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

Specialized Centers in Research in Pediatric Developmental Pharmacology Program (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • March 14, 2011 - See Notice NOT-HD-11-012 This Notice is to inform potential applicants that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is clarifying and correcting information relating to “Page Limitations” and Outreach/Education Core sections.

Funding Opportunity Announcement (FOA) Number

RFA-HD-10-026

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865  

FOA Purpose

The purpose of this FOA is to announce the competition of the Research in Pediatric Developmental Pharmacology Program (RPDP).  The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) proposes to fund a limited number of research Centers which will provide an arena for multidisciplinary interactions between basic and clinical scientists interested in establishing high quality translational research programs in the area of pediatric pharmacology.  The Centers also will serve as national resource for the training and career development of new scientists electing to pursue careers in the conduct of translational research in high priority areas of pediatric developmental pharmacology.  Finally, Center investigators will facilitate important community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

Not applicable

Letter of Intent Due Date

February 22, 2010

Application Due Date(s)

March 22, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

June/July 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 2011

Expiration Date

March 23, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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 Obstetric and Pediatric Pharmacology Branch (OPPB) in the Center for Research in Mothers and Children (CRMC), proposes to fund a limited number of research Centers in developmental pharmacology.  These Centers will provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs which will investigate the fundamental mechanisms of changes in drug disposition and response over the course of human development from birth through adolescence.   The Centers also will serve as a national resource for the training and career development of young scientists electing to pursue careers in the conduct of research in this area. Accordingly, the purpose of this FOA is to announce a competition of the Research in Pediatric Developmental Pharmacology (RPDP) Centers Program.  Applications are sought from investigators who are willing 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 co-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.

Background

Children have been termed the therapeutic orphans of medicinal products due to the lack of adequate dosing information, age appropriate formulations, and efficacy and safety information. During the past two decades, the Federal government has implemented several initiatives to address the knowledge and use gaps between the pediatric and adult populations. 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 approximately 12 years experience with these multiple initiatives, the knowledge and use gaps between the adult and pediatric populations for medicinal products remain.

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 age appropriate knowledge of metabolism, clinical research outcome assessments, assay and analytic techniques calibrated for pediatric use and predictive non-clinical models is lacking for most pediatric populations.

NICHD support for pediatric pharmacology has successfully implemented an infrastructure and recognition of the value of incorporating pharmacokinetic and pharmacodynamic (PK/PD) assessments in pediatric clinical research. In addition, training in pediatric pharmacology has resulted in academic and commercial institutions acquiring the expertise and personnel to perform pediatric PK/PD assessments across therapeutic areas.

NICHD now seeks to establish the next program to address the future of research in pediatric developmental pharmacology.  By issuance of this FOA, NICHD seeks to establish Centers dedicated to exploring and extending the frontiers of methods and knowledge in the field of pediatric 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.

The OPPB 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, the OPPB 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 the OPPB, and also will address important health concerns of the American public.

Objectives

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.

Research Scope

The RPDP will be comprised of research-based grants designed to support interactive groups of research projects and 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 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 the OPPB.  Furthermore, the objectives of this Program require that one of the subprojects be entirely or predominantly clinical and that all basic science subprojects be linked to the clinical component(s) of the Center.

Topics that are considered to be responsive to the research mission areas of the OPPB 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.

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.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intend to commit an estimated total of $3.5 million [Direct plus Facilities and Administrative (F & A) costs] for up to five new awards in FY2011 (future year amounts will depend on annual appropriates).

Award Budget

Direct costs are limited to $500,000 for the first year. A budget for direct costs not to exceed $500,000 for the first year with incremental increases for recurring costs (i.e., personnel, consultants, supplies, travel and other expenses) not to exceed three percent in each subsequent year.  Applications exceeding the budgetary limits specified above will be returned to the applicant without peer review.  Furthermore, increases in out-year budgets for recurring costs are subject to the availability of funds..

Award Project Period

The total project period an applicant for a Center may request in response to this FOA may not exceed five years.

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply as a P.I. However, subcontracts from domestic entities to foreign sites are permitted.  Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Anne Zajicek, MD, Pharm D
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4A01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-435-6865
Email: zajiceka@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service; non-UPS service)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

For New U54 applications, page limits are as follows:

Overview of the Center (for overall U54)                                  12 pages

Research Project Descriptions:                       

Core Descriptions (each Core):                                                 

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Model Organisms Sharing Plan, and Genome Wide Association Studies (GWAS) Sharing Plan) as provided in the PHS 398 Application Guide.

Research Plan

All instructions in the PHS398 Application Guide must be followed.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Other Project Information

The following guidelines provide directions for preparing each section of the application.  The Table of Contents described for PHS-398 Form Page 3 should contain the headings outlined below in Section l —General Information and Section ll – Research Plan.   The Table of Contents should be paginated to enable reviewers to readily find specific information.  

SECTION I:  GENERAL INFORMATION

1.  Face Page (Form Page 1)

Complete all items on the application's face page.  For Item 2, enter the number of this RFA and the title.  Number succeeding pages consecutively.

2.  Description: Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, and Other Significant Contributors (Form Page 2 and 2-continued)

Describe briefly the proposed research program, indicate the research emphasis of the component Research Projects, and identify the purpose of the proposed Core units.

List all Senior/Key personnel and Other Significant Contributors engaged on the project.  Use continuation pages as necessary, numbering consecutively.

3.  Table of Contents (Form Page 3)

Prepare the Table of Contents including the major headings as noted above.

4.  Budget Instructions (Form Page 4)  

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Prepare a series of composite budget tables for the U54 grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.

·       A.  Composite Budget

·       B.  Budgets for Individual Research Project Component and Core Component

5.  Biographical Sketch (Biographical Sketch Format Page)

Follow the instructions on the Biographical Sketch Format Page. This section must contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2.  Biographical sketches are required for all key personnel participating in the Research Project components and Core units.   Begin with the U54 overall PD/PI  and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398. Do not exceed four pages for each person.

6.  Other Support Information (Other Support Format Page)

Information for all current and pending research support of key personnel should be presented in tabular form. Please indicate by an asterisk any research support that overlaps with projects proposed in the subject U54 application. For all key personnel named on page 2, except consultants, beginning with the PD/PI and, thereafter, in alphabetical order, list separately: (1) current support; and (2) applications pending review and/or funding.

7.  Resources (Resources Format Page)

Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II.

Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.

For each Research Project component and Core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

Overview of the Center (12 pages)

·       A.  History and Purpose of the Program

·       B.  Administration, Organization, and Operation

·       C.  Research Program

·       D.  Description of Assurances and Collaborative Agreements

Research Project Descriptions (12 pages for each Research Strategy component)

Identify each project by a Roman numeral (I, II, III...) and a title.

A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following: 

A.  Research Project Face Page (1 page)

B.  Research Project Summary (1 page;  use PHS-398 Form Page 2) 

C.  Content of Research Plan (Begin each section with a section header)

Core Unit Descriptions

Identify each proposed Core unit by a letter (A, B, C...) and a title (e.g., Administrative Core, Molecular/Cellular Core, etc.).  A full description of each Core unit is to be provided following the format presented in Form PHS-398.  Begin the presentation of each Core unit on a separate page.   Include the following:

A.  Core Unit Face Page (1 page)

B.  Core Project Summary (1 page; use PHS-398 Form Page 2)

Include an Abstract that identifies and describes the purpose of the proposed Core unit.  Summarize the Core unit's overall objectives; highlight the decision-making process for use of Core services and plans for cost-effectiveness and quality control.

C.  Core unit Structure, Administration, and Services (6 pages)

·       Administrative Core Unit

·       Additional Core Unit(s)

D.  Use of Core Units by Research Project Components

4.  Progress Report Publication List (for competing renewal applications only)

5.  Letters of Assurance/Agreement 

6.  Checklist

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it may delay the review or result in the return of the application without review.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applications for the U54 grant are to be prepared according to the requirements presented below.  At minimum, an application in response to this FOA should include:

All applicants must document their ability to meet or exceed the minimum requirements as set forth in this FOA.  This specifically includes understanding of and commitment to the cooperative nature of this Program, and willingness to meet the Terms and Conditions of Award.

Requirements of the U54 Center

Minimal requirements:

Minimal requirements for a Center described in this FOA are as follows (see sections on Review Procedures and Award Criteria below):

Optional components:

Optional components of the Center organization include the mix of subprojects and cores to be included in the Center:

Center Structure Options:   

The Principal Investigator 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 subprojects only.  Consistent with NICHD guidelines for establishment of core facilities, utilization by three subprojects is required to justify a core technical service facility.  Percent utilization by any one of the three subprojects justifying the core may not exceed 50 percent or be less than five percent.  The percent utilization of additional subprojects 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 subprojects per se.  No internal charge-back system would be required.

Open Access Structure --  In this center structure, budgeted center subprojects, 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 three projects used to justify a core must be a budgeted center subproject, while the remaining project(s) used in justifying the core must be externally funded NICHD projects administered by the OPPB.  Percent utilization by any internally budgeted center subproject or externally funded OPPB project used to justify a particular core facility may not exceed 50 percent or be less than five percent.  An additional seven federally funded, peer reviewed external research projects addressing program relevant research areas of the OPPB may access the core up to 100 percent of its service capacity.  The 50/5 percent utilization requirement applies to this group of external projects.  Centers must establish an internal management policy for evaluating the acceptability of proposed OPPB 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 OPPB Program Staff who then will evaluate the extent to which the project is relevant to OPPB mission research areas (see Research Scope), and render a decision accordingly.

If Centers choose to operate in an open access format, costs necessary to utilize a particular core facility by budgeted center subprojects must be incorporated into the budget of the subproject 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 subprojects 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.  In choosing to configure a center in an open access center structure, the Principal Investigator must have in place, and adequately describe in the application, management policies that ensure that budgeted center subprojects are given highest priority in receiving services provided by the core.

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 subprojects.  These Centers may, therefore, have a mix of open and restricted access technical service cores.  On the other hand, administrative cores in open center structures may be accessed only by budgeted center subprojects.

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.

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 Principal Investigators and an NICHD Project Scientist from the OPPB, CRMC.  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.

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 the OPPB, CRMC, and Key Investigators of the relevant subproject and/or Core Directors.

Further details of the guidance and management structures and processes may be found under Section VI.2.A. “Cooperative Agreement Terms and Conditions of Award”.

Travel to Meetings:

Principal Investigators should request travel funds to support their participation in the annual Steering Committee Meeting as well as two research focus group meetings.  Key Investigators of budgeted center subprojects and Directors of technical service cores should request travel funds to support participation in two research focus group meetings.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

For U54 applications, peer review of scientific and technical merit focuses on three areas: (1) review of the individual Research Project components; (2) review of the individual Core units; (3) review of the U54 Center as an integrated collection of research projects and cores oriented around a central theme, and the overall merit of the program.

Review Criteria for Individual Research Project Components

The following standard review criteria will be used for the evaluation of the individual Research Project components:

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)

Are the PD/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?

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?

Review Criteria for Core Unit Components

Reviewers will assign an impact/priority score for each core unit component, based on the assessment of each Core unit independently in terms of the specified review criteria for Cores. Separate criterion scores will not be assigned for Cores.  The following review criteria will be used for the evaluation of the individual Core units.

For all Cores, the review will evaluate the following:

For the Administrative Core, the review will also evaluate the following:

Review Criteria for Overall U54 Center

The overall U54 Center application will be evaluated as an integrated research effort focused on a central theme.  The relationship and contributions of each Research Project and Core to the overall theme of the Center will be discussed and evaluated.  Reviewers will assign an impact/priority score based on assessment of the scientific and technical merit of the overall Center. The assessment will take into consideration all proposed Research Projects and Cores, including any with poor ratings.  Separate criterion scores for the overall program will not be assigned. 

The review will assess the level of merit of the U54 Center as an integrated effort, including the following considerations:

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

2.A. 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.

2. A.1. Principal Investigator Rights and Responsibilities

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

2. A.2. NIH Responsibilities

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

2.A.3. Collaborative Responsibilities

Areas of Joint Responsibility include:

2.A.4. 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Anne Zajicek, MD, Pharm D
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6865
Email: zajiceka@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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