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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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

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.

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.

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(s)/PI(s) should have a PhD or other doctoral degree in a relevant field. The PD(s)/PI(s) for the Data Coordinating Center 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.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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).

Applicants must obtain 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, 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.

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, DCH
Chief, Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Blvd, Room 4B03E
Bethesda, MD 20892-MS7510
(Couriers, please use Rockville, MD 20852)
Telephone: 301-402-1872
Email: rajut@mail.nih.gov

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

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.

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

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

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

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

One Senior/Key Person must be designated to lead the DCC in the absence of the PD/PI. The named alternate should also have a doctoral degree in a relevant field and have demonstrated clinical trials experience.

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

The first year budget at the time of application will be limited to a base budget with maximum allowances as follows:

• PD/PI is expected to commit 7.2 - 9.0 person-months (60-75 percent) effort. Applications with differing leadership effort arrangements should document in detail how Network needs will be met.
• The Senior/Key Person named to serve as DCC lead in absence of the PD/PI is required to commit a minimum of 1.8 person-months (15 percent) effort
• Project Manager
• Statisticians
• Accountant - 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.
• 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
• Budgets for the first project year (FY 2017) should include funds for new computer equipment (as required), training costs for staff at research units , and software needed to establish a computer-based distributed data entry system at all research units.

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

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

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 in the Research Strategy section:

• Staffing Plan: The applicant should describe plans for meeting the DCC's staffing needs and accommodate any 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 DCC.
• Management Plan: The applicant should describe a plan to manage the DCC, including the needs and activities of the DCC 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. Track history for meeting deadlines and subcontracting should be described.
• Evidence of Successful Past Performance: Applicants must describe their activities 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 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.
• History of Collaboration: Applicants must describe any relevant international collaborative research activity undertaken between the U.S. PD/PI/ applicant institution and low-income institution(s) they have previously partnered with. 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 Ability to Manage Data and Communications: The applicant must describe past experience 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, 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. 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 Advisory Board, 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 demonstrate successful experience, beyond that described in the biosketches, 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: Describe the process for estimating resources needed for individual Research Units, management of those resources as the work changes qualitatively and quantitatively during the course of the research projects, reporting resource allocations to NICHD, and supplementing resources with subcontracts with outside organizations.
• Describe logistical arrangements for support of Steering Committee meetings (2 per year), Data and Safety Monitoring Board meetings (2 per year), and External Advisory Board meetings, as well as other selected meetings required for DCC operations.
• On-site and Off-site Monitoring: 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 DCC 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.
• Special Strengths of the Investigators or Institution: Applicants are encouraged to describe special or unique strengths that may be relevant to conducting research on maternal and child health in low-income countries. 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 Global Network. Potential strengths would include familiarity/experience with FDA policies and procedures for investigational new drugs (IND).

Letters of support: Include letters of support and commitment for the DCC. There must be a clearly expressed intent to participate in a collaborative manner with the Research Units and with the NICHD. The applicant must state the intent to cooperate with the NICHD in all aspects of research as outlined in this FOA.

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

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.

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

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

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

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.

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 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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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

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 network that it will coordinate and administer? 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 network?

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 a data coordinating center? Do the investigators demonstrate significant experience with coordinating collaborative 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 have experience overseeing selection and management of subawards, if needed? Does the applicant demonstrate extensive experience leading international multicenter randomized clinical trials at a senior scientific level? Do the proposed personnel demonstrate appropriate experience with multicenter randomized clinical trials? Do the investigators have a strong track record in coordinating a DCC in the past 3 to 5 years? Has the applicant documented adequate research productivity as a DCC in previous or ongoing international clinical trials, especially those of with focus on women’s and children’s health?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in managing the data coordinating center? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? What special or unique strengths does the applicant demonstrate that may be relevant to conducting research on maternal and child health in low-income countries ? What plans are described for providing the multidisciplinary support needs of maternal and child health studies?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the data coordinating center? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects and networks as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the DCC is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are appropriate plans 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? Are effective plans proposed 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 ? Does the applicant satisfactorily address how it will be ensured 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 ?

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? Is there adequate support for all types of communications (e.g. email, phone, webinar, travel, in-person meeting services)?

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.

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.

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.

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.

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.

Not Applicable

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

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 score.

Not Applicable

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).

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).

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

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 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 on the basis of established PHS referral guidelines 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.

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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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
• 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. All parties will agree to accept the collaborative nature of the group process and the supportive role of the Data Coordinating Center and follow the GN policy and procedure guidelines on data access and sharing.

DCC awardees will retain custody of and have access rights to the collected data during the award period and retain intellectual property rights to any software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. Long term custody of the data may transfer to a data repository.

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

The NICHD and NIH 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.

NICHD Project Scientist:

The Project Scientist will serve as the principal representative of the NICHD and NIH. The 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;
• 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 the awardee in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee ;
• Provide the SOC with relevant program related information
• 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 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:

The NICHD will appoint a Program Official, apart from the Project Scientist, who will:

• 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.
• Perform other duties required for normal program stewardship of grants.
• Assure the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met.
• Initiate a decision to modify or terminate a study.
• Review and assess Serious Adverse Event reports.

Areas of Joint Responsibility include:

The management of the Global Network includes committees with the following functions:

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 is composed of the PD/PI of the Data Coordinating Center, the U.S. PD/PI and Senior Foreign Investigator (SFI) of each Research Unit, and the NICHD Program Scientist, each of whom have one vote. NICHD will appoint a Chairperson who is not participating as a PI for a minimum term of 2 years. The Steering Committee reviews all presentations and publications via the Publications Subcommittee and the NICHD also will review and clear all presentations an publications.

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) was established by NICHD to monitor the safety of ongoing clinical trials. It provides input to the NICHD on data quality and analysis and ethical and human subject protection 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. DSMB logistical support is provided by the Data Coordinating Center including full minutes of all meetings. Closed session minutes will be considered confidential to be reviewed only by the DSMB members until study completion. The NICHD may request, when a change in study status such as a pause or closure is recommended, access to closed session minutes.

A Scientific Oversight Committee (SOC) will advise the Steering Committee in the identification and prioritization of topics for research. Members of the SOC 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 SOC will have no more than 5 members who will elect the chair. The Chair of the SOC 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 regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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

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 CenterTelephone: 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: 301-710-0267

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

Sherry Dupere, PhD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: duperes@mail.nih.gov

Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6996
Email: williate@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 Part 75.