(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, in consultation with the Direc-
tor of the Office of Management and Budget, 
the development of a comprehensive, cross-cut-
ting 5-year budget analysis with respect to ac-
tivities described in paragraph (3)— 
‘‘(i) to inform prioritization of re-
sources; and 
‘‘(ii) to ensure that challenges are 
adequately addressed. 
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‘‘(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 ability 
of local communities to respond to public health 
emergencies, including by— 
‘‘(i) coordinating the program require-
ments, timelines, and measurable goals of 
such grant programs; and 
‘‘(ii) establishing a system for gath-
ering 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 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); 
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‘‘(B) the Hospital Preparedness Coopera-
tive Agreement Program pursuant to section 
319C–2; 
‘‘(C) the Biomedical Advanced Research 
and Development Authority under section 
319L; 
‘‘(D) the Medical Reserve Corps pursuant 
to section 2813; 
‘‘(E) the Emergency System for Advance 
Registration of Volunteer Health Professionals 
pursuant to section 319I; 
‘‘(F) the Strategic National Stockpile; and 
‘‘(G) the Cities Readiness Initiative; and 
‘‘(2) 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 to 
the Secretary and relevant congressional committees 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-
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termeasures (as defined in section 319F–1), secured 
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 the time elapsed 
from the issuance of the initial solicitation or re-
quest for a proposal to the adjudication (such as the 
award, denial of award, or solicitation termination), 
and including— 
‘‘(A) projected timelines for development 
and procurement of such countermeasures or 
products; 
‘‘(B) clearly defined goals, benchmarks, 
and milestones for each countermeasure or 
product, including information on the number 
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of doses required, the intended use of the coun-
termeasure or product, and the required coun-
termeasure or product characteristics; and 
‘‘(C) 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); 
‘‘(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; and 
‘‘(7) incorporates input from Federal, State, 
local, and tribal stakeholders.’’. 
(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,’’. 
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SEC. 4. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 
REPORTS. 
Section 5 of the Project Bioshield Act of 2004 (42 
U.S.C. 247d–6c) is repealed. 
SEC. 5. 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). 
‘‘(b) IN GENERAL.— 
‘‘(1) INVOLVEMENT
OF
FDA
PERSONNEL
IN 
INTERAGENCY ACTIVITIES.—The Secretary shall ac-
celerate the development, stockpiling, approval, and 
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licensure of countermeasures and products referred 
to in subsection (a) by expanding the involvement of 
Food and Drug Administration personnel in inter-
agency activities with the Biomedical Advanced Re-
search and Development Authority, the Centers for 
Disease Control and Prevention, the National Insti-
tutes 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 Practice) to provide both off- 
site and on-site technical assistance to the manufac-
turers of countermeasures and products referred to 
in subsection (a). 
‘‘(c) AGENCY INTERACTION WITH SECURITY COUN-
TERMEASURE SPONSORS.— 
‘‘(1) COUNTERMEASURE
DEVELOPMENT
PRO-
GRAM.— 
‘‘(A) IN
GENERAL.—For each security 
countermeasure (as defined in section 319F–2 
of the Public Health Service Act) that is pro-
cured under such section 319F–2, the Secretary 
shall initiate, in consultation with the security 
countermeasure sponsor (referred to in this sec-
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tion as the ‘countermeasure sponsor’), a pro-
gram of frequent scientific feedback and inter-
actions regarding the process of developing such 
countermeasure, including— 
‘‘(i) regular meetings between appro-
priate Food and Drug Administration per-
sonnel and the countermeasure sponsor 
during the process of developing the coun-
termeasure, to be scheduled within 45 days 
after attainment of each milestone identi-
fied pursuant to subparagraph (B)(iv)(I) 
in the regulatory management plan for the 
countermeasure; 
‘‘(ii) written feedback from the Food 
and Drug Administration within 30 days 
after submission of a request for feedback 
pursuant to subparagraph (B)(iv)(II) in 
the regulatory management plan for the 
countermeasure; 
‘‘(iii) written feedback from the Food 
and Drug Administration within 30 days 
after submission by the countermeasure 
sponsor of a study report that is consid-
ered to be complete pursuant to subpara-
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graph (B)(iv)(III) in the regulatory man-
agement plan for the countermeasure; 
‘‘(iv) at the request of the Director of 
the Biomedical Advanced Research and 
Development Authority, participation in 
meetings of such Authority on the develop-
ment of the countermeasure; and 
‘‘(v) other meetings, including on-site 
meetings, as appropriate. 
‘‘(B) REGULATORY MANAGEMENT PLAN.— 
In carrying out the program under subpara-
graph (A), the Secretary shall, in consultation 
with the countermeasure sponsor, develop a 
written regulatory management plan for each 
security countermeasure (as defined in section 
319F–2 of the Public Health Service Act) that 
is procured under such section 319F–2. The 
regulatory management plan shall be completed 
within 60 days of issuance of a contract for the 
countermeasure under such section 319F–2 or, 
for a countermeasure that was procured under 
such section 319F–2 before the date of the en-
actment of the Pandemic and All-Hazards Pre-
paredness Reauthorization Act of 2011, within 
60 days after such date of enactment. The reg-
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ulatory management plan for a security coun-
termeasure shall include— 
‘‘(i) an assessment of the current reg-
ulatory status, an assessment of known 
scientific gaps, and a proposed pathway to 
approval or licensure of the counter-
measure; 
‘‘(ii) guidance by the Food and Drug 
Administration regarding the data required 
to support delivery of the countermeasure 
to the Strategic National Stockpile; 
‘‘(iii) guidance 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 
‘‘(iv) an agreement between the Food 
and Drug Administration and the counter-
measure sponsor to identify— 
‘‘(I) 
developmental 
milestones 
that will trigger meetings between the 
Administration and the sponsor; 
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‘‘(II) the process for requesting 
and receiving written or oral feedback 
from the Administration; and 
‘‘(III) the type study reports that 
will be considered by the Administra-
tion to be complete. 
‘‘(C) APPLICABILITY TO CERTAIN QUALI-
FIED PANDEMIC OR EPIDEMIC PRODUCTS.—The 
Secretary may, with respect to qualified pan-
demic or epidemic products (as defined in sec-
tion 319F–3 of the Public Health Service Act) 
for which a contract for advanced research and 
development is entered into under section 319L 
of such Act, choose to apply the provisions of 
subparagraphs (A) and (B) to the same extent 
and in the same manner as such provisions 
apply with respect to security countermeasures. 
‘‘(d) FINAL GUIDANCE ON DEVELOPMENT OF ANI-
MAL MODELS.—Not later than 180 days after the date 
of the enactment of the Pandemic and All-Hazards Pre-
paredness Reauthorization Act of 2011, the Secretary 
shall provide final guidance to industry regarding the de-
velopment of animal models to support approval or licen-
sure of countermeasures and products referred to in sub-
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section (a) when human efficacy studies are not ethical 
or feasible. 
‘‘(e) ANNUAL REPORT.—Not later than January 1, 
2012, and every January 1 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 fiscal year, includes— 
‘‘(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 development of such 
countermeasures 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; 
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‘‘(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) any other measure to determine the effi-
ciency of the regulatory teams described in para-
graph (3); and 
‘‘(7) the regulatory science priorities which the 
Food and Drug Administration is addressing and 
the progress made on these priorities.’’. 
(b) DISCUSSIONS BETWEEN FDA AND SPONSOR ON 
DESIGN AND SIZE OF ANIMAL AND CLINICAL TRIALS IN-
TENDED TO FORM THE PRIMARY BASIS OF AN EFFEC-
TIVENESS CLAIM WHEN HUMAN EFFICACY STUDIES ARE 
NOT ETHICAL OR FEASIBLE.—Subparagraph (B) of sec-
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tion 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 and clinical trials intended to form 
the primary basis of an effectiveness claim 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.’’. 
Æ 
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