PUBLIC LAW 116–22—JUNE 24, 2019  133 STAT. 954  ‘‘(2) REFERENCE OF CERTAIN MASTER FILES.—In the case  that data or information within a medical countermeasure  master file is used only to support the conditional approval  of an application filed under section 571, such master file  may be relied upon to support the effectiveness of a product  that is the subject of a subsequent medical countermeasure  submission only if such application is supplemented by addi- tional data or information to support review and approval in  a manner consistent with the standards applicable to such  review and approval for such countermeasure, qualified  countermeasure, or qualified pandemic or epidemic product.  ‘‘(b) MEDICAL COUNTERMEASURE MASTER FILE CONTENT.—  ‘‘(1) IN GENERAL.—A master file under this section may  include data or information to support—  ‘‘(A) the development of medical countermeasure  submissions to support the approval, licensure, classifica- tion, clearance, conditional approval, or authorization of  one or more security countermeasures, qualified counter- measures, or qualified pandemic or epidemic products; and  ‘‘(B) the manufacture of security countermeasures,  qualified countermeasures, or qualified pandemic or epi- demic products.  ‘‘(2) REQUIRED UPDATES.—The Secretary may require, as  appropriate, that the master file holder ensure that the contents  of such master file are updated during the time such master  file is referenced for a medical countermeasure submission.  ‘‘(c) SPONSOR REFERENCE.—  ‘‘(1) IN GENERAL.—Each incorporation of data or informa- tion 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  512(b)(4), 571(a)(4), and 745A, as applicable, and as specified  in applicable guidance.  ‘‘(2) REFERENCE BY A MASTER FILE HOLDER.—A master file  holder that is the sponsor of a medical countermeasure submis- sion shall notify the Secretary in writing of the intent to ref- erence the medical countermeasure master file as a part of  the submission.  ‘‘(3) REFERENCE BY AN AUTHORIZED PERSON.—A person  submitting an application for review may, where the Secretary  determines appropriate, incorporate by reference all or part  of the contents of a medical countermeasure master file, if  the master file holder authorizes the incorporation in writing.  ‘‘(d) ACKNOWLEDGMENT OF AND RELIANCE UPON A MASTER FILE  BY THE SECRETARY.—  ‘‘(1) IN GENERAL.—The Secretary shall provide the master  file holder with a written notification indicating that the Sec- retary has reviewed and relied upon specified data or informa- tion within a master file and the purposes for which such  data or information was incorporated by reference if the Sec- retary has reviewed and relied upon such specified data or  information to support the approval, classification, conditional  approval, clearance, licensure, or authorization of a security  Notification.  Notification. 