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.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the ‘‘Pandemic

and All-Hazards Preparedness Act’’.

(b) TABLE OF CONTENTS.—The table of contents of this Act

is as follows:

Sec. 1. Short title; table of contents.

TITLE I—NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP,

ORGANIZATION, AND PLANNING

Sec. 101. Public health and medical preparedness and response functions of the

Secretary of Health and Human Services.

Sec. 102. Assistant Secretary for Preparedness and Response.

Sec. 103. National Health Security Strategy.

TITLE II—PUBLIC HEALTH SECURITY PREPAREDNESS

Sec. 201. Improving State and local public health security.

Sec. 202. Using information technology to improve situational awareness in public

health emergencies.

Sec. 203. Public health workforce enhancements.

Sec. 204. Vaccine tracking and distribution.

Sec. 205. National Science Advisory Board for Biosecurity.

Sec. 206. Revitalization of Commissioned Corps.

TITLE III—ALL-HAZARDS MEDICAL SURGE CAPACITY

Sec. 301. National disaster medical system.

Sec. 302. Enhancing medical surge capacity.

Sec. 303. Encouraging health professional volunteers.

Sec. 304. Core education and training.

Sec. 305. Partnerships for State and regional hospital preparedness to improve

surge capacity.

Sec. 306. Enhancing the role of the Department of Veterans Affairs.

TITLE IV—PANDEMIC AND BIODEFENSE VACCINE AND DRUG

DEVELOPMENT

Sec. 401. Biomedical Advanced Research and Development Authority.

Sec. 402. National Biodefense Science Board.

Sec. 403. Clarification of countermeasures covered by Project BioShield.

Sec. 404. Technical assistance.

Sec. 405. Collaboration and coordination.

Sec. 406. Procurement.

Pandemic and

All-Hazards

Preparedness

Act.

42 USC 201 note.

Dec. 19, 2006

[S. 3678]

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

‘‘SEC. 2801. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND

RESPONSE FUNCTIONS.

‘‘(a) IN GENERAL.—The Secretary of Health and Human Services

shall lead all Federal public health and medical response to public

health emergencies and incidents covered by the National Response

Plan developed pursuant to section 502(6) of the Homeland Security

Act of 2002, or any successor plan.

‘‘(b) INTERAGENCY AGREEMENT.—The Secretary, in collaboration

with the Secretary of Veterans Affairs, the Secretary of Transportation, the Secretary of Defense, the Secretary of Homeland Security, and the head of any other relevant Federal agency, shall

establish an interagency agreement, consistent with the National

Response Plan or any successor plan, under which agreement the

Secretary of Health and Human Services shall assume operational

control of emergency public health and medical response assets,

as necessary, in the event of a public health emergency, except

that members of the armed forces under the authority of the Secretary of Defense shall remain under the command and control

of the Secretary of Defense, as shall any associated assets of the

Department of Defense.’’.

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND

RESPONSE.

(a) ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.—

Subtitle B of title XXVIII of the Public Health Service Act (42

U.S.C. 300hh–11 et seq.) is amended—

(1) in the subtitle heading, by inserting ‘‘All-Hazards’’

before ‘‘Emergency Preparedness’’;

42 USC (2) by redesignating section 2811 as section 2812;

300hh–11.

42 USC 300hh.

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.

‘‘(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—

President.

Government

organization.

42 USC

300hh–10.

120 STAT. 2834 PUBLIC LAW 109–417—DEC. 19, 2006

‘‘(A) the National Disaster Medical System (in accordance with section 301 of the Pandemic and All-Hazards

Preparedness Act); and

‘‘(B) the Hospital Preparedness Cooperative Agreement

Program pursuant to section 319C–2;

‘‘(2) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—

‘‘(A) the Medical Reserve Corps pursuant to section

2813;

‘‘(B) the Emergency System for Advance Registration

of Volunteer Health Professionals pursuant to section 319I;

‘‘(C) the Strategic National Stockpile; and

‘‘(D) the Cities Readiness Initiative; and

‘‘(3) assume other duties as determined appropriate by

the Secretary.’’; and

(4) by striking ‘‘Assistant Secretary for Public Health Emergency Preparedness’’ each place it appears and inserting

‘‘Assistant Secretary for Preparedness and Response’’.

(b) TRANSFER OF FUNCTIONS; REFERENCES.—

(1) TRANSFER OF FUNCTIONS.—There shall be transferred

to the Office of the Assistant Secretary for Preparedness and

Response the functions, personnel, assets, and liabilities of

the Assistant Secretary for Public Health Emergency Preparedness as in effect on the day before the date of enactment

of this Act.

(2) REFERENCES.—Any reference in any Federal law, Executive order, rule, regulation, or delegation of authority, or any

document of or pertaining to the Assistant Secretary for Public

Health Emergency Preparedness as in effect the day before

the date of enactment of this Act, shall be deemed to be a

reference to the Assistant Secretary for Preparedness and

Response.

(c) STOCKPILE.—Section 319F–2(a)(1) of the Public Health

Service Act (42 U.S.C. 247d–6b(a)(1)) is amended by—

(1) inserting ‘‘in collaboration with the Director of the Centers for Disease Control and Prevention, and’’ after ‘‘Secretary,’’;

and

(2) inserting at the end the following: ‘‘The Secretary shall

conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile, including non-pharmaceutical supplies, and make necessary additions or modifications to the contents based on such review.’’.

(d) AT-RISK INDIVIDUALS.—Title XXVIII of the Public Health

Service Act (42 U.S.C. 300hh et seq.), as amended by section 303

of this Act, is amended by inserting after section 2813 the following:

‘‘SEC. 2814. AT-RISK INDIVIDUALS.

‘‘The Secretary, acting through such employee of the Department of Health and Human Services as determined by the Secretary

and designated publicly (which may, at the discretion of the Secretary, involve the appointment or designation of an individual

as the Director of At-Risk Individuals), shall—

‘‘(1) oversee the implementation of the National Preparedness goal of taking into account the public health and medical

needs of at-risk individuals in the event of a public health

emergency, as described in section 2802(b)(4);

42 USC

300hh–16.

42 USC

300hh–10 note.

42 USC

300hh–11.

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.’’.

SEC. 103. NATIONAL HEALTH SECURITY STRATEGY.

Title XXVIII of the Public Health Service Act (300hh–11 et

seq.), as amended by section 101, is amended by inserting after

section 2801 the following:

‘‘SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.

‘‘(a) IN GENERAL.— ‘‘(1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC

HEALTH EMERGENCIES.—Beginning in 2009 and every four years

thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a coordinated strategy (to be

known as the National Health Security Strategy) and any revisions thereof, and an accompanying implementation plan for

public health emergency preparedness and response. Such

National Health Security Strategy shall identify the process

for achieving the preparedness goals described in subsection

(b) and shall be consistent with the National Preparedness

Goal, the National Incident Management System, and the

National Response Plan developed pursuant to section 502(6)

of the Homeland Security Act of 2002, or any successor plan.

‘‘(2) EVALUATION OF PROGRESS.—The National Health Security Strategy shall include an evaluation of the progress made

by Federal, State, local, and tribal entities, based on the evidence-based benchmarks and objective standards that measure

levels of preparedness established pursuant to section 319C–

1(g). Such evaluation shall include aggregate and State-specific

breakdowns of obligated funding spent by major category (as

defined by the Secretary) for activities funded through awards

pursuant to sections 319C–1 and 319C–2.

Effective date.

Deadline.

42 USC 300hh–1.

Deadline.

Reports.

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

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

Contracts.

120 STAT. 2838 PUBLIC LAW 109–417—DEC. 19, 2006

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 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 BENCH- MARKS 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

Deadline.

Deadline.

Website.

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).

Effective date.

Deadline.

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

120 STAT. 2842 PUBLIC LAW 109–417—DEC. 19, 2006

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.

PUBLIC LAW 109–417—DEC. 19, 2006 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

Contracts.

120 STAT. 2844 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.

Deadline.

Publication.

Website.

PUBLIC LAW 109–417—DEC. 19, 2006 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).’’.

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).

Deadline.

Deadline.

Website.

120 STAT. 2846 PUBLIC LAW 109–417—DEC. 19, 2006

‘‘(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 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;

Deadline.

Reports.

120 STAT. 2848 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:

‘‘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

42 USC 254u.

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2849

health department that serves a health professional shortage area

or an area at risk of a public health emergency.

‘‘(b) PROCEDURE.—To be eligible to receive assistance under

subsection (a), with respect to the program described in section

338B, an individual shall—

‘‘(1) comply with all rules and requirements described in

such section (other than section 338B(f)(1)(B)(iv)); and

‘‘(2) agree to serve for a time period equal to 2 years,

or such longer period as the individual may agree to, in a

State, local, or tribal health department, described in subsection

(a).

‘‘(c) DESIGNATIONS.—The demonstration project described in

subsection (a), and any healthcare providers who are selected to

participate in such project, shall not be considered by the Secretary

in the designation of health professional shortage areas under section 332 during fiscal years 2007 through 2010.

‘‘(d) REPORT.—Not later than 3 years after the date of enactment of this section, the Secretary shall submit a report to the

relevant committees of Congress that evaluates the participation

of individuals in the demonstration project under subsection (a),

the impact of such participation on State, local, and tribal health

departments, and the benefit and feasibility of permanently

allowing such placements in the Loan Repayment Program.

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized

to be appropriated to carry out this section, such sums as may

be necessary for each of fiscal years 2007 through 2010.’’.

(b) GRANTS FOR LOAN REPAYMENT PROGRAM.—Section 338I of

the Public Health Service Act (42 U.S.C. 254q–1) is amended by

adding at the end the following:

‘‘(j) PUBLIC HEALTH LOAN REPAYMENT.—

‘‘(1) IN GENERAL.—The Secretary may award grants to

States for the purpose of assisting such States in operating

loan repayment programs under which such States enter into

contracts to repay all or part of the eligible loans borrowed

by, or on behalf of, individuals who agree to serve in State,

local, or tribal health departments that serve health professional shortage areas or other areas at risk of a public health

emergency, as designated by the Secretary.

‘‘(2) LOANS ELIGIBLE FOR REPAYMENT.—To be eligible for

repayment under this subsection, a loan shall be a loan made,

insured, or guaranteed by the Federal Government that is

borrowed by, or on behalf of, an individual to pay the cost

of attendance for a program of education leading to a degree

appropriate for serving in a State, local, or tribal health department as determined by the Secretary and the chief executive

officer of the State in which the grant is administered, at

an institution of higher education (as defined in section 102

of the Higher Education Act of 1965), including principal,

interest, and related expenses on such loan.

‘‘(3) APPLICABILITY OF EXISTING REQUIREMENTS.—With

respect to awards made under paragraph (1)—

‘‘(A) the requirements of subsections (b), (f), and (g)

shall apply to such awards; and

‘‘(B) the requirements of subsection (c) shall apply to

such awards except that with respect to paragraph (1)

of such subsection, the State involved may assign an individual only to public and nonprofit private entities that

120 STAT. 2850 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).

PUBLIC LAW 109–417—DEC. 19, 2006 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),’’.

SEC. 205. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.

The National Science Advisory Board for Biosecurity shall,

when requested by the Secretary of Health and Human Services,

provide to relevant Federal departments and agencies, advice, guidance, or recommendations concerning—

(1) a core curriculum and training requirements for workers

in maximum containment biological laboratories; and

(2) periodic evaluations of maximum containment biological

laboratory capacity nationwide and assessments of the future

need for increased laboratory capacity.

SEC. 206. REVITALIZATION OF COMMISSIONED CORPS.

(a) PURPOSE.—It is the purpose of this section to improve the

force management and readiness of the Commissioned Corps to

accomplish the following objectives:

(1) To ensure the Corps is ready to respond rapidly to

urgent or emergency public health care needs and challenges.

(2) To ensure the availability of the Corps for assignments

that address clinical and public health needs in isolated, hardship, and hazardous duty positions, and, when required, to

address needs related to the well-being, security, and defense

of the United States.

(3) To establish the Corps as a resource available to Federal

and State Government agencies for assistance in meeting public

health leadership and service roles.

(b) COMMISSIONED CORPS READINESS.—Title II of the Public

Health Service Act (42 U.S.C. 202 et seq.) is amended by inserting

after section 203 the following:

‘‘SEC. 203A. DEPLOYMENT READINESS.

‘‘(a) READINESS REQUIREMENTS FOR COMMISSIONED CORPS OFFICERS.—

‘‘(1) IN GENERAL.—The Secretary, with respect to members

of the following Corps components, shall establish requirements, including training and medical examinations, to ensure

the readiness of such components to respond to urgent or emergency public health care needs that cannot otherwise be met

at the Federal, State, and local levels:

‘‘(A) Active duty Regular Corps.

‘‘(B) Active Reserves.

‘‘(2) ANNUAL ASSESSMENT OF MEMBERS.—The Secretary

shall annually determine whether each member of the Corps

42 USC 204a.

42 USC 204a

note.

42 USC 262a

note.

42 USC 247d–2,

247d–3.

120 STAT. 2852 PUBLIC LAW 109–417—DEC. 19, 2006

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.

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2853

‘‘(c) DEPLOYMENT OF DETAILED OR ASSIGNED OFFICERS.—For

purposes of pay, allowances, and benefits of a Commissioned Corps

officer who is detailed or assigned to a Federal entity, the deployment of such officer by the Secretary in response to an urgent

or emergency public health care need shall be deemed to be an

authorized activity of the Federal entity to which the officer is

detailed or assigned.’’.

(c) PERSONNEL DEPLOYMENT AUTHORITY.— (1) PERSONNEL DETAILED.—Section 214 of the Public Health

Service Act (42 U.S.C. 215) is amended by adding at the end

the following:

‘‘(e) Except with respect to the United States Coast Guard

and the Department of Defense, and except as provided in agreements negotiated with officials at agencies where officers of the

Commissioned Corps may be assigned, the Secretary shall have

the sole authority to deploy any Commissioned Corps officer

assigned under this section to an entity outside of the Department

of Health and Human Services for service under the Secretary’s

direction in response to an urgent or emergency public health

care need (as defined in section 203A(a)(5)).’’.

(2) NATIONAL HEALTH SERVICE CORPS.—Section 331(f) of

the Public Health Service Act (42 U.S.C. 254d(f)(1)) is amended

by inserting before the period the following: ‘‘, except when

such members are Commissioned Corps officers who entered

into a contract with Secretary under section 338A or 338B

after December 31, 2006 and when the Secretary determines

that exercising the authority provided under section 214 or

216 with respect to any such officer to would not cause

unreasonable disruption to health care services provided in

the community in which such officer is providing health care

services’’.

TITLE III—ALL-HAZARDS MEDICAL

SURGE CAPACITY

SEC. 301. NATIONAL DISASTER MEDICAL SYSTEM.

(a) NATIONAL DISASTER MEDICAL SYSTEM.—Section 2812 of subtitle B of title XXVIII of the Public Health Service Act (42 U.S.C.

300hh–11 et seq.), as redesignated by section 102, is amended—

(1) by striking the section heading and inserting ‘‘NATIONAL

DISASTER MEDICAL SYSTEM’’;

(2) by striking subsection (a);

(3) by redesignating subsections (b) through (h) as subsections (a) through (g);

(4) in subsection (a), as so redesignated—

(A) in paragraph (2)(B), by striking ‘‘Federal Emergency Management Agency’’ and inserting ‘‘Department of

Homeland Security’’; and

(B) in paragraph (3)(C), by striking ‘‘Public Health

Security and Bioterrorism Preparedness and Response Act

of 2002’’ and inserting ‘‘Pandemic and All-Hazards

Preparedness Act’’;

(5) in subsection (b), as so redesignated, by—

(A) striking the subsection heading and inserting

‘‘MODIFICATIONS’’;

(B) redesignating paragraph (2) as paragraph (3); and

120 STAT. 2854 PUBLIC LAW 109–417—DEC. 19, 2006

(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

6 USC 313.

6 USC 314.

42 USC

300hh–11 note.

Deadline.

PUBLIC LAW 109–417—DEC. 19, 2006 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.

SEC. 302. ENHANCING MEDICAL SURGE CAPACITY.

(a) IN GENERAL.—Title XXVIII of the Public Health Service

Act (300hh–11 et seq.), as amended by section 103, is amended

by inserting after section 2802 the following:

‘‘SEC. 2803. ENHANCING MEDICAL SURGE CAPACITY.

‘‘(a) STUDY OF ENHANCING MEDICAL SURGE CAPACITY.—As part

of the joint review described in section 2812(b), the Secretary shall

evaluate the benefits and feasibility of improving the capacity of

the Department of Health and Human Services to provide additional

medical surge capacity to local communities in the event of a

public health emergency. Such study shall include an assessment

of the need for and feasibility of improving surge capacity through—

‘‘(1) acquisition and operation of mobile medical assets by

the Secretary to be deployed, on a contingency basis, to a

community in the event of a public health emergency;

‘‘(2) integrating the practice of telemedicine within the

National Disaster Medical System; and

‘‘(3) other strategies to improve such capacity as determined

appropriate by the Secretary.

‘‘(b) AUTHORITY TO ACQUIRE AND OPERATE MOBILE MEDICAL

ASSETS.—In addition to any other authority to acquire, deploy,

and operate mobile medical assets, the Secretary may acquire,

deploy, and operate mobile medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deployment, and operation is determined to be beneficial and

feasible in improving the capacity of the Department of Health

and Human Services to provide additional medical surge capacity

to local communities in the event of a public health emergency.

‘‘(c) USING FEDERAL FACILITIES TO ENHANCE MEDICAL SURGE

CAPACITY.—

‘‘(1) ANALYSIS.—The Secretary shall conduct an analysis

of whether there are Federal facilities which, in the event

of a public health emergency, could practicably be used as

facilities in which to provide health care.

‘‘(2) MEMORANDA OF UNDERSTANDING.—If, based on the

analysis conducted under paragraph (1), the Secretary determines that there are Federal facilities which, in the event

of a public health emergency, could be used as facilities in

which to provide health care, the Secretary shall, with respect

to each such facility, seek to conclude a memorandum of understanding with the head of the Department or agency that

operates such facility that permits the use of such facility

to provide health care in the event of a public health emergency.’’.

(b) EMTALA.—

(1) IN GENERAL.—Section 1135(b) of the Social Security

Act (42 U.S.C. 1320b–5(b)) is amended—

(A) in paragraph (3), by striking subparagraph (B)

and inserting the following:

42 USC 300hh–2.

6 USC 313 note.

120 STAT. 2856 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.

SEC. 303. ENCOURAGING HEALTH PROFESSIONAL VOLUNTEERS.

(a) VOLUNTEER MEDICAL RESERVE CORPS.—Title XXVIII of the

Public Health Service Act (42 U.S.C. 300hh–11 et seq.), as amended

by this Act, is amended by inserting after section 2812 the following:

‘‘SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.

‘‘(a) IN GENERAL.—Not later than 180 days after the date of

enactment of the Pandemic and All-Hazards Preparedness Act,

the Secretary, in collaboration with State, local, and tribal officials,

shall build on State, local, and tribal programs in existence on

the date of enactment of such Act to establish and maintain a

Medical Reserve Corps (referred to in this section as the ‘Corps’)

to provide for an adequate supply of volunteers in the case of

a Federal, State, local, or tribal public health emergency. The

Corps shall be headed by a Director who shall be appointed by

the Secretary and shall oversee the activities of the Corps chapters

that exist at the State, local, and tribal levels.

‘‘(b) STATE, LOCAL, AND TRIBAL COORDINATION.—The Corps

shall be established using existing State, local, and tribal teams

and shall not alter such teams.

‘‘(c) COMPOSITION.—The Corps shall be composed of individuals

who—

‘‘(1)(A) are health professionals who have appropriate

professional training and expertise as determined appropriate

by the Director of the Corps; or

‘‘(B) are non-health professionals who have an interest

in serving in an auxiliary or support capacity to facilitate

access to health care services in a public health emergency;

‘‘(2) are certified in accordance with the certification program developed under subsection (d);

‘‘(3) are geographically diverse in residence;

‘‘(4) have registered and carry out training exercises with

a local chapter of the Medical Reserve Corps; and

Establishment.

42 USC

300hh–15.

Deadline.

42 USC 1320b–5

note.

Applicability.

Applicability.

PUBLIC LAW 109–417—DEC. 19, 2006 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—

120 STAT. 2858 PUBLIC LAW 109–417—DEC. 19, 2006

(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.

PUBLIC LAW 109–417—DEC. 19, 2006 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

120 STAT. 2860 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).

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2861

‘‘(6) ACADEMIC-WORKFORCE COMMUNICATION.—As a condition of receiving funding from the Secretary under this subsection, a Center shall collaborate with a State, local, or tribal

public health department to—

‘‘(A) define the public health preparedness and

response needs of the community involved;

‘‘(B) assess the extent to which such needs are fulfilled

by existing preparedness and response activities of such

school or health department, and how such activities may

be improved;

‘‘(C) prior to developing new materials or trainings,

evaluate and utilize relevant materials and trainings developed by others Centers; and

‘‘(D) evaluate community impact and the effectiveness

of any newly developed materials or trainings.

‘‘(7) PUBLIC HEALTH SYSTEMS RESEARCH.—In consultation

with relevant public and private entities, the Secretary shall

define the existing knowledge base for public health preparedness and response systems, and establish a research agenda

based on Federal, State, local, and tribal public health

preparedness priorities. As a condition of receiving funding

from the Secretary under this subsection, a Center shall conduct

public health systems research that is consistent with the

agenda described under this paragraph.’’;

(3) by redesignating subsection (h) as subsection (e);

(4) by inserting after subsection (e) (as so redesignated),

the following:

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.— ‘‘(1) FISCAL YEAR 2007.—There are authorized to be appropriated to carry out this section for fiscal year 2007—

‘‘(A) to carry out subsection (a)— ‘‘(i) $5,000,000 to carry out paragraphs (1) through

(4); and ‘‘(ii) $7,000,000 to carry out paragraph (5); ‘‘(B) to carry out subsection (c), $3,000,000; and

‘‘(C) to carry out subsection (d), $31,000,000, of which $5,000,000 shall be used to carry out paragraphs (3)

through (5) of such subsection.

‘‘(2) SUBSEQUENT FISCAL YEARS.—There are authorized to

be appropriated such sums as may be necessary to carry out

this section for fiscal year 2008 and each subsequent fiscal

year.’’; and

(5) by striking subsections (i) and (j).

SEC. 305. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL

PREPAREDNESS TO IMPROVE SURGE CAPACITY.

Section 319C–2 of the Public Health Service Act (42 U.S.C.

247d–3b) is amended to read as follows:

‘‘SEC. 319C–2. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL

PREPAREDNESS TO IMPROVE SURGE CAPACITY.

‘‘(a) 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—

Grants.

Contracts.

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.

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).’’.

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)—

Applicability.

120 STAT. 2864 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.’’.

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:

‘‘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;

42 USC 247d–7e.

120 STAT. 2866 PUBLIC LAW 109–417—DEC. 19, 2006

‘‘(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 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

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

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

Applicability.

Applicability.

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.

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

Applicability.

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.’’.

SEC. 402. NATIONAL BIODEFENSE SCIENCE BOARD.

Title III of the Public Health Service Act (42 U.S.C. 241 et

seq.), as amended by section 401, is further amended by inserting

after section 319L the following:

‘‘SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING

GROUPS.

‘‘(a) IN GENERAL.— ‘‘(1) ESTABLISHMENT AND FUNCTION.—The Secretary shall

establish the National Biodefense Science Board (referred to

in this section as the ‘Board’) to provide expert advice and

guidance to the Secretary on scientific, technical and other

matters of special interest to the Department of Health and

Human Services regarding current and future chemical,

biological, nuclear, and radiological agents, whether naturally

occurring, accidental, or deliberate.

‘‘(2) MEMBERSHIP.—The membership of the Board shall

be comprised of individuals who represent the Nation’s preeminent scientific, public health, and medical experts, as

follows—

‘‘(A) such Federal officials as the Secretary may determine are necessary to support the functions of the Board;

‘‘(B) four individuals representing the pharmaceutical,

biotechnology, and device industries;

‘‘(C) four individuals representing academia; and

‘‘(D) five other members as determined appropriate

by the Secretary, of whom—

‘‘(i) one such member shall be a practicing

healthcare professional; and

‘‘(ii) one such member shall be an individual from

an organization representing healthcare consumers.

‘‘(3) TERM OF APPOINTMENT.—A member of the Board

described in subparagraph (B), (C), or (D) of paragraph (2)

shall serve for a term of 3 years, except that the Secretary

may adjust the terms of the initial Board appointees in order

to provide for a staggered term of appointment for all members.

‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A

member may be appointed to serve not more than 3 terms

on the Board and may serve not more than 2 consecutive

terms.

‘‘(5) DUTIES.—The Board shall—

‘‘(A) advise the Secretary on current and future trends,

challenges, and opportunities presented by advances in

biological and life sciences, biotechnology, and genetic

engineering with respect to threats posed by naturally

occurring infectious diseases and chemical, biological, radiological, and nuclear agents;

42 USC 247d–7f.

Termination

date.

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2873

‘‘(B) at the request of the Secretary, review and consider any information and findings received from the

working groups established under subsection (b); and

‘‘(C) at the request of the Secretary, provide recommendations and findings for expanded, intensified, and

coordinated biodefense research and development activities.

‘‘(6) MEETINGS.— ‘‘(A) 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;

Deadline.

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 321j.

42 USC 247d–6b.

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2875

diagnose, mitigate, prevent, or treat harm resulting from any naturally occurring infectious disease or other public health threat that

are not security countermeasures under section 319F–2(c)(1)(B).’’.

SEC. 404. TECHNICAL ASSISTANCE.

Subchapter E of chapter V of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding

at the end the following:

‘‘SEC. 565. TECHNICAL ASSISTANCE.

‘‘The Secretary, in consultation with the Commissioner of Food

and Drugs, shall establish within the Food and Drug Administration

a team of experts on manufacturing and regulatory activities

(including compliance with current Good Manufacturing Practice)

to provide both off-site and on-site technical assistance to the manufacturers of qualified countermeasures (as defined in section 319F–

1 of the Public Health Service Act), security countermeasures (as

defined in section 319F–2 of such Act), or vaccines, at the request

of such a manufacturer and at the discretion of the Secretary,

if the Secretary determines that a shortage or potential shortage

may occur in the United States in the supply of such vaccines

or countermeasures and that the provision of such assistance would

be beneficial in helping alleviate or avert such shortage.’’.

SEC. 405. COLLABORATION AND COORDINATION.

(a) LIMITED ANTITRUST EXEMPTION.—

(1) MEETINGS AND CONSULTATIONS TO DISCUSS SECURITY

COUNTERMEASURES, QUALIFIED COUNTERMEASURES, OR QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT DEVELOPMENT.—

(A) AUTHORITY TO CONDUCT MEETINGS AND CONSULTATIONS.—The Secretary of Health and Human Services

(referred to in this subsection as the ‘‘Secretary’’), in

coordination with the Attorney General and the Secretary

of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security

countermeasure (as defined in section 319F–2 of the Public

Health Service Act (42 U.S.C. 247d–6b)) (as amended by

this Act), a qualified countermeasure (as defined in section

319F–1 of the Public Health Service Act (42 U.S.C. 247d–

6a)) (as amended by this Act), or a qualified pandemic

or epidemic product (as defined in section 319F–3 of the

Public Health Service Act (42 U.S.C. 247d–6d)) for the

purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The

Secretary may convene such meeting or consultation at

the request of the Secretary of Homeland Security, the

Attorney General, the Chairman of the Federal Trade

Commission (referred to in this section as the ‘‘Chairman’’),

or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such

meeting or consultation, and the topics to be discussed,

to the Attorney General, the Chairman, and the Secretary

of Homeland Security.

(B) MEETING AND CONSULTATION CONDITIONS.—A

meeting or consultation conducted under subparagraph (A)

shall—

(i) be chaired or, in the case of a consultation,

facilitated by the Secretary;

Notice.

42 USC 247d–6a

note.

Establishment.

21 USC

360bbb–4.

120 STAT. 2876 PUBLIC LAW 109–417—DEC. 19, 2006

(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 AGREE- MENT.—It shall not be a violation of the antitrust laws for

a person to engage in conduct in accordance with a written

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2877

agreement to the extent that such agreement has been granted

an exemption under paragraph (4), during the period for which

the exemption is in effect.

(4) ACTION ON WRITTEN AGREEMENTS.—

(A) 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

Applicability.

Deadline.

120 STAT. 2878 PUBLIC LAW 109–417—DEC. 19, 2006

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

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2879

any other conduct to restrict or require participation

by any person participating in such covered activities,

in any unilateral or joint activity that is not reasonably

necessary to carry out such covered activities.

(vii) Entering into any agreement or engaging in

any other conduct restricting or setting the price at

which a countermeasure or product is offered for sale,

whether by bid or otherwise.

SEC. 406. PROCUREMENT.

Section 319F–2 of the Public Health Service Act (42 U.S.C.

247d–6b) is amended—

(1) in the section heading, by inserting ‘‘AND SECURITY

COUNTERMEASURE PROCUREMENTS’’ before the period; and

(2) in subsection (c)—

(A) in the subsection heading, by striking ‘‘BIOMEDICAL’’;

(B) in paragraph (3)—

(i) by striking ‘‘COUNTERMEASURES.—The Secretary’’ and inserting the following: ‘‘COUNTERMEASURES.—

‘‘(A) IN GENERAL.—The Secretary’’; and

(ii) by adding at the end the following:

‘‘(B) 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

Public

information.

120 STAT. 2880 PUBLIC LAW 109–417—DEC. 19, 2006

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

PUBLIC LAW 109–417—DEC. 19, 2006 120 STAT. 2881

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.

Æ

‘‘(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.