Table 3.

KHI Board of Directors structure

I. Cochairs (voting)

i. American Society of Nephrology (ASN) member

ii. FDA member

II. Community members (voting)

i. Four health professionals with expertise in kidney disease

ii. Two patient advocates interested in kidney diseases and related conditions

iii. Four representatives from commercial interests that encompass the breadth of the FDA’s mission

iv. Up to four at-large members, representing health professionals, patient advocates, or commercial interests as well as other stakeholders, such as ethicists and policymakers

III. FDA liaisons (voting)

i. Center for Biologics Evaluation and Research (CBER)

ii. Center for Drug Evaluation and Research (CDER)

iii. Center for Devices and Radiologic Health (CDRH)

iv. Center for Food Safety and Applied Nutrition (CFSAN)

IV. Other governmental liaisons (nonvoting)

i. Centers for Medicare and Medicaid Services (CMS)

ii. National Institutes of Health (NIH)

1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

2. National Center for Advancing Translational Sciences (NCATS)

iii. Centers for Disease Control and Prevention (CDC)

iv. Agency for Healthcare Quality and Research (AHRQ)

V. Ex officio members (nonvoting; as needed to ensure that the KHI Board of Directors is as inclusive, representative, and effective as possible)