(a)
In general— The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Defense and the Secretary of Homeland Security, shall establish a program of entering into partnerships with eligible domestic manufacturers to ensure the availability of qualified personal protective equipment for preparing for, and responding to, public health emergencies.
(b)
Contractual purchasing agreements—
(1)
Process— Not later than 1 year after the date of enactment of this Act, the Secretary shall finalize a process for entering into contractual purchasing agreements with eligible domestic manufacturers to implement the partnerships described in subsection (a).
(2)
Contents— The contractual purchasing agreements entered into under this section, collectively, shall—
(A)
guarantee the availability of supplies and manufacturing lines to produce qualified personal protective equipment in amounts specified by the Secretary to prepare for and respond to public health emergencies; and
(B)
fulfill such other requirements as are—
(i)
deemed necessary by the Secretary to prepare for and respond to a public health emergency; and
(ii)
covered under the contractual purchasing agreement.
(c)
Eligible domestic manufacturers— To be eligible to participate in a partnership described in subsection (a), a manufacturer shall—
(1)
be headquartered in the continental United States;
(2)
manufacture in the continental United States 50 percent of their of the products in 2026, 75 percent of their products by 2027, and 100 percent of their products by 2028 to be supplied to the Federal Government pursuant to such partnership;
(3)
be majority owned and operated by United States citizens;
(4)
have supply agreements in place to verify supply chain security and sourcing; and
(5)
attest in writing to the fact that the manufacturer’s entire product lines meet or exceed all applicable quality guidelines of the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration.
(d)
Qualified personal protective equipment—
(1)
In general— The Secretary shall maintain a list of products that are eligible for treatment as qualified personal protective equipment under this section.
(2)
Requirements— To be included on the list under paragraph (1), a product shall—
(A)
meet or exceed all applicable quality guidelines of the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration;
(B)
have been cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 360(k)); and
(C)
be priced using fair-market benchmarks established by the Secretary.
(e)
Definitions— In this section:
(1)
The term public health emergency means a public health emergency for which a declaration is in effect under section 319 of the Public Health Service Act (
42 U.S.C. 247d).
(2)
The term Secretary means the Secretary of Health and Human Services.