Required Application Instructions

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

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 role of the placenta includes providing for the transfer of nutrients, gases and waste products between the mother and fetus, producing hormones which support the pregnancy, remodel the uterine spiral arteries to create the appropriate vascular environment, prevent immune-mediated rejection of the fetus, and provide protection against infectious agents and noxious environmental insults. Abnormalities of placental development and function are known to underlie many major pathologies of pregnancy and to have a role in the development of health issues later in life.

The assessment of the placenta across pregnancy presents special challenges due to the need to avoid risk to the mother and developing fetus. Thus, most information on human placental biology is obtained by studying placental tissue obtained after delivery from pathological pregnancies such as preterm deliveries occurring predominately in the third trimester, from term deliveries in which placental development has already crested, or from in vitro model systems. There is a paucity of information obtained earlier in gestation when many of the pregnancy pathologies are believed to have their origins, and limited information gleaned throughout gestation from normal pregnancies. The development of real-time, non-invasive (or minimally invasive) methods to assess the development and functionality of the placenta in vivo safely throughout gestation would serve as valuable research and clinical tools for enhancing understanding of placental biology and rooted pathologies and for the management of patients. The development of these tools could lead to the identification of markers and predictors of pregnancy outcome, and provide a future foundation for better pregnancy monitoring in the clinical setting.

There is reason to believe that such technological achievements are possible. Non-invasive imaging methods such as MRI, ultrasound, and optical technology have shown tremendous utility in the areas of cancer, brain, and cardiovascular research, and suggest that application of these technologies to the placenta any time during gestation is feasible. Novel applications of in vivo imaging techniques continue to emerge. In addition, increased assay sensitivity for analytes present in body fluids and miniaturization of sensing devices offer the promise of minimally invasive continuous monitoring capability. Many of these technologies in their current forms cannot be applied directly to pregnant women, but they provide a window into what can be accomplished.

The Human Placenta Project (HPP) is an initiative aimed at revolutionizing understanding of the human placenta. The development and application of innovative technologies that can be used safely in pregnant women should allow researchers to produce a new dynamic picture of placental structure and function in real time, one that assesses key developmental trajectories of placental formation and functional cues critical for successful human pregnancy. The application of these new tools and technologies should ultimately lead to new ways to treat, cure, and even prevent placental dysfunction disorders such as preeclampsia, fetal growth restriction, spontaneous preterm birth, and stillbirth. It is likely that the methods developed will also be applicable to assessment of other internal organs; thus, the impact may be far-reaching.

The overarching goals of the HPP are to:

• Improve current methods, and develop new technologies, for real-time assessment of human placental structure and function across gestation.
• Apply these technologies to understand and monitor, in real time, placental development and function in normal and abnormal human pregnancies.
• Develop and evaluate non-invasive markers of placental dysfunction for prediction of adverse human pregnancy outcomes.
• Understand the contributions of placental development to long-term human health and disease.
• Develop interventions to prevent abnormal human placental development, and hence improve pregnancy outcome.

This FOA is to support the first step along this path: the formation of teams able to identify specific technology gaps and then conceptualize and develop new technologies or new applications of current technologies that address them. The HPP will require an exceptional level of coordination and sharing among investigators. HPP initiative awardees will be expected to cooperate and coordinate their activities after awards are made.

In addition to this HPP initiative, the NICHD continues to have a substantial interest and annual investment in fundamental placental research. The Institute supports those research efforts through investigator-initiated applications received via parent announcements and through specific funding opportunity announcements. Potential applicants to this FOA are strongly encouraged to contact Scientific/Research staff if they have any questions about the best funding opportunity announcement for their research.

The long-term objective is to develop tools for the safe and precise assessment of structure and function of the human placenta at a micro and macro level throughout gestation. To achieve this will require advances in current technology that overcome current limitations while maintaining the required levels of safety for mother and fetus. To make progress, experts in technology need to partner with experts in clinical care for pregnant women. However, the development of such collaborations is often resource- and labor-intensive, particularly when it requires crossing established divisions in the organization, review, and funding of research. This FOA is designed to provide the needed resources to form teams to meet the challenge of developing novel and transformative interdisciplinary approaches to human placenta assessment in vivo.

Applications submitted in response to this FOA should support the formation of interdisciplinary teams that will design and develop novel and innovative tools and technologies that substantively expand the ways by which placental structure and function can be measured or otherwise assessed in humans across gestation. These awards will support efforts to address specific technology gaps, conceptualize a solution or solutions, and perform prototype development projects and/or small scale pilot studies in mammals or humans that would provide proof of principle and core resources for translation into humans for safe, non-invasive, in vivo assessment of placental structure and function. The goal of these activities is to prepare the groundwork for a subsequent full-scale development projects.

All proposed teams must include at least one obstetric clinician to provide insights into current or potential clinical functional or safety limitations of the chosen technology. The range of additional disciplines included may be either broad or relatively narrow (e.g., various subspecialties within a given field) as appropriate to the scientific goals of the application. The application should reflect the expertise of the proposed team. Strong academic-industrial partnerships are welcomed. Any agreements establishing partnerships should delineate the roles of each partner to the agreement.

By the completion of the award period, investigators should have developed novel tools or technology which would enable the field to propose studies of new or next-generation placental assessment technology and/or imaging, suitable for safety and feasibility evaluation in women and with established milestones for progression into use across the human pregnancy time course.

This FOA promotes the development of breakthrough tools and technologies to measure human placental processes that are currently relatively inaccessible during pregnancy and to assess changes in these processes as development progresses, including but not limited to:

• Anatomic and structural changes of the placenta across development.
• Villous cell structure and function.
• Blood flow, oxygenation, diffusion and perfusion within the placenta.
• Maternal-fetal nutrient transfer.
• Dynamic cellular processes in the placenta, including gene expression and regulation, microRNA expression, metabolism and cell turnover, proteomics and other molecular processes.
• Metabolic changes including, but not limited to, oxygenation, oxidative stress, choline, lipids and lactate.
• Placental barrier (targeted, regional) permeability and function in the human placenta.
• Regulation of maternal and fetal immunologic function

Examples of activities that can be supported by this FOA include, but are not limited to:

• Serial meetings of project investigators to develop research concepts and approaches relating to the proposed team's research focus and goals.
• Data-sharing and information exchange among investigators from diverse research backgrounds to coordinate and integrate their research interests in regard to the proposed team’s research focus and goals to advance new measurement and data collection approaches.
• Standardization of data collection across team members to improve comparability of measures and data.
• Prototype development, along with pilot studies to provide proof of concept.

Solutions describing existing, well-established and/or currently supported approaches, especially commonly used strategies, are not of interest unless a compelling case is made that significant, quantifiable advances are proposed and/or the methods and measures are used in unique combinations that have not been previously tested together for the assessment of human placental structure, development, and function.

Examples of research projects that will be considered nonresponsive to this FOA and which will not be reviewed include:

• Development of methodologies which can only be applied postpartum.
• Development of projects that only focus on data collection, data processing, data analysis, and computational modeling and simulation without technology development.
• Development of methodologies or technologies that are contraindicated for use in human pregnancy such as nuclear medicine studies.

Applicants proposing projects in non-mammalian systems that have little potential to be applied to human placenta imaging or assessment should respond to other funding opportunities.

As the goal of this FOA is to support research-driven technology development to meet the objectives of the HPP, program priority will be given to applications that are exceptional in the following aspects: 1) potential for safe in-vivo placental assessment during gestation, 2) the level of interaction among collaborators and 3) the level of innovation. Funds requested must be used primarily to support technology development.

Potential applicants are advised to consult with the Scientific/Research contact listed in Section VII for appropriateness of submission to this FOA.

A Technical Assistance phone conference will be held for potential applicants on the dates listed below. NIH staff will be available to answer questions related to this FOA. NICHD staff members involved in managing this program will provide technical assistance explaining the goals and objectives of this initiative and answering questions from attendees.

Teleconference Information
Date: Thursday, February 12, 2015
Time: 2:00 PM - 3:00 PM (EST)

and

Teleconference Information
Date: Friday, February 13, 2015
Time: 2:00 PM - 3:00 PM (EST)

To obtain the call-in information, please contact Dr. David Weinberg (NICHDHPP@mail.nih.gov) at least 24 hours prior to the call. Potential applicants are encouraged to submit their questions or comments to the above email address in advance of the teleconference. Please include "RFA-HD-15-032 Pre-Application Call in the subject line of the email. While every effort will be made to answer all questions during the teleconference, it is possible that not all will be addressed during the meeting due to time constraints.

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
• 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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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, 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:

David Weinberg, PhD
Telephone: 301-526-0349
Fax: 301-451-5784
Email: david.weinberg@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.

All proposed Senior/Key persons must include at least one obstetric clinician to provide insights into current or potential clinical functional or safety limitations of the chosen technology.

The range of additional disciplines included may be either broad or relatively narrow (e.g., various subspecialties within a given field) as appropriate to the scientific goals of the application. The teams proposed in response to this FOA should consider including researchers from disciplines as diverse as bioengineering, physics, chemistry, material science, nanotechnology, computational and theoretical modeling, imaging, obstetrics and maternal-fetal medicine, pediatrics, dysmorphology, cellular and systems placental research, molecular biology, or other clinical and novel related research areas.

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

It is possible that percent effort may be expected to change among team members over the course of the award period. This should be discussed in the budget justification.

Awardees will be expected to participate in annual meetings with other awardees and NIH staff in the Washington, DC area to exchange scientific information and to discuss strategies for focusing research efforts on the development of novel technologies for human placental in vivo assessment. At a minimum, it is expected that the PD/PI will attend the annual meeting. Awardees should also anticipate participating in teleconferences or other virtual meetings. Appropriate funds should be included for these activities.

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 interdisciplinary teams supported through these U34 projects should focus on conceptualizing areas of research focus, developing research objectives and technical approaches, and initiating next-generation human placenta imaging and/or assessment methods. The application should clearly state specific goals for the activities in the proposed project, including an explanation of how the proposed activities will advance or accelerate assessment of human placental structure and function beyond what existing methods can achieve.

Current State-of-the-Art Statement: Investigators should specifically define the current state of technology as a benchmark against which their proposed new technology or improvements will be measured, with emphasis on the current resolution/timing/performance limits they are trying to improve. A sound rationale should be provided as to why the approach proposed is the most appropriate and likely to generate an exceptionally high impact if successful.

If the approach involves the use of animal models, is the pathway for translation into humans clearly delineated and are potential safety and technical issues associated with human application of the technology/tools adequately discussed?

Letters of Support: Applicants must include letters of support from collaborators and/or potential users in the obstetrical research community. These letters should provide details on the nature of the proposed interaction/collaboration and describe how the proposed new development will benefit their research and/or offer clinical potential.

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.

• All applications submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
• 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 Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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 the NICHD. Applications that are incomplete 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 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.

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?

Does the application present an accurate assessment of the state-of-the-art? Does the application propose new technology development that offers the potential for human in vivo placental assessment capability beyond what is currently available? Will the goals adequately prepare the investigators to develop and use the proposed imaging or assessment technology to measure previously inaccessible regions and processes in the human placenta during gestation rather than postpartum?

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

Does the investigative team include appropriate expertise in clinical obstetrics?

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?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

If the approach involves the use of animal models, is the pathway for translation into humans clearly delineated and are potential safety and technical issues associated with human application of the technology/tools adequately discussed?

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?

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 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.

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

Not Applicable

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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’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.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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

• Defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program;
• The PDs/PIs assume responsibility and accountability to the applicant organization officials and to the NICHD for the performance and proper conduct of the research supported by the U34 in accordance with these terms and conditions of the award;
• Awardees 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 DHHS, 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 Coordinator Roles:

• Coordinate and facilitate the interactions among the U34 awardees under this initiative;
• Serve as liaison between the research awardees and NICHD staff members and investigators involved in the program, facilitating interactions and scientific integration between the U34 awardees;
• Promote and help coordinate collaborative research efforts that involve interactions with other NICHD-sponsored programs, projects, and centers;
• Participate in program meetings;
• Review all major transitional changes that the awardees might propose (e.g., a change in partnering institution) and offer advice on their appropriateness prior to implementation to assure consistency with the goals of this FOA;
• Assist in the interaction between the U34 Research awardees and investigators at other institutions, as appropriate for the program;
• Monitor institutional commitments and resources to the awardees;
• Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- Specifically, the NICHD Project Coordinator may recommend withholding of support, suspension, or termination of a U34 award for lack of adherence to required policies and/or procedures;
• Develop working groups and trans-project efforts as needed; and
• Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees.

NICHD Program Official Role:

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

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

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. One member will be selected by the awardee (or the Steering Committee, with the NICHD member not voting), a second member will be selected by NICHD, and a third designee with expertise in the relevant area will be chosen by the other two. 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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

David H. Weinberg, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-526-0349
Email: david.weinberg@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

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clark1@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.