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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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countermeasure needs, including with re-
spect to reimbursement of the cost of ad-
vanced research and development as a rea-
sonable, allowable, and allocable direct cost 
of the contract involved.’’. 
(b) REAUTHORIZATION OF THE SPECIAL RESERVE 
FUND.—Section 319F–2 of the Public Health Service Act 
(42 U.S.C. 247d–6b) is amended— 
(1) in subsection (c)— 
(A) by striking ‘‘special reserve fund under 
paragraph (10)’’ each place it appears and in-
serting ‘‘special reserve fund as defined in sub-
section (h)’’; and 
(B) by striking paragraphs (9) and (10); 
and 
(2) by adding at the end the following: 
‘‘(g) SPECIAL RESERVE FUND.— 
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—In 
addition to amounts appropriated to the special re-
serve fund prior to the date of the enactment of this 
subsection, there is authorized to be appropriated, 
for the procurement of security countermeasures 
under subsection (c) and for carrying out section 
319L (relating to the Biomedical Advanced Research 
and Development Authority), $2,800,000,000 for the 
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period of fiscal years 2014 through 2018. Amounts 
appropriated pursuant to the preceding sentence are 
authorized to remain available until September 30, 
2019. 
‘‘(2) USE OF SPECIAL RESERVE FUND FOR AD-
VANCED RESEARCH AND DEVELOPMENT.—The Sec-
retary may utilize not more than 50 percent of the 
amounts authorized to be appropriated under para-
graph (1) to carry out section 319L (related to the 
Biomedical Advanced Research and Development 
Authority). Amounts authorized to be appropriated 
under this subsection to carry out section 319L are 
in addition to amounts otherwise authorized to be 
appropriated to carry out such section. 
‘‘(3) RESTRICTIONS
ON
USE
OF
FUNDS.— 
Amounts in the special reserve fund shall not be 
used to pay costs other than payments made by the 
Secretary to a vendor for advanced development 
(under section 319L) or for procurement of a secu-
rity countermeasure under subsection (c)(7). 
‘‘(4) REPORT.—Not later than 30 days after 
any date on which the Secretary determines that the 
amount of funds in the special reserve fund available 
for procurement is less than $1,500,000,000, the 
Secretary shall submit to the appropriate committees 
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of Congress a report detailing the amount of such 
funds available for procurement and the impact such 
reduction in funding will have— 
‘‘(A) in meeting the security counter-
measure needs identified under this section; and 
‘‘(B) on the annual Public Health Emer-
gency Medical Countermeasures Enterprise and 
Strategy Implementation Plan (pursuant to sec-
tion 2811(d)). 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) The term ‘advanced research and develop-
ment’ has the meaning given such term in section 
319L(a). 
‘‘(2) The term ‘special reserve fund’ means the 
‘Biodefense Countermeasures’ appropriations ac-
count, any appropriation made available pursuant to 
section 521(a) of the Homeland Security Act of 
2002, and any appropriation made available pursu-
ant to subsection (g)(1).’’. 
SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL-
OPMENT AUTHORITY. 
(a) DUTIES.—Section 319L(c)(4) of the Public 
Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amend-
ed— 
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(1) in subparagraph (B)(iii), by inserting 
‘‘(which may include advanced research and develop-
ment for purposes of fulfilling requirements under 
the Federal Food, Drug, and Cosmetic Act or sec-
tion 351 of this Act)’’ after ‘‘development’’; and 
(2) in subparagraph (D)(iii), by striking ‘‘and 
vaccine manufacturing technologies’’ and inserting 
‘‘vaccine-manufacturing technologies, dose-sparing 
technologies, efficacy-increasing technologies, and 
platform technologies’’. 
(b) 
TRANSACTION
AUTHORITIES.—Section 
319L(c)(5) of the Public Health Service Act (42 U.S.C. 
247d–7e(c)(5)) is amended by adding at the end the fol-
lowing: 
‘‘(G) GOVERNMENT PURPOSE.—In award-
ing contracts, grants, and cooperative agree-
ments under this section, the Secretary shall 
provide a clear statement of defined Govern-
ment purpose related to activities included in 
subsection (a)(6)(B) for a qualified counter-
measure or qualified pandemic or epidemic 
product.’’. 
(c) FUND.—Paragraph (2) of section 319L(d) of the 
Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is 
amended to read as follows: 
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‘‘(2) FUNDING.—To carry out the purposes of 
this section, there is authorized to be appropriated 
to the Fund $415,000,000 for each of fiscal years 
2013 through 2017, such amounts to remain avail-
able until expended.’’. 
(d) CONTINUED INAPPLICABILITY OF CERTAIN PRO-
VISIONS.—Section 319L(e)(1)(C) of the Public Health 
Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by 
striking ‘‘7 years’’ and inserting ‘‘11 years’’. 
(e) EXTENSION
OF LIMITED ANTITRUST EXEMP-
TION.—Section 405(b) of the Pandemic and All-Hazards 
Preparedness Act (42 U.S.C. 247d–6a note) is amended 
by striking ‘‘6-year’’ and inserting ‘‘11-year’’. 
(f) INDEPENDENT EVALUATION.—Section 319L of 
the Public Health Service Act (42 U.S.C. 247d–7e) is 
amended by adding at the end the following: 
‘‘(f) INDEPENDENT EVALUATION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of enactment of this subsection, the 
Comptroller General of the United States shall con-
duct an independent evaluation of the activities car-
ried out to facilitate flexible manufacturing capacity 
pursuant to this section. 
‘‘(2) REPORT.—Not later than 1 year after the 
date of enactment of this subsection, the Comp-
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troller General of the United States shall submit to 
the appropriate committees of Congress a report 
concerning the results of the evaluation conducted 
under paragraph (1). Such report shall review and 
assess— 
‘‘(A) the extent to which flexible manufac-
turing capacity under this section is dedicated 
to chemical, biological, radiological, and nuclear 
threats; 
‘‘(B) the activities supported by flexible 
manufacturing initiatives; and 
‘‘(C) the ability of flexible manufacturing 
activities carried out under this section to— 
‘‘(i) secure and leverage leading tech-
nical expertise with respect to counter-
measure advanced research, development, 
and manufacturing processes; and 
‘‘(ii) meet the surge manufacturing 
capacity needs presented by novel and 
emerging threats, including chemical, bio-
logical, radiological, and nuclear agents.’’. 
(g) DEFINITIONS.— 
(1) QUALIFIED
COUNTERMEASURE.—Section 
319F–1(a)(2)(A) of the Public Health Service Act 
(42 U.S.C. 247d–6a(a)(2)(A)) is amended— 
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(A) in the matter preceding clause (i), by 
striking ‘‘to—’’ and inserting ‘‘—’’; 
(B) in clause (i)— 
(i) by striking ‘‘diagnose’’ and insert-
ing ‘‘to diagnose’’; and 
(ii) by striking ‘‘; or’’ and inserting a 
semicolon; 
(C) in clause (ii)— 
(i) by striking ‘‘diagnose’’ and insert-
ing ‘‘to diagnose’’; and 
(ii) by striking the period at the end 
and inserting ‘‘; or’’; and 
(D) by adding at the end the following: 
‘‘(iii) is a product or technology in-
tended to enhance the use or effect of a 
drug, biological product, or device de-
scribed in clause (i) or (ii).’’. 
(2) QUALIFIED PANDEMIC OR EPIDEMIC PROD-
UCT.—Section 319F–3(i)(7)(A) of the Public Health 
Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend-
ed— 
(A) in clause (i)(II), by striking ‘‘; or’’ and 
inserting ‘‘;’’; 
(B) in clause (ii), by striking ‘‘; and’’ and 
inserting ‘‘; or’’; and 
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(C) by adding at the end the following: 
‘‘(iii) a product or technology intended 
to enhance the use or effect of a drug, bio-
logical product, or device described in 
clause (i) or (ii); and’’. 
(3) TECHNICAL AMENDMENTS.—Section 319F– 
3(i) of the Public Health Service Act (42 U.S.C. 
247d–6d(i)) is amended— 
(A) in paragraph (1)(C), by inserting ‘‘, 
564A, or 564B’’ after ‘‘564’’; and 
(B) in paragraph (7)(B)(iii), by inserting 
‘‘, 564A, or 564B’’ after ‘‘564’’. 
SEC. 403. STRATEGIC NATIONAL STOCKPILE. 
Section 319F–2 of the Public Health Service Act (42 
U.S.C. 247d–6b) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) by inserting ‘‘consistent with sec-
tion 2811’’ before ‘‘by the Secretary to be 
appropriate’’; and 
(ii) by inserting before the period at 
the end of the second sentence the fol-
lowing: ‘‘and shall submit such review an-
nually to the appropriate congressional 
committees of jurisdiction to the extent 
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that disclosure of such information does 
not compromise national security’’; and 
(B) in paragraph (2)(D), by inserting be-
fore the semicolon at the end the following: 
‘‘and that the potential depletion of counter-
measures currently in the stockpile is identified 
and appropriately addressed, including through 
necessary replenishment’’; and 
(2) 
in 
subsection 
(f)(1), 
by 
striking 
‘‘$640,000,000 for fiscal year 2002, and such sums 
as may be necessary for each of fiscal years 2003 
through 2006. Such authorization is in addition to 
amounts in the special reserve fund referred to in 
subsection (c)(10)(A).’’ and inserting ‘‘$533,800,000 
for each of fiscal years 2013 through 2017. Such 
authorization is in addition to amounts in the special 
reserve fund referred to in subsection (h).’’. 
SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 
Section 319M(a) of the Public Health Service Act (42 
U.S.C. 247d–f(a)) is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (D)— 
(i) in clause (i), by striking ‘‘and’’ at 
the end; 
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(ii) in clause (ii), by striking the pe-
riod and inserting a semicolon; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(iii) one such member shall be an in-
dividual with pediatric subject matter ex-
pertise; and 
‘‘(iv) one such member shall be a 
State, tribal, territorial, or local public 
health official.’’; and 
(B) by adding at the end the following 
flush sentence: 
‘‘Nothing in this paragraph shall preclude a member 
of the Board from satisfying two or more of the re-
quirements described in subparagraph (D).’’; and 
(2) in paragraph (5)— 
(A) in subparagraph (B), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (C), by striking the 
period and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(D) provide any recommendation, finding, 
or report provided to the Secretary under this 
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paragraph to the appropriate committees of 
Congress.’’. 
Passed the House of Representatives December 19, 
2012. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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