Pandemic and All-Hazards Preparedness Act - Title I: National Preparedness and Response, Leadership, Organization, and Planning - (Sec. 101) Amends the Public Health Service Act to require the Secretary of Health and Human Services to lead all federal public health and medical response to public health emergencies and incidents covered by the National Response Plan.
(Sec. 102) Establishes within the Department of Health and Human Services (HHS) the Assistant Secretary for Preparedness and Response to: (1) serve as the principal advisor to the Secretary on federal public health and medical preparedness and response for public health emergencies; (2) oversee advanced research, development, and procurement of qualified countermeasures and qualified pandemic or epidemic products; and (3) provide logistical support for medical and public health aspects of federal responses to public health emergencies. Transfers to the Assistant Secretary functions of the Assistant Secretary for Public Health Emergency Preparedness.
Requires the Secretary to conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile and make necessary additions or modifications.
Requires the Secretary to: (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; (2) provide guidance to and ensure that recipients of state and local public health grants take into account the medical and public health needs of at-risk individuals; (3) ensure that the contents of the strategic national stockpile take into account at-risk populations; (4) oversee the progress of the Advisory Committee on At-Risk Individuals and Public Health Emergencies; and (5) disseminate novel and best practices of outreach to, and care of, at-risk individuals before, during, and following public health emergencies.
(Sec. 103) Requires the Secretary to prepare and submit to Congress the National Health Security Strategy for public health emergency preparedness and response.
Title II: Public Health Security Preparedness - (Sec. 201) Expands the program for state and local public health emergency preparedness to allow political subdivisions of states or a consortium of states to be eligible for funding. Requires the Secretary to: (1) develop and require the application of evidence-based benchmarks and objective standards that measure levels of preparedness that include outcome goals representing operational achievement of the National Preparedness Goals; (2) develop and disseminate to each state the criteria for an effective state plan for responding to pandemic influenza; and (3) withhold funds from entities that fail to meet the benchmarks and performance measures or fail to submit a plan for responding to pandemic influenza that meets the criteria.
Allows the Secretary to award grants an eligible entity to purchase and use advanced diagnostic medical equipment to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance and report any results.
Sets forth matching requirements for emergency preparedness funds.
Requires the Secretary to compile and make available data submitted under this section 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.
(Sec. 202) Requires the Secretary to 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. Allows the Secretary to award grants to states or consortia of states to establish or operate such systems.
Requires the Secretary to: (1) conduct an inventory of telehealth initiatives; (2) identify methods to expand and interconnect telehealth networks; (3) 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; (4) identify methods for reducing legal barriers that deter health care professionals from providing telemedicine services; and (5) evaluate ways to integrate the practice of telemedicine within the National Disaster Medical System.
(Sec. 203) Requires the Secretary to establish a demonstration project to provide for the participation of individuals who are eligible for National Health Service Corps loan repayment program and who agree to complete their service in a state, local, or tribal health department that provides a significant amount of service to health professional shortage areas or areas at risk of a public health emergency. Allows the Secretary to award grants to assist states in operating loan repayment programs for such service.
(Sec. 204) Allows the Secretary to track the initial distribution of federally purchased influenza vaccine in an influenza pandemic.
(Sec. 205) Requires the National Science Advisory Board for Biosecurity, when requested by the Secretary, to 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 laboratory capacity nationwide and assessments of the future need for increased laboratory capacity.
(Sec. 206) Requires the Secretary to establish requirements to ensure the readiness of the Commissioned Corps to respond to urgent or emergency public health care needs that cannot otherwise be met at the federal, state, and local levels. Sets forth provisions regarding disciplinary action and waivers for Corps members who do not meet readiness requirements. Requires the Secretary to: (1) organize members of the Corps into units for rapid deployment to respond to urgent or emergency public health care needs; and (2) ensure that members of the Corps are trained, equipped, and otherwise prepared to fulfill their public health and emergency response roles.
Title III: All-Hazards Medical Surge Capacity - (Sec. 301) Requires the Secretary to conduct a joint review of the National Disaster Medical System, including a review of medical surge capacity. Transfers to the Secretary the functions of the National Disaster Medical System.
Changes the National Advisory Committee on Children and Terrorism to the National Advisory Committee on At-Risk Individuals and Public Health Emergencies to focus on public health emergencies as they relate to at-risk individuals.
(Sec. 302) Requires the Secretary to: (1) evaluate the benefits and feasibility of improving HHS's capacity to provide additional medical surge capacity to local communities in a public health emergency; and (2) conduct an analysis of whether there are federal facilities that could practicably be used as health care facilities in such an emergency.
(Sec. 303) Requires the Secretary to: (1) establish a Medical Reserve Corps to provide for an adequate supply of volunteers in a federal, state, local, or tribal public health emergency; (2) link existing state verification systems to maintain a single national interoperable network of systems to verify the credentials and licenses of health care professionals who volunteer to provide health services during a public health emergency; and (3) encourage states to establish and implement mechanisms to waive the application of licensing requirements applicable to health professionals, seeking to provide medical services during a national, state, local, or tribal public health emergency.
Repeals provisions establishing an interagency working group on the prevention, preparedness, and response to bioterrorism and other public health emergencies.
Requires the Secretary to develop core health and medical response curricula and training by adapting applicable existing curricula and training programs to improve responses to public health emergencies.
Allows the Secretary to establish: (1) an additional 20 officer positions in the Epidemic Intelligence Service Program; and (2) Centers for Public Health Preparedness at accredited schools of public health.
(Sec. 305) Expands programs to improve hospital preparedness for public health emergencies to include grants to improve surge capacity.
(Sec. 306) Requires the Secretary of Veteran Affairs to: (1) ensure the readiness of Department of Veterans Affairs medical centers for a public health emergency; (2) organize, train, and equip the staff of such medical centers to support the Secretary of HHS in the event of a public health emergency and incidents covered by the National Response Plan; and (3) provide medical logistical support to the National Disaster Medical System and the Secretary of HHS as necessary.
Title IV: Pandemic and Biodefense Vaccine and Drug Development - (Sec. 401) Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. Establishes the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). Requires the Secretary to coordinate the acceleration of countermeasure and product advanced research and development.
Requires the Secretary to: (1) facilitate and increase expeditious and direct communication with respect to such research and development; (2) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products; (3) direct and coordinate such research and development activities of HHS; (4) establish strategic initiatives to accelerate such research and development and innovation in priority unmet need areas; and (5) connect interested persons with authorized offices or employees to advise such persons regarding relevant regulatory requirements related to qualified countermeasures or qualified pandemic or epidemic products. Allows the Secretary to award contracts, grants, and cooperative agreements or enter into other transactions to promote: (1) innovation in technologies that may assist such research and development; (2) research on and development of research tools and other devices and technologies; and (3) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
Authorizes the Secretary to enter into other transactions for countermeasure and product advanced research and development in the same manner as the Secretary of Defense. Limits such authority for certain prototype projects and by requiring a written determination for projects that exceed certain costs. Requires the Secretary to establish guidelines regarding such authority. Gives the Secretary expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts. Directs the Secretary to require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction, a person make available to the Secretary all data related to or resulting from such research and development. Authorizes the Secretary to waive advertising and advance payment requirements if such waiver is necessary to obtain countermeasures or products.
Allows the Secretary to: (1) use milestone-based awards and payments; (2) make awards to and enter into transactions with highly qualified foreign national persons outside the United States; (3) establish one or more federally-funded research and development centers or university-affiliated research centers if it is not feasible or appropriate to establish an arrangement with an existing research center; (4) 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, the elderly, and other at-risk individuals; (5) appoint highly qualified individuals to scientific or professional positions in BARDA without regard to federal provisions governing appointments in the competitive service; and (6) appoint special consultants.
Establishes the Biodefense Medical Countermeasure Development Fund to carry out this section.
Requires the Secretary to withhold from disclosure under the Freedom of Information Act specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under this section that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats.
(Sec. 402) Requires the Secretary to establish the National Biodefense Science Board to provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents. Allows the Secretary to establish a working group of experts, or use an existing group, 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 advise regarding 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.
(Sec. 403) Includes within the definition of "qualified countermeasure" a biological agent or toxin to diagnose, mitigate, prevent, or treat harm, including organisms that cause an infectious disease.
(Sec. 404) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to establish within the Food and Drug Administration (FDA) a team of experts on manufacturing and regulatory activities to provide technical assistance to the manufacturers of qualified countermeasures, security countermeasures, or vaccines if the Secretary determines that a shortage or potential shortage may occur.
(Sec. 405) Allows the Secretary to conduct meetings and consultations with persons engaged in the development of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product for the purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. Requires such meetings and consultations to be conducted so as to ensure that national security, confidential, and proprietary information is not disclosed outside the meeting or consultations. Prohibits the Secretary from requiring the disclosure of confidential commercial or proprietary information. Exempts such meetings and consultations from antitrust laws. Requires the Secretary to file a written agreement regarding such covered activities. Requires the Attorney General to grant such exemption if the conduct will not have any substantial anticompetitive effect that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.
(Sec. 406) Requires the Secretary to institute a process for making publicly available the results of assessments of specific countermeasures to address specific threats while withholding information that would reveal public vulnerabilities or would otherwise be exempt from public disclosure. Allows partial payment on a procurement contract for a security countermeasure for significant milestones or a payment to increase manufacturing capacity. Allows procurement contracts to provide: (1) for advance payments for milestones; (2) that the vendor is the sole and exclusive supplier of the product to the government for a specified period if the vendor is able to satisfy the government's needs; (3) that the vendor establish domestic manufacturing capacity of the product to ensure that additional production is available as necessary; (4) dosing and administration requirements for countermeasures; (5) the amount of funding that will be dedicated by the Secretary for countermeasure research and development; and (6) specifications the countermeasure must meet to qualify for procurement under a contract.
[109th Congress Public Law 417]
[From the U.S. Government Publishing Office]
[DOCID: f:publ417.109]
[[Page 120 STAT. 2831]]
Public Law 109-417
109th Congress
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. <<NOTE: Dec. 19, 2006 - [S. 3678]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress <<NOTE: Pandemic and All-Hazards
Preparedness Act. 42 USC 201 note.>> 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.
[[Page 120 STAT. 2832]]
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. <<NOTE: 42 USC 300hh.>> 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 <<NOTE: 42 USC 300hh-
11.>> as section 2812;
[[Page 120 STAT. 2833]]
(3) by inserting after the subtitle heading the following
new section:
``SEC. 2811. <<NOTE: 42 USC 300hh-10.>> COORDINATION OF PREPAREDNESS FOR
AND RESPONSE TO ALL-HAZARDS PUBLIC HEALTH EMERGENCIES.
``(a) <<NOTE: Government organization.>> In General.--There is
established within the Department of Health and Human Services the
position of the Assistant Secretary for Preparedness and Response.
The <<NOTE: President.>> 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--
[[Page 120 STAT. 2834]]
``(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) <<NOTE: 42 USC 300hh-11.>> by striking ``Assistant
Secretary for Public Health Emergency Preparedness'' each place
it appears and inserting ``Assistant Secretary for Preparedness
and Response''.
(b) <<NOTE: 42 USC 300hh-10 note.>> 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. <<NOTE: 42 USC 300hh-16.>> 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);
[[Page 120 STAT. 2835]]
``(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) <<NOTE: Deadline. Reports.>> 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. <<NOTE: 42 USC 300hh-1.>> NATIONAL HEALTH SECURITY
STRATEGY.
``(a) In General.--
``(1) Preparedness and response regarding public health
emergencies.--Beginning <<NOTE: Effective date. Deadline.>> 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.
[[Page 120 STAT. 2836]]
``(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
[[Page 120 STAT. 2837]]
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) <<NOTE: Contracts.>> 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
[[Page 120 STAT. 2838]]
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) <<NOTE: Effective date.>> 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--
[[Page 120 STAT. 2839]]
``(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) <<NOTE: Website.>> 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) <<NOTE: Deadline.>> 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) <<NOTE: Deadline.>> 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
[[Page 120 STAT. 2840]]
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 <<NOTE: Effective
date. Deadline.>> 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).
[[Page 120 STAT. 2841]]
``(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
[[Page 120 STAT. 2842]]
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 <<NOTE: Effective date.>> 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
[[Page 120 STAT. 2843]]
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) <<NOTE: Contracts.>> 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
[[Page 120 STAT. 2844]]
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) <<NOTE: Publication. Website.>> 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. <<NOTE: Deadline.>> 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.
[[Page 120 STAT. 2845]]
``(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) <<NOTE: Website.>> 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) <<NOTE: Deadline.>> 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) <<NOTE: Deadline.>> 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).
[[Page 120 STAT. 2846]]
``(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) <<NOTE: Reports.>> 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--
[[Page 120 STAT. 2847]]
``(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) <<NOTE: Deadline. Reports.>> 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;
[[Page 120 STAT. 2848]]
``(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. <<NOTE: 42 USC 254u.>> 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
[[Page 120 STAT. 2849]]
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
[[Page 120 STAT. 2850]]
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).
[[Page 120 STAT. 2851]]
``(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 <<NOTE: 42 USC 247d-2, 247d-3.>> 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. <<NOTE: 42 USC 262a note.>> 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. <<NOTE: 42 USC 204a note.>> 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. <<NOTE: 42 USC 204a.>> 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
[[Page 120 STAT. 2852]]
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) <<NOTE: Procedures.>> 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.
[[Page 120 STAT. 2853]]
``(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
[[Page 120 STAT. 2854]]
(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 <<NOTE: Deadline.>> 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) <<NOTE: 42 USC 300hh-11 note.>> 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), <<NOTE: 6 USC 314.>> by striking
``, the National Disaster Medical System,''; and
(2) in section 503(5), <<NOTE: 6 USC 313.>> 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
[[Page 120 STAT. 2855]]
(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) <<NOTE: 6 USC 313 note.>> 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. <<NOTE: 42 USC 300hh-2.>> 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:
[[Page 120 STAT. 2856]]
``(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) <<NOTE: Applicability.>> 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) <<NOTE: Applicability.>> 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) <<NOTE: 42 USC 1320b-5 note.>> 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. <<NOTE: Establishment. 42 USC 300hh-
15. Deadline.>> 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
[[Page 120 STAT. 2857]]
``(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--
[[Page 120 STAT. 2858]]
(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) <<NOTE: Deadline.>> 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
[[Page 120 STAT. 2859]]
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
[[Page 120 STAT. 2860]]
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).
[[Page 120 STAT. 2861]]
``(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) <<NOTE: Grants. Contracts.>> 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--
[[Page 120 STAT. 2862]]
``(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.
[[Page 120 STAT. 2863]]
``(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) <<NOTE: Applicability.>> 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)--
[[Page 120 STAT. 2864]]
(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.''.
[[Page 120 STAT. 2865]]
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. <<NOTE: 42 USC 247d-7e.>> 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;
[[Page 120 STAT. 2866]]
``(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) <<NOTE: Deadline. Public information.>> 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.
[[Page 120 STAT. 2867]]
``(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
[[Page 120 STAT. 2868]]
``(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
[[Page 120 STAT. 2869]]
Defense enters into such transactions under
section 2371 of title 10, United States Code.
``(ii) Limitations on authority.--
``(I) <<NOTE: Applicability.>> 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) <<NOTE: Applicability.>> 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
[[Page 120 STAT. 2870]]
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.
[[Page 120 STAT. 2871]]
``(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) <<NOTE: Applicability.>> 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
[[Page 120 STAT. 2872]]
enactment of the Pandemic and All-Hazards Preparedness
Act.
``(2) <<NOTE: Termination date.>> 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. <<NOTE: 42 USC 247d-7f.>> 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;
[[Page 120 STAT. 2873]]
``(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) <<NOTE: Deadline.>> 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;
[[Page 120 STAT. 2874]]
``(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 <<NOTE: 42 USC 247d-
6b.>> 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) <<NOTE: 42 USC 321j.>> 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
[[Page 120 STAT. 2875]]
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. <<NOTE: Establishment. 21 USC 360bbb-4.>> 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. <<NOTE: 42 USC 247d-6a note.>> 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. <<NOTE: Notice.>> 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;
[[Page 120 STAT. 2876]]
(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
[[Page 120 STAT. 2877]]
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) <<NOTE: Deadline.>> 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) <<NOTE: Applicability.>> 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
[[Page 120 STAT. 2878]]
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
[[Page 120 STAT. 2879]]
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) <<NOTE: Public information.>> 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
[[Page 120 STAT. 2880]]
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
[[Page 120 STAT. 2881]]
``(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.''.
Approved December 19, 2006.
LEGISLATIVE HISTORY--S. 3678:
---------------------------------------------------------------------------
SENATE REPORTS: No. 109-319 (Comm. on Health, Education, Labor, and
Pensions).
CONGRESSIONAL RECORD, Vol. 152 (2006):
Dec. 5, considered and passed Senate.
Dec. 8, considered and passed House.
<all>
Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-319.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 583.
Measure laid before Senate by unanimous consent. (consideration: CR S11220-11237; text of measure as reported in Senate: CR S11220-11235)
The committee substitute as amended agreed to by Unanimous Consent.
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Passed Senate with an amendment by Unanimous Consent.
Received in the House.
Message on Senate action sent to the House.
Held at the desk.
Considered by unanimous consent. (consideration: CR 12/8/2006 H9260-9275)
Mr. Barton (TX) asked unanimous consent to take from the Speaker's table and consider.
Passed/agreed to in House: On passage Passed without objection.(text: CR 12/8/2006 H9260-9274)
Enacted as Public Law 109-417
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On passage Passed without objection. (text: CR 12/8/2006 H9260-9274)
Motion to reconsider laid on the table Agreed to without objection.
Presented to President.
Presented to President.
Signed by President.
Signed by President.
Became Public Law No: 109-417.
Became Public Law No: 109-417.