1.Short title; table of
contents
(a)This Act may be cited
as the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2011
.
(b)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 preparedness.
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.
2.Reauthorization
of certain provisions relating to public health preparedness
(a)Vaccine tracking
and distributionSubsection (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 securityEffective 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)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 paragraph (3), by striking (1)(A)(i)(I)
each
place it appears and inserting (1)(A)
.
(c)Partnerships for
State and regional hospital preparedness To improve surge
capacitySection 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)The requirements
of
; and
(B)by adding at the
end the following:
(2)Meeting goals of
National Health Security StrategyThe Secretary shall implement objective,
evidence-based metrics to ensure that entities receiving awards under this
section are meeting, to the extent practicable, the goals of the National
Health Security Strategy under section
2802.
;
and
(3)by amending
subsection (j)(1) to read as follows:
(1)For purposes of
carrying out this section, there is authorized to be appropriated $378,000,000
for each of fiscal years 2012 through
2016.
.
(d)CDC programs for
combating public health threatsSection 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 medical response curricula and trainingSection
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 strategySection 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 dental
health facilities
after mental health facilities
;
and
(B)in subparagraph
(D), by inserting (which may include dental health assets)
after
medical assets
.
(f)Procurement of
countermeasures
(1)Subclause (IX) of
section 319F–2(c)(7)(C)(ii) of the Public Health Service Act (42 U.S.C.
247d–6b(c)(7)(C)(ii)) is amended to read as follows:
(IX)The Secretary, in any
contract for procurement 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 dedicated by the Secretary for development and acquisition
of the countermeasure; and
(CC)the
specifications the countermeasure must meet to qualify for procurement 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 defined in paragraph
(1)(B).
.
(2)Reauthorization
of the special reserve fundSection 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
appears 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)
(1)Authorization of
appropriationsIn addition to
amounts appropriated to the special reserve 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 fundsNot later
than 15 days after any date on which the Secretary 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 Senate a report detailing the amount of
such funds available for procurement and the impact such funding will
have—
(A)in meeting the security countermeasure
needs identified under this section; and
(B)on the annual Countermeasure Implementation
Plan under section 2811(d).
(3)Use of special
reserve fund for advanced research and developmentThe
Secretary may utilize not more than 30 percent of the amounts authorized to be
appropriated under paragraph (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 fundsAmounts 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 development (under
section 319L) or for procurement of a security countermeasure under subsection
(c)(7); and
(B)any administrative
expenses, including salaries.
(5)In
this section, the term special reserve fund means the
Biodefense Countermeasures appropriations account, any
appropriation made available pursuant to section 521(a) of the Homeland
Security Act of 2002, and any appropriation made available pursuant to
paragraph (1) of this
paragraph.
.
(g)Emergency system
for advance registration of Volunteer Health
ProfessionalsSection 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 appropriated $5,900,000 for each of fiscal years 2012 through
2016
.
(h)Biomedical
Advanced Research and Development Authority
(1)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)In awarding contracts, grants, and cooperative agreements
under this section, the Secretary shall provide a clear statement of defined
Government purpose related to activities included in subsection (a)(6)(B) for a
qualified countermeasure or qualified pandemic or epidemic
product.
.
(2)Biodefense
Medical Countermeasure Development FundParagraph (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)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 provisionsSection 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-Hazards Preparedness Act
and inserting
September 30, 2016
.
(i)National
Disaster Medical SystemSection 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)The Secretary may determine and pay claims
for reimbursement for services under subparagraph (A) directly 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 timelineSection 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)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 , including drills and exercises to ensure medical
surge capacity 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, coordination, accessibility,
after
response capabilities,
;
(ii)by
striking including mental health facilities
and inserting
including mental health and ambulatory care facilities
;
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 coordinated medical triage and
evacuation to the appropriate medical institution based on patient medical need
as part of regional systems
.
(l)Volunteer
Medical Reserve CorpsSection 2813(i) of the Public Health
Service Act (42
U.S.C. 300hh–15(i)) is amended by striking $22,000,000
for fiscal 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 exemptionSection 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 on the date of enactment of
this Act
and inserting on September 30, 2016
.
3.Temporary
redeployment of personnel during a public health emergencySection 319 of the Public Health Service Act
(42 U.S.C.
247d) is amended by adding at the end the following:
(e)Temporary
redeployment of personnel during a public health emergency
(1)Emergency
redeployment of federally funded personnelNotwithstanding any other provision of law,
and subject to paragraph (2), upon a request that is from a State, locality,
territory, 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 immediately 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 Services.
(2)Activation of
emergency redeployment
(A)The Secretary may exercise the authority vested by
paragraph (1) only during the period of a public health emergency determined
pursuant to subsection (a).
(B)In
authorizing a temporary redeployment under paragraph (1), the Secretary shall
consider each of the following:
(i)The degree to which the emergency cannot be
adequately and appropriately addressed by the public health workforce.
(ii)The degree to which the emergency requires
or would otherwise benefit from supplemental staffing from those funded through
nonpreparedness Federal programs.
(iii)The degree to
which such programs would be adversely affected by the redeployment.
(iv)Such other
factors as the Secretary may deem appropriate.
(C)Termination and
extension
(i)The
authority to authorize a temporary redeployment of personnel under paragraph
(1) shall terminate upon the earlier of the following:
(I)The Secretary’s
determination that the public health emergency no longer exists.
(II)Subject to clause
(ii), 30 days after the activation of the Secretary’s authority pursuant to
subparagraph (A).
(ii)The Secretary may extend the authority to authorize a
temporary redeployment of personnel 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.
.
4.Coordination by
Assistant Secretary for Preparedness and Response
(a)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 inefficienciesIdentify
gaps, duplication, and other inefficiencies in public health preparedness
activities and the actions necessary to overcome these obstacles.
(E)Development of
Countermeasure Implementation PlanLead the development of a coordinated
Countermeasure Implementation Plan under subsection (d).
(F)Countermeasures
budget analysisOversee the
development of a comprehensive, cross-cutting 5-year budget analysis with
respect to activities described in paragraph (3)—
(i)to
inform prioritization of resources; and
(ii)to ensure that
challenges to such activities are adequately addressed.
(G)Grant programs
for medical and public health preparedness capabilitiesCoordinate, in consultation with the
Secretary of Homeland Security, grant programs of the Department of Health and
Human Services relating to medical and public health preparedness capabilities
and the activities 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 follows:
(c)The Assistant Secretary for Preparedness
and Response shall—
(1)have lead responsibility within the
Department 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 Pandemic and
All-Hazards Preparedness Act);
(B)the Hospital
Preparedness Cooperative 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 appropriate by the
Secretary.
;
and
(4)by adding at the
end the following:
(d)Countermeasure
implementation planNot 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 Committee on Health, Education, Labor, and Pensions of
the Senate a Countermeasure Implementation Plan that—
(1)describes the chemical, biological,
radiological, and nuclear threats facing the Nation and the corresponding
efforts to develop qualified countermeasures (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,
including research, advanced research, development, procurement, stockpiling,
deployment, and utilization;
(3)identifies and
prioritizes near-, mid-, and long-term needs with respect to such
countermeasures 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
countermeasure or product, and the required countermeasure or product
characteristics; and
(D)projected needs
with regard to the replenishment 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
defined 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
populations with respect to such countermeasures and products in the Strategic
National Stockpile and includes—
(A)a list of such
countermeasures and products necessary to address the needs of pediatric
populations;
(B)a description of
measures taken to coordinate with Office of Pediatric Therapeutics of the Food
and Drug Administration to maximize the labeling, dosages, and formulations of
such countermeasures and products for pediatric populations;
(C)a description of
existing gaps in the Strategic National Stockpile and the development 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 subparagraph
(C).
Notwithstanding any other provision
of this subsection, the Plan shall not include any confidential commercial
information, proprietary information, or information that could reveal
vulnerabilities of the Nation in the preparation for or ability to respond to
chemical, biological, radiological, or nuclear
threats..
(b)Consultation in
authorizing medical products for use in emergenciesSubsection
(c) of section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb–3) is amended by striking consultation 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)Not later than one year
after the date of the enactment of this Act, the Secretary 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
communications among disparate biosurveillance systems supported by the
Department of Health and Human Services.
5.Eliminating
duplicative Project Bioshield reportsSection 5 of the Project Bioshield Act of
2004 (42 U.S.C.
247d–6c) is repealed.
6.Authorization for
medical products for use in emergenciesSection 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 provision 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 subparagraph (A), by striking an emergency
justifying
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 significant potential for a public health
emergency, involving a heightened risk to national security or the health and
security of United States citizens abroad, and involving a biological,
chemical, 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)A declaration under
this subsection shall terminate upon a determination by the Secretary, in
consultation with, as appropriate, the Secretary of Homeland Security or the
Secretary of Defense, that the circumstances 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
inserting 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 respect to the
collection and analysis of information concerning the safety and effectiveness
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 paragraph (1)(B)
before the period at the end;
(ii)in
subparagraph (B)(i), by inserting , 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 distribution 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; prescription; practitioner’s
authorizationWith respect to
the emergency use of a product for which an authorization under this section is
issued (whether for an unapproved product or an unapproved use of an approved
product), the Secretary may waive or limit, to the extent appropriate given the
circumstances of the emergency—
(A)requirements
regarding current good manufacturing practice otherwise applicable to the
manufacture, processing, packing, or holding 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 section 503(b); and
(C)requirements
established under section 520(e).
;
and
(D)by adding at the
end the following:
(5)Nothing in this
section restricts any authority vested in the Secretary by any other provision
of this Act or the Public Health Service Act for establishing conditions of
authorization for a product.
;
and
(6)in subsection
(g)—
(A)in the heading, by
striking Revocation of
Authorization
and inserting Review, Modification, and Revocation of
Authorization
;
(B)in paragraph (1),
by striking periodically review
and inserting review not
less than every three years
; and
(C)by adding at the end the following:
(3)The
Secretary may modify an authorization under this section or the conditions of
such an authorization, at any time, based on a review of the authorization or
new information that is otherwise obtained, including information obtained
during an
emergency.
.
7.Additional
provisions related to medical products for emergency use
(a)The Federal Food,
Drug, and Cosmetic Act is amended by inserting after section 564
(21 U.S.C.
360bbb–3) the following:
564A.Additional
provisions related to medical products for emergency use
(a)For
purposes of this section:
(1)The term
product
means a drug, device, or biological product.
(2)The term
eligible product
means a product that is—
(A)approved or
cleared under this chapter or licensed under section 351 of the Public Health
Service Act; and
(B)intended to be
used to diagnose, prevent, 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 attack
with such an agent or agents; or
(ii)a
public health emergency affecting national security or the health and security
of United States citizens abroad.
(b)
(1)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 intended to support the United States’ ability to
protect—
(i)the public health;
or
(ii)military
preparedness and effectiveness; and
(C)the expiration
date extension is supported by an appropriate scientific evaluation that is
conducted or accepted by the Secretary.
(2)Requirements and
conditionsAny 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 include requirements for, or
conditions on, product sampling, storage, packaging or repackaging, transport,
labeling, notice to product recipients, recordkeeping, periodic testing or
retesting, or product disposition.
(3)Notwithstanding
any other provision of this Act or the Public Health Service Act, an eligible
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, with respect to such product, the Secretary has, under paragraph (1),
extended the expiration date and authorized the introduction or delivery for
introduction into interstate commerce of such product after the expiration date
provided by the manufacturer.
(c)Current good
manufacturing practices
(1)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 manufacturing practice requirements otherwise applicable to the
manufacture, processing, packing, or holding of products subject to regulation
under this Act, including 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)Notwithstanding
any other provision of this Act or the Public Health Service Act, an eligible
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, with respect to such product, the Secretary has authorized deviations
from current good manufacturing practices under paragraph (1).
(d)The requirements of section 503(b) and 520(e) shall
not apply to an eligible product, and the 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 it is dispensed without an
individual prescription, if—
(1)the product is
dispensed during an actual emergency described in subsection (a)(2)(B);
and
(2)such dispensing
without an individual prescription 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)The Secretary, acting through an appropriate official
within the Department of Health and Human Services, may create and issue
emergency use instructions to inform health care providers or individuals to
whom an eligible product is to be administered concerning such product’s
approved, licensed, or cleared conditions of use.
(2)Notwithstanding
any other provisions 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 instructions under paragraph (1) with respect to such product;
or
(B)the introduction
or delivery for introduction of such product into interstate commerce
accompanied by such instructions during an emergency response to an actual
emergency described in subsection
(a)(2)(B).
.
(b)Risk evaluation
and mitigation strategiesSection 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 emergenciesThe 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 applied, if the Secretary determines that such waiver is
required 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 biological, chemical, radiological, or nuclear agent, or an
actual or potential public health emergency affecting national security or the
health and security of United States citizens
abroad.
.
8.Products held for
emergency useThe 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:
564B.Products held
for emergency useIt 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.
.
9.Accelerate
countermeasure development by strengthening FDA’s role in reviewing products
for national security priorities
(a)Section 565 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amended
to read as follows:
565.Countermeasure
development and review
(a)Countermeasures
and productsThe countermeasures and products referred to in this
subsection 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)
(1)Involvement of
FDA personnel in interagency activitiesFor the purpose of accelerating 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 Administration personnel in interagency activities
with the Assistant Secretary for Preparedness and Response (including the
Biomedical Advanced Research and Development Authority), the Centers for
Disease Control and Prevention, the National Institutes of Health, and the
Department of Defense.
(2)The Secretary shall establish within the Food and Drug
Administration a team of experts on manufacturing and regulatory activities
(including compliance with current Good Manufacturing Practices) to provide
both off-site and on-site technical assistance to the manufacturers 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 Secretary determines that the provision of
such assistance would accelerate the development, manufacturing, or approval,
clearance, or licensure of countermeasures and products referred to in
subsection (a).
(c)Agency
interaction with security countermeasure sponsors
(1)For security countermeasures (as defined in section
319F–2 of the Public 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 licensure of the security
countermeasures;
(B)such feedback and interactions shall
include meetings and, in accordance with subsection (b)(2), on-site technical
assistance; and
(C)at the request of
the Secretary, the process under this paragraph shall include participation by
the Food and Drug Administration in meetings between the Biomedical Advanced
Research and Development Authority and sponsors on the development of such
countermeasures.
(2)Regulatory
management plan
(A)The process established under paragraph (1) shall allow
for the development of a written regulatory management plan (in this paragraph
referred to as the plan
) for a security countermeasure (as
defined in paragraph (1)) in accordance with this paragraph.
(B)Proposal and
finalization of planIn
carrying out the process under paragraph (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 retain 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
Secretary 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)The plan shall include an agreement on the
nature of, and timelines for, feedback and interactions between the sponsor and
the Food and Drug Administration, shall provide reasonable flexibility in
implementing and adjusting the agreement under this paragraph as warranted
during the countermeasure development process, and shall identify—
(i)the current regulatory status of the
countermeasure, an assessment of known scientific gaps relevant to approval,
clearance, or licensure of the countermeasure, and a proposed pathway to
approval, clearance, or licensure of the countermeasure;
(ii)developmental
milestones whose completion will result in meetings to be scheduled within a
reasonable time between the applicable review division of the Food and Drug
Administration and the sponsor;
(iii)sponsor
submissions that will result in written feedback from the review division
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 Service Act;
(v)feedback by the
Food and Drug Administration regarding data required to support submission of a
proposed agreement on the design and size of clinical trials for review under
section 505(b)(5)(B); and
(vi)other issues that
have the potential to delay approval, clearance, or licensure.
(D)Changes to the plan shall be made by
subsequent agreement between the Secretary and the sponsor. If after reasonable
attempts to negotiate changes to the plan the Secretary and the sponsor are
unable to finalize such changes, the Secretary shall provide to the sponsor, in
writing, the scientific or regulatory rationale why such changes are required
or cannot be included in the plan.
(3)Applicability to
certain qualified pandemic or epidemic productsThe 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
advanced 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
extent and in the same manner as such provisions apply with respect to security
countermeasures.
(d)Final Guidance
on development of animal models
(1)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 industry regarding the development of animal models to support
approval, clearance, or licensure of countermeasures and products referred to
in subsection (a) when human efficacy studies are not ethical or
feasible.
(2)Authority to
extend deadlineThe 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 Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and Pensions of
the Senate.
(e)Not later than January 1, 2013, and every 2 years
thereafter, the Secretary shall submit a report to the Committee on Energy and
Commerce 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, includes—
(1)the number of
full-time equivalent employees of the Food and Drug Administration who directly
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
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;
(5)the number, type,
and frequency of official interactions between the Food and Drug Administration
and—
(A)sponsors of a
countermeasure or product referred to in subsection (a); or
(B)another agency engaged in development or
management of portfolios for such countermeasures or products, including the
Centers for Disease Control and Prevention, the Biomedical Advanced Research
and Development Authority, the National Institutes of Health, and the
appropriate agencies of the Department of Defense;
(6)a description of other measures that, as
determined by the Secretary, are appropriate to determine the efficiency of the
regulatory teams described in paragraph (3); and
(7)the regulatory science priorities that
relate to countermeasures or products referred to in subsection (a) and which
the Food and Drug Administration is addressing and the progress made on these
priorities.
.
(b)Special protocol
assessmentSubparagraph (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
information 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.
Karen L. Haas,
Clerk