133 STAT. 956  PUBLIC LAW 116–22—JUNE 24, 2019  ‘‘(2) The term ‘medical countermeasure submission’ means  an investigational new drug application under section 505(i),  a new drug application under section 505(b), or an abbreviated  new drug application under section 505(j) of this Act, a  biological product license application under section 351(a) of  the Public Health Service Act or a biosimilar biological product  license application under section 351(k) of the Public Health  Service Act, a new animal drug application under section  512(b)(1) or abbreviated new animal drug application under  section 512(b)(2), an application for conditional approval of  a new animal drug under section 571, an investigational device  application under section 520(g), an application with respect  to a device under section 515(c), a request for classification  of a device under section 513(f)(2), a notification with respect  to a device under section 510(k), or a request for an emergency  use authorization under section 564 to support—  ‘‘(A) the approval, licensure, classification, clearance,  conditional approval, or authorization of a security counter- measure, qualified countermeasure, or qualified pandemic  or epidemic product; or  ‘‘(B) a new indication to an approved security counter- measure, qualified countermeasure, or qualified pandemic  or epidemic product.  ‘‘(3) The terms ‘qualified countermeasure’, ‘security counter- measure’, and ‘qualified pandemic or epidemic product’ have  the meanings given such terms in sections 319F–1, 319F–2,  and 319F–3, respectively, of the Public Health Service Act.’’.  (c) STAKEHOLDER INPUT.—Not later than 18 months after the  date of enactment of this Act, the Secretary, acting through the  Commissioner of Food and Drugs and in consultation with the  Assistant Secretary for Preparedness and Response, shall solicit  input from stakeholders, including stakeholders developing security  countermeasures, qualified countermeasures, or qualified pandemic  or epidemic products, and stakeholders developing technologies to  assist in the development of such countermeasures with respect  to how the Food and Drug Administration can advance the use  of tools and technologies to support and advance the development  or manufacture of security countermeasures, qualified counter- measures, and qualified pandemic or epidemic products, including  through reliance on cross-referenced data and information contained  within master files and submissions previously submitted to the  Secretary as set forth in section 565B of the Federal Food, Drug,  and Cosmetic Act, as added by subsection (b).  (d) GUIDANCE.—Not later than 2 years after the date of enact- ment of this Act, the Secretary, acting through the Commissioner  of Food and Drugs, shall publish draft guidance about how reliance  on cross-referenced data and information contained within master  files under section 565B of the Federal Food, Drug, and Cosmetic  Act, as added by subsection (b) or submissions otherwise submitted  to the Secretary may be used for specific tools or technologies  (including platform technologies) that have the potential to support  and advance the development or manufacture of security counter- measures, qualified countermeasures, and qualified pandemic or  epidemic products. The Secretary, acting through the Commissioner  of Food and Drugs, shall publish the final guidance not later than  3 years after the enactment of this Act.  Publication.  Deadlines.  Deadline.  Consultation. 