Notice Number: NOT-HD-16-033

Key Dates
Release Date: November 17, 2016

Estimated Publication Date of Announcement: December 2016-January 2017
First Estimated Application Due Date: February 16, 2017
Earliest Estimated Award Date: October-November 2017
Earliest Estimated Start Date: December 2017

Issued by
National Institutes of Health (NIH)
National Eye Institute (NEI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with other NIH Institutes and Centers (ICs) listed above, intends to re-issue a Funding Opportunity Announcement (FOA) to solicit applications for research on Zika Virus (ZIKV) Complications.

This FOA will replace PAR-16-106."Rapid Assessment of Zika Virus (ZIKV) Complications (R21)" which had been issued to provide an expedited (rapid) funding mechanism in response to the Zika virus public health emergency. The goal of that initiative was to respond quickly to the public health emergency, by reviewing applications rapidly, and making timely awards to support much needed projects. As a result of this effort grants were awarded to support a number of highly meritorious projects that were particularly urgent or time-sensitive. The participating ICs intend to continue their commitment to supporting Zika research, but applications will no longer be accepted on a rolling basis. Instead the re-issued FOA will use standard application due dates and the timeframes for review, council and award dates will now align with standard NIH practices.

The purpose of this Funding Opportunity Announcement (FOA) is to solicit exploratory/developmental research projects on Zika virus (ZIKV) and its complications. ZIKV is a single-stranded RNA virus of the Flaviviridae family. It is transmitted to humans primarily through the bites of infected Aedes mosquitos, though both perinatal/in utero and sexual transmission have been reported. Initially discovered in 1947, it has been reported in the Americas since 2014, with a major outbreak in Brazil starting in 2015. Disease is seen in about 20% of infected people and is usually self-limited. However, a possible association between ZIKV infection in pregnant women and severe microcephaly in their babies has been very concerning and prompted the World Health Organization to declare this potential complication a public health emergency. Additionally the virus has been found in blood, fueling growing concerns about the risk of transfusion-transmission with particular concern over severe outcomes in at risk transfusion recipient populations such as women who are pregnant.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in December 2016-January 2017 with an expected application due date in February 2017.

This FOA will utilize the Exploratory/Developmental Research Grant (R21) activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into appropriate areas of science to begin to consider applying for this new FOA.

This FOA will solicit research projects to determine whether ZIKV infection causes microcephaly and other congenital abnormalities in babies and the potential rapid spread of ZIKV to the United States. Additionally, research to quantify the risk to the blood supply in affected regions and the potential clinical impact of transfusion-transmission of the Zika virus are urgently needed to inform strategies to reduce or prevent Zika transmission by blood transfusion.

Areas of high priority include, but are not limited to, the following:

• Demonstrate the causative role of infection in pregnancy with ZIKV in the etiology of fetal microcephaly, structural brain defects, and other congenital malformations
• Basic research to understand the ZIKV infection pathogenesis and transmission to the fetus, immune responses and immunological interactions with other flaviviruses
• Population-based studies to characterize the epidemiology of ZIKV infection in the mother-infant dyad
• Clinical studies to improve the understanding of the mechanisms and risks of maternal-to-child transmission of ZIKV
• Strategies to prevent transmission of ZIKV to the fetus after infection in the mother
• Studies to determine the optimal screening for and management of ZIKV infection in pregnant women and in exposed fetuses
• Studies to understand the mechanisms by which ZIKV affects the developing nervous system and other organ systems
• Development of novel diagnostic, vaccine and therapeutic strategies against Zika
• Studies of Guillain-Barr Syndrome (GBS), encephalitis or encephalomyelitis associated with ZIKV infection to determine disease course and outcomes, causality, disease mechanisms, effectiveness of current treatments and to develop novel treatments.
• Translational research on the neurodevelopmental consequences in infants of exposure to Zika Virus (ZIKV) during pregnancy or the early postnatal period to better understanding the potential for ZIKV to alter the developing central nervous system and social, cognitive, emotional, and behavioral outcomes relevant to mental health.
• Studies to understand the mechanisms by which ZIKV affects the developing nervous system in infants, particularly in brain regions associated with social, cognitive, or affective function

A more detailed list of IC areas of interest may be found in PAR-16-106.

NOTE: Clinical trials are outside the scope of this FOA.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Nahida Chakhtoura MD, MsGH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: [email protected]

May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: [email protected]

Lillian Shum, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-0618
Email: [email protected]

Mark Challberg, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-496-7453
Email: [email protected]

George McKie, DVM, PhD
National Eye Institute (NEI)
Telephone: 301-435-8152
Email: [email protected]

eila Selimovic, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4577
Email: [email protected]