133 STAT. 955  PUBLIC LAW 116–22—JUNE 24, 2019  countermeasure, qualified countermeasure, or qualified pan- demic or epidemic product. The Secretary may rely upon the  data and information within the medical countermeasure  master file for which such written notification was provided  in additional applications, as applicable and appropriate and  upon the request of the master file holder so notified in writing  or by an authorized person of such holder.  ‘‘(2) CERTAIN APPLICATIONS.—If the Secretary has reviewed  and relied upon specified data or information within a medical  countermeasure master file to support the conditional approval  of an application under section 571 to subsequently support  the approval, clearance, licensure, or authorization of a security  countermeasure, qualified countermeasure, or qualified pan- demic or epidemic product, the Secretary shall provide a brief  written description to the master file holder regarding the  elements of the application fulfilled by the data or information  within the master file and how such data or information con- tained in such application meets the standards of evidence  under subsection (c) or (d) of section 505, subsection (d) of  section 512, or section 351 of the Public Health Service Act  (as applicable), which shall not include any trade secret or  confidential commercial information.  ‘‘(e) RULES OF CONSTRUCTION.—Nothing in this section shall  be construed to—  ‘‘(1) limit the authority of the Secretary to approve, license,  clear, conditionally approve, or authorize drugs, biological prod- ucts, or devices pursuant to, as applicable, this Act or section  351 of the Public Health Service Act (as such applicable Act  is in effect on the day before the date of enactment of the  Pandemic and All-Hazards Preparedness and Advancing  Innovation Act of 2019), including the standards of evidence,  and applicable conditions, for approval under the applicable  Act;  ‘‘(2) alter the standards of evidence with respect to  approval, licensure, or clearance, as applicable, of drugs,  biological products, or devices under this Act or section 351  of the Public Health Service Act, including, as applicable, the  substantial evidence standards under sections 505(d) and 512(d)  or this Act and section 351(a) of the Public Health Service  Act; or  ‘‘(3) alter the authority of the Secretary under this Act  or the Public Health Service Act to determine the types of  data or information previously submitted by a sponsor or any  other person that may be incorporated by reference in an  application, request, or notification for a drug, biological  product, or device submitted under sections 505(i), 505(b),  505(j), 512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g), 515(c),  513(f)(2), or 510(k) of this Act, or subsection (a) or (k) of section  351 of the Public Health Service Act, including a supplement  or amendment to any such submission, and the requirements  associated with such reference.  ‘‘(f) DEFINITIONS.—In this section:  ‘‘(1) The term ‘master file holder’ means a person who  submits data and information to the Secretary with the intent  to reference or authorize another person to reference such data  or information to support a medical countermeasure submis- sion, as described in subsection (a). 