130 
spect to approval in accordance with this subsection 
to the same extent and in the same manner as such 
provisions apply with respect to accelerated approval 
in accordance with section 506(c)(1). 
‘‘(5) TERMINATION OF REQUIREMENTS OR CON-
DITIONS.—If a drug is approved in accordance with 
this subsection for an indication in a limited popu-
lation of patients and is subsequently approved or li-
censed under this section or section 351 of the Pub-
lic Health Service Act, other than in accordance with 
this subsection, for— 
‘‘(A) the same indication and the same 
conditions of use, the Secretary shall remove 
any labeling requirements or postmarketing 
conditions that were made applicable to the 
drug under this subsection; or 
‘‘(B) a different indication or condition of 
use, the Secretary shall not apply the labeling 
requirements and postmarketing conditions that 
were made applicable to the drug under this 
subsection to the subsequent approval of the 
drug for such different indication or condition 
of use. 
‘‘(6) RELATION TO OTHER PROVISIONS.—Noth-
ing in this subsection shall be construed to prohibit
131 
the approval of a drug for use in a limited popu-
lation of patients in accordance with this subsection, 
in combination with— 
‘‘(A) an agreement on the design and size 
of a clinical trial pursuant to subparagraphs 
(B) and (C) of subsection (b)(5); 
‘‘(B) designation and treatment of the 
drug as a breakthrough therapy under section 
506(a); 
‘‘(C) designation and treatment of the 
drug as a fast track product under section 
506(b); or 
‘‘(D) accelerated approval of the drug in 
accordance with section 506(c). 
‘‘(7) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed— 
‘‘(A) to alter the standards of evidence 
under subsection (c) or (d) (including the sub-
stantial evidence standard in subsection (d)); 
‘‘(B) to waive or otherwise preclude the ap-
plication of requirements under subsection (o); 
‘‘(C) to otherwise, in any way, limit the au-
thority of the Secretary to approve products 
pursuant to this Act and the Public Health
132 
Service Act as authorized prior to the date of 
enactment of this subsection; or 
‘‘(D) to restrict in any manner, the pre-
scribing of antibiotics or other products by 
health care providers, or to otherwise limit or 
restrict the practice of health care. 
‘‘(8) EFFECTIVE
IMMEDIATELY.—The Sec-
retary shall have the authorities vested in the Sec-
retary by this subsection beginning on the date of 
enactment of this subsection, irrespective of when 
and whether the Secretary promulgates final regula-
tions or guidance. 
‘‘(9) DEFINITIONS.—In this subsection: 
‘‘(A) EARLY
CONSULTATION
MEETING.— 
The term ‘early consultation meeting’ means a 
pre-investigational new drug meeting or an end- 
of-phase-1 meeting that— 
‘‘(i) is conducted to review and reach 
a written agreement— 
‘‘(I) on the scope of the stream-
lined development plan for a drug for 
which a sponsor intends to request ap-
proval in accordance with this sub-
section; and
133 
‘‘(II) which, as appropriate, may 
include agreement on the design and 
size of necessary preclinical and clin-
ical studies early in the development 
process, including clinical trials whose 
data are intended to form the primary 
basis for an effectiveness claim; and 
‘‘(ii) provides an opportunity to dis-
cuss expectations of the Secretary regard-
ing studies or other information that the 
Secretary deems appropriate for purposes 
of applying paragraph (5), relating to the 
termination of labeling requirements or 
postmarketing conditions. 
‘‘(B) ASSESSMENT
MEETING.—The term 
‘assessment meeting’ means an end-of-phase-2 
meeting, pre-new drug application meeting, or 
pre-biologics license application meeting con-
ducted to resolve questions and issues raised 
during the course of clinical investigations, and 
details addressed in the written agreement re-
garding postapproval commitments or expan-
sion of approved uses. 
‘‘(C) POSTAPPROVAL MEETING.—The term 
‘postapproval meeting’ means a meeting fol-
134 
lowing initial approval or licensure of the drug 
for use in a limited population, to discuss any 
issues identified by the Secretary or the sponsor 
regarding postapproval commitments or expan-
sion of approved uses.’’. 
(c) GUIDANCE.—Not later than 18 months after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall issue draft guidance describing cri-
teria, process, and other general considerations for dem-
onstrating the safety and effectiveness of antibacterial and 
antifungal drugs to be approved for use in a limited popu-
lation in accordance with section 505(z) of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(b). 
(d) CONFORMING AMENDMENTS.— 
(1) LICENSURE OF CERTAIN BIOLOGICAL PROD-
UCTS.—Section 351(j) of the Public Health Service 
Act (42 U.S.C. 262(j)) is amended— 
(A) 
by 
striking 
‘‘(j)’’ 
and 
inserting 
‘‘(j)(1)’’; 
(B) by inserting ‘‘505(z),’’ after ‘‘505(p),’’; 
and 
(C) by adding at the end the following new 
paragraph:
135 
‘‘(2) In applying section 505(z) of the Federal Food, 
Drug, and Cosmetic Act to the licensure of biological prod-
ucts under this section— 
‘‘(A) references to an antibacterial or antifungal 
drug that is intended to treat a serious or life- 
threatening infection shall be construed to refer to 
a biological product intended to treat a serious or 
life-threatening bacterial or fungal infection; and 
‘‘(B) references to approval of a drug under 
section 505(c) of such Act shall be construed to 
refer to a licensure of a biological product under 
subsection (a) of this section.’’. 
(2) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 
amended by adding at the end the following new 
subsection: 
‘‘(dd) If it is a drug approved in accordance with sec-
tion 505(z) and its labeling does not meet the require-
ments under paragraph (3) of such subsection, subject to 
paragraph (5) of such subsection.’’. 
(e) EVALUATION.— 
(1) ASSESSMENT.—Not later than 48 months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall publish 
for public comment an assessment of the program
136 
established under section 505(z) of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (b). Such assessment shall determine if the 
limited-use pathway established under such section 
505(z) has improved or is likely to improve patient 
access to novel antibacterial or antifungal treat-
ments and assess how the pathway could be ex-
panded to cover products for serious or life-threat-
ening diseases or conditions beyond bacterial and 
fungal infections. 
(2) MEETING.—Not later than 90 days after 
the date of the publication of such assessment, the 
Secretary, acting through the Commissioner of Food 
and Drugs, shall hold a public meeting to discuss 
the findings of the assessment, during which public 
stakeholders may present their views on the success 
of the program established under section 505(z) of 
the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (b), and the appropriateness of 
expanding such program. 
(f) EXPANSION OF PROGRAM.—If the Secretary of 
Health and Human Services determines, based on the as-
sessment under subsection (e)(1), evaluation of the assess-
ment, and any other relevant information, that the public 
health would benefit from expansion of the limited-use
137 
pathway established under section 505(z) of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection 
(b)) beyond the drugs approved in accordance with such 
section, the Secretary may expand such limited-use path-
way in accordance with such a determination. The ap-
proval of any drugs under any such expansion shall be 
subject to the considerations and requirements described 
in such section 505(z) for purposes of expansion to other 
serious or life-threatening diseases or conditions. 
(g) MONITORING.—The Public Health Service Act is 
amended by inserting after section 317T (42 U.S.C. 
247b–22) the following: 
‘‘SEC. 
317U. 
MONITORING 
ANTIBACTERIAL 
AND 
ANTIFUNGAL DRUG USE AND RESISTANCE. 
‘‘(a) MONITORING.—The Secretary shall use an ap-
propriate monitoring system to monitor— 
‘‘(1) the use of antibacterial and antifungal 
drugs, including those receiving approval or licensure 
for a limited population pursuant to section 505(z) 
of the Federal Food, Drug, and Cosmetic Act; and 
‘‘(2) changes in bacterial and fungal resistance 
to drugs. 
‘‘(b) PUBLIC AVAILABILITY
OF DATA.—The Sec-
retary shall make summaries of the data derived from
138 
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(z) of the Federal Food, 
Drug, and Cosmetic Act.’’. 
SEC. 2122. 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-
139 
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—
140 
‘‘(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 21st Century Cures 
Act, the Secretary shall establish, and maintain 
thereafter, on the website of the Food and Drug Ad-
ministration, a dedicated website that contains a list 
of any appropriate new or updated susceptibility test 
interpretive criteria standards in accordance with 
paragraph (2) (referred to in this section as the ‘In-
terpretive Criteria 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—
141 
‘‘(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
142 
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
143 
(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
144 
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.
145 
‘‘(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
146 
‘‘(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
147 
public comment. If the Secretary receives comments, 
the Secretary shall 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
148 
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 of 
this Act or section 351 of the Public Health Service 
Act, as applicable, 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
149 
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).
150 
‘‘(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).
151 
‘‘(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;
152 
‘‘(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
153 
‘‘(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) CLERICAL AMENDMENT.—The table of con-
tents in section 2 of the Food and Drug Administra-
tion Amendments Act of 2007 is amended by strik-
ing the item relating to section 1111. 
(3) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352), as 
amended by section 2121, is further amended by 
adding at the end the following:
154 
‘‘(ee) If it is an antimicrobial drug and its labeling 
fails to conform with the requirements under section 
511(d).’’. 
(4) RECOGNITION OF INTERPRETIVE CRITERIA 
AS DEVICE STANDARD.—Section 514(c)(1)(A) of the 
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 2 years 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives 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
155 
interested parties regarding the updating of lists under 
paragraph (2) of subsection (b) section 511 of the Federal 
Food, Drug, and Cosmetic Act (as amended by subsection 
(a)) and posted on the Interpretive Criteria Website estab-
lished under paragraph (1) of such subsection (b). 
(e) NO EFFECT
ON HEALTH CARE PRACTICE.— 
Nothing in this subtitle (including the amendments made 
by this subtitle) shall be construed to restrict, in any man-
ner, the prescribing or administering of antibiotics or 
other products by health care practitioners, or to limit the 
practice of health care. 
SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF 
DISARM DRUGS. 
(a) ADDITIONAL PAYMENT
FOR DISARM DRUGS 
UNDER MEDICARE.— 
(1) IN GENERAL.—Section 1886(d)(5) of the 
Social Security Act (42 U.S.C. 1395ww(d)(5)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(M)(i) As part of the annual rulemaking conducted 
with respect to payment for subsection (d) hospitals for 
each fiscal year beginning with fiscal year 2018, the Sec-
retary shall— 
‘‘(I) include a list of the DISARM drugs for 
such fiscal year; and
156 
‘‘(II) with respect to discharges by eligible hos-
pitals that involve a drug so listed, provide for an 
additional payment to be made under this subsection 
in accordance with the provisions of this subpara-
graph. 
‘‘(ii) Additional payments may not be made for a 
drug under this subparagraph— 
‘‘(I) other than during the 5-fiscal-year period 
beginning with the fiscal year for which the drug is 
first included in the list described in clause (i)(I); 
and 
‘‘(II) with respect to which payment has ever 
been made pursuant to subparagraph (K). 
‘‘(iii) For purposes of this subparagraph, the term 
‘DISARM drug’ means a product that is approved for use, 
or a product for which an indication is first approved for 
use, by the Food and Drug Administration on or after 
December 1, 2014, and that the Food and Drug Adminis-
tration determines is an antimicrobial product (as defined 
in clause (iv)) and is intended to treat an infection— 
‘‘(I) for which there is an unmet medical need; 
and 
‘‘(II) which is associated with high rates of 
mortality or significant patient morbidity, as deter-
mined in consultation with the Director of the Cen-
157 
ters for Disease Control and Prevention and the in-
fectious disease professional community. 
‘‘(iv) For purposes of clause (iii), the term ‘anti-
microbial product’ means a product that either— 
‘‘(I) is intended to treat an infection caused by, 
or likely to be caused by, a qualifying pathogen (as 
defined under section 505E(f) of the Federal Food, 
Drug, and Cosmetic Act); or 
‘‘(II) meets the definition of a qualified infec-
tious disease product under section 505E(g) of the 
Federal Food, Drug, and Cosmetic Act. 
Such determination may be revoked only upon a finding 
that the request for such determination contained an un-
true statement of material fact. 
‘‘(v) For purposes of this subparagraph, the term ‘eli-
gible hospital’ means a subsection (d) hospital that partici-
pates in the National Healthcare Safety Network of the 
Centers for Disease Control and Prevention (or, to the ex-
tent a similar surveillance system that includes reporting 
about antimicrobial drugs is determined by the Secretary 
to be available to such hospitals, such similar surveillance 
system as the Secretary may specify). 
‘‘(vi) Subject to the succeeding provisions of this sub-
paragraph, the additional payment under this subpara-
158 
graph, with respect to a drug, shall be in the amount pro-
vided for such drug under section 1847A. 
‘‘(vii) As part of the rulemaking referred to in clause 
(i) for each fiscal year, the Secretary shall estimate— 
‘‘(I) total add-on payments (as defined in sub-
clause (I) of clause (ix)); and 
‘‘(II) total hospital payments (as defined in 
subclause (II) of such clause). 
‘‘(viii) If the total add-on payments estimated pursu-
ant to clause (vii)(I) for a fiscal year exceed 0.02 percent 
of the total hospital payments estimated pursuant to 
clause (vii)(II) for such fiscal year, the Secretary shall re-
duce in a pro rata manner the amount of each additional 
payment under this subsection pursuant to this subpara-
graph for such fiscal year in order to ensure that the total 
add-on payments estimated for such fiscal year do not ex-
ceed 0.02 percent of the total hospital payments estimated 
for such fiscal year. 
‘‘(ix) In this subparagraph: 
‘‘(I) The term ‘total add-on payments’ means, 
with respect to a fiscal year, the total amount of the 
additional payments under this subsection pursuant 
to this subparagraph for discharges in such fiscal 
year without regard to the application of clause 
(viii).
159 
‘‘(II) The term ‘total hospital payments’ means, 
with respect to a fiscal year, the total amount of 
payments made under this subsection for all dis-
charges in such fiscal year.’’. 
(2) CONFORMING AMENDMENTS.— 
(A) NO DUPLICATIVE NTAP PAYMENTS.— 
Section 1886(d)(5)(K)(vi) of the Social Security 
Act (42 U.S.C. 1395ww(d)(5)(K)(vi)) is amend-
ed by inserting ‘‘and if additional payment has 
never been made under this subsection pursu-
ant to subparagraph (M) with respect to the 
service or technology’’ before the period at the 
end. 
(B) ACCESS
TO
PRICE
INFORMATION.— 
Section 1927(b)(3)(A) of the Social Security 
Act (42 U.S.C. 1396r–8(b)(3)(A)) is amend-
ed— 
(i) in clause (ii)— 
(I) by striking ‘‘for each’’ and in-
serting ‘‘, for each’’; and 
(II) by striking ‘‘and’’ at the end; 
(ii) in clause (iii)— 
(I) in subclause (II), by inserting 
‘‘or under section 1886(d) pursuant to
160 
paragraph (5)(M) of such section,’’ 
after ‘‘1847A,’’; 
(II) in the matter following sub-
clause 
(III), 
by 
striking 
‘‘or 
1881(b)(13)(A)(ii)’’ and inserting ‘‘, 
section 1881(b)(13)(A)(ii), or section 
1886(d)(5)(M)’’; and 
(III) by striking the period at the 
end and inserting ‘‘; and’’; and 
(iii) in clause (iv), by striking the 
semicolon at the end and inserting a pe-
riod. 
(b) STUDY AND REPORT ON REMOVING BARRIERS TO 
DEVELOPMENT OF DISARM DRUGS.— 
(1) STUDY.—The Comptroller General of the 
United States shall, in consultation with the Direc-
tor of the National Institutes of Health, the Com-
missioner of Food and Drugs, and the Director of 
the Centers for Disease Control and Prevention, con-
duct a study to— 
(A) identify and examine the barriers that 
prevent the development of DISARM drugs, as 
defined in section 1886(d)(5)(M)(iii) of the So-
cial 
Security 
Act 
(42 
U.S.C.
161 
1395ww(d)(5)(M)(iii)), as added by subsection 
(a)(1); and 
(B) develop recommendations for actions 
to be taken in order to overcome any barriers 
identified under subparagraph (A). 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
General shall submit to Congress a report on the 
study conducted under paragraph (1). 
(c) STUDY AND REPORT ON THE IMPACT OF ADDI-
TIONAL MEDICARE PAYMENT FOR DISARM DRUGS ON 
USAGE
PRACTICES
AND
DEVELOPMENT
OF
RESIST-
ANCE.— 
(1) STUDY.—The Director of the Centers for 
Disease Control and Prevention shall conduct a 
study to examine the effects of the additional pay-
ment for DISARM drugs under the Medicare Pro-
gram provided under subparagraph (M) of section 
1886(d)(5) of the Social Security Act (42 U.S.C. 
1395ww(d)(5)), as added by subsection (a), on— 
(A) the usage of DISARM drugs (as de-
fined by clause (iii) of such subparagraph) by 
subsection (d) hospitals (as defined in section 
1886(d)(1)(B) of such Act); and
162 
(B) the development of resistance by indi-
viduals to such DISARM drugs. 
(2) REPORT.—Not later than 3 years after the 
date of the enactment of this Act, such Director 
shall submit to Congress a report on the study con-
ducted under paragraph (1). 
Subtitle H—Vaccine Access, 
Certainty, and Innovation 
SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY 
COMMITTEE ON IMMUNIZATION PRACTICES. 
Section 2102(a) of the Public Health Service Act (42 
U.S.C. 300aa–2(a)) is amended by adding at the end the 
following: 
‘‘(10) ADVISORY COMMITTEE ON IMMUNIZATION 
PRACTICES.— 
‘‘(A) STANDARD
PERIODS
OF
TIME
FOR 
MAKING RECOMMENDATIONS.—Upon the licen-
sure of any vaccine or any new indication for a 
vaccine, the Director of the Program shall di-
rect the Advisory Committee on Immunization 
Practices, at its next regularly scheduled meet-
ing, to consider the use of the vaccine. 
‘‘(B) EXPEDITED REVIEW PURSUANT TO 
REQUEST BY SPONSOR OR MANUFACTURER.—If 
the Advisory Committee does not make rec-
163 
ommendations with respect to the use of a vac-
cine at the Advisory Committee’s first regularly 
scheduled meeting after the licensure of the 
vaccine or any new indication for the vaccine, 
the Advisory Committee, at the request of the 
sponsor of the vaccine, shall make such rec-
ommendations on an expedited basis. 
‘‘(C) EXPEDITED
REVIEW
FOR
BREAK-
THROUGH
THERAPIES
AND
FOR
USE
DURING 
PUBLIC HEALTH EMERGENCIES.—If a vaccine 
is designated as a breakthrough therapy under 
section 506 of the Federal Food, Drug, and 
Cosmetic Act, and is licensed under section 351 
of this Act, the Advisory Committee shall make 
recommendations with respect to the use of the 
vaccine on an expedited basis. 
‘‘(D) DEFINITION.—In this paragraph, the 
terms ‘Advisory Committee on Immunization 
Practices’ and ‘Advisory Committee’ mean the 
advisory committee on immunization practices 
established by the Secretary pursuant to section 
222, acting through the Director of the Centers 
for Disease Control and Prevention.’’.
164 
SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF 
ACIP RECOMMENDATIONS. 
(a) REVIEW.—The Director of the Centers for Dis-
ease Control and Prevention shall conduct a review of the 
process used by the Advisory Committee on Immunization 
Practices to evaluate consistency in formulating and 
issuing recommendations pertaining to vaccines. 
(b) CONSIDERATIONS.—The review under subsection 
(a) shall include assessment of— 
(1) the criteria used to evaluate new and exist-
ing vaccines; 
(2) the Grading of Recommendations, Assess-
ment, Development, and Evaluation (GRADE) ap-
proach to the review and analysis of scientific and 
economic data, including the scientific basis for such 
approach; and 
(3) the extent to which the processes used by 
the working groups of the Advisory Committee on 
Immunization 
Practices 
are 
consistent 
among 
groups. 
(c) STAKEHOLDERS.—In carrying out the review 
under subsection (a), the Director of the Centers for Dis-
ease Control and Prevention shall solicit input from vac-
cine stakeholders. 
(d) REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Director of the Centers
165 
for Disease Control and Prevention shall submit to the 
appropriate committees of the Congress and make publicly 
available a report on the results of the review under sub-
section (a), including recommendations on improving the 
consistency of the process described in such subsection. 
(e) DEFINITION.—In this section, the term ‘‘Advisory 
Committee on Immunization Practices’’ means the advi-
sory committee on immunization practices established by 
the Secretary of Health and Human Services pursuant to 
section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Dis-
ease Control and Prevention. 
SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVEL-
OPERS. 
Section 310 of the Public Health Service Act (42 
U.S.C. 242o) is amended by adding at the end the fol-
lowing: 
‘‘(c)(1) In this subsection, the term ‘vaccine devel-
oper’ means a nongovernmental entity engaged in— 
‘‘(A)(i) the development of a vaccine with the 
intent to pursue licensing of the vaccine by the Food 
and Drug Administration; or 
‘‘(ii) the production of a vaccine licensed by the 
Food and Drug Administration; and 
‘‘(B) vaccine research.
166 
‘‘(2)(A) Upon the submission of a written request for 
a meeting by a vaccine developer, that includes a valid jus-
tification for the meeting, the Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall convene a meeting of representatives of the 
vaccine developer and experts from the Centers for Dis-
ease Control and Prevention in immunization programs, 
epidemiology, and other relevant areas at which the Direc-
tor (or the Director’s designee), for the purpose of inform-
ing the vaccine developer’s understanding of public health 
needs and priorities, shall provide the perspectives of the 
Centers for Disease Control and Prevention and other rel-
evant Federal agencies regarding— 
‘‘(i) public health needs, epidemiology, and im-
plementation considerations with regard to a vaccine 
developer’s potential vaccine profile; and 
‘‘(ii) potential implications of such perspectives 
for the vaccine developer’s vaccine research and de-
velopment planning. 
‘‘(B) In addition to the representatives specified in 
subparagraph (A), the Secretary may, with the agreement 
of the vaccine developer requesting a meeting under such 
subparagraph, include in such meeting representatives 
of— 
‘‘(i) the Food and Drug Administration; and
167 
‘‘(ii) the National Vaccine Program. 
‘‘(C) The Secretary shall convene a meeting re-
quested with a valid justification under subparagraph (A) 
not later than 120 days after receipt of the request for 
the meeting. 
‘‘(3)(A) Upon the submission of a written request by 
a vaccine developer, the Secretary, acting through the Di-
rector of the Centers for Disease Control and Prevention, 
shall provide to the vaccine developer any age-based or 
other demographically assessed disease epidemiological 
analyses or data that— 
‘‘(i) are specified in the request; 
‘‘(ii) have been published; 
‘‘(iii) have been performed by or are in the pos-
session of the Centers; 
‘‘(iv) are not a trade secret or commercial or fi-
nancial information that is privileged or confidential 
and subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United 
States Code; and 
‘‘(v) do not contain individually identifiable in-
formation. 
‘‘(B) The Secretary shall provide analyses requested 
by a vaccine manufacturer under subparagraph (A) not
168 
later than 120 calendar days after receipt of the request 
for the analyses. 
‘‘(4) The Secretary shall promptly notify a vaccine 
developer if— 
‘‘(A) the Secretary becomes aware of any sig-
nificant change to information that was— 
‘‘(i) shared by the Secretary with the vac-
cine developer during a meeting under para-
graph (2); or 
‘‘(ii) provided by the Secretary to the vac-
cine developer in one or more analyses under 
paragraph (3); and 
‘‘(B) the change to such information may have 
implications for the vaccine developer’s vaccine re-
search and development.’’. 
Subtitle I—Orphan Product Exten-
sions Now; Incentives for Cer-
tain Products for Limited Popu-
lations 
SEC. 2151. EXTENSION OF EXCLUSIVITY PERIODS FOR A 
DRUG APPROVED FOR A NEW INDICATION 
FOR A RARE DISEASE OR CONDITION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act, as amended by sections 2062
169 
and 2063, is further amended by inserting after section 
505H of such Act the following: 
‘‘SEC. 505I. EXTENSION OF EXCLUSIVITY PERIODS FOR A 
DRUG APPROVED FOR A NEW INDICATION 
FOR A RARE DISEASE OR CONDITION. 
‘‘(a) DESIGNATION.— 
‘‘(1) IN GENERAL.—The Secretary shall des-
ignate a drug as a drug approved for a new indica-
tion to prevent, diagnose, or treat a rare disease or 
condition for purposes of granting the extensions 
under subsection (b) if— 
‘‘(A) prior to approval of an application or 
supplemental application for the new indication, 
the drug was approved or licensed for mar-
keting under section 505(c) of this Act or sec-
tion 351(a) of the Public Health Service Act 
but was not so approved or licensed for the new 
indication; 
‘‘(B)(i) the sponsor of the approved or li-
censed drug files an application or a supple-
mental application for approval of the new indi-
cation for use of the drug to prevent, diagnose, 
or treat the rare disease or condition; and 
‘‘(ii) the Secretary approves the application 
or supplemental application; and
170 
‘‘(C) the application or supplemental appli-
cation for the new indication contains the con-
sent of the applicant to notice being given by 
the Secretary under paragraph (4) respecting 
the designation of the drug. 
‘‘(2) REVOCATION OF DESIGNATION.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), a designation under para-
graph (1) shall not be revoked for any reason. 
‘‘(B) EXCEPTION.—The Secretary may re-
voke a designation of a drug under paragraph 
(1) if the Secretary finds that the application or 
supplemental application resulting in such des-
ignation contained an untrue statement of ma-
terial fact. 
‘‘(3) NOTIFICATION PRIOR TO DISCONTINUANCE 
OF
PRODUCTION
FOR
SOLELY
COMMERCIAL
REA-
SONS.—A designation of a drug under paragraph (1) 
shall be subject to the condition that the sponsor of 
the drug will notify the Secretary of any discontinu-
ance of the production of the drug for solely com-
mercial reasons at least 1 year before such dis-
continuance.
171 
‘‘(4) NOTICE
TO
PUBLIC.—Notice respecting 
the designation of a drug under paragraph (1) shall 
be made available to the public. 
‘‘(b) EXTENSION.—If the Secretary designates a 
drug as a drug approved for a new indication for a rare 
disease or condition, as described in subsection (a)(1)— 
‘‘(1)(A) the 4-, 5-, and 71⁄2-year periods de-
scribed in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) 
of section 505, the 3-year periods described in 
clauses (iii) and (iv) of subsection (c)(3)(E) and 
clauses (iii) and (iv) of subsection (j)(5)(F) of sec-
tion 505, and the 7-year period described in section 
527, as applicable, shall be extended by 6 months; 
or 
‘‘(B) the 4- and 12-year periods described in 
subparagraphs (A) and (B) of section 351(k)(7) of 
the Public Health Service Act and the 7-year period 
described in section 527, as applicable, shall be ex-
tended by 6 months; and 
‘‘(2)(A) if the drug is the subject of a listed 
patent for which a certification has been submitted 
under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 
section 505 or a listed patent for which a certifi-
cation has been submitted under subsections 
(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505,