HR 2405 RFS 
‘‘(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).’’. 
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(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: 
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‘‘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: 
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‘‘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. 
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‘‘(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 
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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 
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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-
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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; 
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‘‘(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 
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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-
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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 
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‘‘(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 
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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: 
KAREN L. HAAS, 
Clerk. 
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