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	Global Network for Women’s and Children’s Health Research Data Coordinating Center (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	Reissue of RFA-HD-05-025
Related Notices	June 3, 2016 - This RFA has been reissued as RFA-HD-17-010.
Funding Opportunity Announcement (FOA) Number	RFA-HD-12-201
Companion FOA	RFA-HD-12-200, U10 Cooperative Clinical Research Cooperative Agreements
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility. An institution may not apply for both RFA HD-12-201 and RFA HD-12-200. See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865
FOA Purpose	This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development solicits grant applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center under a cooperative agreement in an ongoing international multi-center research network designed to perform randomized clinical trials, using common protocols, to reduce the major risk of maternal, neonatal, infant, and early childhood mortality and significant morbidity in low income countries.

Posted Date	May 24, 2011
Open Date (Earliest Submission Date)	July 11, 2011
Letter of Intent Due Date	July 11, 2011
Application Due Date(s)	August 11, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2011
Advisory Council Review	January 2012
Earliest Start Date(s)	April 1, 2012
Expiration Date	August 12, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

The fourth and fifth priorities of the United Nation s Millennium Development Goals (MDGs) are to significantly impact maternal and child health by 2015 by reducing maternal mortality by three -quarters and under 5 mortality by two - thirds, respectively. Achievement of these goals cannot be considered in isolation but rather in the context of progress in parallel goals of poverty reduction, universal primary education, gender empowerment and equality, combating HIV AIDS and ensuring environmental stability. Efforts of the United Nations, the World Health Organization, government institutions and agencies, non-governmental organizations, private sector stakeholders and the global health community at large are all actively being channeled towards finding and applying the interventions that would have the biggest impact in the shortest possible time. The 2008 MDG report states that the goals are achievable if the financial commitments from developed countries are delivered as promised. In his recent address to the United Nations in September, 2010, United Nations Secretary General Ban Ki-Moon reiterated the need to integrate delivery of health services, improve access of women and infants to life-saving interventions, strengthen health systems, particularly the health workforce, and encourage an innovative approach to product development.

Although many developing countries including some of the poorest nations are advancing steadily towards the MDGs each year, 8.8 million children and 342,000 women still die from preventable and/or treatable diseases and illnesses. Sub-Saharan Africa, South Asia, and the least developed countries have fallen behind other developing regions and industrialized countries on most indicators. According to the 2009 UNICEF report, nearly one-half the population of the world’s 49 least-developed countries is under the age of 18, characterizing these countries as rich in children who are at risk of poor child survival and development outcomes. They have the highest rates of child mortality and out-of-school children and the lowest rates of access to basic health care, maternity services, safe drinking water and basic sanitation.

In sub-Saharan Africa, fifty-percent of maternal deaths take place within one day of childbirth. The maternal mortality rate is 50 times higher in developing countries than in industrialized countries. Antenatal care offers opportunities to improve the health of women by providing patient health care interactions that have the potential to improve the prevention and management of HIV infection and malaria, the detection of pre-eclampsia and management of eclampsia, awareness of the need for skilled birth attendants who could manage emergencies such as post-partum hemorrhage, nutrition education on the benefits of iron and folate supplementation the latter being particularly important in low-income countries where micronutrient deficiencies are common. Despite this, less than half of all pregnant women in the world receive the WHO-recommended minimum of four antenatal visits. Antenatal care coverage has improved since 1990, and now at least two- thirds of women see a skilled health provider one or more times during pregnancy. Women living in rural areas are, however, are much less likely to receive antenatal care than their urban counterparts.

The proportion of neonatal deaths is increasing, accounting for 41 percent of all under five deaths in 2008. At least 40% of newborn deaths occur within a day of birth. Most children in developing countries continue to die from preventable or treatable causes, with pneumonia and diarrhea the two main killers. Undernutrition contributes to more than one -third of all under-five deaths. Stunting, an indicator of chronic undernutrition, remains a problem of larger magnitude than underweight. In the developing world, children living in rural areas are almost 1.5 times more likely to be stunted as those in urban areas. Children under 2 years of age are most vulnerable to stunting, after which the effects are largely irreversible.

In light of this enormous burden of morbidity and mortality among women and children in the developing world, continued innovative and implementation-oriented research is urgently needed to provide evidence-based scientific knowledge to determine efficacy of interventions, guide implementation of interventions, and inform health policy and planning of interventions. The Global Network, comprising U.S. and developing country research teams and institutions, will facilitate high quality, sustainable collaborative research that can address many of these problems and issues while simultaneously building the professional capacity and infrastructure in developing country sites.

Originally funded to perform diverse, site-specific individual protocols, the Global Network has transitioned to the conduct of common research protocols to more efficiently address the major causes of morbidity and mortality among women and young children in the developing world. Grantees will be part of a Global Network that will include up to seven (7) clinical Research Units (RUs, dyads of U.S. and foreign teams) and a Data Coordinating Center (DCC).

The Data Coordinating Center plays a pivotal role in data management and analysis, statistical expertise, and logistical services required by the Global Network. The funded Data Coordinating Center will have the primary responsibility to support the research endeavors of the Global Network (GN) in collaboration with the External Advisory Board and Steering Committee. The GN Data Coordinating Center has the responsibility to provide the Network's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and regulatory adherence. In addition, the Data Coordinating Center will financially support specialty consultations, specialty services, and other study needs. It also is responsible for assisting the sites in developing and implementing common protocols, implementing quality assurance procedures, including site monitoring; developing data management systems and databases; and developing analytic capacity. The Data Coordinating Center will be responsible for the creation and integrity of study databases, analytic capacity, and support of and attendance at all Network meetings.

The Global Network is intended to strengthen and enhance the global infrastructure and research capacity for women's and children's health research. It will increase opportunities for scientific linkages, interaction, knowledge development and transfer, and collaborative partnerships among U.S. and foreign investigators and institutions.

The Global Network Clinical Research Unit FOA calls for a broad array of interventional studies to be conducted across sites in competitively selected low income countries. The studies will address health conditions in women and young children, with an emphasis on the perinatal and neonatal periods, but up to and including three years of age. Proposed interventions will emphasize the development, testing, adaptation and implementation of cost-effective, integrated biomedical, behavioral, social, and public health interventions that may reduce causes of premature morbidity and mortality among women of reproductive age and young children.

The Global Network emphasizes a multidisciplinary, team-based approach. Disciplines may include pediatrics, family medicine, obstetrics, infectious diseases, epidemiology, statistics, environmental science, pharmacology, and the behavioral and social sciences. Global Network teams will be based primarily at the institution of the Senior Foreign Investigator (SFI) as it is not the intention of this FOA to support multi-disciplinary teams of investigators in the U.S. The Global Network will function as a collaborative group that fosters communication, innovation, and research excellence. Grantees should expect to propose and participate in multiple common protocols that may be conducted in several or all network sites. Grantees must be willing to work collaboratively and with cultural sensitivity.

In support of the Network activities, the Data Coordinating Center will collaborate in the development, implementation, and monitoring of Network protocols; provide data management and transmission, including preparation of data and safety reports for the Data and Safety Monitoring Board, Network committees, public data files, and manuscripts for publication; collaborate in the analysis of data and publication of results of Network studies; provide services for acquisition and storage of study drugs and placebos and other equipment and supplies; and provide logistical support necessary to run an efficient and productive Network. The awardee is expected to collaborate with the External Advisory Board, Research Unit Principal Investigators, Senior Foreign Investigators, NICHD Program Scientists and other participating NICHD staff, in the design and conduct of protocols, analysis of data, and reporting results from GN research.

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 collaboratively by the Steering Committee with advice from the External Advisory Board.

The Global Network will consist of up to 7 Research Units (RUs) composed of multidisciplinary teams of collaborating U.S. scientists linked to investigators in low income countries as full and equal partners; a single Data Coordinating Center that will provide research support services and methodological and statistical expertise for the Global Network; and the NIH (represented by the NICHD Program Scientist, the Project Officer(s), and Staff Science Collaborators from NICHD/NIH). The Global Network Research Units may include additional consultants needed at specific time periods.

Steering Committee

The Steering Committee will serve as the Global Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee reviews all presentations and publications via the Publications Subcommittee and NICHD clearance mechanisms. The Steering Committee is composed of the U.S. PD/PI and SFI of each RU, the PD/PI of the Data Coordinating Center, and the NICHD Program Scientist, each of whom has one vote. NICHD will appoint a Chairperson, who is not participating as a PD/PI, for a minimum term of 2 years.

The Steering Committee will meet twice annually in person and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems are reviewed for each site.

Data Coordinating Center

The Global Network Data Coordinating Center has the responsibility to provide the Network's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and regulatory adherence. In addition, the Data Coordinating Center will financially support specialty consultations, specialty services, and other study needs. It also is responsible for assisting the sites in developing and implementing common protocols, implementing quality assurance procedures, including site monitoring; developing data management systems and databases; and developing analytic capacity. The Data Coordinating Center will be responsible for the creation and integrity of study databases, analytic capacity, and support of and attendance at all Network meetings.

Data and Safety Monitoring Board

A Data and Safety Monitoring Board (DSMB) has been established by NICHD to monitor the safety of ongoing clinical trials. It also advises the NIH and the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The DSMB members have expertise in clinical trial design and conduct; relevant basic, medical, and behavioral sciences research; and ethics and cultural competency issues, particularly with relevance to developing country populations. The Data Coordinating Center provides coordination, support, travel funding, and logistical arrangements for DSMB and EAB (see below) meetings and activities.

In addition, the Network has established policies and procedures that govern its operations, including publication. These documents are under periodic review, and may be amended and supplemented at the discretion of the NICHD and the Steering Committee.

External Advisory Board

An External Advisory Board (EAB) will advise the Steering Committee on the identification and prioritization of topics for research. Members of the EAB will be chosen by NICHD with input from the Steering Committee and will comprise individuals with expertise in clinical trials; biostatistics; epidemiology; obstetrics; pediatrics; infectious diseases; social sciences; behavioral sciences; basic sciences; and ethics. The EAB will have no more than 5 members who will elect a Chair. The Chair of the EAB will serve for a minimum of 2 years. Additional members will participate based on the need for specific expertise.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal Applications currently funded under RFA-HD-05-025 are permitted in response to this FOA. The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NICHD intends to commit approximately $2.1 million dollars in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2012 to fund 1 new and/or renewal award.
Award Budget	An applicant for the Data Coordinating Center may request a budget of $ 2.1 million in total costs [direct costs plus Facilities and Administrative (F&A) costs] per year.
Award Project Period	An applicant for the Data Coordinating Center may request a project period of up to 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.

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

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)
• 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI for the Data Coordinating Center must be a PhD candidate or recipient in a relevant field such as statistics, biostatistics, epidemiology or other relevant area. The PD/PI must have senior leadership experience with international multicenter randomized clinical trials, biostatistics, data management, data transmission, data analysis, and project management and have familiarity with the supportive role of a data coordinating center.

The PD/PI is required to commit a minimum of 7.2 to 9.0 person months (60 to 75 percent) effort to the Data Coordinating Center activities. The active participation of the PD/PI is expected during all phases of a clinical research study and at Steering Committee meetings and conference calls.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH-IPF number) is allowed.

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. Applicants applying for this FOA may not apply for the companion FOA RFA-HD-12-200.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) 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.

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

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

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

The letter of intent should be sent to:

Linda L. Wright, MD
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 4B05J, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-402-0830
FAX: 301-480-7773
Email: wrightl@mail.nih.gov

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

The instructions for budget requests provided with the SF424 (R&R) Application Guide should be followed. Budgets will be reviewed on the basis of the appropriateness for the work proposed. The budget is limited to $ 2.1 million in total costs [direct costs plus Facilities and Administrative (F&A) costs] per year for 5 years.

The following categories of personnel are needed at a minimum to ensure excellence in the day-to-day activities of the Data Coordinating Center: PD/PI, Senior Statistician, Project Managers, Administrative Assistant(s), Statisticians, Programmers, Data processing staff, and Logistics and Support Staff. In order to provide adequate attention to a plan for distributing and reporting per- protocol costs, a designated accounting staff member is required.

Budgets for the first project year (FY 2012) should include funds for new computer equipment (as required), training, and software needed to establish a computer-based distributed data entry system at all Clinical Sites.

The first year budget at the time of application will be limited to a base budget with allowable costs as indicated:

• PD/PI, minimum 7.2 9.0 person months (60-75 percent) effort
• Senior Statistician, minimum of 1.8 person-months (15% effort)
• Project Manager
• Statisticians
• Accountant
• Programmers/analysts/logistics and support staff
• Costs associated with data entry, management, collection, and analysis, software, and establishing a distributed data entry system
• Supplies and equipment (itemized and justified)
• Travel for Data Coordinating Center staff, Data and Safety Monitoring Board members and the External Advisory Board

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

Research Strategy

Approach (component of Research Strategy)

In the Approach section, applicants should describe plans for administration and operation of the Data Coordinating Center, and provide evidence of relevant experience and past accomplishments/progress. The following issues should be addressed:

• Staffing and Capabilities: Recent collaborative experience with multicenter randomized clinical trials and roles of personnel should be described. The Data Coordinating Center should have flexibility in staffing to meet the changing needs and variation in work effort in the Global Network. For instance, meeting deadlines, trial startup and completion, and other variables occur that require increases and decreases in staff effort from the Data Coordinating Center. Applicants should describe the capabilities of their research organization and include plans for managing funds and accomplishing the proposed research successfully. Details of special administrative strengths or experience such as support for cluster randomized trials, qualitative studies and surveys should be mentioned. Participation in administrative aspects of clinical research such as Data and Safety Monitoring Boards, Institutional Review Boards [IRBs], advisory boards for clinical research, clinical research committees, and special consent procedures should be supplied.
• Management Capabilities and Plans: The PD/PI should describe his/her experience and capabilities in managing a Data Coordinating Center, including provision of the experience and ability to estimate the appropriateness and reasonableness of resources needed for projects and to manage the resources efficiently during the course of the research. Experience meeting deadlines and subcontracting should be described. An accountant should be on staff to prepare at minimum, real-time quarterly spending and projection reports in an approved format for protocol funds for the NICHD Program Officer. Additional reporting of per-protocol funds may be required.
• Past Performance: Applicants must provide evidence of research productivity as a data coordinating center in previous or ongoing international clinical trials, especially those with focus on women’s and children s health. Contributions in key areas of research development and design, data collection and analysis, monitoring of trial progress, and track record of publications should be provided. Applicants must provide evidence of successful performance as a data coordinating center in the past 3 to 5 years.
• History of Collaboration: Applicants must describe any relevant international collaborative research activity undertaken between the U.S. applicant institution and a low-income partner institution. Evidence of successful domestic and/or international research network or multicenter research activity also 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 Plans for Managing Data and Communications: Ability to assist in protocol development with respect to design of protocol and manual of operations, data collection forms, study manuals, data collection systems, electronic technology, and state of the art data entry systems, including distributed data entry and computer-generated randomization must be demonstrated in the application. Prior experience in data quality assurance, including internal form checks as well as other methods is required. The applicant must have experience in developing and maintaining data control and transmission systems. 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, privacy protections, and quality control. 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 Global Network. Previous experience with FDA policies and procedures for investigational new drug (IND) and investigational device exemption (IDE) is preferred. 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. Evidence of timely creation of public use datasets under NIH requirements is also required.
• Reporting Capabilities and Plans: Evidence of 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 Advisory Board, and other reports such as newsletters and monthly updates as needed should be demonstrated in the application. Plans for documenting and disseminating minutes for meetings and conference calls should be described. The applicant must demonstrate successful experience in assisting clinical investigators in the preparation of manuscripts on multicenter research for publication, including rapid turnaround of abstracts for national and international meetings.
• Logistical and Other Support Services: Evidence must be provided of management capability to estimate appropriate and reasonable resources needed for individual RUs, evidence of the ability to manage those resources efficiently, to adjust the assigned resources as the work changes qualitatively and quantitatively changes during the course of the research projects, to report the resource allocations to NICHD, and to supplement resources with subcontracts with outside organizations.

The Data Coordinating Center must provide logistical arrangements for support of Steering Committee meetings (2 per year) and conference calls, Data and Safety Monitoring Board meetings (2 per year) and conference calls, External Advisory Board meetings (1 per year) and conference calls, as well as other selected consultants as needed by the NICHD. The Data Coordinating Center should be represented on all Network calls. The applicant should expect to utilize email and teleconference frequently and to provide support services to the NICHD in the form of written reports and presentations. The applicant must have experience arranging logistical services for international multicenter clinical trials, such as assuring appropriately prepared and labeled supplies of study medications for the Research Units. The ability to coordinate sample storage and study drug and/or equipment shipment is required. The applicant will be expected to provide training for all RU personnel as needed on data management and analysis, quality control and quality assurance.

• Plans for On-site and Off-site Monitoring Ability: The applicant must describe plans for organizing and conducting both on-site and off-site monitoring for international clinical multicenter research studies and for attending to data errors, needed edits, and protocol deviations. The Data Coordinating Center must ensure that the Network Research Units fully comply with NIH regulatory requirements, including Internal Review Board submissions and queries, Human Subjects Protections, issues of informed consent, reporting of adverse events, human and animal welfare provisions, and FDA guidelines as required by specific studies.
• Special Qualifications of the Applicant: Applicants are encouraged to describe special or unique strengths that may be relevant to maternal and child health in low-income countries. This can include state-of-the-art data management systems, which may be shared or made available, to develop and expand the scientific productivity of the Global Network.
• Hypothetical Management Plan: The applicant should complete a hypothetical staffing, data collection, data management, and budget plan in the Research Strategy section of the application based on the following: assume an ongoing health registry, one new protocol and one protocol in development. Assume 7 Research Units will enroll approximately equal numbers for each study and that enrollment is completed in the first year. Using these assumptions, estimate the base costs for professional and support staffing, data management costs, and other appropriate costs for carrying out these tasks as described in this FOA. The hypothetical management plan should be approximately 2 pages in length.

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 SF424 (R&R) Application Guide.

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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF 424 (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.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 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.

Intent to Participate: The application must include appropriate Letters of Commitment expressing the intent to participate in a collaborative manner with the Research Units and with the NICHD. The letter(s) from the applicant must state the intent to cooperate with the NICHD in all aspects of research as outlined in this FOA.

When a Data Coordinating Center application has been favorably recommended and is being considered for funding, the applicant will be required to complete a budget to support those underway and in development in the Network. Therefore, funding levels at the time of award will be negotiated between the grantee institution and the NICHD.

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

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

For this particular announcement, note the following:

The GN Data Coordinating Center has the responsibility to provide the Network's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and regulatory adherence. It also is responsible for assisting the sites in developing and implementing common protocols, implementing quality assurance procedures, including site monitoring; developing data management systems and databases; and developing analytic capacity. The Data Coordinating Center will be responsible for the creation and integrity of study databases, analytic capacity, and support of and attendance at all Network meetings.

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).

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

Significance

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

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Are the Departmental and Institutional commitments documented? Are there special strengths of the environment that could contribute in innovative ways to the research network? Are there special strengths of the institution or collaboration that are relevant to maternal and child health in low-income countries (this can include state-of-the-art data management systems, which may be shared or made available, to develop and expand the scientific productivity of the Global Network)?

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

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.

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

As part of the scientific peer review, all applications:

• 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/priority score.
• Will receive a written critique.

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.

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

• Assistance with identification of priority areas for research
• Assist in developing and implementing Network protocols
• Supervision of data acquisition and transfer to Data Coordinating Center
• Data management and quality control monitoring
• Logistical support for the Network
• Preparation of reports as needed
• Analysis of data and participation in publication of results of the Network trials
• Participate as a voting member of the Steering Committee
• Participate on all protocol and other subcommittees

The Research Units are funded through a separate solicitation as a cooperative agreement (U10). All parties will agree to accept the collaborative nature of the group process and the supportive role of the Data Coordinating Center.

The Global Network will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

NICHD Project Scientist:

The NICHD Project Scientist will serve as the principal representative of NICHD and NIH and will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards and will, in consultation with relevant NICHD program staff and representatives of the other NIH co-sponsors, provide overall programmatic oversight, coordination, and assistance to the Global Network.

Specifically, the NICHD Project Scientist will:

• Facilitate communication, cooperation, and the exchange of information among Network members and between the Network components and other existing programs to support collaborative efforts;
• Participate as a voting member of the Steering Committee;
• Consult with NICHD Program Official and NIH co-sponsors, who may be designated as Staff Science Collaborators assigned to specific studies, when needed for optimal implementation of study designs;
• Assist the Steering Committee in the selection and approval of important research topics and the development and review of protocols for any specific studies;
• Together with the Steering Committee Chairperson, approve formation and membership of any Steering Committee subcommittees;
• Assist in the development and review of protocol budgets, including the identification of study costs and special institutional needs;
• Assist 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 Advisory Board ;
• Assist 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;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Participate in the Steering Committee and all active subcommittees;
• Oversee site participation and performance with the support of the Data Coordinating Center; and
• Participate in study design, data analysis, interpretation, and publication of study results.

NICHD Program Official:

Additionally, a NICHD Program Official will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award and will be named in the award notice. This role is separate from the Project Scientist and will include the following:

• Assurance of scientific merit of the trials, including the option to recommend to withhold support to a participating institution if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met;
• 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;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, DSMB, and/or External Advisory Board with the mutual consent of the Steering Committee and the Scientific Director-; and
• Other duties required for normal program stewardship of grants for the Global Network.

NICHD Scientific Liaison Officers:

Other NICHD staff may be designated as Scientific Liaison Officers (Medical Officer or Program Officers) to provide scientific input in their areas of expertise. They may participate in Steering Committee meetings as non-voting members. Specifically, the NICHD Scientific Liaison Officers will, in consultation and collaboration with the NICHD Project Scientist and Program Official:

• Provide programmatic oversight and assistance to awardees assigned to the NICHD;
• Collaborate with Program Scientist and other team members for defining/developing the appropriate study designs, objectives, endpoints, patient population, efficacy, toxicity and safety indicators;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Assist in overseeing site participation and performance, as needed, with the support of the Data Coordinating Center;
• Participate, as needed, in data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees.

NIH Co-sponsor Staff Science Collaborators:

Program representatives of the other NIH co-sponsors may serve as Staff Science Collaborators for grants assigned to their respective NIH Institutes and Centers. They may participate in Steering Committee meetings as non-voting members. Specifically, the NIH Staff Science Collaborators will:

• Provide programmatic oversight and assistance to awardees assigned to their respective NIH Institutes, in consultation and collaboration with the NICHD Project Scientist;
• Review and assess Serious Adverse Event (SAE) reports forwarded by the DCC and prepare reports for submission to the FDA when necessary;
• Provide advice, when needed, for optimal implementation of intervention designs;
• Assist in overseeing site participation and performance, as needed, with the support of the Data Coordinating Center; and
• Participate, as needed, in study design, data analysis, interpretation, and publication of study results relevant to the research conducted by their respective grantees.

Steering Committee:

The Steering Committee will serve as the Global Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee reviews all presentations and publications via the Publications Subcommittee and NICHD clearance mechanisms. The Steering Committee is composed of the U.S. PD/PI and SFI of each Research Unit, the PD/PI of the Data Coordinating Center, and the NICHD Program Scientist, each of whom have one vote. NICHD will appoint a Chairperson who is not participating as a PD/PI for a minimum term of 2 years.

The Steering Committee will meet twice annually in person and will participate in telephone or video conferences as needed between Steering Committee meetings. During the meetings, research progress and problems are reviewed for each site.

Data and Safety Monitoring Board:

A Data and Safety Monitoring Board (DSMB) has been established by NICHD to monitor the safety of ongoing clinical trials. It advises the Global Network, including the Data Coordinating Center, on research design issues, data quality and analysis, and ethical and human subject issues. The DSMB members have expertise in clinical trial design and conduct; relevant basic, medical, and behavioral sciences research; and ethics and cultural competency issues, with particular relevance to low income country populations.

In addition, the Global Network 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 and are consistent with current NIH policies and procedures.

External Advisory Board:

An External Advisory Board (EAB) will advise the Steering Committee in the identification and prioritization of topics for research. Members of the EAB will be chosen by the NICHD with input from the Steering Committee and will comprise individuals with expertise in clinical trials; biostatistics; epidemiology; obstetrics; pediatrics; infectious diseases; social sciences; behavioral sciences; basic sciences; and ethics. The EAB will have no more than 5 members who will elect the chair. The Chair of the EAB will serve for a minimum of 2 years. Additional members will participate based on the need for specific expertise.

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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

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.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

Linda L. Wright, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0830
Email: wrightl@mail.nih.gov

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

Mario Martinez
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4078
Email: martinem@mail.nih.gov

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.

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.