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

Contraceptive Development Research Centers Program (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

This is a reissue of RFA-HD-06-014

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-12-185

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 purpose of this FOA is to announce the re-competition of the Contraceptive Development Research Centers Program.  The aim of the program is to conduct a wide range of research, both basic and applied, with the ultimate goal of developing clinically useful contraceptive products.  These centers provide a multidisplinary approach to high quality translational research programs in the area of contraceptive product discovery and development.  The Centers will also serve as a national resource for career development of young scientists electing to pursue research in contraceptive development.

Key Dates
Posted Date

May 23, 2011

Letter of Intent Due Date

October 29, 2011

Application Due Date(s)

November 29, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

November 30, 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) invites applications from investigators interested in participating with NICHD in an ongoing multicenter cooperative research program termed the Contraceptive Development Research Centers Program.  This program is designed to expedite the development of new methods to regulate fertility.  The aim of the program is to conduct a wide range of research, both basic and applied, with the ultimate goal of developing clinically useful products. Recognizing that the complexity of contraceptive development can severely limit progress achieved by individual investigators working alone, the NICHD will support up to four Centers composed of research projects and technical service core facilities that are interactively organized to conduct research to discover and develop promising new leads for regulation of fertility. The focus of individual projects may include basic, preclinical or clinical research or a combination of these areas. The Centers will also serve as a national resource for career development of young scientists electing to pursue research in contraceptive development.

Background

Nearly half of all pregnancies in the United States are unintended. Thus, there is a critical need for fertility regulation that fits the needs of women and men throughout their reproductive lives. The ideal contraceptive should be safe and highly effective. A variety of contraceptive methods are needed to address the needs of people with different ethnic, cultural, and religious values, those with inadequate access to services, and those with changing needs related to age.

The primary objective of the Contraceptive Development Research Centers Program described in this FOA is to identify and develop new leads for regulation of fertility. There are three phases to development of new contraceptive methods: basic discovery, proof of concept, and clinical development. New products are needed that act not only as contraceptives, but also to prevent or limit sexually transmitted diseases.

The intent of this program is to establish or maintain an organizational infrastructure that has the scientific and administrative capabilities to address the broad issue of fertility regulation. Approaches to both male and female targets are encouraged. Research on abortion will not be funded.

Research Scope

Research projects can be directed to male or female targets of fertility regulation. The Center must consist of three or more projects, an administrative core, and optional additional core facilities capable of interacting in a coordinated, cooperative fashion.  It is expected that activities may require collaboration with other institutions or other Centers.  By using an interdisciplinary approach, the Centers can conduct activities that are beyond the capabilities of individual investigators or institutions.

Examples of possible research projects or cores may include but are not limited to:

A Center application can build its research strategy primarily on one broad approach to fertility regulation within which the projects are embedded, or a Center application could be structured with research representing different approaches to fertility regulation.  Alternatively, an application can encompass an integrated multidisciplinary Center for target discovery and drug discovery and development in the regulation of fertility.  Further, it is understood that the ultimate goal of Center's programs is to discover, develop and obtain approval of new products to regulate fertility.  Therefore, the proposed projects should be components within the roadmap of discovery through approval of a drug product.  The overall Center plan should stress internal priorities and collaboration and be focused on opportunities for progress and ultimately the drug product.  The Center should encourage career development for new investigators in contraceptive research.

Description of a Center

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

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
Renewal

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

Funds Available and Anticipated Number of Awards

NICHD intends to commit approximately $6.6 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2012 to fund up to four new and/or renewal grants in response to this FOA.

Award Budget

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size 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 and the receipt of a sufficient number of meritorious applications.

Award Project Period

The scope of the proposed project should determine the project period.  The total project period for an application submitted in response to this FOA must be 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.

Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Subcontracts from domestic entities to foreign sites are permitted for subprojects and cores. https://nihguide.nih.gov/Documents/Forms/AllItems.aspx

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. NIH will not accept any application that is essentially the same as one already reviewed.     

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:

Diana Blithe, Ph.D.
Contraception and Reproductive Health Branch (CRHR)
Center for Population Research (CPR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd, Room 8B13, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: 301-435-6990
Email: blithed@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 (DSR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier or non-USPS service)
Telephone: (301) 451-3415
Email: duperes@nih.gov

Page Limitations

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

For U54  applications submitted in response to this FOA, Research Plan page limits are as follows:

Organization of Application

The application should be divided into the following sections:  Section I - Center Preliminary Pages, and Section II - Center Research Plan.  The following guidelines provide directions and descriptions for preparing each section.

Section I – Center Preliminary Pages

1.  Center 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, "Contraceptive Development Research Centers Program (U54)”.  Number succeeding pages consecutively.

2.  Center 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.

3.  Center Table of Contents (Form Page 3):

A Table of Contents should be prepared listing the three major Sections (I, II, and III), paginated to enable reviewers to find specific information readily.

4.  Center Budget Instructions (Form Page 4):

Prepare a series of composite budget tables for the Center 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 Components and Core Components 

Prepare an individual budget for each Research project and Core unit proposed.

Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases or decreases in any category over the first 12-month budget period. Identify such changes with asterisks against the appropriate amounts. If a recurring annual increase in personnel or other costs is anticipated, give the percentage; however, current NIH practice limits escalation to 3%. In addition, for COMPETING CONTINUATION applications, justify any significant increases in any category over the current level of support.

5. Biographical Sketches (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. 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 – Center 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.

1.   Center Introductory Overview (Overview of the Center for overall U54)

Provide an overview of the entire proposed Center describing the central theme and goals.  Describe how the overall Center can achieve its major objectives.  Explain the proposed contribution of each of the projects in achieving the objectives of the center.  Furthermore, the administrative arrangements and support necessary to effect the research should be carefully described in the application.  Shared resources should be described.  In addition, provide detailed information on collaborations, recruitment, facilities and resources.

A. History and Purpose of the Program

Discuss the overall U54 program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level.

B. Administration, Organization, and Operation

Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, a multi-PD/PI leadership plan (if applicable), the use of advisory committees, and space assignment. Describe the organizational framework and provide an organizational chart.

C. Research Program

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.

D. Assurances and Collaborative Agreements.

Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts.  Letters of Assurance/agreement for these arrangements are included in Item 5 described below.

2.  Research Project Descriptions

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), with the following additional instructions.

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

A. Research Project Cover Page

•        Title of Project (Identify each project by a Roman numeral I, II, III...)

•        Research Project Director (Principal Investigator), title, affiliation

•        Other investigators, titles, affiliations

B.  Research Project Description (use PHS-398 Form Page 2)

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

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

1.  Introduction to Application for Resubmission or Revision Applications is not applicable

2. Specific Aims 

3. Research Strategy (Significance, Innovation, and Approach):  Start each section with the appropriate section heading—Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.  For new applications, include information on Preliminary Studies.  For renewal applications, provide a Progress Report within the page limit.  Indicate the Research Project's use of Core unit services, including why they are needed and the advantages and cost effectiveness of Core unit usage for the project.

4. Inclusion Enrollment Report (renewal applications only)

5. Bibliography and References Cited, Progress Report Publication List

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/planned Enrollment Table

9. Inclusion of Children

10. Vertebrate Animals

11. Select Agent Research  

12. Multiple Project Director/Principal Investigator (PD/PI) Leadership Plan (if applicable)

13. Consortium/contractual arrangements

14. Letters of Support:  Include pertinent letters of assurance and collaboration for the Research Project.  For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.

15. 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 with the following modification: 

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement.

3.  Core Unit Descriptions

Identify each proposed core unit by a letter (A, B, C...) and a title (Administrative, Research Training and Education, etc...). Provide a full description of each Core unit.  Begin the presentation of each Core unit on a separate page.  Include the following:

A. Core Unit Cover Page

B. Core Unit Description (use PHS-398 Form Page 2) 

C. Core Unit Structure, Administration, and Services

Administrative Core (required):

Additional Cores (optional):

4. Progress Report Publication List (for 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 and have not already been listed under the individual research projects.

5. Letters of Assurance/Agreement  

Any arrangements for collaborative and cooperative endeavors or subcontracts not already described under the individual research projects should be highlighted here. Include letters of agreement from consultants. For projects to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance signed by the off-site institutional officials must be submitted with the application.

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.

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 will not be reviewed.

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.  

Application requirements: 
Annual 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 this particular announcement, note the following:   

The goal of this FOA is to solicit applications that propose to conduct a wide range of research, both basic and applied, with the ultimate objective of developing clinically useful contraceptive products.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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

Significance

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

Investigator(s)

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

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 Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Center involves 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

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.

The Center as an Integrated Effort

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

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

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.

Scored Review Criteria for Individual Research Projects

For each of the Research Projects, reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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 Components

Each center must have an Administrative Core.  Other cores are optional. 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. 

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

For all other optional Cores, 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  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) Councill. 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.

Cooperative Agreement Terms and Conditions of Award

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

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

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

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

The NICHD Project Scientist will have substantial scientific and programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination that is above and beyond the normal stewardship role in awards. The degree of involvement by the NICHD Project Scientist will include the following:

Areas of Joint Responsibility include:

Overall coordination of the Program, consistent with the stated intent of the FOA, will be done by a Steering Committee consisting of the Principal and Project Investigators from each of the participating Centers and the Project Scientist from NICHD. The Chairperson, who will be someone other than the NIH staff member, will be selected by the Steering Committee. The Steering Committee meetings will be convened at least once yearly. The purpose of these meetings is to assess scientific progress, identify new research opportunities, establish priorities, and discuss strategies that will accelerate the translation of preclinical findings into clinical applications. Each full member will have one vote. Outside consultants/experts may be asked to participate in these discussions as nonvoting advisors. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:

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 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)

Diana Blithe, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6990
Email: blithed@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Teri Ann Pailen
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 435-7010
Email: pailent@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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