Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title

Developing Paradigm-Shifting Innovations for in vivo Human Placental Assessment in Response to Environmental Influences (U01)

Activity Code

U01 Research Project – Cooperative Agreements  

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-HD-15-034

Companion Funding Opportunity

None

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

93.865; 93.286 

Funding Opportunity Purpose

This funding opportunity announcement (FOA) in support of the Human Placenta Project (HPP) aims to support the initial stages of development of entirely new or next-generation placental imaging and assessment technologies and methods that will increase our capability to assess human placental structure and function safely in vivo throughout gestation and to explore the impact of environmental influences on placental structure and function across pregnancy.

Key Dates
Posted Date

February 26, 2015

Open Date (Earliest Submission Date)

May 1, 2015

Letter of Intent Due Date(s)

May 1, 2015

Application Due Date(s)

June 1, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.  No late applications will be accepted for this Funding Opportunity Announcement.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2015  

Advisory Council Review

August 2015  

Earliest Start Date

September 2015

Expiration Date

June 2, 2015

Due Dates for E.O. 12372

Not Applicable

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.


Table of Contents

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

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


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

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, remodeling the uterine spiral arteries to create the appropriate vascular environment, preventing immune-mediated rejection of the fetus, and providing protection against infectious agents and noxious environmental insults.  Abnormalities of placental development and function underlie many major pathologies of pregnancy and play a role in the development of health issues later in life.

A growing literature suggests that environmental inputs to the placenta play a major role in determining the trajectory of placental development and functional sufficiency.  Potential environmental sources of placental dysfunction may be readily quantified discrete physical entities such as cigarette smoke, alcohol, medications, infection, and indoor/outdoor air pollution, or they may be of a more general nature such as exercise, maternal diet and nutritional status, BMI or level of stress. These environmental factors may act directly on the placental cells or indirectly by altering the mother's physiology. Understanding the role of environmental factors on placental development will be essential to crafting strategies that optimize the chances for a successful pregnancy outcome.

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, often 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 pregnancy pathologies 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 patient management.  

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 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 human placental structure and function in real time, one that assesses key developmental trajectories of placental formation and functional cues critical for successful 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 even more 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.
Purpose

The purpose of this FOA is to identify specific technology gaps 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.  A focus of the FOA is to utilize these new technologies to explore the effects of environmental factors on placental structure and function across pregnancy.

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.

Research Objectives

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, 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 meet the challenge of developing novel and transformative interdisciplinary approaches to human placenta assessment in vivo.

Scope

Applications submitted in response to this FOA should propose interdisciplinary teams that will design and develop novel and innovative tools and technologies to expand the ways by which placental structure and function can be measured or otherwise assessed in humans across gestation, as described below. 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. In addition, the awards will support the evaluation of these novel tools for their ability to enable real-time measurement of the impact of environmental factors on placental structure or function across pregnancy.  This FOA is specifically intended to support and encourage high-risk/high-reward approaches that have the potential for transformative changes in the way placenta structure and function are assessed across pregnancy.  - See more at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-15-034.html

The placenta is a dynamic organ which changes over the course of pregnancy.  To be helpful, assessments need to yield results within a time frame that reflects the current structural/functional status.  However, real-time is not meant to imply instantaneous results.  For any proposed technology, the application should outline:

  • The expected time frame from applying the technology to return-of-results.
  • The potential for shortening the time frame.
  • The expected utility of the proposed technology for determining placental structure and/or function status at the time that results are returned.

Specific Requirements

  • 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.  It is recommended that the team also include a member with specific expertise in placental biology. 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 that would enable the field to propose studies of new or next-generation real-time 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.  Proof of concept studies in animals or humans should be completed. 
  • The application must include studies to apply the technology to perform safe and non-invasive (or minimally invasive) real-time assessment of the impact of environmental factor(s) on placental structure and/or function across pregnancy.  The selected factor(s) may be readily quantified discrete physical entities such as cigarette smoke, alcohol, medications, infection, and indoor/outdoor air pollution, or they may be of a more general nature such as exercise, maternal diet and nutritional status, BMI or level of stress.  They must be scientifically justified based on known or suggested effects on placental or fetal development.
  • The PD(s)/PI(s) for each award will become members of the HPP Technology Development Working Group.  Members of this group will be expected to participate in monthly calls with other working group members as well as an annual meeting in the Washington, D.C. metropolitan area. The calls and meeting will provide an opportunity for all investigators funded through this initiative to communicate, discuss the progress of their research, exchange ideas and information, troubleshoot technical issues, share resources, foster collaborations that are relevant to the research goals of the initiative, and provide input and advice to NICHD staff. This requirement is designed to establish an interactive group of investigators who are interested in multidisciplinary approaches to achieving the goals of the Human Placenta Project.

General Technology Characteristics

This FOA promotes the development of breakthrough tools and technologies to enable real-time measurement of 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.
  • 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.
  • Optimization of device design in terms of performance, reliability, cost, and safety characteristics.
  • Prototype development, along with human or animal pilot studies to provide proof of concept and make Go/No-Go decisions regarding further development.
  • Studies of the key physiological variables that may affect the function of the device in humans.
  • Animal or clinical studies that utilize the novel tool/technology to assess the impact of an environmental factor(s) on placental structure/function.

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 not previously tested together for the real-time assessment of human placental structure, development, and function. 

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

  • Development of methodologies that can only be applied in the third trimester of pregnancy or postpartum.
  • Development of projects that only focus on data collection, data processing, data analysis, and computational modeling and simulation without technology development.
  • Basic research and studies of disease mechanisms.
  • Development of projects that are directed at understanding placental biology without the development of novel technology that directly assesses placental structure or function in real-time.
  • Development of technology that has little potential for utility in the first trimester, unless the conditions listed below are met.
  • Development of projects whose primary focus is on the collection and analysis of imaging or omics data for the purpose of biomarker identification or validation.
  • Development of methodologies or technologies that are contraindicated for use in human pregnancy such as nuclear medicine studies

This funding opportunity is to facilitate development of novel technology that may be used across pregnancy for assessment of placental structure and/or function.  Achievement of this goal may require the use of multiple approaches and some may not be able to be utilized within the first trimester at this time.

Projects which are directed at development of technologies with little potential for use in the first trimester will be accepted, provided:

  • The reason(s) it cannot be used in first trimester is detailed.
  • The potential for use in the first trimester is addressed.
  • The value of the technology to the goals of the Human Placenta Project is justified.

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. 

Expected research objectives:

  • Conception and development of novel technology solutions, generation of prototypes, and performance of initial evaluation studies for non-invasive (or minimally invasive) real-time assessment of placental structure and/or function.
  • The technology should provide an improvement over current capabilities in the assessment of real-time placental structure and/or function.
  • Planning for potential regulatory approval for human clinical validation studies.
  • Completion of any additional engineering, development and optimization required to test the assay/device/treatment in a validation model.
  • Completion of the validation trial.
  • Assessment of performance, effectiveness, and promise of the validated technology for clinical utility.
  • Application of the technology to measure the impact of environmental factor(s) on placental structure and function across pregnancy.
Program Priorities

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 innovation, 3) the strength of the investigative team and level of interaction among collaborators.  Funds requested must be used primarily to support technology development and validation.  Selection of environmental factors that disproportionately affect low-and middle-income countries and underrepresented communities is encouraged.

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

Technical Assistance Phone Conference

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, March 19, 2015
Time: 2:00 PM - 3:00 PM (EST)

and

Teleconference Information

Date: Friday, March 20, 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-15-034 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.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

The NICHD intends to fund 8-9 awards, corresponding to a total of $41.5M for fiscal year 2015. 

Award Budget

Applicants may request up to $3 million in direct costs plus applicable Facilities & Administrative (F&A) for the entire project period of up to 4 years. Note when a consortium is involved, the $3 million direct cost limit is exclusive of consortium F&A costs. These can be requested in addition to the $3 million direct costs limit. 

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 4 years.  

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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 will also be expected to participate in monthly teleconferences or other virtual meetings organized by NICHD.  Appropriate funds should be included for these activities.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Organize the Research Strategy in the subsections identified below.

1) Background and Significance

  • Define the technological problem/barrier to be addressed. Define the current state of technology as a benchmark against which the proposed new technology or improvements will be measured, with emphasis on the current resolution/timing/performance limits that would be improved.
  • Outline the proposed technology/assay/device/treatment and its potential to improve placental assessment in real-time across pregnancy.  Clearly state specific goals for the activities in the proposed project. 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. 
  • Explain the rationale for the environmental factor(s) to be evaluated.  Outline the data supporting a role for the factor(s) in placental or fetal development and the value of the proposed studies to the improvement of maternal/fetal health.
  • Provide a timeline with milestones and Go/No-Go decision points.

2) Preliminary data – Preliminary data are not required, but the approach must be scientifically justified (e.g. based upon literature, theoretical underpinnings, or demonstrated use in another field of science)

  • Summarize preliminary data documenting the technology's potential to achieve capabilities for improved real-time assessment of placenta structure/function beyond currently used technology.
  • Summarize preliminary data documenting the impact of the selected environmental factor(s) on maternal/fetal health and development.

3) Investigators Team

Describe how the Investigators Team will be organized and managed. Address the coordination of efforts including, but not limited to, the following:

  • Engineering/assay/treatment development: Expertise relevant to the development of technologies, assays or devices to ensure their suitability for use in placental assessment.
  • Obstetrics and Gynecology: Clinical experience relevant to understanding the practical and safety issues associated with application of the proposed technology in the clinical setting.
  • Placental biology:  Expertise relevant to understanding the developmental changes in placental structure and function across pregnancy in humans

4) Approach

  • Plans to develop entirely new technology or modify existing technology to achieve transformational improvements in real-time placental structure/function assessment across pregnancy. 
  • Plans to test functionality with clinical specimens, animal models or patients. 
  • Potential clinical utility (i.e., what clinical problem the assay/device/treatment addresses, how the assay/device/treatment will solve the clinical problem, its potential specificity, sensitivity, selectivity, and other key functional parameters).
  • The path for performing human validation studies, including plans to address regulatory and human subject issues, especially if developing and validating the technology in an animal model.
  • Specific performance milestones to be achieved, e.g., performance specifications and validation criteria.
  • Plans for any additional engineering or development that might be needed to optimize the technology for validation testing, for example by adding desirable attributes.
  • Plans to validate the use of the technology in a pre-clinical or clinical model to demonstrate efficacy for real-time in vivo placental structure/function assessment across pregnancy.
  • Plans to utilize the technology to measure the impact of environmental factor(s) on real-time assessment of placental structure/function across pregnancy.
  • Justification supporting the selection of the environmental factor(s) to be evaluated.
  • A clear path for translation of animal validation study results to humans, including problems or obstacles anticipated with mitigation strategies clearly articulated.
  • Plans to address technical, safety, or regulatory requirements for the use of the technology in humans.
  • Specific performance specifications and milestones to be achieved

Letters of Support: Applicants must include letters of support from collaborators. 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.  Any agreements establishing partnerships should delineate the roles of each partner to the agreement.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be 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, noncompliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

For this particular announcement, note the following:

This FOA is to support novel, potentially high-risk approaches which can lead to transformative new technology for placental assessment.  It is expected that such approaches may not have preliminary data. Preliminary data are not required, but the approach must be scientifically justified (e.g. based upon literature, theoretical underpinnings, or demonstrated use in another field of science).  This FOA encourages applications that are high-risk/high-reward when attempting to break new ground and it is expected that in those instances the aims may not fall into traditional hypothesis-based categories.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 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?  Is the environmental factor(s) proposed scientifically justified with a suggested or confirmed role in placental or fetal health and development?

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If the 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? Does the application include use of the technology for assessing the impact of environmental factor(s) on placental structure and/or function across pregnancy?

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?

 
Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?    

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

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:

  • Determining experimental approaches, designing protocols, setting project milestones, and overseeing the conduct of experiments;
  • Overseeing and coordinating the effort of the multi-disciplinary team and participating institutions and ensuring their optimal integration;
  • Overseeing the conduct of U01 research projects and ensuring their scientific rigor;
  • Ensuring compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
  • Adhering to the NIH policies regarding intellectual property, data release, and other policies that might be established during the course of this activity. 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;
  • Submitting monthly updates on human subject and accrual reports upon initiation of any human validation studies to NICHD program staff;
  • Serving as members of the HPP Technology Development Working group;
  • Participating in monthly working group teleconferences with NICHD program staff;
  • Attending annual working group meeting organized by the NICHD program staff.

NIH staff will 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 U01 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 U01 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 U01 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 U01 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, 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA 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)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-435-0714

Scientific/Research Contact(s)

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

Guoying Liu, Ph.D.
National Institute of Biomedical Imaging & Bioengineering (NIBIB)
Telephone: 301-594-5220
Email: liug@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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

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