals of the Center. The Specific Aims should not be the same as the specific aims of the other components, but should be overarching and at a high level.

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 as outlined in the Section I, Funding Opportunity Description. Explain the strategy for achieving the goals defined for the Center and how the Administrative Core and each Research Project relate to that strategy. Describe the organizational structure of the Center, including how the components of the Center and any existing resources of the institution(s) will be leveraged by the Center. Explain how the different aspects of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the Center, and how combined resources create a Center that is more than the sum of its parts. Explain how administrative structures and day-to-day management of the program will efficiently support the center's function

Letters of Support: Include letters of support/commitment for the overall Center.

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

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

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Center Director 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 forms appropriate for the specific component will be included in the application package.

The PD/PI (Center Director) must commit 2.4 person months (20%) full-time professional effort to administrative activities directly related to the Center. One or more Associate Directors may be named as well, but the combined efforts for the Center Director and the named Associate Directors should not exceed 6 person-months effort (equivalent to 50% full-time professional effort).

The budget for the Administrative Core must include $30,000 direct costs per year to support translational research experiences. The funds will provide translational research experiences for students, postdoctoral fellows or residents from other Centers, and post-residency scholars supported under NIH institutional training awards or career development programs.

The budget of the Administrative Core may include up to $50,000 direct costs per year to support collaborative projects with investigators supported by other RPDP Centers and/or pilot projects.  These projects could form the basis for large scale clinical trials through other NIH funded clinical research programs.  These funds will be restricted for use to support collaborative and/or pilot projects pending review and selection by the RPDP Steering Committee. Support for a pilot project is limited to a two-year period.

Steering Committee Meetings:   The SC will meet in person once a year throughout the project period. The Administrative Core should also include funds for PD(s)/PI(s), Project Leads, and Core Leads to travel to the annual SC meeting as well as two research focus group meetings. 

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.

Specific Aims: Describe the specific aims of the Administrative Core.

Research Strategy: Describe the organization of the Administrative Core and the importance to the research theme of the Center. The Administrative Core will be responsible for the management and administration of the overall Center. This section of the application should describe the strategies and processes that will be used to manage the Center and achieve the goals.  The Administrative Core will also provide the coordination and communications with the other Centers for potential collaborative clinical studies. 

The Administrative Core, led by the Center Director, will provide oversight for the projects and promote coordination and collaboration within the Center and with investigators and organizations among the other Centers. A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; and the maintenance of ongoing communication. Indicate who will be responsible for each of these activities. Applicants should specify appropriate administrative/business management staff and oversight mechanisms by the Center Director, Associate Director, and/or a local Executive Committee. When multiple performance sites are planned, the Administrative Core should include leadership and communication plans adequate to manage the multiple sites.

The Research Strategy should include a description of the process for reviewing and selecting collaborative and/or pilot projects. In the case of pilot projects, it is encouraged that the center use the funds to support new investigators.

The Centers will play leadership roles in providing research experience for new investigators in the pediatric developmental pharmacology field. Each Center should include plans to establish and maintain an educational environment for pre-doctoral and/or postdoctoral fellows, including clinical fellow investigators in the field of pediatric developmental pharmacology. Each Center must coordinate and integrate research experiences across the Centers with a goal of aiding the development of a new cadre of cross-disciplinary scientists in the field of pediatric developmental pharmacology. Participation of students, postdoctorates, and early-stage scientists from existing training and career development programs is encouraged.

Outreach/Education activities may be organized as optional services provided by the Administrative Core. Outreach can be targeted toward the general public or groups of professionals not specialized in Pediatric Developmental Pharmacology and can include activities such as presentations, flyers, interviews in radio/TV stations/newspapers, websites etc.

The Administrative Core should also establish an Executive Committee, composed of members of the Center, as well as an Advisory Committee, composed of people outside the Center. Members of the Advisory Committee should not be contacted before submission or named in the application. Describe how the Center Advisory Committee will contribute to oversight of the research projects, core facilities and the educational environment of the Center. The Center Advisory Committee should meet approximately once a year and brief reports of the proceedings of the meeting and recommendations of the committee should be included in the progress reports of the Center. Describe plans for working with the Center Advisory Committee.

Letters of Support: Include any letters of support specific to this component.

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

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

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

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

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

When preparing your application in ASSIST, use Component Type Research 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 - Clinical 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 - Clinical Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project - Clinical 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 - Clinical 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 - Clinical 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.
• The Project Lead of the Clinical Research Project should be a board-certified medical doctor, trained in the area of interest, and experienced in research design, participation in and implementation of collaborative clinical research/trials.
• Senior/Key personnel of the Clinical Research Project should include a clinical pharmacologist who will assist the Project Lead in designing and conducting the clinical study.
• A statistician should be designated in the application to demonstrate the capability of the data analysis required to support their proposed science in the Center.
• A research nurse coordinator with appropriate training, experience, qualifications and prior involvement in clinical research may be designated as needed in the application; additional research nursing and support staff should also be available.

Budget (Research Project - Clinical Project)

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.

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

PHS 398 Research Plan (Research Project - Clinical Project)

Specific Aims: Describe the specific aims of the Clinical Project.

Research Strategy: The Clinical Project should present a clinical study proposal related to the Basic/Translational Research Project(s). The Clinical Research Project should explore the developmental aspects of pediatric pharmacology.

Letters of Support: Include any letters of support specific to this component.

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

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

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

Planned Enrollment Report (Research Project - Clinical Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Project - Clinical Project)

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

When preparing your application in ASSIST, use Component Type Research 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 - Basic/Translational 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 - Basic/Translational Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project - Basic/Translational 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 - Basic/Translational 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 - Basic/Translational 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.
• Project Leads should be investigators with a record of external funding as independent PDs/PIs, and should have a record of accomplishment in pediatric developmental pharmacology research.

Budget (Research Project - Basic/Translational Project)

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.

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

PHS 398 Research Plan (Research Project - Basic/Translational Project)

Specific Aims: Describe the specific aims of the Basic/Translational Project.

Research Strategy: Describe the research strategy of the project in the same detail and format as expected for an investigator-initiated R01 grant application. In addition, include a description of the relationship of the Research Project to the Clinical Project and how the Research Project addresses the overall goals of the Center. Describe how the Research Project contributes to the goals of the Administrative Core.

Letters of Support: Include any letters of support specific to this component.

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

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

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

Planned Enrollment Report (Research Project - Basic/Translational Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Project - Basic/Translational Project)

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

When preparing your application in ASSIST, use Component Type Pilot Project.

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

SF424 (R&R) Cover (Pilot 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 (Pilot Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot 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) (Pilot 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 (Pilot 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.
• Individuals receiving support from mentored career development awards (K awards) may serve as Project Leads on Pilot Projects.

Budget (Pilot Project)

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.

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

NOTE: Funds for Pilot Project(s) should be requested as part of the Administrative Core budget.

PHS 398 Research Plan (Pilot Project)

Specific Aims: Describe the specific aims of the Pilot Project.

Research Strategy: The Research Strategy section should describe Pilot Project(s) proposed for years 1 and 2 of the award. Support for pilot projects is limited to a two-year period. Follow the instructions in the SF424 (R&R) application guide, with the exception that little or no preliminary data are required for a Pilot Project. Explain how the pilot project(s) will contribute to the development of new technologies/approaches or will form the basis for larger scale research studies to be pursued by the relevant NICHD-funded Networks/Centers.

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

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

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

Planned Enrollment Report (Pilot Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Project)

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

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

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.

This initiative is not subject to intergovernmental review.

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

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

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

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

Important reminders:

All PD(s)/PI(s) 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.

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

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

After the review of the individual components, an overall impact score will be assigned to the center application. The overall score will emphasize a) the scientific merits of the Research Project(s), b) the overall effectiveness and adequacy of core resources and facilities, c) the qualifications of the Center Director and Associate Director(s), d) the quality of the plans for management and oversight of the Center, and e) the synergy among the components and overall impact of the Center. The overall score for the center application may be higher or lower than the average of the individual components based on the assessment of whether the whole is greater than the sum of its parts.

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).

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.

Does the Center address an important problem or a critical barrier to progress in the field? 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?

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

Does the 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?

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

If the 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 children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

Integration of the Overall Center

• Does the program function as a true Center with the sum of the parts being greater than the individual components rather than as a collection of unrelated support services and research projects?
• Do coordination and integration between the proposed Cores and specific Research Project reflect a cohesive research program?
• Is value added by having the proposed Core and specific Research Project comprise a Center that allows the Center to leverage additional resources that would not have been possible without an integrated Center structure?
• Is the Center specific for research in pediatric developmental pharmacology?
• Are the mechanisms proposed for regular communication and coordination among investigators in the program efficient?
• Are the administrative structures and day-to-day management of the program appropriate?

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

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

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

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

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.

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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).

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 .

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

The Administrative Core provides for leadership and management of all Center activities. Reviewers will consider each of the review criteria below in determining the scientific merit of this core but will not give separate scores for these items. Each assigned reviewer will provide one score for the Administrative Core.  The scientific merit of the Administrative Core should be considered by reviewers in determining the overall score for the Center.

Purpose   

Is the proposed Administrative Core well matched to the needs of the overall center and the goal of educating and engaging the patient/advocacy community?

Management

Is the proposed management appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.? Is the Center scientific and administrative structure sufficient, including its internal and external procedures for monitoring and evaluating the proposed research projects and core facilities/resources? Are there appropriate plans for establishing the Center Advisory Committee, and will this Committee contribute to the oversight of Center research projects, education and other components?

Leadership  

Do the Director and Co-Director have the appropriate leadership and research qualifications to lead the Center? Do they have the collective expertise to identify and focus research projects on clinically relevant issues?  Are there plans for establishing an Executive Committee and interacting with this committee in a way that will promote the success of the Center?

Communication

Is there an appropriate plan for establishing and maintaining effective communications and cooperation among Center investigators and with investigators outside the Center?  Does the application include strategies to encourage patient awareness and participation in clinical studies at the Center or at other institutions?  If outreach activities are proposed as part of the Administrative Core, are there effective plans to reach the proposed target group(s)? Are the activities feasible within the time limit of the Center operation?

Environment

Is the environment for the Administrative Core adequate and appropriate to support the overall Center as proposed? Is there evidence of institutional support for the management of the Center?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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 .

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.

For this particular announcement, note the following:  The Clinical Research Project, Basic/Translational Research Project(s), and any optional Pilot Projects will all be scored using the standard 5 criteria.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Project proposed). An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Project that by its nature is not especially innovative may be essential to advance a field.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

Significance

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

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

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

If the Project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  For preclinical translational research projects, is there a clear step-by-step plan, including adequate milestones, to track and evaluate the therapeutic development effort?

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

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

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.

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.

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

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

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.

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.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

• Pursue research objectives consistent with the research scope of the FOA and research favorably recommended by peer review;
• Conduct experiments and collect the resulting data;
• Analyze, interpret and present results and plans to the Steering Committee for approved activities;
• Publish results, conclusions, and interpretation of the studies.

The awardees will agree to: 1) accept the coordinating role of the Steering Committee which includes evaluating objectives and research goals of the Centers Program, and recommending modification, deletion or addition of protocols within the Centers Program; 2) follow any common protocols in which they participate for multicenter projects that are approved by the Steering Committee; and 3) accept the cooperative nature of the group process, including the establishment, where appropriate, of smaller collaborative groups comprised of interacting subprojects and/or cores focused on a particular reproductive research topic area.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• Participating in the overall coordination of the RPDP with the Steering Committee.  This includes efforts to improve and strengthen inter- and intra- Center cooperation amongst the research projects of the Centers, particularly as it pertains to translational research activities within and between Centers.  As a means of improving inter-center cooperation, the Project Scientist will directly participate in the activities of the smaller collaborative groups established by the Steering Committee comprising subprojects and/or cores focused on a particular reproductive research topic area.  The Project Scientist will also assist the research efforts of the RPDP by facilitating access to fiscal and intellectual resources provided by industry, private foundations and NIH intramural scientists.  The Project Scientist will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the Centers Program and NICHD.  In the event of disagreements among the Program participants, the Project Scientist will assist in forming an arbitration panel as discussed below.
• Interacting with each individual center awardee evaluating objectives and research goals of that particular center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.  The Project Scientist will assist and facilitate this process and not direct it. The Project Scientist will also provide assistance in reviewing and commenting on all major transitional changes of an individual Center's activities prior to implementation to assure consistency with required goals of the RPDP.
• Retaining the option to recommend the withholding of support from a Center subproject or core materially failing to meet the technical performance requirements established by this Centers Program. This includes identifying jointly with participants of the Steering Committee the need to add additional research subprojects or service cores to Centers or to phase out a Center subproject or core when performance standards have not been met.
• Participating, where warranted, in data analyses, interpretations, and the dissemination of study findings to the research community and health care recipients including co authorship of the publication of results of studies conducted by the Centers.
• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Overall Coordination of the Centers Program consistent with the stated intent of the RFA will be done by a Steering Committee consisting of the PD(s)/PI(s) from each of the participating Centers and one NICHD staff member from the OPPTB, NICHD, who will be the Project Scientist.  A member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee.  A non-NIH chairperson for the Steering Committee will be chosen by a majority vote of the PD(s)/PI(s). The Steering Committee meetings will be convened at least once per year.  The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaborations such as with industry, private foundations and/or NIH intramural scientists, establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct the business of the cooperative research program.  In anticipation that some Centers will have common research interests that address a specific basic and/or clinical research problem, it is envisioned that research focus groups will be formed to conduct coordinated research activities recommended by the Steering Committee.  The Steering Committee will review and approve collaborative and/or pilot projects on specific research topics.   As needed, the Steering Committee will develop a publication policy regarding joint authorship of research reports derived from such collaborative efforts.
• Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution Process

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

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

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

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Ekaterini Tsilou, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-6287
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: [email protected]

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

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

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