‘‘(i) assess the potential public health 
consequences of use against the United 
States population of agents identified under 
subparagraph (A)(ii); and 
‘‘(ii) determine, on the basis of such as-
sessment, the agents for which priority 
countermeasures are necessary to protect the 
public health from a material threat. 
‘‘(3) ASSESSMENT OF AVAILABILITY AND APPRO-
PRIATENESS OF COUNTERMEASURES.—The Secretary, 
in consultation with the Homeland Security Sec-
retary, shall assess on an ongoing basis the avail-
ability and appropriateness of specific counter-
measures to address specific threats identified under 
paragraph (2). 
‘‘(4) CALL FOR SECURITY COUNTERMEASURES; 
COMMITMENT FOR RECOMMENDATION FOR PROCURE-
MENT.—
‘‘(A) PROPOSAL
TO
THE
PRESIDENT.—If, 
pursuant to an assessment under paragraph (3), 
the Homeland Security Secretary and the Sec-
retary make a determination that a security 
countermeasure would be appropriate, such Sec-
retaries may jointly submit to the President a 
proposal to—
‘‘(i) issue a call for the development of 
such security countermeasure; and 
‘‘(ii) make a commitment that, upon 
the first development of such security coun-
termeasure that meets the conditions for 
procurement under paragraph (5), the Sec-
retaries will, based in part on information 
obtained pursuant to such call, make a rec-
ommendation under paragraph (6) that the 
special reserve fund under paragraph (10) 
be made available for the procurement of 
such security countermeasure. 
‘‘(B) COUNTERMEASURE SPECIFICATIONS.—
The Homeland Security Secretary and the Sec-
retary shall, to the extent practicable, include in 
the proposal under subparagraph (A)—
‘‘(i) estimated quantity of purchase (in 
the form of number of doses or number of ef-
fective courses of treatments regardless of 
dosage form); 
‘‘(ii) necessary measures of minimum 
safety and effectiveness; 
‘‘(iii) estimated price for each dose or 
effective course of treatment regardless of 
dosage form; and
‘‘(iv) other information that may be 
necessary to encourage and facilitate re-
search, development, and manufacture of the 
countermeasure or to provide specifications 
for the countermeasure. 
‘‘(C) 
PRESIDENTIAL
APPROVAL.—If 
the 
President approves a proposal under subpara-
graph (A), the Homeland Security Secretary and 
the Secretary shall make known to persons who 
may respond to a call for the security counter-
measure involved—
‘‘(i) the call for the countermeasure; 
‘‘(ii) specifications for the counter-
measure under subparagraph (B); and 
‘‘(iii) a commitment described in sub-
paragraph (A)(ii). 
‘‘(5) SECRETARY’S
DETERMINATION
OF
COUN-
TERMEASURES
APPROPRIATE
FOR
FUNDING
FROM 
SPECIAL RESERVE FUND.—
‘‘(A) IN GENERAL.—The Secretary, in ac-
cordance with the provisions of this paragraph, 
shall identify specific security countermeasures 
that the Secretary determines, in consultation 
with the Homeland Security Secretary, to be ap-
propriate for inclusion in the stockpile under
subsection (a) pursuant to procurements made 
with amounts in the special reserve fund under 
paragraph (10) (referred to in this subsection in-
dividually as a ‘procurement under this sub-
section’). 
‘‘(B) REQUIREMENTS.—In making a deter-
mination under subparagraph (A) with respect
to a security countermeasure, the Secretary shall 
determine and consider the following: 
‘‘(i) The quantities of the product that 
will be needed to meet the needs of the stock-
pile. 
‘‘(ii) The feasibility of production and 
delivery within five years of sufficient 
quantities of the product. 
‘‘(iii) Whether there is a lack of a sig-
nificant commercial market for the product 
at the time of procurement, other than as a 
security countermeasure. 
‘‘(6) RECOMMENDATION
FOR
PRESIDENT’S
AP-
PROVAL.—
‘‘(A) RECOMMENDATION
FOR
PROCURE-
MENT.—In the case of a security countermeasure 
that the Secretary has, in accordance with para-
graphs (2), (3), and (5), determined to be appro-
priate for procurement under this subsection, the 
Homeland Security Secretary and the Secretary 
shall jointly submit to the President, in coordi-
nation with the Director of the Office of Manage-
ment and Budget, a recommendation that the 
special reserve fund under paragraph (10) be 
made available for the procurement of such coun-
termeasure.
‘‘(B) PRESIDENTIAL
APPROVAL.—The spe-
cial reserve fund under paragraph (10) is avail-
able for a procurement of a security counter-
measure only if the President has approved a 
recommendation under subparagraph (A) re-
garding the countermeasure. 
‘‘(C) NOTICE TO CONGRESS.—The Secretary 
and the Homeland Security Secretary shall no-
tify the Congress of each decision of the President 
to approve a recommendation under subpara-
graph (A). Such notice shall include an expla-
nation of the decision to make available the spe-
cial reserve fund under paragraph (10) for pro-
curement of such a countermeasure, including, 
where available, the identification of the poten-
tial supplier or suppliers of such counter-
measure, and whether other potential suppliers
of the same or similar countermeasures were con-
sidered and rejected for procurement under this 
section and the reasons therefor. 
‘‘(D) SUBSEQUENT
SPECIFIC
COUNTER-
MEASURES.—Procurement under this subsection 
of a security countermeasure for a particular 
purpose does not preclude the subsequent pro-
curement under this subsection of any other secu-
rity countermeasure for such purpose if the Sec-
retary has determined under paragraph (5)(A) 
that such countermeasure is appropriate for in-
clusion in the stockpile and if, as determined by 
the Secretary, such countermeasure provides im-
proved safety or effectiveness, or for other reasons 
enhances preparedness to respond to threats of 
use of a biological, chemical, radiological, or nu-
clear agent. Such a determination by the Sec-
retary is committed to agency discretion. 
‘‘(E) 
RULE
OF
CONSTRUCTION.—Rec-
ommendations and approvals under this para-
graph apply solely to determinations that the 
special reserve fund under paragraph (10) will 
be made available for a procurement of a secu-
rity countermeasure, and not to the substance of