‘‘(vii) 
recommend 
how 
best 
to 
strengthen and link antimicrobial resist-
ance-related surveillance and prevention 
and control activities; and 
‘‘(viii) collaborate with the Assistant 
Secretary for Preparedness and Response 
to ensure that strategies to address anti-
microbial-resistance are coordinated with 
initiatives aimed at pandemic influenza, in-
cluding the 2009 Influenza A: H1N1 virus 
and H1N1 Avian Influenza virus, severe 
acute respiratory syndrome, bioterrorism, 
and other emerging health threats. 
‘‘(B) ANTIMICROBIAL
RESISTANCE
TASK 
FORCE MEETINGS AND DUTIES.— 
‘‘(i) MEETINGS.—The Antimicrobial 
Resistance Task Force shall convene peri-
odically as the Director of the Anti-
microbial Resistance Task Force deter-
mines to be appropriate, but not fewer 
than twice a year, to consider issues relat-
ing to antimicrobial resistance. 
‘‘(ii) 
PUBLIC
HEALTH
ACTION 
PLAN.—At least twice a year, the task 
force described in paragraph (1) shall have 
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a meeting to review, discuss, and further 
develop the Public Health Action Plan to 
Combat Antimicrobial Resistance issued by 
the interagency task force on antimicrobial 
resistance in 2001. Among other issues, 
the task force may discuss and review, 
based on current need or concern— 
‘‘(I) antimicrobial clinical suscep-
tibility concentrations proposed, estab-
lished, or updated by the Food and 
Drug Administration; 
‘‘(II) data obtained by govern-
ment agencies and, as possible, by pri-
vate 
sources 
on 
emerging 
anti-
microbial resistance related to clinical 
outcomes in terms of how patients 
function, feel, or survive as well as 
data related to how antimicrobial 
drugs may have been used inappropri-
ately; 
‘‘(III) surveillance data and pre-
vention and control activities regard-
ing emerging antimicrobial resistance 
from reliable sources including the 
Centers for Disease Control and Pre-
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vention, the Food and Drug Adminis-
tration, the Department of Defense, 
the Department of Veterans Affairs, 
the Department of Agriculture, the 
Environmental 
Protection 
Agency, 
and as feasible from private sources 
and international bodies; 
‘‘(IV) data on the amount of 
antimicrobial products used in hu-
mans, animals, and plants from reli-
able sources including data from the 
Centers for Disease Control and Pre-
vention, the Food and Drug Adminis-
tration, the Environmental Protection 
Agency, the Department of Veterans 
Affairs, the Centers for Medicare & 
Medicaid Services, the Department of 
Homeland Security, and the Depart-
ment of Agriculture, and as feasible 
from private sources and international 
bodies; 
‘‘(V) the impact of antimicrobial 
resistance on human health resulting 
from the approval of antimicrobial 
drugs for use in humans or animals 
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(including consideration of and rec-
ommendations on potential manage-
ment plans to limit and reduce the 
negative impacts of such resistance on 
human health); 
‘‘(VI) reports of federally sup-
ported antimicrobial resistance re-
search and antimicrobial drug devel-
opment research activities (including 
clinical, epidemiological, prevention, 
and translational research) obtained 
from Federal agencies, as well as re-
ports of research sponsored by other 
countries, industry, and non-govern-
mental organizations; 
‘‘(VII) reports on efforts by the 
Food and Drug Administration to de-
velop policies and guidances which en-
courage antimicrobial drug develop-
ment and appropriate use while main-
taining high standards for safety and 
effectiveness; 
‘‘(VIII) health plan employer 
data and information set (HEDIS) 
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measures pertaining to appropriate 
use of antimicrobial drugs; and 
‘‘(IX) other data and issues the 
task force described in paragraph (1) 
identifies as relevant to the issue of 
antimicrobial resistance. 
‘‘(iii) PENDING
APPLICATIONS.—The 
Food and Drug Administration may con-
sult with the Director of the Antimicrobial 
Resistance Office concerning the pending 
application of any antimicrobial drug appli-
cation submitted to the Secretary under 
section 505 or 512 of the Federal Food, 
Drug, and Cosmetic Act or the Public 
Health Service Act. 
‘‘(C) PUBLIC HEALTH ANTIMICROBIAL AD-
VISORY BOARD MEETINGS AND DUTIES.— 
‘‘(i) MEETINGS.—The Public Health 
Antimicrobial Advisory Board shall meet 
as the Chair of the Public Health Anti-
microbial Advisory Board determines to be 
appropriate, preferably in conjunction with 
meetings of the Antimicrobial Resistance 
Task Force, but not fewer than 2 times 
each year. 
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‘‘(ii) RECOMMENDATIONS.—The Pub-
lic Health Antimicrobial Advisory Board 
shall make recommendations to the Sec-
retary, and the Antimicrobial Resistance 
Office, regarding— 
‘‘(I) ways to encourage the avail-
ability of an adequate supply of safe 
and effective antimicrobial products; 
‘‘(II) 
research 
priorities 
and 
other measures (such as antimicrobial 
drug resistance management plans) to 
enhance the safety and efficacy of 
antimicrobial products; 
‘‘(III) how best to implement and 
update the goals of the Public Health 
Action Plan to Combat Antimicrobial 
Resistance; 
‘‘(IV) incentives necessary to es-
tablish uniform mechanisms and data 
sets for State and local reporting of 
resistance data; 
‘‘(V) the adequacy of existing 
surveillance systems to collect anti-
microbial resistance data and how 
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best to improve the collection, report-
ing, and analysis of such data; 
‘‘(VI) the development of a na-
tional plan for the collection and anal-
ysis of isolates of resistant pathogens, 
including establishing priorities as to 
which isolates should be collected; 
‘‘(VII) the implementation and 
evaluation of interventions to promote 
appropriate antimicrobial drug use in 
both inpatient and outpatient settings; 
and 
‘‘(VIII) areas for government, 
nongovernment, and international co-
operation to strengthen implementa-
tion of the Public Health Action Plan 
to Combat Antimicrobial Resistance. 
‘‘(D) AVAILABILITY
OF
INFORMATION.— 
The Antimicrobial Resistance Office shall en-
sure that all information shall be made avail-
able to the public on the website described in 
subparagraph (A) consistent with section 8 of 
the Strategies to Address Antimicrobial Resist-
ance Act.’’; 
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(2) by amending subsection (b) to read as fol-
lows: 
‘‘(b) ANTIMICROBIAL RESISTANCE STRATEGIC RE-
SEARCH PLAN.—The Secretary, acting through the Direc-
tor of the Antimicrobial Resistance Office, the Director 
of the Centers for Disease Control and Prevention, and 
the Director of the National Institutes of Health, and in 
consultation with other Federal agencies and the Public 
Health Antimicrobial Advisory Board, shall develop an 
antimicrobial resistance strategic research plan that 
strengthens existing epidemiological, interventional, clin-
ical, behavioral, translational, and basic research efforts 
to advance the understanding of— 
‘‘(1) the development, implementation, and effi-
cacy of interventions to prevent and control the 
emergence and transmission of antimicrobial resist-
ance; 
‘‘(2) how best to optimize antimicrobial effec-
tiveness while limiting the emergence of resistance, 
including addressing issues related to duration of 
therapy, effectiveness of therapy in self-resolving dis-
eases, and determining populations most likely to 
benefit from antimicrobial drugs; 
‘‘(3) the extent to which the use of anti-
microbial products in humans, animals, plants, and 
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other uses accelerates development and transmission 
of antimicrobial resistance; 
‘‘(4) the natural histories of infectious diseases 
(including defining the disease, diagnosis, severity, 
and the time course of illness); 
‘‘(5) the development of new therapeutics, in-
cluding antimicrobial drugs, biologics, and devices 
against resistant pathogens, and in particular dis-
eases for which few or no therapeutics are in devel-
opment; 
‘‘(6) the development and testing of medical 
diagnostics to identify patients with infectious dis-
ease and identify the exact cause of infectious dis-
eases syndromes, particularly with respect to the de-
tection of pathogens resistant to antimicrobial drugs; 
‘‘(7) the epidemiology, pathogenesis, mecha-
nisms, and genetics of antimicrobial resistance; and 
‘‘(8) the sequencing of the genomes, or other 
DNA analysis, or other comparative analysis of pri-
ority pathogens (as determined by the Public Health 
Antimicrobial Advisory Board), in collaboration with 
the Department of Defense and the Joint Genome 
Institute of the Department of Energy.’’; 
(3) in subsection (c)— 
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(A) by inserting ‘‘acting through the Di-
rector of the Antimicrobial Resistance Office,’’ 
after ‘‘The Secretary,’’; and 
(B) by striking ‘‘members of the task force 
described in subsection (a),’’; 
(4) in subsection (d)(1), by inserting ‘‘, through 
the Antimicrobial Resistance Office,’’ after ‘‘The 
Secretary’’; and 
(5) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘, act-
ing through the Director of the Antimicrobial 
Resistance Office,’’ after ‘‘The Secretary’’; 
(B) in paragraph (3), by inserting ‘‘, act-
ing through the Antimicrobial Resistance Of-
fice,’’ after ‘‘The Secretary’’; and 
(C) by adding at the end the following: 
‘‘(4) PREFERENCE
IN
MAKING
AWARDS.—In 
making awards under paragraph (1), the Secretary 
shall give preference to eligible entities that will use 
grant funds to establish demonstration projects to 
assess the scope of the antimicrobial resistance prob-
lem and the level of appropriate and inappropriate 
use of antimicrobial drugs especially related to self- 
resolving infections, including the validation of mod-
els that may lead to the development of quality 
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measures for health care providers prescribing anti-
microbial drugs.’’. 
(b) ENSURE ACCESS TO ANTIMICROBIAL DATA AND 
RESEARCH.—The Director of the Antimicrobial Resist-
ance Office shall work with the agencies represented on 
the Antimicrobial Resistance Task Force to identify rel-
evant data and formats, and mechanisms for commu-
nicating such data to the Antimicrobial Resistance Office 
and Antimicrobial Resistance Task Force and, in a man-
ner consistent with section 8 of this Act, with the Public 
Health Antimicrobial Advisory Board and the public, in-
cluding relevant data obtained by the agencies through 
contracts with other organizations, including— 
(1) use and clinical outcomes data on patients 
receiving antimicrobial drugs for the treatment, pre-
vention, or diagnosis of infection or infectious dis-
eases; 
(2) surveillance data regarding emerging anti-
microbial drug resistance; 
(3) susceptibility data related to antimicrobial 
drug use; 
(4) data related to the amount of antimicrobial 
products used in humans, animals, and plants; 
(5) data from federally funded research in-
tended to support antimicrobial drug development; 
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(6) data demonstrating the impact of research, 
surveillance, and prevention and control initiatives in 
understanding and controlling antimicrobial resist-
ance; and 
(7) data regarding implementation and evalua-
tion of interventions to improve antimicrobial drug 
prescribing practices. 
SEC. 4. COLLECTION OF ANTIMICROBIAL DRUG DATA. 
(a) SUBMISSION OF HUMAN AND ANIMAL DRUG DIS-
TRIBUTION DATA.—Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 512 the following: 
‘‘SEC. 512A. SUBMISSION OF HUMAN AND ANIMAL DRUG 
DISTRIBUTION DATA. 
‘‘(a) IN GENERAL.—Notwithstanding any other pro-
vision of law, the Secretary shall require that each sponsor 
of a human antimicrobial drug product which is approved 
under section 505 (including section 505(j)) and sold or 
distributed in the United States, submit antimicrobial 
drug sales and distribution data. Such data shall be— 
‘‘(1) submitted not later than 60 days after the 
beginning of the subsequent calendar year; 
‘‘(2) reported on the calendar year and seg-
regated by month; 
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‘‘(3) in such format, and utilize any such unit 
of measure, as the Secretary by regulation deems 
necessary and appropriate to ensure the reported 
data is comparable and reliable; and 
‘‘(4) made available to the Antimicrobial Resist-
ance Office and the Antimicrobial Resistance Task 
Force. 
‘‘(b) CONFIDENTIALITY.—To protect proprietary 
commercial information, officials who serve in the Anti-
microbial Resistance Office and on the Antimicrobial Re-
sistance Task Force shall sign a confidentiality agreement 
prior to reviewing any such data to which access is granted 
under subsection (a)(4).’’. 
(b) SUBMISSION OF ANIMAL SALES AND DISTRIBU-
TION DATA.—Section 512(l)(3) (21 U.S.C. 360b(l)(3)) is 
amended— 
(1) in subparagraph (C)— 
(A) in clause (ii), by deleting ‘‘and’’ at the 
end; 
(B) in clause (iii), by striking the period at 
the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(iv) contain any such additional in-
formation, be in such format, and utilize 
any such unit of measure as the Secretary 
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by regulation deems necessary and appro-
priate to ensure the reported data is com-
parable and reliable.’’; and 
(2) in subparagraph (D), by striking ‘‘may’’ 
and inserting ‘‘shall’’. 
(c) DATA FROM ADDITIONAL SOURCES.— 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Director of the Antimicrobial Resistance 
Office, shall explore opportunities to secure from pri-
vate vendors and health care organizations reliable 
and comparable animal and human antimicrobial 
drug consumption data (volume antimicrobial dis-
tribution data and antimicrobial use, including pre-
scription data) by State or metropolitan area, as 
necessary, to supplement the antimicrobial drug con-
sumption data to be collected under this section for 
the purpose of demonstrating how the consumption 
of antimicrobial drugs for human and animal uses 
may affect the development of resistance over time 
and within geographic locations and to institute pre-
ventive interventions. 
(2) NEGOTIATIONS.—The Director of the Anti-
microbial Resistance Office may enter into negotia-
tions with private vendors and health care organiza-
tions to determine acceptable scope and parameters 
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for summaries of antimicrobial drug consumption 
data that is collected under this section publicly 
available for research purposes. 
(3) OTHER MEANS TO SECURE DATA.—If the 
Director of the Antimicrobial Resistance Office is 
not able to secure sufficient supplemental anti-
microbial drug consumption data for human and 
animal uses through private vendors and health care 
organizations as provided for in this section, the 
Secretary shall consider other means to secure such 
consumption data, including through the conduct of 
surveys about how antimicrobial drugs are used in 
various settings. 
(d) COLLECTION OF ANTIMICROBIAL PRESCRIPTION 
DATA.— 
(1) CLINICAL OUTCOMES DATA.—The Director 
of the Antimicrobial Resistance Office, the Under 
Secretary for Health of the Department of Veterans 
Affairs, and the Administrator of the Centers for 
Medicare & Medicaid Services shall work together to 
collect and analyze relevant drug utilization data 
and clinical outcomes data, as determined relevant 
by the Director of the Antimicrobial Resistance Of-
fice, on patients who receive services funded by such 
agencies and who are receiving prescription anti-
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microbial agents for the treatment or prevention of 
infection or infectious diseases. 
(2) ORGANIZATION.—Any data collected under 
paragraph (1) shall be organized by— 
(A) indication (including results of diag-
nostic studies when available); 
(B) dosage; 
(C) route of administration; 
(D) duration; 
(E) age of the patient; and 
(F) geographic region. 
(3) 
INTERVENTIONS
AND
ANALYSIS.—The 
Under Secretary for Health of the Department of 
Veterans Affairs, the Administrator of the Centers 
for Medicare & Medicaid Services, and the Director 
of the Antimicrobial Resistance Office shall work to-
gether to identify and report upon interventions that 
prevent and control the development of antimicrobial 
resistance and to include within such reports, where 
appropriate, an analysis of the following— 
(A) intra- and extra-label antimicrobial 
use; 
(B) where challenges to appropriate use re-
main; 
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(C) trends and variations in antimicrobial 
resistance rates; and 
(D) the relationship between drug use and 
resistance. 
(e) PUBLIC AVAILABILITY OF DATA.—The Director 
of the Antimicrobial Resistance Office shall make sum-
maries of the data received under this section publicly 
available and ensure that such summaries are updated and 
published, in a manner consistent with section 8, at least 
once annually on the website described in section 
319E(a)(4)(A) of the Public Health Service Act (42 
U.S.C. 247d–5(a)(4)(A)) in order to support epidemiologic 
and microbiologic research. 
SEC. 5. ANTIMICROBIAL RESISTANCE SURVEILLANCE AND 
RESEARCH NETWORK. 
(a) IN GENERAL.—The Secretary, through the Direc-
tor of the Centers for Disease Control and Prevention and 
the Director of the National Institutes of Health, shall es-
tablish at least 10 Antimicrobial Resistance Surveillance 
and Research Network sites to strengthen the national ca-
pacity to— 
(1) describe and confirm regional outbreaks 
through surveillance of locally available clinical 
specimens; 
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(2) assess, integrate, and address local and na-
tional antimicrobial resistance patterns; 
(3) facilitate research on prevention, control, 
and treatment of resistant organisms; and 
(4) serve as a clinical trials network for opti-
mizing antimicrobial drug effectiveness. 
(b) GEOGRAPHIC DISTRIBUTION.—The sites estab-
lished under subsection (a) shall be geographically distrib-
uted across the United States. 
(c) NONDUPLICATION OF CURRENT NATIONAL CA-
PACITY.—The sites established under subsection (a) may 
be based in academic centers, health departments, and ex-
isting surveillance sites. 
(d) RESPONSIBILITIES.—The Network of sites estab-
lished under subsection (a) shall— 
(1) monitor the emergence and changes in the 
patterns of antimicrobial resistant pathogens in indi-
viduals; 
(2) study the molecular epidemiology of such 
pathogens; 
(3) evaluate the efficacy of new and existing 
interventions to prevent or limit the emergence of 
antimicrobial resistance throughout the geographic 
region of the site; 
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(4) provide to the Centers for Disease Control 
and Prevention isolates of resistant pathogens, and 
in particular, pathogens that show new or atypical 
patterns of resistance adversely affecting public 
health; 
(5) conduct clinical research to develop natural 
histories of infectious disease and to study duration 
of antimicrobial use related to resistance develop-
ment, among other things; 
(6) assess the feasibility, cost-effectiveness, and 
appropriateness of surveillance and screening pro-
grams in differing health care and institutional set-
tings, such as schools; and 
(7) evaluate current treatment protocols and 
make appropriate recommendations on best practices 
for treating drug resistant infections. 
(e) COORDINATION.—The sites established under 
subsection (a) shall share data and cooperate with the 
Centers for Disease Control and Prevention and the Na-
tional Institutes of Health. 
(f) DATA ACCESS.—The Director of the Centers for 
Disease Control and Prevention and the Director of the 
National Institutes of Health shall ensure that summary 
reports of data obtained by the Antimicrobial Resistance 
Surveillance and Research Network sites are made avail-
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able to the Antimicrobial Resistance Task Force and, in 
a manner consistent with section 8 of this Act, with the 
Public Health Antimicrobial Advisory Board and the pub-
lic, for review on an ongoing basis . 
SEC. 6. SUPPLEMENT NOT SUPPLANT. 
Section 319E(f) of the Public Health Service Act (42 
U.S.C. 247d–5(f)) is amended to read as follows: 
‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and 
not supplant other Federal, State, and local public funds 
provided for activities under this section, including funds 
appropriated for the Centers for Disease Control and Pre-
vention and the National Institutes of Health.’’. 
SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 
Section 319E(g) of the Public Health Service Act (42 
U.S.C. 247d–5(g)) is amended to read as follows: 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) AUTHORIZATION.—There are authorized to 
be appropriated to carry out this section (other than 
subsection (b)) $45,000,000 for fiscal year 2010, 
$65,000,000 for fiscal year 2011, and $120,000,000 
for fiscal years 2012 through 2014. 
‘‘(2) ALLOCATION.—Of the amount appro-
priated to carry out this section for a fiscal year, not 
less than one-third of such amount shall be made 
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available for activities of the Centers for Disease 
Control and Prevention under subsections (a)(3)(B) 
and (c), of which an appropriate amount shall be al-
located to educational programs under subsection (c) 
dedicated to the reduction of inappropriate anti-
microbial use.’’. 
SEC. 8. PROTECTION OF CONFIDENTIAL AND NATIONAL SE-
CURITY INFORMATION. 
Except as otherwise required by law, this Act (and 
the amendments made by this Act) shall not permit public 
disclosure of trade secrets, confidential commercial infor-
mation, or material inconsistent with national security 
that is obtained by any person under this Act. 
Æ 
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