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

Purpose

The NIH announced on December 10, 2018 its intention to fund alternative approaches for modeling developmental processes that do not rely on the use of human fetal tissue obtained from pregnancy terminations (NOT-OD-19-042). The purpose of this Notice is to announce the availability of administrative supplements to existing NICHD awards to accelerate the development of such alternative models and/or tissue sources, e.g., derived from human induced pluripotent stem (iPS) cells. Direct comparison to models derived from human fetal tissue are encouraged in research areas outlined below.

Scope of Support

The research proposed in the administrative supplement must be within the scope of the active parent award, augmenting ongoing activities. Research should ?focus on generating alternatives to using human fetal tissue and be likely to lead to progress in developing alternative methodologies and/or tissue sources of interest to the NICHD.

NICHD’s interests include, but are not limited to:

• Studies using organoids to model development and diseases of specific tissues, including but not limited to placenta and brain
• Studies using organoids to understand tissue-specific functions
• Studies to create new technologies or improve existing technologies that allow for modeling and studying function of multiple tissues at the same time (e.g., integrated ‘tissues-on-a-chip’ systems)
• Studies using iPS cells to understand cellular-level mechanistic functions, including generation of female gametes to study meiosis and aneuploidy
• Development and/or standardization of model systems using human iPS cell lines to better understand intellectual and developmental disorders

For applications focused on the placenta, tissues may only be obtained from term placenta or chorionic villous samples obtained as part of standard of care. Applications proposing the use of placenta tissue from first or second trimester as well as placental tissue obtained from miscarriages or stillbirths would not be considered responsive to this notice.

Research on the development of human embryo model systems from iPS cells (e.g., human gastruloids) would be considered not responsive to this notice.

Budget

To be eligible, the parent award must be able to receive funds in FY19 (Oct. 1, 2018-Sept. 30, 2019) and not be in a no-cost extension period at the time of the award.

Supplement budget requests cannot exceed $125,000/year direct costs exclusive of Facilities and Administrative costs on sub-awards. Budgets may not exceed the total direct costs of the current parent award. Requests must reflect the actual needs of the proposed project. Requests may be for up to two years of support. Modular and categorical budgets are permitted.

The earliest anticipated start date is August 1, 2019.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active NICHD grant or cooperative agreement. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Scientific Review Process

NICHD will conduct administrative reviews of submitted applications and will support the most meritorious applications submitted for consideration, based upon availability of funds.

Criteria:

1. Is the work proposed within the scope of the active award?

2. Will the work proposed advance research using alternatives to human fetal tissue?

3. Does the work proposed have scientific merit?

4. Is the work likely to stimulate additional studies leading to progress on uses of alternatives to human fetal tissue research?

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp - Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date(s) - July 1, 2019, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include "NOT-HD-19-011" (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be up to two years of support only.
• The Research Strategy section of the application is limited to 6 pages.
• Individuals must hold an active NICHD grant or cooperative agreement to be eligible to apply.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applicants are strongly encouraged to notify the NICHD program contact supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Stuart B. Moss, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6979
Email: mossstua@mail.nih.gov

Melissa A. Parisi, MD, PhD.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: parisima@mail.nih.gov

David H. Weinberg, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6973
Email: weinbergd@mail.nih.gov