authorized person

(B)For purposes of this paragraph, the term “authorized person” means an officer or employee of the Department of Health and Human Services who has— (i)appropriate credentials, as determined by the Secretary; and (ii)been duly designated by the Secretary to have access to the records required under this section. (f)A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—


21 USC § 379aa(e)(2)(B)

Scoping language

For purposes of this paragraph
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