antimicrobials has also correlated with an increased 
rate in the development of antimicrobial resistance. 
(2) Through mutation as well as other mecha-
nisms, bacteria and other infectious disease-causing 
organisms—viruses, fungi, and parasites—develop 
resistance to antimicrobial drugs over time. The 
more antimicrobials are used, whether appropriately 
or inappropriately, the more this contributes to the 
development of antimicrobial resistance. 
(3) Scientific evidence suggests that the source 
of antibiotic resistance in humans is not just limited 
to use of antibiotics in humans, but may in fact also 
be passed to humans from food-producing animals 
which are exposed to antibiotics. 
(4) Today, antimicrobial resistance poses a seri-
ous patient safety and public health threat through-
out the United States. 
(5) Tuberculosis is emerging as a virulent and 
growing threat to public health in the United States 
and throughout the world. Multidrug resistant tu-
berculosis (MDR–TB) was first documented in the 
early 1990s, and by 2004 there were approximately 
424,000 new cases. Extensively drug resistant tuber-
culosis (XDR–TB) emerged in 2005 and has been 
called ‘‘virtually untreatable’’ by the World Health 
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Organization because this strain is resistant to near-
ly every approved tuberculosis drug. 
(6) Nearly 70 percent of all hospital-acquired 
bacterial infections in the United States are resist-
ant to at least one drug, and in some cases the situ-
ation is much worse. According to the Centers for 
Disease Control and Prevention, almost half of the 
identified methicillin-resistant Staphylococcus aureus 
(MRSA) strains in hospitals are resistant to all but 
a few antibiotics. 
(7) Each year, nearly 2,000,000 people contract 
bacterial infections in hospitals, and approximately 
90,000 of these people die from these infections — 
7 times more than a decade earlier. 
(8) The costs of antibiotic-resistant bacterial 
diseases are hard to quantify, but a 1995 report by 
the Office of Technology Assessment of Congress, 
which looked at 6 different antibiotic-resistant 
strains of bacteria, calculated that the minimum na-
tionwide hospital costs of just these strains of bac-
teria accounted for $1,300,000,000 annually (1992 
dollars). 
(9) A 1989-published study has estimated that 
the total societal cost of all antibiotic-resistant bac-
teria was up to $30,000,000,000 annually. 
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(10) The cost to society of antimicrobial-resist-
ant infections will only rise as antimicrobial resist-
ance continues to spread. 
(11) The Federal interagency Task Force on 
Antimicrobial Resistance was established in 1999, 
but the authorization of appropriations for the Task 
Force expired in 2006 and should be reauthorized to 
enable the continuation of the important coordinated 
Federal interagency effort to combat the adverse im-
pacts of antimicrobial resistance on human health. 
(12) The Congress should strengthen the Task 
Force and give it the tools necessary to carry out the 
Public Health Action Plan to Combat Antimicrobial 
Resistance. 
SEC. 3. ANTIMICROBIAL RESISTANCE TASK FORCE. 
(a) IN GENERAL.—Section 319E of the Public 
Health Service Act (42 U.S.C. 247d–5) is amended— 
(1) in subsection (a)— 
(A) in the subsection heading, by striking 
‘‘TASK FORCE’’ and inserting the following: 
‘‘OFFICE
OF
ANTIMICROBIAL
RESISTANCE, 
TASK FORCE, AND ADVISORY BOARD’’; 
(B) in paragraph (1)— 
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(i) by striking ‘‘as of the date of the 
enactment of this section’’ and inserting 
‘‘September 30, 2006’’; and 
(ii) by adding at the end the fol-
lowing: ‘‘The Secretary shall, not later 
than the end of the calendar year 2008, es-
tablish an Office of Antimicrobial Resist-
ance in the Office of the Assistant Sec-
retary for Health and appoint a director to 
that Office. The Secretary shall, not later 
than the end of the calendar year 2008, es-
tablish the Public Health Antimicrobial 
Advisory Board as a permanent advisory 
board to the Director of the Office of Anti-
microbial Resistance. The Director of the 
Office of Antimicrobial Resistance shall 
serve as the Director of the task force and 
supervise the activities and budgetary allo-
cations of the Office, task force, and advi-
sory board.’’; 
(C) by amending paragraph (2) to read as 
follows: 
‘‘(2) MEMBERS.— 
‘‘(A) MEMBERS
OF
THE
ANTIMICROBIAL 
RESISTANCE TASK FORCE.—The task force de-
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scribed in paragraph (1) shall be composed of 
the following members: 
‘‘(i) The Director of the Office of 
Antimicrobial Resistance. 
‘‘(ii) Representatives of such Federal 
agencies as the Secretary determines nec-
essary, including at a minimum represent-
atives of the following: 
‘‘(I) The Centers for Disease 
Control and Prevention. 
‘‘(II) The Food and Drug Ad-
ministration. 
‘‘(III) The National Institutes of 
Health. 
‘‘(IV) The Agency for Healthcare 
Research and Quality. 
‘‘(V) The Centers for Medicare & 
Medicaid Services. 
‘‘(VI) The Health Resources and 
Services Administration. 
‘‘(VII) The Department of Agri-
culture. 
‘‘(VIII) The Department of De-
fense. 
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‘‘(IX) The Department of Vet-
erans Affairs. 
‘‘(X) The Environmental Protec-
tion Agency. 
‘‘(B) MEMBERS OF THE PUBLIC HEALTH 
ANTIMICROBIAL ADVISORY BOARD.— 
‘‘(i) IN GENERAL.—The Public Health 
Antimicrobial Advisory Board shall be 
composed of 19 voting members, appointed 
by the Secretary. Such members shall in-
clude representatives of the infectious dis-
eases, medical (including hospital and com-
munity-based physicians), public health, 
veterinary, research, and international 
health communities. 
‘‘(ii) 
TERMS.—Each 
member 
ap-
pointed under clause (i) shall be appointed 
for a term of 3 years, except that of the 
19 members first appointed— 
‘‘(I) 6 shall be appointed for a 
term of 1 year; and 
‘‘(II) 6 shall be appointed for a 
term of 2 years. 
‘‘(iii) CHAIR.—The Secretary shall ap-
point a Chair of the Public Health Anti-
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(2) by amending subsection (b) to read as fol-
lows: 
‘‘(b) ANTIMICROBIAL RESISTANCE RESEARCH AND 
PRODUCT
DEVELOPMENT.—The 
Secretary, 
acting 
through the Director of the Office of Antimicrobial Resist-
ance, 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, 
shall develop an antimicrobial resistance strategic research 
plan that strengthens existing epidemiological, inter-
ventional, clinical, translational, and basic research efforts 
and funds directly or through the awards of grants or co-
operative agreements to public or private entities the con-
duct of research, investigations, experiments, demonstra-
tions, and studies that advance 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 antibiotic pressure for the 
emergence of resistance, including addressing issues 
related to duration of therapy, effectiveness of ther-
apy in self-resolving diseases, and determining popu-
lations most likely to benefit from antimicrobials; 
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‘‘(3) the extent to which the use of anti-
microbial products in humans, animals, plants, and 
other uses accelerates development and transmission 
of antimicrobial resistance; 
‘‘(4) the natural histories of infectious diseases 
(including defining the disease, the diagnosis, the se-
verity, 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-
eases 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 advisory 
board), in collaboration with the Department of De-
fense and the Joint Genome Institute of the Depart-
ment of Energy. 
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To the extent practical, such research shall be conducted 
in conjunction with the Antimicrobial Resistance Clinical 
Research and Public Health Network.’’; 
(3) in subsection (c)— 
(A) by inserting ‘‘acting through the Di-
rector of the Office of Antimicrobial Resist-
ance’’ after ‘‘The Secretary,’’; and 
(B) by striking ‘‘members of the task force 
described in subsection (a) of this section,’’; 
(4) in subsection (d)(1), by inserting ‘‘, through 
the Office of Antimicrobial Resistance,’’ after ‘‘The 
Secretary’’; 
(5) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘, act-
ing through the Director of the Office of Anti-
microbial Resistance,’’ after ‘‘The Secretary’’; 
and 
(B) in paragraph (3), by inserting ‘‘, act-
ing through the Office of Antimicrobial Resist-
ance,’’ after ‘‘The Secretary’’; and 
(6) by amending subsection (g) to read as fol-
lows: 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) AUTHORIZATION.—There are authorized to 
be 
appropriated 
to 
carry 
out 
this 
section 
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$45,000,000 for fiscal year 2008, $65,000,000 for 
fiscal year 2009, $120,000,000 for fiscal year 2010, 
and such sums as may be necessary for each subse-
quent fiscal year. 
‘‘(2) ALLOCATION.—Of the amount appro-
priated to carry out this section for a fiscal year, not 
less than $15,000,000 shall be made available for 
activities of the Centers for Disease Control and 
Prevention under subsections (a)(3)(B) and (c), of 
which at least $5,000,000 shall be made available 
for the Centers for Disease Control and Prevention 
educational programs dedicated to the reduction of 
inappropriate antimicrobial use. 
‘‘(3) RATABLE REDUCTION.—If amounts appro-
priated under paragraph (1) for any fiscal year are 
less than the amounts required to comply with para-
graph (2), the Secretary shall ratably reduce the 
amounts to be made available under paragraph (2) 
accordingly.’’. 
(b) ENSURE ACCESS TO ANTIMICROBIAL DATA AND 
RESEARCH.—The heads of government departments and 
agencies, including the Secretary of Health and Human 
Services, the Under Secretary for Health of the Depart-
ment of Veterans Affairs, the Secretary of Defense, the 
Secretary of Agriculture, the Administrator of the Envi-
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ronmental Protection Agency, the Administrator of the 
Centers for Medicare & Medicaid Services, the Director 
of the Centers for Disease Control and Prevention, the Di-
rector of the National Institutes of Health, and the Com-
missioner of Food and Drugs, shall work with the Director 
of the Office of Antimicrobial Resistance and the Anti-
microbial Resistance Task Force to identify relevant data 
and formats, and mechanisms for communicating these 
data to the Office of Antimicrobial Resistance, the Anti-
microbial Resistance Task Force, and the Public Health 
Antimicrobial Advisory Board, including relevant data ob-
tained by the agencies through contracts with other orga-
nizations, including— 
(1) use and clinical outcomes data on patients 
receiving antimicrobial agents for the treatment, 
prevention, or diagnosis of infection or infectious 
diseases; 
(2) surveillance data regarding emerging anti-
microbial resistance; 
(3) susceptibility data related to antimicrobial 
drug use; 
(4) data related to the amount of antimicrobials 
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 pre-
scribing practices. 
In a manner not inconsistent with national security, sum-
maries of such data (excluding any proprietary data) shall 
be made available to the public 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)). 
(c) CONSULTATION BEFORE DRUG APPROVAL.—At 
least 90 days prior to granting approval to any anti-
microbial drug application under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 
Health Service Act (42 U.S.C. 201 et seq.), the Secretary 
of Health and Human Services shall consult with the Anti-
microbial Resistance Task Force regarding antimicrobial 
resistance issues associated with the drug for which the 
application was submitted, including the potential emer-
gence of antimicrobial resistance. 
(d) RELEVANT PORTIONS
OF PENDING APPLICA-
TIONS.—The Secretary of Health and Human Services 
shall make relevant portions of pending antimicrobial drug 
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applications submitted under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health 
Service Act (42 U.S.C. 201 et seq.) available to the Anti-
microbial Resistance Task Force for the purposes of this 
Act and the amendments made by this Act. 
(e) 
IMPROPER
DISCLOSURE
OF
PROPRIETARY 
DATA.—The Secretary of Health and Human Services 
shall take appropriate steps to prevent the improper dis-
closure of proprietary data by the Antimicrobial Resist-
ance Task Force, the Public Health Antimicrobial Advi-
sory Board, or any of their members. 
SEC. 4. COLLECTION OF ANTIMICROBIAL DRUG DATA. 
(a) COLLECTION
OF
ANTIMICROBIAL
PRODUCT 
AMOUNT DATA.— 
(1) HUMAN
ANTIMICROBIAL
USE
REPORTS.— 
Notwithstanding any other provision of law, starting 
in 2008 each sponsor of an antimicrobial drug prod-
uct subject to section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) which is 
sold or distributed in the United States shall, by 
March 31 of each calendar year, submit to the Of-
fice of Antimicrobial Resistance the amount of the 
antimicrobial drug product sold or distributed in the 
United States from January 1 to December 31 of 
the preceding calendar year to support epidemiologic 
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and microbiologic research on the impact of anti-
microbial drug use and resistance development. To 
ensure uniform reporting standards, the Director of 
the Office of Antimicrobial Resistance shall establish 
the specific content and format of antimicrobial use 
data submissions. 
(2) ANIMAL
ANTIMICROBIAL
USE
REPORT.— 
Notwithstanding any other provision of law, starting 
in 2008 each sponsor of an antimicrobial drug prod-
uct subject to section 512 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b) which is 
sold or distributed in the United States shall, by 
March 31 of each calendar year, submit to the Of-
fice of Antimicrobial Resistance the amount of the 
antimicrobial drug product sold or distributed in the 
United States from January 1 to December 31 of 
the preceding calendar year to support epidemiologic 
and microbiologic research on the impact of anti-
microbial drug use in food-producing animals and 
resistance development. The data shall be reported 
as follows: 
(A) By volume separately for use in poul-
try, cattle, aquaculture, and swine. 
(B) By total volume sold for use in all 
food-producing animals. 
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(C) Whatever additional standard criteria 
for reporting the Director of the Office of Anti-
microbial Resistance may establish. 
(3) PUBLIC
AVAILABILITY
OF
SUMMARIES.— 
The Director of the Office of Antimicrobial Resist-
ance shall make summaries of the data received 
under paragraphs (1) and (2) publicly available and 
ensure that such summaries are updated and pub-
lished, in a manner not inconsistent with national 
security and respectful of confidential business infor-
mation, at least once annually on the website de-
scribed 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 re-
search on the impact on human health of anti-
microbial drug use in humans and food-producing 
animals. 
(b) COLLECTION OF ANTIMICROBIAL PRESCRIPTION 
DATA.— 
(1) CLINICAL
OUTCOMES
DATA.—The Under 
Secretary for Health of the Department of Veterans 
Affairs and the Administrator of the Centers for 
Medicare & Medicaid Services shall, as determined 
to be relevant by the Director of the Office of Anti-
microbial Resistance, collect drug utilization data 
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and clinical outcomes data on patients within the 
Department of Veterans Affairs and the Medicare 
and Medicaid service systems, respectively, who are 
receiving prescription antimicrobial agents for the 
treatment, prevention, or diagnosis of infection or 
infectious diseases. 
(2) ORGANIZATION.—The 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; and 
(F) geographic region. 
(3) COMPREHENSIVE ANNUAL REPORTS.—The 
Under Secretary for Health of the Department of 
Veterans Affairs and the Administrator of the Cen-
ters for Medicare & Medicaid Services shall submit 
comprehensive annual reports on such data, to be 
developed in coordination with the Director of the 
Centers for Disease Control and Prevention, to the 
Director of the Office of Antimicrobial Resistance. 
Such reports shall identify, where appropriate, inter-
ventions to prevent and control the development of 
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antimicrobial resistance and may include an analysis 
of the following: 
(A) Intra- and extra-label antimicrobial 
use. 
(B) Where challenges to appropriate use 
remain. 
(C) Trends and variations in rates of anti-
microbial resistance. 
(D) The relationship between drug use and 
resistance. 
(4) DATA REVIEW.—The Under Secretary for 
Health of the Department of Veterans Affairs and 
the Administrator of the Centers for Medicare & 
Medicaid Services shall ensure that all of the data 
collected under paragraph (1), including all such 
data obtained through contracts with other organiza-
tions, are made accessible to the Office of Anti-
microbial Resistance for review on an ongoing basis. 
(5) PUBLIC AVAILABILITY OF REPORTS.—The 
Director of the Office of Antimicrobial Resistance 
shall make the reports received under paragraph (3) 
publicly available and ensure that it is updated and 
published, in a manner not inconsistent with na-
tional security, at least once annually on the website 
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