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 Neonatal Research Network  (U24)  

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-HD-13-014.

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HD-18-010  

Companion Funding Opportunity

None

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

93.865    

Funding Opportunity Purpose

This funding opportunity announcement (FOA) 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

May 1, 2017

Open Date (Earliest Submission Date)

May 30, 2017   

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

June 30, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2017   

Advisory Council Review

January 2018   

Earliest Start Date

April 2018 

Expiration Date

July 1, 2017  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

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 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 NRN 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 15 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 2015, and 15 clinical centers were awarded for the 2016-2021 cycle.  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 and quality control with respect to data, 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 repositories. These include preparation of agenda, setting up meeting dates and times, inviting members, setting up call lines, taking minutes, preparing the minutes of the meetings, summarizing the details of the meetings and decisions made, maintaining and saving such official records as appropriate, and related activities.  

(3) Collaborate in data analysis and publication of results of NRN trials and studies;

(4) Provide the logistical support necessary to run an efficient and productive network, including managing capitation funding to the clinical centers for infants enrolled in the Network studies; the DCC may coordinate external services, including procuring study drugs, equipment, and other supplies, implementing masking and randomization methods, and executing subcontracts, such as for conducting diagnostic tests for specific studies and consultancy agreements with outside experts.

(5) Collect and document 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.  These include preparation of agenda, setting up meeting dates and times, inviting members, setting up call lines, taking minutes, preparing the minutes of the meetings, summarizing the details of the meetings and decisions made, maintaining and saving such official records as appropriate, and related activities.

The Steering Committee is composed of clinical center PD/PIs, the DCC PD/PI, and the Project 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 and participation with Investigational New Drug (IND) Application and investigational device (IDE) procedures is essential. The DCC is also responsible for hosting and maintaining a website for the NRN 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 participates in the NRN Steering Committee consisting of NRN Clinical site PD/PIs and NICHD Project Scientist. The Steering Committee is responsible for identifying research topics of high priority, and in designing protocols appropriate to the evaluation of superior or even optimal management in these research 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 External Expert Advisory Committee (EEAC). The EEAC is an external group appointed by the Director of NICHD whose primary purpose is to advise the NRN in the identification and prioritization of topics for NRN research. The EEAC provides advice to the Steering Committee on the scientific merit and potential impact of proposed studies. 

The Data Coordinating Center will:

  • Provide expertise in the design, conduct, data analyses, and data management of NRN collaborative clinical trials.
  • Coordinate human subject protection oversight of NRN studies. In alignment with emerging federal and NIH policy, shared reliance among Institutional Review Boards (IRB) to consolidate into a single IRB or a federated IRB model will be expected.
  • Use informatics and electronic data technologies to design and produce data collection systems, and modify and redesign such systems as appropriate for new study protocols. Data collection systems should comply with international standards for interoperability such as those developed by the Clinical Data Interchange Standards Consortium (www.cdisc.org). When feasible, Common Data Elements as defined by the NIH should be used. For examples and resources, see the NIH Common Data Element Portal at http://www.nlm.nih.gov/cde/. Data collected by the NRN is expected to be collected in such a manner to make it readily interoperable and integrate with other systems including relevant data repositories for data sharing as appropriate and consistent with achieving the goals of the program.
  • Provide appropriate and capable leadership and expertise in biostatistics, study design, data management, data analysis, and project management. These activities should include,
  • but are not limited to, protocol implementation staff and site training and quality assurance procedures. In addition, the DCC should develop a quality assurance and quality control program to ensure high quality and timely data collection and delivery and maintain data integrity.
  • Provide research support activities in designing data collection modules, operational procedure manuals, quality control systems, and an internet-based communications system for Clinical Site PD/PIs, Research Coordinators, and other NRN staff.
  • Establish an account with clinicaltrials.gov and maintain listings for all Network clinical trials. Information on establishing an account can be found at https://clinicaltrials.gov/ct2/manage-recs/how-apply. Listings include posting study results as per the policies of clinicaltrials.gov and the NIH.
  • Provide meeting and conference support for the activities of the Steering Committee, EEAC, and Data & Safety Monitoring Committee through provision of materials and documentation, meeting planning and logistics, and conference call coordination. The functions include, but are not limited to developing meeting agenda, keeping the minutes of the meeting, summarizing major decisions, and filing the information as official documents.
  • Organize and conduct multisite trial initiation education, protocol in-service, assessing study progress in conjunction with the NICHD Project Scientist, and Grants Management Officials as needed.
  • Provide regular reports to the NIH on a schedule and using data elements and format as stipulated by the NICHD on enrollment, population diversity, adverse events, serious adverse events, protocol changes and deviations, resource allocation and other topics as requested.
  • Respond appropriately to changing work needs, NRN prioritization and re-prioritization, and changes in staffing.
  • Provide administrative and scientific assistance in the preparation of manuscripts for publication of NRN data under the supervision of the NICHD Project Scientist.
  • Develop a Data Sharing Plan consistent with NIH and NICHD policy and guidance and structure data collection to facilitate sharing as appropriate and consistent with achieving the goals of the program. See https://grants.nih.gov/grants/policy/data_sharing/ for additional information.
  • Contribute to the development of specific NRN data access policies. The NRN data sharing and data access policies will be posted for public access to maintain transparency.
  • Prepare and submit high-quality, public and restricted-use analytic Network datasets to appropriate data repositories, such as the NICHD Data and Specimen Hub (DASH https://dash.nichd.nih.gov/ ) in accordance with NIH and NICHD data sharing and access policies.
  • Establish a process for preparing and managing Investigational New Drugs (IND) and Investigational Device Exemption (IDE) reports and other Food and Drug Administration and other relevant regulatory agency requirements. This may include holding full, joint, or shared sponsorship of Network INDs and IDEs.
  • Function as a point of contact for other entities to interface with the NRN to engage network sites for protocols that originate outside the network.

See Section VIII. Other Information for award authorities and regulations.

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, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

NICHD intends to commit $6.7 million in total costs in FY 2018 to fund 1 award. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.   

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI must possess a doctoral degree in a relevant field such as statistics, biostatistics, or epidemiology. 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. 

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

. One application per institution is allowed.    

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

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 activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Tonse N.K. Raju, MD
Pregnancy and Perinatology Branch
National Institutes of Health
Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD)
6710B Rockledge Drive, Room 2330 MSC 7002
Bethesda, M.D. 20892
Telephone: 301-402-1872
Email: rajut@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.    

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

The following personnel are needed to insure excellence in the day-to-day activities of the DCC:

  • Principal Investigator (PD/PI):  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. 
  • Because of the importance of DCC functions, one of the Senior/Key Persons must be designated in the application to direct the center in the absence of the PD/PI.   This individual must possess a doctoral degree in a relevant field such as statistics, biostatistics, or other relevant area.
  • Statisticians
  • Coordinators or Research Project Assistants
  • Programming and analytic staff (including supervisory staff and software expertise staff)
  • Data processing staff
  • Logistics and support staff
R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

The budget should include the following individuals:

  • Principal Investigator (PD/PI): 10.2-12.0 person-months (e.g., 85-100 percent of a 12-month appointment) effort.
  • One of the Senior/Key Persons must be designated to direct the center in the absence of the PD/PI and should commit at least 1.2 person-months (10 percent effort of a 12 month appointment) effort to the project.    
R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

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

Research Strategy

The following items must be addressed. 

Staffing Plan: 

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 support for day-to-day functioning of the Network, assist the NICHD project scientist in coordination of the network to manage clinical site capitation must be described and justified.

Management Plan:

Applications must describe plans to assist in protocol development with respect to design of procedure manuals, data collection forms, data collection systems, electronic technology, data entry systems, and data quality assurance. 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. The DCC also adheres to the existing terms and conditions concerning federal, Agency and NICHD policies concerning research data sharing. These include developing de-identified data sets for submission and deposition at public websites (e.g., NICHD Data and Specimen Hub) and providing relevant data dictionaries in a timely manner.

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 is 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. 

Evidence of Successful Past Performance:

Applicants must describe the activities of their team as a whole coordinating and performing as a data coordinating core under any support in the past 3 to 5 years. Applicants must document research productivity as a DCC in previous or ongoing clinical trials, especially those with focus on neonatal health. Contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and track record of publications, timely provision of de-identified data sets should be provided.  Explain how the team has fostered synergy and maintained it through the course past projects.  

History of Collaboration:

Evidence of successful domestic and/or international research network or multicenter research activity should be provided. Contributions and collaborations in areas such as protocol design, study recruitment, data analysis and interpretation, and publication should be highlighted.

Capacity and Ability to Manage Data and Communications:

The applicant must describe past experience of the DCC team in developing and maintaining data control and transmission systems beyond that described on the biosketches. Applicants should provide evidence of data management and program support capabilities by describing their standard operating procedures to include data collection, management, analysis, data security, data sharing, privacy protections, and quality control including those for FDA regulated protocols. The applicant must describe protocols and processes for de-identifying research data, and preparing and submitting datasets for archival in publicly available websites (e.g., NICHD Data and Specimen Hub, DASH).  

Applicants must include plans for support of electronic mail and communication as well as plans for both public and Research Unit access to a website representing the Neonatal Research Network. Evidence of knowledge of federal patient privacy and data confidentiality requirements and appropriate experience in ensuring that relevant protections are in place for all studies must be provided. Plans for timely creation of public use datasets according to NIH requirements are also required.

Evidence of Reporting Capabilities:

Describe experience with generation of monthly reports on subject enrollment, including NIH Population Tracking for multiple concurrent studies, real-time reports on enrollment, reports on clinical center performance, appropriate reports for use by the Data Safety Monitoring Board, the External Expert Advisory Committee (EEAC), and other reports such as newsletters and monthly updates as needed. Plans to document and disseminate minutes for meetings and conference calls are required. The applicant must describe examples of collaborative team efforts in assisting clinical investigators in the preparation of manuscripts on multicenter research for publication, including rapid turnaround of abstracts for national and international meetings.

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.  Should provide successful examples of Technology Transfer, Data Management and Protocol Training.  T Training and technical expertise of the entire team and how the team will work together should be described. raining sessions for scientific protocols, ongoing yearly certifications necessary for NRN studies (e.g., developmental tests, standardized physician examinations, follow up), and data entry are also expected to be arranged through the DCC.

Logistical and Other Support Services:

Describe the process for estimating resources needed for network centers, management of those resources as the work changes qualitatively and quantitatively during the course of the research projects, reporting resource allocations to NICHD, and potentially supplementing resources with funding from outside organizations. Describe logistical arrangements for support of Steering Committee meetings (4 per year), Data and Safety Monitoring Board meetings (1 per year in person; several by teleconference), and External Expert Advisory Committee (EEAC) meetings, as well as other selected meetings required for NRN operations.

On-site and Off-site Monitoring:

Describe plans for organizing and conducting both on-site and off-site monitoring for quality control of research methods, collected research data, including timeliness and completeness to ensure integrity in research conduct and adherence to research protocols across sites. The applicant should describe plans for multicenter research studies and for attending to data errors, needed edits, and protocol deviations. The DCC must ensure that the NRN centers fully comply with NIH regulatory requirements, including Institutional Review Board submissions and queries, Human Subjects Protections, issues of informed consent, reporting of adverse events, and human and animal welfare provisions.   The DCC should expect that all Clinical centers are expected to participate in all trials unless justifiable reasons are provided. 

Special Strengths of the Investigators or Institution:

Applicants are encouraged to describe special or unique strengths that may be relevant to conducting research in neonatal-perinatal medicine. These can include state-of-the-art procedures for data management, which may be shared or disseminated to develop and expand the scientific productivity of the NRN. Potential strengths would include familiarity/experience with FDA policies and procedures for investigational new drugs (IND) as the DCC will need to have responsibility for IND/IDE studies.  In addition, special administrative strengths or experience as well as participation in administrative aspects of clinical research (IRB, DSMC, clinical research committees, etc.) for the PD/PI and additional staff members should be highlighted. Level of support for clinical trials can be described.

Letters of Support

Letters of support should be provided that clearly express intent to participate in a cooperative manner with other NRN clinical centers, the NICHD, DSMC, and the EEAC in all aspects of research as outlined in this FOA.

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 PD/PI or the CTSA program director.

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

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. In addition, they should state that they will adhere to all NIH policies related to specimen sharing.

Appendix:

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

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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

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

Scored Review Criteria for Coordinating/Administrative Centers/Cores

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 proposed Center address the needs of the research [for the Neonatal Research Network] that it will [coordinate, administer, and serve]? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [conducted by the NRN]?  

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing [neonatal] research? Do the investigators demonstrate significant experience with coordinating collaborative [clinical] research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their [leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the Center? Does the applicant provide examples of overseeing and managing subawards, if needed?  Does the application demonstrate the scientific, administrative, statistical and academic qualifications of the PD/PI and the research team at the DCC, as well as the qualifications of the applicant institution to participate fully as the DCC in the NRN? Do the key personnel possess appropriate and adequate knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, including experience in research design, execution, data management and quality control, preferably in neonatal-perinatal medicine? Does the application demonstrate the commitment, availability, and flexibility of staff time for the satisfactory conduct of the studies? Does the application demonstrate the experience and qualifications of team members who would be responsible for data quality and management activities?     

Innovation

Does the application propose novel [management strategies and statistical approaches] in coordinating the research [network] the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [management strategies and statistical approaches] proposed?   

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research [network] the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the [network/consortium], as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? For new applicants, does the approach provide examples of high quality performance as a DCC in the recent past? For current DCCs, do the applicants demonstrate high quality performance in managing NRN protocols during the most recent grant period? Does the application clearly demonstrate the willingness to work and cooperate with NRN clinical centers and the NICHD? Does the application provide examples of procedures for communication of relevant information among investigators during the conduct of the clinical trials, and examples of procedures for dissemination of the trial results to the public at large when such results become available?  Does the application describe how they will conduct reporting to the investigators within multi-center trials with respect to monthly reports, trial subject enrollment, and DSMC experience? Does the application describe the process for or explain procedures with regard to conducting on-site and off-site monitoring and trial oversight? Does the applicant organization describe how it intends to conduct high-quality protocol training and data entry training for clinical site investigators, as well as the for the relevant personnel within the applicant organization? Does the application describe and provide examples of their past experience with the ability to arrange meetings and conference calls and support the complexity of workflow within the network? Does the application describe their performance in developing and maintaining websites?  Does the application describe an effective plan for generating reports and maintaining study records, as required? Does the application provide examples of overseeing capitation systems to the clinical sites for the ongoing studies and trials?   

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research [network] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?  Does the application demonstrate adequate administrative, statistical, and data organizational management facilities as described in the requirements? Is there institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting? Does the application demonstrate optional administrative strengths, such as affiliations with other research units?     

Authentication of Key Biological and/or Chemical Resources:

For [networks] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources. 

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

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 score.

Applications from Foreign Organizations

Not Applicable 

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For [networks] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources. 

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

  The NICHD NRN consists of Clinical Centers (15 in the current cycle), collaborating clinical sites (4 in the current cycle), one DCC (this award) NICHD Program Official and Project Scientist including NICHD support staff.  The Clinical Centers and collaborating clinical sites are funded through a separate solicitation as cooperative agreements (UG1).

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 Part 75, 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:

  • Assistance with identification of priority areas for research
  • Developing and implementing the network protocols
  • Supervision and acquisition of the data to the DCC
  • Data Management and quality control monitoring
  • Logistical support for the NRN
  • Preparation of reports as needed
  • Analysis of data and publication of results of the NRN trials
  • The PI will be a voting member of the Steering Committee.

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

NICHD Project Scientist

  • Assistance with the identification of important areas of study.
  • Assistance in the development of study protocols.
  • Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs.
  • Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the External Expert Advisory Committee (EEAC).
  • Assistance in reporting results in the community of investigators and health care recipients.
  • Assistance in the conduct of the trials, including ongoing review of progress; possible redirection of activities to improve performance and cooperation; and frequent communication with other members of the Steering Committee.
  • Participation on the Steering Committee and all active subcommittees.

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 Project Scientist and will include the following:
  • Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines.
  • Have the option to withhold support to a participating institution if technical performance and milestone requirements are not met.
  • Initiation of a decision to modify or terminate a study based on the input of the data center, DSMC, and/or External Expert Advisory Committee (EEAC).
  • Assurance of the scientific merit of the trials, including the option to withhold support of a participating center if priorities do not match that of NICHD or if participating centers'  performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met.
  • Ensure that operating procedures of the network are consistent with NIH and NICHD policy and have been submitted for approval by NICHD.
  • Perform other duties required for normal program stewardship of grants.

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 External Expert Advisory Committee (EEAC), and the Data Safety and Monitoring Committee.

  • All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process, and the decisions of the steering committee.
  • The NRN Steering Committee will adhere to policies related to data and specimen sharing developed by the NIH and HHS and related government entities.
  • NRN clinical site awardees will retain custody of and have primary rights to the data and software developed under their awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Steering Committee

A Steering Committee will be responsible for protocol development, assisted by the External Expert Advisory Committee (EEAC) 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 Project Scientist. The NRN Project 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.

External Expert Advisory Committee (EEAC) 

The EEAC assists the Steering Committee in the identification and prioritization of topics for perinatal research. The EEAC 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 is established by the NICHD to monitor the safety of ongoing clinical trials. 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Tonse N. K. Raju, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-1872
Email: rajut@mail.nih.gov

Peer Review Contact(s)

Sherry Dupere, PhD
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)

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

Section VIII. Other Information

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

Authority and Regulations

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

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