Notice of Intent to Publish a Funding Opportunity Announcement for Antenatal Opioid Exposure Longitudinal Study Consortium (PL1 Clinical Trials Not Allowed)

Notice Number: NOT-HD-18-021

Key Dates

Release Date: December 20, 2018
Estimated Publication Date of Funding Opportunity Announcement: January 04, 2019
First Estimated Application Due Date: March 29, 2019
Earliest Estimated Award Date: December 01, 2019
Earliest Estimated Start Date: December 01, 2019

Related Announcements
None

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

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development(NICHD) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications from consortia composed of a Data Coordinating Center and 2 or more Clinical Sites to conduct a multi-center prospective cohort study of infants exposed to opioids in utero compared to unexposed infants. During a 2-year follow-up period, infants will be assessed with serial measures including neuroimaging, medical, neurodevelopmental, behavioral, and home, social, and family life assessments.

Applications from consortia composed of a Data Coordinating Center and 2 or more Clinical Sites to conduct a multi-center prospective cohort study of infants exposed to opioids in utero compared to unexposed infants. During a 2-year follow-up period, infants will be assessed with serial measures including neuroimaging, medical, neurodevelopmental, behavioral, and home, social, and family life assessments.

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 Winter 2019 with an expected application due date in Spring 2019.

This FOA will utilize the PL1 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Ove rall Longitudinal Study Consortium Organization

The Longitudinal Study Consortium will be funded as a consortium of a Data Coordinating Center (DCC) and 2 or more Clinical Sites, which together, in a single application, will put forward a common longitudinal study proposal under the PL1 funding mechanism.  The PL1 supports shared resources for categorical research by a number of investigators who focus on a common research problem.  Under the PL1 Research Program Project mechanism, the DCC will house 2 Cores:  an Administrative Core and a Research Support Core.  The collaborating Clinical Sites are organized to increase sample size, accelerate recruitment, and/or increase sample diversity and geographic representation.  The DCC may be housed at the same institution as one of the Clinical Sites or may be at a separate institution.  The Consortium will collaboratively develop the common protocol prior to application submission.  Awardees will work together as a Consortium to implement a multi-site observational, prospective cohort study with multi-modal assessments of children from birth to two years of age to better understand the consequences of in utero opioid exposure.  The goal of the program is to compare neuroanatomical (as measured by serial neuroimaging studies), medical, neurodevelopmental, behavioral, and home, social, and family outcomes between children who have been exposed to opioids in utero and those who have not been exposed.  Such research is needed to inform development of appropriate care practices and treatments that would benefit exposed infants. 

PL1 Mechanism

The PL1 mechanism is to support shared resources and facilities for categorical research by a number of investigators who focus on a common research problem.  In a PL1 application for the Longitudinal Study program, a consortium of a DCC and at least 2 Clinical Sites with clinical resources sufficient to conduct a study of this size and complexity form a consortium and work together in the pre-application period to develop a single, shared protocol for the conduct of a multi-site longitudinal cohort study comparing outcomes as delineated below among children from birth to 2 years of age who were either exposed or not exposed to opioids in utero.  At the time of award, the PL1 components will be disaggregated, with each Clinical Site being funded through individual but linked research project grants (RL1). The RL1 mechanism supports a discrete, specified, circumscribed project; the grants are linked, and the project is to be performed by the named investigators acting as a consortium.  The DCC and its 2 component Cores will be funded as a PL1.  The PD/PI for the Research Support Core should be the PD/PI for the PL1 application responding to the announcement. If the PL1 is submitted as a multi-PD/PI application, the Research Support Core PD/PI should be the contact PI.

Further details will be included in the forthcoming FOA.

Funding Information

Estimated Total Funding NICHD intends to commit $11 million in multi-year funding in FY 2019. The maximum project period is 4 years.
Expected Number of Awards 1 award to a Consortium of a Data Coordinating Center and 2 or more Clinical Sites
Estimated Award Ceiling
Primary CFDA Numbers 93.865

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Rosemary D. Higgins, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-7909
Email: higginsr@mail.nih.gov