[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3678 Engrossed in Senate (ES)]
109th CONGRESS
2d Session
S. 3678
_______________________________________________________________________
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,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(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:
Sec. 1. Short title; table of contents.
TITLE I--NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP, ORGANIZATION,
AND PLANNING
Sec. 101. Public health and medical preparedness and response functions
of the Secretary of Health and Human
Services.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Health Security Strategy.
TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS
Sec. 201. Improving State and local public health security.
Sec. 202. Using information technology to improve situational awareness
in public health emergencies.
Sec. 203. Public health workforce enhancements.
Sec. 204. Vaccine tracking and distribution.
Sec. 205. National Science Advisory Board for Biosecurity.
Sec. 206. Revitalization of Commissioned Corps.
TITLE III--ALL-HAZARDS MEDICAL SURGE CAPACITY
Sec. 301. National disaster medical system.
Sec. 302. Enhancing medical surge capacity.
Sec. 303. Encouraging health professional volunteers.
Sec. 304. Core education and training.
Sec. 305. Partnerships for State and regional hospital preparedness to
improve surge capacity.
Sec. 306. Enhancing the role of the Department of Veterans Affairs.
TITLE IV--PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT
Sec. 401. Biomedical Advanced Research and Development Authority.
Sec. 402. National Biodefense Science Board.
Sec. 403. Clarification of countermeasures covered by Project
BioShield.
Sec. 404. Technical assistance.
Sec. 405. Collaboration and coordination.
Sec. 406. Procurement.
TITLE I--NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP, ORGANIZATION,
AND PLANNING
SEC. 101. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE FUNCTIONS
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.''.
SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.
(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.''.
SEC. 103. NATIONAL HEALTH SECURITY STRATEGY.
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.''.
TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS
SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.
Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a)
is amended--
(1) by amending the heading to read as follows: ``improving
state and local public health security.'';
(2) by striking subsections (a) through (i) and inserting
the following:
``(a) In General.--To enhance the security of the United States
with respect to public health emergencies, the Secretary shall award
cooperative agreements to eligible entities to enable such entities to
conduct the activities described in subsection (d).
``(b) Eligible Entities.--To be eligible to receive an award under
subsection (a), an entity shall--
``(1)(A) be a State;
``(B) be a political subdivision determined by the
Secretary to be eligible for an award under this section (based
on criteria described in subsection (i)(4)); or
``(C) be a consortium of entities described in subparagraph
(A); and
``(2) prepare and submit to the Secretary an application at
such time, and in such manner, and containing such information
as the Secretary may require, including--
``(A) an All-Hazards Public Health Emergency
Preparedness and Response Plan which shall include--
``(i) a description of the activities such
entity will carry out under the agreement to
meet the goals identified under section 2802;
``(ii) a pandemic influenza plan consistent
with the requirements of paragraphs (2) and (5)
of subsection (g);
``(iii) 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;
``(iv) a description of the mechanism the
entity will implement to utilize the Emergency
Management Assistance Compact or other mutual
aid agreements for medical and public health
mutual aid; and
``(v) a description of how the entity will
include the State Unit on Aging in public
health emergency preparedness;
``(B) an assurance that the entity will report to
the Secretary on an annual basis (or more frequently as
determined by the Secretary) on the evidence-based
benchmarks and objective standards established by the
Secretary to evaluate the preparedness and response
capabilities of such entity under subsection (g);
``(C) an assurance that the entity will conduct, on
at least an annual basis, an exercise or drill that
meets any criteria established by the Secretary to test
the preparedness and response capabilities of such
entity, and that the entity will report back to the
Secretary within the application of the following year
on the strengths and weaknesses identified through such
exercise or drill, and corrective actions taken to
address material weaknesses;
``(D) an assurance that the entity will provide to
the Secretary the data described under section
319D(d)(3) as determined feasible by the Secretary;
``(E) an assurance that the entity will conduct
activities to inform and educate the hospitals within
the jurisdiction of such entity on the role of such
hospitals in the plan required under subparagraph (A);
``(F) an assurance that the entity, with respect to
the plan described under subparagraph (A), has
developed and will implement an accountability system
to ensure that such entity make satisfactory annual
improvement and describe such system in the plan under
subparagraph (A);
``(G) a description of the means by which to obtain
public comment and input on the plan described in
subparagraph (A) and on the implementation of such
plan, that shall include an advisory committee or other
similar mechanism for obtaining comment from the public
and from other State, local, and tribal stakeholders;
and
``(H) as relevant, a description of the process
used by the entity to consult with local departments of
public health to reach consensus, approval, or
concurrence on the relative distribution of amounts
received under this section.
``(c) Limitation.--Beginning in fiscal year 2009, the Secretary may
not award a cooperative agreement to a State unless such State is a
participant in the Emergency System for Advance Registration of
Volunteer Health Professionals described in section 319I.
``(d) Use of Funds.--
``(1) In general.--An award under subsection (a) shall be
expended for activities to achieve the preparedness goals
described under paragraphs (1), (2), (4), (5), and (6) of
section 2802(b).
``(2) Effect of section.--Nothing in this subsection may be
construed as establishing new regulatory authority or as
modifying any existing regulatory authority.
``(e) Coordination With Local Response Capabilities.--An entity
shall, to the extent practicable, ensure that activities carried out
under an award under subsection (a) are coordinated with activities of
relevant Metropolitan Medical Response Systems, local public health
departments, the Cities Readiness Initiative, and local emergency
plans.
``(f) Consultation With Homeland Security.--In making awards under
subsection (a), the Secretary shall consult with the Secretary of
Homeland Security to--
``(1) ensure maximum coordination of public health and
medical preparedness and response activities with the
Metropolitan Medical Response System, and other relevant
activities;
``(2) minimize duplicative funding of programs and
activities;
``(3) analyze activities, including exercises and drills,
conducted under this section to develop recommendations and
guidance on best practices for such activities; and
``(4) disseminate such recommendations and guidance,
including through expanding existing lessons learned
information systems to create a single Internet-based point of
access for sharing and distributing medical and public health
best practices and lessons learned from drills, exercises,
disasters, and other emergencies.
``(g) Achievement of Measurable Evidence-Based Benchmarks and
Objective Standards.--
``(1) In general.--Not later than 180 days after the date
of enactment of the Pandemic and All-Hazards Preparedness Act,
the Secretary shall develop or where appropriate adopt, and
require the application of, measurable evidence-based
benchmarks and objective standards that measure levels of
preparedness with respect to the activities described in this
section and with respect to activities described in section
319C-2. In developing such benchmarks and standards, the
Secretary shall consult with and seek comments from State,
local, and tribal officials and private entities, as
appropriate. Where appropriate, the Secretary shall incorporate
existing objective standards. Such benchmarks and standards
shall--
``(A) include outcome goals representing
operational achievement of the National Preparedness
Goals developed under section 2802(b); and
``(B) at a minimum, require entities to--
``(i) measure progress toward achieving the
outcome goals; and
``(ii) at least annually, test, exercise,
and rigorously evaluate the public health and
medical emergency preparedness and response
capabilities of the entity, and report to the
Secretary on such measured and tested
capabilities and measured and tested progress
toward achieving outcome goals, based on
criteria established by the Secretary.
``(2) Criteria for pandemic influenza plans.--
``(A) In general.--Not later than 180 days after
the date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall develop and
disseminate to the chief executive officer of each
State criteria for an effective State plan for
responding to pandemic influenza.
``(B) Rule of construction.--Nothing in this
section shall be construed to require the duplication
of Federal efforts with respect to the development of
criteria or standards, without regard to whether such
efforts were carried out prior to or after the date of
enactment of this section.
``(3) Technical assistance.--The Secretary shall, as
determined appropriate by the Secretary, provide to a State,
upon request, technical assistance in meeting the requirements
of this section, including the provision of advice by experts
in the development of high-quality assessments, the setting of
State objectives and assessment methods, the development of
measures of satisfactory annual improvement that are valid and
reliable, and other relevant areas.
``(4) Notification of failures.--The Secretary shall
develop and implement a process to notify entities that are
determined by the Secretary to have failed to meet the
requirements of paragraph (1) or (2). Such process shall
provide such entities with the opportunity to correct such
noncompliance. An entity that fails to correct such
noncompliance shall be subject to paragraph (5).
``(5) Withholding of amounts from entities that fail to
achieve benchmarks or submit influenza plan.--Beginning with
fiscal year 2009, and in each succeeding fiscal year, the
Secretary shall--
``(A) withhold from each entity that has failed
substantially to meet the benchmarks and performance
measures described in paragraph (1) for the immediately
preceding fiscal year (beginning with fiscal year
2008), pursuant to the process developed under
paragraph (4), the amount described in paragraph (6);
and
``(B) withhold from each entity that has failed to
submit to the Secretary a plan for responding to
pandemic influenza that meets the criteria developed
under paragraph (2), the amount described in paragraph
(6).
``(6) Amounts described.--
``(A) In general.--The amounts described in this
paragraph are the following amounts that are payable to
an entity for activities described in section 319C-1 or
319C-2:
``(i) For the fiscal year immediately
following a fiscal year in which an entity
experienced a failure described in subparagraph
(A) or (B) of paragraph (5) by the entity, an
amount equal to 10 percent of the amount the
entity was eligible to receive for such fiscal
year.
``(ii) For the fiscal year immediately
following two consecutive fiscal years in which
an entity experienced such a failure, an amount
equal to 15 percent of the amount the entity
was eligible to receive for such fiscal year,
taking into account the withholding of funds
for the immediately preceding fiscal year under
clause (i).
``(iii) For the fiscal year immediately
following three consecutive fiscal years in
which an entity experienced such a failure, an
amount equal to 20 percent of the amount the
entity was eligible to receive for such fiscal
year, taking into account the withholding of
funds for the immediately preceding fiscal
years under clauses (i) and (ii).
``(iv) For the fiscal year immediately
following four consecutive fiscal years in
which an entity experienced such a failure, an
amount equal to 25 percent of the amount the
entity was eligible to receive for such a
fiscal year, taking into account the
withholding of funds for the immediately
preceding fiscal years under clauses (i), (ii),
and (iii).
``(B) Separate accounting.--Each failure described
in subparagraph (A) or (B) of paragraph (5) shall be
treated as a separate failure for purposes of
calculating amounts withheld under subparagraph (A).
``(7) Reallocation of amounts withheld.--
``(A) In general.--The Secretary shall make amounts
withheld under paragraph (6) available for making
awards under section 319C-2 to entities described in
subsection (b)(1) of such section.
``(B) Preference in reallocation.--In making awards
under section 319C-2 with amounts described in
subparagraph (A), the Secretary shall give preference
to eligible entities (as described in section 319C-
2(b)(1)) that are located in whole or in part in States
from which amounts have been withheld under paragraph
(6).
``(8) Waive or reduce withholding.--The Secretary may waive
or reduce the withholding described in paragraph (6), for a
single entity or for all entities in a fiscal year, if the
Secretary determines that mitigating conditions exist that
justify the waiver or reduction.
``(h) Grants for Real-Time Disease Detection Improvement.--
``(1) In general.--The Secretary may award grants to
eligible entities to carry out projects described under
paragraph (4).
``(2) Eligible entity.--For purposes of this section, the
term `eligible entity' means an entity that is--
``(A)(i) a hospital, clinical laboratory,
university; or
``(ii) a poison control center or professional
organization in the field of poison control; and
``(B) a participant in the network established
under subsection 319D(d).
``(3) Application.--Each eligible entity desiring a grant
under this subsection shall submit to the Secretary an
application at such time, in such manner, and containing such
information as the Secretary may require.
``(4) Use of funds.--
``(A) In general.--An eligible entity described in
paragraph (2)(A)(i) that receives a grant under this
subsection shall use the funds awarded pursuant to such
grant to carry out a pilot demonstration project to
purchase and implement the use of advanced diagnostic
medical equipment to analyze real-time clinical
specimens for pathogens of public health or
bioterrorism significance and report any results from
such project to State, local, and tribal public health
entities and the network established under section
319D(d).
``(B) Other entities.--An eligible entity described
in paragraph (2)(A)(ii) that receives a grant under
this section shall use the funds awarded pursuant to
such grant to--
``(i) improve the early detection,
surveillance, and investigative capabilities of
poison control centers for chemical,
biological, radiological, and nuclear events by
training poison information personnel to
improve the accuracy of surveillance data,
improving the definitions used by the poison
control centers for surveillance, and enhancing
timely and efficient investigation of data
anomalies;
``(ii) improve the capabilities of poison
control centers to provide information to
health care providers and the public with
regard to chemical, biological, radiological,
or nuclear threats or exposures, in
consultation with the appropriate State, local,
and tribal public health entities; or
``(iii) provide surge capacity in the event
of a chemical, biological, radiological, or
nuclear event through the establishment of
alternative poison control center worksites and
the training of nontraditional personnel.'';
(3) by redesignating subsection (j) as subsection (i);
(4) in subsection (i), as so redesignated--
(A) by striking paragraphs (1) through (3)(A) and
inserting the following:
``(1) Authorization of appropriations.--
``(A) In general.--For the purpose of carrying out
this section, there is authorized to be appropriated
$824,000,000 for fiscal year 2007, of which $35,000,000
shall be used to carry out subsection (h), for awards
pursuant to paragraph (3) (subject to the authority of
the Secretary to make awards pursuant to paragraphs (4)
and (5)), and such sums as may be necessary for each of
fiscal years 2008 through 2011.
``(B) Coordination.--There are authorized to be
appropriated, $10,000,000 for fiscal year 2007 to carry
out subsection (f)(4) of this section and section 2814.
``(C) Requirement for state matching funds.--
Beginning in fiscal year 2009, in the case of any State
or consortium of two or more States, the Secretary may
not award a cooperative agreement under this section
unless the State or consortium of States agree that,
with respect to the amount of the cooperative agreement
awarded by the Secretary, the State or consortium of
States will make available (directly or through
donations from public or private entities) non-Federal
contributions in an amount equal to--
``(i) for the first fiscal year of the
cooperative agreement, not less than 5 percent
of such costs ($1 for each $20 of Federal funds
provided in the cooperative agreement); and
``(ii) for any second fiscal year of the
cooperative agreement, and for any subsequent
fiscal year of such cooperative agreement, not
less than 10 percent of such costs ($1 for each
$10 of Federal funds provided in the
cooperative agreement).
``(D) Determination of amount of non-federal
contributions.--As determined by the Secretary, non-
Federal contributions required in subparagraph (C) may
be provided directly or through donations from public
or private entities and may be in cash or in kind,
fairly evaluated, including plant, equipment or
services. Amounts provided by the Federal government,
or services assisted or subsidized to any significant
extent by the Federal government, may not be included
in determining the amount of such non-Federal
contributions.
``(2) Maintaining state funding.--
``(A) In general.--An entity that receives an award
under this section shall maintain expenditures for
public health security at a level that is not less than
the average level of such expenditures maintained by
the entity for the preceding 2 year period.
``(B) 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 public health
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).
``(3) Determination of amount.--
``(A) In general.--The Secretary shall award
cooperative agreements under subsection (a) to each
State or consortium of 2 or more States that submits to
the Secretary an application that meets the criteria of
the Secretary for the receipt of such an award and that
meets other implementation conditions established by
the Secretary for such awards.'';
(B) in paragraph (4)(A)--
(i) by striking ``2003'' and inserting
``2007''; and
(ii) by striking ``(A)(i)(I)'';
(C) in paragraph (4)(D), by striking ``2002'' and
inserting ``2006'';
(D) in paragraph (5)--
(i) by striking ``2003'' and inserting
``2007''; and
(ii) by striking ``(A)(i)(I)''; and
(E) by striking paragraph (6) and inserting the
following:
``(6) Funding of local entities.--The Secretary shall, in
making awards under this section, ensure that with respect to
the cooperative agreement awarded, the entity make available
appropriate portions of such award to political subdivisions
and local departments of public health through a process
involving the consensus, approval or concurrence with such
local entities.''; and
(5) by adding at the end the following:
``(j) Administrative and Fiscal Responsibility.--
``(1) Annual reporting requirements.--Each entity shall
prepare and submit to the Secretary annual reports on its
activities under this section and section 319C-2. Each such
report shall be prepared by, or in consultation with, the
health department. In order to properly evaluate and compare
the performance of different entities assisted under this
section and section 319C-2 and to assure the proper expenditure
of funds under this section and section 319C-2, such reports
shall be in such standardized form and contain such information
as the Secretary determines and describes within 180 days of
the date of enactment of the Pandemic and All-Hazards
Preparedness Act (after consultation with the States) to be
necessary to--
``(A) secure an accurate description of those
activities;
``(B) secure a complete record of the purposes for
which funds were spent, and of the recipients of such
funds;
``(C) describe the extent to which the entity has
met the goals and objectives it set forth under this
section or section 319C-2;
``(D) determine the extent to which funds were
expended consistent with the entity's application
transmitted under this section or section 319C-2; and
``(E) publish such information on a Federal
Internet website consistent with subsection (k).
``(2) Audits; implementation.--
``(A) In general.--Each entity receiving funds
under this section or section 319C-2 shall, not less
often than once every 2 years, audit its expenditures
from amounts received under this section or section
319C-2. Such audits shall be conducted by an entity
independent of the agency administering a program
funded under this section or section 319C-2 in
accordance with the Comptroller General's standards for
auditing governmental organizations, programs,
activities, and functions and generally accepted
auditing standards. Within 30 days following the
completion of each audit report, the entity shall
submit a copy of that audit report to the Secretary.
``(B) Repayment.--Each entity shall repay to the
United States amounts found by the Secretary, after
notice and opportunity for a hearing to the entity, not
to have been expended in accordance with this section
or section 319C-2 and, if such repayment is not made,
the Secretary may offset such amounts against the
amount of any allotment to which the entity is or may
become entitled under this section or section 319C-2 or
may otherwise recover such amounts.
``(C) Withholding of payment.--The Secretary may,
after notice and opportunity for a hearing, withhold
payment of funds to any entity which is not using its
allotment under this section or section 319C-2 in
accordance with such section. The Secretary may
withhold such funds until the Secretary finds that the
reason for the withholding has been removed and there
is reasonable assurance that it will not recur.
``(3) Maximum carryover amount.--
``(A) In general.--For each fiscal year, the
Secretary, in consultation with the States and
political subdivisions, shall determine the maximum
percentage amount of an award under this section that
an entity may carryover to the succeeding fiscal year.
``(B) Amount exceeded.--For each fiscal year, if
the percentage amount of an award under this section
unexpended by an entity exceeds the maximum percentage
permitted by the Secretary under subparagraph (A), the
entity shall return to the Secretary the portion of the
unexpended amount that exceeds the maximum amount
permitted to be carried over by the Secretary.
``(C) Action by secretary.--The Secretary shall
make amounts returned to the Secretary under
subparagraph (B) available for awards under section
319C-2(b)(1). In making awards under section 319C-
2(b)(1) with amounts collected under this paragraph the
Secretary shall give preference to entities that are
located in whole or in part in States from which
amounts have been returned under subparagraph (B).
``(D) Waiver.--An entity may apply to the Secretary
for a waiver of the maximum percentage amount under
subparagraph (A). Such an application for a waiver
shall include an explanation why such requirement
should not apply to the entity and the steps taken by
such entity to ensure that all funds under an award
under this section will be expended appropriately.
``(E) Waive or reduce withholding.--The Secretary
may waive the application of subparagraph (B), or
reduce the amount determined under such subparagraph,
for a single entity pursuant to subparagraph (D) or for
all entities in a fiscal year, if the Secretary
determines that mitigating conditions exist that
justify the waiver or reduction.
``(k) Compilation and Availability of Data.--The Secretary shall
compile the data submitted under this section and make such data
available in a timely manner on an appropriate Internet website in a
format that is useful to the public and to other entities and that
provides information on what activities are best contributing to the
achievement of the outcome goals described in subsection (g).''.
SEC. 202. USING INFORMATION TECHNOLOGY TO IMPROVE SITUATIONAL AWARENESS
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.''.
SEC. 203. PUBLIC HEALTH WORKFORCE ENHANCEMENTS.
(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.''.
SEC. 204. VACCINE TRACKING AND DISTRIBUTION.
(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),''.
SEC. 205. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.
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.
SEC. 206. REVITALIZATION OF COMMISSIONED CORPS.
(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''.
TITLE III--ALL-HAZARDS MEDICAL SURGE CAPACITY
SEC. 301. NATIONAL DISASTER MEDICAL SYSTEM.
(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.
SEC. 302. ENHANCING MEDICAL SURGE CAPACITY.
(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.
SEC. 303. ENCOURAGING HEALTH PROFESSIONAL VOLUNTEERS.
(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''.
SEC. 304. CORE EDUCATION AND TRAINING.
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).
SEC. 305. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL PREPAREDNESS TO
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).''.
SEC. 306. ENHANCING THE ROLE OF THE DEPARTMENT OF VETERANS AFFAIRS.
(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.''.
TITLE IV--PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT
SEC. 401. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
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.''.
SEC. 402. NATIONAL BIODEFENSE SCIENCE BOARD.
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.''.
SEC. 403. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT
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).''.
SEC. 404. TECHNICAL ASSISTANCE.
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.''.
SEC. 405. COLLABORATION AND COORDINATION.
(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.
SEC. 406. PROCUREMENT.
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.''.
Passed the Senate December 5, 2006.
Attest:
Secretary.
109th CONGRESS
2d Session
S. 3678
_______________________________________________________________________
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.