Institution: | Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Bethesda, MD, USA,;Division of Inspections and Surveillance, CBER, FDA, Rockville, MD, USA, and;Nutrient and Function Requirement Laboratory, Beltsville Human Nutrition Research Institute, USDA, Agricultural Research Service, Beltsville, MD, USA |