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21 U.S. Code § 360bbb-4. Countermeasure development, review, and technical assistance
(a) DefinitionsIn this section—
(1)
the term “countermeasure” means a qualified countermeasure, a security countermeasure, and a qualified pandemic or epidemic product;
(2)
the term “qualified countermeasure” has the meaning given such term in section 247d–6a of title 42;
(3)
the term “security countermeasure” has the meaning given such term in section 247d–6b of title 42; and
(4) the term “qualified pandemic or epidemic product” means a product that meets the definition given such term in section 247d–6d of title 42 and—
(A)
that has been identified by the Department of Health and Human Services or the Department of Defense as receiving funding directly related to addressing chemical, biological, radiological, or nuclear threats, including pandemic influenza; or
(B)
is included under this paragraph pursuant to a determination by the Secretary.
(b) General dutiesIn order to accelerate the development, stockpiling, approval, licensure, and clearance of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, the Secretary, in consultation with the Assistant Secretary for Preparedness and Response, shall—
(1)
ensure the appropriate involvement of Food and Drug Administration personnel in interagency activities related to countermeasure advanced research and development, consistent with sections 247d–6, 247d–6a, 247d–6b, 247d–6d, 247d–7e, and 300hh–10 of title 42;
(2)
ensure the appropriate involvement and consultation of Food and Drug Administration personnel in any flexible manufacturing activities carried out under section 247d–7e of title 42, including with respect to meeting regulatory requirements set forth in this chapter;
(3) promote countermeasure expertise within the Food and Drug Administration by—
(A)
ensuring that Food and Drug Administration personnel involved in reviewing countermeasures for approval, licensure, or clearance are informed by the Assistant Secretary for Preparedness and Response on the material threat assessment conducted under section 247d–6b of title 42 for the agent or agents for which the countermeasure under review is intended;
(B)
training Food and Drug Administration personnel regarding review of countermeasures for approval, licensure, or clearance;
(C)
holding public meetings at least twice annually to encourage the exchange of scientific ideas; and
(D)
establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures;
(4) maintain teams, composed of Food and Drug Administration personnel with expertise on countermeasures, including specific countermeasures, populations with special clinical needs (including children and pregnant women that may use countermeasures, as applicable and appropriate), classes or groups of countermeasures, or other countermeasure-related technologies and capabilities, that shall—
(A)
consult with countermeasure experts, including countermeasure sponsors and applicants, to identify and help resolve scientific issues related to the approval, licensure, or clearance of countermeasures, through workshops or public meetings; and
(B) improve and advance the science relating to the development of new tools, standards, and approaches to assessing and evaluating countermeasures—
(i)
in order to inform the process for countermeasure approval, clearance, and licensure; and
(ii)
with respect to the development of countermeasures for populations with special clinical needs, including children and pregnant women, in order to meet the needs of such populations, as necessary and appropriate; and