Deadline. Consultation. 

Deadlines. 

Publication. 

‘‘(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. 

