1. FACA Considerations Presented to the NVAC Public Participation Working Group Meeting on Models for Enhancing Public Involvement Presented by Emily Marcus Levine, J.D. Office of the General Counsel U.S. Department of Health & Human Services

2. Statutory Background Federal Advisory Committee Act of 1972, as amended (FACA) created to encourage openness in Government & access to all stakeholders created special rules and requirements for Federal advisory committees (e.g., NVAC), including: meetings must generally be open to the public meetings must be announced in advance committee memberships: fairly balanced & qualified committee members: Federal ethics & conflict of interest requirements

3. Which groups subject to the FACA? General rule: any advisory group (e.g., panels, task forces, similar groups) established or utilized by a Federal agency or the President Supreme Court: utilized = managed or controlled in the interest of obtaining advice or recommendations that has at least one member who is not a Federal employee

4. Which groups exempt from FACA? Many exceptions, including: meetings w/certain State, local & tribal officials groups assembled to exchange facts & information (not advice or recommendations) groups created by non-Federal entities, if they are not actually managed or controlled by the Federal Government groups assembled to provide individual advice (no consensus advice sought or provided) exceptions - vaccine context

5. Final Considerations Important to consider applicability of FACA in considering different options –FACA violations, especially in controversial areas, can lead to lawsuits If not subject to FACA’s requirements, can still decide as good public policy to voluntarily follow some of its requirements. Examples: –opening meetings to the public –announcing meetings in advance –inviting stakeholders with different perspectives to share conflicting views –providing written minutes to the public