make specified quantities of such des-
ignated critical medications or key in-
gredients thereof available when di-
rected by the Secretary, on predeter-
mined terms and conditions; 
‘‘(II) one or more private enti-
ties’ agreement to commence or main-
tain production of one or more such 
designated critical medications, in 
specified locations, or to build or 
maintain specified surge capacity for 
such production, and to manufacture 
or otherwise make specified quantities 
of such designated critical medications 
available, when directed, on predeter-
mined terms and conditions; and 
‘‘(III) compensation for mainte-
nance of such inventory, production, 
or production capacity and associated 
overhead, as necessary or appropriate. 
‘‘(B) FACTORS.—In entering into contracts 
under subparagraph (A)(ii), the Secretary shall 
take into account as factors more significant 
than price— 
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‘‘(i) whether the designated critical 
medication would be produced in the 
United States; 
‘‘(ii) the track record and dem-
onstrated ability of the given manufacturer 
to produce the designated critical medica-
tion in the required quantities when needed 
(in domestic or foreign locations, after con-
sideration of whether supply from such for-
eign locations is at significant risk of dis-
ruption in the event of a public health 
emergency); and 
‘‘(iii) the United States regulatory 
compliance history of the given manufac-
turer. 
‘‘(C) PREFERENCE.—In entering into con-
tracts under subparagraph (A)(ii), the Sec-
retary may give preference to contracting with 
manufacturers of medications which are based 
in the United States. 
‘‘(D) REFERENCES.—References in this 
paragraph to the United States include any ter-
ritory of the United States.’’; 
(2) in subsection (a)(2)(B)— 
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(A) in the matter preceding clause (i), by 
inserting ‘‘and each new or modified contract 
with 
a 
private 
entity 
under 
paragraph 
(1)(A)(ii)’’ after ‘‘for each new or modified 
countermeasure 
procurement 
or 
replenish-
ment’’; 
(B) in clause (i)(III), by inserting ‘‘or con-
tracting for procurement’’ after ‘‘procurement’’; 
(C) in clause (i)(IV), by inserting ‘‘or con-
tracting for procurement’’ after ‘‘whether such 
procurement’’; 
(D) in clause (i)(V), by inserting ‘‘(includ-
ing through one or more contracts under para-
graph (1)(A)(ii))’’ after ‘‘stockpile’’; and 
(E) in clause (ii), by inserting ‘‘or for 
which the Secretary entered into a contract 
with 
a 
private 
entity 
under 
paragraph 
(1)(A)(ii),’’ after ‘‘for each countermeasure pro-
cured or replenished under this subsection,’’; 
(3) in subsection (a)(3)(E) by inserting ‘‘the 
Commissioner of Food and Drugs,’’ after ‘‘Assistant 
Secretary for Preparedness and Response,’’; 
(4) in subsection (a)(5)(A)— 
(A) in the matter preceding clause (i), by 
inserting ‘‘and any contracts entered into under 
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paragraph (1)(A)(ii)’’ after ‘‘any changes to the 
contents or management of the stockpile’’; 
(B) in clause (ii), by striking ‘‘or replenish-
ment’’ and inserting ‘‘replenishment, or con-
tracting’’; 
(C) in clause (iv), by striking ‘‘an account-
ing of countermeasures procured, modified, or 
replenished under paragraph (1)’’ and inserting 
‘‘an accounting of countermeasures procured, 
modified, or replenished under paragraph 
(1)(A)(i) or for which contracts with private en-
tities were entered into under paragraph 
(1)(A)(ii)’’; 
(D) in clause (v)— 
(i) by inserting ‘‘and contracts’’ after 
‘‘decisions’’; and 
(ii) by striking ‘‘or replenished’’ and 
inserting ‘‘replenished or contracted’’; and 
(E) in clause (vii), by inserting ‘‘and new 
or modified contracts with a private entity’’ 
after ‘‘replenishments’’; 
(5) in subsection (c)(7)(B)(ii), by adding at the 
end the following subclause: 
‘‘(X) 
NONAPPLICABILITY
TO 
CERTAIN
CONTRACTS.—None of the 
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requirements set forth in this clause 
(ii) shall apply to contracts entered 
into under subsection (a)(1)(A)(ii), 
other than contracts for procurement 
of security countermeasures from the 
special reserve fund, except that the 
Secretary may, at the Secretary’s dis-
cretion, include any of the terms de-
scribed in this clause, or similar 
terms, in any contract entered into 
under subsection (a)(1)(A)(ii).’’; and 
(6) by amending subsection (e) to read as fol-
lows: 
‘‘(e) DEFINITIONS.—For the purposes of this section: 
‘‘(1) The terms ‘critical medication’, ‘designated 
critical medication’, and ‘medication’ have the mean-
ings given to such terms in section 319F–5. 
‘‘(2) The term ‘stockpile’ includes— 
‘‘(A) a physical accumulation (at one or 
more locations) of the supplies described in sub-
section (a) (including any maintained in inven-
tory under a contract with a private entity 
under subsection (a)(1)(A)(ii) under a contract 
with a private entity entered into under sub-
section (a)(1)(A)(ii)); and 
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‘‘(B) any supplies described in subsection 
(a)(1)(A)(i) which a vendor or vendors agree to 
provide to the Secretary under a contractual 
agreement between the Secretary and such ven-
dor or vendors, and any designated critical 
medications which a private entity is required 
to manufacture or otherwise supply under an 
agreement between the Secretary and such pri-
vate entity entered into pursuant to subsection 
(a)(1)(A)(ii).’’. 
Æ 
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