monitoring under this section publicly available for the 
purposes of— 
‘‘(1) improving the monitoring of important 
trends in antibacterial and antifungal resistance; 
and 
‘‘(2) ensuring appropriate stewardship of anti-
bacterial and antifungal drugs, including those re-
ceiving approval or licensure for a limited population 
pursuant to section 505(x) of the Federal Food, 
Drug, and Cosmetic Act.’’. 
SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROORGANISMS. 
(a) IN GENERAL.—Section 511 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360a) is amended to 
read as follows: 
‘‘SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY 
TEST INTERPRETIVE CRITERIA FOR MICRO-
ORGANISMS. 
‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.— 
‘‘(1) PURPOSE.—The purpose of this section is 
to provide the Secretary with an expedited, flexible 
method for— 
‘‘(A) clearance or premarket approval of 
antimicrobial susceptibility testing devices uti-
lizing updated, recognized susceptibility test in-
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terpretive criteria to characterize the in vitro 
susceptibility of particular bacteria, fungi, or 
other microorganisms to antimicrobial drugs; 
and 
‘‘(B) providing public notice of the avail-
ability of recognized interpretive criteria to 
meet premarket submission requirements or 
other requirements under this Act for anti-
microbial susceptibility testing devices. 
‘‘(2) IN GENERAL.—The Secretary shall iden-
tify appropriate susceptibility test interpretive cri-
teria with respect to antimicrobial drugs— 
‘‘(A) if such criteria are available on the 
date of approval of the drug under section 505 
of this Act or licensure of the drug under sec-
tion 351 of the Public Health Service Act (as 
applicable), upon such approval or licensure; or 
‘‘(B) if such criteria are unavailable on 
such date, on the date on which such criteria 
are available for such drug. 
‘‘(3) BASES
FOR
INITIAL
IDENTIFICATION.— 
The Secretary shall identify appropriate suscepti-
bility test interpretive criteria under paragraph (2), 
based on the Secretary’s review of, to the extent 
available and relevant— 
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‘‘(A) preclinical and clinical data, including 
pharmacokinetic, pharmacodynamic, and epide-
miological data; 
‘‘(B) Bayesian and pharmacometric statis-
tical methodologies; and 
‘‘(C) such other evidence and information 
as the Secretary considers appropriate. 
‘‘(b) SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
WEBSITE.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of the Antibiotic Develop-
ment to Advance Patient Treatment Act, the Sec-
retary shall establish, and maintain thereafter, on 
the website of the Food and Drug Administration, a 
dedicated website that contains a list of any appro-
priate new or updated susceptibility test interpretive 
criteria standards in accordance with paragraph (2) 
(referred to in this section as the ‘Interpretive Cri-
teria Website’). 
‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTER-
PRETIVE CRITERIA STANDARDS.— 
‘‘(A) IN GENERAL.—The list described in 
paragraph (1) shall consist of any new or up-
dated susceptibility test interpretive criteria 
standards that are— 
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‘‘(i) established by a nationally or 
internationally recognized standard devel-
opment organization that— 
‘‘(I) establishes and maintains 
procedures to address potential con-
flicts of interest and ensure trans-
parent decisionmaking; 
‘‘(II) holds open meetings to en-
sure that there is an opportunity for 
public input by interested parties, and 
establishes and maintains processes to 
ensure that such input is considered 
in decisionmaking; and 
‘‘(III) permits its standards to be 
made publicly available, through the 
National Library of Medicine or an-
other similar source acceptable to the 
Secretary; and 
‘‘(ii) recognized in whole, or in part, 
by the Secretary under subsection (c). 
‘‘(B) OTHER LIST.—The Interpretive Cri-
teria Website shall, in addition to the list de-
scribed in subparagraph (A), include a list of 
interpretive criteria, if any, that the Secretary 
has determined to be appropriate with respect 
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to 
legally 
marketed 
antimicrobial 
drugs, 
where— 
‘‘(i) the Secretary does not recognize, 
in whole or in part, an interpretive criteria 
standard described under subparagraph 
(A) otherwise applicable to such a drug; 
‘‘(ii) the Secretary withdraws under 
subsection (c)(1)(B) recognition of a 
standard, in whole or in part, otherwise 
applicable to such a drug; 
‘‘(iii) the Secretary approves an appli-
cation under section 505 of this Act or sec-
tion 351 of the Public Health Service Act, 
as applicable, with respect to marketing of 
such a drug for which there are no rel-
evant interpretive criteria included in a 
standard recognized by the Secretary 
under subsection (c); or 
‘‘(iv) because the characteristics of 
such a drug differ from other drugs with 
the same active ingredient, the interpretive 
criteria with respect to such drug— 
‘‘(I) differ from otherwise appli-
cable interpretive criteria included in 
a standard listed under subparagraph 
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(A) or interpretive criteria otherwise 
listed under this subparagraph; and 
‘‘(II) are determined by the Sec-
retary to be appropriate for the drug. 
‘‘(C) REQUIRED STATEMENTS OF LIMITA-
TIONS OF INFORMATION.—The Interpretive Cri-
teria Website shall include the following: 
‘‘(i) A statement that— 
‘‘(I) the website provides infor-
mation about the susceptibility of bac-
teria, fungi, or other microorganisms 
to a certain drug (or drugs); and 
‘‘(II) the safety and efficacy of 
the drug in treating clinical infections 
due to such bacteria, fungi, or other 
microorganisms may not have been es-
tablished in adequate and well-con-
trolled clinical trials and the clinical 
significance of such susceptibility in-
formation in such trials is unknown. 
‘‘(ii) A statement that directs health 
care practitioners to consult the approved 
product labeling for specific drugs to deter-
mine the uses for which the Food and 
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Drug Administration has approved the 
product. 
‘‘(iii) Any other statement that the 
Secretary determines appropriate to ade-
quately convey the limitations of the data 
supporting susceptibility test interpretive 
criteria standard listed on the website. 
‘‘(3) NOTICE.—Not later than the date on 
which the Interpretive Criteria Website is estab-
lished, the Secretary shall publish a notice of that 
establishment in the Federal Register. 
‘‘(4) INAPPLICABILITY OF MISBRANDING PROVI-
SION.—The inclusion in the approved labeling of an 
antimicrobial drug of a reference or hyperlink to the 
Interpretive Criteria Website, in and of itself, shall 
not cause the drug to be misbranded in violation of 
section 502, or the regulations promulgated there-
under. 
‘‘(5) TRADE SECRETS AND CONFIDENTIAL IN-
FORMATION.—Nothing in this section shall be con-
strued as authorizing the Secretary to disclose any 
information that is a trade secret or confidential in-
formation subject to section 552(b)(4) of title 5, 
United States Code. 
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‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER-
PRETIVE CRITERIA FROM STANDARD DEVELOPMENT OR-
GANIZATIONS.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
the establishment of the Interpretive Criteria 
Website, and at least every 6 months thereafter, the 
Secretary shall— 
‘‘(A) evaluate any appropriate new or up-
dated susceptibility test interpretive criteria 
standards established by a nationally or inter-
nationally recognized standard development or-
ganization described in subsection (b)(2)(A)(i); 
and 
‘‘(B) publish on the public website of the 
Food and Drug Administration a notice— 
‘‘(i) withdrawing recognition of any 
different susceptibility test interpretive cri-
teria standard, in whole or in part; 
‘‘(ii) recognizing the new or updated 
standards; 
‘‘(iii) recognizing one or more parts of 
the new or updated interpretive criteria 
specified in such a standard and declining 
to recognize the remainder of such stand-
ard; and 
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‘‘(iv) making any necessary updates to 
the lists under subsection (b)(2). 
‘‘(2) BASES FOR UPDATING INTERPRETIVE CRI-
TERIA STANDARDS.—In evaluating new or updated 
susceptibility test interpretive criteria standards 
under paragraph (1)(A), the Secretary may con-
sider— 
‘‘(A) the Secretary’s determination that 
such a standard is not applicable to a particular 
drug because the characteristics of the drug dif-
fer from other drugs with the same active in-
gredient; 
‘‘(B) information provided by interested 
third parties, including public comment on the 
annual compilation of notices published under 
paragraph (3); 
‘‘(C) any bases used to identify suscepti-
bility test interpretive criteria under subsection 
(a)(2); and 
‘‘(D) such other information or factors as 
the Secretary determines appropriate. 
‘‘(3) ANNUAL
COMPILATION
OF
NOTICES.— 
Each year, the Secretary shall compile the notices 
published under paragraph (1)(B) and publish such 
compilation in the Federal Register and provide for 
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public comment. If the Secretary receives comments, 
the Secretary will review such comments and, if the 
Secretary determines appropriate, update pursuant 
to this subsection susceptibility test interpretive cri-
teria standards— 
‘‘(A) recognized by the Secretary under 
this subsection; or 
‘‘(B) otherwise listed on the Interpretive 
Criteria Website under subsection (b)(2). 
‘‘(4) RELATION TO SECTION 514(c).—Any sus-
ceptibility test interpretive standard recognized 
under this subsection or any criteria otherwise listed 
under subsection (b)(2)(B) shall be deemed to be 
recognized as a standard by the Secretary under sec-
tion 514(c)(1). 
‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRI-
TERIA.—Nothing in this section prohibits a person 
from seeking approval or clearance of a drug or de-
vice, or changes to the drug or the device, on the 
basis of susceptibility test interpretive criteria stand-
ards which differ from those recognized pursuant to 
paragraph (1). 
‘‘(d) ANTIMICROBIAL DRUG LABELING.— 
‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH-
MENT OF INTERPRETIVE CRITERIA WEBSITE.—With 
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respect to an antimicrobial drug lawfully introduced 
or delivered for introduction into interstate com-
merce for commercial distribution before the estab-
lishment of the Interpretive Criteria Website, a hold-
er of an approved application under section 505 or 
section 351 of the Public Health Service Act, as ap-
plicable, for each such drug— 
‘‘(A) not later than 1 year after establish-
ment of the Interpretive Criteria Website, shall 
submit to the Secretary a supplemental applica-
tion for purposes of changing the drug’s label-
ing to substitute a reference or hyperlink to 
such Website for any susceptibility test inter-
pretive criteria and related information; and 
‘‘(B) may begin distribution of the drug in-
volved upon receipt by the Secretary of the sup-
plemental application for such change. 
‘‘(2) DRUGS MARKETED SUBSEQUENT TO ES-
TABLISHMENT
OF
INTERPRETIVE
CRITERIA 
WEBSITE.—With respect to antimicrobial drugs law-
fully introduced or delivered for introduction into 
interstate commerce for commercial distribution on 
or after the date of the establishment of the Inter-
pretive Criteria Website, the labeling for such a drug 
shall include, in lieu of susceptibility test interpretive 
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criteria and related information, a reference to such 
Website. 
‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTI-
MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— 
‘‘(1) IN
GENERAL.—Notwithstanding sections 
501, 502, 510, 513, and 515, if the conditions speci-
fied in paragraph (2) are met (in addition to other 
applicable provisions under this chapter) with re-
spect to an antimicrobial susceptibility testing device 
described in subsection (f)(1), the Secretary may au-
thorize the marketing of such device for a use de-
scribed in such subsection. 
‘‘(2) 
CONDITIONS
APPLICABLE
TO
ANTI-
MICROBIAL
SUSCEPTIBILITY
TESTING
DEVICES.— 
The conditions specified in this paragraph are the 
following: 
‘‘(A) The device is used to make a deter-
mination of susceptibility using susceptibility 
test interpretive criteria that are— 
‘‘(i) included in a standard recognized 
by the Secretary under subsection (c); or 
‘‘(ii) otherwise listed on the Interpre-
tive Criteria Website under subsection 
(b)(2). 
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‘‘(B) The labeling of such device promi-
nently and conspicuously— 
‘‘(i) includes a statement that— 
‘‘(I) the device provides informa-
tion about the susceptibility of bac-
teria and fungi to certain drugs; and 
‘‘(II) the safety and efficacy of 
such drugs in treating clinical infec-
tions due to such bacteria or fungi 
may not have been established in ade-
quate and well-controlled clinical trials 
and the clinical significance of such 
susceptibility information in those in-
stances is unknown; 
‘‘(ii) includes a statement directing 
health care practitioners to consult the ap-
proved labeling for drugs tested using such 
a device, to determine the uses for which 
the Food and Drug Administration has ap-
proved such drugs; and 
‘‘(iii) includes any other statement the 
Secretary determines appropriate to ade-
quately convey the limitations of the data 
supporting the interpretive criteria de-
scribed in subparagraph (A). 
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‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘antimicrobial susceptibility test-
ing device’ means a device that utilizes susceptibility 
test interpretive criteria to determine and report the 
in vitro susceptibility of certain microorganisms to a 
drug (or drugs). 
‘‘(2) The term ‘qualified infectious disease 
product’ means a qualified infectious disease product 
designated under section 505E(d). 
‘‘(3) The term ‘susceptibility test interpretive 
criteria’ means— 
‘‘(A) one or more specific numerical values 
which characterize the susceptibility of bacteria 
or other microorganisms to the drug tested; and 
‘‘(B) related categorizations of such sus-
ceptibility, including categorization of the drug 
as susceptible, intermediate, resistant, or such 
other term as the Secretary determines appro-
priate. 
‘‘(4)(A) The term ‘antimicrobial drug’ means, 
subject to subparagraph (B), a systemic anti-
bacterial or antifungal drug that— 
‘‘(i) is intended for human use in the treat-
ment of a disease or condition caused by a bac-
terium or fungus; 
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‘‘(ii) may include a qualified infectious dis-
ease product designated under section 505E(d); 
and 
‘‘(iii) is subject to section 503(b)(1). 
‘‘(B) If provided by the Secretary through regu-
lations, such term may include— 
‘‘(i) drugs other than systemic anti-
bacterial and antifungal drugs; and 
‘‘(ii) biological products (as such term is 
defined in section 351 of the Public Health 
Service Act) to the extent such products exhibit 
antimicrobial activity. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed— 
‘‘(1) to alter the standards of evidence— 
‘‘(A) under subsection (c) or (d) of section 
505, including the substantial evidence stand-
ard in section 505(d), or under section 351 of 
the Public Health Service Act (as applicable); 
or 
‘‘(B) with respect to marketing authoriza-
tion for devices, under section 510, 513, or 515; 
‘‘(2) to apply with respect to any drug, device, 
or biological product, in any context other than— 
‘‘(A) an antimicrobial drug; or 
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‘‘(B) an antimicrobial susceptibility testing 
device that uses susceptibility test interpretive 
criteria to characterize and report the in vitro 
susceptibility of certain bacteria, fungi, or other 
microorganisms to antimicrobial drugs in ac-
cordance with this section; or 
‘‘(3) unless specifically stated, to have any ef-
fect on authorities provided under other sections of 
this Act, including any regulations issued under such 
sections.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) REPEAL OF RELATED AUTHORITY.—Section 
1111 of the Food and Drug Administration Amend-
ments Act of 2007 (42 U.S.C. 247d–5a; relating to 
identification of clinically susceptible concentrations 
of antimicrobials) is repealed. 
(2) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352), as 
amended by section 1, is further amended by adding 
at the end the following: 
‘‘(ee) If it is an antimicrobial drug and its labeling 
fails to conform with the requirements under section 
511(d).’’. 
(3) RECOGNITION OF INTERPRETIVE CRITERIA 
AS DEVICE STANDARD.—Section 514(c)(1)(A) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360d(c)(1)(A)) is amended by inserting after ‘‘the 
Secretary shall, by publication in the Federal Reg-
ister’’ the following: ‘‘(or, with respect to suscepti-
bility test interpretive criteria or standards recog-
nized or otherwise listed under section 511, by post-
ing on the Interpretive Criteria Website in accord-
ance with such section)’’. 
(c) REPORT
TO CONGRESS.—Not later than two 
years after the date of enactment of this Act, the Sec-
retary of Health and Human Services 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 
progress made in implementing section 511 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as 
amended by this section. 
(d) REQUESTS FOR UPDATES TO INTERPRETIVE CRI-
TERIA WEBSITE.—Chapter 35 of title 44, United States 
Code, shall not apply to the collection of information from 
interested parties regarding the updating of lists under 
paragraph (2) of subsection (b) of section 511 of the Fed-
eral Food, Drug, and Cosmetic Act (as amended by sub-
section (a)) and posted on the Interpretive Criteria 
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