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this Act would be adversely affected by the reas-
signment. 
‘‘(D) TERMINATION AND EXTENSION.— 
‘‘(i) TERMINATION.—A State or Indian 
tribe’s temporary reassignment of personnel 
under paragraph (1) shall terminate upon 
the earlier of the following: 
‘‘(I) The Secretary’s determina-
tion that the public health emergency 
no longer exists. 
‘‘(II) Subject to clause (ii), the ex-
piration of the 30-day period following 
the date on which the Secretary ap-
proved the State or Indian tribe’s re-
quest for such reassignment flexibility. 
‘‘(ii) EXTENSION
OF
REASSIGNMENT 
FLEXIBILITY.—The Secretary may extend 
reassignment flexibility of personnel under 
paragraph (1) beyond the date otherwise 
applicable under clause (i)(II) if the public 
health emergency still exists as of such date, 
but only if— 
‘‘(I) the State or Indian tribe that 
submitted the initial request for a tem-
porary reassignment of personnel sub-
† HR 307 EAS 
mits a request for an extension of such 
temporary reassignment; and 
‘‘(II) the request for an extension 
contains the same information and as-
surances necessary for the approval of 
an initial request for such temporary 
reassignment pursuant to subpara-
graph (B). 
‘‘(3) VOLUNTARY NATURE OF TEMPORARY REAS-
SIGNMENT OF STATE AND LOCAL PERSONNEL.— 
‘‘(A) IN GENERAL.—Unless otherwise pro-
vided under the law or regulation of the State or 
Indian tribe that receives authorization for tem-
porary reassignment of personnel under para-
graph (1), personnel eligible for reassignment 
pursuant to such authorization— 
‘‘(i) shall have the opportunity to vol-
unteer for temporary reassignment; and 
‘‘(ii) shall not be required to agree to 
a temporary reassignment. 
‘‘(B) PROHIBITION ON CONDITIONING FED-
ERAL AWARDS.—The Secretary may not condi-
tion the award of a grant, contract, or coopera-
tive agreement under this Act on the requirement 
that a State or Indian tribe require that per-
† HR 307 EAS 
sonnel eligible for reassignment pursuant to an 
authorization under paragraph (1) agree to such 
reassignment. 
‘‘(4) NOTICE TO CONGRESS.—The Secretary shall 
give notice to the Congress in conjunction with the 
approval under this subsection of— 
‘‘(A) any initial request for temporary reas-
signment of personnel; and 
‘‘(B) any request for an extension of such 
temporary reassignment. 
‘‘(5) GUIDANCE.—The Secretary shall— 
‘‘(A) not later than 6 months after the en-
actment of this subsection, issue proposed guid-
ance on the temporary reassignment of personnel 
under this subsection; and 
‘‘(B) after providing notice and a 60-day 
period for public comment, finalize such guid-
ance. 
‘‘(6) REPORT TO CONGRESS.—Not later than 4 
years after the date of enactment of the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 
2013, the Comptroller General of the United States 
shall conduct an independent evaluation, and submit 
to the appropriate committees of the Congress a re-
† HR 307 EAS 
port, on temporary reassignment under this sub-
section, including— 
‘‘(A) a description of how, and under what 
circumstances, such temporary reassignment has 
been used by States and Indian tribes; 
‘‘(B) an analysis of how such temporary re-
assignment has assisted States and Indian tribes 
in responding to public health emergencies; 
‘‘(C) an evaluation of how such temporary 
reassignment has improved operational effi-
ciencies in responding to public health emer-
gencies; 
‘‘(D) an analysis of the extent to which, if 
any, Federal programs from which personnel 
have been temporarily reassigned have been ad-
versely affected by the reassignment; and 
‘‘(E) recommendations on how medical 
surge capacity could be improved in responding 
to public health emergencies and the impact of 
the reassignment flexibility under this section on 
such surge capacity. 
‘‘(7) DEFINITIONS.—In this subsection— 
‘‘(A) the terms ‘Indian tribe’ and ‘tribal or-
ganization’ have the meanings given such terms
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in section 4 of the Indian Self-Determination 
and Education Assistance Act; and 
‘‘(B) the term ‘State’ includes, in addition 
to the entities listed in the definition of such 
term in section 2, the Freely Associated States. 
‘‘(8) SUNSET.—This subsection shall terminate 
on September 30, 2018.’’. 
SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH 
SECURITY. 
(a) COOPERATIVE AGREEMENTS.—Section 319C–1 of 
the Public Health Service Act (42 U.S.C. 247d–3a) is 
amended— 
(1) in subsection (b)(1)(C), by striking ‘‘consor-
tium of entities described in subparagraph (A)’’ and 
inserting ‘‘consortium of States’’; 
(2) in subsection (b)(2)— 
(A) in subparagraph (A)— 
(i) by striking clauses (i) and (ii) and 
inserting the following: 
‘‘(i) a description of the activities such 
entity will carry out under the agreement to 
meet the goals identified under section 2802, 
including with respect to chemical, biologi-
cal, radiological, or nuclear threats, whether
† HR 307 EAS 
naturally occurring, unintentional, or delib-
erate; 
‘‘(ii) a description of the activities such 
entity will carry out with respect to pan-
demic influenza, as a component of the ac-
tivities carried out under clause (i), and 
consistent with the requirements of para-
graphs (2) and (5) of subsection (g);’’; 
(ii) in clause (iv), by striking ‘‘and’’ at 
the end; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(vi) a description of how, as appro-
priate, the entity may partner with relevant 
public and private stakeholders in public 
health emergency preparedness and re-
sponse; 
‘‘(vii) a description of how the entity, 
as applicable and appropriate, will coordi-
nate with State emergency preparedness 
and response plans in public health emer-
gency preparedness, including State edu-
cational agencies (as defined in section 
9101(41) of the Elementary and Secondary 
Education Act of 1965) and State child care
† HR 307 EAS 
lead agencies (designated under section 
658D of the Child Care and Development 
Block Grant Act of 1990); 
‘‘(viii) in the case of entities that oper-
ate on the United States-Mexico border or 
the United States-Canada border, a descrip-
tion of the activities such entity will carry 
out under the agreement that are specific to 
the border area including disease detection, 
identification, investigation, and prepared-
ness and response activities related to 
emerging diseases and infectious disease 
outbreaks whether naturally occurring or 
due to bioterrorism, consistent with the re-
quirements of this section; and 
‘‘(ix) a description of any activities 
that such entity will use to analyze real- 
time clinical specimens for pathogens of 
public health or bioterrorism significance, 
including any utilization of poison control 
centers;’’; and 
(B) in subparagraph (C), by inserting ‘‘, 
including addressing the needs of at-risk individ-
uals,’’ after ‘‘capabilities of such entity’’; 
(3) in subsection (f)—
† HR 307 EAS 
(A) in paragraph (2), by adding ‘‘and’’ at 
the end; 
(B) in paragraph (3), by striking ‘‘; and’’ 
and inserting a period; and 
(C) by striking paragraph (4); 
(4) in subsection (g)— 
(A) in paragraph (1), by striking subpara-
graph (A) and inserting the following: 
‘‘(A) include outcome goals representing 
operational achievements of the National Pre-
paredness Goals developed under section 2802(b) 
with respect to all-hazards, including chemical, 
biological, radiological, or nuclear threats; and’’; 
and 
(B) in paragraph (2)(A), by adding at the 
end the following: ‘‘The Secretary shall periodi-
cally update, as necessary and appropriate, such 
pandemic influenza plan criteria and shall re-
quire the integration of such criteria into the 
benchmarks and standards described in para-
graph (1).’’; 
(5) by striking subsection (h); 
(6) by redesignating subsections (i), (j), and (k) 
as subsections (h), (i), and (j), respectively; 
(7) in subsection (h), as so redesignated—
† HR 307 EAS 
(A) in paragraph (1)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘$824,000,000 for 
fiscal year 2007, of which $35,000,000 
shall be used to carry out subsection 
(h),’’ and inserting ‘‘$641,900,000 for 
fiscal year 2014’’; and 
(II) by striking ‘‘such sums as 
may be necessary for each of fiscal 
years 2008 through 2011’’ and insert-
ing ‘‘$641,900,000 for each of fiscal 
years 2015 through 2018’’; 
(ii) by striking subparagraph (B); 
(iii) by redesignating subparagraphs 
(C) and (D) as subparagraphs (B) and (C), 
respectively; and 
(iv) in subparagraph (C), as so redes-
ignated, by striking ‘‘subparagraph (C)’’ 
and inserting ‘‘subparagraph (B)’’; 
(B) in subparagraphs (C) and (D) of para-
graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 
it appears and inserting ‘‘(1)(A)’’; 
(C) in paragraph (4)(B), by striking ‘‘sub-
section (c)’’ and inserting ‘‘subsection (b)’’; and 
(D) by adding at the end the following:
† HR 307 EAS 
‘‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT 
FUNDS.— 
‘‘(A) IN
GENERAL.—Amounts provided to 
an eligible entity under a cooperative agreement 
under subsection (a) for a fiscal year and re-
maining unobligated at the end of such year 
shall remain available to such entity for the next 
fiscal year for the purposes for which such funds 
were provided. 
‘‘(B) FUNDS
CONTINGENT
ON
ACHIEVING 
BENCHMARKS.—The continued availability of 
funds under subparagraph (A) with respect to an 
entity shall be contingent upon such entity 
achieving the benchmarks and submitting the 
pandemic influenza plan as described in sub-
section (g).’’; and 
(8) in subsection (i), as so redesignated— 
(A) in paragraph (1)(E), by striking ‘‘sub-
section (k)’’ and inserting ‘‘subsection (j)’’; 
(B) by striking paragraph (3). 
(b) VACCINE TRACKING AND DISTRIBUTION.—Section 
319A(e) of the Public Health Service Act (42 U.S.C. 247d– 
1(e)) is amended by striking ‘‘such sums for each of fiscal 
years 2007 through 2011’’ and inserting ‘‘$30,800,000 for 
each of fiscal years 2014 through 2018’’.
† HR 307 EAS 
(c) TECHNICAL AND CONFORMING AMENDMENTS.— 
(1) Section 319C–1(b)(1)(B) of the Public Health 
Service Act (42 U.S.C. 247d–3a(b)(1)(B)) is amended 
by striking ‘‘subsection (i)(4)’’ and inserting ‘‘sub-
section (h)(4)’’. 
(2) Section 319C–2 of the Public Health Service 
Act (42 U.S.C. 247d–3b) is amended— 
(A) in subsection (i), by striking ‘‘(j), and 
(k)’’ and inserting ‘‘(i), and (j)’’; and 
(B) in subsection (j)(3), by striking ‘‘319C– 
1(i)’’ and inserting ‘‘319C–1(h)’’. 
SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 
CAPACITY. 
(a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL 
RESPONSE
CURRICULA
AND
TRAINING.—Section 
319F(a)(5)(B) of the Public Health Service Act (42 U.S.C. 
247d–6(a)(5)(B)) is amended by striking ‘‘public health or 
medical’’ and inserting ‘‘public health, medical, or dental’’. 
(b) ENCOURAGING HEALTH PROFESSIONAL VOLUN-
TEERS.— 
(1) EMERGENCY
SYSTEM
FOR
ADVANCE
REG-
ISTRATION
OF
VOLUNTEER
HEALTH
PROFES-
SIONALS.—Section 319I(k) of the Public Health Serv-
ice Act (42 U.S.C. 247d–7b(k)) is amended by strik-
ing ‘‘$2,000,000 for fiscal year 2002, and such sums
† HR 307 EAS 
as may be necessary for each of the fiscal years 2003 
through 2011’’ and inserting ‘‘$5,000,000 for each of 
fiscal years 2014 through 2018’’. 
(2) VOLUNTEERS.—Section 2813 of the Public 
Health Service Act (42 U.S.C. 300hh–15) is amend-
ed— 
(A) in subsection (d)(2), by adding at the 
end the following: ‘‘Such training exercises shall, 
as appropriate and applicable, incorporate the 
needs of at-risk individuals in the event of a 
public health emergency.’’; and 
(B) 
in 
subsection 
(i), 
by 
striking 
‘‘$22,000,000 for fiscal year 2007, and such sums 
as may be necessary for each of fiscal years 2008 
through 2011’’ and inserting ‘‘$11,200,000 for 
each of fiscal years 2014 through 2018’’. 
(c) PARTNERSHIPS FOR STATE AND REGIONAL PRE-
PAREDNESS
TO
IMPROVE
SURGE
CAPACITY.—Section 
319C–2 of the Public Health Service Act (42 U.S.C. 247d– 
3b) is amended— 
(1) in subsection (a), by inserting ‘‘, including, 
as appropriate, capacity and preparedness to address 
the needs of children and other at-risk individuals’’ 
before the period at the end;
† HR 307 EAS 
tional coordination and collaboration with respect to 
activities to achieve the preparedness goals described 
under paragraphs (1), (3), (4), (5), and (6) of section 
2802(b).’’; 
(5) in subsection (i)— 
(A) by striking ‘‘The requirements of’’ and 
inserting the following: 
‘‘(1) IN GENERAL.—The requirements of’’; and 
(B) by adding at the end the following: 
‘‘(2) MEETING GOALS OF NATIONAL HEALTH SE-
CURITY STRATEGY.—The Secretary shall implement 
objective, evidence-based metrics to ensure that enti-
ties receiving awards under this section are meeting, 
to the extent practicable, the applicable goals of the 
National Health Security Strategy under section 
2802.’’; and 
(6) in subsection (j)— 
(A) by amending paragraph (1) to read as 
follows: 
‘‘(1) IN GENERAL.—For purposes of carrying out 
this section, there is authorized to be appropriated 
$374,700,000 for each of fiscal years 2014 through 
2018.’’; and 
(B) by adding at the end the following:
† HR 307 EAS 
‘‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT 
FUNDS.— 
‘‘(A) IN
GENERAL.—Amounts provided to 
an eligible entity under a cooperative agreement 
under subsection (a) for a fiscal year and re-
maining unobligated at the end of such year 
shall remain available to such entity for the next 
fiscal year for the purposes for which such funds 
were provided. 
‘‘(B) FUNDS
CONTINGENT
ON
ACHIEVING 
BENCHMARKS.—The continued availability of 
funds under subparagraph (A) with respect to an 
entity shall be contingent upon such entity 
achieving the benchmarks and submitting the 
pandemic influenza plan as required under sub-
section (i).’’. 
SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIO-
SURVEILLANCE. 
(a) IN GENERAL.—Section 319D of the Public Health 
Service Act (42 U.S.C. 247d–4) is amended— 
(1) in subsection (b)— 
(A) in paragraph (1)(B), by inserting ‘‘poi-
son control centers,’’ after ‘‘hospitals,’’; 
(B) in paragraph (2), by inserting before 
the period at the end the following: ‘‘, allowing
† HR 307 EAS 
for coordination to maximize all-hazards medical 
and public health preparedness and response and 
to minimize duplication of effort’’; and 
(C) in paragraph (3), by inserting before 
the period at the end the following: ‘‘and update 
such standards as necessary’’; 
(2) by striking subsection (c); 
(3) by redesignating subsections (d) through (g) 
as subsections (c) through (f), respectively; 
(4) in subsection (c), as so redesignated— 
(A) in the subsection heading, by striking 
‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 
and inserting ‘‘MODERNIZING PUBLIC HEALTH 
SITUATIONAL
AWARENESS
AND
BIOSURVEIL-
LANCE’’; 
(B) in paragraph (1)— 
(i) by striking ‘‘Pandemic and All- 
Hazards Preparedness Act’’ and inserting 
‘‘Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2013’’; and 
(ii) by inserting ‘‘, novel emerging 
threats,’’ after ‘‘disease outbreaks’’; 
(C) by striking paragraph (2) and inserting 
the following:
† HR 307 EAS 
‘‘(2) STRATEGY AND IMPLEMENTATION PLAN.— 
Not later than 180 days after the date of enactment 
of the Pandemic and All-Hazards Preparedness Reau-
thorization Act of 2013, the Secretary shall submit to 
the appropriate committees of Congress a coordinated 
strategy and an accompanying implementation plan 
that identifies and demonstrates the measurable steps 
the Secretary will carry out to— 
‘‘(A) develop, implement, and evaluate the 
network described in paragraph (1), utilizing the 
elements described in paragraph (3); 
‘‘(B) modernize and enhance biosurveillance 
activities; and 
‘‘(C) improve information sharing, coordi-
nation, and communication among disparate 
biosurveillance systems supported by the Depart-
ment of Health and Human Services.’’; 
(D) in paragraph (3)(D), by inserting 
‘‘community health centers, health centers’’ after 
‘‘poison control,’’; 
(E) in paragraph (5), by striking subpara-
graph (A) and inserting the following: 
‘‘(A) 
utilize 
applicable 
interoperability 
standards as determined by the Secretary, and 
in consultation with the Office of the National
† HR 307 EAS 
Coordinator for Health Information Technology, 
through a joint public and private sector proc-
ess;’’; and 
(F) by adding at the end the following: 
‘‘(6) CONSULTATION WITH THE NATIONAL BIO-
DEFENSE SCIENCE BOARD.—In carrying out this sec-
tion and consistent with section 319M, the National 
Biodefense Science Board shall provide expert advice 
and guidance, including recommendations, regarding 
the measurable steps the Secretary should take to 
modernize and enhance biosurveillance activities pur-
suant to the efforts of the Department of Health and 
Human Services to ensure comprehensive, real-time, 
all-hazards biosurveillance capabilities. In complying 
with the preceding sentence, the National Biodefense 
Science Board shall— 
‘‘(A) identify the steps necessary to achieve 
a national biosurveillance system for human 
health, with international connectivity, where 
appropriate, that is predicated on State, re-
gional, and community level capabilities and 
creates a networked system to allow for two-way 
information flow between and among Federal, 
State, and local government public health au-
thorities and clinical health care providers;
† HR 307 EAS 
‘‘(B) identify any duplicative surveillance 
programs under the authority of the Secretary, 
or changes that are necessary to existing pro-
grams, in order to enhance and modernize such 
activities, minimize duplication, strengthen and 
streamline such activities under the authority of 
the Secretary, and achieve real-time and appro-
priate data that relate to disease activity, both 
human and zoonotic; and 
‘‘(C) coordinate with applicable existing ad-
visory committees of the Director of the Centers 
for Disease Control and Prevention, including 
such advisory committees consisting of represent-
atives from State, local, and tribal public health 
authorities and appropriate public and private 
sector health care entities and academic institu-
tions, in order to provide guidance on public 
health surveillance activities.’’; 
(5) in subsection (d), as so redesignated— 
(A) in paragraph (1), by striking ‘‘sub-
section (d)’’ and inserting ‘‘subsection (c)’’; 
(B) in paragraph (4)(B), by striking ‘‘sub-
section (d)’’ and inserting ‘‘subsection (c)’’; and 
(C) in paragraph (5)—
† HR 307 EAS 
(i) by striking ‘‘4 years after the date 
of enactment of the Pandemic and All-Haz-
ards Preparedness Act’’ and inserting ‘‘3 
years after the date of enactment of the 
Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2013’’; and 
(ii) by striking ‘‘subsection (d)’’ and 
inserting ‘‘subsection (c)’’; 
(6) in subsection (f), as so redesignated, by strik-
ing ‘‘such sums as may be necessary in each of fiscal 
years 
2007 
through 
2011’’ 
and 
inserting 
‘‘$138,300,000 for each of fiscal years 2014 through 
2018’’; and 
(7) by adding at the end the following: 
‘‘(g) DEFINITION.—For purposes of this section the 
term ‘biosurveillance’ means the process of gathering near 
real-time biological data that relates to human and zoonotic 
disease activity and threats to human or animal health, in 
order to achieve early warning and identification of such 
health threats, early detection and prompt ongoing tracking 
of health events, and overall situational awareness of disease 
activity.’’. 
(b) TECHNICAL AND CONFORMING AMENDMENT.—Sec-
tion 319C–1(b)(2)(D) of the Public Health Service Act (42
† HR 307 EAS 
U.S.C. 247d–3a(b)(2)(D)) is amended by striking ‘‘section 
319D(d)(3)’’ and inserting ‘‘section 319D(c)(3)’’. 
SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 
REPORTS. 
Section 5 of the Project Bioshield Act of 2004 (42 
U.S.C. 247d–6c) is repealed. 
TITLE III—ENHANCING MEDICAL 
COUNTERMEASURE REVIEW 
SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 
Section 505(b)(5)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by strik-
ing ‘‘size of clinical trials intended’’ and all that follows 
through ‘‘. The sponsor or applicant’’ and inserting the fol-
lowing: ‘‘size— 
‘‘(i)(I) of clinical trials intended to form the pri-
mary basis of an effectiveness claim; or 
‘‘(II) in the case where human efficacy studies 
are not ethical or feasible, of animal and any associ-
ated clinical trials which, in combination, are in-
tended to form the primary basis of an effectiveness 
claim; or 
‘‘(ii) with respect to an application for approval 
of a biological product under section 351(k) of the 
Public Health Service Act, of any necessary clinical 
study or studies.
† HR 307 EAS 
The sponsor or applicant’’. 
SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 
USE IN EMERGENCIES. 
(a) IN GENERAL.—Section 564 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend-
ed— 
(1) in subsection (a)— 
(A) in paragraph (1), by striking ‘‘sections 
505, 510(k), and 515 of this Act’’ and inserting 
‘‘any provision of this Act’’; 
(B) in paragraph (2)(A), by striking 
‘‘under a provision of law referred to in such 
paragraph’’ and inserting ‘‘under section 505, 
510(k), or 515 of this Act or section 351 of the 
Public Health Service Act’’; and 
(C) in paragraph (3), by striking ‘‘a provi-
sion of law referred to in such paragraph’’ and 
inserting ‘‘a section of this Act or the Public 
Health Service Act referred to in paragraph 
(2)(A)’’; 
(2) in subsection (b)— 
(A) in the subsection heading, by striking 
‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR 
THREAT JUSTIFYING EMERGENCY AUTHORIZED 
USE’’;
† HR 307 EAS 
(B) in paragraph (1)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘may declare an 
emergency’’ and inserting ‘‘may make a 
declaration that the circumstances exist’’; 
(ii) in subparagraph (A), by striking 
‘‘specified’’; 
(iii) in subparagraph (B)— 
(I) by striking ‘‘specified’’; and 
(II) by striking ‘‘; or’’ and insert-
ing a semicolon; 
(iv) by amending subparagraph (C) to 
read as follows: 
‘‘(C) a determination by the Secretary that 
there is a public health emergency, or a signifi-
cant potential for a public health emergency, 
that affects, or has a significant potential to af-
fect, national security or the health and security 
of United States citizens living abroad, and that 
involves a biological, chemical, radiological, or 
nuclear agent or agents, or a disease or condition 
that may be attributable to such agent or agents; 
or’’; and 
(v) by adding at the end the following:
† HR 307 EAS 
‘‘(D) the identification of a material threat 
pursuant to section 319F–2 of the Public Health 
Service Act sufficient to affect national security 
or the health and security of United States citi-
zens living abroad.’’; 
(C) in paragraph (2)— 
(i) in subparagraph (A), by amending 
clause (ii) to read as follows: 
‘‘(ii) a change in the approval status of 
the product such that the circumstances de-
scribed in subsection (a)(2) have ceased to 
exist.’’; 
(ii) by striking subparagraph (B); and 
(iii) by redesignating subparagraph 
(C) as subparagraph (B); 
(D) in paragraph (4), by striking ‘‘advance 
notice of termination, and renewal under this 
subsection.’’ and inserting ‘‘, and advance notice 
of termination under this subsection.’’; and 
(E) by adding at the end the following: 
‘‘(5) EXPLANATION BY SECRETARY.—If an au-
thorization under this section with respect to an un-
approved product or an unapproved use of an ap-
proved product has been in effect for more than 1 
year, the Secretary shall provide in writing to the
† HR 307 EAS 
sponsor of such product an explanation of the sci-
entific, regulatory, or other obstacles to approval, li-
censure, or clearance of such product or use, including 
specific actions to be taken by the Secretary and the 
sponsor to overcome such obstacles.’’; 
(3) in subsection (c)— 
(A) in the matter preceding paragraph 
(1)— 
(i) by inserting ‘‘the Assistant Sec-
retary for Preparedness and Response,’’ 
after ‘‘consultation with’’; 
(ii) by striking ‘‘Health and’’ and in-
serting ‘‘Health, and’’; and 
(iii) by striking ‘‘circumstances of the 
emergency involved’’ and inserting ‘‘appli-
cable circumstances described in subsection 
(b)(1)’’; 
(B) in paragraph (1), by striking ‘‘speci-
fied’’ and inserting ‘‘referred to’’; and 
(C) in paragraph (2)(B), by inserting ‘‘, 
taking into consideration the material threat 
posed by the agent or agents identified in a dec-
laration under subsection (b)(1)(D), if applica-
ble’’ after ‘‘risks of the product’’;
† HR 307 EAS 
(4) in subsection (d)(3), by inserting ‘‘, to the ex-
tent practicable given the circumstances of the emer-
gency,’’ after ‘‘including’’; 
(5) in subsection (e)— 
(A) in paragraph (1)(A), by striking ‘‘cir-
cumstances of the emergency’’ and inserting ‘‘ap-
plicable circumstances described in subsection 
(b)(1)’’; 
(B) in paragraph (1)(B), by amending 
clause (iii) to read as follows: 
‘‘(iii) Appropriate conditions with re-
spect to collection and analysis of informa-
tion concerning the safety and effectiveness 
of the product with respect to the use of such 
product during the period when the author-
ization is in effect and a reasonable time 
following such period.’’; 
(C) in paragraph (2)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘manufacturer of 
the product’’ and inserting ‘‘person’’; 
(II) by striking ‘‘circumstances of 
the emergency’’ and inserting ‘‘appli-
cable circumstances described in sub-
section (b)(1)’’; and
† HR 307 EAS 
(III) by inserting at the end be-
fore the period ‘‘or in paragraph 
(1)(B)’’; 
(ii) in subparagraph (B)(i), by insert-
ing before the period at the end ‘‘, except as 
provided in section 564A with respect to au-
thorized changes to the product expiration 
date’’; and 
(iii) by amending subparagraph (C) to 
read as follows: 
‘‘(C) In establishing conditions under this 
paragraph with respect to the distribution and 
administration of the product for the unap-
proved use, the Secretary shall not impose condi-
tions that would restrict distribution or adminis-
tration of the product when distributed or ad-
ministered for the approved use.’’; and 
(D) by amending paragraph (3) to read as 
follows: 
‘‘(3) GOOD
MANUFACTURING
PRACTICE; PRE-
SCRIPTION.—With respect to the emergency use of a 
product for which an authorization under this section 
is issued (whether an unapproved product or an un-
approved use of an approved product), the Secretary 
may waive or limit, to the extent appropriate given
† HR 307 EAS 
the applicable circumstances described in subsection 
(b)(1)— 
‘‘(A) requirements regarding current good 
manufacturing practice otherwise applicable to 
the manufacture, processing, packing, or holding 
of products subject to regulation under this Act, 
including such requirements established under 
section 501 or 520(f)(1), and including relevant 
conditions prescribed with respect to the product 
by an order under section 520(f)(2); 
‘‘(B) requirements established under section 
503(b); and 
‘‘(C) requirements established under section 
520(e).’’; 
(6) in subsection (g)— 
(A) in the subsection heading, by inserting 
‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 
(B) in paragraph (1), by inserting after the 
period at the end the following: ‘‘As part of such 
review, the Secretary shall regularly review the 
progress made with respect to the approval, li-
censure, or clearance of— 
‘‘(A) an unapproved product for which an 
authorization was issued under this section; or
† HR 307 EAS 
‘‘(B) an unapproved use of an approved 
product for which an authorization was issued 
under this section.’’; and 
(C) by amending paragraph (2) to read as 
follows: 
‘‘(2) REVISION AND REVOCATION.—The Secretary 
may revise or revoke an authorization under this sec-
tion if— 
‘‘(A) the circumstances described under sub-
section (b)(1) no longer exist; 
‘‘(B) the criteria under subsection (c) for 
issuance of such authorization are no longer met; 
or 
‘‘(C) other circumstances make such revision 
or revocation appropriate to protect the public 
health or safety.’’; 
(7) in subsection (h)(1), by adding after the pe-
riod at the end the following: ‘‘The Secretary shall 
make any revisions to an authorization under this 
section available on the Internet Web site of the Food 
and Drug Administration.’’; 
(8) by adding at the end of subsection (j) the fol-
lowing: 
‘‘(4) Nothing in this section shall be construed as 
authorizing a delay in the review or other consider-
† HR 307 EAS 
ation by the Secretary of any application or submis-
sion pending before the Food and Drug Administra-
tion for a product for which an authorization under 
this section is issued.’’; and 
(9) by adding at the end the following: 
‘‘(m) CATEGORIZATION OF LABORATORY TESTS ASSO-
CIATED WITH DEVICES SUBJECT TO AUTHORIZATION.— 
‘‘(1) IN GENERAL.—In issuing an authorization 
under this section with respect to a device, the Sec-
retary may, subject to the provisions of this section, 
determine that a laboratory examination or procedure 
associated with such device shall be deemed, for pur-
poses of section 353 of the Public Health Service Act, 
to be in a particular category of examinations and 
procedures (including the category described by sub-
section (d)(3) of such section) if, based on the totality 
of scientific evidence available to the Secretary— 
‘‘(A) such categorization would be beneficial 
to protecting the public health; and 
‘‘(B) the known and potential benefits of 
such categorization under the circumstances of 
the authorization outweigh the known and poten-
tial risks of the categorization. 
‘‘(2) CONDITIONS OF DETERMINATION.—The Sec-
retary may establish appropriate conditions on the
† HR 307 EAS 
performance of the examination or procedure pursu-
ant to such determination. 
‘‘(3) 
EFFECTIVE
PERIOD.—A 
determination 
under this subsection shall be effective for purposes of 
section 353 of the Public Health Service Act notwith-
standing any other provision of that section during 
the effective period of the relevant declaration under 
subsection (b).’’. 
(b) EMERGENCY USE OF MEDICAL PRODUCTS.—Sub-
chapter E of chapter V of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb et seq.) is amended by insert-
ing after section 564 the following: 
‘‘SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ELIGIBLE
PRODUCT.—The term ‘eligible 
product’ means a product that— 
‘‘(A) is approved or cleared under this 
chapter or licensed under section 351 of the Pub-
lic Health Service Act; 
‘‘(B)(i) is intended for use to prevent, diag-
nose, or treat a disease or condition involving a 
biological, chemical, radiological, or nuclear 
agent or agents; or 
‘‘(ii) is intended for use to prevent, diag-
nose, or treat a serious or life-threatening disease
† HR 307 EAS 
or condition caused by a product described in 
clause (i); and 
‘‘(C) is intended for use during the cir-
cumstances under which— 
‘‘(i) a determination described in sub-
paragraph (A), (B), or (C) of section 
564(b)(1) has been made by the Secretary of 
Homeland Security, the Secretary of De-
fense, or the Secretary, respectively; or 
‘‘(ii) the identification of a material 
threat described in subparagraph (D) of sec-
tion 564(b)(1) has been made pursuant to 
section 319F–2 of the Public Health Service 
Act. 
‘‘(2) PRODUCT.—The term ‘product’ means a 
drug, device, or biological product. 
‘‘(b) EXPIRATION DATING.— 
‘‘(1) IN GENERAL.—The Secretary may extend 
the expiration date and authorize the introduction or 
delivery for introduction into interstate commerce of 
an eligible product after the expiration date provided 
by the manufacturer if— 
‘‘(A) the expiration date extension is in-
tended to support the United States ability to 
protect—
† HR 307 EAS 
‘‘(i) the public health; or 
‘‘(ii) military preparedness and effec-
tiveness; and 
‘‘(B) the expiration date extension is sup-
ported by an appropriate scientific evaluation 
that is conducted or accepted by the Secretary. 
‘‘(2) REQUIREMENTS AND CONDITIONS.—Any ex-
tension of an expiration date under paragraph (1) 
shall, as part of the extension, identify— 
‘‘(A) each specific lot, batch, or other unit 
of the product for which extended expiration is 
authorized; 
‘‘(B) the duration of the extension; and 
‘‘(C) any other requirements or conditions 
as the Secretary may deem appropriate for the 
protection of the public health, which may in-
clude requirements for, or conditions on, product 
sampling, storage, packaging or repackaging, 
transport, labeling, notice to product recipients, 
recordkeeping, periodic testing or retesting, or 
product disposition. 
‘‘(3) EFFECT.—Notwithstanding any other pro-
vision of this Act or the Public Health Service Act, 
an eligible product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A))
† HR 307 EAS 
and shall not be deemed adulterated or misbranded 
under this Act because, with respect to such product, 
the Secretary has, under paragraph (1), extended the 
expiration date and authorized the introduction or 
delivery for introduction into interstate commerce of 
such product after the expiration date provided by the 
manufacturer. 
‘‘(4) EXPIRATION DATE.—For purposes of this 
subsection, the term ‘expiration date’ means the date 
established through appropriate stability testing re-
quired by the regulations issued by the Secretary to 
ensure that the product meets applicable standards of 
identity, strength, quality, and purity at the time of 
use. 
‘‘(c) CURRENT GOOD MANUFACTURING PRACTICE.— 
‘‘(1) IN GENERAL.—The Secretary may, when 
the circumstances of a domestic, military, or public 
health emergency or material threat described in sub-
section (a)(1)(C) so warrant, authorize, with respect 
to an eligible product, deviations from current good 
manufacturing practice requirements otherwise appli-
cable to the manufacture, processing, packing, or 
holding of products subject to regulation under this 
Act, including requirements under section 501 or 
520(f)(1) or applicable conditions prescribed with re-
† HR 307 EAS 
spect to the eligible product by an order under section 
520(f)(2). 
‘‘(2) EFFECT.—Notwithstanding any other pro-
vision of this Act or the Public Health Service Act, 
an eligible product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A)) 
and shall not be deemed adulterated or misbranded 
under this Act because, with respect to such product, 
the Secretary has authorized deviations from current 
good manufacturing practices under paragraph (1). 
‘‘(d) EMERGENCY DISPENSING.—The requirements of 
sections 503(b) and 520(e) shall not apply to an eligible 
product, and the product shall not be considered an unap-
proved product (as defined in section 564(a)(2)(A)) and 
shall not be deemed adulterated or misbranded under this 
Act because it is dispensed without an individual prescrip-
tion, if— 
‘‘(1) the product is dispensed during the cir-
cumstances described in subsection (a)(1)(C); and 
‘‘(2) such dispensing without an individual pre-
scription occurs— 
‘‘(A) as permitted under the law of the 
State in which the product is dispensed; or 
‘‘(B) in accordance with an order issued by 
the Secretary, for the purposes and duration of
† HR 307 EAS 
the 
circumstances 
described 
in 
subsection 
(a)(1)(C). 
‘‘(e) EMERGENCY USE INSTRUCTIONS.— 
‘‘(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through an appropriate official within the Depart-
ment of Health and Human Services, may create and 
issue emergency use instructions to inform health care 
providers or individuals to whom an eligible product 
is to be administered concerning such product’s ap-
proved, licensed, or cleared conditions of use. 
‘‘(2) EFFECT.—Notwithstanding any other pro-
visions of this Act or the Public Health Service Act, 
a product shall not be considered an unapproved 
product and shall not be deemed adulterated or mis-
branded under this Act because of the issuance of 
emergency use instructions under paragraph (1) with 
respect to such product or the introduction or delivery 
for introduction of such product into interstate com-
merce accompanied by such instructions— 
‘‘(A) during an emergency response to an 
actual emergency that is the basis for a deter-
mination described in subsection (a)(1)(C)(i); or 
‘‘(B) by a government entity (including a 
Federal, State, local, or tribal government enti-
ty), or a person acting on behalf of such a gov-
† HR 307 EAS 
ernment entity, in preparation for an emergency 
response.’’. 
(c) RISK EVALUATION
AND MITIGATION STRATE-
GIES.—Section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1), is amended— 
(1) in subsection (f), by striking paragraph (7); 
and 
(2) by adding at the end the following: 
‘‘(k) WAIVER IN PUBLIC HEALTH EMERGENCIES.— 
The Secretary may waive any requirement of this section 
with respect to a qualified countermeasure (as defined in 
section 319F–1(a)(2) of the Public Health Service Act) to 
which a requirement under this section has been applied, 
if the Secretary determines that such waiver is required to 
mitigate the effects of, or reduce the severity of, the cir-
cumstances under which— 
‘‘(1) a determination described in subparagraph 
(A), (B), or (C) of section 564(b)(1) has been made 
by the Secretary of Homeland Security, the Secretary 
of Defense, or the Secretary, respectively; or 
‘‘(2) the identification of a material threat de-
scribed in subparagraph (D) of section 564(b)(1) has 
been made pursuant to section 319F–2 of the Public 
Health Service Act.’’.
† HR 307 EAS 
(d) PRODUCTS HELD FOR EMERGENCY USE.—The 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) is amended by inserting after section 564A, as added 
by subsection (b), the following: 
‘‘SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE. 
‘‘It is not a violation of any section of this Act or of 
the Public Health Service Act for a government entity (in-
cluding a Federal, State, local, or tribal government entity), 
or a person acting on behalf of such a government entity, 
to introduce into interstate commerce a product (as defined 
in section 564(a)(4)) intended for emergency use, if that 
product— 
‘‘(1) is intended to be held and not used; and 
‘‘(2) is held and not used, unless and until that 
product— 
‘‘(A) is approved, cleared, or licensed under 
section 505, 510(k), or 515 of this Act or section 
351 of the Public Health Service Act; 
‘‘(B) is authorized for investigational use 
under section 505 or 520 of this Act or section 
351 of the Public Health Service Act; or 
‘‘(C) is authorized for use under section 
564.’’.
† HR 307 EAS 
SEC. 303. DEFINITIONS. 
Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The Sec-
retary, in consultation’’ and inserting the following: 
‘‘(a) DEFINITIONS.—In this section— 
‘‘(1) the term ‘countermeasure’ means a qualified 
countermeasure, a security countermeasure, and a 
qualified pandemic or epidemic product; 
‘‘(2) the term ‘qualified countermeasure’ has the 
meaning given such term in section 319F–1 of the 
Public Health Service Act; 
‘‘(3) the term ‘security countermeasure’ has the 
meaning given such term in section 319F–2 of such 
Act; and 
‘‘(4) the term ‘qualified pandemic or epidemic 
product’ means a product that meets the definition 
given such term in section 319F–3 of the Public 
Health Service Act and— 
‘‘(A) that has been identified by the Depart-
ment of Health and Human Services or the De-
partment of Defense as receiving funding directly 
related to addressing chemical, biological, radio-
logical, or nuclear threats, including pandemic 
influenza; or 
‘‘(B) is included under this paragraph pur-
suant to a determination by the Secretary.
† HR 307 EAS 
‘‘(b) GENERAL DUTIES.—The Secretary, in consulta-
tion’’. 
SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVI-
TIES. 
Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–4), as amended by section 303, is 
further amended— 
(1) in the section heading, by striking ‘‘TECH-
NICAL
ASSISTANCE’’ and inserting ‘‘COUNTER-
MEASURE DEVELOPMENT, REVIEW, AND TECH-
NICAL ASSISTANCE’’; 
(2) in subsection (b), by striking the subsection 
enumerator and all that follows through ‘‘shall estab-
lish’’ and inserting the following: 
‘‘(b) GENERAL DUTIES.—In order to accelerate the de-
velopment, stockpiling, approval, licensure, and clearance 
of qualified countermeasures, security countermeasures, and 
qualified pandemic or epidemic products, the Secretary, in 
consultation with the Assistant Secretary for Preparedness 
and Response, shall— 
‘‘(1) ensure the appropriate involvement of Food 
and Drug Administration personnel in interagency 
activities related to countermeasure advanced research 
and development, consistent with sections 319F,
† HR 307 EAS 
319F–1, 319F–2, 319F–3, 319L, and 2811 of the 
Public Health Service Act; 
‘‘(2) ensure the appropriate involvement and 
consultation of Food and Drug Administration per-
sonnel in any flexible manufacturing activities car-
ried out under section 319L of the Public Health 
Service Act, including with respect to meeting regu-
latory requirements set forth in this Act; 
‘‘(3) promote countermeasure expertise within 
the Food and Drug Administration by— 
‘‘(A) ensuring that Food and Drug Admin-
istration personnel involved in reviewing coun-
termeasures for approval, licensure, or clearance 
are informed by the Assistant Secretary for Pre-
paredness and Response on the material threat 
assessment conducted under section 319F–2 of 
the Public Health Service Act for the agent or 
agents for which the countermeasure under re-
view is intended; 
‘‘(B) training Food and Drug Administra-
tion personnel regarding review of counter-
measures for approval, licensure, or clearance; 
‘‘(C) holding public meetings at least twice 
annually to encourage the exchange of scientific 
ideas; and
† HR 307 EAS 
‘‘(ii) with respect to the development of 
countermeasures for populations with spe-
cial clinical needs, including children and 
pregnant women, in order to meet the needs 
of such populations, as necessary and ap-
propriate; and 
‘‘(5) establish’’; and 
(3) by adding at the end the following: 
‘‘(c) FINAL GUIDANCE ON DEVELOPMENT OF ANIMAL 
MODELS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of the Pandemic and All- 
Hazards Preparedness Reauthorization Act of 2013, 
the Secretary shall provide final guidance to industry 
regarding the development of animal models to sup-
port approval, clearance, or licensure of counter-
measures referred to in subsection (a) when human ef-
ficacy studies are not ethical or feasible. 
‘‘(2) AUTHORITY
TO
EXTEND
DEADLINE.—The 
Secretary may extend the deadline for providing final 
guidance under paragraph (1) by not more than 6 
months upon submission by the Secretary of a report 
on the status of such guidance to the Committee on 
Energy and Commerce of the House of Representa-
† HR 307 EAS 
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
‘‘(d) DEVELOPMENT AND ANIMAL MODELING PROCE-
DURES.— 
‘‘(1) AVAILABILITY
OF
ANIMAL
MODEL
MEET-
INGS.—To facilitate the timely development of animal 
models and support the development, stockpiling, li-
censure, approval, and clearance of countermeasures, 
the Secretary shall, not later than 180 days after the 
enactment of this subsection, establish a procedure by 
which a sponsor or applicant that is developing a 
countermeasure for which human efficacy studies are 
not ethical or practicable, and that has an approved 
investigational new drug application or investiga-
tional device exemption, may request and receive— 
‘‘(A) a meeting to discuss proposed animal 
model development activities; and 
‘‘(B) a meeting prior to initiating pivotal 
animal studies. 
‘‘(2) PEDIATRIC MODELS.—To facilitate the de-
velopment and selection of animal models that could 
translate to pediatric studies, any meeting conducted 
under paragraph (1) shall include discussion of ani-
mal models for pediatric populations, as appropriate.
† HR 307 EAS 
‘‘(e) 
REVIEW
AND
APPROVAL
OF
COUNTER-
MEASURES.— 
‘‘(1) MATERIAL THREAT.—When evaluating an 
application or submission for approval, licensure, or 
clearance of a countermeasure, the Secretary shall 
take into account the material threat posed by the 
chemical, biological, radiological, or nuclear agent or 
agents identified under section 319F–2 of the Public 
Health Service Act for which the countermeasure 
under review is intended. 
‘‘(2) REVIEW
EXPERTISE.—When practicable 
and appropriate, teams of Food and Drug Adminis-
tration personnel reviewing applications or submis-
sions described under paragraph (1) shall include a 
reviewer with sufficient training or experience with 
countermeasures pursuant to the protocols established 
under subsection (b)(3)(D).’’. 
SEC. 305. REGULATORY MANAGEMENT PLANS. 
Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–4), as amended by section 304, is 
further amended by adding at the end the following: 
‘‘(f) REGULATORY MANAGEMENT PLAN.— 
‘‘(1) DEFINITION.—In this subsection, the term 
‘eligible countermeasure’ means—
† HR 307 EAS 
‘‘(A) a security countermeasure with respect 
to which the Secretary has entered into a pro-
curement contract under section 319F–2(c) of the 
Public Health Service Act; or 
‘‘(B) a countermeasure with respect to 
which the Biomedical Advanced Research and 
Development Authority has provided funding 
under section 319L of the Public Health Service 
Act for advanced research and development. 
‘‘(2) REGULATORY
MANAGEMENT
PLAN
PROC-
ESS.—The Secretary, in consultation with the Assist-
ant Secretary for Preparedness and Response and the 
Director of the Biomedical Advanced Research and 
Development Authority, shall establish a formal proc-
ess for obtaining scientific feedback and interactions 
regarding the development and regulatory review of 
eligible countermeasures by facilitating the develop-
ment of written regulatory management plans in ac-
cordance with this subsection. 
‘‘(3) SUBMISSION OF REQUEST AND PROPOSED 
PLAN BY SPONSOR OR APPLICANT.— 
‘‘(A) IN GENERAL.—A sponsor or applicant 
of an eligible countermeasure may initiate the 
process described under paragraph (2) upon sub-
mission of a written request to the Secretary.
† HR 307 EAS 
Such request shall include a proposed regulatory 
management plan. 
‘‘(B) TIMING OF SUBMISSION.—A sponsor 
or applicant may submit a written request 
under subparagraph (A) after the eligible coun-
termeasure has an investigational new drug or 
investigational device exemption in effect. 
‘‘(C) RESPONSE BY SECRETARY.—The Sec-
retary shall direct the Food and Drug Adminis-
tration, upon submission of a written request by 
a sponsor or applicant under subparagraph (A), 
to work with the sponsor or applicant to agree 
on a regulatory management plan within a rea-
sonable time not to exceed 90 days. If the Sec-
retary determines that no plan can be agreed 
upon, the Secretary shall provide to the sponsor 
or applicant, in writing, the scientific or regu-
latory rationale why such agreement cannot be 
reached. 
‘‘(4) PLAN.—The content of a regulatory man-
agement plan agreed to by the Secretary and a spon-
sor or applicant shall include— 
‘‘(A) an agreement between the Secretary 
and the sponsor or applicant regarding develop-
† HR 307 EAS 
mental milestones that will trigger responses by 
the Secretary as described in subparagraph (B); 
‘‘(B) performance targets and goals for 
timely and appropriate responses by the Sec-
retary to the triggers described under subpara-
graph (A), including meetings between the Sec-
retary and the sponsor or applicant, written 
feedback, decisions by the Secretary, and other 
activities carried out as part of the development 
and review process; and 
‘‘(C) an agreement on how the plan shall be 
modified, if needed. 
‘‘(5) MILESTONES
AND
PERFORMANCE
TAR-
GETS.—The developmental milestones described in 
paragraph (4)(A) and the performance targets and 
goals described in paragraph (4)(B) shall include— 
‘‘(A) feedback from the Secretary regarding 
the data required to support the approval, clear-
ance, or licensure of the eligible countermeasure 
involved; 
‘‘(B) feedback from the Secretary regarding 
the data necessary to inform any authorization 
under section 564; 
‘‘(C) feedback from the Secretary regarding 
the data necessary to support the positioning
† HR 307 EAS 
and delivery of the eligible countermeasure, in-
cluding to the Strategic National Stockpile; 
‘‘(D) feedback from the Secretary regarding 
the data necessary to support the submission of 
protocols for review under section 505(b)(5)(B); 
‘‘(E) feedback from the Secretary regarding 
any gaps in scientific knowledge that will need 
resolution prior to approval, licensure, or clear-
ance of the eligible countermeasure and plans for 
conducting the necessary scientific research; 
‘‘(F) identification of the population for 
which the countermeasure sponsor or applicant 
seeks approval, licensure, or clearance and the 
population for which desired labeling would not 
be appropriate, if known; and 
‘‘(G) as necessary and appropriate, and to 
the extent practicable, a plan for demonstrating 
safety and effectiveness in pediatric populations, 
and for developing pediatric dosing, formulation, 
and administration with respect to the eligible 
countermeasure, provided that such plan would 
not delay authorization under section 564, ap-
proval, licensure, or clearance for adults. 
‘‘(6) PRIORITIZATION.—
† HR 307 EAS 
‘‘(g) ANNUAL REPORT.—Not later than 180 days after 
the date of enactment of this subsection, and annually there-
after, the Secretary shall make publicly available on the 
Web site of the Food and Drug Administration a report 
that details the countermeasure development and review ac-
tivities of the Food and Drug Administration, including— 
‘‘(1) with respect to the development of new tools, 
standards, and approaches to assess and evaluate 
countermeasures— 
‘‘(A) the identification of the priorities of 
the Food and Drug Administration and the 
progress made on such priorities; and 
‘‘(B) the identification of scientific gaps 
that impede the development, approval, licensure, 
or clearance of countermeasures for populations 
with special clinical needs, including children 
and pregnant women, and the progress made on 
resolving these challenges; 
‘‘(2) with respect to countermeasures for which a 
regulatory management plan has been agreed upon 
under subsection (f), the extent to which the perform-
ance targets and goals set forth in subsection (f)(4)(B) 
and the regulatory management plan have been met, 
including, for each such countermeasure—
† HR 307 EAS 
‘‘(A) whether the regulatory management 
plan was completed within the required time-
frame, and the length of time taken to complete 
such plan; 
‘‘(B) whether the Secretary adhered to the 
timely and appropriate response times set forth 
in such plan; and 
‘‘(C) explanations for any failure to meet 
such performance targets and goals; 
‘‘(3) the number of regulatory teams established 
pursuant to subsection (b)(4), the number of products, 
classes of products, or technologies assigned to each 
such team, and the number of, type of, and any 
progress made as a result of consultations carried out 
under subsection (b)(4)(A); 
‘‘(4) an estimate of resources obligated to coun-
termeasure development and regulatory assessment, 
including— 
‘‘(A) Center-specific objectives and accom-
plishments; and 
‘‘(B) the number of full-time equivalent em-
ployees of the Food and Drug Administration 
who directly support the review of counter-
measures;
† HR 307 EAS 
‘‘(5) the number of countermeasure applications 
and submissions submitted, the number of counter-
measures approved, licensed, or cleared, the status of 
remaining submitted applications and submissions, 
and the number of each type of authorization issued 
pursuant to section 564; 
‘‘(6) the number of written requests for a regu-
latory management plan submitted under subsection 
(f)(3)(A), the number of regulatory management plans 
developed, and the number of such plans developed for 
security countermeasures; and 
‘‘(7) the number, type, and frequency of meetings 
between the Food and Drug Administration and— 
‘‘(A) sponsors of a countermeasure as de-
fined in subsection (a); or 
‘‘(B) another agency engaged in develop-
ment or management of portfolios for such coun-
termeasures, including the Centers for Disease 
Control and Prevention, the Biomedical Ad-
vanced Research and Development Authority, the 
National Institutes of Health, and the appro-
priate agencies of the Department of Defense.’’.
† HR 307 EAS 
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 secu-
rity countermeasure (as defined in section 319F–2 of 
the Public Health Service Act), or a qualified pan-
demic or epidemic product (as defined in section 
319F–3 of the Public Health Service Act), the Sec-
retary shall solicit input from the Assistant Secretary 
for Preparedness and Response regarding the need for 
and, from the Director of the Biomedical Advanced 
Research and Development Authority regarding 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 counter-
measure (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-
demic or epidemic product (as defined in section
† HR 307 EAS 
319F–3 of such Act), in addition to any action 
with respect to such drug under subparagraph 
(A) or (B), the Secretary shall notify the Assist-
ant Secretary for Preparedness and Response 
and the Director of the Biomedical Advanced Re-
search and Development Authority of all pedi-
atric studies in the written request issued by the 
Commissioner of Food and Drugs.’’. 
(b) ADDITION TO PRIORITY LIST CONSIDERATIONS.— 
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 pharmacology, 
pharmacogenetic determinants of drug re-
sponse, metabolism of drugs and biologics in 
children, and pediatric clinical trials; 
‘‘(ii) particular pediatric diseases, dis-
orders or conditions where more complete 
knowledge and testing of therapeutics, in-
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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 epi-
demic 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 sub-
section (a)’’. 
(c) ADVICE AND RECOMMENDATIONS OF THE PEDI-
ATRIC
ADVISORY
COMMITTEE
REGARDING
COUNTER-
MEASURES
FOR
PEDIATRIC
POPULATIONS.—Subsection 
(b)(2) of section 14 of the Best Pharmaceuticals for Children 
Act (42 U.S.C. 284m note) is amended—
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(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 popu-
lations.’’. 
TITLE IV—ACCELERATING MED-
ICAL COUNTERMEASURE AD-
VANCED RESEARCH AND DE-
VELOPMENT 
SEC. 401. BIOSHIELD. 
(a) PROCUREMENT OF COUNTERMEASURES.—Section 
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 para-
graph (10))’’ and inserting ‘‘the appropriate commit-
tees of Congress’’; 
(3) in paragraph (5)(B)(ii), by striking ‘‘eight 
years’’ and inserting ‘‘10 years’’; 
(4) in subparagraph (C) of paragraph (6)—
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(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 
for the countermeasure to be 
developed and procured;
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‘‘(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 
countermeasure needs, including with re-
spect to reimbursement of the cost of ad-
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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 (re-
lating to the Biomedical Advanced Research and De-
velopment Authority), $2,800,000,000 for the period 
of fiscal years 2014 through 2018. Amounts appro-
priated pursuant to the preceding sentence are au-
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thorized 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 Au-
thority). Amounts authorized to be appropriated 
under this subsection to carry out section 319L are in 
addition to amounts otherwise authorized to be ap-
propriated 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 Sec-
retary to a vendor for advanced development (under 
section 319L) or for procurement of a security coun-
termeasure 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 Sec-
retary shall submit to the appropriate committees of 
Congress a report detailing the amount of such funds
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available for procurement and the impact such reduc-
tion in funding will have— 
‘‘(A) in meeting the security countermeasure 
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 account, 
any appropriation made available pursuant to sec-
tion 521(a) of the Homeland Security Act of 2002, 
and any appropriation made available pursuant 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 amended— 
(1) in subparagraph (B)(iii), by inserting 
‘‘(which may include advanced research and develop-
ment for purposes of fulfilling requirements under the
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Federal Food, Drug, and Cosmetic Act or section 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 following: 
‘‘(G) GOVERNMENT
PURPOSE.—In award-
ing contracts, grants, and cooperative agreements 
under this section, the Secretary shall provide a 
clear statement of defined Government purpose 
related to activities included in subsection 
(a)(6)(B) for a qualified countermeasure 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 2014 
through 2018, such amounts to remain available until 
expended.’’.
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(d) CONTINUED INAPPLICABILITY OF CERTAIN PROVI-
SIONS.—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 ‘‘12 years’’. 
(e) EXTENSION
OF
LIMITED
ANTITRUST
EXEMP-
TION.— 
(1) IN GENERAL.—Section 405(b) of the Pan-
demic and All-Hazards Preparedness Act (42 U.S.C. 
247d–6a note) is amended by striking ‘‘6-year’’ and 
inserting ‘‘12-year’’. 
(2) EFFECTIVE DATE.—This subsection shall take 
effect as if enacted on December 17, 2012. 
(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 Comptroller 
General of the United States shall submit to the ap-
† HR 307 EAS 
propriate committees of Congress a report concerning 
the results of the evaluation conducted under para-
graph (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 ca-
pacity needs presented by novel and emerg-
ing threats, including chemical, biological, 
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— 
(A) in the matter preceding clause (i), by 
striking ‘‘to—’’ and inserting ‘‘—’’;
† HR 307 EAS 
(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 described 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 
(C) by adding at the end the following:
† HR 307 EAS 
‘‘(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 following: 
‘‘and shall submit such review annually to 
the appropriate congressional committees of 
jurisdiction to the extent that disclosure of
† HR 307 EAS 
such information does not compromise na-
tional security’’; and 
(B) in paragraph (2)(D), by inserting be-
fore the semicolon at the end the following: ‘‘and 
that the potential depletion of countermeasures 
currently in the stockpile is identified and ap-
propriately addressed, including through nec-
essary 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 2014 through 2018. Such authorization is 
in addition to amounts in the special reserve fund re-
ferred 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;
† HR 307 EAS 
(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 offi-
cial.’’; 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 Con-
gress.’’. 
Attest: 
Secretary.