Delegation of Authority Under Section 564A(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a(e))

概要

CDC has redelegated the authority under the Federal Food, Drug, and Cosmetic (FD&C) Act to create and issue amended emergency use instructions (EUI) to inform healthcare providers or individuals to whom an eligible product, as defined under the FD&C Act, is to be administered, concerning the product's approved, licensed, or cleared conditions of use that deviate from approved labeling, standard clinical practice, and/or standard medical modality (e.g., individual prescription within the patient-clinician relationship). This notice announces the redelegation of the above-mentioned authority, without the authority to redelegate, from the Director, CDC, to the Director, National Center for Immunizations and Respiratory Diseases (NCIRD).