I 
112TH CONGRESS 
1ST SESSION H. R. 2405 
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 
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. 
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: 
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Sec. 1. Short title; table of contents. 
Sec. 2. Reauthorization of certain provisions relating to public health prepared-
ness. 
Sec. 3. Coordination by Assistant Secretary for Preparedness and Response. 
Sec. 4. Eliminating duplicative Project Bioshield reports. 
Sec. 5. 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 (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); 
(2) by striking subsection (h); and 
(3) in subsection (i)— 
(A) in paragraph (1)— 
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(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.— 
Paragraph (1) of section 319C–2(j) of the Public Health 
Service Act (42 U.S.C. 247d–3b(j)) is amended 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 
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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’’. 
(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 such dental health as-
sets)’’ after ‘‘medical assets’’. 
(f) PROCUREMENT OF COUNTERMEASURES.— 
(1) CONTRACT TERMS.—Clause (ii) of section 
319F–2(c)(7)(C) of the Public Health Service Act 
(42 U.S.C. 247d–6b(c)(7)(C)) is amended by adding 
at the end the following: 
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‘‘(X) GOVERNMENT PURPOSE.— 
The contract shall provide a clear 
statement of defined Government pur-
pose limited to uses related to a secu-
rity countermeasure, as defined 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 
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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 relevant committees of Congress a report detail-
ing the amount of such funds available for procure-
ment and the impact such funding will have— 
‘‘(A) in meeting the security counter-
measure needs identified under this section; and 
‘‘(B) on the annual Public Health Emer-
gency Medical Countermeasure Enterprise Im-
plementation Plan under section 319F–5(b). 
‘‘(3) USE OF SPECIAL RESERVE FUND FOR AD-
VANCED RESEARCH AND DEVELOPMENT.—The Sec-
retary, acting through the Director of the Bio-
medical Advanced Research and Development Au-
thority, 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 
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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 research 
and development or 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) BIOMEDICAL ADVANCED RESEARCH AND DEVEL-
OPMENT AUTHORITY.— 
(1) 
TRANSACTION
AUTHORITIES.—Section 
319L(c)(5) of the Public Health Service Act (42 
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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 ‘‘7 years’’ and inserting ‘‘10 
years’’. 
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(h) NATIONAL DISASTER MEDICAL SYSTEM.—Sec-
tion 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’’. 
(i) 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 ‘‘6-year’’ and inserting ‘‘10-year’’. 
SEC. 3. 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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