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
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
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—
(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:
‘‘(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-
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—