112TH CONGRESS 
1ST SESSION H. R. 2405 
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,
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)—
(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
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
(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-
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.—
‘‘(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
‘‘(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-
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-
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-
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,’’;
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.
‘‘(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.
‘‘(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
‘‘(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).
‘‘(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.’’;
(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;
‘‘(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;
‘‘(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);
‘‘(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
‘‘(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-
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)—
(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)—
(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-
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.’’;
(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:
‘‘(5) EXISTING AUTHORITIES.—Nothing in this 
section restricts any authority vested in the Sec-
retary by any other provision of this Act or the Pub-
lic Health Service Act for establishing conditions of 
authorization 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 
AUTHORIZATION’’; 
(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 mod-
ify an authorization under this section or the condi-
tions of such an authorization, at any time, based on 
a review of the authorization or new information 
that is otherwise obtained, including information ob-
tained during an emergency.’’. 
SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL 
PRODUCTS FOR EMERGENCY USE. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic 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 prod-
uct that is— 
‘‘(A) approved or cleared under this chap-
ter 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 
‘‘(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 
extension 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, prod-
uct sampling, storage, packaging or repack-
aging, transport, labeling, notice to product re-
cipients, recordkeeping, periodic testing or re-
testing, 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 prod-
uct, the Secretary has, under paragraph (1), ex-
tended the expiration date and authorized the intro-
duction or delivery for introduction into interstate 
commerce of such product after the expiration date 
provided by the manufacturer. 
‘‘(c) CURRENT
GOOD
MANUFACTURING
PRAC-
TICES.— 
‘‘(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 
product, deviations from current good manufac-
turing practice requirements otherwise applicable to 
the manufacture, processing, packing, or holding of 
products subject to regulation under this Act, in-
cluding requirements under section 501 or 520(f)(1)
or applicable 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 prod-
uct, the Secretary has authorized deviations from 
current good manufacturing practices under para-
graph (1). 
‘‘(d) MASS DISPENSING.—The requirements of sec-
tion 503(b) and 520(e) shall not apply to an eligible prod-
uct, 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 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 eli-
gible product is to be administered concerning such 
product’s approved, 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 in-
structions under paragraph (1) with respect to 
such product; or 
‘‘(B) the introduction or delivery for intro-
duction of such product into interstate com-
merce accompanied by such instructions during 
an emergency response to an actual emergency 
described in subsection (a)(2)(B).’’.
(b) RISK EVALUATION AND MITIGATION STRATE-
GIES.—Section 505–1 of the Federal Food, Drug, and 
Cosmetic 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 ap-
plied, if the Secretary determines that such waiver is re-
quired to mitigate the effects of, or reduce the severity 
of, an actual or potential domestic emergency or military 
emergency involving heightened risk of attack with a bio-
logical, chemical, radiological, or nuclear agent, or an ac-
tual or potential public health emergency affecting na-
tional security or the health and security of United States 
citizens abroad.’’. 
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 
(including a Federal, State, local, and 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.’’. 
SEC. 9. ACCELERATE COUNTERMEASURE DEVELOPMENT 
BY STRENGTHENING FDA’S ROLE IN REVIEW-
ING PRODUCTS FOR NATIONAL SECURITY 
PRIORITIES. 
(a) IN GENERAL.—Section 565 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amend-
ed to read as follows:
‘‘SEC. 565. COUNTERMEASURE DEVELOPMENT AND RE-
VIEW. 
‘‘(a) COUNTERMEASURES
AND
PRODUCTS.—The 
countermeasures and products referred to in this sub-
section are— 
‘‘(1) qualified countermeasures (as defined in 
section 319F–1 of the Public Health Service Act); 
‘‘(2) security countermeasures (as defined in 
section 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 ac-
celerating the development, stockpiling, approval, 
clearance, and licensure of countermeasures and 
products referred to in subsection (a), the Secretary 
shall expand the involvement of Food and Drug Ad-
ministration personnel in interagency activities with 
the Assistant Secretary for Preparedness and Re-
sponse (including the Biomedical Advanced Research 
and Development Authority), the Centers for Dis-
ease 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 Adminis-
tration a team of experts on manufacturing and reg-
ulatory 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 Sec-
retary determines that the provision of such assist-
ance would accelerate the development, manufac-
turing, or approval, clearance, or licensure of coun-
termeasures and products referred to in subsection 
(a). 
‘‘(c) AGENCY INTERACTION WITH SECURITY COUN-
TERMEASURE SPONSORS.— 
‘‘(1) IN
GENERAL.—For security counter-
measures (as defined in section 319F–2 of the Pub-
lic Health Service Act) that are procured under such 
section 319F–2— 
‘‘(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 licen-
sure 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 counter-
measures. 
‘‘(2) REGULATORY MANAGEMENT PLAN.— 
‘‘(A) IN
GENERAL.—The process estab-
lished under paragraph (1) shall allow for the 
development of a written regulatory manage-
ment plan (in this paragraph referred to as the 
‘plan’) for a security countermeasure (as de-
fined in paragraph (1)) in accordance with this 
paragraph. 
‘‘(B) PROPOSAL
AND
FINALIZATION
OF 
PLAN.—In carrying out the process under para-
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 re-
tain 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 Sec-
retary shall provide to the sponsor, in writing, 
the scientific or regulatory rationale why such 
agreement cannot be reached. If a final plan is 
agreed upon, it shall be shared with the sponsor 
in writing. 
‘‘(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 Administra-
tion, shall provide reasonable flexibility in im-
plementing and adjusting the agreement under 
this paragraph as warranted during the coun-
termeasure development process, and shall iden-
tify— 
‘‘(i) the current regulatory status of 
the countermeasure, an assessment of 
known scientific gaps relevant to approval, 
clearance, or licensure of the counter-
measure, and a proposed pathway to ap-
proval, clearance, or licensure of the coun-
termeasure; 
‘‘(ii) developmental milestones whose 
completion will result in meetings to be 
scheduled within a reasonable time be-
tween 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 
section 319F–2 of the Public Health Serv-
ice Act;
‘‘(v) feedback by the Food and Drug 
Administration regarding data required to 
support submission of a proposed agree-
ment 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 reason-
able attempts to negotiate changes to the plan 
the Secretary and the sponsor are unable to fi-
nalize such changes, the Secretary shall provide 
to the sponsor, in writing, the scientific or regu-
latory rationale why such changes are required 
or cannot 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 ad-
vanced research and development is entered into 
under section 319L of such Act, choose to apply the
provisions of paragraphs (1) and (2) to the same ex-
tent and in the same manner as such provisions 
apply with respect to security countermeasures. 
‘‘(d) FINAL GUIDANCE ON DEVELOPMENT OF ANI-
MAL 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 indus-
try regarding the development of animal models to 
support 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 Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate. 
‘‘(e) BIENNIAL REPORT.—Not later than January 1, 
2013, and every 2 years thereafter, the Secretary shall 
submit a report to the Committee on Energy and Com-
merce 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, in-
cludes— 
‘‘(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 
countermeasures 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 Adminis-
tration and— 
‘‘(A) sponsors of a countermeasure or 
product referred to in subsection (a); or
‘‘(B) another agency engaged in develop-
ment or management of portfolios for such 
countermeasures or products, including the 
Centers for Disease Control and Prevention, the 
Biomedical Advanced Research and Develop-
ment Authority, the National Institutes of 
Health, and the appropriate agencies of the De-
partment of Defense; 
‘‘(6) a description of other measures that, as 
determined by the Secretary, are appropriate to de-
termine the efficiency of the regulatory teams de-
scribed 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.—Subpara-
graph (B) of section 505(b)(5) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)(5)) is amended to 
read as follows: 
‘‘(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 
‘‘(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.’’. 
Passed the House of Representatives December 6, 
2011. 
Attest: 
Clerk.
112TH CONGRESS 
1ST SESSION 
H. R. 2405 
AN ACT 
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.