(3) by adding after and below subparagraph (B) 
the following: 
‘‘If through publication in the Federal Register the 
Secretary makes a determination that there is credible 
evidence that a biological agent has the potential to 
cause an epidemic or pandemic that may constitute 
a public health emergency, a countermeasure to such 
agent shall, without further administrative action, be 
considered a qualified countermeasure within the 
meaning of this paragraph.’’. 
(b) SECURITY COUNTERMEASURES.—Section 319F– 
2(c)(1)(B)(i)(I) of the Public Health Service Act (42 U.S.C. 
247d–6b(c)(1)(B)(i)(I)) is amended by striking ‘‘to treat’’ 
the first place such term appears and all that follows 
through ‘‘from a condition’’ and inserting the following: ‘‘to 
diagnose, mitigate, prevent, or treat harm from any biologi-
cal agent (including organisms that cause an infectious dis-
ease) or toxin or from any chemical, radiological, or nuclear 
agent identified as a material threat under paragraph 
(2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm 
from a condition’’. 
SEC. 5. TECHNICAL ASSISTANCE. 
Subchapter E of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 
by adding at the end the following: 
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CCOLEMAN on PROD1PC71 with BILLS
‘‘SEC. 565. TECHNICAL ASSISTANCE. 
‘‘The Secretary, in consultation with the Commis-
sioner of Food and Drugs, shall establish within the Food 
and Drug Administration a team of experts on manufac-
turing and regulatory activities (including compliance with 
current Good Manufacturing Practice) to provide both off- 
site and on-site technical assistance to the manufacturers 
of qualified countermeasures (as defined in section 319F– 
1 of the Public Health Service Act), security counter-
measures (as defined in section 319F–2 of such Act), or vac-
cines, at the request of such a manufacturer and at the dis-
cretion of the Secretary, if the Secretary determines that 
a shortage or potential shortage may occur in the United 
States in the supply of such vaccines or countermeasures 
and that the provision of such assistance would be beneficial 
in helping alleviate or avert such shortage.’’. 
SEC. 6. PROCUREMENT. 
Section 319F–2 of the Public Health Service Act (42 
U.S.C. 247d–6b) is amended— 
(1) in the section heading, by inserting ‘‘AND 
SECURITY
COUNTERMEASURE
PROCURE-
MENTS’’ before the period; and 
(2) in subsection (c)— 
(A) in the subsection heading, by striking 
‘‘BIOMEDICAL’’; 
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CCOLEMAN on PROD1PC71 with BILLS
(B) in paragraph (5)(B)(i), by striking ‘‘to 
meet the needs of the stockpile’’ and inserting ‘‘to 
meet the stockpile needs’’; 
(C) in paragraph (7)(B)— 
(i) by striking the subparagraph head-
ing and all that follows through ‘‘Homeland 
Security Secretary’’ and inserting the fol-
lowing: 
‘‘INTERAGENCY
AGREEMENT; 
COST.—The Homeland Security Secretary’’; 
and 
(ii) by striking clause (ii); 
(D) in paragraph (7)(C)(ii)— 
(i) by amending clause (I) to read as 
follows: 
‘‘(I) PAYMENT
CONDITIONED
ON 
DELIVERY.—The contract shall provide 
that no payment may be made until 
delivery of a portion, acceptable to the 
Secretary, of the total number of units 
contracted for, except that, notwith-
standing any other provision of law, 
the contract may provide that, if the 
Secretary determines (in the Sec-
retary’s discretion) that an advance 
payment, partial payment for signifi-
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CCOLEMAN on PROD1PC71 with BILLS
cant milestones, or payment to increase 
manufacturing capacity is necessary to 
ensure success of a project, the Sec-
retary shall pay an amount, not to ex-
ceed 10 percent of the contract amount, 
in advance of delivery. The Secretary 
shall, to the extent practicable, make 
the determination of advance payment 
at the same time as the issuance of a 
solicitation. The contract shall provide 
that such advance payment is required 
to be repaid if there is a failure to per-
form by the vendor under the contract. 
The contract may also provide for ad-
ditional advance payments of 5 percent 
each for meeting the milestones speci-
fied in such contract. Provided that the 
specified milestones are reached, these 
advance payments of 5 percent shall 
not be required to be repaid. Nothing 
in this subclause shall be construed as 
affecting the rights of vendors under 
provisions of law or regulation (includ-
ing the Federal Acquisition Regula-
tion) relating to the termination of 
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CCOLEMAN on PROD1PC71 with BILLS
contracts for the convenience of the 
Government.’’; and 
(ii) by adding at the end the following: 
‘‘(VII) PROCUREMENT
OF
MUL-
TIPLE
PRODUCTS
AND
TECH-
NOLOGIES.—The Secretary may enter 
into multiple transactions for the pro-
curement of multiple technologies and 
products from multiple manufacturers 
of security countermeasures in order to 
mitigate against the risks associated 
with dependence on a single supplier 
or technology. 
‘‘(VIII) SALES
EXCLUSIVITY.— 
The contract may provide that the ven-
dor is the exclusive supplier of the 
product to the Federal Government for 
a specified period of time, not to exceed 
the term of the contract, on the condi-
tion that the vendor is able to satisfy 
the needs of the Government. During 
the agreed period of sales exclusivity, 
the vendor shall not assign its rights of 
sales exclusivity to another entity or 
entities without approval by the Sec-
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