[DOCID: f:publ188.107]
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF
2002
Public Law 107-188
107th Congress
An Act
To improve the ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health
emergencies. <<NOTE: June 12, 2002 - [H.R. 3448]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Public Health
Security and Bioterrorism Preparedness and Response Act of 2002.>>
SECTION 1. SHORT TITLE; TABLE <<NOTE: 42 USC 201 note.>> OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Public Health
Security and Bioterrorism Preparedness and Response Act of 2002''.
(b) Table of Contents.--The table of contents of the Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Public Health Emergency Preparedness;
National Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and
Prevention.
Sec. 104. Advisory committees and communications; study regarding
communications abilities of public health agencies.
Sec. 105. Education of health care personnel; training regarding
pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for advance registration of health
professions volunteers.
Sec. 108. Working group.
Sec. 109. Antimicrobial resistance.
Sec. 110. Supplies and services in lieu of award funds.
Sec. 111. Additional amendments.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
Sec. 121. Strategic national stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Issuance of rule on animal trials.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding
bioterrorist
attack and other public health emergencies.
Sec. 127. Potassium iodide.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
Sec. 131. Grants to improve State, local, and hospital preparedness for
and
response to bioterrorism and other public health emergencies.
Subtitle D--Emergency Authorities; Additional Provisions
Sec. 141. Reporting deadlines.
Sec. 142. Streamlining and clarifying communicable disease quarantine
provisions.
Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP
requirements.
Sec. 144. Provision for expiration of public health emergencies.
Subtitle E--Additional Provisions
Sec. 151. Designated State public emergency announcement plan.
Sec. 152. Expanded research by Secretary of Energy.
Sec. 153. Expanded research on worker health and safety.
Sec. 154. Enhancement of emergency preparedness of Department of
Veterans
Affairs.
Sec. 155. Reauthorization of existing program.
Sec. 156. Sense of Congress.
Sec. 157. General Accounting Office report.
Sec. 158. Certain awards.
Sec. 159. Public access defibrillation programs and public access
defibrillation
demonstration projects.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Sec. 201. Regulation of certain biological agents and toxins.
Sec. 202. Implementation by Department of Health and Human Services.
Sec. 203. Effective dates.
Sec. 204. Conforming amendment.
Subtitle B--Department of Agriculture
Sec. 211. Short title.
Sec. 212. Regulation of certain biological agents and toxins.
Sec. 213. Implementation by Department of Agriculture.
Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins
Sec. 221. Interagency coordination.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
Sec. 231. Criminal penalties.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
Sec. 301. Food safety and security strategy.
Sec. 302. Protection against adulteration of food.
Sec. 303. Administrative detention.
Sec. 304. Debarment for repeated or serious food import violations.
Sec. 305. Registration of food facilities.
Sec. 306. Maintenance and inspection of records for foods.
Sec. 307. Prior notice of imported food shipments.
Sec. 308. Authority to mark articles refused admission into United
States.
Sec. 309. Prohibition against port shopping.
Sec. 310. Notices to States regarding imported food.
Sec. 311. Grants to States for inspections.
Sec. 312. Surveillance and information grants and authorities.
Sec. 313. Surveillance of zoonotic diseases.
Sec. 314. Authority to commission other Federal officials to conduct
inspections.
Sec. 315. Rule of construction.
Subtitle B--Protection of Drug Supply
Sec. 321. Annual registration of foreign manufacturers; shipping
information; drug and device listing.
Sec. 322. Requirement of additional information regarding import
components
intended for use in export products.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
Sec. 331. Expansion of Animal and Plant Health Inspection Service
activities.
Sec. 332. Expansion of Food Safety Inspection Service activities.
Sec. 333. Biosecurity upgrades at the Department of Agriculture.
Sec. 334. Agricultural biosecurity.
Sec. 335. Agricultural bioterrorism research and development.
Sec. 336. Animal enterprise terrorism penalties.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
Sec. 401. Terrorist and other intentional acts.
Sec. 402. Other Safe Drinking Water Act amendments.
Sec. 403. Miscellaneous and technical amendments.
TITLE V--ADDITIONAL PROVISIONS
Subtitle A--Prescription Drug User Fees
Sec. 501. Short title.
Sec. 502. Findings.
Sec. 503. Definitions.
Sec. 504. Authority to assess and use drug fees.
Sec. 505. Accountability and reports.
Sec. 506. Reports of postmarketing studies.
Sec. 507. Savings clause.
Sec. 508. Effective date.
Sec. 509. Sunset clause.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
Sec. 521. Office of Drug Safety.
Sec. 522. Division of Drug Marketing, Advertising, and Communications.
Sec. 523. Office of Generic Drugs.
Subtitle C--Additional Provisions
Sec. 531. Transition to digital television.
Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans;
change in Medicare+Choice reporting deadlines and annual,
coordinated election period for 2003, 2004, and 2005.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.
(a) In General.--The Public Health Service Act (42 U.S.C. 201 et
seq.) is amended by adding at the end the following title:
``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
``Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
``SEC. 2801. NATIONAL <<NOTE: 42 USC 300hh.>> PREPAREDNESS PLAN.
``(a) In General.--
``(1) Preparedness and response regarding public health
emergencies.--The Secretary shall further develop and implement
a coordinated strategy, building upon the core public health
capabilities established pursuant to section 319A,
for carrying out health-related activities to prepare for and
respond effectively to bioterrorism and other public health
emergencies, including the preparation of a plan under this
section. The Secretary shall periodically thereafter review and,
as appropriate, revise the plan.
``(2) National approach.--In carrying out paragraph (1), the
Secretary shall collaborate with the States toward the goal of
ensuring that the activities of the Secretary regarding
bioterrorism and other public health emergencies are coordinated
with activities of the States, including local governments.
``(3) Evaluation of progress.--The plan under paragraph (1)
shall provide for specific benchmarks and outcome measures for
evaluating the progress of the Secretary and the States,
including local governments, with respect to the plan under
paragraph (1), including progress toward achieving the goals
specified in subsection (b).
``(b) Preparedness Goals.--The plan under subsection (a) should
include provisions in furtherance of the following:
``(1) Providing effective assistance to State and local
governments in the event of bioterrorism or other public health
emergency.
``(2) Ensuring that State and local governments have
appropriate capacity to detect and respond effectively to such
emergencies, including capacities for the following:
``(A) Effective public health surveillance and
reporting mechanisms at the State and local levels.
``(B) Appropriate laboratory readiness.
``(C) Properly trained and equipped emergency
response, public health, and medical personnel.
``(D) Health and safety protection of workers
responding to such an emergency.
``(E) Public health agencies that are prepared to
coordinate health services (including mental health
services) during and after such emergencies.
``(F) Participation in communications networks that
can effectively disseminate relevant information in a
timely and secure manner to appropriate public and
private entities and to the public.
``(3) Developing and maintaining medical countermeasures
(such as drugs, vaccines and other biological products, medical
devices, and other supplies) against biological agents and
toxins that may be involved in such emergencies.
``(4) Ensuring coordination and minimizing duplication of
Federal, State, and local planning, preparedness, and response
activities, including during the investigation of a suspicious
disease outbreak or other potential public health emergency.
``(5) Enhancing the readiness of hospitals and other health
care facilities to respond effectively to such emergencies.
``(c) Reports to Congress.--
``(1) In general.--Not <<NOTE: Deadline.>> later than one
year after the date of the enactment of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,
and biennially thereafter, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report concerning progress with
respect to the plan under
subsection (a), including progress toward achieving the goals
specified in subsection (b).
``(2) Additional authority.--Reports submitted under
paragraph (1) by the Secretary (other than the first report)
shall make recommendations concerning--
``(A) any additional legislative authority that the
Secretary determines is necessary for fully implementing
the plan under subsection (a), including meeting the
goals under subsection (b); and
``(B) any additional legislative authority that the
Secretary determines is necessary under section 319 to
protect the public health in the event of an emergency
described in section 319(a).
``(d) Rule of Construction.--This section may not be construed as
expanding or limiting any of the authorities of the Secretary that, on
the day before the date of the enactment of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002, were in effect
with respect to preparing for and responding effectively to bioterrorism
and other public health emergencies.''.
(b) Other <<NOTE: 42 USC 247d-6 note.>> Reports.--
(1) In general.--Not <<NOTE: Deadline.>> later than one year
after the date of the enactment of this Act, the Secretary of
Health and Human Services (referred to in this subsection as the
``Secretary'') shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate, a report
concerning--
(A) the recommendations and findings of the National
Advisory Committee on Children and Terrorism under
section 319F(c)(2) of the Public Health Service Act;
(B) the recommendations and findings of the EPIC
Advisory Committee under section 319F(c)(3) of such Act;
(C) the characteristics that may render a rural
community uniquely vulnerable to a biological attack,
including distance, lack of emergency transport,
hospital or laboratory capacity, lack of integration of
Federal or State public health networks, workforce
deficits, or other relevant characteristics;
(D) the characteristics that may render areas or
populations designated as medically underserved
populations (as defined in section 330 of such Act)
uniquely vulnerable to a biological attack, including
significant numbers of low-income or uninsured
individuals, lack of affordable and accessible health
care services, insufficient public and primary health
care resources, lack of integration of Federal or State
public health networks, workforce deficits, or other
relevant characteristics;
(E) the recommendations of the Secretary with
respect to additional legislative authority that the
Secretary determines is necessary to effectively
strengthen rural communities, or medically underserved
populations (as defined in section 330 of such Act); and
(F) the need for and benefits of a National Disaster
Response Medical Volunteer Service that would be a
private-sector, community-based rapid response corps of
medical volunteers.
(2) Study regarding local emergency response methods.--The
Secretary shall conduct a study of effective methods for the
provision of emergency response services through local
governments (including through private response contractors and
volunteers of such governments) in a consistent manner in
response to acts of bioterrorism or other public health
emergencies. Not <<NOTE: Deadline. Reports.>> later than 180
days after the date of the enactment of this Act, the Secretary
shall submit to the Committee on Energy and Commerce of the
House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
describing the findings of the study.
SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS;
NATIONAL DISASTER MEDICAL SYSTEM.
(a) In General.--Title XXVIII of the Public Health Service Act, as
added by section 101 of this Act, is amended by adding at the end the
following subtitle:
``Subtitle B--Emergency Preparedness and Response
``SEC. 2811. COORDINATION <<NOTE: 42 USC 300hh-11.>> OF PREPAREDNESS FOR
AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
``(a) Assistant Secretary for Public Health Emergency
Preparedness.--
``(1) In general.--There
is <<NOTE: Establishment.>> established within the Department of
Health and Human Services the position of Assistant Secretary
for Public Health Emergency
Preparedness. <<NOTE: President.>> The President shall appoint
an individual to serve in such position. Such Assistant
Secretary shall report to the Secretary.
``(2) Duties.--Subject to the authority of the Secretary,
the Assistant Secretary for Public Health Emergency Preparedness
shall carry out the following duties with respect to
bioterrorism and other public health emergencies:
``(A) Coordinate on behalf of the Secretary--
``(i) interagency interfaces between the
Department of Health and Human Services (referred
to in this paragraph as the `Department') and
other departments, agencies, and offices of the
United States; and
``(ii) interfaces between the Department and
State and local entities with responsibility for
emergency preparedness.
``(B) Coordinate the operations of the National
Disaster Medical System and any other emergency response
activities within the Department of Health and Human
Services that are related to bioterrorism and other
public health emergencies.
``(C) Coordinate the efforts of the Department to
bolster State and local emergency preparedness for a
bioterrorist attack or other public health emergency,
and evaluate the progress of such entities in meeting
the benchmarks and other outcome measures contained in
the national plan and in meeting the core public health
capabilities established pursuant to 319A.
``(D) Any other duties determined appropriate by the
Secretary.
``(b) National Disaster Medical System.--
``(1) In general.--The Secretary shall provide for the
operation in accordance with this section of a system to be
known as the National Disaster Medical System. The Secretary
shall designate the Assistant Secretary for Public Health
Emergency Preparedness as the head of the National Disaster
Medical System, subject to the authority of the Secretary.
``(2) Federal and state collaborative system.--
``(A) In general.--The National Disaster Medical
System shall be a coordinated effort by the Federal
agencies specified in subparagraph (B), working in
collaboration with the States and other appropriate
public or private entities, to carry out the purposes
described in paragraph (3).
``(B) Participating federal agencies.--The Federal
agencies referred to in subparagraph (A) are the
Department of Health and Human Services, the Federal
Emergency Management Agency, the Department of Defense,
and the Department of Veterans Affairs.
``(3) Purpose of system.--
``(A) In general.--The Secretary may activate the
National Disaster Medical System to--
``(i) provide health services, health-related
social services, other appropriate human services,
and appropriate auxiliary services to respond to
the needs of victims of a public health emergency
(whether or not determined to be a public health
emergency under section 319); or
``(ii) be present at locations, and for
limited periods of time, specified by the
Secretary on the basis that the Secretary has
determined that a location is at risk of a public
health emergency during the time specified.
``(B) Ongoing activities.--The National Disaster
Medical System shall carry out such ongoing activities
as may be necessary to prepare for the provision of
services described in subparagraph (A) in the event that
the Secretary activates the National Disaster Medical
System for such purposes.
``(C) Test for mobilization of system.--During the
one-year period beginning on the date of the enactment
of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the Secretary
shall conduct an exercise to test the capability and
timeliness of the National Disaster Medical System to
mobilize and otherwise respond effectively to a
bioterrorist attack or other public health emergency
that affects two or more geographic locations
concurrently. Thereafter, the Secretary may periodically
conduct such exercises regarding the National Disaster
Medical System as the Secretary determines to be
appropriate.
``(c) Criteria.--
``(1) In general.--The Secretary shall establish criteria
for the operation of the National Disaster Medical System.
``(2) Participation agreements for non-federal entities.--In
carrying out paragraph (1), the Secretary shall establish
criteria regarding the participation of States and private
entities in the National Disaster Medical System, including
criteria regarding agreements for such participation. The
criteria shall include the following:
``(A) Provisions relating to the custody and use of
Federal personal property by such entities, which may in
the discretion of the Secretary include authorizing the
custody and use of such property to respond to emergency
situations for which the National Disaster Medical
System has not been activated by the Secretary pursuant
to subsection (b)(3)(A). Any such custody and use of
Federal personal property shall be on a reimbursable
basis.
``(B) Provisions relating to circumstances in which
an individual or entity has agreements with both the
National Disaster Medical System and another entity
regarding the provision of emergency services by the
individual. Such provisions shall address the issue of
priorities among the agreements involved.
``(d) Intermittent Disaster-Response Personnel.--
``(1) In general.--For the purpose of assisting the National
Disaster Medical System in carrying out duties under this
section, the Secretary may appoint individuals to serve as
intermittent personnel of such System in accordance with
applicable civil service laws and regulations.
``(2) Liability.--For purposes of section 224(a) and the
remedies described in such section, an individual appointed
under paragraph (1) shall, while acting within the scope of such
appointment, be considered to be an employee of the Public
Health Service performing medical, surgical, dental, or related
functions. With respect to the participation of individuals
appointed under paragraph (1) in training programs authorized by
the Assistant Secretary for Public Health Emergency Preparedness
or a comparable official of any Federal agency specified in
subsection (b)(2)(B), acts of individuals so appointed that are
within the scope of such participation shall be considered
within the scope of the appointment under paragraph (1)
(regardless of whether the individuals receive compensation for
such participation).
``(e) Certain Employment Issues Regarding Intermittent
Appointments.--
``(1) Intermittent disaster-response appointee.--For
purposes of this subsection, the term `intermittent disaster-
response appointee' means an individual appointed by the
Secretary under subsection (d).
``(2) Compensation for work injuries.--An intermittent
disaster-response appointee shall, while acting in the scope of
such appointment, be considered to be an employee of the Public
Health Service performing medical, surgical, dental, or related
functions, and an injury sustained by such an individual shall
be deemed `in the performance of duty', for purposes of chapter
81 of title 5, United States Code, pertaining to compensation
for work injuries. With respect to the participation of
individuals appointed under subsection (d) in training programs
authorized by the Assistant Secretary for Public Health
Emergency Preparedness or a comparable official of
any Federal agency specified in subsection (b)(2)(B), injuries
sustained by such an individual, while acting within the scope
of such participation, also shall be deemed `in the performance
of duty' for purposes of chapter 81 of title 5, United States
Code (regardless of whether the individuals receive compensation
for such participation). In the event of an injury to such an
intermittent disaster-response appointee, the Secretary of Labor
shall be responsible for making determinations as to whether the
claimant is entitled to compensation or other benefits in
accordance with chapter 81 of title 5, United States Code.
``(3) Employment and reemployment rights.--
``(A) In general.--Service as an intermittent
disaster-response appointee when the Secretary activates
the National Disaster Medical System or when the
individual participates in a training program authorized
by the Assistant Secretary for Public Health Emergency
Preparedness or a comparable official of any Federal
agency specified in subsection (b)(2)(B) shall be deemed
`service in the uniformed services' for purposes of
chapter 43 of title 38, United States Code, pertaining
to employment and reemployment rights of individuals who
have performed service in the uniformed services
(regardless of whether the individual receives
compensation for such participation). All rights and
obligations of such persons and procedures for
assistance, enforcement, and investigation shall be as
provided for in chapter 43 of title 38, United States
Code.
``(B) Notice of absence from position of
employment.--Preclusion of giving notice of service by
necessity of Service as an intermittent disaster-
response appointee when the Secretary activates the
National Disaster Medical System shall be deemed
preclusion by `military necessity' for purposes of
section 4312(b) of title 38, United States Code,
pertaining to giving notice of absence from a position
of employment. A determination of such necessity shall
be made by the Secretary, in consultation with the
Secretary of Defense, and shall not be subject to
judicial review.
``(4) Limitation.--An intermittent disaster-response
appointee shall not be deemed an employee of the Department of
Health and Human Services for purposes other than those
specifically set forth in this section.
``(f) Rule of Construction Regarding Use of Commissioned Corps.--If
the Secretary assigns commissioned officers of the Regular or Reserve
Corps to serve with the National Disaster Medical System, such
assignments do not affect the terms and conditions of their appointments
as commissioned officers of the Regular or Reserve Corps, respectively
(including with respect to pay and allowances, retirement, benefits,
rights, privileges, and immunities).
``(g) Definition.--For purposes of this section, the term `auxiliary
services' includes mortuary services, veterinary services, and other
services that are determined by the Secretary to be appropriate with
respect to the needs referred to in subsection (b)(3)(A).
``(h) Authorization of Appropriations.--For the purpose of providing
for the Assistant Secretary for Public Health Emergency Preparedness and
the operations of the National Disaster Medical
System, other than purposes for which amounts in the Public Health
Emergency Fund under section 319 are available, there are authorized to
be appropriated such sums as may be necessary for each of the fiscal
years 2002 through 2006.''.
(b) Sense of Congress Regarding Resources of National Disaster
Medical System.--It is the sense of the Congress that the Secretary of
Health and Human Services should provide sufficient resources to
entities tasked to carry out the duties of the National Disaster Medical
System for reimbursement of expenses, operations, purchase and
maintenance of equipment, training, and other funds expended in
furtherance of the National Disaster Medical System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL AND
PREVENTION.
Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is
amended to read as follows:
``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
``(a) Facilities; Capacities.--
``(1) Findings.--Congress finds that the Centers for Disease
Control and Prevention has an essential role in defending
against and combatting public health threats and requires secure
and modern facilities, and expanded and improved capabilities
related to bioterrorism and other public health emergencies,
sufficient to enable such Centers to conduct this important
mission.
``(2) Facilities.--
``(A) In general.--The Director of the Centers for
Disease Control and Prevention may design, construct,
and equip new facilities, renovate existing facilities
(including laboratories, laboratory support buildings,
scientific communication facilities, transshipment
complexes, secured and isolated parking structures,
office buildings, and other facilities and
infrastructure), and upgrade security of such
facilities, in order to better conduct the capacities
described in section 319A, and for supporting public
health activities.
``(B) Multiyear contracting authority.--For any
project of designing, constructing, equipping, or
renovating any facility under subparagraph (A), the
Director of the Centers for Disease Control and
Prevention may enter into a single contract or related
contracts that collectively include the full scope of
the project, and the solicitation and contract shall
contain the clause `availability of funds' found at
section 52.232-18 of title 48, Code of Federal
Regulations.
``(3) Improving the capacities of the centers for disease
control and prevention.--The Secretary, taking into account
evaluations under section 319B(a), shall expand, enhance, and
improve the capabilities of the Centers for Disease Control and
Prevention relating to preparedness for and responding
effectively to bioterrorism and other public health emergencies.
Activities that may be carried out under the preceding sentence
include--
``(A) expanding or enhancing the training of
personnel;
``(B) improving communications facilities and
networks, including delivery of necessary information to
rural areas;
``(C) improving capabilities for public health
surveillance and reporting activities, taking into
account the integrated system or systems of public
health alert communications and surveillance networks
under subsection (b); and
``(D) improving laboratory facilities related to
bioterrorism and other public health emergencies,
including increasing the security of such facilities.
``(b) National Communications and Surveillance Networks.--
``(1) In general.--The Secretary, directly or through awards
of grants, contracts, or cooperative agreements, shall provide
for the establishment of an integrated system or systems of
public health alert communications and surveillance networks
between and among--
``(A) Federal, State, and local public health
officials;
``(B) public and private health-related
laboratories, hospitals, and other health care
facilities; and
``(C) any other entities determined appropriate by
the Secretary.
``(2) Requirements.--The Secretary shall ensure that
networks under paragraph (1) allow for the timely sharing and
discussion, in a secure manner, of essential information
concerning bioterrorism or another public health emergency, or
recommended methods for responding to such an attack or
emergency.
``(3) Standards.--Not <<NOTE: Deadline.>> later than one
year after the date of the enactment of the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,
the Secretary, in cooperation with health care providers and
State and local public health officials, shall establish any
additional technical and reporting standards (including
standards for interoperability) for networks under paragraph
(1).
``(c) Authorization of Appropriations.--
``(1) Facilities; capacities.--
``(A) Facilities.--For the purpose of carrying out
subsection (a)(2), there are authorized to be
appropriated $300,000,000 for each of the fiscal years
2002 and 2003, and such sums as may be necessary for
each of the fiscal years 2004 through 2006.
``(B) Mission; Improving capacities.--For the
purposes of achieving the mission of the Centers for
Disease Control and Prevention described in subsection
(a)(1), for carrying out subsection (a)(3), for better
conducting the capacities described in section 319A, and
for supporting public health activities, there are
authorized to be appropriated such sums as may be
necessary for each of the fiscal years 2002 through
2006.
``(2) National communications and surveillance networks.--
For the purpose of carrying out subsection (b), there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 2002 through 2006.''.
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY REGARDING
COMMUNICATIONS ABILITIES OF PUBLIC HEALTH AGENCIES.
(a) In General.--Section 319F of the Public Health Service Act (42
U.S.C. 247d-6) is amended--
(1) by striking subsections (b) and (i);
(2) by redesignating subsections (c) through (h) as
subsections (e) through (j), respectively; and
(3) by inserting after subsection (a) the following
subsections:
``(b) Advice to the Federal Government.--
``(1) Required advisory committees.--
In <<NOTE: Establishment.>> coordination with the working group
under subsection (a), the Secretary shall establish advisory
committees in accordance with paragraphs (2) and (3) to provide
expert recommendations to assist such working groups in carrying
out their respective responsibilities under subsections (a) and
(b).
``(2) National advisory committee on children and
terrorism.--
``(A) In general.--
For <<NOTE: Establishment.>> purposes of paragraph (1),
the Secretary shall establish an advisory committee to
be known as the National Advisory Committee on Children
and Terrorism (referred to in this paragraph as the
`Advisory Committee').
``(B) Duties.--The Advisory Committee shall provide
recommendations regarding--
``(i) the preparedness of the health care
(including mental health care) system to respond
to bioterrorism as it relates to children;
``(ii) needed changes to the health care and
emergency medical service systems and emergency
medical services protocols to meet the special
needs of children; and
``(iii) changes, if necessary, to the national
stockpile under section 121 of the Public Health
Security and Bioterrorism Preparedness and
Response Act of 2002 to meet the emergency health
security of children.
``(C) Composition.--The Advisory Committee shall be
composed of such Federal officials as may be appropriate
to address the special needs of the diverse population
groups of children, and child health experts on
infectious disease, environmental health, toxicology,
and other relevant professional disciplines.
``(D) Termination.--The Advisory Committee
terminates one year after the date of the enactment of
the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002.
``(3) Emergency public information and communications
advisory committee.--
``(A) In general.--For purposes of paragraph (1),
the Secretary shall establish an advisory committee to
be known as the Emergency Public Information and
Communications Advisory Committee (referred to in this
paragraph as the `EPIC Advisory Committee').
``(B) Duties.--The EPIC Advisory Committee shall
make recommendations to the Secretary and the working
group under subsection (a) and report on appropriate
ways
to communicate public health information regarding
bioterrorism and other public health emergencies to the
public.
``(C) Composition.--The EPIC Advisory Committee
shall be composed of individuals representing a diverse
group of experts in public health, medicine,
communications, behavioral psychology, and other areas
determined appropriate by the Secretary.
``(D) Dissemination.--The Secretary shall review the
recommendations of the EPIC Advisory Committee and
ensure that appropriate information is disseminated to
the public.
``(E) Termination.--The EPIC Advisory Committee
terminates one year after the date of the enactment of
Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.
``(c) Strategy for Communication of Information Regarding
Bioterrorism and Other Public Health Emergencies.--In coordination with
working group under subsection (a), the Secretary shall develop a
strategy for effectively communicating information regarding
bioterrorism and other public health emergencies, and shall develop
means by which to communicate such information. The Secretary may carry
out the preceding sentence directly or through grants, contracts, or
cooperative agreements.
``(d) Recommendation of Congress Regarding Official Federal Internet
Site on Bioterrorism.--It is the recommendation of Congress that there
should be established an official Federal Internet site on bioterrorism,
either directly or through provision of a grant to an entity that has
expertise in bioterrorism and the development of websites, that should
include information relevant to diverse populations (including messages
directed at the general public and such relevant groups as medical
personnel, public safety workers, and agricultural workers) and links to
appropriate State and local government sites.''.
(b) Study <<NOTE: 42 USC 247d-6 note.>> Regarding Communications
Abilities of Public Health Agencies.--The Secretary of Health and Human
Services, in consultation with the Federal Communications Commission,
the National Telecommunications and Information Administration, and
other appropriate Federal agencies, shall conduct a study to determine
whether local public health entities have the ability to maintain
communications in the event of a bioterrorist attack or other public
health emergency. The study shall examine whether redundancies are
required in the telecommunications system, particularly with respect to
mobile communications, for public health entities to maintain systems
operability and connectivity during such emergencies. The study shall
also include recommendations to industry and public health entities
about how to implement such redundancies if necessary.
SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING REGARDING
PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as redesignated by
section 104(a)(2) of this <<NOTE: 42 USC 247d-6.>> Act, is amended to
read as follows:
``(g) Education; Training Regarding Pediatric Issues.--
``(1) Materials; core curriculum.--The Secretary, in
collaboration with members of the working group described
in subsection (b), and professional organizations and societies,
shall--
``(A) develop materials for teaching the elements of
a core curriculum for the recognition and identification
of potential bioweapons and other agents that may create
a public health emergency, and for the care of victims
of such emergencies, recognizing the special needs of
children and other vulnerable populations, to public
health officials, medical professionals, emergency
physicians and other emergency department staff,
laboratory personnel, and other personnel working in
health care facilities (including poison control
centers);
``(B) develop a core curriculum and materials for
community-wide planning by State and local governments,
hospitals and other health care facilities, emergency
response units, and appropriate public and private
sector entities to respond to a bioterrorist attack or
other public health emergency;
``(C) develop materials for proficiency testing of
laboratory and other public health personnel for the
recognition and identification of potential bioweapons
and other agents that may create a public health
emergency; and
``(D) provide for dissemination and teaching of the
materials described in subparagraphs (A) through (C) by
appropriate means, which may include telemedicine, long-
distance learning, or other such means.
``(2) Certain entities.--The entities through which
education and training activities described in paragraph (1) may
be carried out include Public Health Preparedness Centers, the
Public Health Service's Noble Training Center, the Emerging
Infections Program, the Epidemic Intelligence Service, the
Public Health Leadership Institute, multi-State, multi-
institutional consortia, other appropriate educational entities,
professional organizations and societies, private accrediting
organizations, and other nonprofit institutions or entities
meeting criteria established by the Secretary.
``(3) Grants and contracts.--In carrying out paragraph (1),
the Secretary may carry out activities directly and through the
award of grants and contracts, and may enter into interagency
cooperative agreements with other Federal agencies.
``(4) Health-related assistance for emergency response
personnel training.--The Secretary, in consultation with the
Attorney General and the Director of the Federal Emergency
Management Agency, may provide technical assistance with respect
to health-related aspects of emergency response personnel
training carried out by the Department of Justice and the
Federal Emergency Management Agency.''.
SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH PROFESSIONALS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 319G the following
section:
``SEC. 319H. GRANTS <<NOTE: 42 USC 247d-7a.>> REGARDING TRAINING AND
EDUCATION OF CERTAIN HEALTH PROFESSIONALS.
``(a) In General.--The Secretary may make awards of grants and
cooperative agreements to appropriate public and nonprofit
private health or educational entities, including health professions
schools and programs as defined in section 799B, for the purpose of
providing low-interest loans, partial scholarships, partial fellowships,
revolving loan funds, or other cost-sharing forms of assistance for the
education and training of individuals in any category of health
professions for which there is a shortage that the Secretary determines
should be alleviated in order to prepare for or respond effectively to
bioterrorism and other public health emergencies.
``(b) Authority Regarding Non-Federal Contributions.--The Secretary
may require as a condition of an award under subsection (a) that a
grantee under such subsection provide non-Federal contributions toward
the purpose described in such subsection.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2002 through 2006.''.
SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH
PROFESSIONS VOLUNTEERS.
Part B of title III of the Public Health Service Act, as amended by
section 106 of this Act, is amended by inserting after section 319H the
following section:
``SEC. 319I. EMERGENCY <<NOTE: 42 USC 247d-7b.>> SYSTEM FOR ADVANCE
REGISTRATION OF HEALTH PROFESSIONS VOLUNTEERS.
``(a) In General.--The Secretary shall, directly or through an award
of a grant, contract, or cooperative agreement, establish and maintain a
system for the advance registration of health professionals for the
purpose of verifying the credentials, licenses, accreditations, and
hospital privileges of such professionals when, during public health
emergencies, the professionals volunteer to provide health services
(referred to in this section as the `verification system'). In carrying
out the preceding sentence, the Secretary shall provide for an
electronic database for the verification system.
``(b) Certain Criteria.--The Secretary shall establish provisions
regarding the promptness and efficiency of the system in collecting,
storing, updating, and disseminating information on the credentials,
licenses, accreditations, and hospital privileges of volunteers
described in subsection (a).
``(c) Other Assistance.--The Secretary may make grants and provide
technical assistance to States and other public or nonprofit private
entities for activities relating to the verification system developed
under subsection (a).
``(d) Coordination Among States.--The Secretary may encourage each
State to provide legal authority during a public health emergency for
health professionals authorized in another State to provide certain
health services to provide such health services in the State.
``(e) Rule of Construction.--This section may not be construed as
authorizing the Secretary to issue requirements regarding the provision
by the States of credentials, licenses, accreditations, or hospital
privileges.
``(f) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $2,000,000 for
fiscal year 2002, and such sums as may be necessary for each of the
fiscal years 2003 through 2006.''.
SEC. 108. WORKING GROUP.
Section 319F of the Public Health Service Act, as amended by section
104(a), <<NOTE: 42 USC 247d-6.>> is amended by striking subsection (a)
and inserting the following:
``(a) Working Group on Bioterrorism and Other Public Health
Emergencies.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Agriculture, the Attorney General, the Director of
Central Intelligence, the Secretary of Defense, the Secretary of
Energy, the Administrator of the Environmental Protection
Agency, the Director of the Federal Emergency Management Agency,
the Secretary of Labor, the Secretary of Veterans Affairs, and
with other similar Federal officials as determined appropriate,
shall establish a working group on the prevention, preparedness,
and response to bioterrorism and other public health
emergencies. Such joint working group, or subcommittees thereof,
shall meet periodically for the purpose of consultation on,
assisting in, and making recommendations on--
``(A) responding to a bioterrorist attack, including
the provision of appropriate safety and health training
and protective measures for medical, emergency service,
and other personnel responding to such attacks;
``(B) prioritizing countermeasures required to
treat, prevent, or identify exposure to a biological
agent or toxin pursuant to section 351A;
``(C) facilitation of the awarding of grants,
contracts, or cooperative agreements for the
development, manufacture, distribution, supply-chain
management, and purchase of priority countermeasures;
``(D) research on pathogens likely to be used in a
biological threat or attack on the civilian population;
``(E) development of shared standards for equipment
to detect and to protect against biological agents and
toxins;
``(F) assessment of the priorities for and
enhancement of the preparedness of public health
institutions, providers of medical care, and other
emergency service personnel (including firefighters) to
detect, diagnose, and respond (including mental health
response) to a biological threat or attack;
``(G) in the recognition that medical and public
health professionals are likely to provide much of the
first response to such an attack, development and
enhancement of the quality of joint planning and
training programs that address the public health and
medical consequences of a biological threat or attack on
the civilian population between--
``(i) local firefighters, ambulance personnel,
police and public security officers, or other
emergency response personnel (including private
response contractors); and
``(ii) hospitals, primary care facilities, and
public health agencies;
``(H) development of strategies for Federal, State,
and local agencies to communicate information to the
public regarding biological threats or attacks;
``(I) ensuring that the activities under this
subsection address the health security needs of children
and other vulnerable populations;
``(J) strategies for decontaminating facilities
contaminated as a result of a biological attack,
including appropriate protections for the safety of
workers conducting such activities;
``(K) subject to compliance with other provisions of
Federal law, clarifying the responsibilities among
Federal officials for the investigation of suspicious
outbreaks of disease and other potential public health
emergencies, and for related revisions of the
interagency plan known as the Federal response plan; and
``(L) in consultation with the National Highway
Traffic Safety Administration and the U.S. Fire
Administration, ways to enhance coordination among
Federal agencies involved with State, local, and
community based emergency medical services, including
issuing a report that--
``(i) identifies needs of community-based
emergency medical services; and
``(ii) identifies ways to streamline and
enhance the process through which Federal agencies
support community-based emergency medical
services.
``(2) Consultation with experts.--In carrying out
subparagraphs (B) and (C) of paragraph (1), the working group
under such paragraph shall consult with the pharmaceutical,
biotechnology, and medical device industries, and other
appropriate experts.
``(3) Use of subcommittees regarding consultation
requirements.--With respect to a requirement under law that the
working group under paragraph (1) be consulted on a matter, the
working group may designate an appropriate subcommittee of the
working group to engage in the consultation.
``(4) Discretion in exercise of duties.--Determinations made
by the working group under paragraph (1) with respect to
carrying out duties under such paragraph are matters committed
to agency discretion for purposes of section 701(a) of title 5,
Unites States Code.
``(5) Rule of construction.--This subsection may not be
construed as establishing new regulatory authority for any of
the officials specified in paragraph (1), or as having any legal
effect on any other provision of law, including the
responsibilities and authorities of the Environmental Protection
Agency.''.
SEC. 109. ANTIMICROBIAL RESISTANCE.
Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is
amended--
(1) in subsection (b)--
(A) by striking ``shall conduct and support'' and
inserting ``shall directly or through awards of grants
or cooperative agreements to public or private entities
provide for the conduct of''; and
(B) by amending paragraph (4) to read as follows:
``(4) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis, of priority pathogens (as
determined by the Director of the National Institutes of Health
in consultation with the task force established under subsection
(a)), in collaboration and coordination with the activities of
the Department of Defense and the Joint Genome Institute of the
Department of Energy; and'';
(2) in subsection (e)(2), by inserting after ``societies,''
the following: ``schools or programs that train medical
laboratory personnel,''; and
(3) in subsection (g), by striking ``and such sums'' and all
that follows and inserting the following: ``$25,000,000 for each
of the fiscal years 2002 and 2003, and such sums as may be
necessary for each of the fiscal years 2004 through 2006.''.
SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
Part B of title III of the Public Health Service Act, as amended by
section 107 of this Act, is amended by inserting after section 319I the
following section:
``SEC. 319J. SUPPLIES <<NOTE: 42 USC 247d-7c.>> AND SERVICES IN LIEU OF
AWARD FUNDS.
``(a) In General.--Upon the request of a recipient of an award under
any of sections 319 through 319I or section 319K, the Secretary may,
subject to subsection (b), provide supplies, equipment, and services for
the purpose of aiding the recipient in carrying out the purposes for
which the award is made and, for such purposes, may detail to the
recipient any officer or employee of the Department of Health and Human
Services.
``(b) Corresponding Reduction in Payments.--With respect to a
request described in subsection (a), the Secretary shall reduce the
amount of payments under the award involved by an amount equal to the
costs of detailing personnel and the fair market value of any supplies,
equipment, or services provided by the Secretary. The Secretary shall,
for the payment of expenses incurred in complying with such request,
expend the amounts withheld.''.
SEC. 111. ADDITIONAL AMENDMENTS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended--
(1) in section 319A(a)(1), <<NOTE: 42 USC 247d-1.>> by
striking ``10 years'' and inserting ``five years'';
(2) in section 319B(a), in <<NOTE: 42 USC 247d-2.>> the
first sentence, by striking ``10 years'' and inserting ``five
years''; and
(3) in section 391F(e)(2), as <<NOTE: 42 USC 247d-
6.>> redesignated by section 104(a)(2) of this Act--
(A) by striking ``or'' after ``clinic,''; and
(B) by inserting before the period following: ``,
professional organization or society, school or program
that trains medical laboratory personnel, private
accrediting organization, or other nonprofit private
institution or entity meeting criteria established by
the Secretary''.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
SEC. 121. STRATEGIC <<NOTE: 42 USC 300hh-12.>> NATIONAL STOCKPILE.
(a) Strategic National Stockpile.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in
coordination with the Secretary of Veterans Affairs, shall
maintain a stockpile or stockpiles of drugs, vaccines and other
biological products, medical devices, and other supplies in such
numbers, types, and amounts as are determined by the Secretary
to be appropriate and practicable, taking into account other
available sources, to provide for the emergency health security
of the United States, including the emergency health security of
children and other vulnerable populations, in the event of a
bioterrorist attack or other public health emergency.
(2) Procedures.--The Secretary, in managing the stockpile
under paragraph (1), shall--
(A) consult with the working group under section
319F(a) of the Public Health Service Act;
(B) ensure that adequate procedures are followed
with respect to such stockpile for inventory management
and accounting, and for the physical security of the
stockpile;
(C) in consultation with Federal, State, and local
officials, take into consideration the timing and
location of special events;
(D) review and revise, as appropriate, the contents
of the stockpile on a regular basis to ensure that
emerging threats, advanced technologies, and new
countermeasures are adequately considered;
(E) devise plans for the effective and timely
supply-chain management of the stockpile, in
consultation with appropriate Federal, State and local
agencies, and the public and private health care
infrastructure; and
(F) ensure the adequate physical security of the
stockpile.
(b) Smallpox Vaccine Development.--
(1) In general.--The <<NOTE: Contracts.>> Secretary shall
award contracts, enter into cooperative agreements, or carry out
such other activities as may reasonably be required in order to
ensure that the stockpile under subsection (a) includes an
amount of vaccine against smallpox as determined by the
Secretary to be sufficient to meet the health security needs of
the United States.
(2) Rule of construction.--Nothing in this section shall be
construed to limit the private distribution, purchase, or sale
of vaccines from sources other than the stockpile described in
subsection (a).
(c) Disclosures.--No Federal agency shall disclose under section
552, United States Code, any information identifying the location at
which materials in the stockpile under subsection (a) are stored.
(d) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
(1) a physical accumulation (at one or more locations) of
the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and a
vendor or vendors under which such vendor or vendors agree to
provide to the Secretary supplies described in subsection (a).
(e) Authorization of Appropriations.--
(1) Strategic national stockpile.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated $640,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
(2) Smallpox vaccine development.--For the purpose of
carrying out subsection (b), there are authorized to be
appropriated $509,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
SEC. 122. ACCELERATED <<NOTE: 21 USC 356-1.>> APPROVAL OF PRIORITY
COUNTERMEASURES.
(a) In General.--The Secretary of Health and Human Services may
designate a priority countermeasure as a fast-track product pursuant to
section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356)
or as a device granted review priority pursuant to section 515(d)(5) of
such Act (21 U.S.C. 360e(d)(5)). Such a designation may be made prior to
the submission of--
(1) a request for designation by the sponsor or applicant;
or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or
applicant from declining such a designation.
(b) Use of Animal Trials.--A drug for which approval is sought under
section 505(b) of the Federal Food, Drug, and Cosmetic Act or section
351 of the Public Health Service Act on the basis of evidence of
effectiveness that is derived from animal studies pursuant to section
123 may be designated as a fast track product for purposes of this
section.
(c) Priority Review of Drugs and Biological Products.--A priority
countermeasure that is a drug or biological product shall be considered
a priority drug or biological product for purposes of performance goals
for priority drugs or biological products agreed to by the Commissioner
of Food and Drugs.
(d) Definitions.--For purposes of this title:
(1) The term ``priority countermeasure'' has the meaning
given such term in section 319F(h)(4) of the Public Health
Service Act.
(2) The term ``priority drugs or biological products'' means
a drug or biological product that is the subject of a drug or
biologics application referred to in section 101(4) of the Food
and Drug Administration Modernization Act of 1997.
SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.
Not later <<NOTE: Deadline.>> than 90 days after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
complete the process of rulemaking that was commenced under authority of
section 505 of the Federal Food, Drug, and Cosmetic Act and section 351
of the Public Health Service Act with the issuance of the proposed rule
entitled ``New Drug and Biological Drug Products; Evidence Needed to
Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently
Disabling Toxic Substances When Efficacy Studies in Humans Ethically
Cannot be Conducted'' published in the Federal Register on October 5,
1999 (64 Fed. Reg. 53960), and shall promulgate a final rule.
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.
Part B of title III of the Public Health Service Act, as amended by
section 110 of this Act, is amended by inserting after section 319J the
following section:
``SEC. 319K. SECURITY <<NOTE: 42 USC 247d-7d.>> FOR COUNTERMEASURE
DEVELOPMENT AND PRODUCTION.
``(a) In General.--The Secretary, in consultation with the Attorney
General and the Secretary of Defense, may provide technical or other
assistance to provide security to persons or facilities that conduct
development, production, distribution, or storage of priority
countermeasures (as defined in section 319F(h)(4)).
``(b) Guidelines.--The Secretary may develop guidelines to enable
entities eligible to receive assistance under subsection (a) to secure
their facilities against potential terrorist attack.''.
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as redesignated by
section 104(a)(2) of this Act, <<NOTE: 42 USC 247d-6.>> is amended to
read as follows:
``(h) Accelerated Research and Development on Priority Pathogens and
Countermeasures.--
``(1) In general.--With respect to pathogens of potential
use in a bioterrorist attack, and other agents that may cause a
public health emergency, the Secretary, taking into
consideration any recommendations of the working group under
subsection (a), shall conduct, and award grants, contracts, or
cooperative agreements for, research, investigations,
experiments, demonstrations, and studies in the health sciences
relating to--
``(A) the epidemiology and pathogenesis of such
pathogens;
``(B) the sequencing of the genomes, or other DNA
analysis, or other comparative analysis, of priority
pathogens (as determined by the Director of the National
Institutes of Health in consultation with the working
group established in subsection (a)), in collaboration
and coordination with the activities of the Department
of Defense and the Joint Genome Institute of the
Department of Energy;
``(C) the development of priority countermeasures;
and
``(D) other relevant areas of research;
with consideration given to the needs of children and other
vulnerable populations.
``(2) Priority.--The Secretary shall give priority under
this section to the funding of research and other studies
related to priority countermeasures.
``(3) Role of department of veterans affairs.--In carrying
out paragraph (1), the Secretary shall consider using the
biomedical research and development capabilities of the
Department of Veterans Affairs, in conjunction with that
Department's affiliations with health-professions universities.
When advantageous to the Government in furtherance of the
purposes of such paragraph, the Secretary may enter into
cooperative agreements with the Secretary of Veterans Affairs to
achieve such purposes.
``(4) Priority countermeasures.--For purposes of this
section, the term `priority countermeasure' means a drug,
biological product, device, vaccine, vaccine adjuvant,
antiviral, or diagnostic test that the Secretary determines to
be--
``(A) a priority to treat, identify, or prevent
infection by a biological agent or toxin listed pursuant
to section 351A(a)(1), or harm from any other agent that
may cause a public health emergency; or
``(B) a priority to diagnose conditions that may
result in adverse health consequences or death and may
be caused by the administering of a drug, biological
product, device, vaccine, vaccine adjuvant, antiviral,
or diagnostic test that is a priority under subparagraph
(A).''.
SEC. 126. EVALUATION OF NEW <<NOTE: 42 USC 300hh-13.>> AND EMERGING
TECHNOLOGIES REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC
HEALTH EMERGENCIES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall promptly carry
out a program to periodically evaluate new and emerging technologies
that, in the determination of the Secretary, are designed to improve or
enhance the ability of public health or safety officials to conduct
public health surveillance activities relating to a bioterrorist attack
or other public health emergency.
(b) Certain Activities.--In carrying out this subsection, the
Secretary shall, to the extent practicable--
(1) survey existing technology programs funded by the
Federal Government for potentially useful technologies;
(2) promptly issue a request, as necessary, for information
from non-Federal public and private entities for ongoing
activities in this area; and
(3) evaluate technologies identified under paragraphs (1)
and (2) pursuant to subsection (c).
(c) Consultation and Evaluation.--In carrying out subsection (b)(3),
the Secretary shall consult with the working group under section 319F(a)
of the Public Health Service Act, as well as other appropriate public,
nonprofit, and private entities, to develop criteria for the evaluation
of such technologies and to conduct such evaluations.
(d) Report.--Not <<NOTE: Deadline.>> later than 180 days after the
date of the enactment of this Act, and periodically thereafter, the
Secretary shall submit to the Committee on Energy and Commerce of the
House of Representatives, and the Committee on Health, Education, Labor,
and Pensions of the Senate, a report on the activities under this
section.
SEC. 127. POTASSIUM <<NOTE: 42 USC 300hh-12 note.>> IODIDE.
(a) In General.--Through the national stockpile under section 121,
the President, subject to subsections (b) and (c), shall make available
to State and local governments potassium iodide tablets for stockpiling
and for distribution as appropriate to public facilities, such as
schools and hospitals, in quantities sufficient to provide adequate
protection for the population within 20 miles of a nuclear power plant.
(b) State and Local Plans.--
(1) In general.--Subsection (a) applies with respect to a
State or local government, subject to paragraph (2), if the
government involved meets the following conditions:
(A) Such government submits to the President a plan
for the stockpiling of potassium iodide tablets, and for
the distribution and utilization of potassium iodide
tablets in the event of a nuclear incident.
(B) The plan is accompanied by certifications by
such government that the government has not already
received sufficient quantities of potassium iodide
tablets from the Federal Government.
(2) Local governments.--Subsection (a) applies with respect
to a local government only if, in addition to the conditions
described in paragraph (1), the following conditions are met:
(A) The State in which the locality involved is
located--
(i) does not have a plan described in
paragraph (1)(A); or
(ii) has a plan described in such paragraph,
but the plan does not address populations at a
distance greater than 10 miles from the nuclear
power plant involved.
(B) The local government has petitioned the State to
modify the State plan to address such populations, not
exceeding 20 miles from such plant, and 60 days have
elapsed without the State modifying the State plan to
address populations at the full distance sought by the
local government through the petition.
(C) The local government has submitted its local
plan under paragraph (1)(A) to the State, and the State
has approved the plan and certified that the plan is not
inconsistent with the State emergency plan.
(c) Guidelines.--Not <<NOTE: Deadline.>> later than one year after
the date of the enactment of this Act, the President, in consultation
with individuals representing appropriate Federal, State, and local
agencies, shall establish guidelines for the stockpiling of potassium
iodide tablets, and for the distribution and utilization of potassium
iodide tablets in the event of a nuclear incident. Such tablets may not
be made available under subsection (a) until such guidelines have been
established.
(d) Information.--The President shall carry out activities to inform
State and local governments of the program under this section.
(e) Reports.--
(1) President.--Not later <<NOTE: Deadline.>> than six
months after the date on which the guidelines under subsection
(c) are issued, the President shall submit to the Congress a
report--
(A) on whether potassium iodide tablets have been
made available under subsection (a) or other Federal,
State, or local programs, and the extent to which State
and local governments have established stockpiles of
such tablets; and
(B) the measures taken by the President to implement
this section.
(2) National academy of sciences.--
(A) In general.--The
President <<NOTE: Contracts.>> shall request the
National Academy of Sciences to enter into an agreement
with the President under which the Academy conducts a
study to determine what is the most effective and safe
way to distribute and administer potassium iodide
tablets
on a mass scale. If the Academy declines to conduct the
study, the President shall enter into an agreement with
another appropriate public or nonprofit private entity
to conduct the study.
(B) Report.--The <<NOTE: Deadline.>> President shall
ensure that, not later than six months after the date of
the enactment of this Act, the study required in
subparagraph (A) is completed and a report describing
the findings made in the study is submitted to the
Congress.
(f) Applicability.--Subsections (a) and (d) cease to apply as
requirements if the President determines that there is an alternative
and more effective prophylaxis or preventive measures for adverse
thyroid conditions that may result from the release of radionuclides
from nuclear power plants.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL PREPAREDNESS FOR
AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319C
the following sections:
``SEC. 319C-1. GRANTS <<NOTE: 42 USC 247d-3a.>> TO IMPROVE STATE, LOCAL,
AND HOSPITAL PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM
AND OTHER PUBLIC HEALTH EMERGENCIES.
``(a) In General.--To enhance the security of the United States with
respect to bioterrorism and other public health emergencies, the
Secretary shall make awards of grants or cooperative agreements to
eligible entities to enable such entities to conduct the activities
described in subsection (d).
``(b) Eligible Entities.--
``(1) In general.--To be eligible to receive an award under
subsection (a), an entity shall--
``(A)(i) be a State; and
``(ii) prepare and submit to the Secretary an
application at such time, and in such manner, and
containing such information as the Secretary may
require, including an assurance that the State--
``(I) has completed an evaluation under
section 319B(a), or an evaluation that is
substantially equivalent to an evaluation
described in such section (as determined by the
Secretary);
``(II) has prepared, or will (within 60 days
of receiving an award under this section) prepare,
a Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan in accordance with
subsection (c);
``(III) has established a means by which to
obtain public comment and input on the plan
prepared under subclause (II), and on the
implementation of such plan,
that shall include an advisory committee or other
similar mechanism for obtaining comment from the
public at large as well as from other State and
local stakeholders;
``(IV) will use amounts received under the
award in accordance with the plan prepared under
subclause (II), including making expenditures to
carry out the strategy contained in the plan; and
``(V) with respect to the plan prepared under
subclause (II), will establish reasonable criteria
to evaluate the effective performance of entities
that receive funds under the award and include
relevant benchmarks in the plan; or
``(B)(i) be a political subdivision of a State or a
consortium of 2 or more such subdivisions; and
``(ii) prepare and submit to the Secretary an
application at such time, and in such manner, and
containing such information as the Secretary may
require.
``(2) Coordination with statewide plans.--An award under
subsection (a) to an eligible entity described in paragraph
(1)(B) may not be made unless the application of such entity is
in coordination with, and consistent with, applicable Statewide
plans described in subsection (d)(1).
``(c) Bioterrorism and Other Public Health Emergency Preparedness
and Response Plan.--Not later <<NOTE: Deadline.>> than 60 days after
receiving amounts under an award under subsection (a), an eligible
entity described in subsection (b)(1)(A) shall prepare and submit to the
Secretary a Bioterrorism and Other Public Health Emergency Preparedness
and Response Plan. Recognizing the assessment of public health needs
conducted under section 319B, such plan shall include a description of
activities to be carried out by the entity to address the needs
identified in such assessment (or an equivalent assessment).
``(d) Use of Funds.--An award under subsection (a) may be expended
for activities that may include the following and similar activities:
``(1) To develop Statewide plans (including the development
of the Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan required under subsection (c)),
and community-wide plans for responding to bioterrorism and
other public health emergencies that are coordinated with the
capacities of applicable national, State, and local health
agencies and health care providers, including poison control
centers.
``(2) To address deficiencies identified in the assessment
conducted under section 319B.
``(3) To purchase or upgrade equipment (including stationary
or mobile communications equipment), supplies, pharmaceuticals
or other priority countermeasures to enhance preparedness for
and response to bioterrorism or other public health emergencies,
consistent with the plan described in subsection (c).
``(4) To conduct exercises to test the capability and
timeliness of public health emergency response activities.
``(5) To develop and implement the trauma care and burn
center care components of the State plans for the provision of
emergency medical services.
``(6) To improve training or workforce development to
enhance public health laboratories.
``(7) To train public health and health care personnel to
enhance the ability of such personnel--
``(A) to detect, provide accurate identification of,
and recognize the symptoms and epidemiological
characteristics of exposure to a biological agent that
may cause a public health emergency; and
``(B) to provide treatment to individuals who are
exposed to such an agent.
``(8) To develop, enhance, coordinate, or improve
participation in systems by which disease detection and
information about biological attacks and other public health
emergencies can be rapidly communicated among national, State,
and local health agencies, emergency response personnel, and
health care providers and facilities to detect and respond to a
bioterrorist attack or other public health emergency, including
activities to improve information technology and communications
equipment available to health care and public health officials
for use in responding to a biological threat or attack or other
public health emergency.
``(9) To enhance communication to the public of information
on bioterrorism and other public health emergencies, including
through the use of 2-1-1 call centers.
``(10) To address the health security needs of children and
other vulnerable populations with respect to bioterrorism and
other public health emergencies.
``(11) To provide training and develop, enhance, coordinate,
or improve methods to enhance the safety of workers and
workplaces in the event of bioterrorism.
``(12) To prepare and plan for contamination prevention
efforts related to public health that may be implemented in the
event of a bioterrorist attack, including training and planning
to protect the health and safety of workers conducting the
activities described in this paragraph.
``(13) To prepare a plan for triage and transport management
in the event of bioterrorism or other public health emergencies.
``(14) To enhance the training of health care professionals
to recognize and treat the mental health consequences of
bioterrorism or other public health emergencies.
``(15) To enhance the training of health care professionals
to assist in providing appropriate health care for large numbers
of individuals exposed to a bioweapon.
``(16) To enhance training and planning to protect the
health and safety of personnel, including health care
professionals, involved in responding to a biological attack.
``(17) To improve surveillance, detection, and response
activities to prepare for emergency response activities
including biological threats or attacks, including training
personnel in these and other necessary functions and including
early warning and surveillance networks that use advanced
information technology to provide early detection of biological
threats or attacks.
``(18) To develop, enhance, and coordinate or improve the
ability of existing telemedicine programs to provide health care
information and advice as part of the emergency public health
response to bioterrorism or other public health emergencies.
Nothing in this subsection may be construed as establishing new
regulatory authority or as modifying any existing regulatory authority.
``(e) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in
subparagraph (B), the Secretary shall, in carrying out
the activities described in this section, address the
following hazards in the following priority:
``(i) Bioterrorism or acute outbreaks of
infectious diseases.
``(ii) Other public health threats and
emergencies.
``(B) Determination of the secretary.--In the case
of the hazard involved, the degree of priority that
would apply to the hazard based on the categories
specified in clauses (i) and (ii) of subparagraph (A)
may be modified by the Secretary if the following
conditions are met:
``(i) The Secretary determines that the
modification is appropriate on the basis of the
following factors:
``(I) The extent to which eligible
entities are adequately prepared for
responding to hazards within the
category specified in clause (i) of
subparagraph (A).
``(II) There has been a significant
change in the assessment of risks to the
public health posed by hazards within
the category specified in clause (ii) of
such subparagraph.
``(ii) Prior to modifying the priority, the
Secretary notifies the appropriate committees of
the Congress of the determination of the Secretary
under clause (i) of this subparagraph.
``(2) Areas of emphasis within categories.--The Secretary
shall determine areas of emphasis within the category of hazards
specified in clause (i) of paragraph (1)(A), and shall determine
areas of emphasis within the category of hazards specified in
clause (ii) of such paragraph, based on an assessment of the
risk and likely consequences of such hazards and on an
evaluation of Federal, State, and local needs, and may also take
into account the extent to which receiving an award under
subsection (a) will develop capacities that can be used for
public health emergencies of varying types.
``(f) Certain Activities.--In administering activities under section
319C(c)(4) or similar activities, the Secretary shall, where
appropriate, give priority to activities that include State or local
government financial commitments, that seek to incorporate multiple
public health and safety services or diagnostic databases into an
integrated public health entity, and that cover geographic areas lacking
advanced diagnostic and laboratory capabilities.
``(g) Coordination with Local Medical Response System.--An eligible
entity and local Metropolitan Medical Response Systems shall, to the
extent practicable, ensure that activities carried out under an award
under subsection (a) are coordinated with activities that are carried
out by local Metropolitan Medical Response Systems.
``(h) Coordination of Federal Activities.--In making awards under
subsection (a), the Secretary shall--
``(1) annually notify the Director of the Federal Emergency
Management Agency, the Director of the Office of Justice
Programs, and the Director of the National Domestic Preparedness
Office, as to the amount, activities covered under, and status
of such awards; and
``(2) coordinate such awards with other activities conducted
or supported by the Secretary to enhance preparedness for
bioterrorism and other public health emergencies.
``(i) Definition.--For purposes of this section, the term `eligible
entity' means an entity that meets the conditions described in
subparagraph (A) or (B) of subsection (b)(1).
``(j) Funding.--
``(1) Authorizations of appropriations.--
``(A) Fiscal year 2003.--
``(i) Authorizations.--For the purpose of
carrying out this section, there is authorized to
be appropriated $1,600,000,000 for fiscal year
2003, of which--
``(I) $1,080,000,000 is authorized
to be appropriated for awards pursuant
to paragraph (3) (subject to the
authority of the Secretary to make
awards pursuant to paragraphs (4) and
(5)); and
``(II) $520,000,000 is authorized to
be appropriated--
``(aa) for awards under
subsection (a) to States,
notwitstanding the eligibility
conditions under subsection (b),
for the purpose of enhancing the
preparedness of hospitals
(including children's
hospitals), clinics, health
centers, and primary care
facilities for bioterrorism and
other public health emergencies;
and
``(bb) for Federal, State,
and local planning and
administrative activities
related to such purpose.
``(ii) Contingent additional authorization.--
If a significant change in circumstances warrants
an increase in the amount authorized to be
appropriated under clause (i) for fiscal year
2003, there are authorized to be appropriated such
sums as may be necessary for such year for
carrying out this section, in addition to the
amount authorized in clause (i).
``(B) Other fiscal years.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of
the fiscal years 2004 through 2006.
``(2) Supplement not supplant.--Amounts appropriated under
paragraph (1) shall be used to supplement and not supplant other
State and local public funds provided for activities under this
section.
``(3) State bioterrorism and other public health emergency
preparedness and response block grant for fiscal year 2003.--
``(A) In general.--For fiscal year 2003, the
Secretary shall, in an amount determined in accordance
with subparagraphs (B) through (D), make an award under
subsection (a) to each State, notwithstanding the
eligibility conditions described in subsection (b), that
submits to the Secretary an application for the award
that meets the criteria of the Secretary for the receipt
of such an award and that meets other implementation
conditions established by the Secretary for such awards.
No other awards may be made under subsection (a) for
such fiscal year, except as provided in paragraph
(1)(A)(i)(II) and paragraphs (4) and (5).
``(B) Base amount.--In determining the amount of an
award pursuant to subparagraph (A) for a State, the
Secretary shall first determine an amount the Secretary
considers appropriate for the State (referred to in this
paragraph as the `base amount'), except that such amount
may not be greater than the minimum amount determined
under subparagraph (D).
``(C) Increase on basis of population.--After
determining the base amount for a State under
subparagraph (B), the Secretary shall increase the base
amount by an amount equal to the product of--
``(i) the amount appropriated under paragraph
(1)(A)(i)(I) for the fiscal year, less an amount
equal to the sum of all base amounts determined
for the States under subparagraph (B), and less
the amount, if any, reserved by the Secretary
under paragraphs (4) and (5); and
``(ii) subject to paragraph (4)(C), the
percentage constituted by the ratio of an amount
equal to the population of the State over an
amount equal to the total population of the States
(as indicated by the most recent data collected by
the Bureau of the Census).
``(D) Minimum amount.--Subject to the amount
appropriated under paragraph (1)(A)(i)(I), an award
pursuant to subparagraph (A) for a State shall be the
greater of the base amount as increased under
subparagraph (C), or the minimum amount under this
subparagraph. The minimum amount under this subparagraph
is--
``(i) in the case of each of the several
States, the District of Columbia, and the
Commonwealth of Puerto Rico, an amount equal to
the lesser of--
``(I) $5,000,000; or
``(II) if the amount appropriated
under paragraph (1)(A)(i)(I) is less
than $667,000,000, an amount equal to
0.75 percent of the amount appropriated
under such paragraph, less the amount,
if any, reserved by the Secretary under
paragraphs (4) and (5); or
``(ii) in the case of each of American Samoa,
Guam, the Commonwealth of the Northern Mariana
Islands, and the Virgin Islands, an amount
determined by the Secretary to be appropriate,
except that such amount may not exceed the amount
determined under clause (i).
``(4) Certain political subdivisions.--
``(A) In general.--For fiscal year 2003, the
Secretary may, before making awards pursuant to
paragraph (3) for such year, reserve from the amount
appropriated under paragraph (1)(A)(i)(I) for the year
an amount determined necessary by the Secretary to make
awards under subsection (a) to political subdivisions
that have a substantial number of residents, have a
substantial local infrastructure for responding to
public health emergencies, and face a high degree of
risk from bioterrorist attacks or other public health
emergencies. Not more than three political subdivisions
may receive awards pursuant to this subparagraph.
``(B) Coordination with statewide plans.--An award
pursuant to subparagraph (A) may not be made unless the
application of the political subdivision involved is in
coordination with, and consistent with, applicable
Statewide plans described in subsection (c).
``(C) Relationship to formula grants.--In the case
of a State that will receive an award pursuant to
paragraph (3), and in which there is located a political
subdivision that will receive an award pursuant to
subparagraph (A), the Secretary shall, in determining
the amount under paragraph (3)(C) for the State,
subtract from the population of the State an amount
equal to the population of such political subdivision.
``(D) Continuity of funding.--In determining whether
to make an award pursuant to subparagraph (A) to a
political subdivision, the Secretary may consider, as a
factor indicating that the award should be made, that
the political subdivision received public health funding
from the Secretary for fiscal year 2002.
``(5) Significant unmet needs; degree of risk.--
``(A) In general.--For fiscal year 2003, the
Secretary may, before making awards pursuant to
paragraph (3) for such year, reserve from the amount
appropriated under paragraph (1)(A)(i)(I) for the year
an amount determined necessary by the Secretary to make
awards under subsection (a) to eligible entities that--
``(i) have a significant need for funds to
build capacity to identify, detect, monitor, and
respond to a bioterrorist or other threat to the
public health, which need will not be met by
awards pursuant to paragraph (3); and
``(ii) face a particularly high degree of risk
of such a threat.
``(B) Recipients of grants.--Awards pursuant to
subparagraph (A) may be supplemental awards to States
that receive awards pursuant to paragraph (3), or may be
awards to eligible entities described in subsection
(b)(1)(B) within such States.
``(C) Finding with respect to district of
columbia.--The Secretary shall consider the District of
Columbia to have a significant unmet need for purposes
of subparagraph (A), and to face a particularly high
degree of risk for such purposes, on the basis of the
concentration of entities of national significance
located within the District.
``(6) Funding of local entities.--For fiscal year 2003, the
Secretary shall in making awards under this section ensure that
appropriate portions of such awards are made available to
political subdivisions, local departments of public health,
hospitals (including children's hospitals), clinics, health
centers, or primary care facilities, or consortia of such
entities.
``SEC. 319C-2. PARTNERSHIPS <<NOTE: 42 USC 247d-3b.>> FOR COMMUNITY AND
HOSPITAL PREPAREDNESS.
``(a) Grants.--The Secretary shall make awards of grants or
cooperative agreements to eligible entities to enable such entities to
improve community and hospital preparedness for bioterrorism and other
public health emergencies.
``(b) Eligibility.--To be eligible for an award under subsection
(a), an entity shall--
``(1) be a partnership consisting of--
``(A) one or more hospitals (including children's
hospitals), clinics, health centers, or primary care
facilities; and
``(B)(i) one or more political subdivisions of
States;
``(ii) one or more States; or
``(iii) one or more States and one or more political
subdivisions of States; and
``(2) prepare, in consultation with the Chief Executive
Officer of the State, District, or territory in which the
hospital, clinic, health center, or primary care facility
described in paragraph (1)(A) is located, and submit to the
Secretary, an application at such time, in such manner, and
containing such information as the Secretary may require.
``(c) Regional Coordination.--In making awards under subsection (a),
the Secretary shall give preference to eligible entities that submit
applications that, in the determination of the Secretary, will--
``(1) enhance coordination--
``(A) among the entities described in subsection
(b)(1)(A); and
``(B) between such entities and the entities
described in subsection (b)(1)(B); and
``(2) serve the needs of a defined geographic area.
``(d) Consistency of Planned Activities.--An entity described in
subsection (b)(1) shall utilize amounts received under an award under
subsection (a) in a manner that is coordinated and consistent, as
determined by the Secretary, with an applicable State Bioterrorism and
Other Public Health Emergency Preparedness and Response Plan.
``(e) Use of Funds.--An award under subsection (a) may be expended
for activities that may include the following and similar activities--
``(1) planning and administration for such award;
``(2) preparing a plan for triage and transport management
in the event of bioterrorism or other public health emergencies;
``(3) enhancing the training of health care professionals to
improve the ability of such professionals to recognize the
symptoms of exposure to a potential bioweapon, to make
appropriate diagnosis, and to provide treatment to those
individuals so exposed;
``(4) enhancing the training of health care professionals to
recognize and treat the mental health consequences of
bioterrorism or other public health emergencies;
``(5) enhancing the training of health care professionals to
assist in providing appropriate health care for large numbers of
individuals exposed to a bioweapon;
``(6) enhancing training and planning to protect the health
and safety of personnel involved in responding to a biological
attack;
``(7) developing and implementing the trauma care and burn
center care components of the State plans for the provision of
emergency medical services; or
``(8) conducting such activities as are described in section
319C-1(d) that are appropriate for hospitals (including
children's hospitals), clinics, health centers, or primary care
facilities.
``(f) Limitation on Awards.--A political subdivision of a State
shall not participate in more than one partnership described in
subsection (b)(1).
``(g) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in
subparagraph (B), the Secretary shall, in carrying out
the activities described in this section, address the
following hazards in the following priority:
``(i) Bioterrorism or acute outbreaks of
infectious diseases.
``(ii) Other public health threats and
emergencies.
``(B) Determination of the secretary.--In the case
of the hazard involved, the degree of priority that
would apply to the hazard based on the categories
specified in clauses (i) and (ii) of subparagraph (A)
may be modified by the Secretary if the following
conditions are met:
``(i) The Secretary determines that the
modification is appropriate on the basis of the
following factors:
``(I) The extent to which eligible
entities are adequately prepared for
responding to hazards within the
category specified in clause (i) of
subparagraph (A).
``(II) There has been a significant
change in the assessment of risks to the
public health posed by hazards within
the category specified in clause (ii) of
such subparagraph.
``(ii) Prior to modifying the priority, the
Secretary notifies the appropriate committees of
the Congress of the determination of the Secretary
under clause (i) of this subparagraph.
``(2) Areas of emphasis within categories.--The Secretary
shall determine areas of emphasis within the category of hazards
specified in clause (i) of paragraph (1)(A), and shall determine
areas of emphasis within the category of hazards specified in
clause (ii) of such paragraph, based on an assessment of the
risk and likely consequences of such hazards and on an
evaluation of Federal, State, and local needs, and may also take
into account the extent to which receiving an award under
subsection (a) will develop capacities that can be used for
public health emergencies of varying types.
``(h) Coordination with Local Medical Response System.--An eligible
entity and local Metropolitan Medical Response Systems shall, to the
extent practicable, ensure that activities carried out under an award
under subsection (a) are coordinated with activities that are carried
out by local Metropolitan Medical Response Systems.
``(i) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of fiscal years 2004 through 2006.''.
(b) Certain Grants.--Section 319C of the Public Health Service Act
(42 U.S.C. 247d-3) is amended by striking subsection (f).
Subtitle D--Emergency Authorities; Additional Provisions
SEC. 141. REPORTING DEADLINES.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended by adding at the end the following:
``(d) Data Submittal and Reporting Deadlines.--In any case in which
the Secretary determines that, wholly or partially as a result of a
public health emergency that has been determined pursuant to subsection
(a), individuals or public or private entities are unable to comply with
deadlines for the submission to the Secretary of data or reports
required under any law administered by the Secretary, the Secretary may,
notwithstanding any other provision of law, grant such extensions of
such deadlines as the circumstances reasonably require, and may waive,
wholly or partially, any sanctions otherwise applicable to such failure
to comply. Before <<NOTE: Federal Register, publication.>> or promptly
after granting such an extension or waiver, the Secretary shall notify
the Congress of such action and publish in the Federal Register a notice
of the extension or waiver.''.
SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE QUARANTINE
PROVISIONS.
(a) Elimination of Prerequisite for National Advisory Health Council
Recommendation Before Issuing Quarantine Rules.--
(1) Executive orders specifying diseases subject to
individual detentions.--Section 361(b) of the Public Health Act
(42 U.S.C. 264(b)) is amended by striking ``Executive orders of
the President upon the recommendation of the National Advisory
Health Council and the Surgeon General'' and inserting
``Executive orders of the President upon the recommendation of
the Secretary, in consultation with the Surgeon General,''.
(2) Regulations providing for apprehension of individuals.--
Section 361(d) of the Public Health Act (42 U.S.C. 264(d)) is
amended by striking ``On recommendation of the National Advisory
Health Council, regulations'' and inserting ``Regulations''.
(3) Regulations providing for apprehension of individuals in
wartime.--Section 363 of the Public Health Act (42 U.S.C. 266)
is amended by striking ``the Surgeon General, on recommendation
of the National Advisory Health Council,'' and
inserting ``the Secretary, in consultation with the Surgeon
General,''.
(b) Apprehension Authority To Apply in Cases of Exposure to
Disease.--
(1) Regulations providing for apprehension of individuals.--
Section 361(d) of the Public Health Act (42 U.S.C. 264(d)), as
amended by subsection (a)(2), is further amended--
(A) by striking ``(1)'' and ``(2)'' and inserting
``(A)'' and ``(B)'', respectively;
(B) by striking ``(d)'' and inserting ``(d)(1)'';
(C) in paragraph (1) (as designated by subparagraph
(B) of this paragraph), in the first sentence, by
striking ``in a communicable stage'' each place such
term appears and inserting ``in a qualifying stage'';
and
(D) by adding at the end the following paragraph:
``(2) For purposes of this subsection, the term `qualifying stage',
with respect to a communicable disease, means that such disease--
``(A) is in a communicable stage; or
``(B) is in a precommunicable stage, if the disease would be
likely to cause a public health emergency if transmitted to
other individuals.''.
(2) Regulations providing for apprehension of individuals in
wartime.--Section 363 of the Public Health Act (42 U.S.C. 266),
as amended by subsection (a)(3), is further amended by striking
``in a communicable stage''.
(c) State Authority.--Section 361 of the Public Health Act (42
U.S.C. 264) is amended by adding at the end the following:
``(e) Nothing in this section or section 363, or the regulations
promulgated under such sections, may be construed as superseding any
provision under State law (including regulations and including
provisions established by political subdivisions of States), except to
the extent that such a provision conflicts with an exercise of Federal
authority under this section or section 363.''.
SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP
REQUIREMENTS.
(a) Waiver Authority.--Title XI of the Social Security Act (42
U.S.C. 1301 et seq.) is amended by inserting after section 1134 the
following new section:
``Sec. 1135. (a) Purpose.--The <<NOTE: 42 USC 1320b-5.>> purpose of
this section is to enable the Secretary to ensure to the maximum extent
feasible, in any emergency area and during an emergency period (as
defined in subsection (g)(1))--
``(1) that sufficient health care items and services are
available to meet the needs of individuals in such area enrolled
in the programs under titles XVIII, XIX, and XXI; and
``(2) that health care providers (as defined in subsection
(g)(2)) that furnish such items and services in good faith, but
that are unable to comply with one or more requirements
described in subsection (b), may be reimbursed for such items
and services and exempted from sanctions for such noncompliance,
absent any determination of fraud or abuse.
``(b) Secretarial Authority.--To the extent necessary to accomplish
the purpose specified in subsection (a), the Secretary
is authorized, subject to the provisions of this section, to temporarily
waive or modify the application of, with respect to health care items
and services furnished by a health care provider (or classes of health
care providers) in any emergency area (or portion of such an area)
during any portion of an emergency period, the requirements of titles
XVIII, XIX, or XXI, or any regulation thereunder (and the requirements
of this title other than this section, and regulations thereunder,
insofar as they relate to such titles), pertaining to--
``(1)(A) conditions of participation or other certification
requirements for an individual health care provider or types of
providers,
``(B) program participation and similar requirements for an
individual health care provider or types of providers, and
``(C) pre-approval requirements;
``(2) requirements that physicians and other health care
professionals be licensed in the State in which they provide
such services, if they have equivalent licensing in another
State and are not affirmatively excluded from practice in that
State or in any State a part of which is included in the
emergency area;
``(3) sanctions under section 1867 (relating to examination
and treatment for emergency medical conditions and women in
labor) for a transfer of an individual who has not been
stabilized in violation of subsection (c) of such section if the
transfer arises out of the circumstances of the emergency;
``(4) sanctions under section 1877(g) (relating to
limitations on physician referral);
``(5) deadlines and timetables for performance of required
activities, except that such deadlines and timetables may only
be modified, not waived; and
``(6) limitations on payments under section 1851(i) for
health care items and services furnished to individuals enrolled
in a Medicare+Choice plan by health care professionals or
facilities not included under such plan.
Insofar as the Secretary exercises authority under paragraph (6) with
respect to individuals enrolled in a Medicare+Choice plan, to the extent
possible given the circumstances, the Secretary shall reconcile payments
made on behalf of such enrollees to ensure that the enrollees do not pay
more than would be required had they received services from providers
within the network of the plan and may reconcile payments to the
organization offering the plan to ensure that such organization pays for
services for which payment is included in the capitation payment it
receives under part C of title XVIII.
``(c) Authority for Retroactive Waiver.--A waiver or modification of
requirements pursuant to this section may, at the Secretary's
discretion, be made retroactive to the beginning of the emergency period
or any subsequent date in such period specified by the Secretary.
``(d) Certification to Congress.--The Secretary shall provide a
certification and advance written notice to the Congress at least two
days before exercising the authority under this section with respect to
an emergency area. Such a certification and notice shall include--
``(1) a description of--
``(A) the specific provisions that will be waived or
modified;
``(B) the health care providers to whom the waiver
or modification will apply;
``(C) the geographic area in which the waiver or
modification will apply; and
``(D) the period of time for which the waiver or
modification will be in effect; and
``(2) a certification that the waiver or modification is
necessary to carry out the purpose specified in subsection (a).
``(e) Duration of Waiver.--
``(1) In general.--A waiver or modification of requirements
pursuant to this section terminates upon--
``(A) the termination of the applicable declaration
of emergency or disaster described in subsection
(g)(1)(A);
``(B) the termination of the applicable declaration
of public health emergency described in subsection
(g)(1)(B); or
``(C) subject to paragraph (2), the termination of a
period of 60 days from the date the waiver or
modification is first published (or, if applicable, the
date of extension of the waiver or modification under
paragraph (2)).
``(2) Extension of 60-day periods.--The Secretary may, by
notice, provide for an extension of a 60-day period described in
paragraph (1)(C) (or an additional period provided under this
paragraph) for additional period or periods (not to exceed,
except as subsequently provided under this paragraph, 60 days
each), but any such extension shall not affect or prevent the
termination of a waiver or modification under subparagraph (A)
or (B) of paragraph (1).
``(f) Report to Congress.--Within one year after the end of the
emergency period in an emergency area in which the Secretary exercised
the authority provided under this section, the Secretary shall report to
the Congress regarding the approaches used to accomplish the purposes
described in subsection (a), including an evaluation of such approaches
and recommendations for improved approaches should the need for such
emergency authority arise in the future.
``(g) Definitions.--For purposes of this section:
``(1) Emergency area; emergency period.--An `emergency area'
is a geographical area in which, and an `emergency period' is
the period during which, there exists--
``(A) an emergency or disaster declared by the
President pursuant to the National Emergencies Act or
the Robert T. Stafford Disaster Relief and Emergency
Assistance Act; and
``(B) a public health emergency declared by the
Secretary pursuant to section 319 of the Public Health
Service Act.
``(2) Health care provider.--The term `health care provider'
means any entity that furnishes health care items or services,
and includes a hospital or other provider of services, a
physician or other health care practitioner or professional, a
health care facility, or a supplier of health care items or
services.''.
(b) Effective Date.--The amendment <<NOTE: 42 USC 1320b-5
note.>> made by subsection (a) shall be effective on and after September
11, 2001.
SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMERGENCIES.
(a) In General.--Section 319(a) of the Public Health Service Act (42
U.S.C. 247d(a)), is amended by adding at the end the following new
sentence: ``Any such determination of a public health emergency
terminates upon the Secretary declaring that the emergency no longer
exists, or upon the expiration of the 90-day period beginning on the
date on which the determination is made by the Secretary, whichever
occurs first. Determinations that terminate under the preceding sentence
may be renewed by the Secretary (on the basis of the same or additional
facts), and the preceding sentence applies to each such renewal. Not
later than 48 hours after making a determination under this subsection
of a public health emergency (including a renewal), the Secretary shall
submit to the Congress written notification of the determination.''.
(b) Applicability.--The <<NOTE: 42 USC 247d note.>> amendment made
by subsection (a) applies to any public health emergency under section
319(a) of the Public Health Service Act, including any such emergency
that was in effect as of the day before the date of the enactment of
this Act. In the case of such an emergency that was in effect as of such
day, the 90-day period described in such section with respect to the
termination of the emergency is deemed to begin on such date of
enactment.
Subtitle E--Additional Provisions
SEC. 151. DESIGNATED STATE PUB