IIB 
112TH CONGRESS 
1ST SESSION H. R. 2405 
IN THE SENATE OF THE UNITED STATES 
DECEMBER 7, 2011 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Pandemic and All-Hazards Preparedness Reauthoriza-
tion 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 
reviewing 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 
carrying out this section, there is authorized to 
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be 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 
pediatric and other at-risk populations’’ before the 
period 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 
SECURITY
STRATEGY.—The Secretary shall imple-
ment objective, evidence-based metrics to ensure that 
entities receiving awards under this section are 
meeting, to the extent practicable, the goals of the 
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National Health Security Strategy under section 
2802.’’; and 
(3) by amending subsection (j)(1) to read as 
follows: 
‘‘(1) IN GENERAL.—For purposes of carrying 
out this section, there is authorized to be appro-
priated $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 MED-
ICAL
RESPONSE
CURRICULA
AND
TRAINING.—Sec-
tion 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’’. 
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(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— 
(A) in the matter preceding subparagraph 
(A), by inserting ‘‘and which may include den-
tal health facilities’’ after ‘‘mental health facili-
ties’’; 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 Serv-
ice 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 
developed and procured; 
‘‘(BB) the amount of 
funding that will be dedi-
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cated by the Secretary for 
development and acquisition 
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).’’. 
(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.— 
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‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—In 
addition to amounts appropriated to the special re-
serve fund prior to the date of the enactment of this 
subsection, there is authorized to be appropriated, 
for the procurement of security countermeasures 
under subsection (c) and for carrying out section 
319L (relating to the Biomedical Advanced Research 
and Development Authority), $2,800,000,000 for the 
period of fiscal years 2014 through 2018. Amounts 
appropriated pursuant to the preceding sentence are 
authorized to remain available until September 30, 
2019. 
‘‘(2) 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, Education, Labor, and Pensions of the Sen-
ate a report detailing the amount of such funds 
available for procurement and the impact such fund-
ing will have— 
‘‘(A) in meeting the security counter-
measure needs identified under this section; and 
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‘‘(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-
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 
Authority). Amounts authorized to be appropriated 
under this subsection to carry out section 319L are 
in addition to amounts otherwise authorized to be 
appropriated to carry out such section. 
‘‘(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 develop-
ment (under section 319L) or for procurement 
of a security countermeasure under subsection 
(c)(7); and 
‘‘(B) any administrative expenses, includ-
ing salaries. 
‘‘(5) DEFINITION.—In this section, the term 
‘special reserve fund’ means the ‘Biodefense Coun-
termeasures’ appropriations account, any appropria-
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tion made available pursuant to section 521(a) of 
the Homeland Security Act of 2002, and any appro-
priation made available pursuant to paragraph (1) of 
this paragraph.’’. 
(g) EMERGENCY SYSTEM FOR ADVANCE REGISTRA-
TION 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 
appropriated $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 appro-
priated $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 agree-
ments under this section, the Secretary shall 
provide a clear statement of defined Govern-
ment purpose related to activities included in 
subsection (a)(6)(B) for a qualified counter-
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measure 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: 
‘‘(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-
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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 
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 
Service 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 ca-
pacity 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 
section— 
(i) by inserting ‘‘availability, coordina-
tion, accessibility,’’ after ‘‘response capa-
bilities,’’; 
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(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 
inserting ‘‘trauma care, critical care, and 
emergency medical service systems’’; and 
(B) in subparagraph (B), by striking 
‘‘Medical evacuation and fatality management’’ 
and inserting ‘‘Fatality management, and co-
ordinated medical triage and evacuation to the 
appropriate 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 fis-
cal 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 
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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: 
‘‘(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 
Secretary may require, the Secretary may authorize 
the requesting entity to temporarily redeploy to im-
mediately address a public health emergency non- 
Federal 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 Serv-
ices. 
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‘‘(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 pub-
lic health emergency determined pursuant to 
subsection (a). 
‘‘(B) CONSIDERATIONS.—In authorizing a 
temporary redeployment under paragraph (1), 
the Secretary shall consider each of the fol-
lowing: 
‘‘(i) The degree to which the emer-
gency cannot be adequately and appro-
priately addressed by the public health 
workforce. 
‘‘(ii) The degree to which the emer-
gency requires or would otherwise benefit 
from supplemental staffing from those 
funded through nonpreparedness Federal 
programs. 
‘‘(iii) The degree to which such pro-
grams would be adversely affected by the 
redeployment. 
‘‘(iv) Such other factors as the Sec-
retary may deem appropriate. 
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‘‘(C) TERMINATION AND EXTENSION.— 
‘‘(i) TERMINATION.—The authority to 
authorize a temporary redeployment of 
personnel under paragraph (1) shall termi-
nate 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), 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 
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‘‘(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 
(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
COUNTER-
MEASURE
IMPLEMENTATION
PLAN.—Lead the 
development of a coordinated Countermeasure 
Implementation Plan under subsection (d). 
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‘‘(F) COUNTERMEASURES BUDGET ANAL-
YSIS.—Oversee the development of a com-
prehensive, 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 
Secretary of Homeland Security, grant pro-
grams of the Department of Health and 
Human Services relating to medical and public 
health preparedness capabilities and the activi-
ties of local communities 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.’’; 
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(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 Pan-
demic and All-Hazards Preparedness Act); 
‘‘(B) the Hospital Preparedness Coopera-
tive Agreement Program pursuant to section 
319C–2; 
‘‘(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; 
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‘‘(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 Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate a Countermeasure Implementation Plan that— 
‘‘(1) describes the chemical, biological, radio-
logical, and nuclear threats facing the Nation and 
the corresponding efforts to develop qualified coun-
termeasures (as defined in section 319F–1), security 
countermeasures (as defined in section 319F–2), or 
qualified pandemic or epidemic products (as defined 
in section 319F–3) for each threat; 
‘‘(2) evaluates the progress of all activities with 
respect to such countermeasures or products, includ-
ing research, advanced research, development, pro-
curement, stockpiling, deployment, and utilization; 
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‘‘(3) identifies and prioritizes near-, mid-, and 
long-term needs with respect to such counter-
measures or products to address chemical, biological, 
radiological, and nuclear threats; 
‘‘(4) identifies, with respect to each category of 
threat, a summary of all advanced development and 
procurement awards, including— 
‘‘(A) the time elapsed from the issuance of 
the initial solicitation or request for a proposal 
to the adjudication (such as the award, denial 
of award, or solicitation termination); 
‘‘(B) projected timelines for development 
and procurement of such countermeasures or 
products; 
‘‘(C) clearly defined goals, benchmarks, 
and milestones for each such countermeasure or 
product, including information on the number 
of doses required, the intended use of the coun-
termeasure or product, and the required coun-
termeasure 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); 
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‘‘(6) reports on the amount of funds available 
for procurement in the special reserve fund as de-
fined 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 popu-
lations with respect to such countermeasures and 
products in the Strategic National Stockpile and in-
cludes— 
‘‘(A) a list of such countermeasures and 
products necessary to address the needs of pedi-
atric populations; 
‘‘(B) a description of measures taken to 
coordinate with Office of Pediatric Therapeutics 
of the Food and Drug Administration to maxi-
mize the labeling, dosages, and formulations of 
such countermeasures and products for pedi-
atric populations; 
‘‘(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 
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‘‘(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 in-
formation, proprietary information, or information that 
could reveal vulnerabilities of the Nation in the prepara-
tion for or ability to respond to chemical, biological, radio-
logical, or nuclear threats.’’. 
(b) CONSULTATION
IN
AUTHORIZING
MEDICAL 
PRODUCTS 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 ‘‘con-
sultation with the Director of the National Institutes of 
Health’’ and inserting ‘‘consultation with the Assistant 
Secretary for Preparedness 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 Sec-
retary 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, 
Education, Labor, and Pensions of the Senate a plan to 
improve information sharing, coordination, and commu-
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nications among disparate biosurveillance systems sup-
ported 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 
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 
paragraph (2)(A)’’; 
(2) in subsection (b)— 
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(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 jus-
tifying’’ 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: 
‘‘(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 citi-
zens abroad, and involving a biological, chem-
ical, radiological, or nuclear agent or agents, or 
a disease or condition that may be attributable 
to such agent or agents.’’; 
(C) in paragraph (2)— 
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(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 Se-
curity 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’’; 
(3) in subsection (c)(1), by striking ‘‘specified 
in’’ and insert ‘‘covered by’’; 
(4) in subsection (d)(3), by inserting ‘‘, to the 
extent practicable given the circumstances of the 
emergency,’’ 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 in-
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formation concerning the safety and effec-
tiveness of the product with respect to the 
actual use of such product pursuant to an 
authorization 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 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.’’; 
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(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 (wheth-
er 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 hold-
ing 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 sec-
tion 503(b); and 
‘‘(C) requirements established under sec-
tion 520(e).’’; and 
(D) by adding at the end the following: 
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