Notice of Special Interest (NOSI): Collaborative and Innovative Research to Advance Regulatory Science: Partnership of FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) and NIH Clinical and Translational Science Award (CTSA) Programs

NOT-TR-24-006

Key Dates

Related Announcements

• May 09, 2022 - Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional). See NOFO PAR-22-167.

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

Background

The National Institutes of Health (NIH)’s National Center for Advancing Translational Sciences (NCATS) and the Food and Drug Administration (FDA)’s Office of the Chief Scientist (OCS) intend to collaborate and foster partnership between the NIH’s Clinical and Translational Science Award (CTSA) Program and the FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to advance regulatory science by leveraging the resources and expertise from both programs.

Regulatory science is the science of developing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products, which include medical devices, drugs, biologics, combination products, veterinary medicine, food, cosmetics, dietary supplements, and tobacco products. In addition to the product areas that FDA regulates, FDA also aims to target cross-cutting areas that have the potential to transform how FDA-regulated products are developed, evaluated, and utilized, such as digital health, artificial intelligence, data science, alternative methods, One Health, patient-centered outcomes, and behavior change/ social science. The FDA hosts the CERSI Program to foster robust and innovative approaches to advance regulatory science. The goal for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the OCS Office of Regulatory Science and Innovation (ORSI), through collaborative interactions with FDA scientific experts and funding offices.

Translational Science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. The NIH supports the CTSA Program to develop innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and the public. The CTSA Program is a national, collaborative consortium led by the NCATS Division of Clinical Innovation.

This Notice of Special Interest (NOSI) related to the CTSA Program Collaborative and Innovative Acceleration (CCIA) Award (PAR-22-167: UG3/UH3 Clinical Trial Optional) Initiative describes the NIH and FDA research priorities for regulatory science. The respective shared goals of regulatory science and translational science provide opportunities to tackle high-impact concepts across all stages of the translational science spectrum. The CCIA Notice of Funding Opportunity (NOFO) PAR-22-167 supports synergistic activities that accelerate the translational research process through collaboration and innovation. This NOFO invites applications to develop, demonstrate and disseminate innovative solutions to transform the field of translational science by addressing the inefficiencies that are common across diseases and bringing more interventions to all people more quickly through collaborative science among the CTSA Program hubs, NIH Institutes, Centers, Offices (ICOs), and/or external stakeholders.

Purpose

The purpose of this NOSI is to invite applications for multi-site research projects from the collaborating CTSA Program and CERSI Program eligible organizations to advance the field of regulatory science by applying the NIH’s translational science principles and the FDA’s regulatory science framework.

The Areas of Research Interest and Priority Include:

Area 1 - Modernize Product Development, Evaluation and Surveillance Methodologies

Appropriate topics include, but are not limited to, the following:

• Improve FDA-regulated product development and evaluation
• Strengthen surveillance and risk communication to patients and consumers
• Consider diverse populations in the process of product development evaluation
• Explore potential alternative methods to support product development and assessment

Area 2 - Community Engagement to Promote Public Health Preparedness for FDA, Patients and Consumers

Appropriate topics include, but are not limited to, the following:

• Enhance FDA's ability and capacity to respond to public health threats
• Engage diverse populations in preparedness
• Utilize novel approaches to minimize misinformation/disinformation for patients and consumers

Area 3 - Data Science and Digital Health Technology

Appropriate topics include, but are not limited to, the following:

• Utilize AI and real-world data for enhanced product evaluation and surveillance
• Harness AI and data science approaches and assess their impact on regulated products and the regulatory pathways
• Explore innovative tools to support regulatory decision-making and adoption.

Area 4 - Workforce Development and Regulatory Science Training

A comprehensive approach to advancing Regulatory Science involves focusing on training and education, promoting collaboration, and establishing a robust Regulatory Science network.

Appropriate topics include, but are not limited to, the following:

• Adoption of regulatory science core competencies and curricular guidelines
• Dissemination of best practices to improve regulatory processes to enhance product safety and public health