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PUBLIC LAW 109–417—DEC. 19, 2006
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.
Dec. 19, 2006
[S. 3678]
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
Pandemic and
All-Hazards
Preparedness
Act.
42 USC 201 note.
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.
Sec.
Sec.
Sec.
Sec.
301.
302.
303.
304.
305.
National disaster medical system.
Enhancing medical surge capacity.
Encouraging health professional volunteers.
Core education and training.
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.
Sec.
Sec.
Sec.
Sec.
Sec.
401.
402.
403.
404.
405.
406.
Biomedical Advanced Research and Development Authority.
National Biodefense Science Board.
Clarification of countermeasures covered by Project BioShield.
Technical assistance.
Collaboration and coordination.
Procurement.
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120 STAT. 2832
PUBLIC LAW 109–417—DEC. 19, 2006
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
42 USC 300hh.
‘‘SEC. 2801. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND
RESPONSE FUNCTIONS.
‘‘(a) IN GENERAL.—The Secretary of Health and Human Services
shall lead all Federal public health and medical response to public
health emergencies and incidents covered by the National Response
Plan developed pursuant to section 502(6) of the Homeland Security
Act of 2002, or any successor plan.
‘‘(b) INTERAGENCY AGREEMENT.—The Secretary, in collaboration
with the Secretary of Veterans Affairs, the Secretary of Transportation, the Secretary of Defense, the Secretary of Homeland Security, and the head of any other relevant Federal agency, shall
establish an interagency agreement, consistent with the National
Response Plan or any successor plan, under which agreement the
Secretary of Health and Human Services shall assume operational
control of emergency public health and medical response assets,
as necessary, in the event of a public health emergency, except
that members of the armed forces under the authority of the Secretary of Defense shall remain under the command and control
of the Secretary of Defense, as shall any associated assets of the
Department of Defense.’’.
SEC.
'
ASSISTANT
RESPONSE.
SECRETARY
FOR
PREPAREDNESS
AND
(a) ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.—
Subtitle B of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh–11 et seq.) is amended—
(1) in the subtitle heading, by inserting ‘‘All-Hazards’’
before ‘‘Emergency Preparedness’’;
(2) by redesignating section 2811 as section 2812;
42 USC
300hh–11.
102.
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PUBLIC LAW 109–417—DEC. 19, 2006
120 STAT. 2833
(3) by inserting after the subtitle heading the following
new section:
‘‘SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE
TO ALL-HAZARDS PUBLIC HEALTH EMERGENCIES.
42 USC
300hh–10.
‘‘(a) IN GENERAL.—There is established within the Department
of Health and Human Services the position of the Assistant Secretary for Preparedness and Response. The President, with the
advice and consent of the Senate, shall appoint an individual to
serve in such position. Such Assistant Secretary shall report to
the Secretary.
‘‘(b) DUTIES.—Subject to the authority of the Secretary, the
Assistant Secretary for Preparedness and Response shall carry out
the following functions:
‘‘(1) LEADERSHIP.—Serve as the principal advisor to the
Secretary on all matters related to Federal public health and
medical preparedness and response for public health emergencies.
‘‘(2) PERSONNEL.—Register, credential, organize, train,
equip, and have the authority to deploy Federal public health
and medical personnel under the authority of the Secretary,
including the National Disaster Medical System, and coordinate
such personnel with the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health
Professionals.
‘‘(3) COUNTERMEASURES.—Oversee advanced research,
development, and procurement of qualified countermeasures
(as defined in section 319F–1) and qualified pandemic or epidemic products (as defined in section 319F–3).
‘‘(4) COORDINATION.—
‘‘(A) FEDERAL INTEGRATION.—Coordinate with relevant
Federal officials to ensure integration of Federal preparedness and response activities for public health emergencies.
‘‘(B) STATE, LOCAL, AND TRIBAL INTEGRATION.—Coordinate with State, local, and tribal public health officials,
the Emergency Management Assistance Compact, health
care systems, and emergency medical service systems to
ensure effective integration of Federal public health and
medical assets during a public health emergency.
‘‘(C)
EMERGENCY
MEDICAL
SERVICES.—Promote
improved emergency medical services medical direction,
system integration, research, and uniformity of data collection, treatment protocols, and policies with regard to public
health emergencies.
‘‘(5) LOGISTICS.—In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General
Services Administration, and other public and private entities,
provide logistical support for medical and public health aspects
of Federal responses to public health emergencies.
‘‘(6) LEADERSHIP.—Provide leadership in international programs, initiatives, and policies that deal with public health
and medical emergency preparedness and response.
‘‘(c) FUNCTIONS.—The Assistant Secretary for Preparedness and
Response shall—
‘‘(1) have authority over and responsibility for—
Government
organization.
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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) by striking ‘‘Assistant Secretary for Public Health Emergency Preparedness’’ each place it appears and inserting
‘‘Assistant Secretary for Preparedness and Response’’.
(b) TRANSFER OF FUNCTIONS; REFERENCES.—
(1) TRANSFER OF FUNCTIONS.—There shall be transferred
to the Office of the Assistant Secretary for Preparedness and
Response the functions, personnel, assets, and liabilities of
the Assistant Secretary for Public Health Emergency Preparedness as in effect on the day before the date of enactment
of this Act.
(2) REFERENCES.—Any reference in any Federal law, Executive order, rule, regulation, or delegation of authority, or any
document of or pertaining to the Assistant Secretary for Public
Health Emergency Preparedness as in effect the day before
the date of enactment of this Act, shall be deemed to be a
reference to the Assistant Secretary for Preparedness and
Response.
(c) STOCKPILE.—Section 319F–2(a)(1) of the Public Health
Service Act (42 U.S.C. 247d–6b(a)(1)) is amended by—
(1) inserting ‘‘in collaboration with the Director of the Centers for Disease Control and Prevention, and’’ after ‘‘Secretary,’’;
and
(2) inserting at the end the following: ‘‘The Secretary shall
conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile, including non-pharmaceutical supplies, and make necessary additions or modifications to the contents based on such review.’’.
(d) AT-RISK INDIVIDUALS.—Title XXVIII of the Public Health
Service Act (42 U.S.C. 300hh et seq.), as amended by section 303
of this Act, is amended by inserting after section 2813 the following:
42 USC
300hh–11.
42 USC
300hh–10 note.
42 USC
300hh–16.
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PUBLIC LAW 109–417—DEC. 19, 2006
‘‘SEC. 2814. AT-RISK INDIVIDUALS.
‘‘The Secretary, acting through such employee of the Department of Health and Human Services as determined by the Secretary
and designated publicly (which may, at the discretion of the Secretary, involve the appointment or designation of an individual
as the Director of At-Risk Individuals), shall—
‘‘(1) oversee the implementation of the National Preparedness goal of taking into account the public health and medical
needs of at-risk individuals in the event of a public health
emergency, as described in section 2802(b)(4);
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PUBLIC LAW 109–417—DEC. 19, 2006
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) 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.’’.
Deadline.
Reports.
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:
42 USC 300hh–1.
‘‘SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.
‘‘(a) IN GENERAL.—
‘‘(1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC
HEALTH EMERGENCIES.—Beginning in 2009 and every four years
thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a coordinated strategy (to be
known as the National Health Security Strategy) and any revisions thereof, and an accompanying implementation plan for
public health emergency preparedness and response. Such
National Health Security Strategy shall identify the process
for achieving the preparedness goals described in subsection
(b) and shall be consistent with the National Preparedness
Goal, the National Incident Management System, and the
National Response Plan developed pursuant to section 502(6)
of the Homeland Security Act of 2002, or any successor plan.
‘‘(2) EVALUATION OF PROGRESS.—The National Health Security Strategy shall include an evaluation of the progress made
by Federal, State, local, and tribal entities, based on the evidence-based benchmarks and objective standards that measure
levels of preparedness established pursuant to section 319C–
1(g). Such evaluation shall include aggregate and State-specific
breakdowns of obligated funding spent by major category (as
defined by the Secretary) for activities funded through awards
pursuant to sections 319C–1 and 319C–2.
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120 STAT. 2836
PUBLIC LAW 109–417—DEC. 19, 2006
‘‘(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
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PUBLIC LAW 109–417—DEC. 19, 2006
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) 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
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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) 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—
Effective date.
PUBLIC LAW 109–417—DEC. 19, 2006
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PUBLIC LAW 109–417—DEC. 19, 2006
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) disseminate such recommendations and guidance,
including through expanding existing lessons learned information systems to create a single Internet-based point of access
for sharing and distributing medical and public health best
practices and lessons learned from drills, exercises, disasters,
and other emergencies.
‘‘(g) ACHIEVEMENT OF MEASURABLE EVIDENCE-BASED BENCHMARKS AND OBJECTIVE STANDARDS.—
‘‘(1) IN GENERAL.—Not later than 180 days after the date
of enactment of the Pandemic and All-Hazards Preparedness
Act, the Secretary shall develop or where appropriate adopt,
and require the application of, measurable evidence-based
benchmarks and objective standards that measure levels of
preparedness with respect to the activities described in this
section and with respect to activities described in section 319C–
2. In developing such benchmarks and standards, the Secretary
shall consult with and seek comments from State, local, and
tribal officials and private entities, as appropriate. Where
appropriate, the Secretary shall incorporate existing objective
standards. Such benchmarks and standards shall—
‘‘(A) include outcome goals representing operational
achievement of the National Preparedness Goals developed
under section 2802(b); and
‘‘(B) at a minimum, require entities to—
‘‘(i) measure progress toward achieving the outcome goals; and
‘‘(ii) at least annually, test, exercise, and rigorously
evaluate the public health and medical emergency
preparedness and response capabilities of the entity,
and report to the Secretary on such measured and
tested capabilities and measured and tested progress
toward achieving outcome goals, based on criteria
established by the Secretary.
‘‘(2) CRITERIA FOR PANDEMIC INFLUENZA PLANS.—
‘‘(A) IN GENERAL.—Not later than 180 days after the
date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall develop and disseminate to the chief executive officer of each State criteria
for an effective State plan for responding to pandemic
influenza.
‘‘(B) RULE OF CONSTRUCTION.—Nothing in this section
shall be construed to require the duplication of Federal
efforts with respect to the development of criteria or standards, without regard to whether such efforts were carried
out prior to or after the date of enactment of this section.
‘‘(3) TECHNICAL ASSISTANCE.—The Secretary shall, as determined appropriate by the Secretary, provide to a State, upon
request, technical assistance in meeting the requirements of
this section, including the provision of advice by experts in
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120 STAT. 2840
PUBLIC LAW 109–417—DEC. 19, 2006
the development of high-quality assessments, the setting of
State objectives and assessment methods, the development of
measures of satisfactory annual improvement that are valid
and reliable, and other relevant areas.
‘‘(4) NOTIFICATION OF FAILURES.—The Secretary shall
develop and implement a process to notify entities that are
determined by the Secretary to have failed to meet the requirements of paragraph (1) or (2). Such process shall provide such
entities with the opportunity to correct such noncompliance.
An entity that fails to correct such noncompliance shall be
subject to paragraph (5).
‘‘(5) WITHHOLDING OF AMOUNTS FROM ENTITIES THAT FAIL
TO ACHIEVE BENCHMARKS OR SUBMIT INFLUENZA PLAN.—Beginning with fiscal year 2009, and in each succeeding fiscal year,
the Secretary shall—
‘‘(A) withhold from each entity that has failed substantially to meet the benchmarks and performance measures
described in paragraph (1) for the immediately preceding
fiscal year (beginning with fiscal year 2008), pursuant to
the process developed under paragraph (4), the amount
described in paragraph (6); and
‘‘(B) withhold from each entity that has failed to submit
to the Secretary a plan for responding to pandemic
influenza that meets the criteria developed under paragraph (2), the amount described in paragraph (6).
‘‘(6) AMOUNTS DESCRIBED.—
‘‘(A) IN GENERAL.—The amounts described in this paragraph are the following amounts that are payable to an
entity for activities described in section 319C–1 or 319C–
2:
‘‘(i) For the fiscal year immediately following a
fiscal year in which an entity experienced a failure
described in subparagraph (A) or (B) of paragraph
(5) by the entity, an amount equal to 10 percent of
the amount the entity was eligible to receive for such
fiscal year.
‘‘(ii) For the fiscal year immediately following two
consecutive fiscal years in which an entity experienced
such a failure, an amount equal to 15 percent of the
amount the entity was eligible to receive for such fiscal
year, taking into account the withholding of funds for
the immediately preceding fiscal year under clause
(i).
‘‘(iii) For the fiscal year immediately following
three consecutive fiscal years in which an entity experienced such a failure, an amount equal to 20 percent
of the amount the entity was eligible to receive for
such fiscal year, taking into account the withholding
of funds for the immediately preceding fiscal years
under clauses (i) and (ii).
‘‘(iv) For the fiscal year immediately following four
consecutive fiscal years in which an entity experienced
such a failure, an amount equal to 25 percent of the
amount the entity was eligible to receive for such a
fiscal year, taking into account the withholding of funds
for the immediately preceding fiscal years under
clauses (i), (ii), and (iii).
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PUBLIC LAW 109–417—DEC. 19, 2006
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
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the accuracy of surveillance data, improving the definitions used by the poison control centers for surveillance, and enhancing timely and efficient investigation
of data anomalies;
‘‘(ii) improve the capabilities of poison control centers to provide information to health care providers
and the public with regard to chemical, biological,
radiological, or nuclear threats or exposures, in consultation with the appropriate State, local, and tribal
public health entities; or
‘‘(iii) provide surge capacity in the event of a chemical, biological, radiological, or nuclear event through
the establishment of alternative poison control center
worksites and the training of nontraditional personnel.’’;
(3) by redesignating subsection (j) as subsection (i);
(4) in subsection (i), as so redesignated—
(A) by striking paragraphs (1) through (3)(A) and
inserting the following:
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(A) IN GENERAL.—For the purpose of carrying out
this section, there is authorized to be appropriated
$824,000,000 for fiscal year 2007, of which $35,000,000
shall be used to carry out subsection (h), for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and
(5)), and such sums as may be necessary for each of fiscal
years 2008 through 2011.
‘‘(B) COORDINATION.—There are authorized to be appropriated, $10,000,000 for fiscal year 2007 to carry out subsection (f)(4) of this section and section 2814.
‘‘(C) REQUIREMENT FOR STATE MATCHING FUNDS.—
Beginning in fiscal year 2009, in the case of any State
or consortium of two or more States, the Secretary may
not award a cooperative agreement under this section
unless the State or consortium of States agree that, with
respect to the amount of the cooperative agreement
awarded by the Secretary, the State or consortium of States
will make available (directly or through donations from
public or private entities) non-Federal contributions in an
amount equal to—
‘‘(i) for the first fiscal year of the cooperative agreement, not less than 5 percent of such costs ($1 for
each $20 of Federal funds provided in the cooperative
agreement); and
‘‘(ii) for any second fiscal year of the cooperative
agreement, and for any subsequent fiscal year of such
cooperative agreement, not less than 10 percent of
such costs ($1 for each $10 of Federal funds provided
in the cooperative agreement).
‘‘(D) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTIONS.—As determined by the Secretary, non-Federal
contributions required in subparagraph (C) may be provided directly or through donations from public or private
entities and may be in cash or in kind, fairly evaluated,
including plant, equipment or services. Amounts provided
Effective date.
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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) 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
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PUBLIC LAW 109–417—DEC. 19, 2006
Preparedness Act (after consultation with the States) to be
necessary to—
‘‘(A) secure an accurate description of those activities;
‘‘(B) secure a complete record of the purposes for which
funds were spent, and of the recipients of such funds;
‘‘(C) describe the extent to which the entity has met
the goals and objectives it set forth under this section
or section 319C–2;
‘‘(D) determine the extent to which funds were
expended consistent with the entity’s application transmitted under this section or section 319C–2; and
‘‘(E) publish such information on a Federal Internet
website consistent with subsection (k).
‘‘(2) AUDITS; IMPLEMENTATION.—
‘‘(A) IN GENERAL.—Each entity receiving funds under
this section or section 319C–2 shall, not less often than
once every 2 years, audit its expenditures from amounts
received under this section or section 319C–2. Such audits
shall be conducted by an entity independent of the agency
administering a program funded under this section or section 319C–2 in accordance with the Comptroller General’s
standards for auditing governmental organizations, programs, activities, and functions and generally accepted
auditing standards. Within 30 days following the completion of each audit report, the entity shall submit a copy
of that audit report to the Secretary.
‘‘(B) REPAYMENT.—Each entity shall repay to the
United States amounts found by the Secretary, after notice
and opportunity for a hearing to the entity, not to have
been expended in accordance with this section or section
319C–2 and, if such repayment is not made, the Secretary
may offset such amounts against the amount of any allotment to which the entity is or may become entitled under
this section or section 319C–2 or may otherwise recover
such amounts.
‘‘(C) WITHHOLDING OF PAYMENT.—The Secretary may,
after notice and opportunity for a hearing, withhold payment of funds to any entity which is not using its allotment
under this section or section 319C–2 in accordance with
such section. The Secretary may withhold such funds until
the Secretary finds that the reason for the withholding
has been removed and there is reasonable assurance that
it will not recur.
‘‘(3) MAXIMUM CARRYOVER AMOUNT.—
‘‘(A) IN GENERAL.—For each fiscal year, the Secretary,
in consultation with the States and political subdivisions,
shall determine the maximum percentage amount of an
award under this section that an entity may carryover
to the succeeding fiscal year.
‘‘(B) AMOUNT EXCEEDED.—For each fiscal year, if the
percentage amount of an award under this section unexpended by an entity exceeds the maximum percentage permitted by the Secretary under subparagraph (A), the entity
shall return to the Secretary the portion of the unexpended
amount that exceeds the maximum amount permitted to
be carried over by the Secretary.
Publication.
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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) 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).’’.
Website.
SEC. 202. USING INFORMATION TECHNOLOGY TO IMPROVE SITUATIONAL AWARENESS IN PUBLIC HEALTH EMERGENCIES.
Section 319D of the Public Health Service Act (42 U.S.C. 247d–
4) is amended—
(1) in subsection (a)(1), by inserting ‘‘domestically and
abroad’’ after ‘‘public health threats’’; and
(2) by adding at the end the following:
‘‘(d) PUBLIC HEALTH SITUATIONAL AWARENESS.—
‘‘(1) IN GENERAL.—Not later than 2 years after the date
of enactment of the Pandemic and All-Hazards Preparedness
Act, the Secretary, in collaboration with State, local, and tribal
public health officials, shall establish a near real-time electronic
nationwide public health situational awareness capability
through an interoperable network of systems to share data
and information to enhance early detection of rapid response
to, and management of, potentially catastrophic infectious disease outbreaks and other public health emergencies that originate domestically or abroad. Such network shall be built on
existing State situational awareness systems or enhanced systems that enable such connectivity.
‘‘(2) STRATEGIC PLAN.—Not later than 180 days after the
date of enactment the Pandemic and All-Hazards Preparedness
Act, the Secretary shall submit to the appropriate committees
of Congress, a strategic plan that demonstrates the steps the
Secretary will undertake to develop, implement, and evaluate
the network described in paragraph (1), utilizing the elements
described in paragraph (3).
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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) 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—
Reports.
PUBLIC LAW 109–417—DEC. 19, 2006
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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) 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;
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PUBLIC LAW 109–417—DEC. 19, 2006
‘‘(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:
42 USC 254u.
‘‘SEC. 338M. PUBLIC HEALTH DEPARTMENTS.
‘‘(a) IN GENERAL.—To the extent that funds are appropriated
under subsection (e), the Secretary shall establish a demonstration
project to provide for the participation of individuals who are eligible
for the Loan Repayment Program described in section 338B and
who agree to complete their service obligation in a State health
department that provides a significant amount of service to health
professional shortage areas or areas at risk of a public health
emergency, as determined by the Secretary, or in a local or tribal
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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
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PUBLIC LAW 109–417—DEC. 19, 2006
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).
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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 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),’’.
42 USC 247d–2,
247d–3.
42 USC 262a
note.
SEC. 205. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.
The National Science Advisory Board for Biosecurity shall,
when requested by the Secretary of Health and Human Services,
provide to relevant Federal departments and agencies, advice, guidance, or recommendations concerning—
(1) a core curriculum and training requirements for workers
in maximum containment biological laboratories; and
(2) periodic evaluations of maximum containment biological
laboratory capacity nationwide and assessments of the future
need for increased laboratory capacity.
42 USC 204a
note.
SEC. 206. REVITALIZATION OF COMMISSIONED CORPS.
(a) PURPOSE.—It is the purpose of this section to improve the
force management and readiness of the Commissioned Corps to
accomplish the following objectives:
(1) To ensure the Corps is ready to respond rapidly to
urgent or emergency public health care needs and challenges.
(2) To ensure the availability of the Corps for assignments
that address clinical and public health needs in isolated, hardship, and hazardous duty positions, and, when required, to
address needs related to the well-being, security, and defense
of the United States.
(3) To establish the Corps as a resource available to Federal
and State Government agencies for assistance in meeting public
health leadership and service roles.
(b) COMMISSIONED CORPS READINESS.—Title II of the Public
Health Service Act (42 U.S.C. 202 et seq.) is amended by inserting
after section 203 the following:
42 USC 204a.
‘‘SEC. 203A. DEPLOYMENT READINESS.
‘‘(a) READINESS REQUIREMENTS FOR COMMISSIONED CORPS OFFICERS.—
‘‘(1) IN GENERAL.—The Secretary, with respect to members
of the following Corps components, shall establish requirements, including training and medical examinations, to ensure
the readiness of such components to respond to urgent or emergency public health care needs that cannot otherwise be met
at the Federal, State, and local levels:
‘‘(A) Active duty Regular Corps.
‘‘(B) Active Reserves.
‘‘(2) ANNUAL ASSESSMENT OF MEMBERS.—The Secretary
shall annually determine whether each member of the Corps
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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) 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.
Procedures.
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‘‘(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
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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 later than 180 days after the date of enactment
of the Pandemic and All-Hazards Preparedness Act, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans
Affairs, shall conduct a joint review of the National Disaster
Medical System. Such review shall include an evaluation of
medical surge capacity, as described by section 2803(a). As
part of the National Health Security Strategy under section
2802, the Secretary shall update the findings from such review
and further modify the policies of the National Disaster Medical
System as necessary.’’;
(6) by striking ‘‘subsection (b)’’ each place it appears and
inserting ‘‘subsection (a)’’;
(7) by striking ‘‘subsection (d)’’ each place it appears and
inserting ‘‘subsection (c)’’; and
(8) in subsection (g), as so redesignated, by striking ‘‘2002
through 2006’’ and inserting ‘‘2007 through 2011’’.
(b) TRANSFER OF NATIONAL DISASTER MEDICAL SYSTEM TO THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES.—There shall be
transferred to the Secretary of Health and Human Services the
functions, personnel, assets, and liabilities of the National Disaster
Medical System of the Department of Homeland Security, including
the functions of the Secretary of Homeland Security and the Under
Secretary for Emergency Preparedness and Response relating
thereto.
(c) CONFORMING AMENDMENTS TO THE HOMELAND SECURITY
ACT OF 2002.—The Homeland Security Act of 2002 (6 U.S.C.
312(3)(B), 313(5)) is amended—
(1) in section 502(3)(B), by striking ‘‘, the National Disaster
Medical System,’’; and
(2) in section 503(5), by striking ‘‘, the National Disaster
Medical System’’.
(d) UPDATE OF CERTAIN PROVISION.—Section 319F(b)(2) of the
Public Health Service Act (42 U.S.C. 247d–6(b)(2)) is amended—
(1) in the paragraph heading, by striking ‘‘CHILDREN AND
TERRORISM’’ and inserting ‘‘AT-RISK INDIVIDUALS AND PUBLIC
HEALTH EMERGENCIES’’;
(2) in subparagraph (A), by striking ‘‘Children and Terrorism’’ and inserting ‘‘At-Risk Individuals and Public Health
Emergencies’’;
(3) in subparagraph (B)—
(A) in clause (i), by striking ‘‘bioterrorism as it relates
to children’’ and inserting ‘‘public health emergencies as
they relate to at-risk individuals’’;
(B) in clause (ii), by striking ‘‘children’’ and inserting
‘‘at-risk individuals’’; and
(C) in clause (iii), by striking ‘‘children’’ and inserting
‘‘at-risk individuals’’;
(4) in subparagraph (C), by striking ‘‘children’’ and all
that follows through the period and inserting ‘‘at-risk populations.’’; and
Deadline.
42 USC
300hh–11 note.
6 USC 314.
6 USC 313.
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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) EFFECTIVE DATE.—The amendments made by subsections
(b) and (c) shall take effect on January 1, 2007.
6 USC 313 note.
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:
42 USC 300hh–2.
‘‘SEC. 2803. ENHANCING MEDICAL SURGE CAPACITY.
‘‘(a) STUDY OF ENHANCING MEDICAL SURGE CAPACITY.—As part
of the joint review described in section 2812(b), the Secretary shall
evaluate the benefits and feasibility of improving the capacity of
the Department of Health and Human Services to provide additional
medical surge capacity to local communities in the event of a
public health emergency. Such study shall include an assessment
of the need for and feasibility of improving surge capacity through—
‘‘(1) acquisition and operation of mobile medical assets by
the Secretary to be deployed, on a contingency basis, to a
community in the event of a public health emergency;
‘‘(2) integrating the practice of telemedicine within the
National Disaster Medical System; and
‘‘(3) other strategies to improve such capacity as determined
appropriate by the Secretary.
‘‘(b) AUTHORITY TO ACQUIRE AND OPERATE MOBILE MEDICAL
ASSETS.—In addition to any other authority to acquire, deploy,
and operate mobile medical assets, the Secretary may acquire,
deploy, and operate mobile medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deployment, and operation is determined to be beneficial and
feasible in improving the capacity of the Department of Health
and Human Services to provide additional medical surge capacity
to local communities in the event of a public health emergency.
‘‘(c) USING FEDERAL FACILITIES TO ENHANCE MEDICAL SURGE
CAPACITY.—
‘‘(1) ANALYSIS.—The Secretary shall conduct an analysis
of whether there are Federal facilities which, in the event
of a public health emergency, could practicably be used as
facilities in which to provide health care.
‘‘(2) MEMORANDA OF UNDERSTANDING.—If, based on the
analysis conducted under paragraph (1), the Secretary determines that there are Federal facilities which, in the event
of a public health emergency, could be used as facilities in
which to provide health care, the Secretary shall, with respect
to each such facility, seek to conclude a memorandum of understanding with the head of the Department or agency that
operates such facility that permits the use of such facility
to provide health care in the event of a public health emergency.’’.
(b) EMTALA.—
(1) IN GENERAL.—Section 1135(b) of the Social Security
Act (42 U.S.C. 1320b–5(b)) is amended—
(A) in paragraph (3), by striking subparagraph (B)
and inserting the following:
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PUBLIC LAW 109–417—DEC. 19, 2006
‘‘(B) the direction or relocation of an individual to
receive medical screening in an alternative location—
‘‘(i) pursuant to an appropriate State emergency
preparedness plan; or
‘‘(ii) in the case of a public health emergency
described in subsection (g)(1)(B) that involves a pandemic infectious disease, pursuant to a State pandemic
preparedness plan or a plan referred to in clause (i),
whichever is applicable in the State;’’;
(B) in the third sentence, by striking ‘‘and shall be
limited to’’ and inserting ‘‘and, except in the case of a
waiver or modification to which the fifth sentence of this
subsection applies, shall be limited to’’; and
(C) by adding at the end the following: ‘‘If a public
health emergency described in subsection (g)(1)(B) involves
a pandemic infectious disease (such as pandemic influenza),
the duration of a waiver or modification under paragraph
(3) shall be determined in accordance with subsection (e)
as such subsection applies to public health emergencies.’’.
(2) EFFECTIVE DATE.—The amendments made by paragraph
(1) shall take effect on the date of the enactment of this Act
and shall apply to public health emergencies declared pursuant
to section 319 of the Public Health Service Act (42 U.S.C.
247d) on or after such date.
Applicability.
Applicability.
42 USC 1320b–5
note.
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:
Establishment.
42 USC
300hh–15.
Deadline.
'
‘‘SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.
‘‘(a) IN GENERAL.—Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness Act,
the Secretary, in collaboration with State, local, and tribal officials,
shall build on State, local, and tribal programs in existence on
the date of enactment of such Act to establish and maintain a
Medical Reserve Corps (referred to in this section as the ‘Corps’)
to provide for an adequate supply of volunteers in the case of
a Federal, State, local, or tribal public health emergency. The
Corps shall be headed by a Director who shall be appointed by
the Secretary and shall oversee the activities of the Corps chapters
that exist at the State, local, and tribal levels.
‘‘(b) STATE, LOCAL, AND TRIBAL COORDINATION.—The Corps
shall be established using existing State, local, and tribal teams
and shall not alter such teams.
‘‘(c) COMPOSITION.—The Corps shall be composed of individuals
who—
‘‘(1)(A) are health professionals who have appropriate
professional training and expertise as determined appropriate
by the Director of the Corps; or
‘‘(B) are non-health professionals who have an interest
in serving in an auxiliary or support capacity to facilitate
access to health care services in a public health emergency;
‘‘(2) are certified in accordance with the certification program developed under subsection (d);
‘‘(3) are geographically diverse in residence;
‘‘(4) have registered and carry out training exercises with
a local chapter of the Medical Reserve Corps; and
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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—
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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) 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
Deadline.
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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 peerreviewed 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
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PUBLIC LAW 109–417—DEC. 19, 2006
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).
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‘‘(6) ACADEMIC-WORKFORCE COMMUNICATION.—As a condition of receiving funding from the Secretary under this subsection, a Center shall collaborate with a State, local, or tribal
public health department to—
‘‘(A) define the public health preparedness and
response needs of the community involved;
‘‘(B) assess the extent to which such needs are fulfilled
by existing preparedness and response activities of such
school or health department, and how such activities may
be improved;
‘‘(C) prior to developing new materials or trainings,
evaluate and utilize relevant materials and trainings developed by others Centers; and
‘‘(D) evaluate community impact and the effectiveness
of any newly developed materials or trainings.
‘‘(7) PUBLIC HEALTH SYSTEMS RESEARCH.—In consultation
with relevant public and private entities, the Secretary shall
define the existing knowledge base for public health preparedness and response systems, and establish a research agenda
based on Federal, State, local, and tribal public health
preparedness priorities. As a condition of receiving funding
from the Secretary under this subsection, a Center shall conduct
public health systems research that is consistent with the
agenda described under this paragraph.’’;
(3) by redesignating subsection (h) as subsection (e);
(4) by inserting after subsection (e) (as so redesignated),
the following:
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) FISCAL YEAR 2007.—There are authorized to be appropriated to carry out this section for fiscal year 2007—
‘‘(A) to carry out subsection (a)—
‘‘(i) $5,000,000 to carry out paragraphs (1) through
(4); and
‘‘(ii) $7,000,000 to carry out paragraph (5);
‘‘(B) to carry out subsection (c), $3,000,000; and
‘‘(C) to carry out subsection (d), $31,000,000, of which
$5,000,000 shall be used to carry out paragraphs (3)
through (5) of such subsection.
‘‘(2) SUBSEQUENT FISCAL YEARS.—There are authorized to
be appropriated such sums as may be necessary to carry out
this section for fiscal year 2008 and each subsequent fiscal
year.’’; and
(5) by striking subsections (i) and (j).
SEC. 305. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL
PREPAREDNESS TO IMPROVE SURGE CAPACITY.
Section 319C–2 of the Public Health Service Act (42 U.S.C.
247d–3b) is amended to read as follows:
‘‘SEC. 319C–2. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL
PREPAREDNESS TO IMPROVE SURGE CAPACITY.
‘‘(a) IN GENERAL.—The Secretary shall award competitive
grants or cooperative agreements to eligible entities to enable such
entities to improve surge capacity and enhance community and
hospital preparedness for public health emergencies.
‘‘(b) ELIGIBILITY.—To be eligible for an award under subsection
(a), an entity shall—
‘‘(1)(A) be a partnership consisting of—
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120 STAT. 2862
PUBLIC LAW 109–417—DEC. 19, 2006
‘‘(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.
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PUBLIC LAW 109–417—DEC. 19, 2006
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) 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).’’.
Applicability.
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)—
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PUBLIC LAW 109–417—DEC. 19, 2006
(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.’’.
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PUBLIC LAW 109–417—DEC. 19, 2006
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:
42 USC 247d–7e.
‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) BARDA.—The term ‘BARDA’ means the Biomedical
Advanced Research and Development Authority.
‘‘(2) FUND.—The term ‘Fund’ means the Biodefense Medical
Countermeasure Development Fund established under subsection (d).
‘‘(3) OTHER TRANSACTIONS.—The term ‘other transactions’
means transactions, other than procurement contracts, grants,
and cooperative agreements, such as the Secretary of Defense
may enter into under section 2371 of title 10, United States
Code.
‘‘(4) QUALIFIED COUNTERMEASURE.—The term ‘qualified
countermeasure’ has the meaning given such term in section
319F–1.
‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term
‘qualified pandemic or epidemic product’ has the meaning given
the term in section 319F–3.
‘‘(6) ADVANCED RESEARCH AND DEVELOPMENT.—
‘‘(A) IN GENERAL.—The term ‘advanced research and
development’ means, with respect to a product that is or
may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
‘‘(i) are conducted after basic research and preclinical development of the product; and
‘‘(ii) are related to manufacturing the product on
a commercial scale and in a form that satisfies the
regulatory requirements under the Federal Food, Drug,
and Cosmetic Act or under section 351 of this Act.
‘‘(B) ACTIVITIES INCLUDED.—The term under subparagraph (A) includes—
‘‘(i) testing of the product to determine whether
the product may be approved, cleared, or licensed
under the Federal Food, Drug, and Cosmetic Act or
under section 351 of this Act for a use that is or
may be the basis for such product becoming a qualified
countermeasure or qualified pandemic or epidemic
product, or to help obtain such approval, clearance,
or license;
‘‘(ii) design and development of tests or models,
including animal models, for such testing;
‘‘(iii) activities to facilitate manufacture of the
product on a commercial scale with consistently high
quality, as well as to improve and make available
new technologies to increase manufacturing surge
capacity;
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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) 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.
Deadline.
Public
information.
PUBLIC LAW 109–417—DEC. 19, 2006
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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
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120 STAT. 2868
PUBLIC LAW 109–417—DEC. 19, 2006
‘‘(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
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PUBLIC LAW 109–417—DEC. 19, 2006
120 STAT. 2869
Defense enters into such transactions under section
2371 of title 10, United States Code.
‘‘(ii) LIMITATIONS ON AUTHORITY.—
‘‘(I) IN GENERAL.—Subsections (b), (c), and (h)
of section 845 of the National Defense Authorization Act for Fiscal Year 1994 (10 U.S.C. 2371 note)
shall apply to other transactions under this
subparagraph as if such transactions were for
prototype projects described by subsection (a) of
such section 845.
‘‘(II) WRITTEN DETERMINATIONS REQUIRED.—
The authority of this subparagraph may be exercised for a project that is expected to cost the
Department of Health and Human Services in
excess of $20,000,000 only upon a written determination by the senior procurement executive for
the Department (as designated for purpose of section 16(c) of the Office of Federal Procurement
Policy Act (41 U.S.C. 414(c))), that the use of such
authority is essential to promoting the success of
the project. The authority of the senior procurement executive under this subclause may not be
delegated.
‘‘(iii) GUIDELINES.—The Secretary shall establish
guidelines regarding the use of the authority under
clause (i). Such guidelines shall include auditing
requirements.
‘‘(B) EXPEDITED AUTHORITIES.—
‘‘(i) IN GENERAL.—In awarding contracts, grants,
and cooperative agreements, and in entering into other
transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited
procurement authorities, the authority to expedite peer
review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of section
319F–1.
‘‘(ii) APPLICATION OF PROVISIONS.—Provisions in
such section 319F–1 that apply to such authorities
and that require institution of internal controls, limit
review, provide for Federal Tort Claims Act coverage
of personal services contractors, and commit decisions
to the discretion of the Secretary shall apply to the
authorities as exercised pursuant to this paragraph.
‘‘(iii) AUTHORITY TO LIMIT COMPETITION.—For purposes of applying section 319F–1(b)(1)(D) to this paragraph, the phrase ‘BioShield Program under the Project
BioShield Act of 2004’ shall be deemed to mean the
countermeasure and product advanced research and
development program under this section.
‘‘(iv) AVAILABILITY OF DATA.—The Secretary shall
require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction under subparagraph (B) or (D) of paragraph
(4), a person make available to the Secretary on an
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120 STAT. 2870
PUBLIC LAW 109–417—DEC. 19, 2006
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 federallyfunded research and development centers, or universityaffiliated 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.
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PUBLIC LAW 109–417—DEC. 19, 2006
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) 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
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120 STAT. 2872
PUBLIC LAW 109–417—DEC. 19, 2006
enactment of the Pandemic and All-Hazards Preparedness
Act.
‘‘(2) REVIEW.—Notwithstanding section 14 of the Federal
Advisory Committee Act, a working group of BARDA under
this section and the National Biodefense Science Board under
section 319M shall each terminate on the date that is 5 years
after the date on which each such group or Board, as applicable,
was established. Such 5-year period may be extended by the
Secretary for one or more additional 5-year periods if the Secretary determines that any such extension is appropriate.’’.
Termination
date.
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:
42 USC 247d–7f.
‘‘SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING
GROUPS.
‘‘(a) IN GENERAL.—
‘‘(1) ESTABLISHMENT AND FUNCTION.—The Secretary shall
establish the National Biodefense Science Board (referred to
in this section as the ‘Board’) to provide expert advice and
guidance to the Secretary on scientific, technical and other
matters of special interest to the Department of Health and
Human Services regarding current and future chemical,
biological, nuclear, and radiological agents, whether naturally
occurring, accidental, or deliberate.
‘‘(2) MEMBERSHIP.—The membership of the Board shall
be comprised of individuals who represent the Nation’s preeminent scientific, public health, and medical experts, as
follows—
‘‘(A) such Federal officials as the Secretary may determine are necessary to support the functions of the Board;
‘‘(B) four individuals representing the pharmaceutical,
biotechnology, and device industries;
‘‘(C) four individuals representing academia; and
‘‘(D) five other members as determined appropriate
by the Secretary, of whom—
‘‘(i) one such member shall be a practicing
healthcare professional; and
‘‘(ii) one such member shall be an individual from
an organization representing healthcare consumers.
‘‘(3) TERM OF APPOINTMENT.—A member of the Board
described in subparagraph (B), (C), or (D) of paragraph (2)
shall serve for a term of 3 years, except that the Secretary
may adjust the terms of the initial Board appointees in order
to provide for a staggered term of appointment for all members.
‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A
member may be appointed to serve not more than 3 terms
on the Board and may serve not more than 2 consecutive
terms.
‘‘(5) DUTIES.—The Board shall—
‘‘(A) advise the Secretary on current and future trends,
challenges, and opportunities presented by advances in
biological and life sciences, biotechnology, and genetic
engineering with respect to threats posed by naturally
occurring infectious diseases and chemical, biological, radiological, and nuclear agents;
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‘‘(B) at the request of the Secretary, review and consider any information and findings received from the
working groups established under subsection (b); and
‘‘(C) at the request of the Secretary, provide recommendations and findings for expanded, intensified, and
coordinated biodefense research and development activities.
‘‘(6) MEETINGS.—
‘‘(A) INITIAL MEETING.—Not later than one year after
the date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall hold the first meeting
of the Board.
‘‘(B) SUBSEQUENT MEETINGS.—The Board shall meet
at the call of the Secretary, but in no case less than
twice annually.
‘‘(7) VACANCIES.—Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the
original appointment.
‘‘(8) CHAIRPERSON.—The Secretary shall appoint a chairperson from among the members of the Board.
‘‘(9) POWERS.—
‘‘(A) HEARINGS.—The Board may hold such hearings,
sit and act at such times and places, take such testimony,
and receive such evidence as the Board considers advisable
to carry out this subsection.
‘‘(B) POSTAL SERVICES.—The Board may use the United
States mails in the same manner and under the same
conditions as other departments and agencies of the Federal Government.
‘‘(10) PERSONNEL.—
‘‘(A) EMPLOYEES OF THE FEDERAL GOVERNMENT.—A
member of the Board that is an employee of the Federal
Government may not receive additional pay, allowances,
or benefits by reason of the member’s service on the Board.
‘‘(B) OTHER MEMBERS.—A member of the Board that
is not an employee of the Federal Government may be
compensated at a rate not to exceed the daily equivalent
of the annual rate of basic pay prescribed for level IV
of the Executive Schedule under section 5315 of title 5,
United States Code, for each day (including travel time)
during which the member is engaged in the actual performance of duties as a member of the Board.
‘‘(C) TRAVEL EXPENSES.—Each member of the Board
shall receive travel expenses, including per diem in lieu
of subsistence, in accordance with applicable provisions
under subchapter I of chapter 57 of title 5, United States
Code.
‘‘(D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal Government employee may be detailed to the Board
with the approval for the contributing agency without
reimbursement, and such detail shall be without interruption or loss of civil service status or privilege.
‘‘(b) OTHER WORKING GROUPS.—The Secretary may establish
a working group of experts, or may use an existing working group
or advisory committee, to—
‘‘(1) identify innovative research with the potential to be
developed as a qualified countermeasure or a qualified pandemic or epidemic product;
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120 STAT. 2874
PUBLIC LAW 109–417—DEC. 19, 2006
‘‘(2) identify accepted animal models for particular diseases
and conditions associated with any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic
infectious disease, and identify strategies to accelerate animal
model and research tool development and validation; and
‘‘(3) obtain advice regarding supporting and facilitating
advanced research and development related to qualified
countermeasures and qualified pandemic or epidemic products
that are likely to be safe and effective with respect to children,
pregnant women, and other vulnerable populations, and other
issues regarding activities under this section that affect such
populations.
‘‘(c) DEFINITIONS.—Any term that is defined in section 319L
and that is used in this section shall have the same meaning
in this section as such term is given in section 319L.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated $1,000,000 to carry out this section for fiscal
year 2007 and each fiscal year thereafter.’’.
SEC. 403. CLARIFICATION OF COUNTERMEASURES COVERED BY
PROJECT BIOSHIELD.
(a) QUALIFIED COUNTERMEASURE.—Section 319F–1(a) of the
Public Health Service Act (42 U.S.C. 247d–6a(a)) is amended by
striking paragraph (2) and inserting the following:
‘‘(2) DEFINITIONS.—In this section:
‘‘(A) QUALIFIED COUNTERMEASURE.—The term ‘qualified
countermeasure’ means a drug (as that term is defined
by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that
term is defined by section 351(i) of this Act (42 U.S.C.
262(i))), or device (as that term is defined by section 201(h)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(h))), that the Secretary determines to be a priority
(consistent with sections 302(2) and 304(a) of the Homeland
Security Act of 2002) to—
‘‘(i) diagnose, mitigate, prevent, or treat harm from
any biological agent (including organisms that cause
an infectious disease) or toxin, chemical, radiological,
or nuclear agent that may cause a public health emergency affecting national security; or
‘‘(ii) diagnose, mitigate, prevent, or treat harm
from a condition that may result in adverse health
consequences or death and may be caused by administering a drug, biological product, or device that is
used as described in this subparagraph.
‘‘(B) INFECTIOUS DISEASE.—The term ‘infectious disease’
means a disease potentially caused by a pathogenic organism (including a bacteria, virus, fungus, or parasite) that
is acquired by a person and that reproduces in that person.’’.
(b) SECURITY COUNTERMEASURE.—Section 319F–2(c)(1)(B) is
amended by striking ‘‘treat, identify, or prevent’’ each place it
appears and inserting ‘‘diagnose, mitigate, prevent, or treat’’.
(c) LIMITATION ON USE OF FUNDS.—Section 510(a) of the Homeland Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding
at the end the following: ‘‘None of the funds made available under
this subsection shall be used to procure countermeasures to
42 USC 247d–6b.
42 USC 321j.
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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:
Establishment.
21 USC
360bbb–4.
‘‘SEC. 565. TECHNICAL ASSISTANCE.
‘‘The Secretary, in consultation with the Commissioner of Food
and Drugs, shall establish within the Food and Drug Administration
a team of experts on manufacturing and regulatory activities
(including compliance with current Good Manufacturing Practice)
to provide both off-site and on-site technical assistance to the manufacturers of qualified countermeasures (as defined in section 319F–
1 of the Public Health Service Act), security countermeasures (as
defined in section 319F–2 of such Act), or vaccines, at the request
of such a manufacturer and at the discretion of the Secretary,
if the Secretary determines that a shortage or potential shortage
may occur in the United States in the supply of such vaccines
or countermeasures and that the provision of such assistance would
be beneficial in helping alleviate or avert such shortage.’’.
42 USC 247d–6a
note.
SEC. 405. COLLABORATION AND COORDINATION.
(a) LIMITED ANTITRUST EXEMPTION.—
(1) MEETINGS AND CONSULTATIONS TO DISCUSS SECURITY
COUNTERMEASURES, QUALIFIED COUNTERMEASURES, OR QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT DEVELOPMENT.—
(A) AUTHORITY TO CONDUCT MEETINGS AND CONSULTATIONS.—The Secretary of Health and Human Services
(referred to in this subsection as the ‘‘Secretary’’), in
coordination with the Attorney General and the Secretary
of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security
countermeasure (as defined in section 319F–2 of the Public
Health Service Act (42 U.S.C. 247d–6b)) (as amended by
this Act), a qualified countermeasure (as defined in section
319F–1 of the Public Health Service Act (42 U.S.C. 247d–
6a)) (as amended by this Act), or a qualified pandemic
or epidemic product (as defined in section 319F–3 of the
Public Health Service Act (42 U.S.C. 247d–6d)) for the
purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The
Secretary may convene such meeting or consultation at
the request of the Secretary of Homeland Security, the
Attorney General, the Chairman of the Federal Trade
Commission (referred to in this section as the ‘‘Chairman’’),
or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such
meeting or consultation, and the topics to be discussed,
to the Attorney General, the Chairman, and the Secretary
of Homeland Security.
(B) MEETING AND CONSULTATION CONDITIONS.—A
meeting or consultation conducted under subparagraph (A)
shall—
(i) be chaired or, in the case of a consultation,
facilitated by the Secretary;
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120 STAT. 2876
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(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
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agreement to the extent that such agreement has been granted
an exemption under paragraph (4), during the period for which
the exemption is in effect.
(4) ACTION ON WRITTEN AGREEMENTS.—
(A) IN GENERAL.—The Attorney General, in consultation with the Chairman, shall grant, deny, grant in part
and deny in part, or propose modifications to an exemption
request regarding a written agreement submitted under
paragraph (2), in a written statement to the Secretary,
within 15 business days of the receipt of such request.
An exemption granted under this paragraph shall take
effect immediately.
(B) EXTENSION.—The Attorney General may extend the
15-day period referred to in subparagraph (A) for an additional period of not to exceed 10 business days.
(C) DETERMINATION.—An exemption shall be granted
regarding a written agreement submitted in accordance
with paragraph (2) only to the extent that the Attorney
General, in consultation with the Chairman and the Secretary, finds that the conduct that will be exempted will
not have any substantial anticompetitive effect that is not
reasonably necessary for ensuring the availability of the
countermeasure or product involved.
(5) LIMITATION ON AND RENEWAL OF EXEMPTIONS.—An
exemption granted under paragraph (4) shall be limited to
covered activities, and such exemption shall be renewed (with
modifications, as appropriate, consistent with the finding
described in paragraph (4)(C)), on the date that is 3 years
after the date on which the exemption is granted unless the
Attorney General in consultation with the Chairman determines that the exemption should not be renewed (with modifications, as appropriate) considering the factors described in paragraph (4).
(6) AUTHORITY TO OBTAIN INFORMATION.—Consideration by
the Attorney General for granting or renewing an exemption
submitted under this section shall be considered an antitrust
investigation for purposes of the Antitrust Civil Process Act
(15 U.S.C. 1311 et seq.).
(7) LIMITATION ON PARTIES.—The use of any information
acquired under an agreement for which an exemption has been
granted under paragraph (4), for any purpose other than specified in the exemption, shall be subject to the antitrust laws
and any other applicable laws.
(8) REPORT.—Not later than one year after the date of
enactment of this Act and biannually thereafter, the Attorney
General and the Chairman shall report to Congress on the
use of the exemption from the antitrust laws provided by this
subsection.
(b) SUNSET.—The applicability of this section shall expire at
the end of the 6-year period that begins on the date of enactment
of this Act.
(c) DEFINITIONS.—In this section:
(1) ANTITRUST LAWS.—The term ‘‘antitrust laws’’—
(A) has the meaning given such term in subsection
(a) of the first section of the Clayton Act (15 U.S.C. 12(a)),
except that such term includes section 5 of the Federal
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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
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any other conduct to restrict or require participation
by any person participating in such covered activities,
in any unilateral or joint activity that is not reasonably
necessary to carry out such covered activities.
(vii) Entering into any agreement or engaging in
any other conduct restricting or setting the price at
which a countermeasure or product is offered for sale,
whether by bid or otherwise.
SEC. 406. PROCUREMENT.
Section 319F–2 of the Public Health Service Act (42 U.S.C.
247d–6b) is amended—
(1) in the section heading, by inserting ‘‘AND SECURITY
COUNTERMEASURE PROCUREMENTS’’ before the period; and
(2) in subsection (c)—
(A) in the subsection heading, by striking ‘‘BIOMEDICAL’’;
(B) in paragraph (3)—
(i) by striking ‘‘COUNTERMEASURES.—The Secretary’’ and inserting the following: ‘‘COUNTERMEASURES.—
‘‘(A) IN GENERAL.—The Secretary’’; and
(ii) by adding at the end the following:
‘‘(B) INFORMATION.—The Secretary shall institute a
process for making publicly available the results of assessments under subparagraph (A) while withholding such
information as—
‘‘(i) would, in the judgment of the Secretary, tend
to reveal public health vulnerabilities; or
‘‘(ii) would otherwise be exempt from disclosure
under section 552 of title 5, United States Code.’’;
(C) in paragraph (4)(A), by inserting ‘‘not developed
or’’ after ‘‘currently’’;
(D) in paragraph (5)(B)(i), by striking ‘‘to meet the
needs of the stockpile’’ and inserting ‘‘to meet the stockpile
needs’’;
(E) in paragraph (7)(B)—
(i) by striking the subparagraph heading and all
that follows through ‘‘Homeland Security Secretary’’
and inserting the following: ‘‘INTERAGENCY AGREEMENT;
COST.—The Homeland Security Secretary’’; and
(ii) by striking clause (ii);
(F) in paragraph (7)(C)(ii)—
(i) by amending subclause (I) to read as follows:
‘‘(I) PAYMENT CONDITIONED ON DELIVERY.—The
contract shall provide that no payment may be
made until delivery of a portion, acceptable to
the Secretary, of the total number of units contracted for, except that, notwithstanding any other
provision of law, the contract may provide that,
if the Secretary determines (in the Secretary’s
discretion) that an advance payment, partial payment for significant milestones, or payment to
increase manufacturing capacity is necessary to
ensure success of a project, the Secretary shall
pay an amount, not to exceed 10 percent of the
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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
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‘‘(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.
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| File Type | application/pdf |
| File Title | PLAW-109publ417.pdf0 |
| Author | JVX2 |
| File Modified | 2013-09-11 |
| File Created | 2013-08-27 |