§379k–1. Electronic format for submissions — Inbound Citations

Citations to 21 U.S.C. § 379k–1 as a whole

• 21 U.S.C. § 360bbb–4b(c)(1)

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  (1) Each incorporation of data or information within a medical countermeasure master file shall describe the incorporated material in a manner in which the Secretary determines appropriate and that permits the review of such information within such master file without necessitating resubmission of such data or information. Master files shall be submitted in an electronic format in accordance with sections 360b(b)(4), 360ccc(a)(4), and 379k–1 of this title, as applicable, and as specified in applicable guidance.