Attachment1_Authorizing_Legislation

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TITLE 42—THE PUBLIC HEALTH AND WELFARE

(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, such sums as may be necessary in each of fiscal years 2007 through 2011.
(July 1, 1944, ch. 373, title III, § 319D, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2318; amended Pub. L. 107–188, title I, § 103,
June 12, 2002, 116 Stat. 603; Pub. L. 109–417, title
II, §§ 202, 204(b)(2), Dec. 19, 2006, 120 Stat. 2845,
2851.)
AMENDMENTS
2006—Subsec. (a)(1). Pub. L. 109–417, § 202(1), inserted
‘‘domestically and abroad’’ after ‘‘public health
threats’’.
Subsec. (a)(3). Pub. L. 109–417, § 204(b)(2), struck out
‘‘, taking into account evaluations under section
247d–2(a) of this title,’’ after ‘‘The Secretary’’ in introductory provisions.
Subsecs. (d) to (g). Pub. L. 109–417, § 202(2), added subsecs. (d) to (g).
2002—Pub. L. 107–188 reenacted section catchline
without change and amended text generally, substituting detailed provisions relating to facilities, capacities,
and national communications and surveillance networks for provisions relating to findings of need for secure and modern facilities.

§ 247d–5. Combating antimicrobial resistance
(a) Task force
(1) In general
The Secretary shall establish an Antimicrobial Resistance Task Force to provide
advice and recommendations to the Secretary
and coordinate Federal programs relating to
antimicrobial resistance. The Secretary may
appoint or select a committee, or other organization in existence as of November 13, 2000,
to serve as such a task force, if such committee, or other organization meets the requirements of this section.
(2) Members of task force
The task force described in paragraph (1)
shall be composed of representatives from
such Federal agencies, and shall seek input
from public health constituencies, manufacturers, veterinary and medical professional societies and others, as determined to be necessary by the Secretary, to develop and implement a comprehensive plan to address the public health threat of antimicrobial resistance.
(3) Agenda
(A) In general
The task force described in paragraph (1)
shall consider factors the Secretary considers appropriate, including—
(i) public health factors contributing to
increasing antimicrobial resistance;
(ii) public health needs to detect and
monitor antimicrobial resistance;
(iii) detection, prevention, and control
strategies for resistant pathogens;
(iv) the need for improved information
and data collection;
(v) the assessment of the risk imposed by
pathogens presenting a threat to the public health; and
(vi) any other issues which the Secretary
determines are relevant to antimicrobial
resistance.

§ 247d–5

(B) Detection and control
The Secretary, in consultation with the
task force described in paragraph (1) and
State and local public health officials,
shall—
(i) develop, improve, coordinate or enhance participation in a surveillance plan
to detect and monitor emerging antimicrobial resistance; and
(ii) develop, improve, coordinate or enhance participation in an integrated information system to assimilate, analyze, and
exchange antimicrobial resistance data between public health departments.
(4) Meetings
The task force described under paragraph (1)
shall convene not less than twice a year, or
more frequently as the Secretary determines
to be appropriate.
(b) Research and development of new antimicrobial drugs and diagnostics
The Secretary and the Director of Agricultural Research Services, consistent with the recommendations of the task force established
under subsection (a) of this section, shall directly or through awards of grants or cooperative agreements to public or private entities
provide for the conduct of research, investigations, experiments, demonstrations, and studies
in the health sciences that are related to—
(1) the development of new therapeutics, including vaccines and antimicrobials, against
resistant pathogens;
(2) the development or testing of medical
diagnostics to detect pathogens resistant to
antimicrobials;
(3) the epidemiology, mechanisms, and
pathogenesis of antimicrobial resistance;
(4) the sequencing of the genomes, or other
DNA analysis, or other comparative analysis,
of priority pathogens (as determined by the
Director of the National Institutes of Health
in consultation with the task force established
under subsection (a) of this section), in collaboration and coordination with the activities of the Department of Defense and the
Joint Genome Institute of the Department of
Energy; and
(5) other relevant research areas.
(c) Education of medical and public health personnel
The Secretary, after consultation with the Assistant Secretary for Health, the Surgeon General, the Director of the Centers for Disease
Control and Prevention, the Administrator of
the Health Resources and Services Administration, the Director of the Agency for Healthcare
Research and Quality, members of the task force
described in subsection (a) of this section, professional organizations and societies, and such
other public health officials as may be necessary, shall—
(1) develop and implement educational programs to increase the awareness of the general
public with respect to the public health threat
of antimicrobial resistance and the appropriate use of antibiotics;
(2) develop and implement educational programs to instruct health care professionals in
the prudent use of antibiotics; and

§ 247d–5a

TITLE 42—THE PUBLIC HEALTH AND WELFARE

(3) develop and implement programs to train
laboratory personnel in the recognition or
identification of resistance in pathogens.
(d) Grants
(1) In general
The Secretary shall award competitive
grants to eligible entities to enable such entities to increase the capacity to detect, monitor, and combat antimicrobial resistance.
(2) Eligible entities
Eligible entities for grants under paragraph
(1) shall be State or local public health agencies, Indian tribes or tribal organizations, or
other public or private nonprofit entities.
(3) Use of funds
An eligible entity receiving a grant under
paragraph (1) shall use funds from such grant
for activities that are consistent with the factors identified by the task force under subsection (a)(3) of this section, which may include activities that—
(A) provide training to enable such entity
to identify patterns of resistance rapidly and
accurately;
(B) develop, improve, coordinate or enhance participation in information systems
by which data on resistant infections can be
shared rapidly among relevant national,
State, and local health agencies and health
care providers; and
(C) develop and implement policies to control the spread of antimicrobial resistance.
(e) Grants for demonstration programs
(1) In general
The Secretary shall award competitive
grants to eligible entities to establish demonstration programs to promote judicious use
of antimicrobial drugs or control the spread of
antimicrobial-resistant pathogens.
(2) Eligible entities
Eligible entities for grants under paragraph
(1) may include hospitals, clinics, institutions
of long-term care, professional medical societies, schools or programs that train medical
laboratory personnel, or other public or private nonprofit entities.
(3) Technical assistance
The Secretary shall provide appropriate
technical assistance to eligible entities that
receive grants under paragraph (1).
(f) Supplement not supplant
Funds appropriated under this section shall be
used to supplement and not supplant other Federal, State, and local public funds provided for
activities under this section.
(g) Authorization of appropriations
There are authorized to be appropriated to
carry out this section, $40,000,000 for fiscal year
2001, $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.
(July 1, 1944, ch. 373, title III, § 319E, as added
Pub. L. 106–505, title I, § 102, Nov. 13, 2000, 114
Stat. 2318; amended Pub. L. 107–188, title I, § 109,
June 12, 2002, 116 Stat. 610.)

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AMENDMENTS
2002—Subsec. (b). Pub. L. 107–188, § 109(1)(A), in introductory provisions, substituted ‘‘shall directly or
through awards of grants or cooperative agreements to
public or private entities provide for the conduct of’’
for ‘‘shall conduct and support’’.
Subsec. (b)(4). Pub. L. 107–188, § 109(1)(B), amended
par. (4) generally. Prior to amendment, par. (4) read as
follows: ‘‘the sequencing of the genomes of priority
pathogens as determined by the Director of the National Institutes of Health in consultation with the
task force established under subsection (a) of this section; and’’.
Subsec. (e)(2). Pub. L. 107–188, § 109(2), inserted
‘‘schools or programs that train medical laboratory
personnel,’’ after ‘‘professional medical societies,’’.
Subsec. (g). Pub. L. 107–188, § 109(3), substituted
‘‘$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’’ for ‘‘and such sums as may
be necessary for each subsequent fiscal year through
2006’’.

§ 247d–5a. Identification of clinically susceptible
concentrations of antimicrobials
(a) Definition
In this section, the term ‘‘clinically susceptible concentrations’’ means specific values
which characterize bacteria as clinically susceptible, intermediate, or resistant to the drug (or
drugs) tested.
(b) Identification
The Secretary of Health and Human Services
(referred to in this section as the ‘‘Secretary’’),
through the Commissioner of Food and Drugs,
shall identify (where such information is reasonably available) and periodically update clinically susceptible concentrations.
(c) Public availability
The Secretary, through the Commissioner of
Food and Drugs, shall make such clinically susceptible concentrations publicly available, such
as by posting on the Internet, not later than 30
days after the date of identification and any update under this section.
(d) Effect
Nothing in this section shall be construed to
restrict, in any manner, the prescribing of antibiotics by physicians, or to limit the practice of
medicine, including for diseases such as Lyme
and tick-borne diseases.
(Pub. L. 110–85, title XI, § 1111, Sept. 27, 2007, 121
Stat. 975.)
CODIFICATION
Section was enacted as part of the Food and Drug Administration Amendments Act of 2007, and not as part
of the Public Health Service Act which comprises this
chapter.

§ 247d–6. Public health countermeasures to a bioterrorist attack
(a) All-hazards public health and medical response curricula and training
(1) In general
The Secretary, in collaboration with the
Secretary of Defense, and in consultation with
relevant public and private entities, shall develop core health and medical response curric-