191 
paragraph (1)(D), for a combination product containing as 
a constituent part an approved drug— 
‘‘(i) the application or request shall include the 
certification 
or 
statement 
described 
in 
section 
505(b)(2); and 
‘‘(ii) the applicant or requester shall provide no-
tice as described in section 505(b)(3). 
‘‘(B) For purposes of this paragraph and paragraph 
(4), the term ‘approved drug’ means an active ingredient— 
‘‘(i) that was in an application previously ap-
proved under section 505(c); 
‘‘(ii) where such application is relied upon by 
the applicant submitting the application or request 
described in subparagraph (A); 
‘‘(iii) for which full reports of investigations that 
have been made to show whether such drug is safe for 
use and whether such drug is effective in use were not 
conducted by or for the applicant submitting the ap-
plication or request described in subparagraph (A); 
and 
‘‘(iv) for which the applicant submitting the ap-
plication or request described in subparagraph (A) 
has not obtained a right of reference or use from the 
person by or for whom the investigations described in 
clause (iii) were conducted.
192 
‘‘(C) The following provisions shall apply with respect 
to an application or request described in subparagraph (A) 
to the same extent and in the same manner as if such appli-
cation or request were an application described in section 
505(b)(2) that referenced the approved drug: 
‘‘(i) Subparagraphs (A), (B), (C), and (D) of 
section 505(c)(3). 
‘‘(ii) Clauses (ii), (iii), and (iv) of section 
505(c)(3)(E). 
‘‘(iii) Subsections (b) and (c) of section 505A. 
‘‘(iv) Section 505E(a). 
‘‘(v) Section 527(a). 
‘‘(D) Notwithstanding any other provision of this sub-
section, an application or request for classification for a 
combination product described in subparagraph (A) shall 
be considered an application submitted under section 
505(b)(2) for purposes of section 271(e)(2)(A) of title 35, 
United States Code. 
‘‘(6) Nothing in this subsection shall be construed as 
prohibiting a sponsor from submitting separate applica-
tions for the constituent parts of a combination product, 
unless the Secretary determines that a single application 
is necessary.’’; 
(5) in paragraph (8) (as redesignated by para-
graph (3))—
193 
(A) in subparagraph (C)— 
(i) by amending clause (i) to read as 
follows: 
‘‘(i) In carrying out this subsection, the Office shall 
help to ensure timely and effective premarket review that 
involves more than one agency center by coordinating such 
reviews, overseeing the timeliness of such reviews, and over-
seeing the alignment of feedback regarding such reviews.’’; 
(ii) in clause (ii), by inserting ‘‘and 
alignment’’ after ‘‘the timeliness’’ each place 
it appears; and 
(iii) by adding at the end the following 
new clauses: 
‘‘(iii) The Office shall ensure that, with respect to a 
combination product, a designated person or persons in the 
primary agency center is the primary point or points of 
contact for the sponsor of such combination product. The 
Office shall also coordinate communications to and from 
any consulting center involved in such premarket review, 
if requested by such primary agency center or any such con-
sulting center. Agency communications and commitments, 
to the extent consistent with other provisions of law and 
the requirements of all affected agency centers, from the pri-
mary agency center shall be considered as communication
194 
from the Secretary on behalf of all agency centers involved 
in the review. 
‘‘(iv) The Office shall, with respect to the premarket 
review of a combination product— 
‘‘(I) ensure that any meeting between the Sec-
retary and the sponsor of such product is attended by 
each agency center involved in the review, as appro-
priate; 
‘‘(II) ensure that each consulting agency center 
has completed its premarket review and provided the 
results of such review to the primary agency center in 
a timely manner; and 
‘‘(III) ensure that each consulting center follows 
the guidance described in clause (vi) and advises, as 
appropriate, on other relevant regulations, guidances, 
and policies. 
‘‘(v) In seeking agency action with respect to a com-
bination product, the sponsor of such product— 
‘‘(I) shall identify the product as a combination 
product; and 
‘‘(II) may request in writing the participation of 
representatives of the Office in meetings related to 
such combination product, or to have the Office other-
wise engage on such regulatory matters concerning 
the combination product.
195 
‘‘(vi) Not later than 4 years after the date of enactment 
of the 21st Century Cures Act, and after a public comment 
period of not less than 60 calendar days, the Secretary shall 
issue a final guidance that describes— 
‘‘(I) the structured process for managing pre-sub-
mission interactions with sponsors developing com-
bination products; 
‘‘(II) the best practices for ensuring that the feed-
back in such pre-submission interactions represents 
the Agency’s best advice based on the information pro-
vided during such pre-submission interactions; 
‘‘(III) the information that is required to be sub-
mitted with a meeting request under paragraph (2), 
how such meetings relate to other types of meetings in 
the Food and Drug Administration, and the form and 
content of any agreement reached through a meeting 
under such paragraph (2);’’; and 
(B) in subparagraph (G)— 
(i) in the matter preceding clause (i), 
by inserting ‘‘(except with respect to clause 
(iv), beginning not later than one year after 
the date of the enactment of the 21st Cen-
tury Cures Act)’’ after ‘‘enactment of this 
paragraph’’;
196 
(ii) in clause (ii), by striking ‘‘and’’ at 
the end; 
(iii) in clause (iii), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(iv) by adding at the end the following 
new clause: 
‘‘(iv) identifying the percentage of combination 
products for which a dispute resolution, with respect 
to premarket review, was requested by the combina-
tion product’s sponsor.’’; and 
(6) in paragraph (9) (as redesignated by para-
graph (3))— 
(A) in subparagraph (C)— 
(i) in clause (i), by striking the comma 
at the end and inserting a semicolon; 
(ii) in clause (ii), by striking ‘‘, and’’ 
at the end and inserting a semicolon; 
(iii) in clause (iii), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(iv) by adding at the end the following: 
‘‘(iv) de novo classification under sec-
tion 513(a)(1).’’; and 
(B) by adding at the end the following: 
‘‘(D) The terms ‘premarket review’ and ‘reviews’ 
include all activities of the Food and Drug Adminis-
197 
tration conducted prior to approval or clearance of 
an application, notification, or request for classifica-
tion submitted under section 505, 510(k), 513(f)(2), 
515, or 520 of this Act or under section 351 of the 
Public Health Service Act, including with respect to 
investigational use of the product.’’. 
(b) INFORMATION FOR APPROVAL OF COMBINATION 
PRODUCTS.—Section 520(h)(4) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(h)(4)) is amended— 
(1) in subparagraph (A), by striking ‘‘Any infor-
mation’’ and inserting ‘‘Subject to subparagraph (C), 
any information’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(C) No information contained in an application for 
premarket approval filed with the Secretary pursuant to 
section 515(c) may be used to approve or clear any applica-
tion submitted under section 515 or 510(k) or to classify 
a product under section 513(f)(2) for a combination product 
containing as a constituent part an approved drug (as de-
fined in section 503(g)(5)(B)) unless— 
‘‘(i) the application includes the certification or 
statement referenced in section 503(g)(5)(A); 
‘‘(ii) the applicant provides notice as described 
in section 503(g)(5)(A); and
198 
‘‘(iii) the Secretary’s approval of such applica-
tion 
is 
subject 
to 
the 
provisions 
in 
section 
503(g)(5)(C).’’. 
(c) VARIATIONS FROM CGMP STREAMLINED AP-
PROACH.—Not later than 18 months after the date of enact-
ment of this Act, the Secretary of Health and Human Serv-
ices (referred to in this subsection as the ‘‘Secretary’’) shall 
identify types of combination products and manufacturing 
processes with respect to which the Secretary proposes that 
good manufacturing processes may be adopted that vary 
from the requirements set forth in section 4.4 of title 21, 
Code of Federal Regulations (or any successor regulations) 
or that the Secretary proposes can satisfy the requirements 
in section 4.4 through alternative or streamlined mecha-
nisms. The Secretary shall identify such types, variations 
from such requirements, and such mechanisms, in a pro-
posed list published in the Federal Register. After a public 
comment period regarding the appropriate good manufac-
turing practices for such types, the Secretary shall publish 
a final list in the Federal Register, notwithstanding section 
553 of title 5, United States Code. The Secretary shall 
evaluate such types, variations, and mechanisms using a 
risk-based approach. The Secretary shall periodically re-
view such final list.
199 
Subtitle E—Antimicrobial 
Innovation and Stewardship 
SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING. 
(a) IN GENERAL.—Section 319E of the Public Health 
Service Act (42 U.S.C. 247d–5) is amended— 
(1) by redesignating subsections (f) and (g) as 
subsections (l) and (m), respectively; and 
(2) by inserting after subsection (e), the fol-
lowing: 
‘‘(f) MONITORING AT FEDERAL HEALTH CARE FACILI-
TIES.—The Secretary shall encourage reporting on aggre-
gate antimicrobial drug use and antimicrobial resistance 
to antimicrobial drugs and the implementation of anti-
microbial stewardship programs by health care facilities of 
the Department of Defense, the Department of Veterans Af-
fairs, and the Indian Health Service and shall provide tech-
nical assistance to the Secretary of Defense and the Sec-
retary of Veterans Affairs, as appropriate and upon request. 
‘‘(g) REPORT ON ANTIMICROBIAL RESISTANCE IN HU-
MANS AND USE OF ANTIMICROBIAL DRUGS.—Not later than 
1 year after the date of enactment of the 21st Century Cures 
Act, and annually thereafter, the Secretary shall prepare 
and make publicly available data and information con-
cerning—
200 
‘‘(1) aggregate national and regional trends of 
antimicrobial resistance in humans to antimicrobial 
drugs, including such drugs approved under section 
506(h) of the Federal Food, Drug, and Cosmetic Act; 
‘‘(2) antimicrobial stewardship, which may in-
clude summaries of State efforts to address anti-
microbial resistance in humans to antimicrobial 
drugs and antimicrobial stewardship; and 
‘‘(3) coordination between the Director of the 
Centers for Disease Control and Prevention and the 
Commissioner of Food and Drugs with respect to the 
monitoring of— 
‘‘(A) any applicable resistance under para-
graph (1); and 
‘‘(B) drugs approved under section 506(h) 
of the Federal Food, Drug, and Cosmetic Act. 
‘‘(h) INFORMATION
RELATED
TO
ANTIMICROBIAL 
STEWARDSHIP PROGRAMS.—The Secretary shall, as appro-
priate, disseminate guidance, educational materials, or 
other appropriate materials related to the development and 
implementation of evidence-based antimicrobial steward-
ship programs or practices at health care facilities, such 
as nursing homes and other long-term care facilities, ambu-
latory surgical centers, dialysis centers, outpatient clinics, 
and hospitals, including community and rural hospitals.
201 
‘‘(i) SUPPORTING STATE-BASED ACTIVITIES TO COM-
BAT ANTIMICROBIAL RESISTANCE.—The Secretary shall 
continue to work with State and local public health depart-
ments on statewide or regional programs related to anti-
microbial resistance. Such efforts may include activities to 
related to— 
‘‘(1) identifying patterns of bacterial and fungal 
resistance in humans to antimicrobial drugs; 
‘‘(2) preventing the spread of bacterial and 
fungal infections that are resistant to antimicrobial 
drugs; and 
‘‘(3) promoting antimicrobial stewardship. 
‘‘(j) ANTIMICROBIAL RESISTANCE AND STEWARDSHIP 
ACTIVITIES.— 
‘‘(1) IN
GENERAL.—For the purposes of sup-
porting stewardship activities, examining changes in 
antimicrobial resistance, and evaluating the effective-
ness of section 506(h) of the Federal Food, Drug, and 
Cosmetic Act, the Secretary shall— 
‘‘(A) provide a mechanism for facilities to 
report data related to their antimicrobial stew-
ardship activities (including analyzing the out-
comes of such activities); and 
‘‘(B) evaluate—
202 
‘‘(i) 
antimicrobial 
resistance 
data 
using a standardized approach; and 
‘‘(ii) trends in the utilization of drugs 
approved under such section 506(h) with re-
spect to patient populations. 
‘‘(2) USE OF SYSTEMS.—The Secretary shall use 
available systems, including the National Healthcare 
Safety Network or other systems identified by the Sec-
retary, to fulfill the requirements or conduct activities 
under this section. 
‘‘(k) ANTIMICROBIAL.—For purposes of subsections (f) 
through (j), the term ‘antimicrobial’ includes any anti-
bacterial or antifungal drugs, and may include drugs that 
eliminate or inhibit the growth of other microorganisms, 
as appropriate.’’. 
(b) AVAILABILITY
OF DATA.—The Secretary shall 
make the data collected pursuant to this subsection public. 
Nothing in this subsection shall be construed as authorizing 
the Secretary to disclose any information that is a trade 
secret or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 1905 
of title 18, United States Code.
203 
SEC. 3042. LIMITED POPULATION PATHWAY. 
Section 506 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356), as amended by section 3033, is further 
amended by adding at the end the following: 
‘‘(h) LIMITED POPULATION PATHWAY
FOR ANTI-
BACTERIAL AND ANTIFUNGAL DRUGS.— 
‘‘(1) IN GENERAL.—The Secretary may approve 
an antibacterial or antifungal drug, alone or in com-
bination with one or more other drugs, as a limited 
population drug pursuant to this subsection only if— 
‘‘(A) the drug is intended to treat a serious 
or life-threatening infection in a limited popu-
lation of patients with unmet needs; 
‘‘(B) the standards for approval under sec-
tion 505(c) and (d), or the standards for licen-
sure under section 351 of the Public Health 
Service Act, as applicable, are met; and 
‘‘(C) the Secretary receives a written request 
from the sponsor to approve the drug as a lim-
ited population drug pursuant to this subsection. 
‘‘(2) BENEFIT-RISK CONSIDERATION.—The Sec-
retary’s determination of safety and effectiveness of 
an antibacterial or antifungal drug shall reflect the 
benefit-risk profile of such drug in the intended lim-
ited population, taking into account the severity, rar-
ity, or prevalence of the infection the drug is intended
204 
to treat and the availability or lack of alternative 
treatment in such limited population. Such drug may 
be approved under this subsection notwithstanding a 
lack of evidence to fully establish a favorable benefit- 
risk profile in a population that is broader than the 
intended limited population. 
‘‘(3) ADDITIONAL REQUIREMENTS.—A drug ap-
proved under this subsection shall be subject to the fol-
lowing requirements, in addition to any other appli-
cable requirements of this Act: 
‘‘(A) LABELING.—To indicate that the safe-
ty and effectiveness of a drug approved under 
this subsection has been demonstrated only with 
respect to a limited population— 
‘‘(i) all labeling and advertising of an 
antibacterial or antifungal drug approved 
under this subsection shall contain the 
statement ‘Limited Population’ in a promi-
nent manner and adjacent to, and not more 
prominent than— 
‘‘(I) the proprietary name of such 
drug, if any; or 
‘‘(II) if there is no proprietary 
name, the established name of the drug, 
if any, as defined in section 503(e)(3),
205 
or, in the case of a drug that is a bio-
logical product, the proper name, as 
defined by regulation; and 
‘‘(ii) the prescribing information for 
the drug required by section 201.57 of title 
21, Code of Federal Regulations (or any 
successor regulation) shall also include the 
following statement: ‘This drug is indicated 
for use in a limited and specific population 
of patients.’. 
‘‘(B) PROMOTIONAL MATERIAL.—The spon-
sor of an antibacterial or antifungal drug subject 
to this subsection shall submit to the Secretary 
copies of all promotional materials related to 
such drug at least 30 calendar days prior to dis-
semination of the materials. 
‘‘(4) OTHER PROGRAMS.—A sponsor of a drug 
that seeks approval of a drug under this subsection 
may also seek designation or approval, as applicable, 
of such drug under other applicable sections or sub-
sections of this Act or the Public Health Service Act. 
‘‘(5) GUIDANCE.—Not later than 18 months after 
the date of enactment of the 21st Century Cures Act, 
the Secretary shall issue draft guidance describing 
criteria, processes, and other general considerations
206 
for demonstrating the safety and effectiveness of lim-
ited population antibacterial and antifungal drugs. 
The Secretary shall publish final guidance within 18 
months of the close of the public comment period on 
such draft guidance. The Secretary may approve 
antibacterial and antifungal drugs under this sub-
section prior to issuing guidance under this para-
graph. 
‘‘(6) ADVICE.—The Secretary shall provide 
prompt advice to the sponsor of a drug for which the 
sponsor seeks approval under this subsection to enable 
the sponsor to plan a development program to obtain 
the necessary data for such approval, and to conduct 
any additional studies that would be required to gain 
approval of such drug for use in a broader popu-
lation. 
‘‘(7) TERMINATION
OF
LIMITATIONS.—If, after 
approval of a drug under this subsection, the Sec-
retary approves a broader indication for such drug 
under section 505(b) or section 351(a) of the Public 
Health Service Act, the Secretary may remove any 
postmarketing conditions, including requirements 
with respect to labeling and review of promotional 
materials under paragraph (3), applicable to the ap-
proval of the drug under this subsection.
207 
‘‘(8) RULES OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to alter the authority of 
the Secretary to approve drugs pursuant to this Act 
or section 351 of the Public Health Service Act, in-
cluding the standards of evidence and applicable con-
ditions for approval under such Acts, the standards of 
approval of a drug under such Acts, or to alter the 
authority of the Secretary to monitor drugs pursuant 
to such Acts. 
‘‘(9) REPORTING AND ACCOUNTABILITY.— 
‘‘(A) BIENNIAL REPORTING.—The Secretary 
shall report to Congress not less often than once 
every 2 years on the number of requests for ap-
proval, and the number of approvals, of an anti-
bacterial or antifungal drug under this sub-
section. 
‘‘(B) GAO REPORT.—Not later than Decem-
ber 2021, the Comptroller General of the United 
States 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 co-
ordination of activities required under section 
319E of the Public Health Service Act. Such re-
port shall include a review of such activities, and
208 
the extent to which the use of the pathway estab-
lished under this subsection has streamlined pre-
market approval for antibacterial or antifungal 
drugs for limited populations, if such pathway 
has functioned as intended, if such pathway has 
helped provide for safe and effective treatment 
for patients, if such premarket approval would 
be appropriate for other categories of drugs, and 
if the authorities under this subsection have af-
fected antibacterial or antifungal resistance.’’. 
SEC. 3043. PRESCRIBING AUTHORITY. 
Nothing in this subtitle, or an amendment made by 
this subtitle, shall be construed to restrict the prescribing 
of antimicrobial drugs or other products, including drugs 
approved under subsection (h) of section 506 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as added 
by section 3042), by health care professionals, or to limit 
the practice of health care. 
SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROORGANISMS; ANTIMICROBIAL SUS-
CEPTIBILITY TESTING DEVICES. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
seq.) is amended by inserting after section 511 the following:
209 
‘‘SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROORGANISMS. 
‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.— 
‘‘(1) PURPOSE.—The purpose of this section is to 
clarify the Secretary’s authority to— 
‘‘(A) efficiently update susceptibility test in-
terpretive criteria for antimicrobial drugs when 
necessary for public health, due to, among other 
things, the constant evolution of microorganisms 
that leads to the development of resistance to 
drugs that have been effective in decreasing mor-
bidity and mortality for patients, which war-
rants unique management of antimicrobial drugs 
that is inappropriate for most other drugs in 
order to delay or prevent the development of fur-
ther resistance to existing therapies; 
‘‘(B) provide for public notice of the avail-
ability of recognized interpretive criteria and in-
terpretive criteria standards; and 
‘‘(C) clear under section 510(k), classify 
under section 513(f)(2), or approve under section 
515, antimicrobial susceptibility testing devices 
utilizing updated, recognized susceptibility test 
interpretive criteria to characterize the in vitro 
susceptibility of particular bacteria, fungi, or
210 
other microorganisms, as applicable, to anti-
microbial drugs. 
‘‘(2) IDENTIFICATION
OF
CRITERIA.—The Sec-
retary shall identify appropriate susceptibility test 
interpretive criteria 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 section 
351 of the Public Health Service Act (as applica-
ble), 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 susceptibility test 
interpretive criteria under paragraph (2), based on 
the Secretary’s review of, to the extent available and 
relevant— 
‘‘(A) preclinical and clinical data, includ-
ing pharmacokinetic, pharmacodynamic, and ep-
idemiological data; 
‘‘(B) the relationship of susceptibility test 
interpretive criteria to morbidity and mortality
211 
associated with the disease or condition for 
which such drug is used; 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 there-
after, on the website of the Food and Drug Adminis-
tration, a dedicated website that contains a list of 
any appropriate new or updated susceptibility test 
interpretive criteria standards and interpretive cri-
teria in accordance with paragraph (2) (referred to in 
this section as the ‘Interpretive Criteria Website’). 
‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTER-
PRETIVE
CRITERIA
STANDARDS
AND
INTERPRETIVE 
CRITERIA.— 
‘‘(A) IN GENERAL.—The list described in 
paragraph (1) shall consist of any new or up-
dated susceptibility test interpretive criteria 
standards that are— 
‘‘(i) established by a nationally or 
internationally recognized standard devel-
opment organization that—
212 
‘‘(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 in-
terpretive criteria, if any, that the Secretary has 
determined to be appropriate with respect to le-
gally marketed antimicrobial drugs, where— 
‘‘(i) the Secretary does not recognize, 
in whole or in part, an interpretive criteria
213 
standard described under subparagraph (A) 
otherwise applicable to such a drug; 
‘‘(ii) the Secretary withdraws under 
subsection (c)(1)(A) recognition of a stand-
ard, in whole or in part, otherwise applica-
ble 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 relevant 
interpretive criteria included in a standard 
recognized by the Secretary under sub-
section (c); or 
‘‘(iv) because the characteristics of such 
a drug differ from other drugs with the 
same active ingredient, the interpretive cri-
teria with respect to such drug— 
‘‘(I) differ from otherwise applica-
ble interpretive criteria included in a 
standard listed under subparagraph 
(A) or interpretive criteria otherwise 
listed under this subparagraph; and 
‘‘(II) are determined by the Sec-
retary to be appropriate for the drug.
214 
‘‘(C) REQUIRED STATEMENTS.—The Inter-
pretive Criteria Website shall include statements 
conveying— 
‘‘(i) that the website provides informa-
tion about the in vitro susceptibility of bac-
teria, fungi, or other microorganisms, as 
applicable to a certain drug (or drugs); 
‘‘(ii) that— 
‘‘(I) the safety and efficacy of such 
drugs in treating clinical infections 
due to such bacteria, fungi, or other 
microorganisms, as applicable, may or 
may not have been established in ade-
quate and well-controlled clinical trials 
in order for the susceptibility informa-
tion described in clause (i) to be in-
cluded on the website; and 
‘‘(II) the clinical significance of 
such susceptibility information in such 
instances is unknown; 
‘‘(iii) that the approved product label-
ing for specific drugs provides the uses for 
which the Secretary has approved the prod-
uct; and
215 
‘‘(iv) any other information that the 
Secretary determines appropriate to ade-
quately convey the meaning of the data sup-
porting the recognition or listing of suscep-
tibility test interpretive criteria standards 
or susceptibility test interpretive criteria 
included on the website. 
‘‘(3) NOTICE.—Not later than the date on which 
the Interpretive Criteria Website is established, 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. 
‘‘(5) TRADE SECRETS AND CONFIDENTIAL INFOR-
MATION.—Nothing in this section shall be construed 
as authorizing the Secretary to disclose any informa-
tion that is a trade secret or confidential information 
subject to section 552(b)(4) of title 5, United States 
Code. 
‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER-
PRETIVE CRITERIA.—
216 
‘‘(1) EVALUATION AND PUBLICATION.— 
‘‘(A) IN GENERAL.—Beginning on the date 
of the establishment of the Interpretive Criteria 
Website, and at least every 6 months thereafter, 
the Secretary shall— 
‘‘(i) evaluate any appropriate new or 
updated susceptibility test interpretive cri-
teria standards established by a nationally 
or internationally recognized standard de-
velopment organization described in sub-
section (b)(2)(A)(i); and 
‘‘(ii) publish on the public website of 
the Food and Drug Administration a no-
tice— 
‘‘(I) withdrawing recognition of 
any different susceptibility test inter-
pretive criteria standard, in whole or 
in part; 
‘‘(II) recognizing the new or up-
dated standards; 
‘‘(III) recognizing one or more 
parts of the new or updated interpre-
tive criteria specified in such a stand-
ard and declining to recognize the re-
mainder of such standard; and
217 
‘‘(IV) making any necessary up-
dates to the lists under subsection 
(b)(2). 
‘‘(B) UPON APPROVAL OF A DRUG.—Upon 
the approval of an initial or supplemental appli-
cation for an antimicrobial drug under section 
505 of this Act or section 351 of the Public 
Health Service Act, as applicable, where such 
approval is based on susceptibility test interpre-
tive criteria which differ from those contained in 
a standard recognized, or from those otherwise 
listed, by the Secretary pursuant to this sub-
section, or for which there are no relevant inter-
pretive criteria standards recognized, or inter-
pretive criteria otherwise listed, by the Secretary 
pursuant to this subsection, the Secretary shall 
update the lists under subparagraphs (A) and 
(B) of subsection (b)(2) to include the suscepti-
bility test interpretive criteria upon which such 
approval was based. 
‘‘(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—
219 
‘‘(B) otherwise listed on the Interpretive 
Criteria Website under subsection (b)(2). 
‘‘(4) RELATION TO SECTION 514(c).—Any suscep-
tibility 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 section 
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 which differ 
from those contained in a standard recognized, or 
from those otherwise listed, by the Secretary pursuant 
to subsection (b)(2). 
‘‘(d) ANTIMICROBIAL DRUG LABELING.— 
‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH-
MENT OF INTERPRETIVE CRITERIA WEBSITE.— 
‘‘(A) IN
GENERAL.—With respect to an 
antimicrobial drug lawfully introduced or deliv-
ered for introduction into interstate commerce 
for commercial distribution before the establish-
ment of the Interpretive Criteria Website, a hold-
er of an approved application under section 505
232 
‘‘(B) take steps to ensure that the design of 
clinical trials is as efficient and flexible as prac-
ticable, when scientifically appropriate; 
‘‘(C) facilitate, when scientifically appro-
priate, expedited and efficient development and 
review of the device through utilization of timely 
postmarket data collection with regard to appli-
cation for approval under section 515(c); and 
‘‘(D) agree in writing to clinical protocols 
that the Secretary will consider binding on the 
Secretary and the sponsor, subject to— 
‘‘(i) changes to such protocols agreed to 
in writing by the sponsor and the Sec-
retary; or 
‘‘(ii) a decision, made by the director 
of the office responsible for reviewing the de-
vice submission, that a substantial scientific 
issue essential to determining the safety or 
effectiveness of such device exists, provided 
that such decision is in writing, and is 
made only after the Secretary provides to 
the device sponsor or applicant an oppor-
tunity for a meeting at which the director 
and the sponsor or applicant are present