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

Data Coordinating Center for the NICHD Cooperative Multicenter Neonatal Research Network (U10)

Activity Code

U10 Cooperative Clinical Research – Cooperative Agreements

Announcement Type

Reissue of RFA-HD-07-002

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-13-014

Companion Funding Opportunity

None 

Number of Applications

Only one application per institution is allowed, as defined in section III.3. Additional Information on Eligibility.    Section III. 3. Additional Information on Eligibility.

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

93.865    

Funding Opportunity Purpose

This funding opportunity announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development invites  applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center (DCC) under a cooperative agreement in an ongoing multi-center research network designed to perform observational and interventional clinical studies, using common protocols, to improve outcomes for neonates.      

Key Dates
Posted Date

June 5, 2012

Letter of Intent Due Date

July 9, 2012

Application Due Date(s)

August 9, 2012  

AIDS Application Due Date(s)

Not Applicable  

Scientific Merit Review

October/November 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

December 1, 2013

Expiration Date

August 10, 2012

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

Research Objectives

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications from institutions willing to participate as the Data Coordinating Center (DCC) for the NICHD Neonatal Research Network (NRN) under a cooperative agreement in an ongoing multicenter clinical research program designed to perform interventional and observational clinical studies in newborn infants, particularly low birth weight infants. The model of multi-site clinical centers for research is well established. The objective of this program is to facilitate the advancement of neonatal care by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and provide answers more rapidly than individual centers acting alone.

The infrastructure is set up for carefully designed randomized double-blinded placebo controlled as well as management trials with the ability to follow both short-term (clinical effect) and long-term (neurodevelopmental outcome) measures. The infrastructure is also set up for observational, longitudinal studies in the neonatal intensive care unit setting. Many randomized clinical trials involve the need for baseline information regarding disease incidence and outcome, which is available from the generic database of neonates <29 weeks gestation in the current NRN.

Currently there are 18 NICHD NRN Clinical Centers and four collaborating centers (sites that conducted trials within Network that are continuing follow up of study subjects).  Ongoing studies include:

The NICHD NRN's mission is to investigate the safety and efficacy of treatment and management strategies for newborn infants.  The clinical centers for the network were re-competed in 2010, and 18 clinical centers were awarded for the 2011-2016 cycle for membership.  The DCC plays a pivotal role in data management and analysis, statistical expertise, and logistical services required for the NRN.  In support of the activities of the NRN, the DCC will (1) collaborate in the development, implementation and monitoring of common Network protocols; (2) provide data management, including preparation of data and safety reports for the Data and Safety Monitoring Committee (DSMC) and preparation of data reports for Network subcommittees, centers and public data files; (3) collaborate in the analysis of data and publication of results of the NRN trials and studies; (4) provide the logistical support necessary to running an efficient and productive network including capitation funding to the clinical centers for infants enrolled in the network studies; (5) collect and file all Institutional Review Board (IRB) reports and communications.

A responsive application must provide strong evidence of the applicant’s ability to cooperate with multiple sites involved in clinical trials in design, execution, data collection and data analysis resulting in publication for multicenter randomized and observational clinical trials, particularly in the area of neonatal-perinatal medicine.  The DCC must provide logistical support for meetings, teleconferences, and the steering committee.  The Steering Committee is composed of clinical center PD/PIs, the DCC PD/PI, and the Program Scientist from NICHD.  The Steering Committee assures compliance with Network policies and procedures; selects topics for investigation; designs study protocols; implements studies; participates in the analysis and interpretation of data; and reports results in presentations and publications.   Experience with the Investigational New Drug (IND) Application procedures is essential.  A website is required and maintained by the DCC for both public access and private secure investigator and staff access. The DCC is the primary liaison to the DSMC and is responsible for coordination of DSMC activities.

Scope

There are a number of controversial issues in neonatology that might be clarified by multicenter collaborative research. The funded DCC will cooperate with the NICHD NRN clinical site PD(s)/PI(s) and the NICHD Program Scientist in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior or even optimal management in these areas. The participating DCC will have primary responsibility for data management and analysis for NRN research in collaboration with the Steering Committee.

The NICHD expects to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. The Advisory Board is an external group appointed by the Director of NICHD whose primary purpose is to advise NICHD and the NRN in the identification and prioritization of topics for NRN research. The Board provides advice to the Steering Committee on the scientific merit and potential impact of proposed studies. 

Areas of potential projects include but are not limited to:

Section II. Award Information
Funding Instrument

Cooperative Agreement

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 $7.2 million in FY 2013 to fund one award. Future year amounts will depend on annual appropriations.

Funds consist of total costs of approximately $3.0 million for a coordinating center base budget and $4.2 million for clinical center capitation for one award, corresponding to a total of $7.2 million for the first year.

Subsequent year budgets are to remain at $7.2 million in total costs with $3 million for coordinating center base budget and $4.2 million reserved for site capitation for protocols.    

Award Budget

Application budgets are limited to $7.2 million total costs and must reflect actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period. The total project period for an application submitted in response to this FOA may not exceed five years.   

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign 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 not allowed.

Required Registrations

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

All Program Directors/Principal Investigators (PD(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 PD/PI must possess a doctoral degree in a relevant field such as statistics, biostatistics, or epidemiology and is required to commit 10.2-12.0 person-months (85 to 100 percent) effort to the DCC activities of the NICHD NRN. The PD/PI must have clinical trials, administrative and statistical expertise.  Active participation of the PD/PI is expected during all phases of a clinical research study.  One individual must be designated as an alternate PD/PI who is able to serve in the absence of the PD/PI.  The alternate PD/PI must possess a doctoral degree in a relevant field such as statistics, biostatistics, or other relevant area and should commit at least 1.2 person-months (10 percent) effort to the project.  

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

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:

The letter of intent should be sent to:

Rosemary D. Higgins, MD
Program Scientist for the Eunice Kennedy Shriver NICHD Neonatal Research Network
Pregnancy and Perinatology Branch, CDBPM
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard, Room 4B03
Bethesda, MD 20852
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-435-7909 or 301-496-5575
FAX: 301-496-3790
Email: higginsr@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, PhD
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: 301-496-3415
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.

Detailed Budget for Initial Budget Period

Follow instructions in the PHS 398 Application Guide, with the following modifications:

Allowable costs and policies governing the research grants programs of the NIH will prevail. F&A costs will be awarded in the same manner as for research project grants. Budgets will be reviewed on the basis of appropriateness for the work proposed.

Base Budget

The first year budget will be limited to a BASE BUDGET of $1.8 - 2.2 million in direct costs and must not exceed $3 million in total costs.   Allowable costs include:   

Capitation Costs  

Capitation costs for studies and trials will be supported with a capitation budget of $4.2 million.  Capitation costs should not be listed on the budget pages.

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide.

Capitation costs for studies and trials will be supported with a capitation budget of $4.2 million.  Capitation costs should not be listed on the budget pages.

Research Plan

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

Research Strategy

Within the Research Strategy section, applications must address the following items:

Evidence of Successful Past Performance

DCC applicants must describe prior experience in the design, conduct, data analysis and management of major collaborative clinical research projects preferably in neonatal-perinatal medicine, and provide evidence of successful performance as a DCC for multi-site studies within the past three to five years.  Further, applicants need to show evidence of monitoring of trials including the ability to generate monthly reports of enrollment and follow up for the NICHD NRN clinical centers and subcommittees, data and safety reports for DSMC, and provision of support of data files.

Academic Productivity

DCC applicants must provide evidence of research productivity in previous or ongoing clinical trials, especially those of a cooperative or multicenter design in the field of neonatal-perinatal medicine. Contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and track record of publications that resulted from participation in the studies should be listed.

Staffing Plan and Capabilities

The application should describe plans for staffing DCC functions and provide evidence of multicenter collaboration on recent clinical trials, especially those in neonatal-perinatal medicine, including publications resulting from these studies.  The proposed DCC should have some degree of flexibility in staffing to be able to respond to the changing needs and seasonal variation in work effort of the NICHD NRN.  For instance, meeting deadlines, trial startup and completion, and other variables occur which necessitate increases and decreases in staff effort from the DCC.   Logistical staff for day to day functioning of the network and support staff to manage clinical site capitation must be described and justified.  The following personnel are needed to insure excellence in the day-to-day activities of the DCC:

Principal Investigator (PD/PI):   10.2-12.0 person-months (85-100 percent) effort

Alternate PD/PI:   Minimum of 1.2 person-months (10 percent) effort

Statisticians

Coordinators or Research Project Assistants

Programming and analytic staff (including supervisory staff and software expertise staff)

Data processing staff

Logistics and support staff

Capacity and Ability to Manage Data and Communications

Applications must describe the ability to assist in protocol development with respect to design of procedure manuals, data collection forms, data collection systems, electronic technology, and data entry systems.  Prior experience in data quality assurance is required.  Applicants should provide evidence of data management and program support capabilities by describing their standard operating procedures to include data collection, management, analysis and quality control. A system to insure availability of patient randomization for studies outside of normal business hours (i.e. nights, weekends, and holidays) is required.  Applicants must include plans for support of electronic mail and communication as well as plans for a website system for participants of the NICHD NRN.  The website should have public and private access links available.  Previous experience in neonatal-perinatal medicine studies and FDA IND (Food and Drug Administration Investigational New Drug) protocols are preferred. Knowledge of federal patient-privacy and data confidentiality requirements and appropriate experience in ensuring that relevant mechanisms and procedures are in place must be provided in the application.  The DCC must develop and maintain a website for both public access and private, secure investigator access.

Evidence of Reporting Capabilities

Applications must provide evidence of experience with generation of monthly reports on subject enrollment for multiple concurrent studies, reports for use by DSMC and advisory board, and reports for Steering Committee meetings is required.  Documentation and dissemination of meeting minutes and minutes of conference call meetings are required to be performed in a timely manner.  The applicant should delineate previous history of such activities in the application.  Further, experience in preparing data presentation and manuscripts for publication is to be described in the Research Plan.   The DCC PD/PI will give a report to the Steering Committee quarterly at the Steering Committee meetings as necessary. 

Logistical and Other Support Services

Applications must describe experience and capabilities with respect to logistical and support services relevant to the NRN.  The DCC provides arrangements and documentation in the form of minutes for the Steering Committee meetings (four per year in the DC metropolitan area) and conference calls, DSMC meetings (one per year and as needed) and committee conference calls, and other meetings as needed by the NICHD NRN.   On occasion, the DCC handles travel arrangements for selected consultants as needed.  The NRN communicates on an ongoing basis via email and teleconference; these activities are supported by the DCC.  The DCC is responsible for supporting the infrastructure for meetings and teleconferences.  Expertise in coordinating sample storage and study drug/equipment assignment is required. 

On-site and Off-site Monitoring Ability

Applications must provide evidence of experience in organizing and conducting both on-site and remote monitoring for clinical research studies.  Generation of data errors and needed edits is required. The DCC needs to ensure that the NRN centers fully comply with NIH regulatory requirements, including Human Subjects Protections, informed consent, reporting of adverse events, human and animal safety and welfare provisions, and FDA requirements as indicated by specific studies.

Technology Transfer, Data Management and Protocol Training Capabilities

Applications are expected to describe capabilities in technology transfer, data management, and protocol training. The DCC must be able to assist the clinical centers in data management and communication activities.  Training and technical expertise as well as experience and resources must be delineated in the Research Plan.  Training sessions for scientific protocols, ongoing yearly certifications necessary for the NICHD NRN studies (e.g., developmental tests, standardized physician examinations, follow up), and data entry are arranged through the DCC.

Administrative and Management Capabilities

The PD/PI should delineate his/her skills as a manager or administrator for a DCC.  The PD/PI must provide evidence of experience and ability to estimate the appropriateness and reasonableness of resources needed for individual projects and ability to manage those resources efficiently during the course of the research.  Flexibility of personnel based on needed effort is required. Prior experience with meeting deadlines (e.g., FDA reporting requirements, national meetings, Steering Committee meetings, DSMC meetings, advisory board meetings, and so forth) should be delineated in the application.  Experience with capitation for study subject recruitment by clinical centers is mandatory.  This includes providing and monitoring funding to the clinical centers for patient recruitment at regular intervals.  Experience with subcontracts is required as there is occasional need to supplement resources through arrangements with outside organizations based on individual protocol requirements. 

Special Strengths of the PD/PI or Institution

Applicants are encouraged to describe special or unique strengths that may be relevant to NRN research. This can include state-of-the art data management systems, which may be shared or may be available to develop and expand the scientific productivity of the NRN.  In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (IRB, DSMC, advisory board for clinical research, clinical research committees and so forth) for the PD/PI and additional staff members should be highlighted. Level of support for clinical trials can be described. Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH or other funded perinatal research centers as resources for conducting the proposed research should provide a letter of agreement that identifies the level of support from the PI or the CTSA program director.

Intent to Participate

There must be a clearly expressed intent to participate in a cooperative manner with other NRN clinical centers, the NICHD, DSMC and advisory board in all aspects of research as outlined in this RFA.  NRN projects are given priority at awarded clinical centers. Clinical centers are expected to participate in all trials unless they describe trials that currently conflict with ongoing network trials as part of their application for this RFA and the DCC provides logistic and data support for the trials.

Letters of Support

The departmental and/or institutional commitments to participate in NRN-supported research should be clearly documented with letters of support from appropriate individuals. Evidence of past support can also be cited. Support in areas of grants management, personnel management; space allocation, data coordination and confidentiality, procurement, and equipment as well as general support of the research should be described as well as evidence of past research support.

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:

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.  

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.

Overall Impact - Overall

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

Scored Review Criteria - 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 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(s)/PI(s), 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?   

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.

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.   

2. Review and Selection Process

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

The NICHD NRN consists of 18 Clinical Centers, collaborating clinical sites, and the DCC (this award).

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

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

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

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

NICHD Program Scientist

NICHD Program Official

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

This role is separate from the Program Scientist and will include the following:

Areas of Joint Responsibility include:

In addition to the above specified rights, responsibilities and involvement, the DCC has collaborative responsibilities involving interactions with the Steering Committee, the Advisory Board, and the Data Safety and Monitoring Committee.

Steering Committee

A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the DSMC.   The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all PD/PIs from the clinical centers, the PD/PI of the DCC, and NICHD staff. The Clinical Centers are supported through separate cooperative agreements solicited in a separate RFA. Participating NICHD staff will include the Pregnancy and Perinatology Branch NRN Program Scientist. The NRN Program Scientist will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside Chairperson, who is not participating as a PD/PI, will be selected by the NICHD.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Advisory Board

The Advisory Board assists the Steering Committee in the identification and prioritization of topics for perinatal research. The Advisory Board is selected by the NICHD and consists of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology, and the Chairperson of the Steering Committee. Additional members will participate based on the need for specific expertise.

Data Safety and Monitoring Committee

A DSMC monitors the safety of ongoing clinical trials. The DSMC is established by the NICHD and reports to the Director of NICHD. The DSMC may recommend halting or termination of studies based on efficacy, safety or futility.  The DCC is the liaison with the DSMC.  The DSMC is composed of individuals with expertise in clinical trial design and conduct, perinatology, neonatology, basic science, and ethics.

In addition, the NICHD NRN has established policies and procedures that govern its operations, including publications. These policies and procedures can be amended by the Steering Committee and the NICHD.

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)

Rosemary D. Higgins, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-7909 or 301-496-5575
Email: higginsr@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)

Grace Poe
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: (301) 435-7011
Email: poeg@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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