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)
Office of Dietary Supplements (ODS/NIH)

Funding Opportunity Title

Developmental Mechanisms of Human Structural Birth Defects (P01)

Activity Code

P01 Research Program Projects

Announcement Type

Reissue of PA-07-419

Related Notices

  • July 25, 2013 - This PAR has been expired and reissued as PAR-13-285.

Funding Opportunity Announcement (FOA) Number

PAR-12-034

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865

FOA Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Office of Dietary Supplements (ODS), National Institutes of Health (NIH) encourages innovative, multidisciplinary, interactive, and synergistic program project (P01) grant applications from institutes/organizations that propose to integrate basic, translational, and clinical approaches to understanding the developmental biology and genetic basis of congenital structural human malformations.  To contain costs, each P01 will consist of only three component projects and associated cores.  At least one project must propose basic research in an animal model system and at least one project must be clinical or translational in nature.  The component projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that is genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans.

Key Dates
Posted Date

November 21, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates

AIDS Application Due Date(s)

Standard dates

Scientific Merit Review

Standard dates

Advisory Council Review

Standard dates

Earliest Start Date(s)

Standard dates

Expiration Date

(Now Expired July 25, 2013 per issuance of PAR-13-285), Originally January 8, 2015

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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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) and Office of Dietary Supplements (ODS), National Institutes of Health (NIH) encourages innovative, multidisciplinary, interactive, and synergistic program project (P01) grant applications from institutes/organizations that propose to integrate basic, translational, and clinical approaches to understanding the developmental biology and genetic basis of congenital structural human malformations.  To contain costs, each P01 will consist of only three component projects and associated cores.  At least one project must propose basic research in an animal model system and at least one project must be clinical or translational in nature.  The component projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that is genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans.

Background

Annually, almost five percent of all live births in the United States (more than 180,000 babies) involve babies born with birth defects, as broadly defined to include both structural and functional/metabolic abnormalities.  Next to accidents, birth defects are the leading cause of death in children; they account for half of all pediatric hospitalizations.  In terms of economic costs, billions of dollars are spent over the lifetimes of children born with any of 17 major, severe, nonfatal birth defects.  In sum, structural birth defects have a great impact on public health, socioeconomics, and family life.  A high priority goal of NICHD’s strategic plan is to address the problem of structural birth defects.

The Developmental Biology, Genetics and Teratology Branch at NICHD has supported a Birth Defects Initiative since 2000 by funding a number of research grants and program project grants focused on the use of molecular genetic approaches for the study of the genetic susceptibility, genetic epidemiology, and developmental biology of human congenital structural malformations.  These grants established the basis for the Birth Defects Working Group whose investigators meet annually to present research updates, share ideas and technical advances, establish new collaborations, and provide input and advice to NICHD staff.  The objective is to capitalize on the rapid and revolutionary discoveries occurring as a result of the Human Genome Project with the ultimate goal of enhancing the translation of basic knowledge and insights from functional genomic studies into development of new, innovative, and efficacious strategies for the molecular diagnosis, treatment, and prevention of human structural birth defects.  Investigators funded through this FOA will become part of NICHD’s Birth Defects Working Group comprised of investigators funded through prior FOAs under NICHD’s Birth Defects Initiative. 

This FOA encourages P01 applications in order to broaden the base of basic scientists and clinicians involved in the Birth Defects Working Group, to enhance this research effort, and to promote the translation of advances from the bench to bedside.

Scope

This FOA encourages research on developmental defects of generalized body patterning and localized dysmorphic anomalies across a variety of organ systems, such as the skeletal, nervous, gut, cardiac, and lymphatic systems, that lead to clinically significant and major congenital structural malformations.  In particular, studies that focus on modifier genes and the role of quantitative aspects of development, such as gene dosage or copy number variation, as well as imaging of developmental processes are encouraged.  While applications that focus on developmental disorders that result in intellectual disabilities and related neurobehavioral disabilities are of interest to the NICHD, they are outside the scope of this FOA.  However, studies that address syndromes of which intellectual disabilities are a part of the phenotype will be considered as long as the project focuses only on the structural defects associated with the phenotype.

Proposed projects must be innovative, multidisciplinary, interactive, and synergistic.  They must integrate basic, translational, and clinical approaches to understanding the developmental biology and genetic basis of congential structural human malformations.  To contain costs, each P01 will consist of only three component projects and associated cores.  At least one project must use basic research in an animal model system and at least one project must be clinical or translational in nature.  The component projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that is genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans.

The basic science component projects may include but are not limited to studies to: 1) identify and characterize the genes, gene modifiers, gene products, mutations, polymorphisms, or multigene and gene/environment interactions that play a role in normal and abnormal embryonic patterning and organogenesis; 2) elucidate the developmental biological processes and pathways, the biochemical, biophysical, cellular, molecular, genetic mechanisms, or spatial and temporal gene expression patterns which are involved in dysmorphogenesis; and/or 3) examine how teratogens and nutritional deficiencies disrupt or modify gene expression and basic developmental processes.

The translational/clinical component projects may include but are not limited to studies to: 1) characterize and classify genotypes and phenotypes of human malformations that are comparable in the animal models being examined; 2) develop physical, genetic, and comparative maps for genes involved in human malformations; 3) identify the developmental genetic processes and molecular pathogenesis of human malformations utilizing animal models; and 4) develop innovative molecular genetic methods, technologies, and strategies to enhance the diagnosis of human malformations or aid in the intervention to ameliorate the formation of the birth defects.

Applicants are encouraged to collaborate with existing population-based birth defects registries, databases, and surveillance programs at the private, state, and Federal levels, especially the Centers for Disease Control and Prevention (CDC) Centers of Excellence for Birth Defects.  Applicants are encouraged to initiate collaborations with the CDC Centers to avail themselves of these valuable resources.

Applicants are encouraged to apply recent technological advances in developmental biology and genetics in their projects and to utilize the many existing research resources, bioinformatic databases, and biotechnological tools in their research cores. The research cores should be structured to share work effort and research resources (e.g., biotechnology, high-throughput instrumentation, microarrays, oligonucleotide chips, animal model development, and technical assistance) among the research projects. The aim of a core is to provide support and enhance the progress, productivity, cost-effectiveness, and outcome of the research projects. 

Applications may include, but are not limited to, new and innovative approaches to investigate: 1) genetic and epigenetic defects, nutritional deficiencies, and teratogens that perturb, modify, or alter gene expression during early development; 2) the identity and function of transcription and growth factors in normal and abnormal gastrulation, embryogenesis, organogenesis, and patterning, as well as their modification by environmental agents; and 3) defective embryonic developmental processes and pathways that ultimately lead to malformations.

Areas of research appropriate for this FOA include, but are not limited to:

The topics listed above are only examples, are not in priority order, and are not intended to be all-inclusive. Investigators are encouraged to explore and develop new, innovative projects and research cores that are consistent with the overall objectives of this FOA.

Research Cores

The aim of a core is to provide support and enhance the progress, productivity, cost-effectiveness, and outcome of the research projects. Applicants are encouraged to make use of recent technological advances in developmental biology, genetics, and genomics in their projects and, when applicable, to utilize resources via research cores. The research cores should be structured to share work effort and research resources (e.g., biotechnology, high-throughput instrumentation, microarrays, oligonucleotide chips, animal model development, and technical assistance) among the research projects in the most cost-effective manner.  A core must be utilized by at least two of the three component projects, preferrably by all three.

Participation in NICHD’s Structural Birth Defects Meetings

The PD(s)/PI(s) for the overall grant and the principal investigators for each component project should plan to attend an NICHD-sponsored three-day meeting generally held on an annual basis in the Washington, D.C. metropolitan area. Funds to pay for this travel should be included in the budget request. The meeting will provide an opportunity for all investigators funded through NICHD’s Birth Defects Initiative to communicate, discuss the progress of their research, exchange ideas and information, share resources, foster collaborations that are relevant to the research goals of the Birth Defects Initiative, and provide input and advice to NICHD staff. This requirement is designed to establish an interactive group of investigators who are interested in multidisciplinary approaches to enhancing our understanding of the genetic epidemiology, etiology, pathogenesis, developmental biology, and genetics of structural birth defects.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Funding caps for P01 grants are as follows:

For new applications, the first-year cap is $750,000 direct costs, with a cumulative cap of $4,000,000 direct costs over a 5-year period.  For renewal applications, the first-year direct cost maximum is either $750,000 or an amount 10% above the direct costs awarded in the last non-competing year, whichever is greater.  In addition, there is a cumulative cap of $5,000,000 in direct costs over a 5-year award period.  For the purpose of funding caps, the calculation of total direct costs may exclude all facilities and administrative (indirect) costs, including those indirect costs associated with subcontracts.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Award Project Period

A five-year total project period for P01 programs is encouraged, but is not mandatory.  The minimum total project period is three years.  There must be at least three component research projects at all times during the grant period.

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

Foreign Institutions

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

Required Registrations

Applicant organizations 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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the overall P01 should be an established scientist with demonstrated administrative capabilities.  Component Research Projects should be led by experienced scientists (Subproject Directors) with a variety of disciplinary and specialty backgrounds. The Core units should be led by investigators (Core Directors) with appropriate scientific and technical expertise.  The PD(s)/PI(s) and component Subproject Directors should be able to collaborate productively so that new scientific information may be freely exchanged and effectively applied by others in the program.  

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.  An investigator can have multiple roles, e.g., as a multiple PD(s)/PI(s) for the overall application and as a Subproject Director.  There can be multiple directors for a subproject, in which case applicants must submit a leadership plan for the component project.  People designated as Subproject Directors do not lose their New Investigator or Early Stage Investigator status.   

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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

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.

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 L. 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-USPS service)
Telephone: (301) 451-3415
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, with the following requirements:

NICHD Program Project (P01) Grant Applications

Applications must be submitted on Grant Application Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

The PHS 398 Application Instructions http://grants.nih.gov/grants/funding/phs398/phs398.html) are to be followed, with the following additional requirements.

For New P01 applications, page limits are as follows:

For Resubmission or Revision applications, also include the following: 

Research Grant Table of Contents

In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information easily.

SECTION I:  PRELIMINARY PAGES

Face Page (Form Page 1)

Complete all items on the application's face page.  For Item 2, enter the number of this FOA and the title, "Developmental Mechanisms of Human Structural Birth Defects (P01)”.  Number succeeding pages consecutively.

Description: Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (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.

Table of Contents (Form Page 3)

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

Budget Instructions (Form Page 4):   

Prepare a series of composite budget tables for the P01 grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.


            Composite Budget

            Budgets for Individual Research Project Component and Core Component  

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 P01 overall PD(s)/PI(s)  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.

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.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

SECTION II

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 Program Project (12 pages)

Discuss the overall P01 program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level.

Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of advisory committees, and space assignment. Describe organizational framework and provide an organizational chart.

Discuss the proposed research program, highlighting its central theme. List by title and investigator's name the component Research Projects and Core units.  Describe  the relationship between the projects and the Core units and their relationship to the central theme.

Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts.  Letters of agreement for these arrangements are included in Item 6. Letters of Assurance/agreement as described below.

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

Cover Page (1 page):  Include the following on the Cover Page

Abstract of Research Plan (1 page;  use PHS-398 Form Page 2):

Discuss the purpose and nature of the project and its relevance to the program's overall theme.

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

Core Unit Descriptions

Cover Page (1 page):  Include the following on the Cover Page

Abstract (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.

Introduction (Resubmission or Revision Applications only;  1 page)

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

Progress Report Publication List (for competing renewal applications only)

List publications prepared during current grant period (or the past five-year period) which report results of research supported by the grant.

Letters of Assurance/Agreement  

Any arrangements for collaborative and cooperative endeavors or subcontracts should be highlighted. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a PHS-398 face page or other documentation, signed by the off-site institutional officials, must be submitted with the application.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398 Application Guide.   

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.

·         All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html. .

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 postmarked on or before the due dates in Part I. Overview Information.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

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 this particular announcement, note the following:

For NICHD Program Project (P01) applications, peer review of scientific and technical merit foruses on three areas:  (1) review of the individual Research Project components, (2) review of the individual Core units; (3) review of the P01 program as an integrated collection of research projects and cores oriented around a central theme as well as the overall merit of the program.

Overall Impact - Overall Program Project

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Program 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 Program Project proposed).

Scored Review Criteria - Overall Program Project

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

Significance

Does the Program Project address an important problem or a critical barrier to progress in the field? If the aims of the Program 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(s)/PI(s), collaborators, and other researchers well suited to the Program 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(s)/PI(s), 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 Program 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 Program 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?      

Additional Review Criteria - Overall Program Project

As applicable for the Program 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.

The Program as an integrated effort

The overall P01 program project 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 program project will be discussed and evaluated.  Reviewers will assign an impact/priority score based on assessment of the scientific and technical merit of the overall program project. 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 be assigned.   The review will assess the level of merit of the program project as an integrated effort, including the following considerations:

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 Program 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

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

Renewals

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

Revisions

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

Additional Review Considerations - Overall Program Project

As applicable for the Program 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.

 Scored Review Criteria - Individual Research Project Components (Subprojects)

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

Significance

Does the component project address an important problem or a critical barrier to progress in the field? If the aims of the component 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(s)/PI(s), collaborators, and other researchers well suited to the component 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(s)/PI(s), 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 component 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 component 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?   

Additional Review Criteria - Individual Research Project Components (Subprojects)

As applicable for the component 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 component 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

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

Renewals

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

Revisions

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

Additional Review Considerations - Individual Research Project Components (Subprojects)

As applicable for the component 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.

Review Criteria for Core Components

Reviewers will assign a score for each core unit component, based on the assessment of each Core unit independently in terms of the specified review criteria for Cores (see below).  Cores will not receive scores for the five standard criteria (significance, investigator(s), innovation, approach, environment). 

For all Cores, the following review criteria will be used:

For the Administrative Core, the following review criteria will be used:

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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 . 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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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)

Lorette C. Javois, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development  (NICHD)
Telephone: 301-496-5541
Email: javoisl@mail.nih.gov

Cindy Davis, Ph.D.
Office of Dietary Supplements (ODS)
Telephone: 301-435-2920
Email:  davisci@mail.nih.gov

Peer Review Contact(s)

Sherry L. Dupere, Ph.D.
Telephone: 301-451-3415
Email:  duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan S. Clark, MBA
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.


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