Congressional Record: December 11, 2001 (House)
Page H9195-H9217
PUBLIC HEALTH SECURITY AND BIOTERRORISM RESPONSE ACT OF 2001
Mr. TAUZIN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 3448) to improve the ability of the United States to
prevent, prepare for, and respond to bioterrorism and other public
health emergencies
The Clerk read as follows:
H.R. 3448
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION. 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the "Public
Health Security and Bioterrorism Response Act of 2001".
(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 Emergency Preparedness; National
Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and
Prevention with respect to bioterrorism and other public
health emergencies; facilities.
Sec. 104. Advisory committees and communications.
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 verification of credentials of health
professions volunteers.
Sec. 108. Enhancing preparedness activities for bioterrorism and other
public health emergencies.
Sec. 109. Improving State and local core public health capacities.
Sec. 110. Antimicrobial resistance program.
Sec. 111. Study regarding communications abilities of public health
agencies.
Sec. 112. Supplies and services in lieu of award funds.
Sec. 113. Additional amendments.
Sec. 114. Study regarding local emergency response methods.
Subtitle B--National Stockpile; Development of Priority Countermeasures
Sec. 121. National stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Use of animal trials in approval of certain drugs and
biologics; issuance of rule.
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--Emergency Authorities; Additional Provisions
Sec. 131. Expanded authority of Secretary of Health and Human Services
to respond to public health emergencies.
Sec. 132. Streamlining and clarifying communicable disease quarantine
provisions.
Sec. 133. Emergency waiver of Medicare, Medicaid, and SCHIP
requirements.
Sec. 134. Provision for expiration of public health emergencies.
Sec. 135. Designated State public emergency announcement plan.
Sec. 136. Expanded research by Secretary of Energy.
Sec. 137. Agency for Toxic Substances and Disease Registry.
Sec. 138. Expanded research on worker health and safety.
Sec. 139. Technology opportunities program support.
Subtitle D--Authorization of Appropriations
Sec. 151. Authorization of Appropriations.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Sec. 201. Regulation of certain biological agents and toxins.
TITLE III--AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT
Subtitle A--Protection of Food Supply
Sec. 301. Protection against intentional adulteration of food.
Sec. 302. Administrative detention.
Sec. 303. Permissive debarment regarding food importation.
Sec. 304. Maintenance and inspection of records for foods.
Sec. 305. Registration.
Sec. 306. Prior notice of imported food shipments.
Sec. 307. Authority to mark articles refused admission into United
States.
Sec. 308. Prohibition against port shopping for importation.
Sec. 309. Notices to States regarding imported food.
Sec. 310. Grants to States for inspections; response to notice
regarding adulterated imported food.
Subtitle B--Protection of Drug Supply
Sec. 311. Annual registration of foreign manufacturers; shipping
information; drug and device listing.
Sec. 312. Requirement of additional information regarding import
components intended for use in export products.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
Sec. 401. Amendment of the Safe Drinking Water Act.
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.
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 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-
[[Page H9196]]
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) Consultation.--The Secretary shall carry out
paragraph (1) in consultation with the Secretary of Defense,
the Director of the Federal Emergency Management Agency, the
Secretary of Veterans Affairs, the Attorney General, the
Secretary of Agriculture, the Secretary of Energy, the
Secretary of Labor, and the Administrator of the
Environmental Protection Agency, and with other appropriate
public and private entities.
"(3) 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
through local governments, such that there is a national plan
for preparedness for and responding effectively to such
emergencies.
"(4) 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)
shall include provisions for achieving the following goals
with respect to preparedness for and responding effectively
to bioterrorism and other public health emergencies:
"(1) Providing effective assistance to State and local
governments in the event of such an emergency.
"(2) Ensuring that State and local governments have
adequate and 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) Adequate laboratory readiness.
"(C) Properly trained and equipped emergency response,
public health, and medical personnel.
"(D) Health and safety protection of workers involved in
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, and
medical devices) against biological agents that may be used
in such emergencies.
"(4) Ensuring coordination and minimizing duplication of
Federal, State, and local planning, preparedness, and
response activities, including among agencies during the
investigation of a suspicious disease outbreak.
"(5) Ensuring adequate readiness of hospitals and other
health care facilities to respond effectively to such
emergencies.
"(c) Evaluation of Using VA R&D Capabilities.--The
Secretary shall evaluate the feasibility of using the
biomedical research and development capabilities of the
Department of Veterans Affairs, in conjunction with that
Department's affiliations with health-professions
universities, as a means to assist the Secretary in achieving
the goals specified in subsection (b).
"(d) Reports to Congress.--
"(1) Initial report to congress.--Not later than one year
after the date of the enactment of the Public Health Security
and Bioterrorism Response Act of 2001, 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) Biennial reports.--Not later than 2 years after the
date on which the report under paragraph (1) is submitted,
and biennially thereafter, the Secretary shall submit to each
of the committees specified in such paragraph a report
concerning the progress made with respect to the plan under
subsection (a), including the goals under subsection (b).
"(3) Additional authority.--Reports submitted under
paragraph (2) by the Secretary 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 that a condition
described in section 319(a) occurs.
"(e) Other Reports.--Not later than one year after the
date of the enactment of the Public Health Security and
Bioterrorism Response Act of 2001, the Secretary shall submit
to each of the committees specified in paragraph (1) a report
concerning--
"(1) the recommendations and findings of the EPIC Advisory
Committee under section 319F(c)(3);
"(2) 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
conditions;
"(3) the characteristics that may render areas or
populations designated as medically underserved populations
(as defined in section 330) 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 conditions; and
"(4) 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).
"(f) 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
Response Act of 2001, were in effect with respect to
preparing for and responding effectively to bioterrorism and
other public health emergencies.".
SEC. 102. ASSISTANT SECRETARY FOR 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 OF PREPAREDNESS FOR AND RESPONSE TO
BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
"(a) Assistant Secretary for Emergency Preparedness.--
"(1) In general.--There is established within the
Department of Health and Human Services the position of
Assistant Secretary for Emergency Preparedness. The
President, by and with the advice and consent of the Senate,
shall appoint an individual to serve in such position. Such
Assistant Secretary shall report to the Secretary.
"(2) Duties.--Subject to the authority of the Secretary,
the Assistant Secretary for Emergency Preparedness shall
carry out the following duties:
"(A) Coordinate on behalf of the Secretary--
"(i) all 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, including the activities of the joint
interdepartmental working groups under subsections (a) and
(b) of section 319F; and
"(ii) all 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 or 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) Coordinate the activities of the Department with
respect to research and development of priority vaccines,
other biological products, drugs, and devices useful for
detecting or responding to a bioterrorist attack or other
public health emergency.
"(E) Coordinate the activities of the Department with
respect to public education, awareness, and information
relating to bioterrorism or other public health emergencies,
including the activities and recommendations of the EPIC
Advisory Committee under section 319F(c)(3).
"(F) Coordinate all other functions within the Department
of Health and Human Services relating to emergency
preparedness, including matters relating to bioterrorism and
other public health emergencies that are addressed in the
national plan under section 2801.
"(G) 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 (in this
section referred to as the `National System'). The Secretary
shall designate the Assistant Secretary for Emergency
Preparedness as the head of the National System, subject to
the authority of the Secretary.
"(2) Federal and state collaborative system.--
"(A) In general.--The National 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,
[[Page H9197]]
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
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 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 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 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 Response Act of 2001, the
Secretary shall conduct an exercise to test the capability
and timeliness of the National 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 System as the Secretary determines to be
appropriate.
"(c) Criteria.--
"(1) In general.--The Secretary shall establish criteria
for the operation of the National System.
"(2) Education and training of personnel.--In carrying out
paragraph (1), the Secretary shall establish criteria
regarding the education and training of individuals who
provide emergency services through the National System. In
the case of permanent, full-time positions in the Department
of Health and Human Services that involve significant
supervisory roles within the National System, the criteria
shall require that individuals in such positions have
completed appropriate education or training programs as
determined by the Secretary.
"(3) 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 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 on a reimbursable basis to respond
to emergency situations for which the National System has not
been activated by the Secretary pursuant to subsection
(b)(3)(A).
"(B) Provisions relating to circumstances in which an
individual or entity has agreements with both the National
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 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 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 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
System or when the individual participates in a training
program authorized by the Assistant Secretary for 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 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) 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).
"(g) Authorization of Appropriations.--For the purpose of
providing for the Assistant Secretary for Emergency
Preparedness and the operations of the National 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
System.--It is the sense of the Congress that the Secretary
of Health and Human Services should provide sufficient
resources to individuals and 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 such National System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL
AND PREVENTION WITH RESPECT TO BIOTERRORISM AND
OTHER PUBLIC HEALTH EMERGENCIES; FACILITIES.
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) Findings.--Congress finds that the Centers for
Disease Control and Prevention have an essential role in
defending against and combatting public health threats of the
21st century and requires secure and modern facilities, and
expanded and improved capabilities related to biological
threats or attacks or other public health emergencies,
sufficient to enable such Centers to conduct this important
mission.
"(b) Improving the Capacities of the Centers for Disease
Control and Prevention.--
"(1) In general.--The Secretary 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;
"(C) improving capabilities for public health surveillance
and reporting activities;
"(D) improving laboratory facilities related to
bioterrorism, including increasing the security of such
facilities; and
"(E) such other activities as the Secretary determines
appropriate.
"(2) Improving public health laboratory capacity.--
"(A) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements, shall
provide for the
[[Page H9198]]
establishment of a coordinated network of public health
laboratories, that may, at the discretion of the Secretary,
include laboratories that serve as regional reference
laboratories.
"(B) Priority.--In carrying out subparagraph (A), the
Secretary shall give priority to projects 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 or
regional reference laboratory, and that cover geographic
areas lacking advanced diagnostic and safety-level laboratory
capabilities.
"(3) National public health communications and
surveillance network.--
"(A) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements, shall
provide for the establishment of integrated public health
communications and surveillance networks between and among--
"(i) Federal, State, and local public health officials;
"(ii) public and private health-related laboratories,
hospitals, and other health care facilities; and
"(iii) any other entities determined appropriate by the
Secretary.
"(B) Requirements.--The Secretary shall ensure that
networks under subparagraph (A) allow for the timely sharing
and discussion, in a secure manner, of essential information
concerning a bioterrorist attack or other public health
emergency, or recommended methods for responding to such an
attack or emergency.
"(4) Continuity of effort.--To the maximum extent
practicable, the Secretary, in conducting activities under
paragraphs (1) through (3), shall administer such activities
in a manner that intensifies, expands, or enhances activities
being carried out on the date of enactment of this
subsection.
"(c) Facilities.--
"(1) 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 related public
health activities.
"(2) Multiyear contracting authority.--For any project of
designing, constructing, equipping, or renovating any
facility under paragraph (1), 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.
"(d) Authorization of Appropriations.--
"(1) In general.--For the purposes of achieving the
mission of the Centers for Disease Control and Prevention
described in subsection (a), for carrying out subsection (b),
for better conducting the capacities described in section
319A, and for supporting related 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) Facilities.--For the purpose of carrying out
subsection (c), 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.".
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS.
Section 319F of the Public Health Service Act (42 U.S.C.
247d-6) is amended--
(1) by redesignating subsections (c) through (i) as
subsections (e) through (k), respectively; and
(2) by inserting after subsection (b) the following
subsections:
"(c) Advice to the Federal Government.--
"(1) Required advisory committees.--In coordination with
the working groups under subsections (a) and (b), 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 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 Response Act of 2001 to meet the special needs
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 Response Act of 2001.
"(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 and report on appropriate ways to communicate
public-health information regarding biological attacks to the
public.
"(C) Composition.--The EPIC Advisory Committee shall be
composed of individuals representing a diverse group of
experts in public health, communications, behavioral
psychology, and other areas determined appropriate by the
Secretary.
"(D) Dissemination.--The Secretary shall ensure that the
recommendations of the EPIC Advisory Committee are widely
disseminated to the media, State and local governments,
poison control centers, and others as the Secretary
determines appropriate.
"(E) Termination.--The EPIC Advisory Committee terminates
one year after the date of the enactment of the Public Health
Security and Bioterrorism Response Act of 2001.
"(d) Strategy for Communication of Information Regarding
Biological Attack.--In coordination with the joint
interdepartmental working group under subsection (b), the
Secretary, acting through the Assistant Secretary for
Emergency Preparedness, shall develop a strategy for
effectively communicating information regarding a biological
attack, 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.".
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(1) of this 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 (including
proficiency testing) 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) provide for dissemination and teaching of the
materials described in subparagraphs (A) and (B) by all
appropriate means, including telemedicine, long-distance
learning, or other such means; and
"(D) to the extent practicable, establish and maintain an
electronic database of individuals participating in training
or education programs carried out under this section, for the
purpose of providing continuing education materials and
information to such participants.
"(2) Grants.--In carrying out paragraph (1), the Secretary
may award grants to, or enter into cooperative agreements
with, professional organizations and societies, private
accrediting organizations, or other nonprofit institutions or
entities meeting criteria established by the Secretary, and
may enter into interagency cooperative agreements with other
Federal agencies.
"(3) 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 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 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,
[[Page H9199]]
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 VERIFICATION OF CREDENTIALS 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 SYSTEM FOR VERIFICATION 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 verifying the
credentials, licenses, accreditations, and hospital
privileges of individuals, who during public health
emergencies volunteer to serve as health professionals
(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
criteria regarding the verification system under subsection
(a), including 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) Advance Registration of Volunteers.--In order to
facilitate the availability of health professionals during a
public health emergency, the Secretary shall provide for the
advance registration with the system of health professionals
who are willing to serve as volunteers described in
subsection (a), and may carry out activities to encourage
health professionals to register with the system.
"(d) 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).
"(e) Coordination Among States.--The Secretary shall
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.
"(f) 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.
"(g) 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. ENHANCING PREPAREDNESS ACTIVITIES FOR BIOTERRORISM
AND OTHER PUBLIC HEALTH EMERGENCIES.
Section 319F of the Public Health Service Act (42 U.S.C.
247d-6) is amended--
(1) by amending subsection (a) to read as follows:
"(a) Working Group on Preparedness for Acts of
Bioterrorism.--The Secretary, in coordination with the
Secretary of Defense, the Director of the Federal Emergency
Management Agency, the Attorney General, the Secretary of
Veterans Affairs, the Secretary of Agriculture, the Secretary
of Energy, and the Administrator of the Environmental
Protection Agency shall establish a joint interdepartmental
working group on preparedness and readiness for the medical
and public health effects of a bioterrorist attack on the
civilian population. Such joint working group shall--
"(1) coordinate and prioritize research on, and the
development of countermeasures against, pathogens likely to
be used in a bioterrorist attack on the civilian population;
"(2) facilitate the development, production, and
regulatory review of priority countermeasures (as defined in
subsection (h)(2)(C)) for a bioterrorist attack on the
civilian population;
"(3) coordinate research and development into equipment to
detect pathogens likely to be used in a bioterrorist attack
on the civilian population and protect against infection from
such pathogens;
"(4) develop shared standards for equipment to detect and
to protect against infection from pathogens likely to be used
in a bioterrorist attack on the civilian population; and
"(5) coordinate the development, maintenance, and
procedures for the release and distribution of strategic
reserves of vaccines, drugs, and medical supplies which may
be needed rapidly after a bioterrorist attack upon the
civilian population, including consideration of vulnerable
populations (such as children, the elderly, and individuals
with disabilities).";
(2) in subsection (b)(1), by striking "The Secretary" and
all that follows through "shall establish" and inserting
the following: "The Secretary, in collaboration with the
Secretary of Defense, the Director of the Federal Emergency
Management Agency, the Attorney General, the Secretary of
Veterans Affairs, the Secretary of Agriculture, the Secretary
of Labor, and the Administrator of the Environmental
Protection Agency, shall establish";
(3) in subsection (b)(2)--
(A) in subparagraph (A), by striking "respond to a
bioterrorist attack; and" and inserting the following:
"respond 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) in subparagraph (B), by striking the period and
inserting "; and"; and
(C) by adding at the end the following subparagraph:
"(C) subject to compliance with other provisions of
Federal law, clarify the responsibilities among Federal
officials for the investigation of suspicious outbreaks of
disease, and revise the interagency plan known as the Federal
response plan accordingly.";
(4) in subsection (b)(3), by striking "Assistant Secretary
for Health" and inserting "Assistant Secretary for
Emergency Preparedness"; and
(5) in subsection (e) (as redesignated by section 104(1) of
this Act)--
(A) in paragraph (1), by striking "The Secretary" and all
that follows and inserting the following: "In consultation
with the working group established under subsection (b), the
Secretary shall, based on criteria established by the
Secretary, award grants to or enter into cooperative
agreements with eligible entities to increase their capacity
to detect, diagnose, and respond to acts of bioterrorism upon
the civilian population.";
(B) in paragraph (2)--
(i) by striking "or" after "clinic,"; and
(ii) by inserting before the period the following: ",
professional organizations and societies, schools or programs
that train medical laboratory personnel, private accrediting
organizations, or other nonprofit institutions or entities
meeting criteria established by the Secretary";
(C) in paragraph (3)--
(i) in the matter preceding subparagraph (A), by striking
"the priorities" and inserting "any priorities"; and
(ii) by striking subparagraphs (A) through (D) and
inserting the following:
"(A) developing community-wide plans involving the public
and private health care infrastructure to respond to
bioterrorism or other public health emergencies, which are
coordinated with the capacities of applicable national,
State, and local health agencies;
"(B) training health care professionals and public health
personnel to enhance the ability of such personnel to
recognize the symptoms and epidemiological characteristics of
exposure to a potential bioweapon, or other agents that may
cause a public health emergency;
"(C) addressing rapid and accurate identification of
potential bioweapons, or other agents that may cause a public
health emergency;
"(D) coordinating medical care for individuals during
public health emergencies, including bioterrorism;
"(E) conducting exercises to test the capability and
timeliness of public health emergency response activities;
"(F) facilitating and coordinating rapid communication of
data generated from a bioterrorist attack or public health
emergency among national, State, and local health agencies,
emergency response personnel, and health care providers and
facilities; and
"(G) purchasing or upgrading equipment, supplies,
pharmaceuticals or other countermeasures to enhance
preparedness for and response to bioterrorism or other public
health emergencies, consistent with a plan described in
subparagraph (A)."; and
(D) in paragraph (4)--
(i) in subparagraph (A), by striking "and" after the
semicolon at the end;
(ii) in subparagraph (B), by striking the period at the end
and inserting "; and"; and
(iii) by adding at the end the following subparagraph:
"(C) coordinate grants under this subsection with grants
under 319C.".
SEC. 109. IMPROVING STATE AND LOCAL CORE PUBLIC HEALTH
CAPACITIES.
Section 319C of the Public Health Service Act (42 U.S.C.
247d-3) is amended--
(1) in subsection (a), by striking "competitive "; and
(2) in subsection (c)--
(A) in paragraph (3), by striking "health care providers;
and" and inserting "health care providers, including poison
control centers;";
(B) by redesignating paragraph (4) as paragraph (7); and
(C) by inserting after paragraph (3) the following
paragraphs:
"(4) purchase or upgrade equipment, supplies,
pharmaceuticals or other countermeasures to enhance
preparedness for and response to bioterrorism or other public
health emergencies, consistent with a plan described in
paragraph (3);
[[Page H9200]]
"(5) conduct exercises to test the capability and
timeliness of public health emergency response activities;
"(6) within the meaning of part B of title XII, develop
and implement the trauma care component of the State plan for
the provision of emergency medical services; and";
SEC. 110. ANTIMICROBIAL RESISTANCE PROGRAM.
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 appropriate
DNA analysis, or other necessary 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. 111. STUDY 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 ensure
that 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 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. 112. 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 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. 113. 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), by striking "10 years" and
inserting "five years"; and
(2) in section 319B(a), in the first sentence, by striking
"10 years" and inserting "five years".
SEC. 114. STUDY REGARDING LOCAL EMERGENCY RESPONSE METHODS.
The Secretary of Health and Human Services shall conduct a
study of best-practices methods for the provision of
emergency response services through local governments
(including through contractors and volunteers of such
governments) in a consistent manner in response to acts of
bioterrorism or other public health emergencies. Not later
than 180 days after the date of the enactment of this Act,
the Secretary shall submit to the Congress a report
describing the findings of the study.
Subtitle B--National Stockpile; Development of Priority Countermeasures
SEC. 121. NATIONAL STOCKPILE.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the "Secretary") 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 adequate to meet the health
security needs of the United States, including consideration
of vulnerable populations (such as children, the elderly, and
individuals with disabilities), in the event of a
bioterrorist attack or other public health emergency.
(b) Procedures.--The Secretary, in managing the stockpile
under subsection (a), shall--
(1) consult with the Director of the Federal Emergency
Management Agency, the Secretary of Defense, the Secretary of
Veterans Affairs, the Attorney General, the Secretary of
Energy, and the Administrator of the Environmental Protection
Agency;
(2) ensure that adequate procedures are followed with
respect to such stockpile for inventory management and
accounting, and for the physical security of the stockpile;
(3) in consultation with Federal, State, and local
officials, take into consideration the timing and location of
special events;
(4) 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; and
(5) devise plans for the effective and timely distribution
of the stockpile, in consultation with appropriate Federal,
State and local agencies, and the public and private health
care infrastructure.
(c) 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).
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $1,155,000,000 for fiscal year 2002, and such
sums as may be necessary for each of fiscal years 2003
through 2006.
SEC. 122. ACCELERATED 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). Such a designation may be
made prior to the submission of--
(1) a request for designation by the sponsor; 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 from declining such a
designation.
(b) Review of Priority Countermeasure Not Designated as
Fast-Track Product.--A priority countermeasure shall be
subject to the performance goals established by the
Commissioner of Food and Drugs, unless it is designated as a
fast-track product.
(c) Definition.--For purposes of this section, the term
"priority countermeasure" means a drug or biological
product that is a countermeasure 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.
SEC. 123. USE OF ANIMAL TRIALS IN APPROVAL OF CERTAIN DRUGS
AND BIOLOGICS; ISSUANCE OF RULE.
Not later than 180 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 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).
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
Part B of title III of the Public Health Service Act, as
amended by section 112 of this Act, is amended by inserting
after section 319J the following section:
"SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
"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)(2)(C)).".
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND
DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as
redesignated by section 104(1) of this Act, is amended--
(1) by redesignating paragraphs (1) through (4), as
subparagraphs (A) through (D), respectively;
(2) by striking "The Secretary" and inserting the
following:
"(1) In general.--The Secretary";
(3) by moving each of subparagraphs (A) through (D) (as so
redesignated) two ems to the right; and
(4) by adding at the end the following:
"(2) Accelerated countermeasure research and
development.--
"(A) 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--
"(i) the epidemiology and pathogenesis of such pathogens;
[[Page H9201]]
"(ii) the development of new vaccines and therapeutics for
use against such pathogens and other agents;
"(iii) the development of diagnostic tests to detect such
pathogens and other agents; and
"(iv) other relevant areas of research;
with consideration given to the needs of children and other
vulnerable populations.
"(B) Role of department of veterans affairs.--In carrying
out subparagraph (A), 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 subparagraph, the
Secretary may enter into cooperative agreements with the
Secretary of Veterans Affairs to achieve such purposes.
"(C) Priority countermeasures.--For purposes of this
paragraph, the term `priority countermeasure' means a
countermeasure, including a drug, medical or other
technological device, biological product, or diagnostic test,
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.".
SEC. 126. EVALUATION OF NEW 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 evaluate new and emerging
technologies that are designed to improve or enhance the
ability of public health or safety officials to detect,
identify, diagnose, or 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--
(1) survey existing technology programs funded by the
Federal Government for potentially useful technologies;
(2) promptly issue a request 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 joint
interdepartmental 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 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 that provides a
list of priority technologies whose development or deployment
or both should be accelerated, and the estimated cost of
doing so.
SEC. 127. POTASSIUM IODIDE.
(a) In General.--Through the national stockpile under
section 121, the Secretary of Health and Human Services (in
this section referred to as the "Secretary"), subject to
subsection (b), 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, that are within 20 miles of a nuclear
power plant, in quantities sufficient to provide adequate
protection for the populations within such miles.
(b) State and Local Plans.--Subsection (a) applies with
respect to a State or local government if the government
involved meets the following conditions:
(1) Such government submits to the Secretary, and to the
Director of the Federal Emergency Management Agency, 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.
(2) The plan is accompanied by certifications by such
government that--
(A) the government has not received sufficient quantities
of potassium iodide tablets from the Nuclear Regulatory
Commission; and
(B) in the case of a local government, such government has
submitted the plan to the State involved.
(c) Guidelines.--In consultation with the Director of the
Federal Emergency Management Agency and with the Nuclear
Regulatory Commission, the Secretary 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.
(d) Information.--The Secretary shall carry out activities
to inform State and local governments of the program under
this section.
(e) Report.--Not later than six months after the date of
the enactment of this Act, the Secretary shall submit to the
Congress a report--
(1) on whether potassium iodide tablets have been made
available under subsection (a) and the extent to which State
and local governments have established stockpiles of such
tablets; and
(2) the measures taken by the Secretary to implement this
section.
(f) Applicability.--Subsections (a) and (d) cease to apply
as requirements if the Secretary determines that there is an
alternative and more effective medical treatment to address
adverse thyroid conditions that may result from the release
of radionuclides from nuclear power plants.
Subtitle C--Emergency Authorities; Additional Provisions
SEC. 131. EXPANDED AUTHORITY OF SECRETARY OF HEALTH AND HUMAN
SERVICES TO RESPOND TO PUBLIC HEALTH
EMERGENCIES.
(a) Transfers of Funds.--Section 319 of the Public Health
Service Act (42 U.S.C. 247d) is amended by adding at the end
the following:
"(d) Transfers of Funds Between Programs and Accounts.--
"(1) In general.--At any time during a public health
emergency declared by the Secretary under subsection (a), the
Secretary may, subject to paragraph (2), transfer funds, to
the extent authorized by law, between appropriations accounts
administered by the Secretary under this Act, without regard
to any waiting period imposed by any other provision of law,
including any provision of an appropriations Act, except as
provided in paragraphs (3) and (4).
"(2) Amount of transfers.--With respect to the public
health emergency involved:
"(A) The Secretary may not make a transfer under paragraph
(1) in an amount exceeding a reasonable estimate by the
Secretary of the amount necessary to respond to the emergency
involved for a period of 60 days.
"(B) Subsequent transfers under paragraph (1) may be made
by the Secretary, subject to compliance with subparagraph
(A).
"(3) Notification.--Not later than 48 hours prior to
making a transfer under paragraph (1), the Secretary shall
submit a notice of the intent to make such transfer to the
Committee on Appropriations of the House of Representatives,
the Committee on Energy and Commerce of the House of
Representatives, the Committee on Appropriations of the
Senate, and the Committee on Health, Education, Labor, and
Pensions of the Senate.
"(4) Scope.--Paragraph (1) shall apply, notwithstanding
any other provision of law including any provision of an
appropriations Act and any Act enacted after the date of
enactment of this subsection, unless such provision
specifically refers to and overrides this subsection.".
(b) Reporting Deadlines.--Section 319 of the Public Health
Service Act (42 U.S.C. 247d), as amended by subsection (a),
is further amended by adding at the end the following:
"(e) 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
declared 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 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. 132. 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 by inserting "or exposed to" after "to be infected
with".
(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
inserting "or exposed to" after "to be infected with".
(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
[[Page H9202]]
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. 133. 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. AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL
EMERGENCIES.
"(a) Purpose.--
"(1) In general.--The 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--
"(A) 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
"(B) that health care providers (as defined in subsection
(g)) 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.
"(2) Emergency area; emergency period.--For purposes of
this section, 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.
"(b) Secretarial Authority.--To the extent necessary to
accomplish the purposes 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 in
any emergency area (or portion of such an area) during an
emergency period, the requirements of titles XVIII, XIX, or
XXI, or any regulation thereunder (and the requirements of
this title, and regulations thereunder, insofar as they
relate to such titles), pertaining to--
"(1) conditions of participation or other certification
requirements for an individual health care provider or types
of providers; program participation and similar requirements
for an individual health care provider or types of providers;
and 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;
"(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); and
"(5) deadlines and timetables for performance of required
activities, except that such deadlines and timetables may
only be modified, not waived.
"(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) Notification of Congress.--The Secretary shall
provide 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 notice shall include a
description of the specific provisions that will be waived or
modified, the health care providers to whom the waiver or
modification will apply, the geographic area in which the
waiver or modification will apply, and the period of time for
which the waiver or modification will be in effect.
"(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 (a)(2)(B);
"(B) the termination of the applicable declaration of
public health emergency described in subsection (a)(2)(B); or
"(C) subject to paragraph (2), the termination of a period
of 90 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 90-day periods.--The Secretary may, by
notice, provide for an extension of a 90-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,
90 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 the success of
such approaches and recommendations for improved approaches
should the need for such emergency authority arise in the
future.
"(g) Health Care Provider Defined.--For purposes of this
section, 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 amendments made by subsection (a)
shall be effective on and after September 11, 2001.
SEC. 134. PROVISION FOR EXPIRATION OF PUBLIC HEALTH
EMERGENCIES.
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.".
SEC. 135. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT
PLAN.
Section 613(b) of the Robert T. Stafford Disaster Relief
and Emergency Assistance Act (42 U.S.C. 5196b(b)) is
amended--
(1) in paragraph (5), by striking "and" at the end;
(2) in paragraph (6), by striking the period and inserting
"; and"; and
(3) by adding at the end the following:
"(7) include a plan for providing information to the
public in a coordinated manner.".
SEC. 136. EXPANDED RESEARCH BY SECRETARY OF ENERGY.
(a) In General.--In coordination with the joint
interdepartmental working group under section 319F(a) of the
Public Health Service Act, the Secretary of Energy and the
Administrator of the National Nuclear Security Administration
shall expand, enhance, and intensify research relevant to the
rapid detection and identification of pathogens likely to be
used in a bioterrorism attack or other agents that may cause
a public health emergency.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2002 through 2006.
SEC. 137. AGENCY FOR TOXIC SUBSTANCE AND DISEASE REGISTRY.
(a) In General.--In planning for and responding to
bioterrorism and other public health emergencies, including
assisting State health departments, the Secretary of Health
and Human Services (in this section referred to as the
"Secretary") shall take into account the role and expertise
of the Agency for Toxic Substances and Disease Registry (in
this section referred to as "ATSDR").
(b) Authorization of Appropriations.--For the purpose of
providing resources (including increased personnel, as
appropriate) for ATSDR to use authorities under section
104(i) of the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 to assist the
Secretary in planning for or responding to bioterrorism or
other public health emergencies, there are authorized to be
appropriated to the Secretary such sums as may be necessary
for each of the fiscal years 2002 through 2006, in addition
to any other authorizations of appropriations that are
available for such purpose.
SEC. 138. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.
The Secretary, acting through the Director of the National
Institute of Occupational Safety and Health, shall enhance
and expand research as deemed appropriate on the health and
safety of workers who are at risk for bioterrorist threats or
attacks in the workplace.
SEC. 139. TECHNOLOGY OPPORTUNITIES PROGRAM SUPPORT.
For fiscal years 2003 and 2004, all of the information
infrastructure grants provided by the National
Telecommunications and Information Administration (under the
program also known as the Technology Opportunities Program)
shall be used to provide grants to health providers to
facilitate participation in the national public health
communications and surveillance networks authorized under
section 319D(b)(3) of the Public Health Service Act.
Subtitle D--Authorization of Appropriations
SEC. 151. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For the purpose of carrying out activities
of the Department of Health and Human Services in accordance
with the provisions referred to in subsection (b), including
making awards of grants, cooperative agreements, or contracts
and providing other assistance to States and other public or
private entities, there are authorized to be appropriated
$2,720,000,000 for fiscal year 2002, and such sums as may be
necessary for each of the fiscal years 2003 through 2006.
(b) Relevant Provisions.--For purposes of this section, the
provisions referred to in this subsection are--
[[Page H9203]]
(1) the provisions of this title;
(2) sections 319A through 319K of the Public Health Service
Act;
(3) title XXVIII of such Act; and
(4) section 301 of such Act, to the extent that such
section is used as the authority of the Secretary of Health
and Human Services to carry out activities to supplement the
activities carried out under the provisions referred to in
paragraphs (1) through (3);
except that this section does not have any applicability with
respect to the use of section 301 of such Act as authority
for activities of the National Institutes of Health.
(c) Fiscal Year 2002.--
(1) In general.--The aggregate amount of authorizations of
appropriations under this title and under the Public Health
Service Act for fiscal year 2002 for the purpose described in
subsection (a) does not exceed the amount specified for
fiscal year 2002 in such subsection, notwithstanding other
authorizations of appropriations.
(2) Allocations of authorizations.--Of the amount that is
authorized to be appropriated under subsection (a) for fiscal
year 2002, the following authorizations of appropriations for
such fiscal year for the purpose described in such subsection
apply:
(A) For making awards of grants, cooperative agreements, or
contracts and providing other assistance to States and other
public or private entities, $1,000,000,000 is authorized, of
which--
(i) $455,000,000 is authorized for grants under section
319C of the Public Health Service Act;
(ii) $455,000,000 is authorized for grants or cooperative
agreements under section 319F of such Act; and
(iii) $40,000,000 is authorized for grants or cooperative
agreements under section 319H of the Public Health Service
Act, as added by section 106 of this Act (relating to
shortages of certain health professionals).
(B) For the national stockpile under section 121 of this
Act, other than activities of the National Institutes of
Health regarding smallpox vaccine, $1,155,000,000 is
authorized, of which $509,000,0000 is authorized for the
acquisition of smallpox vaccine.
(C) For the Centers for Disease Control and Prevention,
other than purposes to which the authorization established in
subparagraph (A) applies, $450,000,000, of which $300,000,000
is authorized for facilities of such Centers for purposes
described in section 399D(c) of the Public Health Service
Act.
(D) For activities on antimicrobial resistance under
section 319E of such Act, $25,000,000 is authorized.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Biological Agents Provisions of the Antiterrorism and
Effective Death Penalty Act of 1996; Codification in the
Public Health Service Act, With Amendments.--
(1) Public health service act.--Subpart 1 of part F of
title III of the Public Health Service Act (42 U.S.C. 262 et
seq.) is amended by inserting after section 351 the
following:
"SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS
AND TOXINS.
"(a) Regulatory Control of Certain Biological Agents and
Toxins.--
"(1) List of biological agents and toxins.--
"(A) In general.--The Secretary shall by regulation
establish and maintain a list of each biological agent and
each toxin that has the potential to pose a severe threat to
public health and safety.
"(B) Criteria.--In determining whether to include an agent
or toxin on the list under subparagraph (A), the Secretary
shall--
"(i) consider--
"(I) the effect on human health of exposure to the agent
or toxin;
"(II) the degree of contagiousness of the agent or toxin
and the methods by which the agent or toxin is transferred to
humans;
"(III) the availability and effectiveness of immunizations
to prevent and treatments for any illness resulting from
infection by the agent or toxin; and
"(IV) any other criteria that the Secretary considers
appropriate; and
"(ii) consult with scientific experts representing
appropriate professional groups.
"(2) Biennial publication.--The Secretary shall publish
the list under paragraph (1) biennially, or at such more
frequent intervals as the Secretary determines to be
appropriate. Before publishing the list, the Secretary shall
review the list, and shall make such revisions as are
appropriate to protect the public health and safety. In
reviewing and revising the list, the Secretary shall consider
the needs of vulnerable populations, including children, and
shall consult with appropriate Federal agencies and State and
local public health officials.
"(b) Regulation of Transfers of Listed Biological Agents
and Toxins.--The Secretary shall by regulation provide for--
"(1) the establishment and enforcement of safety
procedures for the transfer of biological agents and toxins
listed pursuant to subsection (a)(1), including measures to
ensure--
"(A) proper training and appropriate skills to handle such
agents and toxins; and
"(B) proper laboratory facilities to contain and dispose
of such agents and toxins;
"(2) safeguards to prevent access to such agents and
toxins for use in domestic or international terrorism or for
any other criminal purpose;
"(3) the establishment of procedures to protect the public
safety in the event of a transfer or potential transfer of a
biological agent or toxin in violation of the safety
procedures established under paragraph (1) or the safeguards
established under paragraph (2); and
"(4) appropriate availability of biological agents and
toxins for research, education, and other legitimate
purposes.
"(c) Possession and Use of Listed Biological Agents and
Toxins.--The Secretary shall by regulation provide for the
establishment and enforcement of standards and procedures
governing the possession and use of biological agents and
toxins listed pursuant to subsection (a)(1) in order to
protect the public health and safety, including the measures,
safeguards, procedures, and availability of such agents and
toxins described in paragraphs (1) through (4) of subsection
(b), respectively.
"(d) Registration and Traceability Mechanisms; Database.--
Regulations under subsections (b) and (c) shall require
registration of the possession, use, and transfer of
biological agents and toxins listed pursuant to subsection
(a)(1), and such registration shall include (if available to
the registered person) information regarding the
characterization of such biological agents and toxins to
facilitate their identification and traceability. The
Secretary shall maintain a national database of the location
of such agents and toxins, with information regarding their
characterizations.
"(e) Inspections.--The Secretary may conduct inspections
to ensure that persons subject to regulations under
subsection (b) or (c) are in compliance with such
regulations, including provisions regarding security and
restrictions on access under subsection (g).
"(f) Exemptions.--The Secretary may establish exemptions
from the applicability of provisions of regulations under
subsection (b) or (c) if the Secretary determines that such
exemptions are consistent with protecting the public health
and safety. In the case of a clinical laboratory that is in
possession of a biological agent or toxin listed pursuant to
subsection (a)(1), such an exemption may be provided only if
such agent or toxin has been presented for diagnosis,
verification, or proficiency testing, and upon identification
or verification of the agent or toxin, such laboratory--
"(1) promptly notifies the Secretary or other public
health authorities when required under Federal or State law;
and
"(2) transfers or destroys the agent or toxin in
accordance with such regulations.
"(g) Security Requirements for Registered Persons.--
"(1) In general.--In carrying out the provisions of
subsections (b) and (c) that relate to safeguards, the
Secretary, in consultation with the Attorney General, shall
by regulation establish appropriate security requirements for
persons possessing, using, or transferring biological agents
or toxins listed pursuant to subsection (a)(1), and ensure
compliance with such requirements as a condition of
registration under subsection (b) or (c).
"(2) Limiting access to listed agents and toxins.--
"(A) In general.--Regulations issued under subsections (b)
and (c) shall include provisions--
"(i) to restrict access to biological agents and toxins
listed pursuant to subsection (a)(1) to only those
individuals who have a legitimate need for access, as
determined according to the purposes for which the
registration under such regulations is provided; and
"(ii) to ensure that individuals granted such access are
not--
"(I) restricted persons, as defined in section 175b of
title 18, United States Code;
"(II) named in a warrant issued to a Federal or State law
enforcement agency for participation in any domestic or
international act of terrorism or other act of violence;
"(III) under investigation for involvement with a domestic
or international terrorist or criminal organization by any
Federal law enforcement or intelligence agency; or
"(IV) suspected by any Federal law enforcement or
intelligence agency of seeking to obtain covertly information
relating to biological agents or toxins on behalf of the
intelligence or military operations of a foreign nation.
"(B) Screening protocol.--To carry out subparagraph (A),
the Secretary shall require that registered persons promptly
submit the names and other identifying information for
individuals described in subparagraph (A)(i) to the Secretary
and the Attorney General, with which information the Attorney
General shall promptly use criminal, immigration, and
national security databases available to the Federal
Government to identify whether such individuals satisfy the
conditions for access under subparagraph (A)(ii). The
Secretary, in consultation with the Attorney General and
other Federal agencies, shall periodically review and as
appropriate revise the protocol for screening individuals for
purposes of subparagraph (A), and may require by regulation
additional screening measures if determined necessary to
achieve the purposes of this section.
"(3) Assistance for certain entities.--The Secretary, in
consultation with the Attorney General, may make awards of
grants, contracts, or cooperative agreements to public and
nonprofit private entities (other than Federal agencies), and
may provide technical assistance to such entities, to improve
security of the facilities of registered persons.
[[Page H9204]]
"(h) Disclosure of Information.--
"(1) In general.--Any information in the possession of any
Federal agency that identifies a person, or the geographic
location of a person, who is registered pursuant to
regulations under this section (including regulations
promulgated before the effective date of this subsection),
and any site-specific information relating to the type,
quantity, or identity of a biological agent or toxin listed
pursuant to subsection (a)(1) or the site-specific security
mechanisms in place to protect such agents and toxins, shall
not be disclosed under section 552(a) of title 5, United
States Code.
"(2) Disclosures for public health and safety; congress.--
Nothing in this section may be construed as preventing the
head of any Federal agency--
"(A) from making disclosures of information described in
paragraph (1) for purposes of protecting the public health
and safety; or
"(B) from making disclosures of such information to any
committee or subcommittee of the Congress with appropriate
jurisdiction, upon request.
"(i) Civil Money Penalty.--
"(1) In general.--In addition to any other penalties that
may apply under law, any person who violates any provision of
regulations under subsection (b) or (c) shall be subject to
the United States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and $500,000
in the case of any other person.
"(2) Applicability of certain provisions.--The provisions
of section 1128A of the Social Security Act (other than
subsections (a), (b), (h), and (i), the first sentence of
subsection (c), and paragraphs (1) and (2) of subsection (f))
shall apply to a civil money penalty under paragraph (1) in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A(a) of such Act. The Secretary
may delegate authority under this subsection in the same
manner as provided in section 1128A(j)(2) of the Social
Security Act, and such authority shall include all powers as
contained in section 6 of the Inspector General Act of 1978.
"(j) Coordination With Regulations Under Virus-Serum-Toxin
Act.--
"(1) In general.--In establishing and enforcing
regulations under subsections (b) and (c), the Secretary
shall consult with the Secretary of Agriculture to ensure
that such activities are coordinated, to the greatest extent
practicable, with regulations governing certain biological
agents and toxins listed pursuant to subsection (a)(1) issued
by the Secretary of Agriculture under the Act commonly known
as the Virus-Serum-Toxin Act (the eighth paragraph under the
heading `Bureau of Animal Industry' in the Act of March 4,
1913; 21 U.S.C. 151-159) (in this subsection referred to as
the `VST Act'). The purpose of such coordination shall be--
"(A) to minimize any conflicts between the regulations
issued by, or the activities of, the Secretary of Health and
Human Services and the Secretary of Agriculture with respect
to such agents and toxins;
"(B) to minimize the administrative burden on persons
subject to regulations under both this section and the VST
Act;
"(C) to ensure the appropriate availability of such agents
and toxins for legitimate agricultural or veterinary
research, education, or other such purposes; and
"(D) to ensure the establishment of a national database of
such agents or toxins pursuant to subsection (d).
"(2) Persons regulated by department of agriculture.--With
respect to persons possessing or using biological agents or
toxins listed pursuant to subsection (a)(1) who, as of the
date of enactment of the Public Health Security and
Bioterrorism Response Act of 2001, possess an unexpired,
unrevoked, and unsuspended permit or license from the
Department of Agriculture for such possession or use, such
persons may, for purposes of registration under subsection
(b) or (c), submit to the Secretary of Health and Human
Services the same information previously provided to the
Secretary of Agriculture to obtain such permit or license,
provided that the information so submitted is accurate as of
the time of submittal to the Secretary of Health and Human
Services, and provided further that such Secretary may, after
review of such submission, request such additional
information as the Secretary determines to be necessary to
achieve the purposes of this section.
"(3) Savings provision.--Nothing in this section shall be
construed as limiting any authority of the Secretary of
Agriculture under the VST Act or any regulations issued
thereunder.
"(k) Definitions.--For purposes of this section:
"(1) The terms `biological agent' and `toxin' have the
meanings given such terms in section 178 of title 18, United
States Code.
"(2) The term `registered person' means a person
registered under regulations under subsection (b) or (c).
"(l) 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.".
(2) Relation to other laws.--
(A) Rule of construction.--Regulations promulgated by the
Secretary of Health and Human Services under section 511 of
the Antiterrorism and Effective Death Penalty Act of 1996 are
deemed to have been promulgated under section 351A of the
Public Health Service Act, as added by paragraph (1) of this
subsection. Such regulations, including the list under
subsection (d)(1) of such section 511, that were in effect on
the day before the date of the enactment of this Act remain
in effect until modified by the Secretary (including any
revisions required under subsection (a)(2) of such section
351A).
(B) Conforming amendment.--Subsections (d), (e), (f), and
(g) of section 511 of the Antiterrorism and Effective Death
Penalty Act of 1996 (42 U.S.C. 262 note) are repealed.
(3) Date certain for promulgation of certain regulations;
effective date regarding criminal and civil penalties.--With
respect to section 351A of the Public Health Service Act (as
added by paragraph (1) of this subsection):
(A) Not later than 30 days after the date of the enactment
of this Act, the Secretary of Health and Human Services shall
promulgate an interim final rule requiring all persons in
possession of biological agents or toxins listed pursuant to
subsection (a)(1) of such section (unless exempt under
subsection (e) of such section) to provide notice to the
Secretary of such possession, and to include in the notice
such additional information as the Secretary may require for
compliance with subsection (d) of such section or any other
provision of such section, by not later than 30 days after
the date on which such rule is promulgated. Such interim
final rule takes effect on the date on which the rule is
promulgated, except as follows:
(i) For purposes of section 175b(c) of title 18, United
States Code (relating to criminal penalties), as added by
subsection (a)(1)(E) of this section, the rule takes effect
60 days after the date on which the rule is promulgated.
(ii) For purposes of subsection (i) of such section 351A
(relating to civil penalties), the rule takes effect 60 days
after the date on which the rule is promulgated.
(B) Not later than 120 days after the date of enactment of
this Act, such Secretary shall promulgate an interim final
rule for carrying out subsections (b) and (c) of such section
351A. Such interim final rule takes effect 60 days after the
date on which the rule is promulgated.
(4) Effective date regarding disclosure of information.--
Subsection (h) of section 351A of the Public Health Service
Act, as added by paragraph (1) of this subsection, is deemed
to have taken effect on the effective date of the
Antiterrorism and Effective Death Penalty Act of 1996.
(b) Criminal Penalties Regarding Select Agents.--
(1) In general.--Section 175b of title 18, United States
Code, as added by section 817 of Public Law 107-56, is
amended--
(A) by striking "(a)" and inserting "(a)(1)";
(B) by transferring subsection (c) from the current
placement of the subsection and inserting the subsection
before subsection (b);
(C) by striking "(c)" and inserting "(2);
(D) by redesignating subsection (b) as subsection (d); and
(E) by inserting before subsection (d) (as so redesignated)
the following subsections:
"(b) Transfer to Unregistered Person.--Whoever knowingly
transfers a select agent to a person without first verifying
with the Secretary of Health and Human Services that the
person has obtained a registration required by regulations
under subsection (b) or (c) of section 351A of the Public
Health Service Act shall be fined under this title, or
imprisoned for not more than 5 years, or both.
"(c) Unregistered for Possession.--Whoever knowingly
possesses a biological agent or toxin where such agent or
toxin is a select agent for which such person has not
obtained a registration required by regulations under section
351A(c) of the Public Health Service Act shall be fined under
this title, or imprisoned for not more than 5 years, or
both.".
(2) Conforming amendments.--Chapter 10 of title 18, United
States Code, is amended--
(A) in section 175b (as added by section 817 of Public Law
107-56 and amended by paragraph (1) of this subsection)--
(i) in subsection (d)(1), by striking "The term" and all
that follows through "does not include" and inserting the
following: "The term `select agent' means a biological agent
or toxin to which subsection (a) applies. Such term
(including for purposes of subsection (a)) does not
include"; and
(ii) in the heading for the section, by striking
"Possession by restricted persons" and inserting "Select
agents"; and
(B) in the chapter analysis, in the item relating to
section 175b, by striking "Possession by restricted
persons." and inserting "Select agents.".
(3) Technical corrections.--Chapter 10 of title 18, United
States Code, as amended by section 817 of Public Law 107-56
and paragraphs (1) and (2) of this subsection, is amended--
(A) in section 175--
(i) in subsection (a), in the second sentence, by striking
"this section" and inserting "this subsection"; and
(ii) in subsection (c), by striking "protective" and all
that follows and inserting "protective, bona fide research,
or other peaceful purposes.";
(B) in section 175b--
(i) in subsection (a)(1), by striking "described in
subsection (b)" and all that follows and inserting the
following: "shall ship or transport in or affecting
interstate or foreign commerce, or possess in or affecting
interstate or foreign commerce, any biological agent or
toxin, or receive any biological agent or toxin that has been
shipped or
[[Page H9205]]
transported in interstate or foreign commerce, if the
biological agent or toxin is listed as a select agent in
Appendix A of part 72 of title 42, Code of Federal
Regulations, pursuant to section 351A of the Public Health
Service Act, and is not exempted under subsection (h) of
section 72.6, or Appendix A of part 72, of title 42, Code of
Federal Regulations."; and
(ii) in subsection (d)(3), by striking "section
1010(a)(3)" and inserting "section 101(a)(3)";
(C) in section 176(a)(1)(A), by striking "exists by reason
of" and inserting "pertains to"; and
(D) in section 178--
(i) in paragraph (1), by striking "means any micro-
organism" and all that follows through "product, capable
of" and inserting the following: "means any microorganism
(including, but not limited to, bacteria, viruses, fungi,
rickettsiae or protozoa), or infectious substance, or any
naturally occurring, bioengineered or synthesized component
of any such microorganism or infectious substance, capable
of";
(ii) in paragraph (2), by striking "means the toxic" and
all that follows through "including--" and inserting the
following: "means the toxic material or product of plants,
animals, microorganisms (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or protozoa), or
infectious substances, or a recombinant or synthesized
molecule, whatever their origin and method of production, and
includes--"; and
(iii) in paragraph (4), by striking "recombinant
molecule," and all that follows through "biotechnology,"
and inserting "recombinant or synthesized molecule,".
(4) Additional technical correction.--Section 2332a of
title 18, United States Code, is amended--
(A) in subsection (a), in the matter preceding paragraph
(1), by striking "section 229F)" and all that follows
through "section 178)--" and inserting "section 229F)--";
and
(B) in subsection (c)(2)(C), by striking "a disease
organism" and inserting "a biological agent, toxin, or
vector (as those terms are defined in section 178 of this
title)".
(c) Security Upgrades at the Department of Health and Human
Services.--For the purpose of enabling the Secretary of
Health and Human Services to secure existing facilities of
the Department of Health and Human Services where biological
agents or toxins listed under section 351A(a)(1) of the
Public Health Service Act are housed or researched, or where
vaccines are housed or researched, there are authorized to be
appropriated such sums as may be necessary for fiscal year
2002 and each subsequent fiscal year.
(d) Report to Congress.--Not later than 1 year after the
date of the enactment of this Act, the Secretary of Health
and Human Services, after consultation with other appropriate
Federal agencies, shall submit to the Congress a report
that--
(1) describes the extent to which there has been compliance
by governmental and private entities with applicable
regulations under section 351A of the Public Health Service
Act (as added by subsection (a) of this section), including
the extent of compliance before the date of the enactment of
this Act, and including the extent of compliance with
regulations promulgated after such date of enactment;
(2) describes the actions to date and future plans of the
Secretary for updating the list of biological agents and
toxins under such section 351A;
(3) describes the actions to date and future plans of the
Secretary for determining compliance with regulations under
such section 351A and for taking appropriate enforcement
actions; and
(4) provides any recommendations of the Secretary for
administrative or legislative initiatives regarding such
section 351A.
TITLE III-AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT
Subtitle A--Protection of Food Supply
SEC. 301. PROTECTION AGAINST INTENTIONAL ADULTERATION OF
FOOD.
(a) Increasing Inspections for Detection of Intentional
Adulteration of Food.--Section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381) is amended by adding at the
end the following subsection:
"(h)(1) The Secretary shall give high priority to
increasing the number of inspections under this section for
the purpose of enabling the Secretary to inspect food offered
for import at ports of entry into the United States, with the
greatest priority given to inspections to detect the
intentional adulteration of food.".
(b) Improvements to Information Management Systems.--
Section 801(h) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (a) of this section, is amended by
adding at the end the following paragraphs:
"(2) The Secretary shall give high priority to making
necessary improvements to the information management systems
of the Food and Drug Administration that contain information
related to foods imported or offered for import into the
United States for purposes of improving the ability of the
Secretary to allocate resources, detect the intentional
adulteration of food, and facilitate the importation of food
that is in compliance with this Act.
"(3) 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, periodic reports describing the activities of the
Secretary under paragraphs (1) and (2).".
(c) Testing for Rapid Detection of Intentional Adulteration
of Food.--Section 801 of the Federal Food, Drug, and Cosmetic
Act, as amended by subsection (a) of this section, is amended
by adding at the end the following:
"(i)(1) For use in inspections of food under this section,
the Secretary shall provide for research on the development
of tests and sampling methodologies--
"(A) whose purpose is to test food in order to rapidly
detect the adulteration of the food, with the greatest
priority given to detect the intentional adulteration of
food; and
"(B) whose results offer significant improvements over the
available technology in terms of accuracy, timing, or costs.
"(2) In providing for research under paragraph (1), the
Secretary shall give priority to conducting research on the
development of tests that are suitable for inspections of
food at ports of entry into the United States.
"(3) In providing for research under paragraph (1), the
Secretary shall as appropriate coordinate with the Director
of the Centers for Disease Control and Prevention, the
Director of the National Institutes of Health, the
Administrator of the Environmental Protection Agency, and the
Secretary of Agriculture.
"(4) The Secretary shall annually 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 progress made in research
under paragraph (1), including progress regarding paragraph
(2).".
(d) Assessment of Threat of Intentional Adulteration of
Food.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall ensure
that, not later than six months after the date of the
enactment of this Act--
(1) the assessment that (as of such date of enactment) is
being conducted on the threat of the intentional adulteration
of food is completed; and
(2) a report describing the findings of the assessment is
submitted to the Committee on Energy and Commerce of the
House of Representatives and to the Committee on Health,
Education, Labor, and Pensions of the Senate.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section and the amendments made by this
section, there are authorized to be appropriated $100,000,000
for fiscal year 2002, and such sums as may be necessary for
each of the fiscal years 2003 through 2006, in addition to
other authorizations of appropriations that are available for
such purpose.
SEC. 302. ADMINISTRATIVE DETENTION.
(a) Expanded Authority.--Section 304 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding
at the end the following subsection:
"(h) Administrative Detention of Foods.--
"(1) Detention authority.--
"(A) In general.--An officer or qualified employee of the
Food and Drug Administration may order the detention, in
accordance with this subsection, of any article of food that
is found during an inspection, examination, or investigation
under this Act conducted by such officer or qualified
employee, if the officer or qualified employee has credible
evidence or information indicating that such article presents
a threat of serious adverse health consequences or death to
humans or animals.
"(B) Secretary's approval.--An article of food may be
ordered detained under subparagraph (A) only if the Secretary
or an official designated by the Secretary approves the
order. An official may not be so designated unless the
official is the director of the district under this Act in
which the article involved is located, or is an official
senior to such director.
"(2) Period of detention.--An article of food may be
detained under paragraph (1) for a reasonable period, not to
exceed 20 days, unless a greater period, not to exceed 30
days, is necessary, to enable the Secretary to institute an
action under subsection (a) or section 302. The Secretary
shall by regulation provide for procedures for instituting
such action on an expedited basis with respect to perishable
foods.
"(3) Security of detained article.--An order under
paragraph (1) with respect to an article of food may require
that such article be labeled or marked as detained, and may
require that the article be removed to a secure facility. An
article subject to such an order shall not be transferred by
any person from the place at which the article is ordered
detained, or from the place to which the article is so
removed, as the case may be, until released by the Secretary
or until the expiration of the detention period applicable
under such order, whichever occurs first.
"(4) Appeal of detention order.--With respect to an
article of food ordered detained under paragraph (1), any
person who would be entitled to be a claimant for such
article if the article were seized under subsection (a) may
appeal the order to the Secretary. Within 72 hours after such
an appeal is filed, the Secretary, after providing
opportunity for an informal hearing, shall confirm or
terminate the order involved, and such confirmation by the
Secretary shall be considered a final agency action for
purposes of section 702 of
[[Page H9206]]
title 5, United States Code. If during such 72-hour period
the Secretary fails to provide such an opportunity, or to
confirm or terminate such order, the order is deemed to be
terminated.".
(b) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the
end the following:
"(bb) The transfer of an article of food in violation of
an order under section 304(h), or the removal or alteration
of any mark or label required by the order to identify the
article as detained.".
(c) Temporary Holds at Ports of Entry.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
301(c) of this Act, is amended by adding at the end the
following:
"(j)(1) If an officer or qualified employee of the Food
and Drug Administration has credible evidence or information
indicating that an article of food presents a threat of
serious adverse health consequences or death to humans or
animals, and such officer or qualified employee is unable to
inspect, examine, or investigate such article upon the
article being offered for import at a port of entry into the
United States, the officer or qualified employee shall
request the Secretary of Treasury to hold the food at the
port of entry for a reasonable period of time, not to exceed
24 hours, for the purpose of enabling the Secretary to
inspect, examine, or investigate the article as appropriate.
"(2) The Secretary shall request the Secretary of Treasury
to remove an article held pursuant to paragraph (1) to a
secure facility, as appropriate. During the period of time
that such article is so held, the article shall not be
transferred by any person from the port of entry into the
United States for the article, or from the secure facility to
which the article has been removed, as the case may be.
"(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if
the Secretary or an official designated by the Secretary
approves the request. An official may not be so designated
unless the official is the director of the district under
this Act in which the article involved is located, or is an
official senior to such director.
"(4) With respect to an article of food for which a
request under paragraph (1) is made, the Secretary, promptly
after the request is made, shall notify the State in which
the port of entry involved is located that the request has
been made, and as applicable, that such article is being held
under this subsection.".
SEC. 303. PERMISSIVE DEBARMENT REGARDING FOOD IMPORTATION.
(a) In General.--Section 306(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking "or" after the comma
at the end;
(B) in subparagraph (B), by striking the period at the end
and inserting ", or"; and
(C) by adding at the end the following subparagraph:
"(C) a person from importing an article of food or
offering such an article for import into the United
States.";
(2) in paragraph (2), in the matter preceding subparagraph
(A), by inserting "subparagraph (A) or (B) of" before
"paragraph (1)";
(3) by redesignating paragraph (3) as paragraph (4); and
(4) by inserting after paragraph (2) the following
paragraph:
"(3) Persons subject to permissive debarment; food
importation.--A person is subject to debarment under
paragraph (1)(C) if--
"(A) the person has been convicted of a felony for conduct
relating to the importation into the United States of any
article of food; or
"(B)(i) the person has repeatedly imported or offered for
import adulterated articles of food; and
"(ii) the person knew, or should have known, that such
articles were adulterated.".
(b) Conforming Amendments.--Section 306 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended--
(1) in subsection (a), in the heading for the subsection,
by striking "Mandatory Debarment.--" and inserting
"Mandatory Debarment; Certain Drug Applications.--";
(2) in subsection (b)--
(A) in the heading for the subsection, by striking
"Permissive Debarment.--" and inserting "Permissive
Debarment; Certain Drug Applications; Food Imports.--"; and
(B) in paragraph (2), in the heading for the paragraph, by
striking "permissive debarment.--" and inserting
"permissive debarment; certain drug applications.--";
(3) in subsection (c)(2)(A)(iii), by striking "subsection
(b)(2)" and inserting "paragraph (2) or (3) of subsection
(b)";
(4) in subsection (d)(3)--
(A) in subparagraph (A)(i), by striking "or (b)(2)(A)"
and inserting " or paragraph (2)(A) or (3) o