[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3678 Enrolled Bill (ENR)]
S.3678
One Hundred Ninth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and six
An Act
To amend the Public Health Service Act with respect to public health
security and all-hazards preparedness and response, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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(a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:

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8616d3e9188e021d0c66f0ecfe5711ebb9a605f13da78f7c9eef30b32b63e37b

of the Secretary of Health and Human Services.

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TITLE I

-NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP, ORGANIZATION,

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TITLE II

-PUBLIC HEALTH SECURITY PREPAREDNESS

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TITLE III

-ALL-HAZARDS MEDICAL SURGE CAPACITY

TITLE IV

-PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT

OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.
Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11
et seq.) is amended--
(1) by striking the title heading and inserting the following:
``TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH
EMERGENCIES'';
and
(2) by amending subtitle A to read as follows:
``Subtitle A--National All-Hazards Preparedness and Response Planning,
Coordinating, and Reporting
``SEC. 2801. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE
FUNCTIONS.
``(a) In General.--The Secretary of Health and Human Services shall
lead all Federal public health and medical response to public health
emergencies and incidents covered by the National Response Plan
developed pursuant to section 502(6) of the Homeland Security Act of
2002, or any successor plan.
``(b) Interagency Agreement.--The Secretary, in collaboration with
the Secretary of Veterans Affairs, the Secretary of Transportation, the
Secretary of Defense, the Secretary of Homeland Security, and the head
of any other relevant Federal agency, shall establish an interagency
agreement, consistent with the National Response Plan or any successor
plan, under which agreement the Secretary of Health and Human Services
shall assume operational control of emergency public health and medical
response assets, as necessary, in the event of a public health
emergency, except that members of the armed forces under the authority
of the Secretary of Defense shall remain under the command and control
of the Secretary of Defense, as shall any associated assets of the
Department of Defense.''.

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(a) Assistant Secretary for Preparedness and Response.--Subtitle B
of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11 et
seq.) is amended--
(1) in the subtitle heading, by inserting ``All-Hazards''
before ``Emergency Preparedness'';
(2) by redesignating section 2811 as section 2812;
(3) by inserting after the subtitle heading the following new
section:
``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-
HAZARDS PUBLIC HEALTH EMERGENCIES.
``(a) In General.--There is established within the Department of
Health and Human Services the position of the Assistant Secretary for
Preparedness and Response. The President, with the advice and consent
of the Senate, shall appoint an individual to serve in such position.
Such Assistant Secretary shall report to the Secretary.
``(b) Duties.--Subject to the authority of the Secretary, the
Assistant Secretary for Preparedness and Response shall carry out the
following functions:
``(1) Leadership.--Serve as the principal advisor to the
Secretary on all matters related to Federal public health and
medical preparedness and response for public health emergencies.
``(2) Personnel.--Register, credential, organize, train, equip,
and have the authority to deploy Federal public health and medical
personnel under the authority of the Secretary, including the
National Disaster Medical System, and coordinate such personnel
with the Medical Reserve Corps and the Emergency System for Advance
Registration of Volunteer Health Professionals.
``(3) Countermeasures.--Oversee advanced research, development,
and procurement of qualified countermeasures (as defined in section
319F-1) and qualified pandemic or epidemic products (as defined in
section 319F-3).
``(4) Coordination.--
``(A) Federal integration.--Coordinate with relevant
Federal officials to ensure integration of Federal preparedness
and response activities for public health emergencies.
``(B) State, local, and tribal integration.--Coordinate
with State, local, and tribal public health officials, the
Emergency Management Assistance Compact, health care systems,
and emergency medical service systems to ensure effective
integration of Federal public health and medical assets during
a public health emergency.
``(C) Emergency medical services.--Promote improved
emergency medical services medical direction, system
integration, research, and uniformity of data collection,
treatment protocols, and policies with regard to public health
emergencies.
``(5) Logistics.--In coordination with the Secretary of
Veterans Affairs, the Secretary of Homeland Security, the General
Services Administration, and other public and private entities,
provide logistical support for medical and public health aspects of
Federal responses to public health emergencies.
``(6) Leadership.--Provide leadership in international
programs, initiatives, and policies that deal with public health
and medical emergency preparedness and response.
``(c) Functions.--The Assistant Secretary for Preparedness and
Response shall--
``(1) 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); and
``(B) the Hospital Preparedness Cooperative Agreement
Program pursuant to section 319C-2;
``(2) exercise the responsibilities and authorities of the
Secretary with respect to the coordination of--
``(A) the Medical Reserve Corps pursuant to section 2813;
``(B) the Emergency System for Advance Registration of
Volunteer Health Professionals pursuant to section 319I;
``(C) the Strategic National Stockpile; and
``(D) the Cities Readiness Initiative; and
``(3) assume other duties as determined appropriate by the
Secretary.''; and
(4) by striking ``Assistant Secretary for Public Health
Emergency Preparedness'' each place it appears and inserting
``Assistant Secretary for Preparedness and Response''.
(b) Transfer of Functions; References.--
(1) Transfer of functions.--There shall be transferred to the
Office of the Assistant Secretary for Preparedness and Response the
functions, personnel, assets, and liabilities of the Assistant
Secretary for Public Health Emergency Preparedness as in effect on
the day before the date of enactment of this Act.
(2) References.--Any reference in any Federal law, Executive
order, rule, regulation, or delegation of authority, or any
document of or pertaining to the Assistant Secretary for Public
Health Emergency Preparedness as in effect the day before the date
of enactment of this Act, shall be deemed to be a reference to the
Assistant Secretary for Preparedness and Response.
(c) Stockpile.--Section 319F-2(a)(1) of the Public Health Service
Act (42 U.S.C. 247d-6b(a)(1)) is amended by--
(1) inserting ``in collaboration with the Director of the
Centers for Disease Control and Prevention, and'' after
``Secretary,''; and
(2) inserting at the end the following: ``The Secretary shall
conduct an annual review (taking into account at-risk individuals)
of the contents of the stockpile, including non-pharmaceutical
supplies, and make necessary additions or modifications to the
contents based on such review.''.
(d) At-Risk Individuals.--Title XXVIII of the Public Health Service
Act (42 U.S.C. 300hh et seq.), as amended by section 303 of this Act,
is amended by inserting after section 2813 the following:
``SEC. 2814. AT-RISK INDIVIDUALS.
``The Secretary, acting through such employee of the Department of
Health and Human Services as determined by the Secretary and designated
publicly (which may, at the discretion of the Secretary, involve the
appointment or designation of an individual as the Director of At-Risk
Individuals), shall--
``(1) oversee the implementation of the National Preparedness
goal of taking into account the public health and medical needs of
at-risk individuals in the event of a public health emergency, as
described in section 2802(b)(4);
``(2) assist other Federal agencies responsible for planning
for, responding to, and recovering from public health emergencies
in addressing the needs of at-risk individuals;
``(3) provide guidance to and ensure that recipients of State
and local public health grants include preparedness and response
strategies and capabilities that take into account the medical and
public health needs of at-risk individuals in the event of a public
health emergency, as described in section 319C-1(b)(2)(A)(iii);
``(4) ensure that the contents of the strategic national
stockpile take into account at-risk populations as described in
section 2811(b)(3)(B);
``(5) oversee the progress of the Advisory Committee on At-Risk
Individuals and Public Health Emergencies established under section
319F(b)(2) and make recommendations with a focus on opportunities
for action based on the work of the Committee;
``(6) oversee curriculum development for the public health and
medical response training program on medical management of
casualties, as it concerns at-risk individuals as described in
subparagraphs (A) through (C) of section 319F(a)(2);
``(7) disseminate novel and best practices of outreach to and
care of at-risk individuals before, during, and following public
health emergencies; and
``(8) not later than one year after the date of enactment of
the Pandemic and All-Hazards Preparedness Act, prepare and submit
to Congress a report describing the progress made on implementing
the duties described in this section.''.

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Title XXVIII of the Public Health Service Act (300hh-11 et seq.),
as amended by section 101, is amended by inserting after section 2801
the following:
``SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.
``(a) In General.--
``(1) Preparedness and response regarding public health
emergencies.--Beginning in 2009 and every four years thereafter,
the Secretary shall prepare and submit to the relevant committees
of Congress a coordinated strategy (to be known as the National
Health Security Strategy) and any revisions thereof, and an
accompanying implementation plan for public health emergency
preparedness and response. Such National Health Security Strategy
shall identify the process for achieving the preparedness goals
described in subsection (b) and shall be consistent with the
National Preparedness Goal, the National Incident Management
System, and the National Response Plan developed pursuant to
section 502(6) of the Homeland Security Act of 2002, or any
successor plan.
``(2) Evaluation of progress.--The National Health Security
Strategy shall include an evaluation of the progress made by
Federal, State, local, and tribal entities, based on the evidence-
based benchmarks and objective standards that measure levels of
preparedness established pursuant to section 319C-1(g). Such
evaluation shall include aggregate and State-specific breakdowns of
obligated funding spent by major category (as defined by the
Secretary) for activities funded through awards pursuant to
sections 319C-1 and 319C-2.
``(3) Public health workforce.--In 2009, the National Health
Security Strategy shall include a national strategy for
establishing an effective and prepared public health workforce,
including defining the functions, capabilities, and gaps in such
workforce, and identifying strategies to recruit, retain, and
protect such workforce from workplace exposures during public
health emergencies.
``(b) Preparedness Goals.--The National Health Security Strategy
shall include provisions in furtherance of the following:
``(1) Integration.--Integrating public health and public and
private medical capabilities with other first responder systems,
including through--
``(A) the periodic evaluation of Federal, State, local, and
tribal preparedness and response capabilities through drills
and exercises; and
``(B) integrating public and private sector public health
and medical donations and volunteers.
``(2) Public health.--Developing and sustaining Federal, State,
local, and tribal essential public health security capabilities,
including the following:
``(A) Disease situational awareness domestically and
abroad, including detection, identification, and investigation.
``(B) Disease containment including capabilities for
isolation, quarantine, social distancing, and decontamination.
``(C) Risk communication and public preparedness.
``(D) Rapid distribution and administration of medical
countermeasures.
``(3) Medical.--Increasing the preparedness, response
capabilities, and surge capacity of hospitals, other health care
facilities (including mental health facilities), and trauma care
and emergency medical service systems, with respect to public
health emergencies, which shall include developing plans for the
following:
``(A) Strengthening public health emergency medical
management and treatment capabilities.
``(B) Medical evacuation and fatality management.
``(C) Rapid distribution and administration of medical
countermeasures.
``(D) Effective utilization of any available public and
private mobile medical assets and integration of other Federal
assets.
``(E) Protecting health care workers and health care first
responders from workplace exposures during a public health
emergency.
``(4) At-risk individuals.--
``(A) Taking into account the public health and medical
needs of at-risk individuals in the event of a public health
emergency.
``(B) For purpose of this section and sections 319C-1,
319F, and 319L, the term `at-risk individuals' means children,
pregnant women, senior citizens and other individuals who have
special needs in the event of a public health emergency, as
determined by the Secretary.
``(5) Coordination.--Minimizing duplication of, and ensuring
coordination between, Federal, State, local, and tribal planning,
preparedness, and response activities (including the State
Emergency Management Assistance Compact). Such planning shall be
consistent with the National Response Plan, or any successor plan,
and National Incident Management System and the National
Preparedness Goal.
``(6) Continuity of operations.--Maintaining vital public
health and medical services to allow for optimal Federal, State,
local, and tribal operations in the event of a public health
emergency.''.

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IN PUBLIC HEALTH EMERGENCIES.
Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is
amended--
(1) in subsection (a)(1), by inserting ``domestically and
abroad'' after ``public health threats''; and
(2) by adding at the end the following:
``(d) Public Health Situational Awareness.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary, in collaboration with State, local, and tribal public
health officials, shall establish a near real-time electronic
nationwide public health situational awareness capability through
an interoperable network of systems to share data and information
to enhance early detection of rapid response to, and management of,
potentially catastrophic infectious disease outbreaks and other
public health emergencies that originate domestically or abroad.
Such network shall be built on existing State situational awareness
systems or enhanced systems that enable such connectivity.
``(2) Strategic plan.--Not later than 180 days after the date
of enactment the Pandemic and All-Hazards Preparedness Act, the
Secretary shall submit to the appropriate committees of Congress, a
strategic plan that demonstrates the steps the Secretary will
undertake to develop, implement, and evaluate the network described
in paragraph (1), utilizing the elements described in paragraph
(3).
``(3) Elements.--The network described in paragraph (1) shall
include data and information transmitted in a standardized format
from--
``(A) State, local, and tribal public health entities,
including public health laboratories;
``(B) Federal health agencies;
``(C) zoonotic disease monitoring systems;
``(D) public and private sector health care entities,
hospitals, pharmacies, poison control centers or professional
organizations in the field of poison control, and clinical
laboratories, to the extent practicable and provided that such
data are voluntarily provided simultaneously to the Secretary
and appropriate State, local, and tribal public health
agencies; and
``(E) such other sources as the Secretary may deem
appropriate.
``(4) Rule of construction.--Paragraph (3) shall not be
construed as requiring separate reporting of data and information
from each source listed.
``(5) Required activities.--In establishing and operating the
network described in paragraph (1), the Secretary shall--
``(A) utilize applicable interoperability standards as
determined by the Secretary through a joint public and private
sector process;
``(B) define minimal data elements for such network;
``(C) in collaboration with State, local, and tribal public
health officials, integrate and build upon existing State,
local, and tribal capabilities, ensuring simultaneous sharing
of data, information, and analyses from the network described
in paragraph (1) with State, local, and tribal public health
agencies; and
``(D) in collaboration with State, local, and tribal public
health officials, develop procedures and standards for the
collection, analysis, and interpretation of data that States,
regions, or other entities collect and report to the network
described in paragraph (1).
``(e) State and Regional Systems To Enhance Situational Awareness
in Public Health Emergencies.--
``(1) In general.--To implement the network described in
subsection (d), the Secretary may award grants to States or
consortia of States to enhance the ability of such States or
consortia of States to establish or operate a coordinated public
health situational awareness system for regional or Statewide early
detection of, rapid response to, and management of potentially
catastrophic infectious disease outbreaks and public health
emergencies, in collaboration with appropriate public health
agencies, sentinel hospitals, clinical laboratories, pharmacies,
poison control centers, other health care organizations, and animal
health organizations within such States.
``(2) Eligibility.--To be eligible to receive a grant under
paragraph (1), the State or consortium of States shall submit to
the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require, including
an assurance that the State or consortium of States will submit to
the Secretary--
``(A) reports of such data, information, and metrics as the
Secretary may require;
``(B) a report on the effectiveness of the systems funded
under the grant; and
``(C) a description of the manner in which grant funds will
be used to enhance the timelines and comprehensiveness of
efforts to detect, respond to, and manage potentially
catastrophic infectious disease outbreaks and public health
emergencies.
``(3) Use of funds.--A State or consortium of States that
receives an award under this subsection--
``(A) shall establish, enhance, or operate a coordinated
public health situational awareness system for regional or
Statewide early detection of, rapid response to, and management
of potentially catastrophic infectious disease outbreaks and
public health emergencies;
``(B) may award grants or contracts to entities described
in paragraph (1) within or serving such State to assist such
entities in improving the operation of information technology
systems, facilitating the secure exchange of data and
information, and training personnel to enhance the operation of
the system described in subparagraph (A); and
``(C) may conduct a pilot program for the development of
multi-State telehealth network test beds that build on,
enhance, and securely link existing State and local telehealth
programs to prepare for, monitor, respond to, and manage the
events of public health emergencies, facilitate coordination
and communication among medical, public health, and emergency
response agencies, and provide medical services through
telehealth initiatives within the States that are involved in
such a multi-State telehealth network test bed.
``(4) Limitation.--Information technology systems acquired or
implemented using grants awarded under this section must be
compliant with--
``(A) interoperability and other technological standards,
as determined by the Secretary; and
``(B) data collection and reporting requirements for the
network described in subsection (d).
``(5) Independent evaluation.--Not later than 4 years after the
date of enactment of the Pandemic and All-Hazards Preparedness Act,
the Government Accountability Office shall conduct an independent
evaluation, and submit to the Secretary and the appropriate
committees of Congress a report concerning the activities conducted
under this subsection and subsection (d).
``(f) Telehealth Enhancements for Emergency Response.--
``(1) Evaluation.--The Secretary, in consultation with the
Federal Communications Commission and other relevant Federal
agencies, shall--
``(A) conduct an inventory of telehealth initiatives in
existence on the date of enactment of the Pandemic and All-
Hazards Preparedness Act, including--
``(i) the specific location of network components;
``(ii) the medical, technological, and communications
capabilities of such components;
``(iii) the functionality of such components; and
``(iv) the capacity and ability of such components to
handle increased volume during the response to a public
health emergency;
``(B) identify methods to expand and interconnect the
regional health information networks funded by the Secretary,
the State and regional broadband networks funded through the
rural health care support mechanism pilot program funded by the
Federal Communications Commission, and other telehealth
networks;
``(C) evaluate ways to prepare for, monitor, respond
rapidly to, or manage the events of, a public health emergency
through the enhanced use of telehealth technologies, including
mechanisms for payment or reimbursement for use of such
technologies and personnel during public health emergencies;
``(D) identify methods for reducing legal barriers that
deter health care professionals from providing telemedicine
services, such as by utilizing State emergency health care
professional credentialing verification systems, encouraging
States to establish and implement mechanisms to improve
interstate medical licensure cooperation, facilitating the
exchange of information among States regarding investigations
and adverse actions, and encouraging States to waive the
application of licensing requirements during a public health
emergency;
``(E) evaluate ways to integrate the practice of
telemedicine within the National Disaster Medical System; and
``(F) promote greater coordination among existing Federal
interagency telemedicine and health information technology
initiatives.
``(2) Report.--Not later than 12 months after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary shall prepare and submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives
regarding the findings and recommendations pursuant to
subparagraphs (A) through (F) of paragraph (1).
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, such sums as may be necessary
in each of fiscal years 2007 through 2011.''.

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(a) Demonstration Project.--Subpart III of part D of title III of
the Public Health Service Act (42 U.S.C. 254l) is amended by adding at
the end the following:
``SEC. 338M. PUBLIC HEALTH DEPARTMENTS.
``(a) In General.--To the extent that funds are appropriated under
subsection (e), the Secretary shall establish a demonstration project
to provide for the participation of individuals who are eligible for
the Loan Repayment Program described in section 338B and who agree to
complete their service obligation in a State health department that
provides a significant amount of service to health professional
shortage areas or areas at risk of a public health emergency, as
determined by the Secretary, or in a local or tribal health department
that serves a health professional shortage area or an area at risk of a
public health emergency.
``(b) Procedure.--To be eligible to receive assistance under
subsection (a), with respect to the program described in section 338B,
an individual shall--
``(1) comply with all rules and requirements described in such
section (other than section 338B(f)(1)(B)(iv)); and
``(2) agree to serve for a time period equal to 2 years, or
such longer period as the individual may agree to, in a State,
local, or tribal health department, described in subsection (a).
``(c) Designations.--The demonstration project described in
subsection (a), and any healthcare providers who are selected to
participate in such project, shall not be considered by the Secretary
in the designation of health professional shortage areas under section
332 during fiscal years 2007 through 2010.
``(d) Report.--Not later than 3 years after the date of enactment
of this section, the Secretary shall submit a report to the relevant
committees of Congress that evaluates the participation of individuals
in the demonstration project under subsection (a), the impact of such
participation on State, local, and tribal health departments, and the
benefit and feasibility of permanently allowing such placements in the
Loan Repayment Program.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, such sums as may be necessary
for each of fiscal years 2007 through 2010.''.
(b) Grants for Loan Repayment Program.--Section 338I of the Public
Health Service Act (42 U.S.C. 254q-1) is amended by adding at the end
the following:
``(j) Public Health Loan Repayment.--
``(1) In general.--The Secretary may award grants to States for
the purpose of assisting such States in operating loan repayment
programs under which such States enter into contracts to repay all
or part of the eligible loans borrowed by, or on behalf of,
individuals who agree to serve in State, local, or tribal health
departments that serve health professional shortage areas or other
areas at risk of a public health emergency, as designated by the
Secretary.
``(2) Loans eligible for repayment.--To be eligible for
repayment under this subsection, a loan shall be a loan made,
insured, or guaranteed by the Federal Government that is borrowed
by, or on behalf of, an individual to pay the cost of attendance
for a program of education leading to a degree appropriate for
serving in a State, local, or tribal health department as
determined by the Secretary and the chief executive officer of the
State in which the grant is administered, at an institution of
higher education (as defined in section 102 of the Higher Education
Act of 1965), including principal, interest, and related expenses
on such loan.
``(3) Applicability of existing requirements.--With respect to
awards made under paragraph (1)--
``(A) the requirements of subsections (b), (f), and (g)
shall apply to such awards; and
``(B) the requirements of subsection (c) shall apply to
such awards except that with respect to paragraph (1) of such
subsection, the State involved may assign an individual only to
public and nonprofit private entities that serve health
professional shortage areas or areas at risk of a public health
emergency, as determined by the Secretary.
``(4) Authorization of appropriations.--There are authorized to
be appropriated to carry out this subsection, such sums as may be
necessary for each of fiscal years 2007 through 2010.''.

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(a) In General.--Section 319A of the Public Health Service Act (42
U.S.C. 247d-1) is amended to read as follows:
``SEC. 319A. VACCINE TRACKING AND DISTRIBUTION.
``(a) Tracking.--The Secretary, together with relevant
manufacturers, wholesalers, and distributors as may agree to cooperate,
may track the initial distribution of federally purchased influenza
vaccine in an influenza pandemic. Such tracking information shall be
used to inform Federal, State, local, and tribal decision makers during
an influenza pandemic.
``(b) Distribution.--The Secretary shall promote communication
between State, local, and tribal public health officials and such
manufacturers, wholesalers, and distributors as agree to participate,
regarding the effective distribution of seasonal influenza vaccine.
Such communication shall include estimates of high priority
populations, as determined by the Secretary, in State, local, and
tribal jurisdictions in order to inform Federal, State, local, and
tribal decision makers during vaccine shortages and supply disruptions.
``(c) Confidentiality.--The information submitted to the Secretary
or its contractors, if any, under this section or under any other
section of this Act related to vaccine distribution information shall
remain confidential in accordance with the exception from the public
disclosure of trade secrets, commercial or financial information, and
information obtained from an individual that is privileged and
confidential, as provided for in section 552(b)(4) of title 5, United
States Code, and subject to the penalties and exceptions under sections
1832 and 1833 of title 18, United States Code, relating to the
protection and theft of trade secrets, and subject to privacy
protections that are consistent with the regulations promulgated under
section 264(c) of the Health Insurance Portability and Accountability
Act of 1996. None of such information provided by a manufacturer,
wholesaler, or distributor shall be disclosed without its consent to
another manufacturer, wholesaler, or distributor, or shall be used in
any manner to give a manufacturer, wholesaler, or distributor a
proprietary advantage.
``(d) Guidelines.--The Secretary, in order to maintain the
confidentiality of relevant information and ensure that none of the
information contained in the systems involved may be used to provide
proprietary advantage within the vaccine market, while allowing State,
local, and tribal health officials access to such information to
maximize the delivery and availability of vaccines to high priority
populations, during times of influenza pandemics, vaccine shortages,
and supply disruptions, in consultation with manufacturers,
distributors, wholesalers and State, local, and tribal health
departments, shall develop guidelines for subsections (a) and (b).
``(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, such sums for each of fiscal
years 2007 through 2011.
``(f) Report to Congress.--As part of the National Health Security
Strategy described in section 2802, the Secretary shall provide an
update on the implementation of subsections (a) through (d).''.
(b) Conforming Amendments.--
(1) In general.--Title III of the Public Health Service Act (42
U.S.C. 241 et seq.) is amended by striking sections 319B and 319C.
(2) Technical amendment.--Section 319D(a)(3) of the Public
Health Service Act (42 U.S.C. 247d-4(a)(3)) is amended by striking
``, taking into account evaluations under section 319B(a),''.

2e222030dec2c7510f0b59ff7fb6581e20a23ed01aa7811b819b2a768e8977f1

The National Science Advisory Board for Biosecurity shall, when
requested by the Secretary of Health and Human Services, provide to
relevant Federal departments and agencies, advice, guidance, or
recommendations concerning--
(1) a core curriculum and training requirements for workers in
maximum containment biological laboratories; and
(2) periodic evaluations of maximum containment biological
laboratory capacity nationwide and assessments of the future need
for increased laboratory capacity.

9f01d308c8eeaeda87831fa86bedefa5056fcdc0177e659bd1cc598c928ca7d6

(a) Purpose.--It is the purpose of this section to improve the
force management and readiness of the Commissioned Corps to accomplish
the following objectives:
(1) To ensure the Corps is ready to respond rapidly to urgent
or emergency public health care needs and challenges.
(2) To ensure the availability of the Corps for assignments
that address clinical and public health needs in isolated,
hardship, and hazardous duty positions, and, when required, to
address needs related to the well-being, security, and defense of
the United States.
(3) To establish the Corps as a resource available to Federal
and State Government agencies for assistance in meeting public
health leadership and service roles.
(b) Commissioned Corps Readiness.--Title II of the Public Health
Service Act (42 U.S.C. 202 et seq.) is amended by inserting after
section 203 the following:
``SEC. 203A. DEPLOYMENT READINESS.
``(a) Readiness Requirements for Commissioned Corps Officers.--
``(1) In general.--The Secretary, with respect to members of
the following Corps components, shall establish requirements,
including training and medical examinations, to ensure the
readiness of such components to respond to urgent or emergency
public health care needs that cannot otherwise be met at the
Federal, State, and local levels:
``(A) Active duty Regular Corps.
``(B) Active Reserves.
``(2) Annual assessment of members.--The Secretary shall
annually determine whether each member of the Corps meets the
applicable readiness requirements established under paragraph (1).
``(3) Failure to meet requirements.--A member of the Corps who
fails to meet or maintain the readiness requirements established
under paragraph (1) or who fails to comply with orders to respond
to an urgent or emergency public health care need shall, except as
provided in paragraph (4), in accordance with procedures
established by the Secretary, be subject to disciplinary action as
prescribed by the Secretary.
``(4) Waiver of requirements.--
``(A) In general.--The Secretary may waive one or more of
the requirements established under paragraph (1) for an
individual who is not able to meet such requirements because
of--
``(i) a disability;
``(ii) a temporary medical condition; or
``(iii) any other extraordinary limitation as
determined by the Secretary.
``(B) Regulations.--The Secretary shall promulgate
regulations under which a waiver described in subparagraph (A)
may be granted.
``(5) Urgent or emergency public health care need.--For
purposes of this section and section 214, the term `urgent or
emergency public health care need' means a health care need, as
determined by the Secretary, arising as the result of--
``(A) a national emergency declared by the President under
the National Emergencies Act (50 U.S.C. 1601 et seq.);
``(B) an emergency or major disaster declared by the
President under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5121 et seq.);
``(C) a public health emergency declared by the Secretary
under section 319 of this Act; or
``(D) any emergency that, in the judgment of the Secretary,
is appropriate for the deployment of members of the Corps.
``(b) Corps Management for Deployment.--The Secretary shall--
``(1) organize members of the Corps into units for rapid
deployment by the Secretary to respond to urgent or emergency
public health care needs;
``(2) establish appropriate procedures for the command and
control of units or individual members of the Corps that are
deployed at the direction of the President or the Secretary in
response to an urgent or emergency public health care need of
national, State or local significance;
``(3) ensure that members of the Corps are trained, equipped
and otherwise prepared to fulfill their public health and emergency
response roles; and
``(4) ensure that deployment planning takes into account--
``(A) any deployment exemptions that may be granted by the
Secretary based on the unique requirements of an agency and an
individual's functional role in such agency; and
``(B) the nature of the urgent or emergency public health
care need.
``(c) Deployment of Detailed or Assigned Officers.--For purposes of
pay, allowances, and benefits of a Commissioned Corps officer who is
detailed or assigned to a Federal entity, the deployment of such
officer by the Secretary in response to an urgent or emergency public
health care need shall be deemed to be an authorized activity of the
Federal entity to which the officer is detailed or assigned.''.
(c) Personnel Deployment Authority.--
(1) Personnel detailed.--Section 214 of the Public Health
Service Act (42 U.S.C. 215) is amended by adding at the end the
following:
``(e) Except with respect to the United States Coast Guard and the
Department of Defense, and except as provided in agreements negotiated
with officials at agencies where officers of the Commissioned Corps may
be assigned, the Secretary shall have the sole authority to deploy any
Commissioned Corps officer assigned under this section to an entity
outside of the Department of Health and Human Services for service
under the Secretary's direction in response to an urgent or emergency
public health care need (as defined in section 203A(a)(5)).''.
(2) National health service corps.--Section 331(f) of the
Public Health Service Act (42 U.S.C. 254d(f)(1)) is amended by
inserting before the period the following: ``, except when such
members are Commissioned Corps officers who entered into a contract
with Secretary under section 338A or 338B after December 31, 2006
and when the Secretary determines that exercising the authority
provided under section 214 or 216 with respect to any such officer
to would not cause unreasonable disruption to health care services
provided in the community in which such officer is providing health
care services''.

b28582ba71a7c339bb1cfad642371d79787f2036b501925de15fa5195958fc3f

(a) National Disaster Medical System.--Section 2812 of subtitle B
of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11 et
seq.), as redesignated by section 102, is amended--
(1) by striking the section heading and inserting ``national
disaster medical system'';
(2) by striking subsection (a);
(3) by redesignating subsections (b) through (h) as subsections
(a) through (g);
(4) in subsection (a), as so redesignated--
(A) in paragraph (2)(B), by striking ``Federal Emergency
Management Agency'' and inserting ``Department of Homeland
Security''; and
(B) in paragraph (3)(C), by striking ``Public Health
Security and Bioterrorism Preparedness and Response Act of
2002'' and inserting ``Pandemic and All-Hazards Preparedness
Act'';
(5) in subsection (b), as so redesignated, by--
(A) striking the subsection heading and inserting
``Modifications'';
(B) redesignating paragraph (2) as paragraph (3); and
(C) striking paragraph (1) and inserting the following:
``(1) In general.--Taking into account the findings from the
joint review described under paragraph (2), the Secretary shall
modify the policies of the National Disaster Medical System as
necessary.
``(2) Joint review and medical surge capacity strategic plan.--
Not later than 180 days after the date of enactment of the Pandemic
and All-Hazards Preparedness Act, the Secretary, in coordination
with the Secretary of Homeland Security, the Secretary of Defense,
and the Secretary of Veterans Affairs, shall conduct a joint review
of the National Disaster Medical System. Such review shall include
an evaluation of medical surge capacity, as described by section
2803(a). As part of the National Health Security Strategy under
section 2802, the Secretary shall update the findings from such
review and further modify the policies of the National Disaster
Medical System as necessary.'';
(6) by striking ``subsection (b)'' each place it appears and
inserting ``subsection (a)'';
(7) by striking ``subsection (d)'' each place it appears and
inserting ``subsection (c)''; and
(8) in subsection (g), as so redesignated, by striking ``2002
through 2006'' and inserting ``2007 through 2011''.
(b) Transfer of National Disaster Medical System to the Department
of Health and Human Services.--There shall be transferred to the
Secretary of Health and Human Services the functions, personnel,
assets, and liabilities of the National Disaster Medical System of the
Department of Homeland Security, including the functions of the
Secretary of Homeland Security and the Under Secretary for Emergency
Preparedness and Response relating thereto.
(c) Conforming Amendments to the Homeland Security Act of 2002.--
The Homeland Security Act of 2002 (6 U.S.C. 312(3)(B), 313(5)) is
amended--
(1) in section 502(3)(B), by striking ``, the National Disaster
Medical System,''; and
(2) in section 503(5), by striking ``, the National Disaster
Medical System''.
(d) Update of Certain Provision.--Section 319F(b)(2) of the Public
Health Service Act (42 U.S.C. 247d-6(b)(2)) is amended--
(1) in the paragraph heading, by striking ``Children and
terrorism'' and inserting ``At-risk individuals and public health
emergencies'';
(2) in subparagraph (A), by striking ``Children and Terrorism''
and inserting ``At-Risk Individuals and Public Health
Emergencies'';
(3) in subparagraph (B)--
(A) in clause (i), by striking ``bioterrorism as it relates
to children'' and inserting ``public health emergencies as they
relate to at-risk individuals'';
(B) in clause (ii), by striking ``children'' and inserting
``at-risk individuals''; and
(C) in clause (iii), by striking ``children'' and inserting
``at-risk individuals'';
(4) in subparagraph (C), by striking ``children'' and all that
follows through the period and inserting ``at-risk populations.'';
and
(5) in subparagraph (D), by striking ``one year'' and inserting
``six years''.
(e) Conforming Amendment.--Section 319F(b)(3)(B) of the Public
Health Service Act (42 U.S.C. 247d-6(b)(3)(B)) is amended by striking
``and the working group under subsection (a)''.
(f) Effective Date.--The amendments made by subsections (b) and (c)
shall take effect on January 1, 2007.

804822552bbeb970993f19091dbf0c09509007d730cdb11a7775ec117e144e63

(a) In General.--Title XXVIII of the Public Health Service Act
(300hh-11 et seq.), as amended by section 103, is amended by inserting
after section 2802 the following:
``SEC. 2803. ENHANCING MEDICAL SURGE CAPACITY.
``(a) Study of Enhancing Medical Surge Capacity.--As part of the
joint review described in section 2812(b), the Secretary shall evaluate
the benefits and feasibility of improving the capacity of the
Department of Health and Human Services to provide additional medical
surge capacity to local communities in the event of a public health
emergency. Such study shall include an assessment of the need for and
feasibility of improving surge capacity through--
``(1) acquisition and operation of mobile medical assets by the
Secretary to be deployed, on a contingency basis, to a community in
the event of a public health emergency;
``(2) integrating the practice of telemedicine within the
National Disaster Medical System; and
``(3) other strategies to improve such capacity as determined
appropriate by the Secretary.
``(b) Authority To Acquire and Operate Mobile Medical Assets.--In
addition to any other authority to acquire, deploy, and operate mobile
medical assets, the Secretary may acquire, deploy, and operate mobile
medical assets if, taking into consideration the evaluation conducted
under subsection (a), such acquisition, deployment, and operation is
determined to be beneficial and feasible in improving the capacity of
the Department of Health and Human Services to provide additional
medical surge capacity to local communities in the event of a public
health emergency.
``(c) Using Federal Facilities To Enhance Medical Surge Capacity.--
``(1) Analysis.--The Secretary shall conduct an analysis of
whether there are Federal facilities which, in the event of a
public health emergency, could practicably be used as facilities in
which to provide health care.
``(2) Memoranda of understanding.--If, based on the analysis
conducted under paragraph (1), the Secretary determines that there
are Federal facilities which, in the event of a public health
emergency, could be used as facilities in which to provide health
care, the Secretary shall, with respect to each such facility, seek
to conclude a memorandum of understanding with the head of the
Department or agency that operates such facility that permits the
use of such facility to provide health care in the event of a
public health emergency.''.
(b) EMTALA.--
(1) In general.--Section 1135(b) of the Social Security Act (42
U.S.C. 1320b-5(b)) is amended--
(A) in paragraph (3), by striking subparagraph (B) and
inserting the following:
``(B) the direction or relocation of an individual to
receive medical screening in an alternative location--
``(i) pursuant to an appropriate State emergency
preparedness plan; or
``(ii) in the case of a public health emergency
described in subsection (g)(1)(B) that involves a pandemic
infectious disease, pursuant to a State pandemic
preparedness plan or a plan referred to in clause (i),
whichever is applicable in the State;'';
(B) in the third sentence, by striking ``and shall be
limited to'' and inserting ``and, except in the case of a
waiver or modification to which the fifth sentence of this
subsection applies, shall be limited to''; and
(C) by adding at the end the following: ``If a public
health emergency described in subsection (g)(1)(B) involves a
pandemic infectious disease (such as pandemic influenza), the
duration of a waiver or modification under paragraph (3) shall
be determined in accordance with subsection (e) as such
subsection applies to public health emergencies.''.
(2) Effective date.--The amendments made by paragraph (1) shall
take effect on the date of the enactment of this Act and shall
apply to public health emergencies declared pursuant to section 319
of the Public Health Service Act (42 U.S.C. 247d) on or after such
date.

e2e2cfc4f18fa4652eee0bfb781f61d6e6c5a48d6b2c3611dcccee89f8ea0576

(a) Volunteer Medical Reserve Corps.--Title XXVIII of the Public
Health Service Act (42 U.S.C. 300hh-11 et seq.), as amended by this
Act, is amended by inserting after section 2812 the following:
``SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.
``(a) In General.--Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary, in collaboration with State, local, and tribal officials,
shall build on State, local, and tribal programs in existence on the
date of enactment of such Act to establish and maintain a Medical
Reserve Corps (referred to in this section as the `Corps') to provide
for an adequate supply of volunteers in the case of a Federal, State,
local, or tribal public health emergency. The Corps shall be headed by
a Director who shall be appointed by the Secretary and shall oversee
the activities of the Corps chapters that exist at the State, local,
and tribal levels.
``(b) State, Local, and Tribal Coordination.--The Corps shall be
established using existing State, local, and tribal teams and shall not
alter such teams.
``(c) Composition.--The Corps shall be composed of individuals
who--
``(1)(A) are health professionals who have appropriate
professional training and expertise as determined appropriate by
the Director of the Corps; or
``(B) are non-health professionals who have an interest in
serving in an auxiliary or support capacity to facilitate access to
health care services in a public health emergency;
``(2) are certified in accordance with the certification
program developed under subsection (d);
``(3) are geographically diverse in residence;
``(4) have registered and carry out training exercises with a
local chapter of the Medical Reserve Corps; and
``(5) indicate whether they are willing to be deployed outside
the area in which they reside in the event of a public health
emergency.
``(d) Certification; Drills.--
``(1) Certification.--The Director, in collaboration with
State, local, and tribal officials, shall establish a process for
the periodic certification of individuals who volunteer for the
Corps, as determined by the Secretary, which shall include the
completion by each individual of the core training programs
developed under section 319F, as required by the Director. Such
certification shall not supercede State licensing or credentialing
requirements.
``(2) Drills.--In conjunction with the core training programs
referred to in paragraph (1), and in order to facilitate the
integration of trained volunteers into the health care system at
the local level, Corps members shall engage in periodic training
exercises to be carried out at the local level.
``(e) Deployment.--During a public health emergency, the Secretary
shall have the authority to activate and deploy willing members of the
Corps to areas of need, taking into consideration the public health and
medical expertise required, with the concurrence of the State, local,
or tribal officials from the area where the members reside.
``(f) Expenses and Transportation.--While engaged in performing
duties as a member of the Corps pursuant to an assignment by the
Secretary (including periods of travel to facilitate such assignment),
members of the Corps who are not otherwise employed by the Federal
Government shall be allowed travel or transportation expenses,
including per diem in lieu of subsistence.
``(g) Identification.--The Secretary, in cooperation and
consultation with the States, shall develop a Medical Reserve Corps
Identification Card that describes the licensure and certification
information of Corps members, as well as other identifying information
determined necessary by the Secretary.
``(h) Intermittent Disaster-Response Personnel.--
``(1) In general.--For the purpose of assisting the Corps in
carrying out duties under this section, during a public health
emergency, the Secretary may appoint selected individuals to serve
as intermittent personnel of such Corps in accordance with
applicable civil service laws and regulations. In all other cases,
members of the Corps are subject to the laws of the State in which
the activities of the Corps are undertaken.
``(2) Applicable protections.--Subsections (c)(2), (d), and (e)
of section 2812 shall apply to an individual appointed under
paragraph (1) in the same manner as such subsections apply to an
individual appointed under section 2812(c).
``(3) Limitation.--State, local, and tribal officials shall
have no authority to designate a member of the Corps as Federal
intermittent disaster-response personnel, but may request the
services of such members.
``(i) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $22,000,000 for fiscal year
2007, and such sums as may be necessary for each of fiscal years 2008
through 2011.''.
(b) Encouraging Health Professions Volunteers.--Section 319I of the
Public Health Service Act (42 U.S.C. 247d-7b) is amended--
(1) by redesignating subsections (e) and (f) as subsections (j)
and (k), respectively;
(2) by striking subsections (a) and (b) and inserting the
following:
``(a) In General.--Not later than 12 months after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary shall link existing State verification systems to maintain a
single national interoperable network of systems, each system being
maintained by a State or group of States, for the purpose of verifying
the credentials and licenses of health care professionals who volunteer
to provide health services during a public health emergency.
``(b) Requirements.--The interoperable network of systems
established under subsection (a) (referred to in this section as the
`verification network') shall include--
``(1) with respect to each volunteer health professional
included in the verification network--
``(A) information necessary for the rapid identification
of, and communication with, such professionals; and
``(B) the credentials, certifications, licenses, and
relevant training of such individuals; and
``(2) the name of each member of the Medical Reserve Corps, the
National Disaster Medical System, and any other relevant federally-
sponsored or administered programs determined necessary by the
Secretary.'';
(3) in subsection (c), strike ``system'' and insert
``network''; and
(4) by striking subsection (d) and inserting the following:
``(d) Accessibility.--The Secretary shall ensure that the
verification network is electronically accessible by State, local, and
tribal health departments and can be linked with the identification
cards under section 2813.
``(e) Confidentiality.--The Secretary shall establish and require
the application of and compliance with measures to ensure the effective
security of, integrity of, and access to the data included in the
verification network.
``(f) Coordination.--The Secretary shall coordinate with the
Secretary of Veterans Affairs and the Secretary of Homeland Security to
assess the feasibility of integrating the verification network under
this section with the VetPro system of the Department of Veterans
Affairs and the National Emergency Responder Credentialing System of
the Department of Homeland Security. The Secretary shall, if feasible,
integrate the verification network under this section with such VetPro
system and the National Emergency Responder Credentialing System.
``(g) Updating of Information.--The States that are participants in
the verification network shall, on at least a quarterly basis, work
with the Director to provide for the updating of the information
contained in the verification network.
``(h) Clarification.--Inclusion of a health professional in the
verification network shall not constitute appointment of such
individual as a Federal employee for any purpose, either under section
2812(c) or otherwise. Such appointment may only be made under section
2812 or 2813.
``(i) Health Care Provider Licenses.--The Secretary shall encourage
States to establish and implement mechanisms to waive the application
of licensing requirements applicable to health professionals, who are
seeking to provide medical services (within their scope of practice),
during a national, State, local, or tribal public health emergency upon
verification that such health professionals are licensed and in good
standing in another State and have not been disciplined by any State
health licensing or disciplinary board.''; and
(5) in subsection (k) (as so redesignated), by striking
``2006'' and inserting ``2011''.

4648f19e18ce129630c2552273f06ff8d686e5340faf833d28d207af701e5475

Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is
amended--
(1) by striking subsection (a) and inserting the following:
``(a) All-Hazards Public Health and Medical Response Curricula and
Training.--
``(1) In general.--The Secretary, in collaboration with the
Secretary of Defense, and in consultation with relevant public and
private entities, shall develop core health and medical response
curricula and trainings by adapting applicable existing curricula
and training programs to improve responses to public health
emergencies.
``(2) Curriculum.--The public health and medical response
training program may include course work related to--
``(A) medical management of casualties, taking into account
the needs of at-risk individuals;
``(B) public health aspects of public health emergencies;
``(C) mental health aspects of public health emergencies;
``(D) national incident management, including coordination
among Federal, State, local, tribal, international agencies,
and other entities; and
``(E) protecting health care workers and health care first
responders from workplace exposures during a public health
emergency.
``(3) Peer review.--On a periodic basis, products prepared as
part of the program shall be rigorously tested and peer-reviewed by
experts in the relevant fields.
``(4) Credit.--The Secretary and the Secretary of Defense
shall--
``(A) take into account continuing professional education
requirements of public health and healthcare professions; and
``(B) cooperate with State, local, and tribal accrediting
agencies and with professional associations in arranging for
students enrolled in the program to obtain continuing
professional education credit for program courses.
``(5) Dissemination and training.--
``(A) In general.--The Secretary may provide for the
dissemination and teaching of the materials described in
paragraphs (1) and (2) by appropriate means, as determined by
the Secretary.
``(B) Certain entities.--The education and training
activities described in subparagraph (A) may be carried out by
Federal public health or medical entities, appropriate
educational entities, professional organizations and societies,
private accrediting organizations, and other nonprofit
institutions or entities meeting criteria established by the
Secretary.
``(C) Grants and contracts.--In carrying out this
subsection, the Secretary may carry out activities directly or
through the award of grants and contracts, and may enter into
interagency agreements with other Federal agencies.''.
(2) by striking subsections (c) through (g) and inserting the
following:
``(c) Expansion of Epidemic Intelligence Service Program.--The
Secretary may establish 20 officer positions in the Epidemic
Intelligence Service Program, in addition to the number of the officer
positions offered under such Program in 2006, for individuals who agree
to participate, for a period of not less than 2 years, in the Career
Epidemiology Field Officer program in a State, local, or tribal health
department that serves a health professional shortage area (as defined
under section 332(a)), a medically underserved population (as defined
under section 330(b)(3)), or a medically underserved area or area at
high risk of a public health emergency as designated by the Secretary.
``(d) Centers for Public Health Preparedness; Core Curricula and
Training.--
``(1) In general.--The Secretary may establish at accredited
schools of public health, Centers for Public Health Preparedness
(hereafter referred to in this section as the `Centers').
``(2) Eligibility.--To be eligible to receive an award under
this subsection to establish a Center, an accredited school of
public health shall agree to conduct activities consistent with the
requirements of this subsection.
``(3) Core curricula.--The Secretary, in collaboration with the
Centers and other public or private entities shall establish core
curricula based on established competencies leading to a 4-year
bachelor's degree, a graduate degree, a combined bachelor and
master's degree, or a certificate program, for use by each Center.
The Secretary shall disseminate such curricula to other accredited
schools of public health and other health professions schools
determined appropriate by the Secretary, for voluntary use by such
schools.
``(4) Core competency-based training program.--The Secretary,
in collaboration with the Centers and other public or private
entities shall facilitate the development of a competency-based
training program to train public health practitioners. The Centers
shall use such training program to train public health
practitioners. The Secretary shall disseminate such training
program to other accredited schools of public health, health
professions schools, and other public or private entities as
determined by the Secretary, for voluntary use by such entities.
``(5) Content of core curricula and training program.--The
Secretary shall ensure that the core curricula and training program
established pursuant to this subsection respond to the needs of
State, local, and tribal public health authorities and integrate
and emphasize essential public health security capabilities
consistent with section 2802(b)(2).
``(6) Academic-workforce communication.--As a condition of
receiving funding from the Secretary under this subsection, a
Center shall collaborate with a State, local, or tribal public
health department to--
``(A) define the public health preparedness and response
needs of the community involved;
``(B) assess the extent to which such needs are fulfilled
by existing preparedness and response activities of such school
or health department, and how such activities may be improved;
``(C) prior to developing new materials or trainings,
evaluate and utilize relevant materials and trainings developed
by others Centers; and
``(D) evaluate community impact and the effectiveness of
any newly developed materials or trainings.
``(7) Public health systems research.--In consultation with
relevant public and private entities, the Secretary shall define
the existing knowledge base for public health preparedness and
response systems, and establish a research agenda based on Federal,
State, local, and tribal public health preparedness priorities. As
a condition of receiving funding from the Secretary under this
subsection, a Center shall conduct public health systems research
that is consistent with the agenda described under this
paragraph.'';
(3) by redesignating subsection (h) as subsection (e);
(4) by inserting after subsection (e) (as so redesignated), the
following:
``(f) Authorization of Appropriations.--
``(1) Fiscal year 2007.--There are authorized to be
appropriated to carry out this section for fiscal year 2007--
``(A) to carry out subsection (a)--
``(i) $5,000,000 to carry out paragraphs (1) through
(4); and
``(ii) $7,000,000 to carry out paragraph (5);
``(B) to carry out subsection (c), $3,000,000; and
``(C) to carry out subsection (d), $31,000,000, of which
$5,000,000 shall be used to carry out paragraphs (3) through
(5) of such subsection.
``(2) Subsequent fiscal years.--There are authorized to be
appropriated such sums as may be necessary to carry out this
section for fiscal year 2008 and each subsequent fiscal year.'';
and
(5) by striking subsections (i) and (j).

ada0c9b39a19ea9908ae58482b6a37540ddc6b6442d36bccda63bd895cf8c33d

IMPROVE SURGE CAPACITY.
Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b)
is amended to read as follows:
``SEC. 319C-2. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL
PREPAREDNESS TO IMPROVE SURGE CAPACITY.
``(a) In General.--The Secretary shall award competitive grants or
cooperative agreements to eligible entities to enable such entities to
improve surge capacity and enhance community and hospital preparedness
for public health emergencies.
``(b) Eligibility.--To be eligible for an award under subsection
(a), an entity shall--
``(1)(A) be a partnership consisting of--
``(i) one or more hospitals, at least one of which shall be
a designated trauma center, consistent with section 1213(c);
``(ii) one or more other local health care facilities,
including clinics, health centers, primary care facilities,
mental health centers, mobile medical assets, or nursing homes;
and
``(iii)(I) one or more political subdivisions;
``(II) one or more States; or
``(III) one or more States and one or more political
subdivisions; and
``(B) prepare, in consultation with the Chief Executive Officer
and the lead health officials of the State, District, or territory
in which the hospital and health care facilities described in
subparagraph (A) are located, and submit to the Secretary, an
application at such time, in such manner, and containing such
information as the Secretary may require; or
``(2)(A) be an entity described in section 319C-1(b)(1); and
``(B) submit an application at such time, in such manner, and
containing such information as the Secretary may require, including
the information or assurances required under section 319C-1(b)(2)
and an assurance that the State will adhere to any applicable
guidelines established by the Secretary.
``(c) Use of Funds.--An award under subsection (a) shall be
expended for activities to achieve the preparedness goals described
under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).
``(d) Preferences.--
``(1) Regional coordination.--In making awards under subsection
(a), the Secretary shall give preference to eligible entities that
submit applications that, in the determination of the Secretary--
``(A) will enhance coordination--
``(i) among the entities described in subsection
(b)(1)(A)(i); and
``(ii) between such entities and the entities described
in subsection (b)(1)(A)(ii); and
``(B) include, in the partnership described in subsection
(b)(1)(A), a significant percentage of the hospitals and health
care facilities within the geographic area served by such
partnership.
``(2) Other preferences.--In making awards under subsection
(a), the Secretary shall give preference to eligible entities that,
in the determination of the Secretary--
``(A) include one or more hospitals that are participants
in the National Disaster Medical System;
``(B) are located in a geographic area that faces a high
degree of risk, as determined by the Secretary in consultation
with the Secretary of Homeland Security; or
``(C) have a significant need for funds to achieve the
medical preparedness goals described in section 2802(b)(3).
``(e) Consistency of Planned Activities.--The Secretary may not
award a cooperative agreement to an eligible entity described in
subsection (b)(1) unless the application submitted by the entity is
coordinated and consistent with an applicable State All-Hazards Public
Health Emergency Preparedness and Response Plan and relevant local
plans, as determined by the Secretary in consultation with relevant
State health officials.
``(f) Limitation on Awards.--A political subdivision shall not
participate in more than one partnership described in subsection
(b)(1).
``(g) Coordination With Local Response Capabilities.--An eligible
entity shall, to the extent practicable, ensure that activities carried
out under an award under subsection (a) are coordinated with activities
of relevant local Metropolitan Medical Response Systems, local Medical
Reserve Corps, the Cities Readiness Initiative, and local emergency
plans.
``(h) Maintenance of Funding.--
``(1) In general.--An entity that receives an award under this
section shall maintain expenditures for health care preparedness at
a level that is not less than the average level of such
expenditures maintained by the entity for the preceding 2 year
period.
``(2) Rule of construction.--Nothing in this section shall be
construed to prohibit the use of awards under this section to pay
salary and related expenses of public health and other
professionals employed by State, local, or tribal agencies who are
carrying out activities supported by such awards (regardless of
whether the primary assignment of such personnel is to carry out
such activities).
``(i) Performance and Accountability.--The requirements of section
319C-1(g), (j), and (k) shall apply to entities receiving awards under
this section (regardless of whether such entities are described under
subsection (b)(1)(A) or (b)(2)(A)) in the same manner as such
requirements apply to entities under section 319C-1. An entity
described in subsection (b)(1)(A) shall make such reports available to
the lead health official of the State in which such partnership is
located.
``(j) Authorization of Appropriations.--
``(1) In general.--For the purpose of carrying out this
section, there is authorized to be appropriated $474,000,000 for
fiscal year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2011.
``(2) Reservation of amounts for partnerships.--Prior to making
awards described in paragraph (3), the Secretary may reserve from
the amount appropriated under paragraph (1) for a fiscal year, an
amount determined appropriate by the Secretary for making awards to
entities described in subsection (b)(1)(A).
``(3) Awards to states and political subdivisions.--
``(A) In general.--From amounts appropriated for a fiscal
year under paragraph (1) and not reserved under paragraph (2),
the Secretary shall make awards to entities described in
subsection (b)(2)(A) that have completed an application as
described in subsection (b)(2)(B).
``(B) Amount.--The Secretary shall determine the amount of
an award to each entity described in subparagraph (A) in the
same manner as such amounts are determined under section 319C-
1(h).''.

3ad4ead82c7c9d522b8ca256e604e75aeff0c4d44c7badc42e7f6386be995f3b

(a) In General.--Section 8117 of title 38, United States Code, is
amended--
(1) in subsection (a)--
(A) in paragraph (1), by--
(i) striking ``chemical or biological attack'' and
inserting ``a public health emergency (as defined in
section 2801 of the Public Health Service Act)'';
(ii) striking ``an attack'' and inserting ``such an
emergency''; and
(iii) striking ``public health emergencies'' and
inserting ``such emergencies''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``; and'' and
inserting a semicolon;
(ii) in subparagraph (B), by striking the period and
inserting a semicolon; and
(iii) by adding at the end the following:
``(C) organizing, training, and equipping the staff of such
centers to support the activities carried out by the Secretary
of Health and Human Services under section 2801 of the Public
Health Service Act in the event of a public health emergency
and incidents covered by the National Response Plan developed
pursuant to section 502(6) of the Homeland Security Act of
2002, or any successor plan; and
``(D) providing medical logistical support to the National
Disaster Medical System and the Secretary of Health and Human
Services as necessary, on a reimbursable basis, and in
coordination with other designated Federal agencies.'';
(2) in subsection (c), by striking ``a chemical or biological
attack or other terrorist attack.'' and inserting ``a public health
emergency. The Secretary shall, through existing medical
procurement contracts, and on a reimbursable basis, make available
as necessary, medical supplies, equipment, and pharmaceuticals in
response to a public health emergency in support of the Secretary
of Health and Human Services.'';
(3) in subsection (d), by--
(A) striking ``develop and'';
(B) striking ``biological, chemical, or radiological
attacks'' and inserting ``public health emergencies''; and
(C) by inserting ``consistent with section 319F(a) of the
Public Health Service Act'' before the period; and
(4) in subsection (e)--
(A) in paragraph (1), by striking ``2811(b)'' and inserting
``2812''; and
(B) in paragraph (2)--
(i) by striking ``bioterrorism and other''; and
(ii) by striking ``319F(a)'' and inserting ``319F''.
(b) Authorization of Appropriations.--Section 8117 of title 38,
United States Code, is amended by adding at the end the following:
``(g) Authorization of Appropriations.--There are authorized to be
appropriated, such sums as may be necessary to carry out this section
for each of fiscal years 2007 through 2011.''.

9562cc8691a512bda2544ac80c116f84fc26dbdc728bdf35e5a5daedf290729e

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by inserting after section 319K the following:
``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
``(a) Definitions.--In this section:
``(1) BARDA.--The term `BARDA' means the Biomedical Advanced
Research and Development Authority.
``(2) Fund.--The term `Fund' means the Biodefense Medical
Countermeasure Development Fund established under subsection (d).
``(3) Other transactions.--The term `other transactions' means
transactions, other than procurement contracts, grants, and
cooperative agreements, such as the Secretary of Defense may enter
into under section 2371 of title 10, United States Code.
``(4) Qualified countermeasure.--The term `qualified
countermeasure' has the meaning given such term in section 319F-1.
``(5) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning given the
term in section 319F-3.
``(6) Advanced research and development.--
``(A) In general.--The term `advanced research and
development' means, with respect to a product that is or may
become a qualified countermeasure or a qualified pandemic or
epidemic product, activities that predominantly--
``(i) are conducted after basic research and
preclinical development of the product; and
``(ii) are related to manufacturing the product on a
commercial scale and in a form that satisfies the
regulatory requirements under the Federal Food, Drug, and
Cosmetic Act or under section 351 of this Act.
``(B) Activities included.--The term under subparagraph (A)
includes--
``(i) testing of the product to determine whether the
product may be approved, cleared, or licensed under the
Federal Food, Drug, and Cosmetic Act or under section 351
of this Act for a use that is or may be the basis for such
product becoming a qualified countermeasure or qualified
pandemic or epidemic product, or to help obtain such
approval, clearance, or license;
``(ii) design and development of tests or models,
including animal models, for such testing;
``(iii) activities to facilitate manufacture of the
product on a commercial scale with consistently high
quality, as well as to improve and make available new
technologies to increase manufacturing surge capacity;
``(iv) activities to improve the shelf-life of the
product or technologies for administering the product; and
``(v) such other activities as are part of the advanced
stages of testing, refinement, improvement, or preparation
of the product for such use and as are specified by the
Secretary.
``(7) Security countermeasure.--The term `security
countermeasure' has the meaning given such term in section 319F-2.
``(8) Research tool.--The term `research tool' means a device,
technology, biological material (including a cell line or an
antibody), reagent, animal model, computer system, computer
software, or analytical technique that is developed to assist in
the discovery, development, or manufacture of qualified
countermeasures or qualified pandemic or epidemic products.
``(9) Program manager.--The term `program manager' means an
individual appointed to carry out functions under this section and
authorized to provide project oversight and management of strategic
initiatives.
``(10) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or private
corporation, and a Federal, State, or local government agency or
department.
``(b) Strategic Plan for Countermeasure Research, Development, and
Procurement.--
``(1) In general.--Not later than 6 months after the date of
enactment of the Pandemic and All-Hazards Preparedness Act, the
Secretary shall develop and make public a strategic plan to
integrate biodefense and emerging infectious disease requirements
with the advanced research and development, strategic initiatives
for innovation, and the procurement of qualified countermeasures
and qualified pandemic or epidemic products. The Secretary shall
carry out such activities as may be practicable to disseminate the
information contained in such plan to persons who may have the
capacity to substantially contribute to the activities described in
such strategic plan. The Secretary shall update and incorporate
such plan as part of the National Health Security Strategy
described in section 2802.
``(2) Content.--The strategic plan under paragraph (1) shall
guide--
``(A) research and development, conducted or supported by
the Department of Health and Human Services, of qualified
countermeasures and qualified pandemic or epidemic products
against possible biological, chemical, radiological, and
nuclear agents and to emerging infectious diseases;
``(B) innovation in technologies that may assist advanced
research and development of qualified countermeasures and
qualified pandemic or epidemic products (such research and
development referred to in this section as `countermeasure and
product advanced research and development'); and
``(C) procurement of such qualified countermeasures and
qualified pandemic or epidemic products by such Department.
``(c) Biomedical Advanced Research and Development Authority.--
``(1) Establishment.--There is established within the
Department of Health and Human Services the Biomedical Advanced
Research and Development Authority.
``(2) In general.--Based upon the strategic plan described in
subsection (b), the Secretary shall coordinate the acceleration of
countermeasure and product advanced research and development by--
``(A) facilitating collaboration between the Department of
Health and Human Services and other Federal agencies, relevant
industries, academia, and other persons, with respect to such
advanced research and development;
``(B) promoting countermeasure and product advanced
research and development;
``(C) facilitating contacts between interested persons and
the offices or employees authorized by the Secretary to advise
such persons regarding requirements under the Federal Food,
Drug, and Cosmetic Act and under section 351 of this Act; and
``(D) promoting innovation to reduce the time and cost of
countermeasure and product advanced research and development.
``(3) Director.--The BARDA shall be headed by a Director
(referred to in this section as the `Director') who shall be
appointed by the Secretary and to whom the Secretary shall delegate
such functions and authorities as necessary to implement this
section.
``(4) Duties.--
``(A) Collaboration.--To carry out the purpose described in
paragraph (2)(A), the Secretary shall--
``(i) facilitate and increase the expeditious and
direct communication between the Department of Health and
Human Services and relevant persons with respect to
countermeasure and product advanced research and
development, including by--
``(I) facilitating such communication regarding the
processes for procuring such advanced research and
development with respect to qualified countermeasures
and qualified pandemic or epidemic products of
interest; and
``(II) soliciting information about and data from
research on potential qualified countermeasures and
qualified pandemic or epidemic products and related
technologies;
``(ii) at least annually--
``(I) convene meetings with representatives from
relevant industries, academia, other Federal agencies,
international agencies as appropriate, and other
interested persons;
``(II) sponsor opportunities to demonstrate the
operation and effectiveness of relevant biodefense
countermeasure technologies; and
``(III) convene such working groups on
countermeasure and product advanced research and
development as the Secretary may determine are
necessary to carry out this section; and
``(iii) carry out the activities described in section
405 of the Pandemic and All-Hazards Preparedness Act.
``(B) Support advanced research and development.--To carry
out the purpose described in paragraph (2)(B), the Secretary
shall--
``(i) conduct ongoing searches for, and support calls
for, potential qualified countermeasures and qualified
pandemic or epidemic products;
``(ii) direct and coordinate the countermeasure and
product advanced research and development activities of the
Department of Health and Human Services;
``(iii) establish strategic initiatives to accelerate
countermeasure and product advanced research and
development and innovation in such areas as the Secretary
may identify as priority unmet need areas; and
``(iv) award contracts, grants, cooperative agreements,
and enter into other transactions, for countermeasure and
product advanced research and development.
``(C) Facilitating advice.--To carry out the purpose
described in paragraph (2)(C) the Secretary shall--
``(i) connect interested persons with the offices or
employees authorized by the Secretary to advise such
persons regarding the regulatory requirements under the
Federal Food, Drug, and Cosmetic Act and under section 351
of this Act related to the approval, clearance, or
licensure of qualified countermeasures or qualified
pandemic or epidemic products; and
``(ii) with respect to persons performing
countermeasure and product advanced research and
development funded under this section, enable such offices
or employees to provide to the extent practicable such
advice in a manner that is ongoing and that is otherwise
designed to facilitate expeditious development of qualified
countermeasures and qualified pandemic or epidemic products
that may achieve such approval, clearance, or licensure.
``(D) Supporting innovation.--To carry out the purpose
described in paragraph (2)(D), the Secretary may award
contracts, grants, and cooperative agreements, or enter into
other transactions, such as prize payments, to promote--
``(i) innovation in technologies that may assist
countermeasure and product advanced research and
development;
``(ii) research on and development of research tools
and other devices and technologies; and
``(iii) research to promote strategic initiatives, such
as rapid diagnostics, broad spectrum antimicrobials, and
vaccine manufacturing technologies.
``(5) Transaction authorities.--
``(A) Other transactions.--
``(i) In general.--The Secretary shall have the
authority to enter into other transactions under this
subsection in the same manner as the Secretary of Defense
enters into such transactions under section 2371 of title
10, United States Code.
``(ii) Limitations on authority.--
``(I) In general.--Subsections (b), (c), and (h) of
section 845 of the National Defense Authorization Act
for Fiscal Year 1994 (10 U.S.C. 2371 note) shall apply
to other transactions under this subparagraph as if
such transactions were for prototype projects described
by subsection (a) of such section 845.
``(II) Written determinations required.--The
authority of this subparagraph may be exercised for a
project that is expected to cost the Department of
Health and Human Services in excess of $20,000,000 only
upon a written determination by the senior procurement
executive for the Department (as designated for purpose
of section 16(c) of the Office of Federal Procurement
Policy Act (41 U.S.C. 414(c))), that the use of such
authority is essential to promoting the success of the
project. The authority of the senior procurement
executive under this subclause may not be delegated.
``(iii) Guidelines.--The Secretary shall establish
guidelines regarding the use of the authority under clause
(i). Such guidelines shall include auditing requirements.
``(B) Expedited authorities.--
``(i) In general.--In awarding contracts, grants, and
cooperative agreements, and in entering into other
transactions under subparagraph (B) or (D) of paragraph
(4), the Secretary shall have the expedited procurement
authorities, the authority to expedite peer review, and the
authority for personal services contracts, supplied by
subsections (b), (c), and (d) of section 319F-1.
``(ii) Application of provisions.--Provisions in such
section 319F-1 that apply to such authorities and that
require institution of internal controls, limit review,
provide for Federal Tort Claims Act coverage of personal
services contractors, and commit decisions to the
discretion of the Secretary shall apply to the authorities
as exercised pursuant to this paragraph.
``(iii) Authority to limit competition.--For purposes
of applying section 319F-1(b)(1)(D) to this paragraph, the
phrase `BioShield Program under the Project BioShield Act
of 2004' shall be deemed to mean the countermeasure and
product advanced research and development program under
this section.
``(iv) Availability of data.--The Secretary shall
require that, as a condition of being awarded a contract,
grant, cooperative agreement, or other transaction under
subparagraph (B) or (D) of paragraph (4), a person make
available to the Secretary on an ongoing basis, and submit
upon request to the Secretary, all data related to or
resulting from countermeasure and product advanced research
and development carried out pursuant to this section.
``(C) Advance payments; advertising.--The Secretary may
waive the requirements of section 3324(a) of title 31, United
States Code, or section 3709 of the Revised Statutes of the
United States (41 U.S.C. 5) upon the determination by the
Secretary that such waiver is necessary to obtain
countermeasures or products under this section.
``(D) Milestone-based payments allowed.--In awarding
contracts, grants, and cooperative agreements, and in entering
into other transactions, under this section, the Secretary may
use milestone-based awards and payments.
``(E) Foreign nationals eligible.--The Secretary may under
this section award contracts, grants, and cooperative
agreements to, and may enter into other transactions with,
highly qualified foreign national persons outside the United
States, alone or in collaboration with American participants,
when such transactions may inure to the benefit of the American
people.
``(F) Establishment of research centers.--The Secretary may
assess the feasibility and appropriateness of establishing,
through contract, grant, cooperative agreement, or other
transaction, an arrangement with an existing research center in
order to achieve the goals of this section. If such an
agreement is not feasible and appropriate, the Secretary may
establish one or more federally-funded research and development
centers, or university-affiliated research centers, in
accordance with section 303(c)(3) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C. 253(c)(3)).
``(6) At-risk individuals.--In carrying out the functions under
this section, the Secretary may give priority to the advanced
research and development of qualified countermeasures and qualified
pandemic or epidemic products that are likely to be safe and
effective with respect to children, pregnant women, elderly, and
other at-risk individuals.
``(7) Personnel authorities.--
``(A) Specially qualified scientific and professional
personnel.--
``(i) In general.--In addition to any other personnel
authorities, the Secretary may--
``(I) without regard to those provisions of title
5, United States Code, governing appointments in the
competitive service, appoint highly qualified
individuals to scientific or professional positions in
BARDA, such as program managers, to carry out this
section; and
``(II) compensate them in the same manner and
subject to the same terms and conditions in which
individuals appointed under section 9903 of such title
are compensated, without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such
title relating to classification and General Schedule
pay rates.
``(ii) Manner of exercise of authority.--The authority
provided for in this subparagraph shall be exercised
subject to the same limitations described in section 319F-
1(e)(2).
``(iii) Term of appointment.--The term limitations
described in section 9903(c) of title 5, United States
Code, shall apply to appointments under this subparagraph,
except that the references to the `Secretary' and to the
`Department of Defense's national security missions' shall
be deemed to be to the Secretary of Health and Human
Services and to the mission of the Department of Health and
Human Services under this section.
``(B) Special consultants.--In carrying out this section,
the Secretary may appoint special consultants pursuant to
section 207(f).
``(C) Limitation.--
``(i) In general.--The Secretary may hire up to 100
highly qualified individuals, or up to 50 percent of the
total number of employees, whichever is less, under the
authorities provided for in subparagraphs (A) and (B).
``(ii) Report.--The Secretary shall report to Congress
on a biennial basis on the implementation of this
subparagraph.
``(d) Fund.--
``(1) Establishment.--There is established the Biodefense
Medical Countermeasure Development Fund, which shall be available
to carry out this section in addition to such amounts as are
otherwise available for this purpose.
``(2) Funding.--To carry out the purposes of this section,
there are authorized to be appropriated to the Fund--
``(A) $1,070,000,000 for fiscal years 2006 through 2008,
the amounts to remain available until expended; and
``(B) such sums as may be necessary for subsequent fiscal
years, the amounts to remain available until expended.
``(e) Inapplicability of Certain Provisions.--
``(1) Disclosure.--
``(A) In general.--The Secretary shall withhold from
disclosure under section 552 of title 5, United States Code,
specific technical data or scientific information that is
created or obtained during the countermeasure and product
advanced research and development carried out under subsection
(c) that reveals significant and not otherwise publicly known
vulnerabilities of existing medical or public health defenses
against biological, chemical, nuclear, or radiological threats.
Such information shall be deemed to be information described in
section 552(b)(3) of title 5, United States Code.
``(B) Review.--Information subject to nondisclosure under
subparagraph (A) shall be reviewed by the Secretary every 5
years, or more frequently as determined necessary by the
Secretary, to determine the relevance or necessity of continued
nondisclosure.
``(C) Sunset.--This paragraph shall cease to have force or
effect on the date that is 7 years after the date of enactment
of the Pandemic and All-Hazards Preparedness Act.
``(2) Review.--Notwithstanding section 14 of the Federal
Advisory Committee Act, a working group of BARDA under this section
and the National Biodefense Science Board under section 319M shall
each terminate on the date that is 5 years after the date on which
each such group or Board, as applicable, was established. Such 5-
year period may be extended by the Secretary for one or more
additional 5-year periods if the Secretary determines that any such
extension is appropriate.''.

1f81f0e76678234b5c1d28b5fa5ccb6832687eff9acf694ca88131e48436e3be

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.),
as amended by section 401, is further amended by inserting after
section 319L the following:
``SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING GROUPS.
``(a) In General.--
``(1) Establishment and function.--The Secretary shall
establish the National Biodefense Science Board (referred to in
this section as the `Board') to provide expert advice and guidance
to the Secretary on scientific, technical and other matters of
special interest to the Department of Health and Human Services
regarding current and future chemical, biological, nuclear, and
radiological agents, whether naturally occurring, accidental, or
deliberate.
``(2) Membership.--The membership of the Board shall be
comprised of individuals who represent the Nation's preeminent
scientific, public health, and medical experts, as follows--
``(A) such Federal officials as the Secretary may determine
are necessary to support the functions of the Board;
``(B) four individuals representing the pharmaceutical,
biotechnology, and device industries;
``(C) four individuals representing academia; and
``(D) five other members as determined appropriate by the
Secretary, of whom--
``(i) one such member shall be a practicing healthcare
professional; and
``(ii) one such member shall be an individual from an
organization representing healthcare consumers.
``(3) Term of appointment.--A member of the Board described in
subparagraph (B), (C), or (D) of paragraph (2) shall serve for a
term of 3 years, except that the Secretary may adjust the terms of
the initial Board appointees in order to provide for a staggered
term of appointment for all members.
``(4) Consecutive appointments; maximum terms.--A member may be
appointed to serve not more than 3 terms on the Board and may serve
not more than 2 consecutive terms.
``(5) Duties.--The Board shall--
``(A) advise the Secretary on current and future trends,
challenges, and opportunities presented by advances in
biological and life sciences, biotechnology, and genetic
engineering with respect to threats posed by naturally
occurring infectious diseases and chemical, biological,
radiological, and nuclear agents;
``(B) at the request of the Secretary, review and consider
any information and findings received from the working groups
established under subsection (b); and
``(C) at the request of the Secretary, provide
recommendations and findings for expanded, intensified, and
coordinated biodefense research and development activities.
``(6) Meetings.--
``(A) Initial meeting.--Not later than one year after the
date of enactment of the Pandemic and All-Hazards Preparedness
Act, the Secretary shall hold the first meeting of the Board.
``(B) Subsequent meetings.--The Board shall meet at the
call of the Secretary, but in no case less than twice annually.
``(7) Vacancies.--Any vacancy in the Board shall not affect its
powers, but shall be filled in the same manner as the original
appointment.
``(8) Chairperson.--The Secretary shall appoint a chairperson
from among the members of the Board.
``(9) Powers.--
``(A) Hearings.--The Board may hold such hearings, sit and
act at such times and places, take such testimony, and receive
such evidence as the Board considers advisable to carry out
this subsection.
``(B) Postal services.--The Board may use the United States
mails in the same manner and under the same conditions as other
departments and agencies of the Federal Government.
``(10) Personnel.--
``(A) Employees of the federal government.--A member of the
Board that is an employee of the Federal Government may not
receive additional pay, allowances, or benefits by reason of
the member's service on the Board.
``(B) Other members.--A member of the Board that is not an
employee of the Federal Government may be compensated at a rate
not to exceed the daily equivalent of the annual rate of basic
pay prescribed for level IV of the Executive Schedule under
section 5315 of title 5, United States Code, for each day
(including travel time) during which the member is engaged in
the actual performance of duties as a member of the Board.
``(C) Travel expenses.--Each member of the Board shall
receive travel expenses, including per diem in lieu of
subsistence, in accordance with applicable provisions under
subchapter I of chapter 57 of title 5, United States Code.
``(D) Detail of government employees.--Any Federal
Government employee may be detailed to the Board with the
approval for the contributing agency without reimbursement, and
such detail shall be without interruption or loss of civil
service status or privilege.
``(b) Other Working Groups.--The Secretary may establish a working
group of experts, or may use an existing working group or advisory
committee, to--
``(1) identify innovative research with the potential to be
developed as a qualified countermeasure or a qualified pandemic or
epidemic product;
``(2) identify accepted animal models for particular diseases
and conditions associated with any biological, chemical,
radiological, or nuclear agent, any toxin, or any potential
pandemic infectious disease, and identify strategies to accelerate
animal model and research tool development and validation; and
``(3) obtain advice regarding supporting and facilitating
advanced research and development related to qualified
countermeasures and qualified pandemic or epidemic products that
are likely to be safe and effective with respect to children,
pregnant women, and other vulnerable populations, and other issues
regarding activities under this section that affect such
populations.
``(c) Definitions.--Any term that is defined in section 319L and
that is used in this section shall have the same meaning in this
section as such term is given in section 319L.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated $1,000,000 to carry out this section for fiscal year 2007
and each fiscal year thereafter.''.

49c117d41624ee14a5ddd744130ca5cc148734f6449b35e7254e20ad7f5562c4

BIOSHIELD.
(a) Qualified Countermeasure.--Section 319F-1(a) of the Public
Health Service Act (42 U.S.C. 247d-6a(a)) is amended by striking
paragraph (2) and inserting the following:
``(2) Definitions.--In this section:
``(A) Qualified countermeasure.--The term `qualified
countermeasure' means a drug (as that term is defined by
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1))), biological product (as that term is
defined by section 351(i) of this Act (42 U.S.C. 262(i))), or
device (as that term is defined by section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that
the Secretary determines to be a priority (consistent with
sections 302(2) and 304(a) of the Homeland Security Act of
2002) to--
``(i) diagnose, mitigate, prevent, or treat harm from
any biological agent (including organisms that cause an
infectious disease) or toxin, chemical, radiological, or
nuclear agent that may cause a public health emergency
affecting national security; or
``(ii) diagnose, mitigate, prevent, or treat harm from
a condition that may result in adverse health consequences
or death and may be caused by administering a drug,
biological product, or device that is used as described in
this subparagraph.
``(B) Infectious disease.--The term `infectious disease'
means a disease potentially caused by a pathogenic organism
(including a bacteria, virus, fungus, or parasite) that is
acquired by a person and that reproduces in that person.''.
(b) Security Countermeasure.--Section 319F-2(c)(1)(B) is amended by
striking ``treat, identify, or prevent'' each place it appears and
inserting ``diagnose, mitigate, prevent, or treat''.
(c) Limitation on Use of Funds.--Section 510(a) of the Homeland
Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding at the end
the following: ``None of the funds made available under this subsection
shall be used to procure countermeasures to diagnose, mitigate,
prevent, or treat harm resulting from any naturally occurring
infectious disease or other public health threat that are not security
countermeasures under section 319F-2(c)(1)(B).''.

b60fd3401b58e3ebcf7ddb47c465b318b62ff537063d21a28e8f72da6ae1085c

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:
``SEC. 565. TECHNICAL ASSISTANCE.
``The Secretary, in consultation with the Commissioner of Food and
Drugs, shall establish within the Food and Drug Administration a team
of experts on manufacturing and regulatory activities (including
compliance with current Good Manufacturing Practice) to provide both
off-site and on-site technical assistance to the manufacturers of
qualified countermeasures (as defined in section 319F-1 of the Public
Health Service Act), security countermeasures (as defined in section
319F-2 of such Act), or vaccines, at the request of such a manufacturer
and at the discretion of the Secretary, if the Secretary determines
that a shortage or potential shortage may occur in the United States in
the supply of such vaccines or countermeasures and that the provision
of such assistance would be beneficial in helping alleviate or avert
such shortage.''.

040004a11f9ed15bb071016bb8a2ee328e433c165bc9ea797ab0cc9744291749

(a) Limited Antitrust Exemption.--
(1) Meetings and consultations to discuss security
countermeasures, qualified countermeasures, or qualified pandemic
or epidemic product development.--
(A) Authority to conduct meetings and consultations.--The
Secretary of Health and Human Services (referred to in this
subsection as the ``Secretary''), in coordination with the
Attorney General and the Secretary of Homeland Security, may
conduct meetings and consultations with persons engaged in the
development of a security countermeasure (as defined in section
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b))
(as amended by this Act), a qualified countermeasure (as
defined in section 319F-1 of the Public Health Service Act (42
U.S.C. 247d-6a)) (as amended by this Act), or a qualified
pandemic or epidemic product (as defined in section 319F-3 of
the Public Health Service Act (42 U.S.C. 247d-6d)) for the
purpose of the development, manufacture, distribution,
purchase, or storage of a countermeasure or product. The
Secretary may convene such meeting or consultation at the
request of the Secretary of Homeland Security, the Attorney
General, the Chairman of the Federal Trade Commission (referred
to in this section as the ``Chairman''), or any interested
person, or upon initiation by the Secretary. The Secretary
shall give prior notice of any such meeting or consultation,
and the topics to be discussed, to the Attorney General, the
Chairman, and the Secretary of Homeland Security.
(B) Meeting and consultation conditions.--A meeting or
consultation conducted under subparagraph (A) shall--
(i) be chaired or, in the case of a consultation,
facilitated by the Secretary;
(ii) be open to persons involved in the development,
manufacture, distribution, purchase, or storage of a
countermeasure or product, as determined by the Secretary;
(iii) be open to the Attorney General, the Secretary of
Homeland Security, and the Chairman;
(iv) be limited to discussions involving covered
activities; and
(v) be conducted in such manner as to ensure that no
national security, confidential commercial, or proprietary
information is disclosed outside the meeting or
consultation.
(C) Limitation.--The Secretary may not require participants
to disclose confidential commercial or proprietary information.
(D) Transcript.--The Secretary shall maintain a complete
verbatim transcript of each meeting or consultation conducted
under this subsection. Such transcript (or a portion thereof)
shall not be disclosed under section 552 of title 5, United
States Code, to the extent that the Secretary, in consultation
with the Attorney General and the Secretary of Homeland
Security, determines that disclosure of such transcript (or
portion thereof) would pose a threat to national security. The
transcript (or portion thereof) with respect to which the
Secretary has made such a determination shall be deemed to be
information described in subsection (b)(3) of such section 552.
(E) Exemption.--
(i) In general.--Subject to clause (ii), it shall not
be a violation of the antitrust laws for any person to
participate in a meeting or consultation conducted in
accordance with this paragraph.
(ii) Limitation.--Clause (i) shall not apply to any
agreement or conduct that results from a meeting or
consultation and that is not covered by an exemption
granted under paragraph (4).
(2) Submission of written agreements.--The Secretary shall
submit each written agreement regarding covered activities that is
made pursuant to meetings or consultations conducted under
paragraph (1) to the Attorney General and the Chairman for
consideration. In addition to the proposed agreement itself, any
submission shall include--
(A) an explanation of the intended purpose of the
agreement;
(B) a specific statement of the substance of the agreement;
(C) a description of the methods that will be utilized to
achieve the objectives of the agreement;
(D) an explanation of the necessity for a cooperative
effort among the particular participating persons to achieve
the objectives of the agreement; and
(E) any other relevant information determined necessary by
the Attorney General, in consultation with the Chairman and the
Secretary.
(3) Exemption for conduct under approved agreement.--It shall
not be a violation of the antitrust laws for a person to engage in
conduct in accordance with a written agreement to the extent that
such agreement has been granted an exemption under paragraph (4),
during the period for which the exemption is in effect.
(4) Action on written agreements.--
(A) In general.--The Attorney General, in consultation with
the Chairman, shall grant, deny, grant in part and deny in
part, or propose modifications to an exemption request
regarding a written agreement submitted under paragraph (2), in
a written statement to the Secretary, within 15 business days
of the receipt of such request. An exemption granted under this
paragraph shall take effect immediately.
(B) Extension.--The Attorney General may extend the 15-day
period referred to in subparagraph (A) for an additional period
of not to exceed 10 business days.
(C) Determination.--An exemption shall be granted regarding
a written agreement submitted in accordance with paragraph (2)
only to the extent that the Attorney General, in consultation
with the Chairman and the Secretary, finds that the conduct
that will be exempted will not have any substantial
anticompetitive effect that is not reasonably necessary for
ensuring the availability of the countermeasure or product
involved.
(5) Limitation on and renewal of exemptions.--An exemption
granted under paragraph (4) shall be limited to covered activities,
and such exemption shall be renewed (with modifications, as
appropriate, consistent with the finding described in paragraph
(4)(C)), on the date that is 3 years after the date on which the
exemption is granted unless the Attorney General in consultation
with the Chairman determines that the exemption should not be
renewed (with modifications, as appropriate) considering the
factors described in paragraph (4).
(6) Authority to obtain information.--Consideration by the
Attorney General for granting or renewing an exemption submitted
under this section shall be considered an antitrust investigation
for purposes of the Antitrust Civil Process Act (15 U.S.C. 1311 et
seq.).
(7) Limitation on parties.--The use of any information acquired
under an agreement for which an exemption has been granted under
paragraph (4), for any purpose other than specified in the
exemption, shall be subject to the antitrust laws and any other
applicable laws.
(8) Report.--Not later than one year after the date of
enactment of this Act and biannually thereafter, the Attorney
General and the Chairman shall report to Congress on the use of the
exemption from the antitrust laws provided by this subsection.
(b) Sunset.--The applicability of this section shall expire at the
end of the 6-year period that begins on the date of enactment of this
Act.
(c) Definitions.--In this section:
(1) Antitrust laws.--The term ``antitrust laws''--
(A) has the meaning given such term in subsection (a) of
the first section of the Clayton Act (15 U.S.C. 12(a)), except
that such term includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent such section 5
applies to unfair methods of competition; and
(B) includes any State law similar to the laws referred to
in subparagraph (A).
(2) Countermeasure or product.--The term ``countermeasure or
product'' refers to a security countermeasure, qualified
countermeasure, or qualified pandemic or epidemic product (as those
terms are defined in subsection (a)(1)).
(3) Covered activities.--
(A) In general.--Except as provided in subparagraph (B),
the term ``covered activities'' includes any activity relating
to the development, manufacture, distribution, purchase, or
storage of a countermeasure or product.
(B) Exception.--The term ``covered activities'' shall not
include, with respect to a meeting or consultation conducted
under subsection (a)(1) or an agreement for which an exemption
has been granted under subsection (a)(4), the following
activities involving 2 or more persons:
(i) Exchanging information among competitors relating
to costs, profitability, or distribution of any product,
process, or service if such information is not reasonably
necessary to carry out covered activities--
(I) with respect to a countermeasure or product
regarding which such meeting or consultation is being
conducted; or
(II) that are described in the agreement as
exempted.
(ii) Entering into any agreement or engaging in any
other conduct--
(I) to restrict or require the sale, licensing, or
sharing of inventions, developments, products,
processes, or services not developed through, produced
by, or distributed or sold through such covered
activities; or
(II) to restrict or require participation, by any
person participating in such covered activities, in
other research and development activities, except as
reasonably necessary to prevent the misappropriation of
proprietary information contributed by any person
participating in such covered activities or of the
results of such covered activities.
(iii) Entering into any agreement or engaging in any
other conduct allocating a market with a competitor that is
not expressly exempted from the antitrust laws under
subsection (a)(4).
(iv) Exchanging information among competitors relating
to production (other than production by such covered
activities) of a product, process, or service if such
information is not reasonably necessary to carry out such
covered activities.
(v) Entering into any agreement or engaging in any
other conduct restricting, requiring, or otherwise
involving the production of a product, process, or service
that is not expressly exempted from the antitrust laws
under subsection (a)(4).
(vi) Except as otherwise provided in this subsection,
entering into any agreement or engaging in any other
conduct to restrict or require participation by any person
participating in such covered activities, in any unilateral
or joint activity that is not reasonably necessary to carry
out such covered activities.
(vii) Entering into any agreement or engaging in any
other conduct restricting or setting the price at which a
countermeasure or product is offered for sale, whether by
bid or otherwise.

d9ed895dde727f081f67d39dade85989d651a0eb0d76ca854ca63b2b3478efc2

Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in the section heading, by inserting ``and security
countermeasure procurements'' before the period; and
(2) in subsection (c)--
(A) in the subsection heading, by striking ``Biomedical'';
(B) in paragraph (3)--
(i) by striking ``countermeasures.--The Secretary'' and
inserting the following: ``countermeasures.--
``(A) In general.--The Secretary''; and
(ii) by adding at the end the following:
``(B) Information.--The Secretary shall institute a process
for making publicly available the results of assessments under
subparagraph (A) while withholding such information as--
``(i) would, in the judgment of the Secretary, tend to
reveal public health vulnerabilities; or
``(ii) would otherwise be exempt from disclosure under
section 552 of title 5, United States Code.'';
(C) in paragraph (4)(A), by inserting ``not developed or''
after ``currently'';
(D) in paragraph (5)(B)(i), by striking ``to meet the needs
of the stockpile'' and inserting ``to meet the stockpile
needs'';
(E) in paragraph (7)(B)--
(i) by striking the subparagraph heading and all that
follows through ``Homeland Security Secretary'' and
inserting the following: ``Interagency agreement; cost.--
The Homeland Security Secretary''; and
(ii) by striking clause (ii);
(F) in paragraph (7)(C)(ii)--
(i) by amending subclause (I) to read as follows:
``(I) Payment conditioned on delivery.--The
contract shall provide that no payment may be made
until delivery of a portion, acceptable to the
Secretary, of the total number of units contracted for,
except that, notwithstanding any other provision of
law, the contract may provide that, if the Secretary
determines (in the Secretary's discretion) that an
advance payment, partial payment for significant
milestones, or payment to increase manufacturing
capacity is necessary to ensure success of a project,
the Secretary shall pay an amount, not to exceed 10
percent of the contract amount, in advance of delivery.
The Secretary shall, to the extent practicable, make
the determination of advance payment at the same time
as the issuance of a solicitation. The contract shall
provide that such advance payment is required to be
repaid if there is a failure to perform by the vendor
under the contract. The contract may also provide for
additional advance payments of 5 percent each for
meeting the milestones specified in such contract,
except that such payments shall not exceed 50 percent
of the total contract amount. If the specified
milestones are reached, the advanced payments of 5
percent shall not be required to be repaid. Nothing in
this subclause shall be construed as affecting the
rights of vendors under provisions of law or regulation
(including the Federal Acquisition Regulation) relating
to the termination of contracts for the convenience of
the Government.''; and
(ii) by adding at the end the following:
``(VII) Sales exclusivity.--The contract may
provide that the vendor is the exclusive supplier of
the product to the Federal Government for a specified
period of time, not to exceed the term of the contract,
on the condition that the vendor is able to satisfy the
needs of the Government. During the agreed period of
sales exclusivity, the vendor shall not assign its
rights of sales exclusivity to another entity or
entities without approval by the Secretary. Such a
sales exclusivity provision in such a contract shall
constitute a valid basis for a sole source procurement
under section 303(c)(1) of the Federal Property and
Administrative Services Act of 1949 (41 U.S.C.
253(c)(1)).
``(VIII) Warm based surge capacity.--The contract
may provide that the vendor establish domestic
manufacturing capacity of the product to ensure that
additional production of the product is available in
the event that the Secretary determines that there is a
need to quickly purchase additional quantities of the
product. Such contract may provide a fee to the vendor
for establishing and maintaining such capacity in
excess of the initial requirement for the purchase of
the product. Additionally, the cost of maintaining the
domestic manufacturing capacity shall be an allowable
and allocable direct cost of the contract.
``(IX) Contract terms.--The Secretary, in any
contract for procurement under this section, 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
(G) in paragraph (8)(A), by adding at the end the
following: ``Such agreements may allow other executive agencies
to order qualified and security countermeasures under
procurement contracts or other agreements established by the
Secretary. Such ordering process (including transfers of
appropriated funds between an agency and the Department of
Health and Human Services as reimbursements for such orders for
countermeasures) may be conducted under the authority of
section 1535 of title 31, United States Code, except that all
such orders shall be processed under the terms established
under this subsection for the procurement of
countermeasures.''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

70923313221f9653fd98588ff1c72fb998c46a92cf41a5e74f33cbaa9d91cbb9

Pandemic and All-Hazards Preparedness Act

Other Sections

TITLE I

TITLE II

TITLE III

TITLE IV

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