Notice Number: NOT-OD-16-150

Key Dates
Release Date: September 16, 2016

Estimated Publication Date of Announcement: February 2017
First Estimated Application Due Date: July 2017
Earliest Estimated Award Date: June 2018
Earliest Estimated Start Date: July 2018

NOT-OD-16-151

Issued by
National Institutes of Health (NIH)
U.S. Food and Drug Administration, Center for Tobacco Products (CTP)

Purpose

The National Institutes of Health (NIH) Tobacco Regulatory Science Program (TRSP), the National Cancer Institute (NCI) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) intend to publish a Funding Opportunity Announcement (FOA) for its Center for Coordination of Analytics, Science, Training, and Logistics (CASTL) in Tobacco Regulatory Science. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive proposals.

The overall objective of CASTL is to support training and research programs that can inform the FDA CTP in tobacco product regulatory activities and actions. Through leadership, coordination, and facilitation of collaborative efforts, CASTL can accelerate the advancement of science relevant to the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

The FOA is expected to be published in February 2017 with an expected application due date in July 2017. The NIH anticipates holding a pre-application web-based teleconference to which all interested prospective applicants are invited. Information about this pre-application web-based teleconference call will be available at (https://prevention.nih.gov/tobacco-regulatory-science-program). .

This FOA will utilize the U54 activity code, which will allow substantial NIH and FDA involvement with the awardees. A separate FOA will solicit cooperative agreement applications for a U54 Tobacco Centers of Regulatory Science for Research (TCORS) Program.

Details of the planned CASTL FOA are provided below. Details regarding the TCORS FOA can be found in NOT-OD-16-151.

Research Initiative Details

CASTL is expected to serve as the scientific research coordinator for the advancement of a broad base tobacco regulatory research program that supports excellence in research, training, and leadership that will contribute to the science base FDA CTP uses to inform the development of tobacco regulatory activities and actions. CASTL, in cooperation with NIH and FDA CTP, will serve as the coordinator and facilitator of the CTP-funded research program, building a broad base of knowledge and resources for the advancement, dissemination and translation of tobacco regulatory science.

CASTL will be expected to provide intellectual and scientific leadership as well as logistical support infrastructure for the entire CTP-funded research program, including research supported through CTP partnerships with the National Institutes of Health, FDA’s National Center for Toxicological Research and the Centers for Disease Control and Prevention. CASTL will encourage and support networks among CTP-funded tobacco regulatory scientists that foster communication, collaboration, and high-quality research that address the research priorities related to the regulatory authority of the FDA CTP. CASTL also will have an important role in coordinating and integrating the efforts of the Tobacco Centers of Regulatory Science (TCORS) (see related Notice), including the TCORS training programs, and will enable collaboration and consultation with other CTP-funded training awardees, investigators, and other experts conducting tobacco regulatory research.  

CASTL will work with CTP-funded researchers and the NIH and FDA CTP scientific, administrative, and program staff to coordinate research program activities. CASTL must be able to connect and build upon available expertise and infrastructure to integrate activities of the awarded research projects so as to minimize duplication, maximize the use of existing resources, and establish new resources when necessary to facilitate collaboration, data synthesis and integration, and the dissemination of research findings and outcomes, and to enable new, novel research questions that can be developed and answered with integrated data.

Required Structure and Main Components of CASTL:
All applicants will be expected to address the following main aspects for the proposed CASTL.

1) Leadership and Logistics Core - CASTL must be able to provide close coordination of research efforts across the CTP-funded research program. This role will require strong leadership, scientific insight, capacity to bring diverse teams together and ability to provide the logistical skills needed to support a large, multi-agency research portfolio.

2) Analytics and Synthesis Core - CASTL must be able to provide a "big picture" perspective on the CTP-funded research program, identifying areas of commonality as well as research gaps. This role will require understanding the breadth of tobacco regulatory research and the ability to identify and facilitate pursuit of pressing research questions.

3) Education and Training Core - CASTL must develop an infrastructure that can both inventory and integrate training programs and associated resources across TCORS and other CTP-funded researchers.

4) Dissemination Core - CASTL must support, coordinate and enable dissemination of research outcomes to appropriate audiences.

NOTE: Interested applicant institutions should be aware that multiple applications in response to the forthcoming CASTL FOA and the forthcoming TCORS FOA can be submitted. However, key personnel of the CASTL award may not be the same as key personnel of a TCORS award.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Tobacco Regulatory Science Program
Office of Disease Prevention
Telephone: 301-451-7464
Email: [email protected]