H. R. 3448—19
(1) IN
GENERAL.—The Secretary of Health and Human
Services (referred to in this section as the ‘‘Secretary’’), in
coordination with the Secretary of Veterans Affairs, shall main-
tain 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 Sec-
retary to be appropriate and practicable, taking into account
other available sources, to provide for the emergency health
security of the United States, including the emergency health
security of children and other vulnerable populations, in the
event of a bioterrorist attack or other public health emergency.
(2) PROCEDURES.—The Secretary, in managing the stockpile
under paragraph (1), shall—
(A) consult with the working group under section
319F(a) of the Public Health Service Act;
(B) ensure that adequate procedures are followed with
respect to such stockpile for inventory management and
accounting, and for the physical security of the stockpile;
(C) in consultation with Federal, State, and local offi-
cials, take into consideration the timing and location of
special events;
(D) review and revise, as appropriate, the contents
of the stockpile on a regular basis to ensure that emerging
threats, advanced technologies, and new countermeasures
are adequately considered;
(E) devise plans for the effective and timely supply-
chain management of the stockpile, in consultation with
appropriate Federal, State and local agencies, and the
public and private health care infrastructure; and
(F) ensure the adequate physical security of the stock-
pile.
(b) SMALLPOX VACCINE DEVELOPMENT.—
(1) IN
GENERAL.—The Secretary shall award contracts,
enter into cooperative agreements, or carry out such other
activities as may reasonably be required in order to ensure
that the stockpile under subsection (a) includes an amount
of vaccine against smallpox as determined by the Secretary
to be sufficient to meet the health security needs of the United
States.
(2) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to limit the private distribution, purchase, or
sale of vaccines from sources other than the stockpile described
in subsection (a).
(c) DISCLOSURES.—No Federal agency shall disclose under sec-
tion 552, United States Code, any information identifying the loca-
tion at which materials in the stockpile under subsection (a) are
stored.
(d) DEFINITION.—For purposes of subsection (a), the term
‘‘stockpile’’ includes—
(1) a physical accumulation (at one or more locations) of
the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and
a vendor or vendors under which such vendor or vendors agree
to provide to the Secretary supplies described in subsection
(a).
(e) AUTHORIZATION OF APPROPRIATIONS.—
H. R. 3448—20
(1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of
carrying out subsection (a), there are authorized to be appro-
priated $640,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
(2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of
carrying out subsection (b), there are authorized to be appro-
priated $509,000,000 for fiscal year 2002, and such sums as
may be necessary for each of fiscal years 2003 through 2006.
SEC. 
122. 
ACCELERATED 
APPROVAL 
OF 
PRIORITY 
COUNTER-
MEASURES.
(a) IN GENERAL.—The Secretary of Health and Human Services
may designate a priority countermeasure as a fast-track product
pursuant to section 506 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356) or as a device granted review priority pursuant
to section 515(d)(5) of such Act (21 U.S.C. 360e(d)(5)). Such a
designation may be made prior to the submission of—
(1) a request for designation by the sponsor or applicant;
or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor
or applicant from declining such a designation.
(b) USE
OF ANIMAL TRIALS.—A drug for which approval is
sought under section 505(b) of the Federal Food, Drug, and Cosmetic
Act or section 351 of the Public Health Service Act on the basis
of evidence of effectiveness that is derived from animal studies
pursuant to section 123 may be designated as a fast track product
for purposes of this section.
(c) PRIORITY REVIEW OF DRUGS AND BIOLOGICAL PRODUCTS.—
A priority countermeasure that is a drug or biological product
shall be considered a priority drug or biological product for purposes
of performance goals for priority drugs or biological products agreed
to by the Commissioner of Food and Drugs.
(d) DEFINITIONS.—For purposes of this title:
(1) The term ‘‘priority countermeasure’’ has the meaning
given such term in section 319F(h)(4) of the Public Health
Service Act.
(2) The term ‘‘priority drugs or biological products’’ means
a drug or biological product that is the subject of a drug
or biologics application referred to in section 101(4) of the
Food and Drug Administration Modernization Act of 1997.
SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.
Not later than 90 days after the date of the enactment of
this Act, the Secretary of Health and Human Services shall complete
the process of rulemaking that was commenced under authority
of section 505 of the Federal Food, Drug, and Cosmetic Act and
section 351 of the Public Health Service Act with the issuance
of the proposed rule entitled ‘‘New Drug and Biological Drug Prod-
ucts; Evidence Needed to Demonstrate Efficacy of New Drugs for
Use Against Lethal or Permanently Disabling Toxic Substances
When Efficacy Studies in Humans Ethically Cannot be Conducted’’
published in the Federal Register on October 5, 1999 (64 Fed.
Reg. 53960), and shall promulgate a final rule.
H. R. 3448—21
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
Part B of title III of the Public Health Service Act, as amended
by section 110 of this Act, is amended by inserting after section
319J the following section:
‘‘SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
‘‘(a) IN GENERAL.—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, distribution, or storage of
priority countermeasures (as defined in section 319F(h)(4)).
‘‘(b) GUIDELINES.—The Secretary may develop guidelines to
enable entities eligible to receive assistance under subsection (a)
to secure their facilities against potential terrorist attack.’’.
SEC. 
125. 
ACCELERATED 
COUNTERMEASURE 
RESEARCH 
AND
DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as redesig-
nated by section 104(a)(2) of this Act, is amended to read as follows:
‘‘(h) ACCELERATED RESEARCH AND DEVELOPMENT ON PRIORITY
PATHOGENS AND COUNTERMEASURES.—
‘‘(1) IN GENERAL.—With respect to pathogens of potential
use in a bioterrorist attack, and other agents that may cause
a public health emergency, the Secretary, taking into consider-
ation any recommendations of the working group under sub-
section (a), shall conduct, and award grants, contracts, or
cooperative agreements for, research, investigations, experi-
ments, demonstrations, and studies in the health sciences
relating to—
‘‘(A) the epidemiology and pathogenesis of such patho-
gens;
‘‘(B) the sequencing of the genomes, or other DNA
analysis, or other comparative analysis, of priority patho-
gens (as determined by the Director of the National
Institutes of Health in consultation with the working group
established in subsection (a)), in collaboration and coordina-
tion with the activities of the Department of Defense and
the Joint Genome Institute of the Department of Energy;
‘‘(C) the development of priority countermeasures; and
‘‘(D) other relevant areas of research;
with consideration given to the needs of children and other
vulnerable populations.
‘‘(2) PRIORITY.—The Secretary shall give priority under this
section to the funding of research and other studies related
to priority countermeasures.
‘‘(3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In car-
rying out paragraph (1), the Secretary shall consider using
the biomedical research and development capabilities of the
Department of Veterans Affairs, in conjunction with that
Department’s affiliations with health-professions universities.
When advantageous to the Government in furtherance of the
purposes of such paragraph, the Secretary may enter into
cooperative agreements with the Secretary of Veterans Affairs
to achieve such purposes.
H. R. 3448—22
‘‘(4) PRIORITY COUNTERMEASURES.—For purposes of this sec-
tion, the term ‘priority countermeasure’ means a drug, biological
product, device, vaccine, vaccine adjuvant, antiviral, or diag-
nostic test that the Secretary determines to be—
‘‘(A) a priority to treat, identify, or prevent infection
by a biological agent or toxin listed pursuant to section
351A(a)(1), or harm from any other agent that may cause
a public health emergency; or
‘‘(B) a priority to diagnose conditions that may result
in adverse health consequences or death and may be caused
by the administering of a drug, biological product, device,
vaccine, vaccine adjuvant, antiviral, or diagnostic test that
is a priority under subparagraph (A).’’.
SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES
REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC
HEALTH EMERGENCIES.
(a) IN GENERAL.—The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’) shall promptly carry
out a program to periodically evaluate new and emerging tech-
nologies that, in the determination of the Secretary, are designed
to improve or enhance the ability of public health or safety officials
to conduct public health surveillance activities relating to a bioter-
rorist attack or other public health emergency.
(b) CERTAIN ACTIVITIES.—In carrying out this subsection, the
Secretary shall, to the extent practicable—
(1) survey existing technology programs funded by the Fed-
eral Government for potentially useful technologies;
(2) promptly issue a request, as necessary, for information
from non-Federal public and private entities for ongoing activi-
ties in this area; and
(3) evaluate technologies identified under paragraphs (1)
and (2) pursuant to subsection (c).
(c) CONSULTATION
AND EVALUATION.—In carrying out sub-
section (b)(3), the Secretary shall consult with the working group
under section 319F(a) of the Public Health Service Act, as well
as other appropriate public, nonprofit, and private entities, to
develop criteria for the evaluation of such technologies and to con-
duct such evaluations.
(d) REPORT.—Not later than 180 days after the date of the
enactment of this Act, and periodically thereafter, the Secretary
shall submit to the Committee on Energy and Commerce of the
House of Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report on the activities under
this section.
SEC. 127. POTASSIUM IODIDE.
(a) IN GENERAL.—Through the national stockpile under section
121, the President, subject to subsections (b) and (c), shall make
available to State and local governments potassium iodide tablets
for stockpiling and for distribution as appropriate to public facilities,
such as schools and hospitals, in quantities sufficient to provide
adequate protection for the population within 20 miles of a nuclear
power plant.
(b) STATE AND LOCAL PLANS.—
(1) IN GENERAL.—Subsection (a) applies with respect to
a State or local government, subject to paragraph (2), if the
government involved meets the following conditions: