(C) by adding at the end the following sub-
paragraph:
‘‘(C) subject to compliance with other pro-
visions of Federal law, clarify the responsibil-
ities among Federal officials for the investiga-
tion of suspicious outbreaks of disease, and re-
vise the interagency plan known as the Federal
response plan accordingly.’’;
(4) in subsection (b)(3), by striking ‘‘Assistant
Secretary for Health’’ and inserting ‘‘Assistant Sec-
retary 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 Sec-
retary shall, based on criteria established by the
Secretary, award grants to or enter into cooper-
ative agreements with eligible entities to in-
crease 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 ac-
crediting organizations, or other nonprofit
institutions or entities meeting criteria es-
tablished by the Secretary’’;
(C) in paragraph (3)—
(i) in the matter preceding subpara-
graph (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 in-
volving the public and private health care infra-
structure to respond to bioterrorism or other
public health emergencies, which are coordi-
nated 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 identi-
fication of potential bioweapons, or other agents
that may cause a public health emergency;
‘‘(D) coordinating medical care for individ-
uals during public health emergencies, including
bioterrorism;
‘‘(E) conducting exercises to test the capa-
bility and timeliness of public health emergency
response activities;
‘‘(F) facilitating and coordinating rapid
communication of data generated from a bioter-
rorist attack or public health emergency among
national, State, and local health agencies, emer-
gency response personnel, and health care pro-
viders and facilities; and
‘‘(G) purchasing or upgrading equipment,
supplies, pharmaceuticals or other counter-
measures to enhance preparedness for and re-
sponse 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 fol-
lowing subparagraph:
‘‘(C) coordinate grants under this sub-
section 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 en-
hance preparedness for and response to bioterrorism
or other public health emergencies, consistent with a
plan described in paragraph (3);
‘‘(5) conduct exercises to test the capability and
timeliness of public health emergency response ac-
tivities;
‘‘(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 sup-
port’’ and inserting ‘‘shall directly or through
awards of grants or cooperative agreements to
public or private entities provide for the con-
duct 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 com-
parative analysis, of priority pathogens (as deter-
mined by the Director of the National Institutes of
Health in consultation with the task force estab-
lished under subsection (a)), in collaboration and co-
ordination with the activities of the Department of
Defense and the Joint Genome Institute of the De-
partment of Energy; and’’;
(2) in subsection (e)(2), by inserting after ‘‘so-
cieties,’’ 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 fol-
lowing: ‘‘$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 con-
sultation with the Federal Communications Commission,
the National Telecommunications and Information Ad-
ministration, 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 emer-
gency. 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 en-
tities about how to implement such redundancies if nec-
essary.
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 in-
serting 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 pur-
pose 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 De-
partment 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 detail-
ing personnel and the fair market value of any supplies,
equipment, or services provided by the Secretary. The Sec-
retary shall, for the payment of expenses incurred in com-
plying 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 RE-
SPONSE METHODS.
The Secretary of Health and Human Services shall
conduct a study of best-practices methods for the provi-
sion of emergency response services through local govern-
ments (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; De-
velopment of Priority Counter-
measures
SEC. 121. NATIONAL STOCKPILE.
(a) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the ‘‘Sec-
retary’’) 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 At-
torney General, the Secretary of Energy, and the
Administrator of the Environmental Protection
Agency;
(2) ensure that adequate procedures are fol-
lowed 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 con-
tents 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 dis-
tribution of the stockpile, in consultation with appro-
priate 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 lo-
cations) of the supplies described in subsection (a);
or
(2) a contractual agreement between the Sec-
retary 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 COUN-
TERMEASURES.
(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, un-
less it is designated as a fast-track product.
(c) DEFINITION.—For purposes of this section, the
term ‘‘priority countermeasure’’ means a drug or biologi-
cal product that is a countermeasure to treat, identify, or
prevent infection by a biological agent or toxin listed pur-
suant 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 CER-
TAIN DRUGS AND BIOLOGICS; ISSUANCE OF
RULE.
Not later than 180 days after the date of the enact-
ment 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 Sub-
stances When Efficacy Studies in Humans Ethically Can-
not be Conducted’’ published in the Federal Register on
October 5, 1999 (64 Fed. Reg. 53960).
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOP-
MENT AND PRODUCTION.
Part B of title III of the Public Health Service Act,
as amended by section 112 of this Act, is amended by in-
serting after section 319J the following section:
‘‘SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOP-
MENT AND PRODUCTION.
‘‘The Secretary, in consultation with the Attorney
General and the Secretary of Defense, may provide tech-
nical or other assistance to provide security to persons or
facilities that conduct development, production, distribu-
tion, 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
RE-
SEARCH AND DEVELOPMENT.—
‘‘(A) IN GENERAL.—With respect to patho-
gens 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 con-
duct, and award grants, contracts, or coopera-
tive agreements for, research, investigations, ex-
periments, demonstrations, and studies in the
health sciences relating to—
‘‘(i) the epidemiology and patho-
genesis of such pathogens;
‘‘(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 chil-
dren and other vulnerable populations.
‘‘(B) ROLE
OF
DEPARTMENT
OF
VET-
ERANS
AFFAIRS.—In carrying out subpara-
graph (A), the Secretary shall consider using
the biomedical research and development capa-
bilities of the Department of Veterans Affairs,
in conjunction with that Department’s affili-
ations 
with 
health-professions 
universities.
When advantageous to the Government in fur-
therance of the purposes of such subparagraph,
the Secretary may enter into cooperative agree-
ments 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, in-
cluding a drug, medical or other technological
device, biological product, or diagnostic test, to
treat, identify, or prevent infection by a biologi-
cal 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 TECH-
NOLOGIES REGARDING BIOTERRORIST AT-
TACK AND OTHER PUBLIC HEALTH EMER-
GENCIES.
(a) IN GENERAL.—The Secretary of Health and
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall promptly carry out a program to evaluate
new and emerging technologies that are designed to im-
prove or enhance the ability of public health or safety offi-
cials 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 sub-
section, 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 on-
going activities in this area; and
(3) evaluate technologies identified under para-
graphs (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 de-
velop 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, Edu-
cation, 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 esti-
mated 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) ap-
plies 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 Man-
agement Agency, a plan for the stockpiling of potas-
sium iodide tablets, and for the distribution and uti-
lization 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 suffi-
cient 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 potas-
sium iodide tablets in the event of a nuclear incident.
(d) INFORMATION.—The Secretary shall carry out ac-
tivities to inform State and local governments of the pro-
gram under this section.
(e) REPORT.—Not later than six months after the
date of the enactment of this Act, the Secretary shall sub-
mit to the Congress a report—
(1) on whether potassium iodide tablets have
been made available under subsection (a) and the ex-
tent to which State and local governments have es-
tablished 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 treat-
ment to address adverse thyroid conditions that may re-
sult 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 Pub-
lic 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 pub-
lic health emergency declared by the Secretary under
subsection (a), the Secretary may, subject to para-
graph (2), transfer funds, to the extent authorized
by law, between appropriations accounts adminis-
tered by the Secretary under this Act, without re-
gard to any waiting period imposed by any other
provision of law, including any provision of an ap-
propriations 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 trans-
fer under paragraph (1) in an amount exceed-
ing a reasonable estimate by the Secretary of
the amount necessary to respond to the emer-
gency involved for a period of 60 days.
‘‘(B) Subsequent transfers under para-
graph (1) may be made by the Secretary, sub-
ject 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 En-
ergy and Commerce of the House of Representa-
tives, the Committee on Appropriations of the Sen-
ate, and the Committee on Health, Education,
Labor, and Pensions of the Senate.
‘‘(4) SCOPE.—Paragraph (1) shall apply, not-
withstanding any other provision of law including
any provision of an appropriations Act and any Act
enacted after the date of enactment of this sub-
section, 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 DEAD-
LINES.—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 dead-
lines as the circumstances reasonably require, and may
waive, wholly or partially, any sanctions otherwise applica-
ble 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 Fed-
eral Register a notice of the extension or waiver.’’.
SEC. 
132. 
STREAMLINING 
AND 
CLARIFYING 
COMMU-
NICABLE 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 con-
sultation with the Surgeon General,’’.
(2) REGULATIONS PROVIDING FOR APPREHEN-
SION OF INDIVIDUALS.—Section 361(d) of the Pub-
lic Health Act (42 U.S.C. 264(d)) is amended by
striking ‘‘On recommendation of the National Advi-
sory Health Council, regulations’’ and inserting
‘‘Regulations’’.
(3) REGULATIONS PROVIDING FOR APPREHEN-
SION OF INDIVIDUALS IN WARTIME.—Section 363 of
the Public Health Act (42 U.S.C. 266) is amended
by striking ‘‘the Surgeon General, on recommenda-
tion 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 APPREHEN-
SION OF INDIVIDUALS.—Section 361(d) of the Pub-
lic 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 APPREHEN-
SION 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 sections, may be con-
strued as superseding any provision under State law (in-
cluding regulations and including provisions established by
political subdivisions of States), except to the extent that
such a provision conflicts with an exercise of Federal au-
thority under this section or section 363.’’.
SEC. 133. EMERGENCY WAIVER OF MEDICARE, MEDICAID,
AND SCHIP REQUIREMENTS.
(a) WAIVER AUTHORITY.—Title XI of the Social Se-
curity Act (42 U.S.C. 1301 et seq.) is amended by insert-
ing 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 indi-
viduals 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 de-
scribed 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
PE-
RIOD.—For purposes of this section, an ‘emergency
area’ is a geographical area in which, and an ‘emer-
gency period’ is the period during which, there
exists—
‘‘(A) an emergency or disaster declared by
the President pursuant to the National Emer-
gencies 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 nec-
essary 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 applica-
tion of, with respect to health care items and services fur-
nished 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 certifi-
cation 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 equiv-
alent 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 retro-
active 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 dec-
laration of emergency or disaster described in
subsection (a)(2)(B);
‘‘(B) the termination of the applicable dec-
laration of public health emergency described in
subsection (a)(2)(B); or
‘‘(C) subject to paragraph (2), the termi-
nation 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, ex-
cept as subsequently provided under this paragraph,
90 days each), but any such extension shall not af-
fect or prevent the termination of a waiver or modi-
fication under subparagraph (A) or (B) of para-
graph (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 Con-
gress regarding the approaches used to accomplish the
purposes described in subsection (a), including an evalua-
tion of the success of such approaches and recommenda-
tions for improved approaches should the need for such
emergency authority arise in the future.
‘‘(g) HEALTH CARE PROVIDER DEFINED.—For pur-
poses 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 physi-
cian 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 fol-
lowing new sentence: ‘‘Any such determination of a public
health emergency terminates upon the Secretary declaring
that the emergency no longer exists, or upon the expira-
tion of the 90-day period beginning on the date on which
the determination is made by the Secretary, whichever oc-
curs first. Determinations that terminate under the pre-
ceding 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 AN-
NOUNCEMENT PLAN.
Section 613(b) of the Robert T. Stafford Disaster Re-
lief 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 EN-
ERGY.
(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 re-
search 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, in-
cluding 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 per-
sonnel, as appropriate) for ATSDR to use authorities
under section 104(i) of the Comprehensive Environmental
Response, Compensation, and Liability Act of 1980 to as-
sist the Secretary in planning for or responding to bioter-
rorism or other public health emergencies, there are au-
thorized 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 Na-
tional 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 bioter-
rorist threats or attacks in the workplace.
SEC. 139. TECHNOLOGY OPPORTUNITIES PROGRAM SUP-
PORT.
For fiscal years 2003 and 2004, all of the informa-
tion infrastructure grants provided by the National Tele-
communications and Information Administration (under
the program also known as the Technology Opportunities
Program) shall be used to provide grants to health pro-
viders to facilitate participation in the national public
health communications and surveillance networks author-
ized under section 319D(b)(3) of the Public Health Serv-
ice 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 Serv-
ices in accordance with the provisions referred to in sub-
section (b), including making awards of grants, coopera-
tive agreements, or contracts and providing other assist-
ance to States and other public or private entities, there
are authorized to be appropriated $2,720,000,000 for fis-
cal 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—
(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 Sec-
retary 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 au-
thority 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 au-
thorizations of appropriations.
(2) ALLOCATIONS
OF
AUTHORIZATIONS.—Of
the amount that is authorized to be appropriated
under subsection (a) for fiscal year 2002, the fol-
lowing authorizations of appropriations for such fis-
cal year for the purpose described in such subsection
apply:
(A) For making awards of grants, coopera-
tive 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 pro-
fessionals).
(B) For the national stockpile under sec-
tion 121 of this Act, other than activities of the
National Institutes of Health regarding small-
pox vaccine, $1,155,000,000 is authorized, of
which $509,000,000 is authorized for the acqui-
sition 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 resist-
ance 
under 
section 
319E 
of 
such 
Act,
$25,000,000 is authorized.
TITLE 
II—ENHANCING 
CON-
TROLS ON DANGEROUS BIO-
LOGICAL AGENTS AND TOX-
INS
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 SERV-
ICE 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 BIOLOGI-
CAL AGENTS AND TOXINS.
‘‘(a) REGULATORY CONTROL OF CERTAIN BIOLOGI-
CAL AGENTS AND TOXINS.—
‘‘(1) LIST OF BIOLOGICAL AGENTS AND TOX-
INS.—
‘‘(A) IN GENERAL.—The Secretary shall by
regulation establish and maintain a list of each
biological agent and each toxin that has the po-
tential 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 contagious-
ness of the agent or toxin and the
methods by which the agent or toxin
is transferred to humans;
‘‘(III) the availability and effec-
tiveness of immunizations to prevent
and treatments for any illness result-
ing 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 revis-
ing 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 BIO-
LOGICAL AGENTS AND TOXINS.—The Secretary shall by
regulation provide for—
‘‘(1) the establishment and enforcement of safe-
ty procedures for the transfer of biological agents
and toxins listed pursuant to subsection (a)(1), in-
cluding 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 inter-
national terrorism or for any other criminal purpose;
‘‘(3) the establishment of procedures to protect
the public safety in the event of a transfer or poten-
tial transfer of a biological agent or toxin in viola-
tion of the safety procedures established under para-
graph (1) or the safeguards established under para-
graph (2); and
‘‘(4) appropriate availability of biological agents
and toxins for research, education, and other legiti-
mate purposes.
‘‘(c) POSSESSION AND USE OF LISTED BIOLOGICAL
AGENTS AND TOXINS.—The Secretary shall by regulation
provide for the establishment and enforcement of stand-
ards 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, in-
cluding the measures, safeguards, procedures, and avail-
ability of such agents and toxins described in paragraphs
(1) through (4) of subsection (b), respectively.
‘‘(d) REGISTRATION
AND TRACEABILITY MECHA-
NISMS; DATABASE.—Regulations under subsections (b)
and (c) shall require registration of the possession, use,
and transfer of biological agents and toxins listed pursu-
ant to subsection (a)(1), and such registration shall in-
clude (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 re-
garding their characterizations.
‘‘(e) INSPECTIONS.—The Secretary may conduct in-
spections 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 ex-
emptions 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 labora-
tory 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 pre-
sented 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 Fed-
eral 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 provi-
sions of subsections (b) and (c) that relate to safe-
guards, the Secretary, in consultation with the At-
torney General, shall by regulation establish appro-
priate security requirements for persons possessing,
using, or transferring biological agents or toxins list-
ed pursuant to subsection (a)(1), and ensure compli-
ance with such requirements as a condition of reg-
istration 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 sub-
section (a)(1) to only those individuals who
have a legitimate need for access, as deter-
mined according to the purposes for which
the registration under such regulations is
provided; and
‘‘(ii) to ensure that individuals grant-
ed such access are not—
‘‘(I) restricted persons, as de-
fined 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 domes-
tic or international act of terrorism or
other act of violence;
‘‘(III) under investigation for in-
volvement with a domestic or inter-
national terrorist or criminal organi-
zation by any Federal law enforce-
ment or intelligence agency; or
‘‘(IV) suspected by any Federal
law enforcement or intelligence agency
of seeking to obtain covertly informa-
tion relating to biological agents or
toxins on behalf of the intelligence or
military operations of a foreign na-
tion.
‘‘(B) SCREENING
PROTOCOL.—To carry
out subparagraph (A), the Secretary shall re-
quire 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 na-
tional security databases available to the Fed-
eral Government to identify whether such indi-
viduals satisfy the conditions for access under
subparagraph (A)(ii). The Secretary, in con-
sultation 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 pri-
vate entities (other than Federal agencies), and may
provide technical assistance to such entities, to im-
prove security of the facilities of registered persons.
‘‘(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 sec-
tion (including regulations promulgated before the
effective date of this subsection), and any site-spe-
cific 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 tox-
ins, 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 informa-
tion described in paragraph (1) for purposes of
protecting the public health and safety; or
‘‘(B) from making disclosures of such in-
formation 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 sub-
section (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
PROVI-
SIONS.—The provisions of section 1128A of the So-
cial 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 sec-
tion 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 enforc-
ing regulations under subsections (b) and (c), the
Secretary shall consult with the Secretary of Agri-
culture to ensure that such activities are coordi-
nated, to the greatest extent practicable, with regu-
lations 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 In-
dustry’ 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 bur-
den 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 agricul-
tural or veterinary research, education, or other
such purposes; and
‘‘(D) to ensure the establishment of a na-
tional database of such agents or toxins pursu-
ant to subsection (d).
‘‘(2) PERSONS
REGULATED
BY
DEPARTMENT
OF
AGRICULTURE.—With respect to persons pos-
sessing 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 Bioter-
rorism 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 registra-
tion under subsection (b) or (c), submit to the Sec-
retary of Health and Human Services the same in-
formation previously provided to the Secretary of
Agriculture to obtain such permit or license, pro-
vided 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 sub-
mission, request such additional information as the
Secretary determines to be necessary to achieve the
purposes of this section.
‘‘(3) SAVINGS PROVISION.—Nothing in this sec-
tion 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 per-
son 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.—Regula-
tions 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 Serv-
ice Act, as added by paragraph (1) of this sub-
section. 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.—Sub-
sections (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 REGARD-
ING 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 in-
terim final rule takes effect on the date on
which the rule is promulgated, except as fol-
lows:
(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 ef-
fect 60 days after the date on which the
rule is promulgated.
(ii) For purposes of subsection (i) of
such section 351A (relating to civil pen-
alties), 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 promul-
gated.
(4) EFFECTIVE DATE REGARDING DISCLOSURE
OF INFORMATION.—Subsection (h) of section 351A
of the Public Health Service Act, as added by para-
graph (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 Pub-
lic 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 insert-
ing the subsection before subsection (b);
(C) by striking ‘‘(c)’’ and inserting ‘‘(2);
(D) by redesignating subsection (b) as sub-
section (d); and
(E) by inserting before subsection (d) (as
so redesignated) the following subsections:
‘‘(b) TRANSFER TO UNREGISTERED PERSON.—Who-
ever 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 re-
quired 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 fol-
lowing: ‘‘The term ‘select agent’ means a
biological agent or toxin to which sub-
section (a) applies. Such term (including
for purposes of subsection (a)) does not in-
clude’’; 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 re-
lating 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 in-
serting ‘‘this subsection’’; and
(ii) in subsection (c), by striking ‘‘pro-
tective’’ 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 af-
fecting interstate or foreign commerce, any
biological agent or toxin, or receive any bi-
ological agent or toxin that has been
shipped or transported in interstate or for-
eign commerce, if the biological agent or
toxin is listed as a select agent in Appen-
dix A of part 72 of title 42, Code of Fed-
eral Regulations, pursuant to section 351A
of the Public Health Service Act, and is
not exempted under subsection (h) of sec-
tion 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 ‘‘sec-
tion 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 micro-
organism (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or pro-
tozoa), or infectious substance, or any nat-
urally occurring, bioengineered or syn-
thesized component of any such microorga-
nism 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, vi-
ruses, fungi, rickettsiae or protozoa), or in-
fectious substances, or a recombinant or
synthesized molecule, whatever their origin
and method of production, and includes—
’’; and
(iii) in paragraph (4), by striking ‘‘re-
combinant 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 pre-
ceding 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 de-
fined in section 178 of this title)’’.
(c) SECURITY UPGRADES AT THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES.—For the purpose of en-
abling the Secretary of Health and Human Services to se-
cure 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 sub-
section (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 enact-
ment;
(2) describes the actions to date and future
plans of the Secretary for updating the list of bio-
logical 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 Sec-
retary for administrative or legislative initiatives re-
garding such section 351A.
TITLE 
III—AMENDMENTS 
TO
FEDERAL FOOD, DRUG, AND
COSMETIC ACT
Subtitle A—Protection of Food
Supply
SEC. 301. PROTECTION AGAINST INTENTIONAL ADULTERA-
TION 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 sub-
section:
‘‘(h)(1) The Secretary shall give high priority to in-
creasing the number of inspections under this section for
the purpose of enabling the Secretary to inspect food of-
fered 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 sec-
tion, is amended by adding at the end the following para-
graphs:
‘‘(2) The Secretary shall give high priority to making
necessary improvements to the information management
systems of the Food and Drug Administration that con-
tain 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 im-
portation 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 ac-
tivities of the Secretary under paragraphs (1) and (2).’’.
(c) TESTING
FOR RAPID DETECTION
OF INTEN-
TIONAL 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 sec-
tion, the Secretary shall provide for research on the devel-
opment 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 in-
tentional adulteration of food; and
‘‘(B) whose results offer significant im-
provements 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 Di-
rector of the Centers for Disease Control and Prevention,
the Director of the National Institutes of Health, the Ad-
ministrator of the Environmental Protection Agency, and
the Secretary of Agriculture.
‘‘(4) The Secretary shall annually submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report describing
the progress made in research under paragraph (1), in-
cluding 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 en-
actment) is being conducted on the threat of the in-
tentional adulteration of food is completed; and
(2) a report describing the findings of the as-
sessment 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 appro-
priated $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 ap-
propriations 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 in-
vestigation under this Act conducted by such
officer or qualified employee, if the officer or
qualified employee has credible evidence or in-
formation 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 subpara-
graph (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 rea-
sonable 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 perish-
able 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 de-
tained, 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 pe-
riod applicable under such order, whichever occurs
first.
‘‘(4) APPEAL OF DETENTION ORDER.—With re-
spect 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
100
for purposes of section 702 of 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 amend-
ed 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 alter-
ation of any mark or label required by the order to identify
the article as detained.’’.
(c) TEMPORARY HOLDS AT PORTS OF ENTRY.—Sec-
tion 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 infor-
mation 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 un-
able 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
101
port of entry for a reasonable period of time, not to exceed
24 hours, for the purpose of enabling the Secretary to in-
spect, 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 facil-
ity 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 para-
graph (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 lo-
cated, 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 re-
quest has been made, and as applicable, that such article
is being held under this subsection.’’.
102
SEC. 303. PERMISSIVE DEBARMENT REGARDING FOOD IM-
PORTATION.
(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 sub-
paragraph:
‘‘(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 para-
graph (4); and
(4) by inserting after paragraph (2) the fol-
lowing paragraph:
‘‘(3) PERSONS
SUBJECT
TO
PERMISSIVE
DE-
BARMENT; FOOD IMPORTATION.—A person is subject
to debarment under paragraph (1)(C) if—
115
‘‘(3)(A) This subsection may not be construed as lim-
iting the authority of the Secretary to obtain information
under any other provision of this Act.
‘‘(B) This subsection may not be construed as au-
thorizing the Secretary to impose any requirements with
respect to a food to the extent that it is within the exclu-
sive jurisdiction of the Secretary of Agriculture pursuant
to the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C. 451
et seq.), or the Egg Products Inspection Act (21 U.S.C.
1031 et seq).’’.
(b) PROHIBITED ACT.—Section 301 of the Federal
Food, Drug, and Cosmetic Act, as amended by section
305(b)(1) of this Act, is amended by adding at the end
the following:
‘‘(ee) The importing or offering for import into the
United States of an article of food in violation of regula-
tions under section 801(k).’’.
SEC. 307. AUTHORITY TO MARK ARTICLES REFUSED ADMIS-
SION INTO UNITED STATES.
(a) IN GENERAL.—Section 801 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended
by section 306(a) of this Act, is amended by adding at
the end the following: