IB 
Union Calendar No. 189 
112TH CONGRESS 
1ST SESSION H. R. 2405 
[Report No. 112–286] 
To reauthorize certain provisions of the Public Health Service Act and the 
Federal Food, Drug, and Cosmetic Act relating to public health prepared-
ness and countermeasure development, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 28, 2011 
Mr. ROGERS of Michigan (for himself, Mrs. MYRICK, and Mr. GENE GREEN 
of Texas) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
NOVEMBER 16, 2011 
Additional sponsors: Mr. BURGESS and Ms. ESHOO 
NOVEMBER 16, 2011 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on June 28, 2011] 
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A BILL 
To reauthorize certain provisions of the Public Health Serv-
ice Act and the Federal Food, Drug, and Cosmetic Act 
relating to public health preparedness and counter-
measure development, and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Pandemic and All-Hazards Preparedness Reauthorization 
Act of 2011’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Reauthorization of certain provisions relating to public health prepared-
ness. 
Sec. 3. Temporary redeployment of personnel during a public health emergency. 
Sec. 4. Coordination by Assistant Secretary for Preparedness and Response. 
Sec. 5. Eliminating duplicative Project Bioshield reports. 
Sec. 6. Authorization for medical products for use in emergencies. 
Sec. 7. Additional provisions related to medical products for emergency use. 
Sec. 8. Products held for emergency use. 
Sec. 9. Accelerate countermeasure development by strengthening FDA’s role in re-
viewing products for national security priorities. 
SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RE-
LATING TO PUBLIC HEALTH PREPAREDNESS. 
(a) VACCINE TRACKING
AND DISTRIBUTION.—Sub-
section (e) of section 319A of the Public Health Service Act 
(42 U.S.C. 247d–1) is amended by striking ‘‘such sums for 
each of fiscal years 2007 through 2011’’ and inserting 
‘‘$30,800,000 for each of fiscal years 2012 through 2016’’. 
(b) IMPROVING STATE AND LOCAL PUBLIC HEALTH 
SECURITY.—Effective on October 1, 2011, section 319C–1 
of the Public Health Service Act (42 U.S.C. 247d–3a) is 
amended— 
(1) in subsection (b)(2)(A)— 
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(A) in clause (iv), by striking ‘‘and’’ at the 
end; 
(B) in clause (v), by adding ‘‘and’’ at the 
end; and 
(C) by adding at the end the following: 
‘‘(vi) 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;’’; 
(2) in subsection (f)— 
(A) in paragraph (2), by inserting ‘‘and’’ at 
the end; 
(B) in paragraph (3), by striking ‘‘; and’’ 
and inserting a period; and 
(C) by striking paragraph (4); 
(3) by striking subsection (h); and 
(4) in subsection (i)— 
(A) in paragraph (1)— 
(i) by amending subparagraph (A) to 
read as follows: 
‘‘(A) IN GENERAL.—For the purpose of car-
rying out this section, there is authorized to be 
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appropriated $632,900,000 for each of fiscal 
years 2012 through 2016.’’; and 
(ii) by striking subparagraph (B); and 
(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) PARTNERSHIPS FOR STATE AND REGIONAL HOS-
PITAL PREPAREDNESS 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 
capacity and preparedness to address the needs of pe-
diatric and other at-risk populations’’ before the pe-
riod at the end; 
(2) 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 goals of the National 
Health Security Strategy under section 2802.’’; and 
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(3) by amending subsection (j)(1) to read as fol-
lows: 
‘‘(1) IN GENERAL.—For purposes of carrying out 
this section, there is authorized to be appropriated 
$378,000,000 for each of fiscal years 2012 through 
2016.’’. 
(d) CDC PROGRAMS FOR COMBATING PUBLIC HEALTH 
THREATS.—Section 319D of the Public Health Service Act 
(42 U.S.C. 247d–4) is amended— 
(1) by striking subsection (c); and 
(2) in subsection (g), by striking ‘‘such sums as 
may be necessary in each of fiscal years 2007 through 
2011’’ and inserting ‘‘$160,121,000 for each of fiscal 
years 2012 through 2016’’. 
(e) DENTAL
EMERGENCY
RESPONDERS: PUBLIC 
HEALTH AND MEDICAL RESPONSE.— 
(1) 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’’. 
(2) NATIONAL HEALTH SECURITY STRATEGY.— 
Section 2802(b)(3) of the Public Health Service Act 
(42 U.S.C. 300hh–1(b)(3)) is amended— 
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(A) in the matter preceding subparagraph 
(A), by inserting ‘‘and which may include dental 
health facilities’’ after ‘‘mental health facilities’’; 
and 
(B) in subparagraph (D), by inserting 
‘‘(which may include dental health assets)’’ after 
‘‘medical assets’’. 
(f) PROCUREMENT OF COUNTERMEASURES.— 
(1) CONTRACT TERMS.—Subclause (IX) of sec-
tion 319F–2(c)(7)(C)(ii) of the Public Health Service 
Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)) is amended to 
read as follows: 
‘‘(IX) 
CONTRACT
TERMS.—The 
Secretary, in any contract for procure-
ment under this section— 
‘‘(aa) may specify— 
‘‘(AA) the dosing and 
administration requirements 
for countermeasures to be de-
veloped and procured; 
‘‘(BB) the amount of 
funding that will be dedi-
cated by the Secretary for de-
velopment and acquisition of 
the countermeasure; and 
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‘‘(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).’’. 
(2) REAUTHORIZATION
OF
THE
SPECIAL
RE-
SERVE FUND.—Section 319F–2 of the Public Health 
Service Act (42 U.S.C. 247d–6b) is amended— 
(A) in subsection (c)— 
(i) by striking ‘‘special reserve fund 
under paragraph (10)’’ each place it ap-
pears and inserting ‘‘special reserve fund as 
defined in subsection (g)(5)’’; and 
(ii) by striking paragraphs (9) and 
(10); and 
(B) 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 
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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-
thorized to remain available until September 30, 
2019. 
‘‘(2) NOTICE
OF
INSUFFICIENT
FUNDS.—Not 
later than 15 days after any date on which the Sec-
retary 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 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a report de-
tailing the amount of such funds available for pro-
curement and the impact such funding will have— 
‘‘(A) in meeting the security countermeasure 
needs identified under this section; and 
‘‘(B) on the annual Countermeasure Imple-
mentation Plan under section 2811(d). 
‘‘(3) USE OF SPECIAL RESERVE FUND FOR AD-
VANCED
RESEARCH
AND
DEVELOPMENT.—The Sec-
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retary may utilize not more than 30 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. 
‘‘(4) RESTRICTIONS
ON
USE
OF
FUNDS.— 
Amounts in the special reserve fund shall not be used 
to pay— 
‘‘(A) costs other than payments made by the 
Secretary to a vendor for advanced development 
(under section 319L) or for procurement of a se-
curity countermeasure under subsection (c)(7); 
and 
‘‘(B) any administrative expenses, includ-
ing salaries. 
‘‘(5) DEFINITION.—In this section, the term ‘spe-
cial reserve fund’ means the ‘Biodefense Counter-
measures’ appropriations account, any appropriation 
made available pursuant to section 521(a) of the 
Homeland Security Act of 2002, and any appropria-
tion made available pursuant to paragraph (1) of this 
paragraph.’’. 
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(g) EMERGENCY SYSTEM FOR ADVANCE REGISTRATION 
OF
VOLUNTEER
HEALTH
PROFESSIONALS.—Section 
319I(k) of the Public Health Service Act (42 U.S.C. 247d– 
7b(k)) is amended by striking ‘‘are authorized to be appro-
priated $2,000,000 for fiscal year 2002, and such sums as 
may be necessary for each of the fiscal years 2003 through 
2011’’ and inserting ‘‘is authorized to be appropriated 
$5,900,000 for each of fiscal years 2012 through 2016’’. 
(h) BIOMEDICAL ADVANCED RESEARCH AND DEVEL-
OPMENT AUTHORITY.— 
(1) 
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.’’. 
(2) BIODEFENSE
MEDICAL
COUNTERMEASURE 
DEVELOPMENT
FUND.—Paragraph (2) of section 
319L(d) of the Public Health Service Act (42 U.S.C. 
247d–7e(d)) 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 2012 
through 2016, the amounts to remain available until 
expended.’’. 
(3) CONTINUED
INAPPLICABILITY
OF
CERTAIN 
PROVISIONS.—Section 319L(e)(1)(C) of the Public 
Health Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is 
amended by striking ‘‘the date that is 7 years after 
the date of enactment of the Pandemic and All-Haz-
ards Preparedness Act’’ and inserting ‘‘September 30, 
2016’’. 
(i) NATIONAL DISASTER MEDICAL SYSTEM.—Section 
2812 of the Public Health Service Act (42 U.S.C. 300hh– 
11) is amended— 
(1) in subsection (a)(3), by adding at the end the 
following: 
‘‘(D) 
ADMINISTRATION.—The 
Secretary 
may determine and pay claims for reimburse-
ment for services under subparagraph (A) di-
rectly or by contract providing for payment in 
advance or by way of reimbursement.’’; and 
(2) in subsection (g), by striking ‘‘such sums as 
may be necessary for each of the fiscal years 2007 
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through 2011’’ and inserting ‘‘$56,000,000 for each of 
fiscal years 2012 through 2016’’. 
(j) 
NATIONAL
HEALTH
SECURITY
STRATEGY 
TIMELINE.—Section 2802(a)(1) of the Public Health Serv-
ice Act (42 U.S.C. 300hh–1(a)(1)) is amended by striking 
‘‘2009’’ and inserting ‘‘2014’’. 
(k) ENHANCING SURGE CAPACITY.—Section 2802(b) of 
the Public Health Service Act (42 U.S.C. 300hh–1(b)(3)) 
is amended— 
(1) in paragraph (1)(A), by inserting ‘‘, includ-
ing drills and exercises to ensure medical surge capac-
ity for events without notice’’ after ‘‘exercises’’; and 
(2) in paragraph (3)— 
(A) in the matter preceding subparagraph 
(A), as amended by subsection (e)(2) of this sec-
tion— 
(i) by inserting ‘‘availability, coordi-
nation, accessibility,’’ after ‘‘response capa-
bilities,’’; 
(ii) by striking ‘‘including mental 
health facilities’’ and inserting ‘‘including 
mental health and ambulatory care facili-
ties’’; and 
(iii) by striking ‘‘trauma care and 
emergency medical service systems’’ and in-
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serting ‘‘trauma care, critical care, and 
emergency medical service systems’’; and 
(B) in subparagraph (B), by striking ‘‘Med-
ical evacuation and fatality management’’ and 
inserting ‘‘Fatality management, and coordi-
nated medical triage and evacuation to the ap-
propriate medical institution based on patient 
medical need as part of regional systems’’. 
(l) VOLUNTEER MEDICAL RESERVE CORPS.—Section 
2813(i) of the Public Health Service Act (42 U.S.C. 300hh– 
15(i)) is amended 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 ‘‘$11,900,000 for 
each of fiscal years 2012 through 2016’’. 
(m) EXTENSION
OF LIMITED ANTITRUST EXEMP-
TION.—Section 405(b) of the Pandemic and All-Hazard 
Preparedness Act (42 U.S.C. 247d–6a note) is amended by 
striking ‘‘at the end of the 6-year period that begins on the 
date of enactment of this Act’’ and inserting ‘‘on September 
30, 2016’’. 
SEC. 3. TEMPORARY REDEPLOYMENT OF PERSONNEL DUR-
ING A PUBLIC HEALTH EMERGENCY. 
Section 319 of the Public Health Service Act (42 
U.S.C. 247d) is amended by adding at the end the fol-
lowing: 
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‘‘(e) TEMPORARY REDEPLOYMENT
OF PERSONNEL 
DURING A PUBLIC HEALTH EMERGENCY.— 
‘‘(1) EMERGENCY
REDEPLOYMENT
OF
FEDER-
ALLY
FUNDED
PERSONNEL.—Notwithstanding any 
other provision of law, and subject to paragraph (2), 
upon a request that is from a State, locality, terri-
tory, tribe, or the Freely Associated States and that 
includes such information and assurances as the Sec-
retary may require, the Secretary may authorize the 
requesting entity to temporarily redeploy to imme-
diately address a public health emergency non-Fed-
eral personnel funded in whole or in part through— 
‘‘(A) any program under this Act; or 
‘‘(B) at the discretion of the Secretary, any 
other program funded in whole or in part by the 
Department of Health and Human Services. 
‘‘(2) ACTIVATION
OF
EMERGENCY
REDEPLOY-
MENT.— 
‘‘(A) PUBLIC
HEALTH
EMERGENCY.—The 
Secretary may exercise the authority vested by 
paragraph (1) only during the period of a public 
health emergency determined pursuant to sub-
section (a). 
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‘‘(B) CONSIDERATIONS.—In authorizing a 
temporary redeployment under paragraph (1), 
the Secretary shall consider each of the following: 
‘‘(i) The degree to which the emergency 
cannot be adequately and appropriately ad-
dressed by the public health workforce. 
‘‘(ii) The degree to which the emer-
gency requires or would otherwise benefit 
from supplemental staffing from those fund-
ed through nonpreparedness Federal pro-
grams. 
‘‘(iii) The degree to which such pro-
grams would be adversely affected by the re-
deployment. 
‘‘(iv) Such other factors as the Sec-
retary may deem appropriate. 
‘‘(C) TERMINATION AND EXTENSION.— 
‘‘(i) TERMINATION.—The authority to 
authorize a temporary redeployment of per-
sonnel 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. 
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‘‘(II) Subject to clause (ii), 30 
days after the activation of the Sec-
retary’s authority pursuant to sub-
paragraph (A). 
‘‘(ii) 
EXTENSION
AUTHORITY.—The 
Secretary may extend the authority to au-
thorize a temporary redeployment of per-
sonnel under paragraph (1) beyond the date 
otherwise applicable under clause (i)(II) if 
the public health emergency still exists, but 
only if— 
‘‘(I) the extension is requested by 
the entity that requested authority to 
authorize a temporary redeployment; 
and 
‘‘(II) the Secretary gives notice to 
the Congress in conjunction with the 
extension.’’. 
SEC. 4. COORDINATION BY ASSISTANT SECRETARY FOR 
PREPAREDNESS AND RESPONSE. 
(a) IN GENERAL.—Section 2811 of the Public Health 
Service Act (42 U.S.C. 300hh–10) is amended— 
(1) in subsection (b)(3)— 
(A) by inserting ‘‘stockpiling, distribution,’’ 
before ‘‘and procurement’’; and 
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(B) by inserting ‘‘, security measures (as 
defined in section 319F–2,’’ after ‘‘qualified 
countermeasures (as defined in section 319F–1)’’; 
(2) in subsection (b)(4), by adding at the end the 
following: 
‘‘(D) 
IDENTIFICATION
OF
INEFFICIEN-
CIES.—Identify gaps, duplication, and other in-
efficiencies in public health preparedness activi-
ties and the actions necessary to overcome these 
obstacles. 
‘‘(E) DEVELOPMENT OF COUNTERMEASURE 
IMPLEMENTATION PLAN.—Lead the development 
of a coordinated Countermeasure Implementa-
tion Plan under subsection (d). 
‘‘(F) COUNTERMEASURES
BUDGET
ANAL-
YSIS.—Oversee the development of a comprehen-
sive, cross-cutting 5-year budget analysis with 
respect to activities described in paragraph (3)— 
‘‘(i) to inform prioritization of re-
sources; and 
‘‘(ii) to ensure that challenges to such 
activities are adequately addressed. 
‘‘(G) GRANT PROGRAMS FOR MEDICAL AND 
PUBLIC
HEALTH
PREPAREDNESS
CAPABILI-
TIES.—Coordinate, in consultation with the Sec-
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retary of Homeland Security, grant programs of 
the Department of Health and Human Services 
relating to medical and public health prepared-
ness capabilities and the activities of local com-
munities to respond to public health emergencies, 
including the— 
‘‘(i) coordination of relevant program 
requirements, timelines, and measurable 
goals of such grant programs; and 
‘‘(ii) establishment of a system for 
gathering and disseminating best practices 
among grant recipients.’’; 
(3) by amending subsection (c) to read as fol-
lows: 
‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre-
paredness and Response shall— 
‘‘(1) have lead responsibility within the Depart-
ment of Health and Human Services for emergency 
preparedness and response policy and coordination; 
‘‘(2) have authority over and responsibility for— 
‘‘(A) the National Disaster Medical System 
(in accordance with section 301 of the Pandemic 
and All-Hazards Preparedness Act); 
‘‘(B) the Hospital Preparedness Cooperative 
Agreement Program pursuant to section 319C–2; 
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‘‘(C) the Biomedical Advanced Research 
and Development Authority under section 319L; 
and 
‘‘(D) the Emergency System for Advance 
Registration of Volunteer Health Professionals 
pursuant to section 319I; 
‘‘(3) provide policy coordination and oversight 
of— 
‘‘(A) the Strategic National Stockpile under 
section 319F–2; 
‘‘(B) the Cities Readiness Initiative; and 
‘‘(C) the Medical Reserve Corps pursuant to 
section 2813; and 
‘‘(4) assume other duties as determined appro-
priate by the Secretary.’’; and 
(4) by adding at the end the following: 
‘‘(d) COUNTERMEASURE IMPLEMENTATION PLAN.— 
Not later than 6 months after the date of enactment of this 
subsection, and annually thereafter, the Assistant Secretary 
for Preparedness and Response shall submit through the 
Secretary to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a Counter-
measure Implementation Plan that— 
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‘‘(C) clearly defined goals, benchmarks, and 
milestones for each such countermeasure or prod-
uct, including information on the number of 
doses required, the intended use of the counter-
measure or product, and the required counter-
measure or product characteristics; and 
‘‘(D) projected needs with regard to the re-
plenishment of the Strategic National Stockpile; 
‘‘(5) evaluates progress made in meeting the 
goals, benchmarks, and milestones identified under 
paragraph (4)(C); 
‘‘(6) reports on the amount of funds available for 
procurement in the special reserve fund as defined in 
section 319F–2(g)(5) and the impact this funding 
will have on meeting the requirements under section 
319F–2; 
‘‘(7) incorporates input from Federal, State, 
local, and tribal stakeholders; and 
‘‘(8) addresses the needs of pediatric populations 
with respect to such countermeasures and products in 
the Strategic National Stockpile and includes— 
‘‘(A) a list of such countermeasures and 
products necessary to address the needs of pedi-
atric populations; 
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‘‘(B) a description of measures taken to co-
ordinate with Office of Pediatric Therapeutics of 
the Food and Drug Administration to maximize 
the labeling, dosages, and formulations of such 
countermeasures and products for pediatric pop-
ulations; 
‘‘(C) a description of existing gaps in the 
Strategic National Stockpile and the develop-
ment of such countermeasures and products to 
address the needs of pediatric populations; and 
‘‘(D) an evaluation of the progress made in 
addressing gaps identified pursuant to subpara-
graph (C). 
Notwithstanding any other provision of this subsection, the 
Plan shall not include any confidential commercial infor-
mation, proprietary information, or information that could 
reveal vulnerabilities of the Nation in the preparation for 
or ability to respond to chemical, biological, radiological, 
or nuclear threats.’’. 
(b) CONSULTATION IN AUTHORIZING MEDICAL PROD-
UCTS FOR USE IN EMERGENCIES.—Subsection (c) of section 
564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–3) is amended by striking ‘‘consultation with the 
Director of the National Institutes of Health’’ and inserting 
‘‘consultation with the Assistant Secretary for Preparedness 
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and Response, the Director of the National Institutes of 
Health,’’. 
(c) BIOSURVEILLANCE PLAN.—Not later than one year 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services shall prepare and submit 
to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate a plan to improve 
information sharing, coordination, and communications 
among disparate biosurveillance systems supported by the 
Department of Health and Human Services. 
SEC. 5. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 
REPORTS. 
Section 5 of the Project Bioshield Act of 2004 (42 
U.S.C. 247d–6c) is repealed. 
SEC. 6. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE 
IN EMERGENCIES. 
Section 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–3) is amended— 
(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 
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paragraph’’ and inserting ‘‘under a provision of 
law in 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 provision of law referred to in para-
graph (2)(A)’’; 
(2) in subsection (b)— 
(A) in the subsection heading, by striking 
‘‘DECLARATION OF EMERGENCY’’ and inserting 
‘‘DECLARATION SUPPORTING EMERGENCY USE 
AUTHORIZATION’’; 
(B) in paragraph (1)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘an emergency justi-
fying’’ and inserting ‘‘that circumstances 
exist justifying’’; 
(ii) in subparagraph (A), by striking 
‘‘specified’’; 
(iii) in subparagraph (B), by striking 
‘‘specified’’; and 
(iv) by amending subparagraph (C) to 
read as follows: 
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‘‘(C) a determination by the Secretary that 
there is a public health emergency, or a signifi-
cant potential for a public health emergency, in-
volving a heightened risk to national security or 
the health and security of United States citizens 
abroad, and involving a biological, chemical, ra-
diological, or nuclear agent or agents, or a dis-
ease or condition that may be attributable to 
such agent or agents.’’; 
(C) in paragraph (2)— 
(i) by amending subparagraph (A) to 
read as follows: 
‘‘(A) IN
GENERAL.—A declaration under 
this subsection shall terminate upon a deter-
mination by the Secretary, in consultation with, 
as appropriate, the Secretary of Homeland Secu-
rity or the Secretary of Defense, that the cir-
cumstances described in paragraph (1) have 
ceased to exist.’’; 
(ii) by striking subparagraph (B); and 
(iii) by redesignating subparagraph 
(C) as subparagraph (B); and 
(D) in paragraph (4), by striking ‘‘advance 
notice of termination, and renewal’’ and insert-
ing ‘‘and advance notice of termination’’; 
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(3) in subsection (c)(1), by striking ‘‘specified 
in’’ and insert ‘‘covered by’’; 
(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)(B), by amending 
clause (iii) to read as follows: 
‘‘(iii) Appropriate conditions with re-
spect to the collection and analysis of infor-
mation concerning the safety and effective-
ness of the product with respect to the ac-
tual use of such product pursuant to an au-
thorization under this section.’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘manufacturer of 
the product’’ and inserting ‘‘person’’; 
and 
(II) by inserting ‘‘or in para-
graph (1)(B)’’ before the period at the 
end; 
(ii) in subparagraph (B)(i), by insert-
ing ‘‘, with the exception of extensions of a 
product’s expiration date authorized under 
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section 564A(b)’’ before the period at the 
end; 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 a product, the Secretary shall 
not impose conditions that would restrict dis-
tribution or administration of the product that 
is solely for the approved uses.’’; 
(C) by amending paragraph (3) to read as 
follows: 
‘‘(3) GOOD
MANUFACTURING
PRACTICE; PRE-
SCRIPTION; PRACTITIONER’S
AUTHORIZATION.—With 
respect to the emergency use of a product for which 
an authorization under this section is issued (whether 
for an unapproved product or an unapproved use of 
an approved product), the Secretary may waive or 
limit, to the extent appropriate given the cir-
cumstances of the emergency— 
‘‘(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 
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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).’’; and 
(D) by adding at the end the following: 
‘‘(5) EXISTING AUTHORITIES.—Nothing in this 
section restricts any authority vested in the Secretary 
by any other provision of this Act or the Public 
Health Service Act for establishing conditions of au-
thorization for a product.’’; and 
(6) in subsection (g)— 
(A) in the heading, by striking ‘‘REVOCA-
TION OF AUTHORIZATION’’ and inserting ‘‘RE-
VIEW, MODIFICATION, AND REVOCATION OF AU-
THORIZATION’’; 
(B) in paragraph (1), by striking ‘‘periodi-
cally review’’ and inserting ‘‘review not less than 
every three years’’; and 
(C) by adding at the end the following: 
‘‘(3) MODIFICATION.—The Secretary may modify 
an authorization under this section or the conditions 
of such an authorization, at any time, based on a re-
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view of the authorization or new information that is 
otherwise obtained, including information obtained 
during an emergency.’’. 
SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL 
PRODUCTS FOR EMERGENCY USE. 
(a) IN GENERAL.—The Federal Food, Drug, and Cos-
metic Act is amended by inserting after section 564 (21 
U.S.C. 360bbb–3) the following: 
‘‘SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MED-
ICAL PRODUCTS FOR EMERGENCY USE. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘product’ means a drug, device, or 
biological product. 
‘‘(2) The term ‘eligible product’ means a product 
that is— 
‘‘(A) approved or cleared under this chapter 
or licensed under section 351 of the Public 
Health Service Act; and 
‘‘(B) intended to be used to diagnose, pre-
vent, or treat a disease or condition involving a 
biological, chemical, radiological, or nuclear 
agent or agents during— 
‘‘(i) a domestic emergency or military 
emergency involving heightened risk of at-
tack with such an agent or agents; or 
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‘‘(ii) a public health emergency affect-
ing national security or the health and se-
curity of United States citizens abroad. 
‘‘(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 eligible product is intended to be 
held for use for a domestic, military, or public 
health 
emergency 
described 
in 
subsection 
(a)(2)(B); 
‘‘(B) the expiration date extension is in-
tended to support the United States’ ability to 
protect— 
‘‘(i) the public health; or 
‘‘(ii) military preparedness and effec-
tiveness; and 
‘‘(C) 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— 
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‘‘(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)) 
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. 
‘‘(c) CURRENT GOOD MANUFACTURING PRACTICES.— 
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‘‘(1) IN GENERAL.—The Secretary may, when 
the circumstances of a domestic, military, or public 
health emergency described in subsection (a)(2)(B) so 
warrant, authorize, with respect to an eligible prod-
uct, deviations from current good manufacturing 
practice requirements otherwise applicable to the 
manufacture, processing, packing, or holding of prod-
ucts subject to regulation under this Act, including re-
quirements under section 501 or 520(f)(1) or applica-
ble conditions prescribed with respect 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) MASS DISPENSING.—The requirements of section 
503(b) and 520(e) shall not apply to an eligible product, 
and the product shall not be considered an unapproved 
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 prescription, if— 
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‘‘(1) the product is dispensed during an actual 
emergency described in subsection (a)(2)(B); 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. 
‘‘(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 (as defined in section 564(a)(2)(A)) and shall 
not be deemed adulterated or misbranded under this 
Act because of— 
‘‘(A) the issuance of emergency use instruc-
tions under paragraph (1) with respect to such 
product; or 
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‘‘(B) the introduction or delivery for intro-
duction of such product into interstate commerce 
accompanied by such instructions during an 
emergency response to an actual emergency de-
scribed in subsection (a)(2)(B).’’. 
(b) 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, an actual 
or potential domestic emergency or military emergency in-
volving heightened risk of attack with a biological, chemical, 
radiological, or nuclear agent, or an actual or potential 
public health emergency affecting national security or the 
health and security of United States citizens abroad.’’. 
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SEC. 8. 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 section 7, 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, and tribal government enti-
ty), or a person acting on behalf of such a government enti-
ty, to introduce into interstate commerce a product (as de-
fined 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.’’. 
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SEC. 9. ACCELERATE COUNTERMEASURE DEVELOPMENT BY 
STRENGTHENING FDA’S ROLE IN REVIEWING 
PRODUCTS FOR NATIONAL SECURITY PRIOR-
ITIES. 
(a) IN GENERAL.—Section 565 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amended 
to read as follows: 
‘‘SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW. 
‘‘(a) COUNTERMEASURES AND PRODUCTS.—The coun-
termeasures and products referred to in this subsection 
are— 
‘‘(1) qualified countermeasures (as defined in 
section 319F–1 of the Public Health Service Act); 
‘‘(2) security countermeasures (as defined in sec-
tion 319F–2 of such Act); and 
‘‘(3) qualified pandemic or epidemic products 
(as defined in section 319F–3 of such Act) that the 
Secretary determines to be a priority. 
‘‘(b) IN GENERAL.— 
‘‘(1) INVOLVEMENT
OF
FDA
PERSONNEL
IN 
INTERAGENCY ACTIVITIES.—For the purpose of accel-
erating the development, stockpiling, approval, clear-
ance, and licensure of countermeasures and products 
referred to in subsection (a), the Secretary shall ex-
pand the involvement of Food and Drug Administra-
tion personnel in interagency activities with the As-
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sistant Secretary for Preparedness and Response (in-
cluding the Biomedical Advanced Research and De-
velopment Authority), the Centers for Disease Control 
and Prevention, the National Institutes of Health, 
and the Department of Defense. 
‘‘(2) TECHNICAL
ASSISTANCE.—The Secretary 
shall establish within the Food and Drug Administra-
tion a team of experts on manufacturing and regu-
latory activities (including compliance with current 
Good Manufacturing Practices) to provide both off- 
site and on-site technical assistance to the manufac-
turers of countermeasures and products referred to in 
subsection (a). On-site technical assistance shall be 
provided upon the request of the manufacturer and at 
the discretion of the Secretary if the Secretary deter-
mines that the provision of such assistance would ac-
celerate the development, manufacturing, or approval, 
clearance, or licensure of countermeasures and prod-
ucts referred to in subsection (a). 
‘‘(c) AGENCY INTERACTION WITH SECURITY COUNTER-
MEASURE SPONSORS.— 
‘‘(1) 
IN
GENERAL.—For 
security 
counter-
measures (as defined in section 319F–2 of the Public 
Health Service Act) that are procured under such sec-
tion 319F–2— 
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‘‘(A) the Secretary shall establish a process 
for frequent scientific feedback and interactions 
between the Food and Drug Administration and 
the security countermeasure sponsor (referred to 
in this subsection as the ‘sponsor’), designed to 
facilitate the approval, clearance, and licensure 
of the security countermeasures; 
‘‘(B) such feedback and interactions shall 
include meetings and, in accordance with sub-
section (b)(2), on-site technical assistance; and 
‘‘(C) at the request of the Secretary, the 
process under this paragraph shall include par-
ticipation by the Food and Drug Administration 
in meetings between the Biomedical Advanced 
Research and Development Authority and spon-
sors on the development of such countermeasures. 
‘‘(2) REGULATORY MANAGEMENT PLAN.— 
‘‘(A) IN GENERAL.—The process established 
under paragraph (1) shall allow for the develop-
ment of a written regulatory management plan 
(in this paragraph referred to as the ‘plan’) for 
a security countermeasure (as defined in para-
graph (1)) in accordance with this paragraph. 
‘‘(B) PROPOSAL
AND
FINALIZATION
OF 
PLAN.—In carrying out the process under para-
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graph (1), the Secretary shall direct the Food 
and Drug Administration, upon submission of a 
written request by the sponsor that includes a 
proposed plan and relevant data and future 
planning detail to support such a plan, to work 
with the sponsor to agree on a final plan within 
a reasonable time not to exceed 90 days. The 
basis for this agreement shall be the proposed 
plan submitted by the sponsor. Notwithstanding 
the preceding sentence, the Secretary shall retain 
full discretion to determine the contents of the 
final plan or to determine that no such plan can 
be agreed upon. If the Secretary determines that 
no final plan can be agreed upon, the Secretary 
shall provide to the sponsor, in writing, the sci-
entific or regulatory rationale why such agree-
ment cannot be reached. If a final plan is agreed 
upon, it shall be shared with the sponsor in writ-
ing. 
‘‘(C) CONTENTS.—The plan shall include an 
agreement on the nature of, and timelines for, 
feedback and interactions between the sponsor 
and the Food and Drug Administration, shall 
provide reasonable flexibility in implementing 
and adjusting the agreement under this para-
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graph as warranted during the countermeasure 
development process, and shall identify— 
‘‘(i) the current regulatory status of the 
countermeasure, an assessment of known 
scientific gaps relevant to approval, clear-
ance, or licensure of the countermeasure, 
and a proposed pathway to approval, clear-
ance, or licensure of the countermeasure; 
‘‘(ii) developmental milestones whose 
completion will result in meetings to be 
scheduled within a reasonable time between 
the applicable review division of the Food 
and Drug Administration and the sponsor; 
‘‘(iii) sponsor submissions that will re-
sult in written feedback from the review di-
vision within a reasonable time; 
‘‘(iv) feedback by the Food and Drug 
Administration regarding the data required 
to support delivery of the countermeasure to 
the Strategic National Stockpile under sec-
tion 319F–2 of the Public Health Service 
Act; 
‘‘(v) feedback by the Food and Drug 
Administration regarding data required to 
support submission of a proposed agreement 
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on the design and size of clinical trials for 
review under section 505(b)(5)(B); and 
‘‘(vi) other issues that have the poten-
tial to delay approval, clearance, or licen-
sure. 
‘‘(D) CHANGES.—Changes to the plan shall 
be made by subsequent agreement between the 
Secretary and the sponsor. If after reasonable at-
tempts to negotiate changes to the plan the Sec-
retary and the sponsor are unable to finalize 
such changes, the Secretary shall provide to the 
sponsor, in writing, the scientific or regulatory 
rationale why such changes are required or can-
not be included in the plan. 
‘‘(3) APPLICABILITY
TO
CERTAIN
QUALIFIED 
PANDEMIC OR EPIDEMIC PRODUCTS.—The Secretary 
may, with respect to qualified pandemic or epidemic 
products (as defined in section 319F–3 of the Public 
Health Service Act) for which a contract for advanced 
research and development is entered into under sec-
tion 319L of such Act, choose to apply the provisions 
of paragraphs (1) and (2) to the same extent and in 
the same manner as such provisions apply with re-
spect to security countermeasures. 
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‘‘(d) 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 2011, 
the Secretary shall provide final guidance to industry 
regarding the development of animal models to sup-
port approval, clearance, or licensure of counter-
measures and products referred to in subsection (a) 
when human efficacy studies are not ethical or fea-
sible. 
‘‘(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-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
‘‘(e) BIENNIAL REPORT.—Not later than January 1, 
2013, and every 2 years thereafter, the Secretary shall sub-
mit a report to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate, that, 
with respect to the preceding 2 fiscal years, includes— 
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‘‘(1) the number of full-time equivalent employ-
ees of the Food and Drug Administration who di-
rectly support the review of countermeasures and 
products referred to in subsection (a); 
‘‘(2) estimates of funds obligated by the Food 
and Drug Administration for review of such counter-
measures and products; 
‘‘(3) the number of regulatory teams at the Food 
and Drug Administration specific to such counter-
measures and products and, for each such team, the 
assigned products, classes of products, or technologies; 
‘‘(4) the length of time between each request by 
the sponsor of such a countermeasure or product for 
information and the provision of such information by 
the Food and Drug Administration; 
‘‘(5) the number, type, and frequency of official 
interactions between the Food and Drug Administra-
tion and— 
‘‘(A) sponsors of a countermeasure or prod-
uct referred to in subsection (a); or 
‘‘(B) another agency engaged in develop-
ment or management of portfolios for such coun-
termeasures or products, including the Centers 
for Disease Control and Prevention, the Bio-
medical Advanced Research and Development 
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Authority, the National Institutes of Health, and 
the appropriate agencies of the Department of 
Defense; 
‘‘(6) a description of other measures that, as de-
termined by the Secretary, are appropriate to deter-
mine the efficiency of the regulatory teams described 
in paragraph (3); and 
‘‘(7) the regulatory science priorities that relate 
to countermeasures or products referred to in sub-
section (a) and which the Food and Drug Adminis-
tration is addressing and the progress made on these 
priorities.’’. 
(b) SPECIAL PROTOCOL ASSESSMENT.—Subparagraph 
(B) of section 505(b)(5) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(b)(5)) is amended to read as fol-
lows: 
‘‘(B)(i) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service 
Act if the sponsor or applicant makes a reasonable written 
request for a meeting for the purpose of reaching agreement 
on the design and size of— 
‘‘(I) clinical trials intended to form the primary 
basis of an effectiveness claim; or 
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‘‘(II) animal efficacy trials and any associated 
clinical trials that in combination are intended to 
form the primary basis of an effectiveness claim for 
a countermeasure or product referred to in section 
565(a) when human efficacy studies are not ethical or 
feasible. 
‘‘(ii) The sponsor or applicant shall provide informa-
tion necessary for discussion and agreement on the design 
and size of the clinical trials. Minutes of any such meeting 
shall be prepared by the Secretary and made available to 
the sponsor or applicant upon request.’’. 
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Union Calendar No. 189 
112TH CONGRESS 
1ST SESSION 
H. R. 2405 
[Report No. 112–286] 
A BILL 
To reauthorize certain provisions of the Public 
Health Service Act and the Federal Food, Drug, 
and Cosmetic Act relating to public health pre-
paredness and countermeasure development, and 
for other purposes. 
NOVEMBER 16, 2011 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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