109TH CONGRESS

2D SESSION S. 3678

AN ACT

To amend the Public Health Service Act with respect to

public health security and all-hazards preparedness and

response, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

5 ‘‘Pandemic and All-Hazards Preparedness Act’’.
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1 (b) TABLE OF CONTENTS.—The table of contents of

2 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.
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1 TITLE I—NATIONAL PREPARED2 NESS AND RESPONSE, LEAD3 ERSHIP, ORGANIZATION, AND

4 PLANNING

5 SEC. 101. PUBLIC HEALTH AND MEDICAL PREPAREDNESS

6 AND RESPONSE FUNCTIONS OF THE SEC7 RETARY OF HEALTH AND HUMAN SERVICES.

8 Title XXVIII of the Public Health Service Act (42

9 U.S.C. 300hh–11 et seq.) is amended—

10 (1) by striking the title heading and inserting

11 the following:

12 ‘‘TITLE XXVIII—NATIONAL ALL13 HAZARDS PREPAREDNESS

14 FOR PUBLIC HEALTH EMER15 GENCIES’’;

16 and

17 (2) by amending subtitle A to read as follows:

18 ‘‘Subtitle A—National All-Hazards

19 Preparedness and Response

20 Planning, Coordinating, and Re21 porting

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

23 AND RESPONSE FUNCTIONS.

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

25 Human Services shall lead all Federal public health and
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1 medical response to public health emergencies and inci2 dents covered by the National Response Plan developed

3 pursuant to section 502(6) of the Homeland Security Act

4 of 2002, or any successor plan.

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

6 collaboration with the Secretary of Veterans Affairs, the

7 Secretary of Transportation, the Secretary of Defense, the

8 Secretary of Homeland Security, and the head of any

9 other relevant Federal agency, shall establish an inter10 agency agreement, consistent with the National Response

11 Plan or any successor plan, under which agreement the

12 Secretary of Health and Human Services shall assume

13 operational control of emergency public health and medical

14 response assets, as necessary, in the event of a public

15 health emergency, except that members of the armed

16 forces under the authority of the Secretary of Defense

17 shall remain under the command and control of the Sec18 retary of Defense, as shall any associated assets of the

19 Department of Defense.’’.

20 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND

21 RESPONSE.

22 (a) ASSISTANT SECRETARY FOR PREPAREDNESS AND

23 RESPONSE.—Subtitle B of title XXVIII of the Public

24 Health Service Act (42 U.S.C. 300hh–11 et seq.) is

25 amended—
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1 (1) in the subtitle heading, by inserting ‘‘All2 Hazards’’ before ‘‘Emergency Preparedness’’;

3 (2) by redesignating section 2811 as section

4 2812;

5 (3) by inserting after the subtitle heading the

6 following new section:

7 ‘‘SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND

8 RESPONSE TO ALL-HAZARDS PUBLIC HEALTH

9 EMERGENCIES.

10 ‘‘(a) IN GENERAL.—There is established within the

11 Department of Health and Human Services the position

12 of the Assistant Secretary for Preparedness and Response.

13 The President, with the advice and consent of the Senate,

14 shall appoint an individual to serve in such position. Such

15 Assistant Secretary shall report to the Secretary.

16 ‘‘(b) DUTIES.—Subject to the authority of the Sec17 retary, the Assistant Secretary for Preparedness and Re18 sponse shall carry out the following functions:

19 ‘‘(1) LEADERSHIP.—Serve as the principal ad20 visor to the Secretary on all matters related to Fed21 eral public health and medical preparedness and re22 sponse for public health emergencies.

23 ‘‘(2) PERSONNEL.—Register, credential, orga24 nize, train, equip, and have the authority to deploy

25 Federal public health and medical personnel under
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1 the authority of the Secretary, including the Na2 tional Disaster Medical System, and coordinate such

3 personnel with the Medical Reserve Corps and the

4 Emergency System for Advance Registration of Vol5 unteer Health Professionals.

6 ‘‘(3) COUNTERMEASURES.—Oversee advanced

7 research, development, and procurement of qualified

8 countermeasures (as defined in section 319F–1) and

9 qualified pandemic or epidemic products (as defined

10 in section 319F–3).

11 ‘‘(4) COORDINATION.—

12 ‘‘(A) FEDERAL INTEGRATION.—Coordinate

13 with relevant Federal officials to ensure inte14 gration of Federal preparedness and response

15 activities for public health emergencies.

16 ‘‘(B) STATE, LOCAL, AND TRIBAL INTE17 GRATION.—Coordinate with State, local, and

18 tribal public health officials, the Emergency

19 Management Assistance Compact, health care

20 systems, and emergency medical service systems

21 to ensure effective integration of Federal public

22 health and medical assets during a public

23 health emergency.

24 ‘‘(C) EMERGENCY MEDICAL SERVICES.—

25 Promote improved emergency medical services
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1 medical direction, system integration, research,

2 and uniformity of data collection, treatment

3 protocols, and policies with regard to public

4 health emergencies.

5 ‘‘(5) LOGISTICS.—In coordination with the Sec6 retary of Veterans Affairs, the Secretary of Home7 land Security, the General Services Administration,

8 and other public and private entities, provide

9 logistical support for medical and public health as10 pects of Federal responses to public health emer11 gencies.

12 ‘‘(6) LEADERSHIP.—Provide leadership in

13 international programs, initiatives, and policies that

14 deal with public health and medical emergency pre15 paredness and response.

16 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre17 paredness and Response shall—

18 ‘‘(1) have authority over and responsibility

19 for—

20 ‘‘(A) the National Disaster Medical System

21 (in accordance with section 301 of the Pan22 demic and All-Hazards Preparedness Act); and

23 ‘‘(B) the Hospital Preparedness Coopera24 tive Agreement Program pursuant to section

25 319C–2;
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1 ‘‘(2) exercise the responsibilities and authorities

2 of the Secretary with respect to the coordination

3 of—

4 ‘‘(A) the Medical Reserve Corps pursuant

5 to section 2813;

6 ‘‘(B) the Emergency System for Advance

7 Registration of Volunteer Health Professionals

8 pursuant to section 319I;

9 ‘‘(C) the Strategic National Stockpile; and

10 ‘‘(D) the Cities Readiness Initiative; and

11 ‘‘(3) assume other duties as determined appro12 priate by the Secretary.’’; and

13 (4) by striking ‘‘Assistant Secretary for Public

14 Health Emergency Preparedness’’ each place it ap15 pears and inserting ‘‘Assistant Secretary for Pre16 paredness and Response’’.

17 (b) TRANSFER OF FUNCTIONS; REFERENCES.—

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

19 transferred to the Office of the Assistant Secretary

20 for Preparedness and Response the functions, per21 sonnel, assets, and liabilities of the Assistant Sec22 retary for Public Health Emergency Preparedness as

23 in effect on the day before the date of enactment of

24 this Act.
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1 (2) REFERENCES.—Any reference in any Fed2 eral law, Executive order, rule, regulation, or delega3 tion of authority, or any document of or pertaining

4 to the Assistant Secretary for Public Health Emer5 gency Preparedness as in effect the day before the

6 date of enactment of this Act, shall be deemed to be

7 a reference to the Assistant Secretary for Prepared8 ness and Response.

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

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

11 by—

12 (1) inserting ‘‘in collaboration with the Director

13 of the Centers for Disease Control and Prevention,

14 and’’ after ‘‘Secretary,’’; and

15 (2) inserting at the end the following: ‘‘The

16 Secretary shall conduct an annual review (taking

17 into account at-risk individuals) of the contents of

18 the stockpile, including non-pharmaceutical supplies,

19 and make necessary additions or modifications to

20 the contents based on such review.’’.

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

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

23 amended by section 303 of this Act, is amended by insert24 ing after section 2813 the following:
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1 ‘‘SEC. 2814. AT-RISK INDIVIDUALS.

2 ‘‘The Secretary, acting through such employee of the

3 Department of Health and Human Services as determined

4 by the Secretary and designated publicly (which may, at

5 the discretion of the Secretary, involve the appointment

6 or designation of an individual as the Director of At-Risk

7 Individuals), shall—

8 ‘‘(1) oversee the implementation of the National

9 Preparedness goal of taking into account the public

10 health and medical needs of at-risk individuals in the

11 event of a public health emergency, as described in

12 section 2802(b)(4);

13 ‘‘(2) assist other Federal agencies responsible

14 for planning for, responding to, and recovering from

15 public health emergencies in addressing the needs of

16 at-risk individuals;

17 ‘‘(3) provide guidance to and ensure that recipi18 ents of State and local public health grants include

19 preparedness and response strategies and capabili20 ties that take into account the medical and public

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

22 public health emergency, as described in section

23 319C–1(b)(2)(A)(iii);

24 ‘‘(4) ensure that the contents of the strategic

25 national stockpile take into account at-risk popu26 lations as described in section 2811(b)(3)(B);
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1 ‘‘(5) oversee the progress of the Advisory Com2 mittee on At-Risk Individuals and Public Health

3 Emergencies established under section 319F(b)(2)

4 and make recommendations with a focus on opportu5 nities for action based on the work of the Com6 mittee;

7 ‘‘(6) oversee curriculum development for the

8 public health and medical response training program

9 on medical management of casualties, as it concerns

10 at-risk individuals as described in subparagraphs (A)

11 through (C) of section 319F(a)(2);

12 ‘‘(7) disseminate novel and best practices of

13 outreach to and care of at-risk individuals before,

14 during, and following public health emergencies; and

15 ‘‘(8) not later than one year after the date of

16 enactment of the Pandemic and All-Hazards Pre17 paredness Act, prepare and submit to Congress a re18 port describing the progress made on implementing

19 the duties described in this section.’’.

20 SEC. 103. NATIONAL HEALTH SECURITY STRATEGY.

21 Title XXVIII of the Public Health Service Act

22 (300hh–11 et seq.), as amended by section 101, is amend23 ed by inserting after section 2801 the following:

24 ‘‘SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.

25 ‘‘(a) IN GENERAL.—
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1 ‘‘(1) PREPAREDNESS AND RESPONSE REGARD2 ING PUBLIC HEALTH EMERGENCIES.—Beginning in

3 2009 and every four years thereafter, the Secretary

4 shall prepare and submit to the relevant committees

5 of Congress a coordinated strategy (to be known as

6 the National Health Security Strategy) and any revi7 sions thereof, and an accompanying implementation

8 plan for public health emergency preparedness and

9 response. Such National Health Security Strategy

10 shall identify the process for achieving the prepared11 ness goals described in subsection (b) and shall be

12 consistent with the National Preparedness Goal, the

13 National Incident Management System, and the Na14 tional Response Plan developed pursuant to section

15 502(6) of the Homeland Security Act of 2002, or

16 any successor plan.

17 ‘‘(2) EVALUATION OF PROGRESS.—The Na18 tional Health Security Strategy shall include an

19 evaluation of the progress made by Federal, State,

20 local, and tribal entities, based on the evidence-based

21 benchmarks and objective standards that measure

22 levels of preparedness established pursuant to sec23 tion 319C–1(g). Such evaluation shall include aggre24 gate and State-specific breakdowns of obligated

25 funding spent by major category (as defined by the
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1 Secretary) for activities funded through awards pur2 suant to sections 319C–1 and 319C–2.

3 ‘‘(3) PUBLIC HEALTH WORKFORCE.—In 2009,

4 the National Health Security Strategy shall include

5 a national strategy for establishing an effective and

6 prepared public health workforce, including defining

7 the functions, capabilities, and gaps in such work8 force, and identifying strategies to recruit, retain,

9 and protect such workforce from workplace expo10 sures during public health emergencies.

11 ‘‘(b) PREPAREDNESS GOALS.—The National Health

12 Security Strategy shall include provisions in furtherance

13 of the following:

14 ‘‘(1) INTEGRATION.—Integrating public health

15 and public and private medical capabilities with

16 other first responder systems, including through—

17 ‘‘(A) the periodic evaluation of Federal,

18 State, local, and tribal preparedness and re19 sponse capabilities through drills and exercises;

20 and

21 ‘‘(B) integrating public and private sector

22 public health and medical donations and volun23 teers.

24 ‘‘(2) PUBLIC HEALTH.—Developing and sus25 taining Federal, State, local, and tribal essential
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1 public health security capabilities, including the fol2 lowing:

3 ‘‘(A) Disease situational awareness domes4 tically and abroad, including detection, identi5 fication, and investigation.

6 ‘‘(B) Disease containment including capa7 bilities for isolation, quarantine, social

8 distancing, and decontamination.

9 ‘‘(C) Risk communication and public pre10 paredness.

11 ‘‘(D) Rapid distribution and administra12 tion of medical countermeasures.

13 ‘‘(3) MEDICAL.—Increasing the preparedness,

14 response capabilities, and surge capacity of hos15 pitals, other health care facilities (including mental

16 health facilities), and trauma care and emergency

17 medical service systems, with respect to public

18 health emergencies, which shall include developing

19 plans for the following:

20 ‘‘(A) Strengthening public health emer21 gency medical management and treatment ca22 pabilities.

23 ‘‘(B) Medical evacuation and fatality man24 agement.
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1 ‘‘(C) Rapid distribution and administration

2 of medical countermeasures.

3 ‘‘(D) Effective utilization of any available

4 public and private mobile medical assets and in5 tegration of other Federal assets.

6 ‘‘(E) Protecting health care workers and

7 health care first responders from workplace ex8 posures during a public health emergency.

9 ‘‘(4) AT-RISK INDIVIDUALS.—

10 ‘‘(A) Taking into account the public health

11 and medical needs of at-risk individuals in the

12 event of a public health emergency.

13 ‘‘(B) For purpose of this section and sec14 tions 319C–1, 319F, and 319L, the term ‘at15 risk individuals’ means children, pregnant

16 women, senior citizens and other individuals

17 who have special needs in the event of a public

18 health emergency, as determined by the Sec19 retary.

20 ‘‘(5) COORDINATION.—Minimizing duplication

21 of, and ensuring coordination between, Federal,

22 State, local, and tribal planning, preparedness, and

23 response activities (including the State Emergency

24 Management Assistance Compact). Such planning

25 shall be consistent with the National Response Plan,
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1 or any successor plan, and National Incident Man2 agement System and the National Preparedness

3 Goal.

4 ‘‘(6) CONTINUITY OF OPERATIONS.—Maintain5 ing vital public health and medical services to allow

6 for optimal Federal, State, local, and tribal oper7 ations in the event of a public health emergency.’’.

8 TITLE II—PUBLIC HEALTH

9 SECURITY PREPAREDNESS

10 SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH

11 SECURITY.

12 Section 319C–1 of the Public Health Service Act (42

13 U.S.C. 247d–3a) is amended—

14 (1) by amending the heading to read as follows:

15 ‘‘IMPROVING STATE AND LOCAL PUBLIC

16 HEALTH SECURITY.’’;

17 (2) by striking subsections (a) through (i) and

18 inserting the following:

19 ‘‘(a) IN GENERAL.—To enhance the security of the

20 United States with respect to public health emergencies,

21 the Secretary shall award cooperative agreements to eligi22 ble entities to enable such entities to conduct the activities

23 described in subsection (d).

24 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive

25 an award under subsection (a), an entity shall—
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1 ‘‘(1)(A) be a State;

2 ‘‘(B) be a political subdivision determined by

3 the Secretary to be eligible for an award under this

4 section (based on criteria described in subsection

5 (i)(4)); or

6 ‘‘(C) be a consortium of entities described in

7 subparagraph (A); and

8 ‘‘(2) prepare and submit to the Secretary an

9 application at such time, and in such manner, and

10 containing such information as the Secretary may

11 require, including—

12 ‘‘(A) an All-Hazards Public Health Emer13 gency Preparedness and Response Plan which

14 shall include—

15 ‘‘(i) a description of the activities such

16 entity will carry out under the agreement

17 to meet the goals identified under section

18 2802;

19 ‘‘(ii) a pandemic influenza plan con20 sistent with the requirements of para21 graphs (2) and (5) of subsection (g);

22 ‘‘(iii) preparedness and response strat23 egies and capabilities that take into ac24 count the medical and public health needs
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1 of at-risk individuals in the event of a pub2 lic health emergency;

3 ‘‘(iv) a description of the mechanism

4 the entity will implement to utilize the

5 Emergency Management Assistance Com6 pact or other mutual aid agreements for

7 medical and public health mutual aid; and

8 ‘‘(v) a description of how the entity

9 will include the State Unit on Aging in

10 public health emergency preparedness;

11 ‘‘(B) an assurance that the entity will re12 port to the Secretary on an annual basis (or

13 more frequently as determined by the Sec14 retary) on the evidence-based benchmarks and

15 objective standards established by the Secretary

16 to evaluate the preparedness and response capa17 bilities of such entity under subsection (g);

18 ‘‘(C) an assurance that the entity will con19 duct, on at least an annual basis, an exercise or

20 drill that meets any criteria established by the

21 Secretary to test the preparedness and response

22 capabilities of such entity, and that the entity

23 will report back to the Secretary within the ap24 plication of the following year on the strengths

25 and weaknesses identified through such exercise
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1 or drill, and corrective actions taken to address

2 material weaknesses;

3 ‘‘(D) an assurance that the entity will pro4 vide to the Secretary the data described under

5 section 319D(d)(3) as determined feasible by

6 the Secretary;

7 ‘‘(E) an assurance that the entity will con8 duct activities to inform and educate the hos9 pitals within the jurisdiction of such entity on

10 the role of such hospitals in the plan required

11 under subparagraph (A);

12 ‘‘(F) an assurance that the entity, with re13 spect to the plan described under subparagraph

14 (A), has developed and will implement an ac15 countability system to ensure that such entity

16 make satisfactory annual improvement and de17 scribe such system in the plan under subpara18 graph (A);

19 ‘‘(G) a description of the means by which

20 to obtain public comment and input on the plan

21 described in subparagraph (A) and on the im22 plementation of such plan, that shall include an

23 advisory committee or other similar mechanism

24 for obtaining comment from the public and
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1 from other State, local, and tribal stakeholders;

2 and

3 ‘‘(H) as relevant, a description of the proc4 ess used by the entity to consult with local de5 partments of public health to reach consensus,

6 approval, or concurrence on the relative dis7 tribution of amounts received under this sec8 tion.

9 ‘‘(c) LIMITATION.—Beginning in fiscal year 2009,

10 the Secretary may not award a cooperative agreement to

11 a State unless such State is a participant in the Emer12 gency System for Advance Registration of Volunteer

13 Health Professionals described in section 319I.

14 ‘‘(d) USE OF FUNDS.—

15 ‘‘(1) IN GENERAL.—An award under subsection

16 (a) shall be expended for activities to achieve the

17 preparedness goals described under paragraphs (1),

18 (2), (4), (5), and (6) of section 2802(b).

19 ‘‘(2) EFFECT OF SECTION.—Nothing in this

20 subsection may be construed as establishing new

21 regulatory authority or as modifying any existing

22 regulatory authority.

23 ‘‘(e) COORDINATION WITH LOCAL RESPONSE CAPA24 BILITIES.—An entity shall, to the extent practicable, en25 sure that activities carried out under an award under sub-
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1 section (a) are coordinated with activities of relevant Met2 ropolitan Medical Response Systems, local public health

3 departments, the Cities Readiness Initiative, and local

4 emergency plans.

5 ‘‘(f) CONSULTATION WITH HOMELAND SECURITY.—

6 In making awards under subsection (a), the Secretary

7 shall consult with the Secretary of Homeland Security

8 to—

9 ‘‘(1) ensure maximum coordination of public

10 health and medical preparedness and response ac11 tivities with the Metropolitan Medical Response Sys12 tem, and other relevant activities;

13 ‘‘(2) minimize duplicative funding of programs

14 and activities;

15 ‘‘(3) analyze activities, including exercises and

16 drills, conducted under this section to develop rec17 ommendations and guidance on best practices for

18 such activities; and

19 ‘‘(4) disseminate such recommendations and

20 guidance, including through expanding existing les21 sons learned information systems to create a single

22 Internet-based point of access for sharing and dis23 tributing medical and public health best practices

24 and lessons learned from drills, exercises, disasters,

25 and other emergencies.
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1 ‘‘(g) ACHIEVEMENT OF MEASURABLE EVIDENCE2 BASED BENCHMARKS AND OBJECTIVE STANDARDS.—

3 ‘‘(1) IN GENERAL.—Not later than 180 days

4 after the date of enactment of the Pandemic and

5 All-Hazards Preparedness Act, the Secretary shall

6 develop or where appropriate adopt, and require the

7 application of, measurable evidence-based bench8 marks and objective standards that measure levels of

9 preparedness with respect to the activities described

10 in this section and with respect to activities de11 scribed in section 319C–2. In developing such bench12 marks and standards, the Secretary shall consult

13 with and seek comments from State, local, and tribal

14 officials and private entities, as appropriate. Where

15 appropriate, the Secretary shall incorporate existing

16 objective standards. Such benchmarks and standards

17 shall—

18 ‘‘(A) include outcome goals representing

19 operational achievement of the National Pre20 paredness Goals developed under section

21 2802(b); and

22 ‘‘(B) at a minimum, require entities to—

23 ‘‘(i) measure progress toward achiev24 ing the outcome goals; and
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1 ‘‘(ii) at least annually, test, exercise,

2 and rigorously evaluate the public health

3 and medical emergency preparedness and

4 response capabilities of the entity, and re5 port to the Secretary on such measured

6 and tested capabilities and measured and

7 tested progress toward achieving outcome

8 goals, based on criteria established by the

9 Secretary.

10 ‘‘(2) CRITERIA FOR PANDEMIC INFLUENZA

11 PLANS.—

12 ‘‘(A) IN GENERAL.—Not later than 180

13 days after the date of enactment of the Pan14 demic and All-Hazards Preparedness Act, the

15 Secretary shall develop and disseminate to the

16 chief executive officer of each State criteria for

17 an effective State plan for responding to pan18 demic influenza.

19 ‘‘(B) RULE OF CONSTRUCTION.—Nothing

20 in this section shall be construed to require the

21 duplication of Federal efforts with respect to

22 the development of criteria or standards, with23 out regard to whether such efforts were carried

24 out prior to or after the date of enactment of

25 this section.
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1 ‘‘(3) TECHNICAL ASSISTANCE.—The Secretary

2 shall, as determined appropriate by the Secretary,

3 provide to a State, upon request, technical assistance

4 in meeting the requirements of this section, includ5 ing the provision of advice by experts in the develop6 ment of high-quality assessments, the setting of

7 State objectives and assessment methods, the devel8 opment of measures of satisfactory annual improve9 ment that are valid and reliable, and other relevant

10 areas.

11 ‘‘(4) NOTIFICATION OF FAILURES.—The Sec12 retary shall develop and implement a process to no13 tify entities that are determined by the Secretary to

14 have failed to meet the requirements of paragraph

15 (1) or (2). Such process shall provide such entities

16 with the opportunity to correct such noncompliance.

17 An entity that fails to correct such noncompliance

18 shall be subject to paragraph (5).

19 ‘‘(5) WITHHOLDING OF AMOUNTS FROM ENTI20 TIES THAT FAIL TO ACHIEVE BENCHMARKS OR SUB21 MIT INFLUENZA PLAN.—Beginning with fiscal year

22 2009, and in each succeeding fiscal year, the Sec23 retary shall—

24 ‘‘(A) withhold from each entity that has

25 failed substantially to meet the benchmarks and
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1 performance measures described in paragraph

2 (1) for the immediately preceding fiscal year

3 (beginning with fiscal year 2008), pursuant to

4 the process developed under paragraph (4), the

5 amount described in paragraph (6); and

6 ‘‘(B) withhold from each entity that has

7 failed to submit to the Secretary a plan for re8 sponding to pandemic influenza that meets the

9 criteria developed under paragraph (2), the

10 amount described in paragraph (6).

11 ‘‘(6) AMOUNTS DESCRIBED.—

12 ‘‘(A) IN GENERAL.—The amounts de13 scribed in this paragraph are the following

14 amounts that are payable to an entity for ac15 tivities described in section 319C–1 or 319C–2:

16 ‘‘(i) For the fiscal year immediately

17 following a fiscal year in which an entity

18 experienced a failure described in subpara19 graph (A) or (B) of paragraph (5) by the

20 entity, an amount equal to 10 percent of

21 the amount the entity was eligible to re22 ceive for such fiscal year.

23 ‘‘(ii) For the fiscal year immediately

24 following two consecutive fiscal years in

25 which an entity experienced such a failure,
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1 an amount equal to 15 percent of the

2 amount the entity was eligible to receive

3 for such fiscal year, taking into account

4 the withholding of funds for the imme5 diately preceding fiscal year under clause

6 (i).

7 ‘‘(iii) For the fiscal year immediately

8 following three consecutive fiscal years in

9 which an entity experienced such a failure,

10 an amount equal to 20 percent of the

11 amount the entity was eligible to receive

12 for such fiscal year, taking into account

13 the withholding of funds for the imme14 diately preceding fiscal years under clauses

15 (i) and (ii).

16 ‘‘(iv) For the fiscal year immediately

17 following four consecutive fiscal years in

18 which an entity experienced such a failure,

19 an amount equal to 25 percent of the

20 amount the entity was eligible to receive

21 for such a fiscal year, taking into account

22 the withholding of funds for the imme23 diately preceding fiscal years under clauses

24 (i), (ii), and (iii).
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1 ‘‘(B) SEPARATE ACCOUNTING.—Each fail2 ure described in subparagraph (A) or (B) of

3 paragraph (5) shall be treated as a separate

4 failure for purposes of calculating amounts

5 withheld under subparagraph (A).

6 ‘‘(7) REALLOCATION OF AMOUNTS WITH7 HELD.—

8 ‘‘(A) IN GENERAL.—The Secretary shall

9 make amounts withheld under paragraph (6)

10 available for making awards under section

11 319C–2 to entities described in subsection

12 (b)(1) of such section.

13 ‘‘(B) PREFERENCE IN REALLOCATION.—In

14 making awards under section 319C–2 with

15 amounts described in subparagraph (A), the

16 Secretary shall give preference to eligible enti17 ties (as described in section 319C–2(b)(1)) that

18 are located in whole or in part in States from

19 which amounts have been withheld under para20 graph (6).

21 ‘‘(8) WAIVE OR REDUCE WITHHOLDING.—The

22 Secretary may waive or reduce the withholding de23 scribed in paragraph (6), for a single entity or for

24 all entities in a fiscal year, if the Secretary deter-
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1 mines that mitigating conditions exist that justify

2 the waiver or reduction.

3 ‘‘(h) GRANTS FOR REAL-TIME DISEASE DETECTION

4 IMPROVEMENT.—

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

6 grants to eligible entities to carry out projects de7 scribed under paragraph (4).

8 ‘‘(2) ELIGIBLE ENTITY.—For purposes of this

9 section, the term ‘eligible entity’ means an entity

10 that is—

11 ‘‘(A)(i) a hospital, clinical laboratory, uni12 versity; or

13 ‘‘(ii) a poison control center or professional

14 organization in the field of poison control; and

15 ‘‘(B) a participant in the network estab16 lished under subsection 319D(d).

17 ‘‘(3) APPLICATION.—Each eligible entity desir18 ing a grant under this subsection shall submit to the

19 Secretary an application at such time, in such man20 ner, and containing such information as the Sec21 retary may require.

22 ‘‘(4) USE OF FUNDS.—

23 ‘‘(A) IN GENERAL.—An eligible entity de24 scribed in paragraph (2)(A)(i) that receives a

25 grant under this subsection shall use the funds
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1 awarded pursuant to such grant to carry out a

2 pilot demonstration project to purchase and im3 plement the use of advanced diagnostic medical

4 equipment to analyze real-time clinical speci5 mens for pathogens of public health or bioter6 rorism significance and report any results from

7 such project to State, local, and tribal public

8 health entities and the network established

9 under section 319D(d).

10 ‘‘(B) OTHER ENTITIES.—An eligible entity

11 described in paragraph (2)(A)(ii) that receives a

12 grant under this section shall use the funds

13 awarded pursuant to such grant to—

14 ‘‘(i) improve the early detection, sur15 veillance, and investigative capabilities of

16 poison control centers for chemical, biologi17 cal, radiological, and nuclear events by

18 training poison information personnel to

19 improve the accuracy of surveillance data,

20 improving the definitions used by the poi21 son control centers for surveillance, and

22 enhancing timely and efficient investigation

23 of data anomalies;

24 ‘‘(ii) improve the capabilities of poison

25 control centers to provide information to
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1 health care providers and the public with

2 regard to chemical, biological, radiological,

3 or nuclear threats or exposures, in con4 sultation with the appropriate State, local,

5 and tribal public health entities; or

6 ‘‘(iii) provide surge capacity in the

7 event of a chemical, biological, radiological,

8 or nuclear event through the establishment

9 of alternative poison control center work10 sites and the training of nontraditional

11 personnel.’’;

12 (3) by redesignating subsection (j) as sub13 section (i);

14 (4) in subsection (i), as so redesignated—

15 (A) by striking paragraphs (1) through

16 (3)(A) and inserting the following:

17 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

18 ‘‘(A) IN GENERAL.—For the purpose of

19 carrying out this section, there is authorized to

20 be appropriated $824,000,000 for fiscal year

21 2007, of which $35,000,000 shall be used to

22 carry out subsection (h), for awards pursuant

23 to paragraph (3) (subject to the authority of

24 the Secretary to make awards pursuant to

25 paragraphs (4) and (5)), and such sums as may
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1 be necessary for each of fiscal years 2008

2 through 2011.

3 ‘‘(B) COORDINATION.—There are author4 ized to be appropriated, $10,000,000 for fiscal

5 year 2007 to carry out subsection (f)(4) of this

6 section and section 2814.

7 ‘‘(C) REQUIREMENT FOR STATE MATCHING

8 FUNDS.—Beginning in fiscal year 2009, in the

9 case of any State or consortium of two or more

10 States, the Secretary may not award a coopera11 tive agreement under this section unless the

12 State or consortium of States agree that, with

13 respect to the amount of the cooperative agree14 ment awarded by the Secretary, the State or

15 consortium of States will make available (di16 rectly or through donations from public or pri17 vate entities) non-Federal contributions in an

18 amount equal to—

19 ‘‘(i) for the first fiscal year of the co20 operative agreement, not less than 5 per21 cent of such costs ($1 for each $20 of Fed22 eral funds provided in the cooperative

23 agreement); and

24 ‘‘(ii) for any second fiscal year of the

25 cooperative agreement, and for any subse-
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1 quent fiscal year of such cooperative agree2 ment, not less than 10 percent of such

3 costs ($1 for each $10 of Federal funds

4 provided in the cooperative agreement).

5 ‘‘(D) DETERMINATION OF AMOUNT OF

6 NON-FEDERAL CONTRIBUTIONS.—As deter7 mined by the Secretary, non-Federal contribu8 tions required in subparagraph (C) may be pro9 vided directly or through donations from public

10 or private entities and may be in cash or in

11 kind, fairly evaluated, including plant, equip12 ment or services. Amounts provided by the Fed13 eral government, or services assisted or sub14 sidized to any significant extent by the Federal

15 government, may not be included in deter16 mining the amount of such non-Federal con17 tributions.

18 ‘‘(2) MAINTAINING STATE FUNDING.—

19 ‘‘(A) IN GENERAL.—An entity that re20 ceives an award under this section shall main21 tain expenditures for public health security at a

22 level that is not less than the average level of

23 such expenditures maintained by the entity for

24 the preceding 2 year period.
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1 ‘‘(B) RULE OF CONSTRUCTION.—Nothing

2 in this section shall be construed to prohibit the

3 use of awards under this section to pay salary

4 and related expenses of public health and other

5 professionals employed by State, local, or tribal

6 public health agencies who are carrying out ac7 tivities supported by such awards (regardless of

8 whether the primary assignment of such per9 sonnel is to carry out such activities).

10 ‘‘(3) DETERMINATION OF AMOUNT.—

11 ‘‘(A) IN GENERAL.—The Secretary shall

12 award cooperative agreements under subsection

13 (a) to each State or consortium of 2 or more

14 States that submits to the Secretary an applica15 tion that meets the criteria of the Secretary for

16 the receipt of such an award and that meets

17 other implementation conditions established by

18 the Secretary for such awards.’’;

19 (B) in paragraph (4)(A)—

20 (i) by striking ‘‘2003’’ and inserting

21 ‘‘2007’’; and

22 (ii) by striking ‘‘(A)(i)(I)’’;

23 (C) in paragraph (4)(D), by striking

24 ‘‘2002’’ and inserting ‘‘2006’’;

25 (D) in paragraph (5)—
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1 (i) by striking ‘‘2003’’ and inserting

2 ‘‘2007’’; and

3 (ii) by striking ‘‘(A)(i)(I)’’; and

4 (E) by striking paragraph (6) and insert5 ing the following:

6 ‘‘(6) FUNDING OF LOCAL ENTITIES.—The Sec7 retary shall, in making awards under this section,

8 ensure that with respect to the cooperative agree9 ment awarded, the entity make available appropriate

10 portions of such award to political subdivisions and

11 local departments of public health through a process

12 involving the consensus, approval or concurrence

13 with such local entities.’’; and

14 (5) by adding at the end the following:

15 ‘‘(j) ADMINISTRATIVE AND FISCAL RESPONSI16 BILITY.—

17 ‘‘(1) ANNUAL REPORTING REQUIREMENTS.—

18 Each entity shall prepare and submit to the Sec19 retary annual reports on its activities under this sec20 tion and section 319C–2. Each such report shall be

21 prepared by, or in consultation with, the health de22 partment. In order to properly evaluate and compare

23 the performance of different entities assisted under

24 this section and section 319C–2 and to assure the

25 proper expenditure of funds under this section and
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1 section 319C–2, such reports shall be in such stand2 ardized form and contain such information as the

3 Secretary determines and describes within 180 days

4 of the date of enactment of the Pandemic and All5 Hazards Preparedness Act (after consultation with

6 the States) to be necessary to—

7 ‘‘(A) secure an accurate description of

8 those activities;

9 ‘‘(B) secure a complete record of the pur10 poses for which funds were spent, and of the re11 cipients of such funds;

12 ‘‘(C) describe the extent to which the enti13 ty has met the goals and objectives it set forth

14 under this section or section 319C–2;

15 ‘‘(D) determine the extent to which funds

16 were expended consistent with the entity’s ap17 plication transmitted under this section or sec18 tion 319C–2; and

19 ‘‘(E) publish such information on a Fed20 eral Internet website consistent with subsection

21 (k).

22 ‘‘(2) AUDITS; IMPLEMENTATION.—

23 ‘‘(A) IN GENERAL.—Each entity receiving

24 funds under this section or section 319C–2

25 shall, not less often than once every 2 years,
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1 audit its expenditures from amounts received

2 under this section or section 319C–2. Such au3 dits shall be conducted by an entity independent

4 of the agency administering a program funded

5 under this section or section 319C–2 in accord6 ance with the Comptroller General’s standards

7 for auditing governmental organizations, pro8 grams, activities, and functions and generally

9 accepted auditing standards. Within 30 days

10 following the completion of each audit report,

11 the entity shall submit a copy of that audit re12 port to the Secretary.

13 ‘‘(B) REPAYMENT.—Each entity shall

14 repay to the United States amounts found by

15 the Secretary, after notice and opportunity for

16 a hearing to the entity, not to have been ex17 pended in accordance with this section or sec18 tion 319C–2 and, if such repayment is not

19 made, the Secretary may offset such amounts

20 against the amount of any allotment to which

21 the entity is or may become entitled under this

22 section or section 319C–2 or may otherwise re23 cover such amounts.

24 ‘‘(C) WITHHOLDING OF PAYMENT.—The

25 Secretary may, after notice and opportunity for
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1 a hearing, withhold payment of funds to any

2 entity which is not using its allotment under

3 this section or section 319C–2 in accordance

4 with such section. The Secretary may withhold

5 such funds until the Secretary finds that the

6 reason for the withholding has been removed

7 and there is reasonable assurance that it will

8 not recur.

9 ‘‘(3) MAXIMUM CARRYOVER AMOUNT.—

10 ‘‘(A) IN GENERAL.—For each fiscal year,

11 the Secretary, in consultation with the States

12 and political subdivisions, shall determine the

13 maximum percentage amount of an award

14 under this section that an entity may carryover

15 to the succeeding fiscal year.

16 ‘‘(B) AMOUNT EXCEEDED.—For each fis17 cal year, if the percentage amount of an award

18 under this section unexpended by an entity ex19 ceeds the maximum percentage permitted by

20 the Secretary under subparagraph (A), the enti21 ty shall return to the Secretary the portion of

22 the unexpended amount that exceeds the max23 imum amount permitted to be carried over by

24 the Secretary.
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1 ‘‘(C) ACTION BY SECRETARY.—The Sec2 retary shall make amounts returned to the Sec3 retary under subparagraph (B) available for

4 awards under section 319C–2(b)(1). In making

5 awards under section 319C–2(b)(1) with

6 amounts collected under this paragraph the

7 Secretary shall give preference to entities that

8 are located in whole or in part in States from

9 which amounts have been returned under sub10 paragraph (B).

11 ‘‘(D) WAIVER.—An entity may apply to

12 the Secretary for a waiver of the maximum per13 centage amount under subparagraph (A). Such

14 an application for a waiver shall include an ex15 planation why such requirement should not

16 apply to the entity and the steps taken by such

17 entity to ensure that all funds under an award

18 under this section will be expended appro19 priately.

20 ‘‘(E) WAIVE OR REDUCE WITHHOLDING.—

21 The Secretary may waive the application of

22 subparagraph (B), or reduce the amount deter23 mined under such subparagraph, for a single

24 entity pursuant to subparagraph (D) or for all

25 entities in a fiscal year, if the Secretary deter-
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1 mines that mitigating conditions exist that jus2 tify the waiver or reduction.

3 ‘‘(k) COMPILATION AND AVAILABILITY OF DATA.—

4 The Secretary shall compile the data submitted under this

5 section and make such data available in a timely manner

6 on an appropriate Internet website in a format that is use7 ful to the public and to other entities and that provides

8 information on what activities are best contributing to the

9 achievement of the outcome goals described in subsection

10 (g).’’.

11 SEC. 202. USING INFORMATION TECHNOLOGY TO IMPROVE

12 SITUATIONAL AWARENESS IN PUBLIC

13 HEALTH EMERGENCIES.

14 Section 319D of the Public Health Service Act (42

15 U.S.C. 247d–4) is amended—

16 (1) in subsection (a)(1), by inserting ‘‘domesti17 cally and abroad’’ after ‘‘public health threats’’; and

18 (2) by adding at the end the following:

19 ‘‘(d) PUBLIC HEALTH SITUATIONAL AWARENESS.—

20 ‘‘(1) IN GENERAL.—Not later than 2 years

21 after the date of enactment of the Pandemic and

22 All-Hazards Preparedness Act, the Secretary, in col23 laboration with State, local, and tribal public health

24 officials, shall establish a near real-time electronic

25 nationwide public health situational awareness capa-
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1 bility through an interoperable network of systems

2 to share data and information to enhance early de3 tection of rapid response to, and management of, po4 tentially catastrophic infectious disease outbreaks

5 and other public health emergencies that originate

6 domestically or abroad. Such network shall be built

7 on existing State situational awareness systems or

8 enhanced systems that enable such connectivity.

9 ‘‘(2) STRATEGIC PLAN.—Not later than 180

10 days after the date of enactment the Pandemic and

11 All-Hazards Preparedness Act, the Secretary shall

12 submit to the appropriate committees of Congress, a

13 strategic plan that demonstrates the steps the Sec14 retary will undertake to develop, implement, and

15 evaluate the network described in paragraph (1), uti16 lizing the elements described in paragraph (3).

17 ‘‘(3) ELEMENTS.—The network described in

18 paragraph (1) shall include data and information

19 transmitted in a standardized format from—

20 ‘‘(A) State, local, and tribal public health

21 entities, including public health laboratories;

22 ‘‘(B) Federal health agencies;

23 ‘‘(C) zoonotic disease monitoring systems;

24 ‘‘(D) public and private sector health care

25 entities, hospitals, pharmacies, poison control
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1 centers or professional organizations in the field

2 of poison control, and clinical laboratories, to

3 the extent practicable and provided that such

4 data are voluntarily provided simultaneously to

5 the Secretary and appropriate State, local, and

6 tribal public health agencies; and

7 ‘‘(E) such other sources as the Secretary

8 may deem appropriate.

9 ‘‘(4) RULE OF CONSTRUCTION.—Paragraph (3)

10 shall not be construed as requiring separate report11 ing of data and information from each source listed.

12 ‘‘(5) REQUIRED ACTIVITIES.—In establishing

13 and operating the network described in paragraph

14 (1), the Secretary shall—

15 ‘‘(A) utilize applicable interoperability

16 standards as determined by the Secretary

17 through a joint public and private sector proc18 ess;

19 ‘‘(B) define minimal data elements for

20 such network;

21 ‘‘(C) in collaboration with State, local, and

22 tribal public health officials, integrate and build

23 upon existing State, local, and tribal capabili24 ties, ensuring simultaneous sharing of data, in25 formation, and analyses from the network de-
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1 scribed in paragraph (1) with State, local, and

2 tribal public health agencies; and

3 ‘‘(D) in collaboration with State, local, and

4 tribal public health officials, develop procedures

5 and standards for the collection, analysis, and

6 interpretation of data that States, regions, or

7 other entities collect and report to the network

8 described in paragraph (1).

9 ‘‘(e) STATE AND REGIONAL SYSTEMS TO ENHANCE

10 SITUATIONAL AWARENESS IN PUBLIC HEALTH EMER11 GENCIES.—

12 ‘‘(1) IN GENERAL.—To implement the network

13 described in subsection (d), the Secretary may award

14 grants to States or consortia of States to enhance

15 the ability of such States or consortia of States to

16 establish or operate a coordinated public health situ17 ational awareness system for regional or Statewide

18 early detection of, rapid response to, and manage19 ment of potentially catastrophic infectious disease

20 outbreaks and public health emergencies, in collabo21 ration with appropriate public health agencies, sen22 tinel hospitals, clinical laboratories, pharmacies, poi23 son control centers, other health care organizations,

24 and animal health organizations within such States.
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1 ‘‘(2) ELIGIBILITY.—To be eligible to receive a

2 grant under paragraph (1), the State or consortium

3 of States shall submit to the Secretary an applica4 tion at such time, in such manner, and containing

5 such information as the Secretary may require, in6 cluding an assurance that the State or consortium of

7 States will submit to the Secretary—

8 ‘‘(A) reports of such data, information,

9 and metrics as the Secretary may require;

10 ‘‘(B) a report on the effectiveness of the

11 systems funded under the grant; and

12 ‘‘(C) a description of the manner in which

13 grant funds will be used to enhance the

14 timelines and comprehensiveness of efforts to

15 detect, respond to, and manage potentially cata16 strophic infectious disease outbreaks and public

17 health emergencies.

18 ‘‘(3) USE OF FUNDS.—A State or consortium of

19 States that receives an award under this

20 subsection—

21 ‘‘(A) shall establish, enhance, or operate a

22 coordinated public health situational awareness

23 system for regional or Statewide early detection

24 of, rapid response to, and management of po-
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1 tentially catastrophic infectious disease out2 breaks and public health emergencies;

3 ‘‘(B) may award grants or contracts to en4 tities described in paragraph (1) within or serv5 ing such State to assist such entities in improv6 ing the operation of information technology sys7 tems, facilitating the secure exchange of data

8 and information, and training personnel to en9 hance the operation of the system described in

10 subparagraph (A); and

11 ‘‘(C) may conduct a pilot program for the

12 development of multi-State telehealth network

13 test beds that build on, enhance, and securely

14 link existing State and local telehealth pro15 grams to prepare for, monitor, respond to, and

16 manage the events of public health emergencies,

17 facilitate coordination and communication

18 among medical, public health, and emergency

19 response agencies, and provide medical services

20 through telehealth initiatives within the States

21 that are involved in such a multi-State tele22 health network test bed.

23 ‘‘(4) LIMITATION.—Information technology sys24 tems acquired or implemented using grants awarded

25 under this section must be compliant with—
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1 ‘‘(A) interoperability and other techno2 logical standards, as determined by the Sec3 retary; and

4 ‘‘(B) data collection and reporting require5 ments for the network described in subsection

6 (d).

7 ‘‘(5) INDEPENDENT EVALUATION.—Not later

8 than 4 years after the date of enactment of the Pan9 demic and All-Hazards Preparedness Act, the Gov10 ernment Accountability Office shall conduct an inde11 pendent evaluation, and submit to the Secretary and

12 the appropriate committees of Congress a report

13 concerning the activities conducted under this sub14 section and subsection (d).

15 ‘‘(f) TELEHEALTH ENHANCEMENTS FOR EMER16 GENCY RESPONSE.—

17 ‘‘(1) EVALUATION.—The Secretary, in consulta18 tion with the Federal Communications Commission

19 and other relevant Federal agencies, shall—

20 ‘‘(A) conduct an inventory of telehealth ini21 tiatives in existence on the date of enactment of

22 the Pandemic and All-Hazards Preparedness

23 Act, including—

24 ‘‘(i) the specific location of network

25 components;
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1 ‘‘(ii) the medical, technological, and

2 communications capabilities of such com3 ponents;

4 ‘‘(iii) the functionality of such compo5 nents; and

6 ‘‘(iv) the capacity and ability of such

7 components to handle increased volume

8 during the response to a public health

9 emergency;

10 ‘‘(B) identify methods to expand and inter11 connect the regional health information net12 works funded by the Secretary, the State and

13 regional broadband networks funded through

14 the rural health care support mechanism pilot

15 program funded by the Federal Communica16 tions Commission, and other telehealth net17 works;

18 ‘‘(C) evaluate ways to prepare for, monitor,

19 respond rapidly to, or manage the events of, a

20 public health emergency through the enhanced

21 use of telehealth technologies, including mecha22 nisms for payment or reimbursement for use of

23 such technologies and personnel during public

24 health emergencies;
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1 ‘‘(D) identify methods for reducing legal

2 barriers that deter health care professionals

3 from providing telemedicine services, such as by

4 utilizing State emergency health care profes5 sional credentialing verification systems, en6 couraging States to establish and implement

7 mechanisms to improve interstate medical licen8 sure cooperation, facilitating the exchange of in9 formation among States regarding investiga10 tions and adverse actions, and encouraging

11 States to waive the application of licensing re12 quirements during a public health emergency;

13 ‘‘(E) evaluate ways to integrate the prac14 tice of telemedicine within the National Dis15 aster Medical System; and

16 ‘‘(F) promote greater coordination among

17 existing Federal interagency telemedicine and

18 health information technology initiatives.

19 ‘‘(2) REPORT.—Not later than 12 months after

20 the date of enactment of the Pandemic and All-Haz21 ards Preparedness Act, the Secretary shall prepare

22 and submit a report to the Committee on Health,

23 Education, Labor, and Pensions of the Senate and

24 the Committee on Energy and Commerce of the

25 House of Representatives regarding the findings and
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1 recommendations pursuant to subparagraphs (A)

2 through (F) of paragraph (1).

3 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There

4 are authorized to be appropriated to carry out this section,

5 such sums as may be necessary in each of fiscal years

6 2007 through 2011.’’.

7 SEC. 203. PUBLIC HEALTH WORKFORCE ENHANCEMENTS.

8 (a) DEMONSTRATION PROJECT.—Subpart III of part

9 D of title III of the Public Health Service Act (42 U.S.C.

10 254l) is amended by adding at the end the following:

11 ‘‘SEC. 338M. PUBLIC HEALTH DEPARTMENTS.

12 ‘‘(a) IN GENERAL.—To the extent that funds are ap13 propriated under subsection (e), the Secretary shall estab14 lish a demonstration project to provide for the participa15 tion of individuals who are eligible for the Loan Repay16 ment Program described in section 338B and who agree

17 to complete their service obligation in a State health de18 partment that provides a significant amount of service to

19 health professional shortage areas or areas at risk of a

20 public health emergency, as determined by the Secretary,

21 or in a local or tribal health department that serves a

22 health professional shortage area or an area at risk of a

23 public health emergency.
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1 ‘‘(b) PROCEDURE.—To be eligible to receive assist2 ance under subsection (a), with respect to the program

3 described in section 338B, an individual shall—

4 ‘‘(1) comply with all rules and requirements de5 scribed in such section (other than section

6 338B(f)(1)(B)(iv)); and

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

8 2 years, or such longer period as the individual may

9 agree to, in a State, local, or tribal health depart10 ment, described in subsection (a).

11 ‘‘(c) DESIGNATIONS.—The demonstration project de12 scribed in subsection (a), and any healthcare providers

13 who are selected to participate in such project, shall not

14 be considered by the Secretary in the designation of health

15 professional shortage areas under section 332 during fis16 cal years 2007 through 2010.

17 ‘‘(d) REPORT.—Not later than 3 years after the date

18 of enactment of this section, the Secretary shall submit

19 a report to the relevant committees of Congress that eval20 uates the participation of individuals in the demonstration

21 project under subsection (a), the impact of such participa22 tion on State, local, and tribal health departments, and

23 the benefit and feasibility of permanently allowing such

24 placements in the Loan Repayment Program.
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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

2 are authorized to be appropriated to carry out this section,

3 such sums as may be necessary for each of fiscal years

4 2007 through 2010.’’.

5 (b) GRANTS FOR LOAN REPAYMENT PROGRAM.—

6 Section 338I of the Public Health Service Act (42 U.S.C.

7 254q–1) is amended by adding at the end the following:

8 ‘‘(j) PUBLIC HEALTH LOAN REPAYMENT.—

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

10 grants to States for the purpose of assisting such

11 States in operating loan repayment programs under

12 which such States enter into contracts to repay all

13 or part of the eligible loans borrowed by, or on be14 half of, individuals who agree to serve in State, local,

15 or tribal health departments that serve health pro16 fessional shortage areas or other areas at risk of a

17 public health emergency, as designated by the Sec18 retary.

19 ‘‘(2) LOANS ELIGIBLE FOR REPAYMENT.—To

20 be eligible for repayment under this subsection, a

21 loan shall be a loan made, insured, or guaranteed by

22 the Federal Government that is borrowed by, or on

23 behalf of, an individual to pay the cost of attendance

24 for a program of education leading to a degree ap25 propriate for serving in a State, local, or tribal
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1 health department as determined by the Secretary

2 and the chief executive officer of the State in which

3 the grant is administered, at an institution of higher

4 education (as defined in section 102 of the Higher

5 Education Act of 1965), including principal, inter6 est, and related expenses on such loan.

7 ‘‘(3) APPLICABILITY OF EXISTING REQUIRE8 MENTS.—With respect to awards made under para9 graph (1)—

10 ‘‘(A) the requirements of subsections (b),

11 (f), and (g) shall apply to such awards; and

12 ‘‘(B) the requirements of subsection (c)

13 shall apply to such awards except that with re14 spect to paragraph (1) of such subsection, the

15 State involved may assign an individual only to

16 public and nonprofit private entities that serve

17 health professional shortage areas or areas at

18 risk of a public health emergency, as deter19 mined by the Secretary.

20 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

21 There are authorized to be appropriated to carry out

22 this subsection, such sums as may be necessary for

23 each of fiscal years 2007 through 2010.’’.
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1 SEC. 204. VACCINE TRACKING AND DISTRIBUTION.

2 (a) IN GENERAL.—Section 319A of the Public

3 Health Service Act (42 U.S.C. 247d–1) is amended to

4 read as follows:

5 ‘‘SEC. 319A. VACCINE TRACKING AND DISTRIBUTION.

6 ‘‘(a) TRACKING.—The Secretary, together with rel7 evant manufacturers, wholesalers, and distributors as may

8 agree to cooperate, may track the initial distribution of

9 federally purchased influenza vaccine in an influenza pan10 demic. Such tracking information shall be used to inform

11 Federal, State, local, and tribal decision makers during

12 an influenza pandemic.

13 ‘‘(b) DISTRIBUTION.—The Secretary shall promote

14 communication between State, local, and tribal public

15 health officials and such manufacturers, wholesalers, and

16 distributors as agree to participate, regarding the effective

17 distribution of seasonal influenza vaccine. Such commu18 nication shall include estimates of high priority popu19 lations, as determined by the Secretary, in State, local,

20 and tribal jurisdictions in order to inform Federal, State,

21 local, and tribal decision makers during vaccine shortages

22 and supply disruptions.

23 ‘‘(c) CONFIDENTIALITY.—The information submitted

24 to the Secretary or its contractors, if any, under this sec25 tion or under any other section of this Act related to vac26 cine distribution information shall remain confidential in
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1 accordance with the exception from the public disclosure

2 of trade secrets, commercial or financial information, and

3 information obtained from an individual that is privileged

4 and confidential, as provided for in section 552(b)(4) of

5 title 5, United States Code, and subject to the penalties

6 and exceptions under sections 1832 and 1833 of title 18,

7 United States Code, relating to the protection and theft

8 of trade secrets, and subject to privacy protections that

9 are consistent with the regulations promulgated under sec10 tion 264(c) of the Health Insurance Portability and Ac11 countability Act of 1996. None of such information pro12 vided by a manufacturer, wholesaler, or distributor shall

13 be disclosed without its consent to another manufacturer,

14 wholesaler, or distributor, or shall be used in any manner

15 to give a manufacturer, wholesaler, or distributor a propri16 etary advantage.

17 ‘‘(d) GUIDELINES.—The Secretary, in order to main18 tain the confidentiality of relevant information and ensure

19 that none of the information contained in the systems in20 volved may be used to provide proprietary advantage with21 in the vaccine market, while allowing State, local, and trib22 al health officials access to such information to maximize

23 the delivery and availability of vaccines to high priority

24 populations, during times of influenza pandemics, vaccine

25 shortages, and supply disruptions, in consultation with
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1 manufacturers, distributors, wholesalers and State, local,

2 and tribal health departments, shall develop guidelines for

3 subsections (a) and (b).

4 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

5 are authorized to be appropriated to carry out this section,

6 such sums for each of fiscal years 2007 through 2011.

7 ‘‘(f) REPORT TO CONGRESS.—As part of the National

8 Health Security Strategy described in section 2802, the

9 Secretary shall provide an update on the implementation

10 of subsections (a) through (d).’’.

11 (b) CONFORMING AMENDMENTS.—

12 (1) IN GENERAL.—Title III of the Public

13 Health Service Act (42 U.S.C. 241 et seq.) is

14 amended by striking sections 319B and 319C.

15 (2) TECHNICAL AMENDMENT.—Section

16 319D(a)(3) of the Public Health Service Act (42

17 U.S.C. 247d–4(a)(3)) is amended by striking ‘‘, tak18 ing into account evaluations under section

19 319B(a),’’.

20 SEC. 205. NATIONAL SCIENCE ADVISORY BOARD FOR BIO21 SECURITY.

22 The National Science Advisory Board for Biosecurity

23 shall, when requested by the Secretary of Health and

24 Human Services, provide to relevant Federal departments
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1 and agencies, advice, guidance, or recommendations

2 concerning—

3 (1) a core curriculum and training requirements

4 for workers in maximum containment biological lab5 oratories; and

6 (2) periodic evaluations of maximum contain7 ment biological laboratory capacity nationwide and

8 assessments of the future need for increased labora9 tory capacity.

10 SEC. 206. REVITALIZATION OF COMMISSIONED CORPS.

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

12 improve the force management and readiness of the Com13 missioned Corps to accomplish the following objectives:

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

15 rapidly to urgent or emergency public health care

16 needs and challenges.

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

18 assignments that address clinical and public health

19 needs in isolated, hardship, and hazardous duty po20 sitions, and, when required, to address needs related

21 to the well-being, security, and defense of the United

22 States.

23 (3) To establish the Corps as a resource avail24 able to Federal and State Government agencies for
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1 assistance in meeting public health leadership and

2 service roles.

3 (b) COMMISSIONED CORPS READINESS.—Title II of

4 the Public Health Service Act (42 U.S.C. 202 et seq.) is

5 amended by inserting after section 203 the following:

6 ‘‘SEC. 203A. DEPLOYMENT READINESS.

7 ‘‘(a) READINESS REQUIREMENTS FOR COMMIS8 SIONED CORPS OFFICERS.—

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

10 to members of the following Corps components, shall

11 establish requirements, including training and med12 ical examinations, to ensure the readiness of such

13 components to respond to urgent or emergency pub14 lic health care needs that cannot otherwise be met

15 at the Federal, State, and local levels:

16 ‘‘(A) Active duty Regular Corps.

17 ‘‘(B) Active Reserves.

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

19 Secretary shall annually determine whether each

20 member of the Corps meets the applicable readiness

21 requirements established under paragraph (1).

22 ‘‘(3) FAILURE TO MEET REQUIREMENTS.—A

23 member of the Corps who fails to meet or maintain

24 the readiness requirements established under para25 graph (1) or who fails to comply with orders to re-
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1 spond to an urgent or emergency public health care

2 need shall, except as provided in paragraph (4), in

3 accordance with procedures established by the Sec4 retary, be subject to disciplinary action as prescribed

5 by the Secretary.

6 ‘‘(4) WAIVER OF REQUIREMENTS.—

7 ‘‘(A) IN GENERAL.—The Secretary may

8 waive one or more of the requirements estab9 lished under paragraph (1) for an individual

10 who is not able to meet such requirements be11 cause of—

12 ‘‘(i) a disability;

13 ‘‘(ii) a temporary medical condition;

14 or

15 ‘‘(iii) any other extraordinary limita16 tion as determined by the Secretary.

17 ‘‘(B) REGULATIONS.—The Secretary shall

18 promulgate regulations under which a waiver

19 described in subparagraph (A) may be granted.

20 ‘‘(5) URGENT OR EMERGENCY PUBLIC HEALTH

21 CARE NEED.—For purposes of this section and sec22 tion 214, the term ‘urgent or emergency public

23 health care need’ means a health care need, as de24 termined by the Secretary, arising as the result of—
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1 ‘‘(A) a national emergency declared by the

2 President under the National Emergencies Act

3 (50 U.S.C. 1601 et seq.);

4 ‘‘(B) an emergency or major disaster de5 clared by the President under the Robert T.

6 Stafford Disaster Relief and Emergency Assist7 ance Act (42 U.S.C. 5121 et seq.);

8 ‘‘(C) a public health emergency declared by

9 the Secretary under section 319 of this Act; or

10 ‘‘(D) any emergency that, in the judgment

11 of the Secretary, is appropriate for the deploy12 ment of members of the Corps.

13 ‘‘(b) CORPS MANAGEMENT FOR DEPLOYMENT.—The

14 Secretary shall—

15 ‘‘(1) organize members of the Corps into units

16 for rapid deployment by the Secretary to respond to

17 urgent or emergency public health care needs;

18 ‘‘(2) establish appropriate procedures for the

19 command and control of units or individual members

20 of the Corps that are deployed at the direction of the

21 President or the Secretary in response to an urgent

22 or emergency public health care need of national,

23 State or local significance;

24 ‘‘(3) ensure that members of the Corps are

25 trained, equipped and otherwise prepared to fulfill
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1 their public health and emergency response roles;

2 and

3 ‘‘(4) ensure that deployment planning takes

4 into account—

5 ‘‘(A) any deployment exemptions that may

6 be granted by the Secretary based on the

7 unique requirements of an agency and an indi8 vidual’s functional role in such agency; and

9 ‘‘(B) the nature of the urgent or emer10 gency public health care need.

11 ‘‘(c) DEPLOYMENT OF DETAILED OR ASSIGNED OF12 FICERS.—For purposes of pay, allowances, and benefits

13 of a Commissioned Corps officer who is detailed or as14 signed to a Federal entity, the deployment of such officer

15 by the Secretary in response to an urgent or emergency

16 public health care need shall be deemed to be an author17 ized activity of the Federal entity to which the officer is

18 detailed or assigned.’’.

19 (c) PERSONNEL DEPLOYMENT AUTHORITY.—

20 (1) PERSONNEL DETAILED.—Section 214 of

21 the Public Health Service Act (42 U.S.C. 215) is

22 amended by adding at the end the following:

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

24 Guard and the Department of Defense, and except as pro25 vided in agreements negotiated with officials at agencies
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1 where officers of the Commissioned Corps may be as2 signed, the Secretary shall have the sole authority to de3 ploy any Commissioned Corps officer assigned under this

4 section to an entity outside of the Department of Health

5 and Human Services for service under the Secretary’s di6 rection in response to an urgent or emergency public

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

8 (2) NATIONAL HEALTH SERVICE CORPS.—Sec9 tion 331(f) of the Public Health Service Act (42

10 U.S.C. 254d(f)(1)) is amended by inserting before

11 the period the following: ‘‘, except when such mem12 bers are Commissioned Corps officers who entered

13 into a contract with Secretary under section 338A or

14 338B after December 31, 2006 and when the Sec15 retary determines that exercising the authority pro16 vided under section 214 or 216 with respect to any

17 such officer to would not cause unreasonable disrup18 tion to health care services provided in the commu19 nity in which such officer is providing health care

20 services’’.

21 TITLE III—ALL-HAZARDS

22 MEDICAL SURGE CAPACITY

23 SEC. 301. NATIONAL DISASTER MEDICAL SYSTEM.

24 (a) NATIONAL DISASTER MEDICAL SYSTEM.—Sec25 tion 2812 of subtitle B of title XXVIII of the Public
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1 Health Service Act (42 U.S.C. 300hh–11 et seq.), as re2 designated by section 102, is amended—

3 (1) by striking the section heading and insert4 ing ‘‘NATIONAL DISASTER MEDICAL SYSTEM’’;

5 (2) by striking subsection (a);

6 (3) by redesignating subsections (b) through (h)

7 as subsections (a) through (g);

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

9 (A) in paragraph (2)(B), by striking ‘‘Fed10 eral Emergency Management Agency’’ and in11 serting ‘‘Department of Homeland Security’’;

12 and

13 (B) in paragraph (3)(C), by striking ‘‘Pub14 lic Health Security and Bioterrorism Prepared15 ness and Response Act of 2002’’ and inserting

16 ‘‘Pandemic and All-Hazards Preparedness Act’’;

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

18 (A) striking the subsection heading and in19 serting ‘‘MODIFICATIONS’’;

20 (B) redesignating paragraph (2) as para21 graph (3); and

22 (C) striking paragraph (1) and inserting

23 the following:

24 ‘‘(1) IN GENERAL.—Taking into account the

25 findings from the joint review described under para-
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1 graph (2), the Secretary shall modify the policies of

2 the National Disaster Medical System as necessary.

3 ‘‘(2) JOINT REVIEW AND MEDICAL SURGE CA4 PACITY STRATEGIC PLAN.—Not later than 180 days

5 after the date of enactment of the Pandemic and

6 All-Hazards Preparedness Act, the Secretary, in co7 ordination with the Secretary of Homeland Security,

8 the Secretary of Defense, and the Secretary of Vet9 erans Affairs, shall conduct a joint review of the Na10 tional Disaster Medical System. Such review shall

11 include an evaluation of medical surge capacity, as

12 described by section 2803(a). As part of the Na13 tional Health Security Strategy under section 2802,

14 the Secretary shall update the findings from such re15 view and further modify the policies of the National

16 Disaster Medical System as necessary.’’;

17 (6) by striking ‘‘subsection (b)’’ each place it

18 appears and inserting ‘‘subsection (a)’’;

19 (7) by striking ‘‘subsection (d)’’ each place it

20 appears and inserting ‘‘subsection (c)’’; and

21 (8) in subsection (g), as so redesignated, by

22 striking ‘‘2002 through 2006’’ and inserting ‘‘2007

23 through 2011’’.

24 (b) TRANSFER OF NATIONAL DISASTER MEDICAL

25 SYSTEM TO THE DEPARTMENT OF HEALTH AND HUMAN
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1 SERVICES.—There shall be transferred to the Secretary

2 of Health and Human Services the functions, personnel,

3 assets, and liabilities of the National Disaster Medical

4 System of the Department of Homeland Security, includ5 ing the functions of the Secretary of Homeland Security

6 and the Under Secretary for Emergency Preparedness and

7 Response relating thereto.

8 (c) CONFORMING AMENDMENTS TO THE HOMELAND

9 SECURITY ACT OF 2002.—The Homeland Security Act of

10 2002 (6 U.S.C. 312(3)(B), 313(5))) is amended—

11 (1) in section 502(3)(B), by striking ‘‘, the Na12 tional Disaster Medical System,’’; and

13 (2) in section 503(5), by striking ‘‘, the Na14 tional Disaster Medical System’’.

15 (d) UPDATE OF CERTAIN PROVISION.—Section

16 319F(b)(2) of the Public Health Service Act (42 U.S.C.

17 247d–6(b)(2)) is amended—

18 (1) in the paragraph heading, by striking

19 ‘‘CHILDREN AND TERRORISM’’ and inserting ‘‘AT20 RISK INDIVIDUALS AND PUBLIC HEALTH EMER21 GENCIES’’;

22 (2) in subparagraph (A), by striking ‘‘Children

23 and Terrorism’’ and inserting ‘‘At-Risk Individuals

24 and Public Health Emergencies’’;

25 (3) in subparagraph (B)—
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1 (A) in clause (i), by striking ‘‘bioterrorism

2 as it relates to children’’ and inserting ‘‘public

3 health emergencies as they relate to at-risk in4 dividuals’’;

5 (B) in clause (ii), by striking ‘‘children’’

6 and inserting ‘‘at-risk individuals’’; and

7 (C) in clause (iii), by striking ‘‘children’’

8 and inserting ‘‘at-risk individuals’’;

9 (4) in subparagraph (C), by striking ‘‘children’’

10 and all that follows through the period and inserting

11 ‘‘at-risk populations.’’; and

12 (5) in subparagraph (D), by striking ‘‘one

13 year’’ and inserting ‘‘six years’’.

14 (e) CONFORMING AMENDMENT.—Section

15 319F(b)(3)(B) of the Public Health Service Act (42

16 U.S.C. 247d–6(b)(3)(B)) is amended by striking ‘‘and the

17 working group under subsection (a)’’.

18 (f) EFFECTIVE DATE.—The amendments made by

19 subsections (b) and (c) shall take effect on January 1,

20 2007.

21 SEC. 302. ENHANCING MEDICAL SURGE CAPACITY.

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

23 Service Act (300hh–11 et seq.), as amended by section

24 103, is amended by inserting after section 2802 the fol25 lowing:
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1 ‘‘SEC. 2803. ENHANCING MEDICAL SURGE CAPACITY.

2 ‘‘(a) STUDY OF ENHANCING MEDICAL SURGE CA3 PACITY.—As part of the joint review described in section

4 2812(b), the Secretary shall evaluate the benefits and fea5 sibility of improving the capacity of the Department of

6 Health and Human Services to provide additional medical

7 surge capacity to local communities in the event of a pub8 lic health emergency. Such study shall include an assess9 ment of the need for and feasibility of improving surge

10 capacity through—

11 ‘‘(1) acquisition and operation of mobile med12 ical assets by the Secretary to be deployed, on a con13 tingency basis, to a community in the event of a

14 public health emergency;

15 ‘‘(2) integrating the practice of telemedicine

16 within the National Disaster Medical System; and

17 ‘‘(3) other strategies to improve such capacity

18 as determined appropriate by the Secretary.

19 ‘‘(b) AUTHORITY TO ACQUIRE AND OPERATE MO20 BILE MEDICAL ASSETS.—In addition to any other author21 ity to acquire, deploy, and operate mobile medical assets,

22 the Secretary may acquire, deploy, and operate mobile

23 medical assets if, taking into consideration the evaluation

24 conducted under subsection (a), such acquisition, deploy25 ment, and operation is determined to be beneficial and fea26 sible in improving the capacity of the Department of
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1 Health and Human Services to provide additional medical

2 surge capacity to local communities in the event of a pub3 lic health emergency.

4 ‘‘(c) USING FEDERAL FACILITIES TO ENHANCE

5 MEDICAL SURGE CAPACITY.—

6 ‘‘(1) ANALYSIS.—The Secretary shall conduct

7 an analysis of whether there are Federal facilities

8 which, in the event of a public health emergency,

9 could practicably be used as facilities in which to

10 provide health care.

11 ‘‘(2) MEMORANDA OF UNDERSTANDING.—If,

12 based on the analysis conducted under paragraph

13 (1), the Secretary determines that there are Federal

14 facilities which, in the event of a public health emer15 gency, could be used as facilities in which to provide

16 health care, the Secretary shall, with respect to each

17 such facility, seek to conclude a memorandum of un18 derstanding with the head of the Department or

19 agency that operates such facility that permits the

20 use of such facility to provide health care in the

21 event of a public health emergency.’’.

22 (b) EMTALA.—

23 (1) IN GENERAL.—Section 1135(b) of the So24 cial Security Act (42 U.S.C. 1320b–5(b)) is

25 amended—
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1 (A) in paragraph (3), by striking subpara2 graph (B) and inserting the following:

3 ‘‘(B) the direction or relocation of an indi4 vidual to receive medical screening in an alter5 native location—

6 ‘‘(i) pursuant to an appropriate State

7 emergency preparedness plan; or

8 ‘‘(ii) in the case of a public health

9 emergency described in subsection

10 (g)(1)(B) that involves a pandemic infec11 tious disease, pursuant to a State pan12 demic preparedness plan or a plan referred

13 to in clause (i), whichever is applicable in

14 the State;’’;

15 (B) in the third sentence, by striking ‘‘and

16 shall be limited to’’ and inserting ‘‘and, except

17 in the case of a waiver or modification to which

18 the fifth sentence of this subsection applies,

19 shall be limited to’’; and

20 (C) by adding at the end the following: ‘‘If

21 a public health emergency described in sub22 section (g)(1)(B) involves a pandemic infectious

23 disease (such as pandemic influenza), the dura24 tion of a waiver or modification under para25 graph (3) shall be determined in accordance
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1 with subsection (e) as such subsection applies

2 to public health emergencies.’’.

3 (2) EFFECTIVE DATE.—The amendments made

4 by paragraph (1) shall take effect on the date of the

5 enactment of this Act and shall apply to public

6 health emergencies declared pursuant to section 319

7 of the Public Health Service Act (42 U.S.C. 247d)

8 on or after such date.

9 SEC. 303. ENCOURAGING HEALTH PROFESSIONAL VOLUN10 TEERS.

11 (a) VOLUNTEER MEDICAL RESERVE CORPS.—Title

12 XXVIII of the Public Health Service Act (42 U.S.C.

13 300hh–11 et seq.), as amended by this Act, is amended

14 by inserting after section 2812 the following:

15 ‘‘SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.

16 ‘‘(a) IN GENERAL.—Not later than 180 days after

17 the date of enactment of the Pandemic and All-Hazards

18 Preparedness Act, the Secretary, in collaboration with

19 State, local, and tribal officials, shall build on State, local,

20 and tribal programs in existence on the date of enactment

21 of such Act to establish and maintain a Medical Reserve

22 Corps (referred to in this section as the ‘Corps’) to provide

23 for an adequate supply of volunteers in the case of a Fed24 eral, State, local, or tribal public health emergency. The

25 Corps shall be headed by a Director who shall be ap-
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1 pointed by the Secretary and shall oversee the activities

2 of the Corps chapters that exist at the State, local, and

3 tribal levels.

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

5 The Corps shall be established using existing State, local,

6 and tribal teams and shall not alter such teams.

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

8 individuals who—

9 ‘‘(1)(A) are health professionals who have ap10 propriate professional training and expertise as de11 termined appropriate by the Director of the Corps;

12 or

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

14 interest in serving in an auxiliary or support capac15 ity to facilitate access to health care services in a

16 public health emergency;

17 ‘‘(2) are certified in accordance with the certifi18 cation program developed under subsection (d);

19 ‘‘(3) are geographically diverse in residence;

20 ‘‘(4) have registered and carry out training ex21 ercises with a local chapter of the Medical Reserve

22 Corps; and

23 ‘‘(5) indicate whether they are willing to be de24 ployed outside the area in which they reside in the

25 event of a public health emergency.
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1 ‘‘(d) CERTIFICATION; DRILLS.—

2 ‘‘(1) CERTIFICATION.—The Director, in collabo3 ration with State, local, and tribal officials, shall es4 tablish a process for the periodic certification of in5 dividuals who volunteer for the Corps, as determined

6 by the Secretary, which shall include the completion

7 by each individual of the core training programs de8 veloped under section 319F, as required by the Di9 rector. Such certification shall not supercede State

10 licensing or credentialing requirements.

11 ‘‘(2) DRILLS.—In conjunction with the core

12 training programs referred to in paragraph (1), and

13 in order to facilitate the integration of trained volun14 teers into the health care system at the local level,

15 Corps members shall engage in periodic training ex16 ercises to be carried out at the local level.

17 ‘‘(e) DEPLOYMENT.—During a public health emer18 gency, the Secretary shall have the authority to activate

19 and deploy willing members of the Corps to areas of need,

20 taking into consideration the public health and medical ex21 pertise required, with the concurrence of the State, local,

22 or tribal officials from the area where the members reside.

23 ‘‘(f) EXPENSES AND TRANSPORTATION.—While en24 gaged in performing duties as a member of the Corps pur25 suant to an assignment by the Secretary (including peri-
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1 ods of travel to facilitate such assignment), members of

2 the Corps who are not otherwise employed by the Federal

3 Government shall be allowed travel or transportation ex4 penses, including per diem in lieu of subsistence.

5 ‘‘(g) IDENTIFICATION.—The Secretary, in coopera6 tion and consultation with the States, shall develop a Med7 ical Reserve Corps Identification Card that describes the

8 licensure and certification information of Corps members,

9 as well as other identifying information determined nec10 essary by the Secretary.

11 ‘‘(h) INTERMITTENT DISASTER-RESPONSE PER12 SONNEL.—

13 ‘‘(1) IN GENERAL.—For the purpose of assist14 ing the Corps in carrying out duties under this sec15 tion, during a public health emergency, the Sec16 retary may appoint selected individuals to serve as

17 intermittent personnel of such Corps in accordance

18 with applicable civil service laws and regulations. In

19 all other cases, members of the Corps are subject to

20 the laws of the State in which the activities of the

21 Corps are undertaken.

22 ‘‘(2) APPLICABLE PROTECTIONS.—Subsections

23 (c)(2), (d), and (e) of section 2812 shall apply to an

24 individual appointed under paragraph (1) in the
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1 same manner as such subsections apply to an indi2 vidual appointed under section 2812(c).

3 ‘‘(3) LIMITATION.—State, local, and tribal offi4 cials shall have no authority to designate a member

5 of the Corps as Federal intermittent disaster-re6 sponse personnel, but may request the services of

7 such members.

8 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There is

9 authorized to be appropriated to carry out this section,

10 $22,000,000 for fiscal year 2007, and such sums as may

11 be necessary for each of fiscal years 2008 through 2011.’’.

12 (b) ENCOURAGING HEALTH PROFESSIONS VOLUN13 TEERS.—Section 319I of the Public Health Service Act

14 (42 U.S.C. 247d–7b) is amended—

15 (1) by redesignating subsections (e) and (f) as

16 subsections (j) and (k), respectively;

17 (2) by striking subsections (a) and (b) and in18 serting the following:

19 ‘‘(a) IN GENERAL.—Not later than 12 months after

20 the date of enactment of the Pandemic and All-Hazards

21 Preparedness Act, the Secretary shall link existing State

22 verification systems to maintain a single national inter23 operable network of systems, each system being main24 tained by a State or group of States, for the purpose of

25 verifying the credentials and licenses of health care profes-
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1 sionals who volunteer to provide health services during a

2 public health emergency.

3 ‘‘(b) REQUIREMENTS.—The interoperable network of

4 systems established under subsection (a) (referred to in

5 this section as the ‘verification network’) shall include—

6 ‘‘(1) with respect to each volunteer health pro7 fessional included in the verification network—

8 ‘‘(A) information necessary for the rapid

9 identification of, and communication with, such

10 professionals; and

11 ‘‘(B) the credentials, certifications, li12 censes, and relevant training of such individ13 uals; and

14 ‘‘(2) the name of each member of the Medical

15 Reserve Corps, the National Disaster Medical Sys16 tem, and any other relevant federally-sponsored or

17 administered programs determined necessary by the

18 Secretary.’’;

19 (3) in subsection (c), strike ‘‘system’’ and insert

20 ‘‘network’’; and

21 (4) by striking subsection (d) and inserting the

22 following:

23 ‘‘(d) ACCESSIBILITY.—The Secretary shall ensure

24 that the verification network is electronically accessible by
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1 State, local, and tribal health departments and can be

2 linked with the identification cards under section 2813.

3 ‘‘(e) CONFIDENTIALITY.—The Secretary shall estab4 lish and require the application of and compliance with

5 measures to ensure the effective security of, integrity of,

6 and access to the data included in the verification network.

7 ‘‘(f) COORDINATION.—The Secretary shall coordinate

8 with the Secretary of Veterans Affairs and the Secretary

9 of Homeland Security to assess the feasibility of inte10 grating the verification network under this section with

11 the VetPro system of the Department of Veterans Affairs

12 and the National Emergency Responder Credentialing

13 System of the Department of Homeland Security. The

14 Secretary shall, if feasible, integrate the verification net15 work under this section with such VetPro system and the

16 National Emergency Responder Credentialing System.

17 ‘‘(g) UPDATING OF INFORMATION.—The States that

18 are participants in the verification network shall, on at

19 least a quarterly basis, work with the Director to provide

20 for the updating of the information contained in the

21 verification network.

22 ‘‘(h) CLARIFICATION.—Inclusion of a health profes23 sional in the verification network shall not constitute ap24 pointment of such individual as a Federal employee for

25 any purpose, either under section 2812(c) or otherwise.
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1 Such appointment may only be made under section 2812

2 or 2813.

3 ‘‘(i) HEALTH CARE PROVIDER LICENSES.—The Sec4 retary shall encourage States to establish and implement

5 mechanisms to waive the application of licensing require6 ments applicable to health professionals, who are seeking

7 to provide medical services (within their scope of practice),

8 during a national, State, local, or tribal public health

9 emergency upon verification that such health professionals

10 are licensed and in good standing in another State and

11 have not been disciplined by any State health licensing or

12 disciplinary board.’’; and

13 (5) in subsection (k) (as so redesignated), by

14 striking ‘‘2006’’ and inserting ‘‘2011’’.

15 SEC. 304. CORE EDUCATION AND TRAINING.

16 Section 319F of the Public Health Service Act (42

17 U.S.C. 247d–6) is amended—

18 (1) by striking subsection (a) and inserting the

19 following;

20 ‘‘(a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

21 RESPONSE CURRICULA AND TRAINING.—

22 ‘‘(1) IN GENERAL.—The Secretary, in collabo23 ration with the Secretary of Defense, and in con24 sultation with relevant public and private entities,

25 shall develop core health and medical response cur-
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1 ricula and trainings by adapting applicable existing

2 curricula and training programs to improve re3 sponses to public health emergencies.

4 ‘‘(2) CURRICULUM.—The public health and

5 medical response training program may include

6 course work related to—

7 ‘‘(A) medical management of casualties,

8 taking into account the needs of at-risk individ9 uals;

10 ‘‘(B) public health aspects of public health

11 emergencies;

12 ‘‘(C) mental health aspects of public health

13 emergencies;

14 ‘‘(D) national incident management, in15 cluding coordination among Federal, State,

16 local, tribal, international agencies, and other

17 entities; and

18 ‘‘(E) protecting health care workers and

19 health care first responders from workplace ex20 posures during a public health emergency.

21 ‘‘(3) PEER REVIEW.—On a periodic basis, prod22 ucts prepared as part of the program shall be rigor23 ously tested and peer-reviewed by experts in the rel24 evant fields.
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1 ‘‘(4) CREDIT.—The Secretary and the Sec2 retary of Defense shall—

3 ‘‘(A) take into account continuing profes4 sional education requirements of public health

5 and healthcare professions; and

6 ‘‘(B) cooperate with State, local, and tribal

7 accrediting agencies and with professional asso8 ciations in arranging for students enrolled in

9 the program to obtain continuing professional

10 education credit for program courses.

11 ‘‘(5) DISSEMINATION AND TRAINING.—

12 ‘‘(A) IN GENERAL.—The Secretary may

13 provide for the dissemination and teaching of

14 the materials described in paragraphs (1) and

15 (2) by appropriate means, as determined by the

16 Secretary.

17 ‘‘(B) CERTAIN ENTITIES.—The education

18 and training activities described in subpara19 graph (A) may be carried out by Federal public

20 health or medical entities, appropriate edu21 cational entities, professional organizations and

22 societies, private accrediting organizations, and

23 other nonprofit institutions or entities meeting

24 criteria established by the Secretary.
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1 ‘‘(C) GRANTS AND CONTRACTS.—In car2 rying out this subsection, the Secretary may

3 carry out activities directly or through the

4 award of grants and contracts, and may enter

5 into interagency agreements with other Federal

6 agencies.’’.

7 (2) by striking subsections (c) through (g) and

8 inserting the following:

9 ‘‘(c) EXPANSION OF EPIDEMIC INTELLIGENCE SERV10 ICE PROGRAM.—The Secretary may establish 20 officer

11 positions in the Epidemic Intelligence Service Program, in

12 addition to the number of the officer positions offered

13 under such Program in 2006, for individuals who agree

14 to participate, for a period of not less than 2 years, in

15 the Career Epidemiology Field Officer program in a State,

16 local, or tribal health department that serves a health pro17 fessional shortage area (as defined under section 332(a)),

18 a medically underserved population (as defined under sec19 tion 330(b)(3)), or a medically underserved area or area

20 at high risk of a public health emergency as designated

21 by the Secretary.

22 ‘‘(d) CENTERS FOR PUBLIC HEALTH PREPARED23 NESS; CORE CURRICULA AND TRAINING.—

24 ‘‘(1) IN GENERAL.—The Secretary may estab25 lish at accredited schools of public health, Centers
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1 for Public Health Preparedness (hereafter referred

2 to in this section as the ‘Centers’).

3 ‘‘(2) ELIGIBILITY.—To be eligible to receive an

4 award under this subsection to establish a Center,

5 an accredited school of public health shall agree to

6 conduct activities consistent with the requirements

7 of this subsection.

8 ‘‘(3) CORE CURRICULA.—The Secretary, in col9 laboration with the Centers and other public or pri10 vate entities shall establish core curricula based on

11 established competencies leading to a 4-year bach12 elor’s degree, a graduate degree, a combined bach13 elor and master’s degree, or a certificate program,

14 for use by each Center. The Secretary shall dissemi15 nate such curricula to other accredited schools of

16 public health and other health professions schools

17 determined appropriate by the Secretary, for vol18 untary use by such schools.

19 ‘‘(4) CORE COMPETENCY-BASED TRAINING PRO20 GRAM.—The Secretary, in collaboration with the

21 Centers and other public or private entities shall fa22 cilitate the development of a competency-based train23 ing program to train public health practitioners. The

24 Centers shall use such training program to train

25 public health practitioners. The Secretary shall dis-
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1 seminate such training program to other accredited

2 schools of public health, health professions schools,

3 and other public or private entities as determined by

4 the Secretary, for voluntary use by such entities.

5 ‘‘(5) CONTENT OF CORE CURRICULA AND

6 TRAINING PROGRAM.—The Secretary shall ensure

7 that the core curricula and training program estab8 lished pursuant to this subsection respond to the

9 needs of State, local, and tribal public health au10 thorities and integrate and emphasize essential pub11 lic health security capabilities consistent with section

12 2802(b)(2).

13 ‘‘(6) ACADEMIC-WORKFORCE COMMUNICA14 TION.—As a condition of receiving funding from the

15 Secretary under this subsection, a Center shall col16 laborate with a State, local, or tribal public health

17 department to—

18 ‘‘(A) define the public health preparedness

19 and response needs of the community involved;

20 ‘‘(B) assess the extent to which such needs

21 are fulfilled by existing preparedness and re22 sponse activities of such school or health de23 partment, and how such activities may be im24 proved;
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1 ‘‘(C) prior to developing new materials or

2 trainings, evaluate and utilize relevant materials

3 and trainings developed by others Centers; and

4 ‘‘(D) evaluate community impact and the

5 effectiveness of any newly developed materials

6 or trainings.

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

8 consultation with relevant public and private enti9 ties, the Secretary shall define the existing knowl10 edge base for public health preparedness and re11 sponse systems, and establish a research agenda

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

13 health preparedness priorities. As a condition of re14 ceiving funding from the Secretary under this sub15 section, a Center shall conduct public health systems

16 research that is consistent with the agenda described

17 under this paragraph.’’;

18 (3) by redesignating subsection (h) as sub19 section (e);

20 (4) by inserting after subsection (e) (as so re21 designated), the following:

22 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

23 ‘‘(1) FISCAL YEAR 2007.—There are authorized

24 to be appropriated to carry out this section for fiscal

25 year 2007—
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1 ‘‘(A) to carry out subsection (a)—

2 ‘‘(i) $5,000,000 to carry out para3 graphs (1) through (4); and

4 ‘‘(ii) $7,000,000 to carry out para5 graph (5);

6 ‘‘(B) to carry out subsection (c),

7 $3,000,000; and

8 ‘‘(C) to carry out subsection (d),

9 $31,000,000, of which $5,000,000 shall be used

10 to carry out paragraphs (3) through (5) of such

11 subsection.

12 ‘‘(2) SUBSEQUENT FISCAL YEARS.—There are

13 authorized to be appropriated such sums as may be

14 necessary to carry out this section for fiscal year

15 2008 and each subsequent fiscal year.’’; and

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

17 SEC. 305. PARTNERSHIPS FOR STATE AND REGIONAL HOS18 PITAL PREPAREDNESS TO IMPROVE SURGE

19 CAPACITY.

20 Section 319C–2 of the Public Health Service Act (42

21 U.S.C. 247d–3b) is amended to read as follows:
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1 ‘‘SEC. 319C–2. PARTNERSHIPS FOR STATE AND REGIONAL

2 HOSPITAL PREPAREDNESS TO IMPROVE

3 SURGE CAPACITY.

4 ‘‘(a) IN GENERAL.—The Secretary shall award com5 petitive grants or cooperative agreements to eligible enti6 ties to enable such entities to improve surge capacity and

7 enhance community and hospital preparedness for public

8 health emergencies.

9 ‘‘(b) ELIGIBILITY.—To be eligible for an award under

10 subsection (a), an entity shall—

11 ‘‘(1)(A) be a partnership consisting of—

12 ‘‘(i) one or more hospitals, at least one of

13 which shall be a designated trauma center, con14 sistent with section 1213(c);

15 ‘‘(ii) one or more other local health care

16 facilities, including clinics, health centers, pri17 mary care facilities, mental health centers, mo18 bile medical assets, or nursing homes; and

19 ‘‘(iii)(I) one or more political subdivisions;

20 ‘‘(II) one or more States; or

21 ‘‘(III) one or more States and one or more

22 political subdivisions; and

23 ‘‘(B) prepare, in consultation with the Chief

24 Executive Officer and the lead health officials of the

25 State, District, or territory in which the hospital and

26 health care facilities described in subparagraph (A)
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1 are located, and submit to the Secretary, an applica2 tion at such time, in such manner, and containing

3 such information as the Secretary may require; or

4 ‘‘(2)(A) be an entity described in section 319C–

5 1(b)(1); and

6 ‘‘(B) submit an application at such time, in

7 such manner, and containing such information as

8 the Secretary may require, including the information

9 or assurances required under section 319C–1(b)(2)

10 and an assurance that the State will adhere to any

11 applicable guidelines established by the Secretary.

12 ‘‘(c) USE OF FUNDS.—An award under subsection

13 (a) shall be expended for activities to achieve the prepared14 ness goals described under paragraphs (1), (3), (4), (5),

15 and (6) of section 2802(b).

16 ‘‘(d) PREFERENCES.—

17 ‘‘(1) REGIONAL COORDINATION.—In making

18 awards under subsection (a), the Secretary shall give

19 preference to eligible entities that submit applica20 tions that, in the determination of the Secretary—

21 ‘‘(A) will enhance coordination—

22 ‘‘(i) among the entities described in

23 subsection (b)(1)(A)(i); and
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1 ‘‘(ii) between such entities and the en2 tities described in subsection (b)(1)(A)(ii);

3 and

4 ‘‘(B) include, in the partnership described

5 in subsection (b)(1)(A), a significant percentage

6 of the hospitals and health care facilities within

7 the geographic area served by such partnership.

8 ‘‘(2) OTHER PREFERENCES.—In making

9 awards under subsection (a), the Secretary shall give

10 preference to eligible entities that, in the determina11 tion of the Secretary—

12 ‘‘(A) include one or more hospitals that are

13 participants in the National Disaster Medical

14 System;

15 ‘‘(B) are located in a geographic area that

16 faces a high degree of risk, as determined by

17 the Secretary in consultation with the Secretary

18 of Homeland Security; or

19 ‘‘(C) have a significant need for funds to

20 achieve the medical preparedness goals de21 scribed in section 2802(b)(3).

22 ‘‘(e) CONSISTENCY OF PLANNED ACTIVITIES.—The

23 Secretary may not award a cooperative agreement to an

24 eligible entity described in subsection (b)(1) unless the ap25 plication submitted by the entity is coordinated and con-
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1 sistent with an applicable State All-Hazards Public Health

2 Emergency Preparedness and Response Plan and relevant

3 local plans, as determined by the Secretary in consultation

4 with relevant State health officials..

5 ‘‘(f) LIMITATION ON AWARDS.—A political subdivi6 sion shall not participate in more than one partnership

7 described in subsection (b)(1).

8 ‘‘(g) COORDINATION WITH LOCAL RESPONSE CAPA9 BILITIES.—An eligible entity shall, to the extent prac10 ticable, ensure that activities carried out under an award

11 under subsection (a) are coordinated with activities of rel12 evant local Metropolitan Medical Response Systems, local

13 Medical Reserve Corps, the Cities Readiness Initiative,

14 and local emergency plans.

15 ‘‘(h) MAINTENANCE OF FUNDING.—

16 ‘‘(1) IN GENERAL.—An entity that receives an

17 award under this section shall maintain expenditures

18 for health care preparedness at a level that is not

19 less than the average level of such expenditures

20 maintained by the entity for the preceding 2 year

21 period.

22 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in

23 this section shall be construed to prohibit the use of

24 awards under this section to pay salary and related

25 expenses of public health and other professionals
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1 employed by State, local, or tribal agencies who are

2 carrying out activities supported by such awards (re3 gardless of whether the primary assignment of such

4 personnel is to carry out such activities).

5 ‘‘(i) PERFORMANCE AND ACCOUNTABILITY.—The re6 quirements of section 319C–1(g), (j), and (k) shall apply

7 to entities receiving awards under this section (regardless

8 of whether such entities are described under subsection

9 (b)(1)(A) or (b)(2)(A)) in the same manner as such re10 quirements apply to entities under section 319C–1. An en11 tity described in subsection (b)(1)(A) shall make such re12 ports available to the lead health official of the State in

13 which such partnership is located.

14 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—

15 ‘‘(1) IN GENERAL.—For the purpose of car16 rying out this section, there is authorized to be ap17 propriated $474,000,000 for fiscal year 2007, and

18 such sums as may be necessary for each of fiscal

19 years 2008 through 2011.

20 ‘‘(2) RESERVATION OF AMOUNTS FOR PART21 NERSHIPS.—Prior to making awards described in

22 paragraph (3), the Secretary may reserve from the

23 amount appropriated under paragraph (1) for a fis24 cal year, an amount determined appropriate by the
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1 Secretary for making awards to entities described in

2 subsection (b)(1)(A).

3 ‘‘(3) AWARDS TO STATES AND POLITICAL SUB4 DIVISIONS.—

5 ‘‘(A) IN GENERAL.—From amounts appro6 priated for a fiscal year under paragraph (1)

7 and not reserved under paragraph (2), the Sec8 retary shall make awards to entities described

9 in subsection (b)(2)(A) that have completed an

10 application as described in subsection (b)(2)(B).

11 ‘‘(B) AMOUNT.—The Secretary shall deter12 mine the amount of an award to each entity de13 scribed in subparagraph (A) in the same man14 ner as such amounts are determined under sec15 tion 319C–1(h).’’.

16 SEC. 306. ENHANCING THE ROLE OF THE DEPARTMENT OF

17 VETERANS AFFAIRS.

18 (a) IN GENERAL.—Section 8117 of title 38, United

19 States Code, is amended—

20 (1) in subsection (a)—

21 (A) in paragraph (1), by—

22 (i) striking ‘‘chemical or biological at23 tack’’ and inserting ‘‘a public health emer24 gency (as defined in section 2801 of the

25 Public Health Service Act)’’;
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1 (ii) striking ‘‘an attack’’ and inserting

2 ‘‘such an emergency’’; and

3 (iii) striking ‘‘public health emer4 gencies’’ and inserting ‘‘such emergencies’’;

5 and

6 (B) in paragraph (2)—

7 (i) in subparagraph (A), by striking ‘‘;

8 and’’ and inserting a semicolon;

9 (ii) in subparagraph (B), by striking

10 the period and inserting a semicolon; and

11 (iii) by adding at the end the fol12 lowing:

13 ‘‘(C) organizing, training, and equipping

14 the staff of such centers to support the activi15 ties carried out by the Secretary of Health and

16 Human Services under section 2801 of the

17 Public Health Service Act in the event of a pub18 lic health emergency and incidents covered by

19 the National Response Plan developed pursuant

20 to section 502(6) of the Homeland Security Act

21 of 2002, or any successor plan; and

22 ‘‘(D) providing medical logistical support

23 to the National Disaster Medical System and

24 the Secretary of Health and Human Services as

25 necessary, on a reimbursable basis, and in co-
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1 ordination with other designated Federal agen2 cies.’’;

3 (2) in subsection (c), by striking ‘‘a chemical or

4 biological attack or other terrorist attack.’’ and in5 serting ‘‘a public health emergency. The Secretary

6 shall, through existing medical procurement con7 tracts, and on a reimbursable basis, make available

8 as necessary, medical supplies, equipment, and phar9 maceuticals in response to a public health emergency

10 in support of the Secretary of Health and Human

11 Services.’’;

12 (3) in subsection (d), by—

13 (A) striking ‘‘develop and’’;

14 (B) striking ‘‘biological, chemical, or radio15 logical attacks’’ and inserting ‘‘public health

16 emergencies’’; and

17 (C) by inserting ‘‘consistent with section

18 319F(a) of the Public Health Service Act’’ be19 fore the period; and

20 (4) in subsection (e)—

21 (A) in paragraph (1), by striking

22 ‘‘2811(b)’’ and inserting ‘‘2812’’; and

23 (B) in paragraph (2)—

24 (i) by striking ‘‘bioterrorism and

25 other’’; and
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1 (ii) by striking ‘‘319F(a)’’ and insert2 ing ‘‘319F’’.

3 (b) AUTHORIZATION OF APPROPRIATIONS.—Section

4 8117 of title 38, United States Code, is amended by add5 ing at the end the following:

6 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There

7 are authorized to be appropriated, such sums as may be

8 necessary to carry out this section for each of fiscal years

9 2007 through 2011.’’.

10 TITLE IV—PANDEMIC AND BIO11 DEFENSE VACCINE AND

12 DRUG DEVELOPMENT

13 SEC. 401. BIOMEDICAL ADVANCED RESEARCH AND DEVEL14 OPMENT AUTHORITY.

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

16 241 et seq.) is amended by inserting after section 319K

17 the following:

18 ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE19 VELOPMENT AUTHORITY.

20 ‘‘(a) DEFINITIONS.—In this section:

21 ‘‘(1) BARDA.—The term ‘BARDA’ means the

22 Biomedical Advanced Research and Development

23 Authority.
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1 ‘‘(2) FUND.—The term ‘Fund’ means the Bio2 defense Medical Countermeasure Development Fund

3 established under subsection (d).

4 ‘‘(3) OTHER TRANSACTIONS.—The term ‘other

5 transactions’ means transactions, other than pro6 curement contracts, grants, and cooperative agree7 ments, such as the Secretary of Defense may enter

8 into under section 2371 of title 10, United States

9 Code.

10 ‘‘(4) QUALIFIED COUNTERMEASURE.—The term

11 ‘qualified countermeasure’ has the meaning given

12 such term in section 319F–1.

13 ‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PROD14 UCT.—The term ‘qualified pandemic or epidemic

15 product’ has the meaning given the term in section

16 319F–3.

17 ‘‘(6) ADVANCED RESEARCH AND DEVELOP18 MENT.—

19 ‘‘(A) IN GENERAL.—The term ‘advanced

20 research and development’ means, with respect

21 to a product that is or may become a qualified

22 countermeasure or a qualified pandemic or epi23 demic product, activities that predominantly—
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1 ‘‘(i) are conducted after basic research

2 and preclinical development of the product;

3 and

4 ‘‘(ii) are related to manufacturing the

5 product on a commercial scale and in a

6 form that satisfies the regulatory require7 ments under the Federal Food, Drug, and

8 Cosmetic Act or under section 351 of this

9 Act.

10 ‘‘(B) ACTIVITIES INCLUDED.—The term

11 under subparagraph (A) includes—

12 ‘‘(i) testing of the product to deter13 mine whether the product may be ap14 proved, cleared, or licensed under the Fed15 eral Food, Drug, and Cosmetic Act or

16 under section 351 of this Act for a use

17 that is or may be the basis for such prod18 uct becoming a qualified countermeasure

19 or qualified pandemic or epidemic product,

20 or to help obtain such approval, clearance,

21 or license;

22 ‘‘(ii) design and development of tests

23 or models, including animal models, for

24 such testing;
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1 ‘‘(iii) activities to facilitate manufac2 ture of the product on a commercial scale

3 with consistently high quality, as well as to

4 improve and make available new tech5 nologies to increase manufacturing surge

6 capacity;

7 ‘‘(iv) activities to improve the shelf-life

8 of the product or technologies for admin9 istering the product; and

10 ‘‘(v) such other activities as are part

11 of the advanced stages of testing, refine12 ment, improvement, or preparation of the

13 product for such use and as are specified

14 by the Secretary.

15 ‘‘(7) SECURITY COUNTERMEASURE.—The term

16 ‘security countermeasure’ has the meaning given

17 such term in section 319F–2.

18 ‘‘(8) RESEARCH TOOL.—The term ‘research

19 tool’ means a device, technology, biological material

20 (including a cell line or an antibody), reagent, ani21 mal model, computer system, computer software, or

22 analytical technique that is developed to assist in the

23 discovery, development, or manufacture of qualified

24 countermeasures or qualified pandemic or epidemic

25 products.
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1 ‘‘(9) PROGRAM MANAGER.—The term ‘program

2 manager’ means an individual appointed to carry out

3 functions under this section and authorized to pro4 vide project oversight and management of strategic

5 initiatives.

6 ‘‘(10) PERSON.—The term ‘person’ includes an

7 individual, partnership, corporation, association, en8 tity, or public or private corporation, and a Federal,

9 State, or local government agency or department.

10 ‘‘(b) STRATEGIC PLAN FOR COUNTERMEASURE RE11 SEARCH, DEVELOPMENT, AND PROCUREMENT.—

12 ‘‘(1) IN GENERAL.—Not later than 6 months

13 after the date of enactment of the Pandemic and

14 All-Hazards Preparedness Act, the Secretary shall

15 develop and make public a strategic plan to inte16 grate biodefense and emerging infectious disease re17 quirements with the advanced research and develop18 ment, strategic initiatives for innovation, and the

19 procurement of qualified countermeasures and quali20 fied pandemic or epidemic products. The Secretary

21 shall carry out such activities as may be practicable

22 to disseminate the information contained in such

23 plan to persons who may have the capacity to sub24 stantially contribute to the activities described in

25 such strategic plan. The Secretary shall update and
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1 incorporate such plan as part of the National Health

2 Security Strategy described in section 2802.

3 ‘‘(2) CONTENT.—The strategic plan under

4 paragraph (1) shall guide—

5 ‘‘(A) research and development, conducted

6 or supported by the Department of Health and

7 Human Services, of qualified countermeasures

8 and qualified pandemic or epidemic products

9 against possible biological, chemical, radio10 logical, and nuclear agents and to emerging in11 fectious diseases;

12 ‘‘(B) innovation in technologies that may

13 assist advanced research and development of

14 qualified countermeasures and qualified pan15 demic or epidemic products (such research and

16 development referred to in this section as ‘coun17 termeasure and product advanced research and

18 development’); and

19 ‘‘(C) procurement of such qualified coun20 termeasures and qualified pandemic or epidemic

21 products by such Department.

22 ‘‘(c) BIOMEDICAL ADVANCED RESEARCH AND DE23 VELOPMENT AUTHORITY.—

24 ‘‘(1) ESTABLISHMENT.—There is established

25 within the Department of Health and Human Serv-
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1 ices the Biomedical Advanced Research and Develop2 ment Authority.

3 ‘‘(2) IN GENERAL.—Based upon the strategic

4 plan described in subsection (b), the Secretary shall

5 coordinate the acceleration of countermeasure and

6 product advanced research and development by—

7 ‘‘(A) facilitating collaboration between the

8 Department of Health and Human Services and

9 other Federal agencies, relevant industries, aca10 demia, and other persons, with respect to such

11 advanced research and development;

12 ‘‘(B) promoting countermeasure and prod13 uct advanced research and development;

14 ‘‘(C) facilitating contacts between inter15 ested persons and the offices or employees au16 thorized by the Secretary to advise such persons

17 regarding requirements under the Federal

18 Food, Drug, and Cosmetic Act and under sec19 tion 351 of this Act; and

20 ‘‘(D) promoting innovation to reduce the

21 time and cost of countermeasure and product

22 advanced research and development.

23 ‘‘(3) DIRECTOR.—The BARDA shall be headed

24 by a Director (referred to in this section as the ‘Di25 rector’) who shall be appointed by the Secretary and
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1 to whom the Secretary shall delegate such functions

2 and authorities as necessary to implement this sec3 tion.

4 ‘‘(4) DUTIES.—

5 ‘‘(A) COLLABORATION.—To carry out the

6 purpose described in paragraph (2)(A), the Sec7 retary shall—

8 ‘‘(i) facilitate and increase the expedi9 tious and direct communication between

10 the Department of Health and Human

11 Services and relevant persons with respect

12 to countermeasure and product advanced

13 research and development, including by—

14 ‘‘(I) facilitating such communica15 tion regarding the processes for pro16 curing such advanced research and

17 development with respect to qualified

18 countermeasures and qualified pan19 demic or epidemic products of inter20 est; and

21 ‘‘(II) soliciting information about

22 and data from research on potential

23 qualified countermeasures and quali24 fied pandemic or epidemic products

25 and related technologies;
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1 ‘‘(ii) at least annually—

2 ‘‘(I) convene meetings with rep3 resentatives from relevant industries,

4 academia, other Federal agencies,

5 international agencies as appropriate,

6 and other interested persons;

7 ‘‘(II) sponsor opportunities to

8 demonstrate the operation and effec9 tiveness of relevant biodefense coun10 termeasure technologies; and

11 ‘‘(III) convene such working

12 groups on countermeasure and prod13 uct advanced research and develop14 ment as the Secretary may determine

15 are necessary to carry out this sec16 tion; and

17 ‘‘(iii) carry out the activities described

18 in section 405 of the Pandemic and All19 Hazards Preparedness Act.

20 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

21 DEVELOPMENT.—To carry out the purpose de22 scribed in paragraph (2)(B), the Secretary

23 shall—

24 ‘‘(i) conduct ongoing searches for, and

25 support calls for, potential qualified coun-
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1 termeasures and qualified pandemic or epi2 demic products;

3 ‘‘(ii) direct and coordinate the coun4 termeasure and product advanced research

5 and development activities of the Depart6 ment of Health and Human Services;

7 ‘‘(iii) establish strategic initiatives to

8 accelerate countermeasure and product ad9 vanced research and development and in10 novation in such areas as the Secretary

11 may identify as priority unmet need areas;

12 and

13 ‘‘(iv) award contracts, grants, cooper14 ative agreements, and enter into other

15 transactions, for countermeasure and prod16 uct advanced research and development.

17 ‘‘(C) FACILITATING ADVICE.—To carry out

18 the purpose described in paragraph (2)(C) the

19 Secretary shall—

20 ‘‘(i) connect interested persons with

21 the offices or employees authorized by the

22 Secretary to advise such persons regarding

23 the regulatory requirements under the

24 Federal Food, Drug, and Cosmetic Act

25 and under section 351 of this Act related
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1 to the approval, clearance, or licensure of

2 qualified countermeasures or qualified pan3 demic or epidemic products; and

4 ‘‘(ii) with respect to persons per5 forming countermeasure and product ad6 vanced research and development funded

7 under this section, enable such offices or

8 employees to provide to the extent prac9 ticable such advice in a manner that is on10 going and that is otherwise designed to fa11 cilitate expeditious development of quali12 fied countermeasures and qualified pan13 demic or epidemic products that may

14 achieve such approval, clearance, or licen15 sure.

16 ‘‘(D) SUPPORTING INNOVATION.—To carry

17 out the purpose described in paragraph (2)(D),

18 the Secretary may award contracts, grants, and

19 cooperative agreements, or enter into other

20 transactions, such as prize payments, to

21 promote—

22 ‘‘(i) innovation in technologies that

23 may assist countermeasure and product

24 advanced research and development;
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1 ‘‘(ii) research on and development of

2 research tools and other devices and tech3 nologies; and

4 ‘‘(iii) research to promote strategic

5 initiatives, such as rapid diagnostics, broad

6 spectrum antimicrobials, and vaccine man7 ufacturing technologies.

8 ‘‘(5) TRANSACTION AUTHORITIES.—

9 ‘‘(A) OTHER TRANSACTIONS.—

10 ‘‘(i) IN GENERAL.—The Secretary

11 shall have the authority to enter into other

12 transactions under this subsection in the

13 same manner as the Secretary of Defense

14 enters into such transactions under section

15 2371 of title 10, United States Code.

16 ‘‘(ii) LIMITATIONS ON AUTHORITY.—

17 ‘‘(I) IN GENERAL.—Subsections

18 (b), (c), and (h) of section 845 of the

19 National Defense Authorization Act

20 for Fiscal Year 1994 (10 U.S.C. 2371

21 note) shall apply to other transactions

22 under this subparagraph as if such

23 transactions were for prototype

24 projects described by subsection (a) of

25 such section 845.
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1 ‘‘(II) WRITTEN DETERMINATIONS

2 REQUIRED.—The authority of this

3 subparagraph may be exercised for a

4 project that is expected to cost the

5 Department of Health and Human

6 Services in excess of $20,000,000 only

7 upon a written determination by the

8 senior procurement executive for the

9 Department (as designated for pur10 pose of section 16(c) of the Office of

11 Federal Procurement Policy Act (41

12 U.S.C. 414(c))), that the use of such

13 authority is essential to promoting the

14 success of the project. The authority

15 of the senior procurement executive

16 under this subclause may not be dele17 gated.

18 ‘‘(iii) GUIDELINES.—The Secretary

19 shall establish guidelines regarding the use

20 of the authority under clause (i). Such

21 guidelines shall include auditing require22 ments.

23 ‘‘(B) EXPEDITED AUTHORITIES.—

24 ‘‘(i) IN GENERAL.—In awarding con25 tracts, grants, and cooperative agreements,
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1 and in entering into other transactions

2 under subparagraph (B) or (D) of para3 graph (4), the Secretary shall have the ex4 pedited procurement authorities, the au5 thority to expedite peer review, and the au6 thority for personal services contracts, sup7 plied by subsections (b), (c), and (d) of

8 section 319F–1.

9 ‘‘(ii) APPLICATION OF PROVISIONS.—

10 Provisions in such section 319F–1 that

11 apply to such authorities and that require

12 institution of internal controls, limit re13 view, provide for Federal Tort Claims Act

14 coverage of personal services contractors,

15 and commit decisions to the discretion of

16 the Secretary shall apply to the authorities

17 as exercised pursuant to this paragraph.

18 ‘‘(iii) AUTHORITY TO LIMIT COMPETI19 TION.—For purposes of applying section

20 319F–1(b)(1)(D) to this paragraph, the

21 phrase ‘BioShield Program under the

22 Project BioShield Act of 2004’ shall be

23 deemed to mean the countermeasure and

24 product advanced research and develop25 ment program under this section.
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1 ‘‘(iv) AVAILABILITY OF DATA.—The

2 Secretary shall require that, as a condition

3 of being awarded a contract, grant, cooper4 ative agreement, or other transaction

5 under subparagraph (B) or (D) of para6 graph (4), a person make available to the

7 Secretary on an ongoing basis, and submit

8 upon request to the Secretary, all data re9 lated to or resulting from countermeasure

10 and product advanced research and devel11 opment carried out pursuant to this sec12 tion.

13 ‘‘(C) ADVANCE PAYMENTS; ADVER14 TISING.—The Secretary may waive the require15 ments of section 3324(a) of title 31, United

16 States Code, or section 3709 of the Revised

17 Statutes of the United States (41 U.S.C. 5)

18 upon the determination by the Secretary that

19 such waiver is necessary to obtain counter20 measures or products under this section.

21 ‘‘(D) MILESTONE-BASED PAYMENTS AL22 LOWED.—In awarding contracts, grants, and

23 cooperative agreements, and in entering into

24 other transactions, under this section, the Sec-
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1 retary may use milestone-based awards and

2 payments.

3 ‘‘(E) FOREIGN NATIONALS ELIGIBLE.—

4 The Secretary may under this section award

5 contracts, grants, and cooperative agreements

6 to, and may enter into other transactions with,

7 highly qualified foreign national persons outside

8 the United States, alone or in collaboration with

9 American participants, when such transactions

10 may inure to the benefit of the American peo11 ple.

12 ‘‘(F) ESTABLISHMENT OF RESEARCH CEN13 TERS.—The Secretary may assess the feasibility

14 and appropriateness of establishing, through

15 contract, grant, cooperative agreement, or other

16 transaction, an arrangement with an existing

17 research center in order to achieve the goals of

18 this section. If such an agreement is not fea19 sible and appropriate, the Secretary may estab20 lish one or more federally-funded research and

21 development centers, or university-affiliated re22 search centers, in accordance with section

23 303(c)(3) of the Federal Property and Adminis24 trative Services Act of 1949 (41 U.S.C.

25 253(c)(3)).
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1 ‘‘(6) AT-RISK INDIVIDUALS.—In carrying out

2 the functions under this section, the Secretary may

3 give priority to the advanced research and develop4 ment of qualified countermeasures and qualified

5 pandemic or epidemic products that are likely to be

6 safe and effective with respect to children, pregnant

7 women, elderly, and other at-risk individuals.

8 ‘‘(7) PERSONNEL AUTHORITIES.—

9 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC

10 AND PROFESSIONAL PERSONNEL.—

11 ‘‘(i) IN GENERAL.—In addition to any

12 other personnel authorities, the Secretary

13 may—

14 ‘‘(I) without regard to those pro15 visions of title 5, United States Code,

16 governing appointments in the com17 petitive service, appoint highly quali18 fied individuals to scientific or profes19 sional positions in BARDA, such as

20 program managers, to carry out this

21 section; and

22 ‘‘(II) compensate them in the

23 same manner and subject to the same

24 terms and conditions in which individ25 uals appointed under section 9903 of
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1 such title are compensated, without

2 regard to the provisions of chapter 51

3 and subchapter III of chapter 53 of

4 such title relating to classification and

5 General Schedule pay rates.

6 ‘‘(ii) MANNER OF EXERCISE OF AU7 THORITY.—The authority provided for in

8 this subparagraph shall be exercised sub9 ject to the same limitations described in

10 section 319F–1(e)(2).

11 ‘‘(iii) TERM OF APPOINTMENT.—The

12 term limitations described in section

13 9903(c) of title 5, United States Code,

14 shall apply to appointments under this

15 subparagraph, except that the references

16 to the ‘Secretary’ and to the ‘Department

17 of Defense’s national security missions’

18 shall be deemed to be to the Secretary of

19 Health and Human Services and to the

20 mission of the Department of Health and

21 Human Services under this section.

22 ‘‘(B) SPECIAL CONSULTANTS.—In carrying

23 out this section, the Secretary may appoint spe24 cial consultants pursuant to section 207(f).

25 ‘‘(C) LIMITATION.—
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1 ‘‘(i) IN GENERAL.—The Secretary

2 may hire up to 100 highly qualified indi3 viduals, or up to 50 percent of the total

4 number of employees, whichever is less,

5 under the authorities provided for in sub6 paragraphs (A) and (B).

7 ‘‘(ii) REPORT.—The Secretary shall

8 report to Congress on a biennial basis on

9 the implementation of this subparagraph.

10 ‘‘(d) FUND.—

11 ‘‘(1) ESTABLISHMENT.—There is established

12 the Biodefense Medical Countermeasure Develop13 ment Fund, which shall be available to carry out this

14 section in addition to such amounts as are otherwise

15 available for this purpose.

16 ‘‘(2) FUNDING.—To carry out the purposes of

17 this section, there are authorized to be appropriated

18 to the Fund—

19 ‘‘(A) $1,070,000,000 for fiscal years 2006

20 through 2008, the amounts to remain available

21 until expended; and

22 ‘‘(B) such sums as may be necessary for

23 subsequent fiscal years, the amounts to remain

24 available until expended.

25 ‘‘(e) INAPPLICABILITY OF CERTAIN PROVISIONS.—
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1 ‘‘(1) DISCLOSURE.—

2 ‘‘(A) IN GENERAL.—The Secretary shall

3 withhold from disclosure under section 552 of

4 title 5, United States Code, specific technical

5 data or scientific information that is created or

6 obtained during the countermeasure and prod7 uct advanced research and development carried

8 out under subsection (c) that reveals significant

9 and not otherwise publicly known vulnerabilities

10 of existing medical or public health defenses

11 against biological, chemical, nuclear, or radio12 logical threats. Such information shall be

13 deemed to be information described in section

14 552(b)(3) of title 5, United States Code.

15 ‘‘(B) REVIEW.—Information subject to

16 nondisclosure under subparagraph (A) shall be

17 reviewed by the Secretary every 5 years, or

18 more frequently as determined necessary by the

19 Secretary, to determine the relevance or neces20 sity of continued nondisclosure.

21 ‘‘(C) SUNSET.—This paragraph shall cease

22 to have force or effect on the date that is 7

23 years after the date of enactment of the Pan24 demic and All-Hazards Preparedness Act.
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1 ‘‘(2) REVIEW.—Notwithstanding section 14 of

2 the Federal Advisory Committee Act, a working

3 group of BARDA under this section and the Na4 tional Biodefense Science Board under section 319M

5 shall each terminate on the date that is 5 years after

6 the date on which each such group or Board, as ap7 plicable, was established. Such 5-year period may be

8 extended by the Secretary for one or more additional

9 5-year periods if the Secretary determines that any

10 such extension is appropriate.’’.

11 SEC. 402. NATIONAL BIODEFENSE SCIENCE BOARD.

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

13 241 et seq.), as amended by section 401, is further amend14 ed by inserting after section 319L the following:

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

16 WORKING GROUPS.

17 ‘‘(a) IN GENERAL.—

18 ‘‘(1) ESTABLISHMENT AND FUNCTION.—The

19 Secretary shall establish the National Biodefense

20 Science Board (referred to in this section as the

21 ‘Board’) to provide expert advice and guidance to

22 the Secretary on scientific, technical and other mat23 ters of special interest to the Department of Health

24 and Human Services regarding current and future

25 chemical, biological, nuclear, and radiological agents,
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1 whether naturally occurring, accidental, or delib2 erate.

3 ‘‘(2) MEMBERSHIP.—The membership of the

4 Board shall be comprised of individuals who rep5 resent the Nation’s preeminent scientific, public

6 health, and medical experts, as follows—

7 ‘‘(A) such Federal officials as the Sec8 retary may determine are necessary to support

9 the functions of the Board;

10 ‘‘(B) four individuals representing the

11 pharmaceutical, biotechnology, and device in12 dustries;

13 ‘‘(C) four individuals representing aca14 demia; and

15 ‘‘(D) five other members as determined ap16 propriate by the Secretary, of whom—

17 ‘‘(i) one such member shall be a prac18 ticing healthcare professional; and

19 ‘‘(ii) one such member shall be an in20 dividual from an organization representing

21 healthcare consumers.

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

23 the Board described in subparagraph (B), (C), or

24 (D) of paragraph (2) shall serve for a term of 3

25 years, except that the Secretary may adjust the
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1 terms of the initial Board appointees in order to

2 provide for a staggered term of appointment for all

3 members.

4 ‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM

5 TERMS.—A member may be appointed to serve not

6 more than 3 terms on the Board and may serve not

7 more than 2 consecutive terms.

8 ‘‘(5) DUTIES.—The Board shall—

9 ‘‘(A) advise the Secretary on current and

10 future trends, challenges, and opportunities pre11 sented by advances in biological and life

12 sciences, biotechnology, and genetic engineering

13 with respect to threats posed by naturally oc14 curring infectious diseases and chemical, bio15 logical, radiological, and nuclear agents;

16 ‘‘(B) at the request of the Secretary, re17 view and consider any information and findings

18 received from the working groups established

19 under subsection (b); and

20 ‘‘(C) at the request of the Secretary, pro21 vide recommendations and findings for ex22 panded, intensified, and coordinated biodefense

23 research and development activities.

24 ‘‘(6) MEETINGS.—
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1 ‘‘(A) INITIAL MEETING.—Not later than

2 one year after the date of enactment of the

3 Pandemic and All-Hazards Preparedness Act,

4 the Secretary shall hold the first meeting of the

5 Board.

6 ‘‘(B) SUBSEQUENT MEETINGS.—The

7 Board shall meet at the call of the Secretary,

8 but in no case less than twice annually.

9 ‘‘(7) VACANCIES.—Any vacancy in the Board

10 shall not affect its powers, but shall be filled in the

11 same manner as the original appointment.

12 ‘‘(8) CHAIRPERSON.—The Secretary shall ap13 point a chairperson from among the members of the

14 Board.

15 ‘‘(9) POWERS.—

16 ‘‘(A) HEARINGS.—The Board may hold

17 such hearings, sit and act at such times and

18 places, take such testimony, and receive such

19 evidence as the Board considers advisable to

20 carry out this subsection.

21 ‘‘(B) POSTAL SERVICES.—The Board may

22 use the United States mails in the same man23 ner and under the same conditions as other de24 partments and agencies of the Federal Govern25 ment.
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1 ‘‘(10) PERSONNEL.—

2 ‘‘(A) EMPLOYEES OF THE FEDERAL GOV3 ERNMENT.—A member of the Board that is an

4 employee of the Federal Government may not

5 receive additional pay, allowances, or benefits

6 by reason of the member’s service on the

7 Board.

8 ‘‘(B) OTHER MEMBERS.—A member of the

9 Board that is not an employee of the Federal

10 Government may be compensated at a rate not

11 to exceed the daily equivalent of the annual rate

12 of basic pay prescribed for level IV of the Exec13 utive Schedule under section 5315 of title 5,

14 United States Code, for each day (including

15 travel time) during which the member is en16 gaged in the actual performance of duties as a

17 member of the Board.

18 ‘‘(C) TRAVEL EXPENSES.—Each member

19 of the Board shall receive travel expenses, in20 cluding per diem in lieu of subsistence, in ac21 cordance with applicable provisions under sub22 chapter I of chapter 57 of title 5, United States

23 Code.

24 ‘‘(D) DETAIL OF GOVERNMENT EMPLOY25 EES.—Any Federal Government employee may
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1 be detailed to the Board with the approval for

2 the contributing agency without reimbursement,

3 and such detail shall be without interruption or

4 loss of civil service status or privilege.

5 ‘‘(b) OTHER WORKING GROUPS.—The Secretary may

6 establish a working group of experts, or may use an exist7 ing working group or advisory committee, to—

8 ‘‘(1) identify innovative research with the po9 tential to be developed as a qualified countermeasure

10 or a qualified pandemic or epidemic product;

11 ‘‘(2) identify accepted animal models for par12 ticular diseases and conditions associated with any

13 biological, chemical, radiological, or nuclear agent,

14 any toxin, or any potential pandemic infectious dis15 ease, and identify strategies to accelerate animal

16 model and research tool development and validation;

17 and

18 ‘‘(3) obtain advice regarding supporting and fa19 cilitating advanced research and development related

20 to qualified countermeasures and qualified pandemic

21 or epidemic products that are likely to be safe and

22 effective with respect to children, pregnant women,

23 and other vulnerable populations, and other issues

24 regarding activities under this section that affect

25 such populations.
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1 ‘‘(c) DEFINITIONS.—Any term that is defined in sec2 tion 319L and that is used in this section shall have the

3 same meaning in this section as such term is given in sec4 tion 319L.

5 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

6 are authorized to be appropriated $1,000,000 to carry out

7 this section for fiscal year 2007 and each fiscal year there8 after.’’.

9 SEC. 403. CLARIFICATION OF COUNTERMEASURES COV10 ERED BY PROJECT BIOSHIELD.

11 (a) QUALIFIED COUNTERMEASURE.—Section 319F–

12 1(a) of the Public Health Service Act (42 U.S.C. 247d–

13 6a(a)) is amended by striking paragraph (2) and inserting

14 the following:

15 ‘‘(2) DEFINITIONS.—In this section:

16 ‘‘(A) QUALIFIED COUNTERMEASURE.—The

17 term ‘qualified countermeasure’ means a drug

18 (as that term is defined by section 201(g)(1) of

19 the Federal Food, Drug, and Cosmetic Act (21

20 U.S.C. 321(g)(1))), biological product (as that

21 term is defined by section 351(i) of this Act (42

22 U.S.C. 262(i))), or device (as that term is de23 fined by section 201(h) of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 321(h))),

25 that the Secretary determines to be a priority
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1 (consistent with sections 302(2) and 304(a) of

2 the Homeland Security Act of 2002) to—

3 ‘‘(i) diagnose, mitigate, prevent, or

4 treat harm from any biological agent (in5 cluding organisms that cause an infectious

6 disease) or toxin, chemical, radiological, or

7 nuclear agent that may cause a public

8 health emergency affecting national secu9 rity; or

10 ‘‘(ii) diagnose, mitigate, prevent, or

11 treat harm from a condition that may re12 sult in adverse health consequences or

13 death and may be caused by administering

14 a drug, biological product, or device that is

15 used as described in this subparagraph.

16 ‘‘(B) INFECTIOUS DISEASE.—The term ‘in17 fectious disease’ means a disease potentially

18 caused by a pathogenic organism (including a

19 bacteria, virus, fungus, or parasite) that is ac20 quired by a person and that reproduces in that

21 person.’’.

22 (b) SECURITY COUNTERMEASURE.—Section 319F–

23 2(c)(1)(B) is amended by striking ‘‘treat, identify, or pre24 vent’’ each place it appears and inserting ‘‘diagnose, miti25 gate, prevent, or treat’’.
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1 (c) LIMITATION ON USE OF FUNDS.—Section 510(a)

2 of the Homeland Security Act of 2002 (6 U.S.C. 320(a))

3 is amended by adding at the end the following: ‘‘None of

4 the funds made available under this subsection shall be

5 used to procure countermeasures to diagnose, mitigate,

6 prevent, or treat harm resulting from any naturally occur7 ring infectious disease or other public health threat that

8 are not security countermeasures under section 319F–

9 2(c)(1)(B).’’.

10 SEC. 404. TECHNICAL ASSISTANCE.

11 Subchapter E of chapter V of the Federal Food,

12 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is

13 amended by adding at the end the following:

14 ‘‘SEC. 565. TECHNICAL ASSISTANCE.

15 ‘‘The Secretary, in consultation with the Commis16 sioner of Food and Drugs, shall establish within the Food

17 and Drug Administration a team of experts on manufac18 turing and regulatory activities (including compliance with

19 current Good Manufacturing Practice) to provide both off20 site and on-site technical assistance to the manufacturers

21 of qualified countermeasures (as defined in section 319F–

22 1 of the Public Health Service Act), security counter23 measures (as defined in section 319F–2 of such Act), or

24 vaccines, at the request of such a manufacturer and at

25 the discretion of the Secretary, if the Secretary determines
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1 that a shortage or potential shortage may occur in the

2 United States in the supply of such vaccines or counter3 measures and that the provision of such assistance would

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

5 SEC. 405. COLLABORATION AND COORDINATION.

6 (a) LIMITED ANTITRUST EXEMPTION.—

7 (1) MEETINGS AND CONSULTATIONS TO DIS8 CUSS SECURITY COUNTERMEASURES, QUALIFIED

9 COUNTERMEASURES, OR QUALIFIED PANDEMIC OR

10 EPIDEMIC PRODUCT DEVELOPMENT.—

11 (A) AUTHORITY TO CONDUCT MEETINGS

12 AND CONSULTATIONS.—The Secretary of

13 Health and Human Services (referred to in this

14 subsection as the ‘‘Secretary’’), in coordination

15 with the Attorney General and the Secretary of

16 Homeland Security, may conduct meetings and

17 consultations with persons engaged in the devel18 opment of a security countermeasure (as de19 fined in section 319F–2 of the Public Health

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

21 by this Act), a qualified countermeasure (as de22 fined in section 319F–1 of the Public Health

23 Service Act (42 U.S.C. 247d–6a)) (as amended

24 by this Act), or a qualified pandemic or epi25 demic product (as defined in section 319F–3 of
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1 the Public Health Service Act (42 U.S.C.

2 247d–6d)) for the purpose of the development,

3 manufacture, distribution, purchase, or storage

4 of a countermeasure or product. The Secretary

5 may convene such meeting or consultation at

6 the request of the Secretary of Homeland Secu7 rity, the Attorney General, the Chairman of the

8 Federal Trade Commission (referred to in this

9 section as the ‘‘Chairman’’), or any interested

10 person, or upon initiation by the Secretary. The

11 Secretary shall give prior notice of any such

12 meeting or consultation, and the topics to be

13 discussed, to the Attorney General, the Chair14 man, and the Secretary of Homeland Security.

15 (B) MEETING AND CONSULTATION CONDI16 TIONS.—A meeting or consultation conducted

17 under subparagraph (A) shall—

18 (i) be chaired or, in the case of a con19 sultation, facilitated by the Secretary;

20 (ii) be open to persons involved in the

21 development, manufacture, distribution,

22 purchase, or storage of a countermeasure

23 or product, as determined by the Sec24 retary;
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1 (iii) be open to the Attorney General,

2 the Secretary of Homeland Security, and

3 the Chairman;

4 (iv) be limited to discussions involving

5 covered activities; and

6 (v) be conducted in such manner as to

7 ensure that no national security, confiden8 tial commercial, or proprietary information

9 is disclosed outside the meeting or con10 sultation.

11 (C) LIMITATION.—The Secretary may not

12 require participants to disclose confidential

13 commercial or proprietary information.

14 (D) TRANSCRIPT.—The Secretary shall

15 maintain a complete verbatim transcript of each

16 meeting or consultation conducted under this

17 subsection. Such transcript (or a portion there18 of) shall not be disclosed under section 552 of

19 title 5, United States Code, to the extent that

20 the Secretary, in consultation with the Attorney

21 General and the Secretary of Homeland Secu22 rity, determines that disclosure of such tran23 script (or portion thereof) would pose a threat

24 to national security. The transcript (or portion

25 thereof) with respect to which the Secretary has
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1 made such a determination shall be deemed to

2 be information described in subsection (b)(3) of

3 such section 552.

4 (E) EXEMPTION.—

5 (i) IN GENERAL.—Subject to clause

6 (ii), it shall not be a violation of the anti7 trust laws for any person to participate in

8 a meeting or consultation conducted in ac9 cordance with this paragraph.

10 (ii) LIMITATION.—Clause (i) shall not

11 apply to any agreement or conduct that re12 sults from a meeting or consultation and

13 that is not covered by an exemption grant14 ed under paragraph (4).

15 (2) SUBMISSION OF WRITTEN AGREEMENTS.—

16 The Secretary shall submit each written agreement

17 regarding covered activities that is made pursuant to

18 meetings or consultations conducted under para19 graph (1) to the Attorney General and the Chairman

20 for consideration. In addition to the proposed agree21 ment itself, any submission shall include—

22 (A) an explanation of the intended purpose

23 of the agreement;

24 (B) a specific statement of the substance

25 of the agreement;
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1 (C) a description of the methods that will

2 be utilized to achieve the objectives of the

3 agreement;

4 (D) an explanation of the necessity for a

5 cooperative effort among the particular partici6 pating persons to achieve the objectives of the

7 agreement; and

8 (E) any other relevant information deter9 mined necessary by the Attorney General, in

10 consultation with the Chairman and the Sec11 retary.

12 (3) EXEMPTION FOR CONDUCT UNDER AP13 PROVED AGREEMENT.—It shall not be a violation of

14 the antitrust laws for a person to engage in conduct

15 in accordance with a written agreement to the extent

16 that such agreement has been granted an exemption

17 under paragraph (4), during the period for which

18 the exemption is in effect.

19 (4) ACTION ON WRITTEN AGREEMENTS.—

20 (A) IN GENERAL.—The Attorney General,

21 in consultation with the Chairman, shall grant,

22 deny, grant in part and deny in part, or pro23 pose modifications to an exemption request re24 garding a written agreement submitted under

25 paragraph (2), in a written statement to the
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1 Secretary, within 15 business days of the re2 ceipt of such request. An exemption granted

3 under this paragraph shall take effect imme4 diately.

5 (B) EXTENSION.—The Attorney General

6 may extend the 15-day period referred to in

7 subparagraph (A) for an additional period of

8 not to exceed 10 business days.

9 (C) DETERMINATION.—An exemption shall

10 be granted regarding a written agreement sub11 mitted in accordance with paragraph (2) only to

12 the extent that the Attorney General, in con13 sultation with the Chairman and the Secretary,

14 finds that the conduct that will be exempted

15 will not have any substantial anticompetitive ef16 fect that is not reasonably necessary for ensur17 ing the availability of the countermeasure or

18 product involved.

19 (5) LIMITATION ON AND RENEWAL OF EXEMP20 TIONS.—An exemption granted under paragraph (4)

21 shall be limited to covered activities, and such ex22 emption shall be renewed (with modifications, as ap23 propriate, consistent with the finding described in

24 paragraph (4)(C)), on the date that is 3 years after

25 the date on which the exemption is granted unless
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1 the Attorney General in consultation with the Chair2 man determines that the exemption should not be

3 renewed (with modifications, as appropriate) consid4 ering the factors described in paragraph (4).

5 (6) AUTHORITY TO OBTAIN INFORMATION.—

6 Consideration by the Attorney General for granting

7 or renewing an exemption submitted under this sec8 tion shall be considered an antitrust investigation for

9 purposes of the Antitrust Civil Process Act (15

10 U.S.C. 1311 et seq.).

11 (7) LIMITATION ON PARTIES.—The use of any

12 information acquired under an agreement for which

13 an exemption has been granted under paragraph (4),

14 for any purpose other than specified in the exemp15 tion, shall be subject to the antitrust laws and any

16 other applicable laws.

17 (8) REPORT.—Not later than one year after the

18 date of enactment of this Act and biannually there19 after, the Attorney General and the Chairman shall

20 report to Congress on the use of the exemption from

21 the antitrust laws provided by this subsection.

22 (b) SUNSET.—The applicability of this section shall

23 expire at the end of the 6-year period that begins on the

24 date of enactment of this Act.

25 (c) DEFINITIONS.—In this section:
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1 (1) ANTITRUST LAWS.—The term ‘‘antitrust

2 laws’’—

3 (A) has the meaning given such term in

4 subsection (a) of the first section of the Clayton

5 Act (15 U.S.C. 12(a)), except that such term

6 includes section 5 of the Federal Trade Com7 mission Act (15 U.S.C. 45) to the extent such

8 section 5 applies to unfair methods of competi9 tion; and

10 (B) includes any State law similar to the

11 laws referred to in subparagraph (A).

12 (2) COUNTERMEASURE OR PRODUCT.—The

13 term ‘‘countermeasure or product’’ refers to a secu14 rity countermeasure, qualified countermeasure, or

15 qualified pandemic or epidemic product (as those

16 terms are defined in subsection (a)(1)).

17 (3) COVERED ACTIVITIES.—

18 (A) IN GENERAL.—Except as provided in

19 subparagraph (B), the term ‘‘covered activities’’

20 includes any activity relating to the develop21 ment, manufacture, distribution, purchase, or

22 storage of a countermeasure or product.

23 (B) EXCEPTION.—The term ‘‘covered ac24 tivities’’ shall not include, with respect to a

25 meeting or consultation conducted under sub-
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1 section (a)(1) or an agreement for which an ex2 emption has been granted under subsection

3 (a)(4), the following activities involving 2 or

4 more persons:

5 (i) Exchanging information among

6 competitors relating to costs, profitability,

7 or distribution of any product, process, or

8 service if such information is not reason9 ably necessary to carry out covered

10 activities—

11 (I) with respect to a counter12 measure or product regarding which

13 such meeting or consultation is being

14 conducted; or

15 (II) that are described in the

16 agreement as exempted.

17 (ii) Entering into any agreement or

18 engaging in any other conduct—

19 (I) to restrict or require the sale,

20 licensing, or sharing of inventions, de21 velopments, products, processes, or

22 services not developed through, pro23 duced by, or distributed or sold

24 through such covered activities; or
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1 (II) to restrict or require partici2 pation, by any person participating in

3 such covered activities, in other re4 search and development activities, ex5 cept as reasonably necessary to pre6 vent the misappropriation of propri7 etary information contributed by any

8 person participating in such covered

9 activities or of the results of such cov10 ered activities.

11 (iii) Entering into any agreement or

12 engaging in any other conduct allocating a

13 market with a competitor that is not ex14 pressly exempted from the antitrust laws

15 under subsection (a)(4).

16 (iv) Exchanging information among

17 competitors relating to production (other

18 than production by such covered activities)

19 of a product, process, or service if such in20 formation is not reasonably necessary to

21 carry out such covered activities.

22 (v) Entering into any agreement or

23 engaging in any other conduct restricting,

24 requiring, or otherwise involving the pro25 duction of a product, process, or service
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1 that is not expressly exempted from the

2 antitrust laws under subsection (a)(4).

3 (vi) Except as otherwise provided in

4 this subsection, entering into any agree5 ment or engaging in any other conduct to

6 restrict or require participation by any per7 son participating in such covered activities,

8 in any unilateral or joint activity that is

9 not reasonably necessary to carry out such

10 covered activities.

11 (vii) Entering into any agreement or

12 engaging in any other conduct restricting

13 or setting the price at which a counter14 measure or product is offered for sale,

15 whether by bid or otherwise.

16 SEC. 406. PROCUREMENT.

17 Section 319F–2 of the Public Health Service Act (42

18 U.S.C. 247d–6b) is amended—

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

20 SECURITY COUNTERMEASURE PROCURE21 MENTS’’ before the period; and

22 (2) in subsection (c)—

23 (A) in the subsection heading, by striking

24 ‘‘BIOMEDICAL’’;

25 (B) in paragraph (3)—
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1 (i) by striking ‘‘COUNTER2 MEASURES.—The Secretary’’ and inserting

3 the following: ‘‘COUNTERMEASURES.—

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

5 (ii) by adding at the end the fol6 lowing:

7 ‘‘(B) INFORMATION.—The Secretary shall

8 institute a process for making publicly available

9 the results of assessments under subparagraph

10 (A) while withholding such information as—

11 ‘‘(i) would, in the judgment of the

12 Secretary, tend to reveal public health

13 vulnerabilities; or

14 ‘‘(ii) would otherwise be exempt from

15 disclosure under section 552 of title 5,

16 United States Code.’’;

17 (C) in paragraph (4)(A), by inserting ‘‘not

18 developed or’’ after ‘‘currently’’;

19 (D) in paragraph (5)(B)(i), by striking ‘‘to

20 meet the needs of the stockpile’’ and inserting

21 ‘‘to meet the stockpile needs’’;

22 (E) in paragraph (7)(B)—

23 (i) by striking the subparagraph head24 ing and all that follows through ‘‘Home25 land Security Secretary’’ and inserting the
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1 following: ‘‘INTERAGENCY AGREEMENT;

2 COST.—The Homeland Security Sec3 retary’’; and

4 (ii) by striking clause (ii);

5 (F) in paragraph (7)(C)(ii)—

6 (i) by amending subclause (I) to read

7 as follows:

8 ‘‘(I) PAYMENT CONDITIONED ON

9 DELIVERY.—The contract shall pro10 vide that no payment may be made

11 until delivery of a portion, acceptable

12 to the Secretary, of the total number

13 of units contracted for, except that,

14 notwithstanding any other provision of

15 law, the contract may provide that, if

16 the Secretary determines (in the Sec17 retary’s discretion) that an advance

18 payment, partial payment for signifi19 cant milestones, or payment to in20 crease manufacturing capacity is nec21 essary to ensure success of a project,

22 the Secretary shall pay an amount,

23 not to exceed 10 percent of the con24 tract amount, in advance of delivery.

25 The Secretary shall, to the extent
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1 practicable, make the determination of

2 advance payment at the same time as

3 the issuance of a solicitation. The con4 tract shall provide that such advance

5 payment is required to be repaid if

6 there is a failure to perform by the

7 vendor under the contract. The con8 tract may also provide for additional

9 advance payments of 5 percent each

10 for meeting the milestones specified in

11 such contract, except that such pay12 ments shall not exceed 50 percent of

13 the total contract amount. If the spec14 ified milestones are reached, the ad15 vanced payments of 5 percent shall

16 not be required to be repaid. Nothing

17 in this subclause shall be construed as

18 affecting the rights of vendors under

19 provisions of law or regulation (in20 cluding the Federal Acquisition Regu21 lation) relating to the termination of

22 contracts for the convenience of the

23 Government.’’; and

24 (ii) by adding at the end the fol25 lowing:
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1 ‘‘(VII) SALES EXCLUSIVITY.—

2 The contract may provide that the

3 vendor is the exclusive supplier of the

4 product to the Federal Government

5 for a specified period of time, not to

6 exceed the term of the contract, on

7 the condition that the vendor is able

8 to satisfy the needs of the Govern9 ment. During the agreed period of

10 sales exclusivity, the vendor shall not

11 assign its rights of sales exclusivity to

12 another entity or entities without ap13 proval by the Secretary. Such a sales

14 exclusivity provision in such a con15 tract shall constitute a valid basis for

16 a sole source procurement under sec17 tion 303(c)(1) of the Federal Property

18 and Administrative Services Act of

19 1949 (41 U.S.C. 253(c)(1)).

20 ‘‘(VIII) WARM BASED SURGE CA21 PACITY.—The contract may provide

22 that the vendor establish domestic

23 manufacturing capacity of the product

24 to ensure that additional production

25 of the product is available in the event
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1 that the Secretary determines that

2 there is a need to quickly purchase

3 additional quantities of the product.

4 Such contract may provide a fee to

5 the vendor for establishing and main6 taining such capacity in excess of the

7 initial requirement for the purchase of

8 the product. Additionally, the cost of

9 maintaining the domestic manufac10 turing capacity shall be an allowable

11 and allocable direct cost of the con12 tract.

13 ‘‘(IX) CONTRACT TERMS.—The

14 Secretary, in any contract for procure15 ment under this section, may

16 specify—

17 ‘‘(aa) the dosing and admin18 istration requirements for coun19 termeasures to be developed and

20 procured;

21 ‘‘(bb) the amount of funding

22 that will be dedicated by the Sec23 retary for development and ac24 quisition of the countermeasure;

25 and
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1 ‘‘(cc) the specifications the

2 countermeasure must meet to

3 qualify for procurement under a

4 contract under this section.’’; and

5 (G) in paragraph (8)(A), by adding at the

6 end the following: ‘‘Such agreements may allow

7 other executive agencies to order qualified and

8 security countermeasures under procurement

9 contracts or other agreements established by

10 the Secretary. Such ordering process (including

11 transfers of appropriated funds between an

12 agency and the Department of Health and

13 Human Services as reimbursements for such or14 ders for countermeasures) may be conducted

15 under the authority of section 1535 of title 31,

16 United States Code, except that all such orders

17 shall be processed under the terms established

18 under this subsection for the procurement of

19 countermeasures.’’.

Passed the Senate December 5, 2006.

Attest:

Secretary.
109TH CONGRESS

2D SESSION S. 3678

AN ACT

To amend the Public Health Service Act with reposes. preparedness and response, and for other pur- spect to public health security and all-hazards