2013 Nanotechnology Regulatory Science Research Plan

Contents

• Goal
• Framework
• Implementation Strategy
• Outcomes

FDA Nanotechnology Regulatory Science Research Plan—Goal

What is FDA’s Plan for Nanotechnology Regulatory Science Research?

The FDA Nanotechnology Regulatory Science Research Plan lays out a framework and implementation plan to provide coordinated leadership on regulatory science activities and issues related to FDA-regulated products that either contain nanomaterial or otherwise involve the application of nanotechnology. The goal of providing coordinated leadership of FDA’s regulatory science research helps to address key scientific gaps in knowledge, methods, or tools needed to make regulatory assessments of these products.

Why does FDA have a Nanotechnology Regulatory Science Research Program?

FDA is developing a regulatory science program in nanotechnology to foster the responsible development of FDA-regulated products that may contain nanomaterials or otherwise involve the application of nanotechnology. The program establishes the tools, methods, and data to assist in regulatory decision-making, while also providing in-house scientific expertise and capacity that is responsive to nanotechnology-related FDA-regulated products.

FDA defines Regulatory Science as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. FDA has recently published a Strategic Plan for Regulatory Science that identifies eight priority topics for the Agency to focus in the coming years. A critical area identified in the FDA plan is to “Ensure FDA Readiness to Evaluate Innovative Emerging Technology”, and nanotechnology is a part of the strategic plan.

Who is leading this effort?

The FDA Nanotechnology Task Force, with representatives from across the Agency, will facilitate communication on nanotechnology regulatory science both within FDA and with national and international stakeholders, and provide overall coordination of FDA’s nanotechnology regulatory science research efforts.

The FDA Nanotechnology Regulatory Science Research Plan—Framework

The Program contains four areas:

1. Staff Training and Professional Development
   Staff training and professional development to strengthen the nanotechnology-specific scientific expertise within the agency.
2. Laboratory Core Facilities
   Laboratory Core Facilities to support regulatory science.
3. Collaborative Opportunities for Research Excellence in Science (CORES) Program
   Collaborative Opportunities for Research Excellence in Science (CORES) Program to promote cross-center and external collaborative research opportunities for identified high priority FDA regulatory science nanotechnology research needs, reflecting the National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy (see Table 1: NNI EHS Research Needs Cross Walk to FDA Regulatory Science Research Categories).

Table 1: NNI EHS Research Needs Cross Walk to FDA Regulatory Science Research Categories

NNI EHS Research Needs	FDA Regulatory Science Research Categories	FDA Research Goals
Develop measurement tools for determination of physico-chemical properties of Engineered Nanomaterials (ENMs) in relevant media.	Physico-chemical Characterization	Develop improved methods and tools to detect and measure the physical structure, chemical properties, and safety of nanomaterials in FDA-regulated products: In biological matrices, to assess the impact of biological systems on physical structure, chemical properties, and safety; and To be used by manufacturers to assess product quality and consistency.
Identify or develop appropriate in vitro and in vivo assays and models to predict in vivo human response to nanomaterials.	Nonclinical Models	Develop and evaluate in vitro and in vivo assays and models to assess safety and/or efficacy of nanomaterials in FDA-regulated products, in order to: Better understand the adequacy of preclinical evaluations necessary to assess safety and efficacy of nanomaterials; Obtain data on absorption, distribution, metabolism, and excretion, relevant to in vivo fate of nanomaterials; and Obtain data to improve understanding of structure-function relationships.
Incorporate the relevant risk characterization information, hazard identification, exposure science, and risk modeling and methods into the safety evaluation of nanomaterials.	Risk Characterization	Targeted research in FDA-regulated product areas of potential nanotechnology applications where risk characterization information would help to enhance the understanding of hazard identification, exposure science, and risk modeling.
Evaluate risk assessment approaches for risk management.	Risk Assessment	Enhance state of knowledge and scientific evidence to support potential development of generalized class-based approaches to risk assessment of FDA-regulated products containing nanomaterials.
Integrate and standardize risk communication within the risk management framework	Risk Communication	Improve risk communication associated with FDA regulated product areas that either contain nanomaterials or product areas otherwise relevant to nanotechnology

4. FDA Coordination
   Coordination of FDA’s nanotechnology regulatory science research efforts, including CORES-funding and activities supported by other funding sources (see Figure 1 below).

Figure 1: FDA Nanotechnology Regulatory Science Program

FDA Nanotechnology Regulatory Science Research Plan—Implementation Strategy

The Nanotechnology Regulatory Science Research Program encompasses all FDA nanotechnology regulatory science projects and related activities (e.g., reporting) and is implemented through program oversight and strategic partnerships.

Program Oversight

Ensure resources are used responsibly to address FDA’s nanotechnology regulatory science needs:

1. Use internal databases and other resources to track and manage resources and outcomes:
   1. CORES and Center-funded research projects will be tracked
   2. Specialized equipment for the conducting of nanotechnology-related projects will be available to staff
2. Provide CORES funding for collaborative projects addressing identified priority needs in nanotechnology regulatory science through peer-reviewed processes:
   1. intramural competitive grants
   2. extramural competitive grants or contracts
3. Perform periodic reviews of nanotechnology regulatory science research:
   1. Review of ongoing CORES and Center-funded projects for relevance to identified priority needs, scientific quality, and productivity
   2. Monitor progress of individual projects funded through the CORES program, as well as Center-funded regulatory science projects
   3. Identify gaps in portfolio, synergistic efforts, and new collaborators
   4. Periodically revisit stated nanotechnology research priorities and revise as needs and state-of-art change

Strategic Partnerships

Leverage and use resources efficiently across the agency and with other government agencies, academia, and industry by facilitating collaborations within and external to FDA, as appropriate

1. Engage United States Government Agencies
   1. National Nanotechnology Initiative Member Agencies
2. Engage in Domestic and International Collaborations
   1. Pursue additional collaborative efforts with outside FDA groups: academia, industry, international governments and organizations through Public-Private Partnerships as well as informal collaborations.

FDA Nanotechnology Regulatory Science Research Plan—Outcomes

Posting the FDA Nanotechnology Regulatory Science Research Plan ensures transparency and public awareness of FDA’s activities and investment strategy in nanotechnology regulatory science.

The FDA Nanotechnology Regulatory Science Research Plan uses resources efficiently to address FDA’s nanotechnology regulatory science needs to support FDA readiness to evaluate products that incorporate or use nanotechnology.

Successful implementation of the FDA’s Nanotechnology Regulatory Science Program enhances or facilitates development and availability of safe, and as applicable, effective FDA-regulated products that contain or apply the science of nanotechnology.