# Presentation: 273082

## FDA Nanotechnology Task Force

- Report released July 25, 2007
- http://www.fda.gov/nanotechnology/
- taskforce/report2007.html

- 9/8/2008

## Scope of this talk

- To provide a framework and information for the discussions in breakouts in terms of FDA’s Task Force report
- Present the recommendations in the FDA Task Force report
- Provide our actions, activities, and direction relevant to the recommendations

- 9/8/2008

## Content of the Task Force Report

- Recommendations about definitions
- Synopsis of the state of the science with respect to biological interactions of nanoscale materials relevant to FDA mission
- Analysis and recommendations for science needs
- Analysis and recommendations for regulatory policy needs

- 9/8/2008

## Task Force Bottom Lines

- Nanoscale materials could be used in most types of products regulated by FDA
- Nanoscale materials present challenges similar to other emerging technologies
- The fact that safety and efficacy can vary with size can complicate the challenges

- 9/8/2008

## Bottom Lines (continued)

- Not apparent that nanoscale materials as a group would have more inherent hazard than other materials as a group
- Steps should be taken to better inform FDA reviewers and industry about what is known and expected for analysis of nanoscale materials in products.

- 9/8/2008

## Science Recommendations

***Adequacy of testing approaches***
- Evaluate adequacy of testing approaches to assess safety, effectiveness, and quality of products with nanoscale materials
- Promote/participate in the development of
- characterization methods and standards for nanoscale materials; and
- models for the behavior of nanoscale particles in-vitro and in-vivo.

- 9/8/2008

## Science Recommendations

***Understanding biological interactions***
- Promote/participate in developing more knowledge about
- biological interactions
- detection and measurement
- Build in-house expertise and infrastructure to share and leverage knowledge
- Ensure Agency-wide regulatory-science coordination for nanoscale materials

- 9/8/2008

## Slide 8

| Science Recommendation | Actions/Directions |
| --- | --- |
| Developing knowledge  | FDA research, evaluation of genetic toxicity assays
National Toxicology Program 
Collaboration with NCL and NIST
OECD testing program
Working with academia and public private partnerships to develop data and modeling for biological interaction |
| Build expertise and infrastructure  |  |
| Evaluate testing approaches |  |
| Develop methods, standards, and models  |  |
| Coordinate regulatory science  | FDA Task Force
Executive Branch NEHI, GIN, and NPCG 
“Bilaterals” with major trading partners
Work in international forums |

- 9/8/2008

## FDA research related to product reviews 
Silver nanoparticle toxicity assays
Dermal penetration of nanoparticles

National Toxicology Program (NTP)
FDA lead  
Titanium dioxide, Zinc Oxide
Silver, Gold
Collaborating on 
Fullerenes, Carbon nanotubes
Quantum dots

- Silver nanoparticle toxicity assays
- Dermal penetration of nanoparticles
- National Toxicology Program (NTP)
- FDA lead
- Titanium dioxide, Zinc Oxide
- Silver, Gold
- Collaborating on
- Fullerenes, Carbon nanotubes
- Quantum dots

- 9/8/2008

## Collaboration with the National Cancer Institute’s Cancer Nanotechnology Alliance
Nanotechnology Characterization Laboratory 
Dermal penetration of sunscreen nanomaterials
Oversight board with regard to test program development and directions for the lab
Co-chair nanotechnology subcommittee of the Interagency Oncology Task Force

Collaboration with the National Institute of Standards and Technology (NIST)
Selection of standard reference nanomaterials
Upcoming review of round robin testing

- Nanotechnology Characterization Laboratory
- Dermal penetration of sunscreen nanomaterials
- Oversight board with regard to test program development and directions for the lab
- Co-chair nanotechnology subcommittee of the Interagency Oncology Task Force
- Collaboration with the National Institute of Standards and Technology (NIST)
- Selection of standard reference nanomaterials
- Upcoming review of round robin testing

- 9/8/2008

## Organization of Economic Cooperation and Development (OECD) 

Contributing to testing program of up to 14 nanomaterials for 59 endpoints by OECD member countries and industry
Co-chairing development of guidance on how to conduct the test program
Reviewing test guidelines and what to measure and report in toxicity tests
Participating in review of risk assessment methods as applied to nanoscale materials

- Contributing to testing program of up to 14 nanomaterials for 59 endpoints by OECD member countries and industry
- Co-chairing development of guidance on how to conduct the test program
- Reviewing test guidelines and what to measure and report in toxicity tests
- Participating in review of risk assessment methods as applied to nanoscale materials

- 9/8/2008

## Working to with Academia and Public Private Partnerships to Develop Methods, Data, and Modeling

Foundation for the National Institutes of Health and the NIH NanoHealth Enterprise
Working groups described priority projects
At least one project in development

Alliance for NanoHealth (Houston based consortium of medical research institutions)
Workshop prioritized Critical Path research needs

*Foundation for the National Institutes of Health and the NIH NanoHealth Enterprise*
- Working groups described priority projects
- At least one project in development
*Alliance for NanoHealth (Houston based consortium of medical research institutions)*
- Workshop prioritized Critical Path research needs

- 9/8/2008

## Slide 13

| Science Recommendation | Actions/Directions |
| --- | --- |
| Developing knowledge  | FDA research, evaluation of genetox assays
National Toxicology Program 
Collaboration with NCL and NIST
OECD testing program
Working with academia and public private partnerships to develop data and modeling for biological interaction |
| Build expertise and infrastructure  |  |
| Evaluate testing approaches |  |
| Develop methods, standards, and models  |  |
| Coordinate regulatory science  | FDA Task Force
Executive Branch NEHI, GIN, and NPCG 
“Bilaterals” with major trading partners
Work in international forums |

- 9/8/2008

## FDA Nanotechnology Task Force
Cross Center/product areas
Science and regulatory policy
 Links to similar working groups in Centers on nanotechnology

- Cross Center/product areas
- Science and regulatory policy
-  Links to similar working groups in Centers on nanotechnology

- 9/8/2008

## US Executive Branch Regulatory Science Coordination
Nanotechnology Environmental Health Implications (NEHI)
Prioritization of research needs 
Global Issues in Nanotechnology (GIN)
International interactions on policy and science 
Nanotechnology Policy Coordination Group (NPCG)
Coordination on science and regulatory policy

*Nanotechnology Environmental Health Implications (NEHI)*
- Prioritization of research needs
*Global Issues in Nanotechnology (GIN)*
- International interactions on policy and science
*Nanotechnology Policy Coordination Group (NPCG)*
- Coordination on science and regulatory policy

- 9/8/2008

## International regulatory science coordination

Bilateral discussions with major trading partners 
Informal but direct and clear
Major policy conclusions are very similar
OECD 
Review of risk assessment
Data needs, reporting standards, sharing policy documents 
Emerging discussions in International Cooperation on Cosmetic Regulation, CODEX, etc.

- Bilateral discussions with major trading partners
- Informal but direct and clear
- Major policy conclusions are very similar
- OECD
- Review of risk assessment
- Data needs, reporting standards, sharing policy documents
- Emerging discussions in International Cooperation on Cosmetic Regulation, CODEX, etc.

- 9/8/2008

## Regulatory policy topics addressed in the Task Force report

- Ability to Identify Products that Contain Nanoscale Materials
- Authority Regarding Evaluation of Safety and Effectiveness
- Permissible and Mandatory Labeling
- National Environmental Policy Act

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## Identification of Products Containing Nanomaterials

- FDA’s authority to obtain information about particle size varies
- Comprehensive for products subject to premarket authorization
- More limited for products not subject to premarket authorization
- For some product categories, information requirements can vary (e.g., over-the-counter drugs, food and color additives)

- 9/8/2008

## Identification of Products Containing Nanomaterials

**Recommendations**
- Issue guidance recommending that sponsors identify particle size of small particle materials in submissions for products subject to premarket authorization or notice requirements
- When warranted, request data on particle size for over-the-counter drugs and food and color additives

- 9/8/2008

## Product Safety and Effectiveness

- FDA’s oversight authority for product safety and effectiveness varies
- Most comprehensive for products subject to premarket authorization
- Less comprehensive for products not subject to pre-market authorization
- But manufacturers still responsible for ensuring the safety of their products
- Presence of nanoscale materials may change regulatory status

- 9/8/2008

## Product Safety and Effectiveness

**Recommendations**
- Issue calls for safety and effectiveness data
- Issue guidance on
- Manufacturing
- Devices
- GRAS (generally recognized as safe) food ingredients
- Food and color additives
- Cosmetics
- Dietary supplements

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## Slide 22

| Regulatory Policy Recommendations | Actions/Directions |
| --- | --- |
| Guidance on particle size identification | Food contact notification guidance, and examining similar additions elsewhere; Request for comment on OTC sunscreens rule; Today’s meeting |
| Calls for safety and effectiveness data | Data call in notice for this meeting and in sunscreens proposed rule; Generate data through NTP, FDA research, OECD |
| Labeling  | Case by case evaluation based on the materials in the product |
| NEPA | Case by case evaluation;
Coordinating agency approach |

- 9/8/2008

## Slide 23

| Regulatory Policy Recommendations | Actions/Directions |
| --- | --- |
| Safety/effectiveness guidance on  |  |
| Manufacturing | Request for comment in sunscreens proposed rule; Case studies for food contact materials; Today’s meeting |
| GRAS food ingredients | Case studies for food contact materials; Bilateral discussions; Initial discussions on work within WHO/FAO; Today’s meeting |
| Food and Color Additives
 |  |

- 9/8/2008

## Slide 24

| Regulatory Policy Recommendations | Actions/Directions |
| --- | --- |
| Safety/effectiveness guidance on  |  |
| Devices
 | Participation in Global Harmonization Task Force; Bilateral discussions; Today’s meeting |
| Cosmetics | Participation in ICCR; Today’s meeting |
| Dietary Supplements | Today’s meeting |

- 9/8/2008

## Final thoughts

- The emerging and uncertain nature of nanotechnology and potential for rapid development of FDA-regulated products highlight the need for a transparent, consistent, and predictable regulatory pathway.
- Give us your thoughts on how to accomplish this.
- We are here to listen.

- 9/8/2008

## Final final thoughts....

**Playing an active role—avoiding delay and surprises**
- Consult with us early and often
- Provide data and participate in research planning
- Engage in international harmonization and coordination efforts

- 9/8/2008