Key Dates

Related Announcements

RFA-HD-24-002 - Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed)

Issued by

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

Purpose

The purpose of this Notice is to alert potential applicants of a clarification in the Research Scope section of RFA-HD-24-002 "Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed) to ensure the criteria match the intention of the Branch and align with the current Branch Research Priorities.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Scope

Currently reads:

Applications focused in the following areas are considered not responsive and will not be reviewed:

• Applications not focused on the development of a contraceptive product or delivery system
• Applications focused on molecular targets for which there is no human ortholog
• Applications based on mechanisms of contraceptive action that may act post-fertilization
• Applications that focus on the development of methods that may act via the oviduct or uterus
• Applications based on intrauterine devices/intrauterine systems
• Application focused on the development of molecules or devices that disrupt/perturb the blood-testis and/or blood-epididymal barriers
• Applications for the development of molecules for male or female contraception that act via steroid receptors
• Applications for the development of contraceptive methods that require the administration of one or more exogenous steroidal molecules that act via nuclear steroid receptors
• Applications focused on male or female condom development
• Applications focused on target identification, unless they are to identify the target of a low molecular weight molecule with contraceptive properties that acts via an unknown molecular interaction
• Applications focused on targeted protein degradation (e.g., use of PROTACs, LYTACs, AUTACs) unless application is focused on specific degradation of a known/defined contraceptive target
• Applications focused on the development of type I-II kinase inhibitors
• Applications based on the following class of targets:
  • Retinoic acid receptor alpha (RARα), unless the modulation proposed is (1) targeted protein degradation or (2) the research studies after the chemical optimization phase include monitoring immunological response (expression changes in T cells, B cells, granulocytes, macrophages, dendritic cells, and natural killer cells) following chronic compound administration. Immunological monitoring must occur during the R61 phase with results included in the transition package. For applications targeting RARα via targeted protein degradation, immunological monitoring is not required during the R61 phase.
• Applications for the development of the following molecules and/or their chemical derivatives:
  • Gamendazole
  • H2-Gamendazole
  • Adjudin
  • Gossypol
  • alpha-chlorohydrin

Modified to read (changes in bold italics):

Applications focused in the following areas are considered not responsive and will not be reviewed:

• Applications not focused on the development of a contraceptive product or delivery system
• Applications focused on molecular targets for which there is no human ortholog
• Applications based on mechanisms of contraceptive action that may act post-fertilization
• Applications that focus on the development of methods that may act via the oviduct or uterus, unless they act by oviductal occlusion
• Applications based on intrauterine devices/intrauterine systems
• Application focused on the development of molecules or devices that disrupt/perturb the blood-testis and/or blood-epididymal barriers
• Applications for the development of molecules for male or female contraception that act via steroid receptors
• Applications for the development of contraceptive methods that require the administration of one or more exogenous steroidal molecules that act via nuclear steroid receptors
• Applications focused on male or female condom development
• Applications focused on target identification, unless they are to identify the target of a low molecular weight molecule with contraceptive properties that acts via an unknown molecular interaction
• Applications focused on targeted protein degradation (e.g., use of PROTACs, LYTACs, AUTACs) unless application is focused on specific degradation of a known/defined contraceptive target
• Applications focused on the development of type I-II kinase inhibitors
• Applications based on the following class of targets:
  • Retinoic acid receptor alpha (RARα), unless the modulation proposed is (1) targeted protein degradation or (2) the research studies after the chemical optimization phase include monitoring immunological response (expression changes in T cells, B cells, granulocytes, macrophages, dendritic cells, and natural killer cells) following chronic compound administration. Immunological monitoring must occur during the R61 phase with results included in the transition package. For applications targeting RARα via targeted protein degradation, immunological monitoring is not required during the R61 phase.
• Applications for the development of the following molecules and/or their chemical derivatives:
  • Gamendazole
  • H2-Gamendazole
  • Adjudin
  • Gossypol
  • alpha-chlorohydrin

All other aspects of this Funding Opportunity Announcement remain the same.

Inquiries

Please direct all inquiries to:

Leigh Allen, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-9151
Email: [email protected]