SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 
(a) PEDIATRIC STUDIES OF DRUGS.—Section 505A 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) is amended— 
(1) in subsection (d), by adding at the end the 
following: 
‘‘(5) CONSULTATION.—With respect to a drug 
that is a qualified countermeasure (as defined in sec-
tion 319F–1 of the Public Health Service Act), a se-
curity countermeasure (as defined in section 319F– 
2 of the Public Health Service Act), or a qualified 
pandemic or epidemic product (as defined in section 
319F–3 of the Public Health Service Act), the Sec-
retary shall solicit input from the Assistant Sec-
retary for Preparedness and Response regarding the 
need for and, from the Director of the Biomedical 
Advanced Research and Development Authority re-
garding the conduct of, pediatric studies under this 
section.’’; and 
(2) in subsection (n)(1), by adding at the end 
the following: 
‘‘(C) For a drug that is a qualified coun-
termeasure (as defined in section 319F–1 of the 
Public Health Service Act), a security counter-
measure (as defined in section 319F–2 of the 
Public Health Service Act), or a qualified pan-
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demic or epidemic product (as defined in sec-
tion 319F–3 of such Act), in addition to any 
action with respect to such drug under subpara-
graph (A) or (B), the Secretary shall notify the 
Assistant Secretary for Preparedness and Re-
sponse and the Director of the Biomedical Ad-
vanced Research and Development Authority of 
all pediatric studies in the written request 
issued by the Commissioner of Food and 
Drugs.’’. 
(b) ADDITION
TO
PRIORITY
LIST
CONSIDER-
ATIONS.—Section 409I of the Public Health Service Act 
(42 U.S.C. 284m) is amended— 
(1) by striking subsection (a)(2) and inserting 
the following: 
‘‘(2) CONSIDERATION OF AVAILABLE INFORMA-
TION.—In developing and prioritizing the list under 
paragraph (1), the Secretary— 
‘‘(A) shall consider— 
‘‘(i) therapeutic gaps in pediatrics 
that may include developmental pharma-
cology, pharmacogenetic determinants of 
drug response, metabolism of drugs and 
biologics in children, and pediatric clinical 
trials; 
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‘‘(ii) particular pediatric diseases, dis-
orders or conditions where more complete 
knowledge and testing of therapeutics, in-
cluding drugs and biologics, may be bene-
ficial in pediatric populations; and 
‘‘(iii) the adequacy of necessary infra-
structure to conduct pediatric pharma-
cological research, including research net-
works and trained pediatric investigators; 
and 
‘‘(B) may consider the availability of quali-
fied countermeasures (as defined in section 
319F–1), security countermeasures (as defined 
in section 319F–2), and qualified pandemic or 
epidemic products (as defined in section 319F– 
3) to address the needs of pediatric populations, 
in consultation with the Assistant Secretary for 
Preparedness and Response, consistent with the 
purposes of this section.’’; and 
(2) in subsection (b), by striking ‘‘subsection 
(a)’’ and inserting ‘‘paragraphs (1) and (2)(A) of 
subsection (a)’’. 
(c) ADVICE AND RECOMMENDATIONS OF THE PEDI-
ATRIC ADVISORY COMMITTEE REGARDING COUNTER-
MEASURES
FOR PEDIATRIC POPULATIONS.—Subsection 
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(b)(2) of section 14 of the Best Pharmaceuticals for Chil-
dren Act (42 U.S.C. 284m note) is amended— 
(1) in subparagraph (C), by striking the period 
and inserting ‘‘; and’’; and 
(2) by adding at the end the following: 
‘‘(D) the development of countermeasures 
(as defined in section 565(a) of the Federal 
Food, Drug, and Cosmetic Act) for pediatric 
populations.’’. 
TITLE IV—ACCELERATING MED-
ICAL COUNTERMEASURE AD-
VANCED RESEARCH AND DE-
VELOPMENT 
SEC. 401. BIOSHIELD. 
(a) PROCUREMENT
OF COUNTERMEASURES.—Sec-
tion 319F–2(c) of the Public Health Service Act (42 
U.S.C. 247d–6b(c)) is amended— 
(1) in paragraph (1)(B)(i)(III)(bb), by striking 
‘‘eight years’’ and inserting ‘‘10 years’’; 
(2) in paragraph (2)(C), by striking ‘‘the des-
ignated congressional committees (as defined in 
paragraph (10))’’ and inserting ‘‘the appropriate 
committees of Congress’’; 
(3) in paragraph (5)(B)(ii), by striking ‘‘eight 
years’’ and inserting ‘‘10 years’’; 
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(4) in subparagraph (C) of paragraph (6)— 
(A) in the subparagraph heading, by strik-
ing ‘‘DESIGNATED
CONGRESSIONAL
COMMIT-
TEES’’ and inserting ‘‘APPROPRIATE CONGRES-
SIONAL COMMITTEES’’; and 
(B) by striking ‘‘the designated congres-
sional committees’’ and inserting ‘‘the appro-
priate congressional committees’’; and 
(5) in paragraph (7)(C)— 
(A) in clause (i)(I), by inserting ‘‘including 
advanced research and development,’’ after ‘‘as 
may reasonably be required,’’; 
(B) in clause (ii)— 
(i) in subclause (III), by striking 
‘‘eight years’’ and inserting ‘‘10 years’’; 
and 
(ii) by striking subclause (IX) and in-
serting the following: 
‘‘(IX) CONTRACT
TERMS.—The 
Secretary, in any contract for procure-
ment under this section— 
‘‘(aa) may specify— 
‘‘(AA) the dosing and 
administration requirements 
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for the countermeasure to be 
developed and procured; 
‘‘(BB) the amount of 
funding that will be dedi-
cated by the Secretary for 
advanced research, develop-
ment, and procurement of 
the countermeasure; and 
‘‘(CC) the specifications 
the 
countermeasure 
must 
meet to qualify for procure-
ment under a contract under 
this section; and 
‘‘(bb) shall provide a clear 
statement of defined Government 
purpose limited to uses related to 
a security countermeasure, as de-
fined in paragraph (1)(B).’’; and 
(C) by adding at the end the following: 
‘‘(viii) FLEXIBILITY.—In carrying out 
this section, the Secretary may, consistent 
with the applicable provisions of this sec-
tion, enter into contracts and other agree-
ments that are in the best interest of the 
Government in meeting identified security 
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