Notice Number: NOT-HD-15-014

Key Dates
Release Date: March 27, 2015

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

Purpose

This Notice is to clarify the Scope for RFA-HD-15-034.

Part 2. Section I. Funding Opportunity Description

Scope

I. Responsiveness of projects directed at development of technologies which may not be used in the first trimester
Current language:
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.
• 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

Language is changed to:
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.

II. Clarification of the limits which constitute "Real-Time" assessment
Current language:
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 in real-time. 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. 

Language is changed to:
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: https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-15-034.html#sthash.aAKhJycp.dpuf

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.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

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