Notification. 

Notification. 

‘‘(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 

