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42 U.S. Code § 247d-6a. Authority for use of certain procedures regarding qualified countermeasure research and development activities
(a) In general
(1) Authority
In conducting and supporting research and development activities regarding countermeasures under section 247d–6(e) of this title, the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under section 285f of this title, if the activities concern qualified countermeasures.
(2) DefinitionsIn this section:
(A) Qualified countermeasureThe term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—
(i)
to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;
(ii)
to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or
(iii)
is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).
(B) Infectious disease
The term “infectious disease” means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and that reproduces in that person.
(3) Interagency cooperation
(A) In general
In carrying out activities under this section, the Secretary is authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government.
(B) Limitation
An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section.
(4) Availability of facilities to the Secretary
In any grant, contract, or cooperative agreement entered into under the authority provided in this section with respect to a biocontainment laboratory or other related or ancillary specialized research facility that the Secretary determines necessary for the purpose of performing, administering, or supporting qualified countermeasure research and development, the Secretary may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be available as needed to the Secretary to respond to public health emergencies affecting national security.
(5) Transfers of qualified countermeasures
Each agreement for an award of a grant, contract, or cooperative agreement under section 247d–6(e) of this title for the development of a qualified countermeasure shall provide that the recipient of the award will comply with all applicable export-related controls with respect to such countermeasure.