118 
351 of the Public Health Service Act shall not apply 
to health care economic information provided to such 
a payor, committee, or entity in accordance with this 
paragraph’’; and 
(5) by striking ‘‘In this paragraph, the term’’ 
and all that follows and inserting the following: 
‘‘(2)(A) For purposes of this paragraph, the term 
‘health care economic information’ means any analysis (in-
cluding the clinical data, inputs, clinical or other assump-
tions, methods, results, and other components underlying or 
comprising the analysis) that identifies, measures, or de-
scribes the economic consequences, which may be based on 
the separate or aggregated clinical consequences of the rep-
resented health outcomes, of the use of a drug. Such analysis 
may be comparative to the use of another drug, to another 
health care intervention, or to no intervention. 
‘‘(B) Such term does not include any analysis that re-
lates only to an indication that is not approved under sec-
tion 505 or under section 351 of the Public Health Service 
Act for such drug.’’. 
SEC. 2102. FACILITATING RESPONSIBLE COMMUNICATION 
OF 
SCIENTIFIC 
AND 
MEDICAL 
DEVELOP-
MENTS. 
(a) GUIDANCE.—Not later than 18 months after the 
date of enactment of this Act, the Secretary of Health and 
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119 
Human Services shall issue draft guidance on facilitating 
the responsible dissemination of truthful and nonmisleading 
scientific and medical information not included in the ap-
proved labeling of drugs and devices. 
(b) DEFINITION.—In this section, the terms ‘‘drug’’ 
and ‘‘device’’ have the meaning given to such terms in sec-
tion 201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321). 
Subtitle G—Antibiotic Drug 
Development 
SEC. 2121. APPROVAL OF CERTAIN DRUGS FOR USE IN A 
LIMITED POPULATION OF PATIENTS. 
(a) PURPOSE.—The purpose of this section is to help 
to expedite the development and availability of treatments 
for serious or life-threatening bacterial or fungal infections 
in patients with unmet needs, while maintaining safety and 
effectiveness standards for such treatments, taking into ac-
count the severity of the infection and the availability or 
lack of alternative treatments. 
(b) APPROVAL
OF
CERTAIN
ANTIBACTERIAL
AND 
ANTIFUNGAL DRUGS.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355), as amended by 
section 2001, is further amended by adding at the end the 
following new subsection: 
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‘‘(z) APPROVAL
OF CERTAIN ANTIBACTERIAL
AND 
ANTIFUNGAL DRUGS FOR USE IN A LIMITED POPULATION 
OF PATIENTS.— 
‘‘(1) PROCESS.—At the request of the sponsor of 
an antibacterial or antifungal drug that is intended 
to treat a serious or life-threatening infection, the 
Secretary— 
‘‘(A) may execute a written agreement with 
the sponsor on the process for developing data to 
support an application for approval of such 
drug, for use in a limited population of patients 
in accordance with this subsection; 
‘‘(B) shall proceed in accordance with this 
subsection only if a written agreement is reached 
under subparagraph (A); 
‘‘(C) shall provide the sponsor with an op-
portunity to request meetings under paragraph 
(2); 
‘‘(D) if a written agreement is reached 
under subparagraph (A), may approve the drug 
under this subsection for such use— 
‘‘(i) in a limited population of pa-
tients for which there is an unmet medical 
need; 
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121 
‘‘(ii) based on a streamlined develop-
ment program; and 
‘‘(iii) only if the standards for ap-
proval under subsections (c) and (d) of this 
section or licensure under section 351 of the 
Public Health Service Act, as applicable, 
are met; and 
‘‘(E) in approving a drug in accordance 
with this subsection, subject to subparagraph 
(D)(iii), may rely upon— 
‘‘(i) traditional endpoints, alternate 
endpoints, or a combination of traditional 
and alternate endpoints, and, as appro-
priate, data sets of a limited size; and 
‘‘(ii)(I) additional data, including pre-
clinical, pharmacologic, or pathophysiologic 
evidence; 
‘‘(II) nonclinical susceptibility and 
pharmacokinetic data; 
‘‘(III) data from phase 2 clinical 
trials; and 
‘‘(IV) such other confirmatory evidence 
as the Secretary determines appropriate to 
approve the drug. 
‘‘(2) FORMAL MEETINGS.— 
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‘‘(A) IN GENERAL.—To help to expedite and 
facilitate the development and review of a drug 
for which a sponsor intends to request approval 
in accordance with this subsection, the Secretary 
may, at the request of the sponsor, conduct meet-
ings that provide early consultation, timely ad-
vice, and sufficient opportunities to develop an 
agreement described in paragraph (1)(A) and 
help the sponsor design and conduct a drug de-
velopment program as efficiently as possible, in-
cluding the following types of meetings: 
‘‘(i) An early consultation meeting. 
‘‘(ii) An assessment meeting. 
‘‘(iii) A postapproval meeting. 
‘‘(B) NO ALTERING OF GOALS.—Nothing in 
this paragraph shall be construed to alter agreed 
upon goals and procedures identified in the let-
ters described in section 101(b) of the Prescrip-
tion Drug User Fee Amendments of 2012. 
‘‘(C) BREAKTHROUGH THERAPIES.—In the 
case of a drug designated as a breakthrough ther-
apy under section 506(a), the sponsor of such 
drug may elect to utilize meetings provided 
under such section with respect to such drug in 
lieu of meetings described in subparagraph (A). 
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‘‘(3) LABELING REQUIREMENT.—The labeling of 
an antibacterial or antifungal drug approved in ac-
cordance with this subsection shall contain the state-
ment ‘Limited Population’ in a prominent manner 
and adjacent to, and not more prominent than, the 
brand name of the product. The prescribing informa-
tion for such antibacterial or antifungal drug re-
quired by section 201.57 of title 21, Code of Federal 
Regulations (or any successor regulation) shall also 
include the following statement: ‘This drug is indi-
cated for use in a limited and specific population of 
patients.’. 
‘‘(4) PROMOTIONAL MATERIALS.—The provisions 
of section 506(c)(2)(B) shall apply with respect to ap-
proval in accordance with this subsection to the same 
extent and in the same manner as such provisions 
apply with respect to accelerated approval in accord-
ance 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 Public 
Health Service Act, other than in accordance with 
this subsection, for— 
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124 
‘‘(A) the same indication and the same con-
ditions of use, the Secretary shall remove any la-
beling 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 re-
quirements and postmarketing conditions that 
were made applicable to the drug under this sub-
section to the subsequent approval of the drug for 
such different indication or condition of use. 
‘‘(6) RELATION TO OTHER PROVISIONS.—Nothing 
in this subsection shall be construed to prohibit the 
approval of a drug for use in a limited population 
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 ac-
cordance with section 506(c). 
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125 
‘‘(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 pur-
suant to this Act and the Public Health 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 re-
strict the practice of health care. 
‘‘(8) EFFECTIVE IMMEDIATELY.—The Secretary 
shall have the authorities vested in the Secretary by 
this subsection beginning on the date of enactment of 
this subsection, irrespective of when and whether the 
Secretary promulgates final regulations or guidance. 
‘‘(9) DEFINITIONS.—In this subsection: 
‘‘(A) EARLY CONSULTATION MEETING.—The 
term ‘early consultation meeting’ means a pre- 
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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 
‘‘(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 regarding 
studies or other information that the Sec-
retary deems appropriate for purposes of 
applying paragraph (5), relating to the ter-
mination of labeling requirements or post-
marketing conditions. 
‘‘(B) ASSESSMENT MEETING.—The term ‘as-
sessment meeting’ means an end-of-phase 2 meet-
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127 
ing, pre-new drug application meeting, or pre- 
biologics license application meeting conducted 
to resolve questions and issues raised during the 
course of clinical investigations, and details ad-
dressed in the written agreement regarding post-
approval commitments or expansion of approved 
uses. 
‘‘(C) POSTAPPROVAL MEETING.—The term 
‘postapproval meeting’ means a meeting fol-
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 criteria, 
process, and other general considerations for demonstrating 
the safety and effectiveness of antibacterial and antifungal 
drugs to be approved for use in a limited population in 
accordance with section 505(z) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (b). 
(d) CONFORMING AMENDMENTS.— 
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128 
(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: 
‘‘(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-threat-
ening infection shall be construed to refer to a biologi-
cal product intended to treat a serious or life-threat-
ening bacterial or fungal infection; and 
‘‘(B) references to approval of a drug under sec-
tion 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 sub-
section: 
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129 
‘‘(dd) If it is a drug approved in accordance with sec-
tion 505(z) and its labeling does not meet the requirements 
under paragraph (3) of such subsection, subject to para-
graph (5) of such subsection.’’. 
(e) EVALUATION.— 
(1) ASSESSMENT.—Not later than 48 months 
after the date of enactment of this Act, the Secretary 
of Health and Human Services shall publish for pub-
lic comment an assessment of the program established 
under section 505(z) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (b). Such assess-
ment shall determine if the limited-use pathway es-
tablished under such section 505(z) has improved or 
is likely to improve patient access to novel anti-
bacterial or antifungal treatments and assess how the 
pathway could be expanded to cover products for seri-
ous or life-threatening 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 Sec-
retary, acting through the Commissioner of Food and 
Drugs, shall hold a public meeting to discuss the find-
ings of the assessment, during which public stake-
holders may present their views on the success of the 
program established under section 505(z) of the Fed-
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130 
eral Food, Drug, and Cosmetic Act, as added by sub-
section (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 path-
way 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 pathway in accord-
ance with such a determination. The approval of any drugs 
under any such expansion shall be subject to the consider-
ations 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 appro-
priate monitoring system to monitor— 
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‘‘(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 Secretary 
shall make summaries of the data derived from 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.— 
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‘‘(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-
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 re-
quirements under this Act for antimicrobial sus-
ceptibility testing devices. 
‘‘(2) IN GENERAL.—The Secretary 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 
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‘‘(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) 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 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 in accordance with 
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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— 
‘‘(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-
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136 
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. 
‘‘(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 informa-
tion 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 micro-
organisms may not have been estab-
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lished in adequate and well-controlled 
clinical trials and the clinical signifi-
cance of such susceptibility informa-
tion 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 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 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, or the regulations promulgated there-
under. 
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138 
‘‘(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 FROM STANDARD DEVELOPMENT ORGA-
NIZATIONS.— 
‘‘(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; 
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139 
‘‘(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 standard; 
and 
‘‘(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 differ 
from other drugs with the same active ingredient; 
‘‘(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 
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140 
‘‘(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 compila-
tion in the Federal Register and provide for public 
comment. If the Secretary receives comments, the Sec-
retary will review such comments and, if the Sec-
retary determines appropriate, update pursuant to 
this subsection susceptibility test interpretive criteria 
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 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 
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141 
of susceptibility test interpretive criteria standards 
which differ from those recognized pursuant to para-
graph (1). 
‘‘(d) ANTIMICROBIAL DRUG LABELING.— 
‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH-
MENT OF INTERPRETIVE CRITERIA WEBSITE.—With 
respect to an antimicrobial drug lawfully introduced 
or delivered for introduction into interstate commerce 
for commercial distribution before the establishment of 
the Interpretive Criteria Website, a holder of an ap-
proved application under section 505 of this Act 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 labeling 
to substitute a reference or hyperlink to such 
Website for any susceptibility test interpretive 
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 ESTAB-
LISHMENT OF INTERPRETIVE CRITERIA WEBSITE.— 
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With respect to antimicrobial drugs lawfully intro-
duced or delivered for introduction into interstate 
commerce for commercial distribution on or after the 
date of the establishment of the Interpretive Criteria 
Website, the labeling for such a drug shall include, in 
lieu of susceptibility test interpretive criteria and re-
lated 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 respect 
to an antimicrobial susceptibility testing device de-
scribed 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 fol-
lowing: 
‘‘(A) The device is used to make a deter-
mination of susceptibility using susceptibility 
test interpretive criteria that are— 
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‘‘(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). 
‘‘(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 bacteria 
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 
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144 
‘‘(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). 
‘‘(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 prod-
uct’ means a qualified infectious disease product des-
ignated under section 505E(d). 
‘‘(3) The term ‘susceptibility test interpretive cri-
teria’ 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 suscep-
tibility, including categorization of the drug as 
susceptible, intermediate, resistant, or such other 
term as the Secretary determines appropriate. 
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145 
‘‘(4)(A) The term ‘antimicrobial drug’ means, 
subject to subparagraph (B), a systemic antibacterial 
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; 
‘‘(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 antibacterial 
and antifungal drugs; and 
‘‘(ii) biological products (as such term is de-
fined in section 351 of the Public Health Service 
Act) to the extent such products exhibit anti-
microbial 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 standard 
in section 505(d), or under section 351 of the 
Public Health Service Act (as applicable); or 
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146 
‘‘(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 
‘‘(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 effect 
on authorities provided under other sections of this 
Act, including any regulations issued under such sec-
tions.’’. 
(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 striking 
the item relating to section 1111. 
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147 
(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 add-
ing 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).’’. 
(4) RECOGNITION OF INTERPRETIVE CRITERIA AS 
DEVICE STANDARD.—Section 514(c)(1)(A) of the Fed-
eral 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 posting 
on the Interpretive Criteria Website in accordance 
with such section)’’. 
(c) REPORT TO CONGRESS.—Not later than two years 
after the date of enactment of this Act, the Secretary 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 Pen-
sions of the Senate a report on the progress made in imple-
menting section 511 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360a), as amended by this section. 
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(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) 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.—Noth-
ing in this subtitle (including the amendments made by this 
subtitle) shall be construed to restrict, in any manner, the 
prescribing or administering of antibiotics or other prod-
ucts by health care practitioners, or to limit the practice 
of health care. 
SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF 
NEW ANTIMICROBIAL DRUGS. 
(a) ADDITIONAL PAYMENT FOR NEW ANTIMICROBIAL 
DRUGS UNDER MEDICARE.— 
(1) IN GENERAL.—Section 1886(d)(5) of the So-
cial Security Act (42 U.S.C. 1395ww(d)(5)) is 
amended by adding at the end the following new sub-
paragraph: 
‘‘(M)(i) As part of the annual rulemaking under this 
subsection for payment for subsection (d) hospitals for each 
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fiscal year beginning with fiscal year 2018, the Secretary 
shall— 
‘‘(I) include publication of a list of the new anti-
microbial drugs for such fiscal year; and 
‘‘(II) with respect to discharges by eligible hos-
pitals that involve a drug so published, 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 publication 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 
‘new antimicrobial drug’ means a product that is approved 
for use, or a product for which an indication is first ap-
proved for use, by the Food and Drug Administration on 
or after December 1, 2014, and that the Food and Drug 
Administration determines— 
‘‘(I) either— 
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‘‘(aa) 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 
‘‘(bb) meets the definition of a qualified in-
fectious disease product under section 505E(g) of 
the Federal Food, Drug, and Cosmetic Act; and 
‘‘(II) is intended to treat an infection— 
‘‘(aa) for which there is an unmet medical 
need; and 
‘‘(bb) which is associated with high rates of 
mortality or significant patient morbidity, as 
determined in consultation with the Director of 
the Centers for Disease Control and Prevention 
and the infectious disease professional commu-
nity. 
Such determination may be revoked only upon a finding 
that the request for such determination contained an untrue 
statement of material fact. 
‘‘(iv) 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 Cen-
ters for Disease Control and Prevention (or, to the extent 
a similar surveillance system reporting program that in-
cludes reporting about antimicrobial drugs is determined 
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151 
by the Secretary to be available to such hospitals, such simi-
lar surveillance system as the Secretary may specify). 
‘‘(v)(I) Subject to the succeeding provisions of this 
clause, the additional payment under this subparagraph, 
with respect to a drug, shall be in the amount provided 
for such drug under section 1847A. 
‘‘(II) The Secretary shall, as part of the rulemaking 
referred to in clause (i) for each fiscal year, estimate— 
‘‘(aa) the total amount of the additional pay-
ments that will be made under this subsection pursu-
ant to this subparagraph for discharges in such fiscal 
year without regard to the application of subclause 
(III); and 
‘‘(bb) the total program payments to be made 
under this subsection for all discharges in such fiscal 
year. 
‘‘(III) If the estimated total amount described in sub-
clause (II)(aa) for a fiscal year exceeds the applicable per-
centage of the estimated total program payments described 
in subclause (II)(bb) for such fiscal year, the Secretary shall 
reduce 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 
amount of the additional payments under this subsection 
pursuant to this subparagraph for such fiscal year do not 
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152 
exceed the applicable percentage of the estimated total pro-
gram payments described in subclause (II)(bb) for such fis-
cal year. 
‘‘(IV) For purposes of subclause (III), the term ‘appli-
cable percentage’ means 0.03 percent.’’. 
(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 amended 
by inserting ‘‘if additional payment has never 
been made under this subsection pursuant to sub-
paragraph (M) with respect to the service or 
technology’’ after ‘‘if the service or technology’’. 
(B) ACCESS TO PRICE INFORMATION.—Sec-
tion 1927(b)(3)(A)(iii) of the Social Security Act 
(42 U.S.C. 1396r–8(b)(3)(A)(iii)) is amended— 
(i) in subclause (II), by inserting ‘‘or 
under section 1886(d) pursuant to para-
graph 
(5)(M) 
of 
such 
section,’’ 
after 
‘‘1847A,’’; and 
(ii) in the matter following subclause 
(III), 
by 
inserting 
‘‘or 
section 
1886(d)(5)(M)’’ after ‘‘1881(b)(13)(A)(ii)’’. 
(b) STUDY AND REPORT ON REMOVING BARRIERS TO 
DEVELOPMENT OF NEW ANTIMICROBIAL DRUGS.— 
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(1) STUDY.—The Comptroller General of the 
United States shall, in consultation with the Director 
of the National Institutes of Health, the Commissioner 
of Food and Drugs, and the Director of the Centers 
for Disease Control and Prevention, conduct a study 
to— 
(A) identify and examine the barriers that 
prevent the development of new antimicrobial 
drugs, as defined in section 1886(d)(5)(M)(iii) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
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 iden-
tified 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). 
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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 direct 
the Advisory Committee on Immunization Prac-
tices, at its next regularly scheduled meeting, to 
consider the use of the vaccine. 
‘‘(B) EXPEDITED REVIEW PURSUANT TO RE-
QUEST BY SPONSOR OR MANUFACTURER.—If the 
Advisory Committee does not make recommenda-
tions with respect to the use of a vaccine 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 
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vaccine, shall make such recommendations 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 sec-
tion 506 of the Federal Food, Drug, and Cos-
metic Act and is licensed under section 351 of 
this Act, the Advisory Committee shall make rec-
ommendations with respect to the use of the vac-
cine 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.’’. 
SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF 
ACIP RECOMMENDATIONS. 
(a) REVIEW.—The Director of the Centers for Disease 
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 rec-
ommendations pertaining to vaccines. 
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156 
(b) CONSIDERATIONS.—The review under subsection 
(a) shall include assessment of— 
(1) the criteria used to evaluate new and existing 
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 Immu-
nization Practices are consistent among groups. 
(c) STAKEHOLDERS.—In carrying out the review 
under subsection (a), the Director of the Centers for Disease 
Control and Prevention shall solicit input from vaccine 
stakeholders. 
(d) REPORT.—Not later than 18 months after the date 
of enactment of this Act, the Director of the Centers for Dis-
ease 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 subsection (a), in-
cluding 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 advisory 
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157 
committee on immunization practices established by the 
Secretary of Health and Human Services pursuant to sec-
tion 222 of the Public Health Service Act (42 U.S.C. 217a), 
acting through the Director of the Centers for Disease Con-
trol 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 following: 
‘‘(c)(1) In this subsection, the term ‘vaccine developer’ 
means a nongovernmental entity engaged in— 
‘‘(A)(i) the development of a vaccine with the in-
tent 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. 
‘‘(2)(A) Upon the submission of a written request for 
a meeting by a vaccine developer, that includes a justifica-
tion for the meeting, the Secretary, acting through the Di-
rector of the Centers for Disease Control and Prevention, 
shall convene a meeting of representatives of the vaccine de-
veloper and experts from the Centers for Disease Control 
and Prevention in immunization programs, epidemiology, 
and other relevant areas at which the Director (or the Di-
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rector’s designee), for the purpose of informing the vaccine 
developer’s understanding of public health needs and prior-
ities, shall provide the perspectives of the Centers for Dis-
ease Control and Prevention and other relevant 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 devel-
opment 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 
‘‘(ii) the National Vaccine Program. 
‘‘(C) The Secretary shall convene a meeting requested 
under subparagraph (A) not later than 120 days after re-
ceipt of the request for the meeting. 
‘‘(3)(A) Upon the submission of a written request by 
a vaccine developer, the Secretary, acting through the Direc-
tor of the Centers for Disease Control and Prevention, shall 
provide to the vaccine developer any age-based or other de-
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159 
mographically 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 later 
than 120 calendar days after receipt of the request for the 
analyses. 
‘‘(4) The Secretary shall promptly notify a vaccine de-
veloper if— 
‘‘(A) the Secretary becomes aware of any change 
to information that was— 
‘‘(i) shared by the Secretary with the vac-
cine developer during a meeting under para-
graph (2); or 
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‘‘(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 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 
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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 marketing 
under section 505(c) of this Act or section 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 
‘‘(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. 
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162 
‘‘(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 mate-
rial 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 discontinuance 
of the production of the drug for solely commercial 
reasons at least one year before such discontinuance. 
‘‘(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 section 505, and the 
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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 sub-
paragraphs (A) and (B) of section 351(k)(7) of the 
Public Health Service Act and the 7-year period de-
scribed in section 527, as applicable, shall be extended 
by 6 months; and 
‘‘(2)(A) if the drug is the subject of a listed pat-
ent 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 certification has 
been submitted under subsections (b)(2)(A)(iii) or 
(j)(2)(A)(vii)(III) of section 505, the period during 
which an application may not be approved under sec-
tion 505(c)(3) or section 505(j)(5)(B) shall be ex-
tended by a period of 6 months after the date the pat-
ent expires (including any patent extensions); or 
‘‘(B) if the drug is the subject of a listed patent 
for which a certification has been submitted under 
subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 
505, and in the patent infringement litigation result-
ing from the certification the court determines that 
the patent is valid and would be infringed, the period 
during which an application may not be approved 
under section 505(c)(3) or section 505(j)(5)(B) shall 
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164 
be extended by a period of 6 months after the date the 
patent expires (including any patent extensions). 
‘‘(c) RELATION TO PEDIATRIC AND QUALIFIED INFEC-
TIOUS DISEASE PRODUCT EXCLUSIVITY.—Any extension 
under subsection (b) of a period shall be in addition to any 
extension of the periods under sections 505A and 505E of 
this Act and section 351(m) of the Public Health Service 
Act, as applicable, with respect to the drug. 
‘‘(d) LIMITATIONS.—The extension described in sub-
section (b) shall not apply if the drug designated under sub-
section (a)(1) has previously received an extension by oper-
ation of subsection (b). 
‘‘(e) DEFINITION.—In this section, the term ‘rare dis-
ease or condition’ has the meaning given to such term in 
section 526(a)(2).’’. 
(b) APPLICATION.—Section 505G of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), applies 
only with respect to a drug for which an application or 
supplemental 
application 
described 
in 
subsection 
(a)(1)(B)(i) of such section 505G is first approved under 
section 505(c) of such Act (21 U.S.C. 355(c)) or section 
351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
on or after the date of the enactment of this Act. 
(c) CONFORMING AMENDMENTS.— 
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165 
(1) RELATION TO PEDIATRIC EXCLUSIVITY FOR 
DRUGS.—Section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) is amended— 
(A) in subsection (b), by adding at the end 
the following: 
‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG AP-
PROVED FOR A NEW INDICATION FOR A RARE DISEASE 
OR
CONDITION.—Notwithstanding the references in 
paragraph (1) to the lengths of the exclusivity periods 
after application of pediatric exclusivity, the 6-month 
extensions described in paragraph (1) shall be in ad-
dition to any extensions under section 505G.’’; and 
(B) in subsection (c), by adding at the end 
the following: 
‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG AP-
PROVED FOR A NEW INDICATION FOR A RARE DISEASE 
OR
CONDITION.—Notwithstanding the references in 
paragraph (1) to the lengths of the exclusivity periods 
after application of pediatric exclusivity, the 6-month 
extensions described in paragraph (1) shall be in ad-
dition to any extensions under section 505G.’’. 
(2) RELATION TO EXCLUSIVITY FOR NEW QUALI-
FIED
INFECTIOUS
DISEASE
PRODUCTS
THAT
ARE 
DRUGS.—Subsection (b) of section 505E of the Fed-
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166 
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355f) 
is amended— 
(A) by amending the subsection heading to 
read as follows: ‘‘RELATION TO PEDIATRIC EX-
CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP-
PROVED FOR A NEW INDICATION FOR A RARE 
DISEASE OR CONDITION.—’’; and 
(B) by striking ‘‘any extension of the period 
under section 505A’’ and inserting ‘‘any exten-
sion of the periods under sections 505A and 
505G, as applicable,’’. 
(3) RELATION TO PEDIATRIC EXCLUSIVITY FOR 
BIOLOGICAL PRODUCTS.—Section 351(m) of the Pub-
lic Health Service Act (42 U.S.C. 262(m)) is amended 
by adding at the end the following: 
‘‘(5) RELATION TO EXCLUSIVITY FOR A BIOLOGI-
CAL PRODUCT APPROVED FOR A NEW INDICATION FOR 
A
RARE
DISEASE
OR
CONDITION.—Notwithstanding 
the references in paragraphs (2)(A), (2)(B), (3)(A), 
and (3)(B) to the lengths of the exclusivity periods 
after application of pediatric exclusivity, the 6-month 
extensions described in such paragraphs shall be in 
addition to any extensions under section 505G.’’. 
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167 
SEC. 2152. REAUTHORIZATION OF RARE PEDIATRIC DIS-
EASE PRIORITY REVIEW VOUCHER INCENTIVE 
PROGRAM. 
(a) IN GENERAL.—Section 529 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff) is amended— 
(1) in subsection (a)— 
(A) in paragraph (3), by amending sub-
paragraph (A) to read as follows: 
‘‘(A) The disease is a serious or life-threat-
ening disease in which the serious or life-threat-
ening manifestations primarily affect individ-
uals aged from birth to 18 years, including age 
groups often called neonates, infants, children, 
and adolescents.’’; and 
(B) in paragraph (4)— 
(i) in subparagraph (E), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (F), by striking 
the period at the end and inserting ‘‘; and’’; 
and 
(iii) by adding at the end the fol-
lowing: 
‘‘(G) is for a drug or biological product for 
which a priority review voucher has not been 
issued under section 524 (relating to tropical 
disease products).’’; and 
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(2) in subsection (b), by striking paragraph (5) 
and inserting the following: 
‘‘(5) TERMINATION
OF
AUTHORITY.—The Sec-
retary may not award any priority review vouchers 
under paragraph (1) after December 31, 2018.’’. 
(b) GAO STUDY AND REPORT.— 
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study on the effective-
ness of awarding priority review vouchers under sec-
tion 529 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360ff) in providing incentives for the de-
velopment of drugs that treat or prevent rare pedi-
atric diseases (as defined in subsection (a)(3) of such 
section) that would not otherwise have been developed. 
In conducting such study, the Comptroller General 
shall examine the following: 
(A) The indications for which each drug for 
which a priority review voucher was awarded 
under such section 529 was approved under sec-
tion 505 of such Act (21 U.S.C. 355) or section 
351 of the Public Health Service Act (42 U.S.C. 
262). 
(B) Whether the priority review voucher im-
pacted a sponsor’s decision to invest in devel-
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169 
oping a drug to treat or prevent a rare pediatric 
disease. 
(C) An analysis of the drugs that utilized 
such priority review vouchers, which shall in-
clude— 
(i) the indications for which such 
drugs were approved under section 505 of 
the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or section 351 of the Public 
Health Service Act (42 U.S.C. 262); 
(ii) whether unmet medical needs were 
addressed through the approval of such 
drugs, including, for each such drug— 
(I) if an alternative therapy was 
previously available to treat the indi-
cation; and 
(II) the benefit or advantage the 
drug provided over another available 
therapy; 
(iii) the number of patients potentially 
treated by such drugs; 
(iv) the value of the priority review 
voucher if transferred; and 
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170 
(v) the length of time between the date 
on which a priority review voucher was 
awarded and the date on which it was used. 
(D) With respect to the priority review 
voucher program under section 529 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff)— 
(i) the resources used by, and burden 
placed on, the Food and Drug Administra-
tion in implementing such program, includ-
ing the effect of such program on the Food 
and Drug Administration’s review of drugs 
for which a priority review voucher was not 
awarded or used; 
(ii) the impact of the program on the 
public health as a result of the expedited re-
view of applications for drugs that treat or 
prevent non-serious indications that are 
generally used by the broader public; and 
(iii) alternative approaches to improv-
ing such program so that the program is 
appropriately targeted toward providing in-
centives for the development of clinically 
important drugs that— 
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171 
(I) prevent or treat rare pediatric 
diseases; and 
(II) would likely not otherwise 
have been developed to prevent or treat 
such diseases. 
(2) REPORT.—Not later than December 31, 2017, 
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 containing the results of the study of con-
ducted under paragraph (1). 
Subtitle 
J—Domestic 
Manufac-
turing and Export Efficiencies 
SEC. 2161. GRANTS FOR STUDYING THE PROCESS OF CON-
TINUOUS DRUG MANUFACTURING. 
(a) IN GENERAL.—The Commissioner of Food and 
Drugs may award grants to institutions of higher education 
and nonprofit organizations for the purpose of studying 
and recommending improvements to the process of contin-
uous manufacturing of drugs and biological products and 
similar innovative monitoring and control techniques. 
(b) DEFINITIONS.—In this section: 
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172 
(1) The term ‘‘drug’’ has the meaning given to 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(2) The term ‘‘biological product’’ has the mean-
ing given to such term in section 351(i) of the Public 
Health Service Act (42 U.S.C. 262(i)). 
(3) The term ‘‘institution of higher education’’ 
has the meaning given to such term in section 101 of 
the Higher Education Act of 1965 (20 U.S.C. 1001). 
(c) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this section 
$5,000,000 for each of fiscal years 2016 through 2020. 
SEC. 2162. RE-EXPORTATION AMONG MEMBERS OF THE EU-
ROPEAN ECONOMIC AREA. 
Section 1003 of the Controlled Substances Import and 
Export Act (21 U.S.C. 953) is amended— 
(1) in subsection (f)— 
(A) in paragraph (5)— 
(i) by striking ‘‘(5)’’ and inserting 
‘‘(5)(A)’’; 
(ii) by inserting ‘‘, except that the con-
trolled substance may be exported from the 
second country to another country that is a 
member of the European Economic Area’’ 
before the period at the end; and 
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175 
Subtitle K—Enhancing 
Combination Products Review 
SEC. 2181. ENHANCING COMBINATION PRODUCTS REVIEW. 
Section 503(g)(4)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(g)(4)(C)) is amended by add-
ing at the end the following new clause: 
‘‘(iii) Not later than 18 months after the date of the 
enactment of the 21st Century Cures Act, the Secretary shall 
issue final guidance that describes the responsibilities of 
each agency center regarding its review of combination 
products. The Secretary shall, after soliciting public com-
ment, review and update the guidance periodically.’’. 
Subtitle L—Priority Review for 
Breakthrough Devices 
SEC. 2201. PRIORITY REVIEW FOR BREAKTHROUGH DE-
VICES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended— 
(1) in section 515(d)— 
(A) by striking paragraph (5); and 
(B) by redesignating paragraph (6) as 
paragraph (5); and 
(2) by inserting after section 515A (21 U.S.C. 
360e–1) the following: 
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176 
‘‘SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DE-
VICES. 
‘‘(a) IN GENERAL.—In order to provide for more effec-
tive treatment or diagnosis of life-threatening or irrevers-
ibly debilitating human diseases or conditions, the Sec-
retary shall establish a program to provide priority review 
for devices— 
‘‘(1) representing breakthrough technologies; 
‘‘(2) for which no approved alternatives exist; 
‘‘(3) offering significant advantages over existing 
approved or cleared alternatives, including the poten-
tial to, compared to existing approved or cleared al-
ternatives, reduce or eliminate the need for hos-
pitalization, improve patient quality of life, facilitate 
patients’ ability to manage their own care (such as 
through self-directed personal assistance), or establish 
long-term clinical efficiencies; or 
‘‘(4) the availability of which is in the best inter-
est of patients. 
‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a de-
vice may request that the Secretary designate the device for 
priority review under this section. Any such request for des-
ignation may be made at any time prior to the submission 
of an application under section 515(c), a petition for classi-
fication under section 513(f)(2), or a notification under sec-
tion 510(k). 
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177 
‘‘(c) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Not later than 60 calendar 
days after the receipt of a request under subsection 
(b), the Secretary shall determine whether the device 
that is the subject of the request meets the criteria de-
scribed in subsection (a). If the Secretary determines 
that the device meets the criteria, the Secretary shall 
designate the device for priority review. 
‘‘(2) REVIEW.—Review of a request under sub-
section (b) shall be undertaken by a team that is com-
posed of experienced staff and managers of the Food 
and Drug Administration and is chaired by a senior 
manager. 
‘‘(3) DESIGNATION
DETERMINATION.—A deter-
mination approving or denying a request under sub-
section (b) shall be considered a significant decision 
under section 517A and the Secretary shall provide a 
written, substantive summary of the basis for the de-
termination in accordance with section 517A(a). 
‘‘(4) RECONSIDERATION.— 
‘‘(A) REQUEST
FOR
RECONSIDERATION.— 
Any person whose request under subsection (b) is 
denied may, within 30 days of the denial, re-
quest reconsideration of the denial in accordance 
with section 517A(b)— 
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178 
‘‘(i) based upon the submission of doc-
uments by such person; or 
‘‘(ii) based upon such documents and a 
meeting or teleconference. 
‘‘(B) RESPONSE.—Reconsideration of a des-
ignation determination under this paragraph 
shall be conducted in accordance with section 
517A(b). 
‘‘(5) WITHDRAWAL.—If the Secretary approves a 
priority review designation for a device under this 
section, the Secretary may not withdraw the designa-
tion based on the fact that the criteria specified in 
subsection (a) are no longer met because of the subse-
quent clearance or approval of another device that 
was designated under— 
‘‘(A) this section; or 
‘‘(B) section 515(d)(5) (as in effect imme-
diately prior to the enactment of the 21st Cen-
tury Cures Act). 
‘‘(d) PRIORITY REVIEW.— 
‘‘(1) ACTIONS.—For purposes of expediting the 
development and review of devices designated under 
subsection (c), the Secretary shall— 
‘‘(A) assign a team of staff, including a 
team leader with appropriate subject matter ex-
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179 
pertise and experience, for each device for which 
a request is submitted under subsection (b); 
‘‘(B) provide for oversight of the team by 
senior agency personnel to facilitate the efficient 
development of the device and the efficient review 
of any submission described in subsection (b) for 
the device; 
‘‘(C) adopt an efficient process for timely 
dispute resolution; 
‘‘(D) provide for interactive communication 
with the sponsor of the device during the review 
process; 
‘‘(E) expedite the Secretary’s review of 
manufacturing and quality systems compliance, 
as applicable; 
‘‘(F) disclose to the sponsor in advance the 
topics of any consultation concerning the spon-
sor’s device that the Secretary intends to under-
take with external experts or an advisory com-
mittee and provide the sponsor an opportunity 
to recommend such external experts; 
‘‘(G) for applications submitted under sec-
tion 515(c), provide for advisory committee 
input, as the Secretary determines appropriate 
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180 
(including in response to the request of the spon-
sor); and 
‘‘(H) assign staff to be available within a 
reasonable time to address questions posed by in-
stitutional review committees concerning the con-
ditions and clinical testing requirements appli-
cable to the investigational use of the device pur-
suant to an exemption under section 520(g). 
‘‘(2) ADDITIONAL ACTIONS.—In addition to the 
actions described in paragraph (1), for purposes of 
expediting the development and review of devices des-
ignated under subsection (c), the Secretary, in col-
laboration with the device sponsor, may, as appro-
priate— 
‘‘(A) coordinate with the sponsor regarding 
early agreement on a data development plan; 
‘‘(B) take steps to ensure that the design of 
clinical trials is as efficient as practicable, such 
as through adoption of shorter or smaller clinical 
trials, application of surrogate endpoints, and 
use of adaptive trial designs and Bayesian sta-
tistics, to the extent scientifically appropriate; 
‘‘(C) facilitate, to the extent scientifically 
appropriate, expedited and efficient development 
and review of the device through utilization of 
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181 
timely postmarket data collection, with regard to 
applications for approval under section 515(c); 
and 
‘‘(D) agree to clinical protocols that the Sec-
retary will consider binding on the Secretary 
and the sponsor, subject to— 
‘‘(i) changes agreed to by the sponsor 
and the Secretary; 
‘‘(ii) changes that the Secretary deter-
mines are required to prevent an unreason-
able risk to the public health; or 
‘‘(iii) the identification of a substan-
tial scientific issue determined by the Sec-
retary to be essential to the safety or effec-
tiveness of the device involved. 
‘‘(e) PRIORITY REVIEW GUIDANCE.— 
‘‘(1) CONTENT.—The Secretary shall issue guid-
ance on the implementation of this section. Such 
guidance shall include the following: 
‘‘(A) The process for a person to seek a pri-
ority review designation. 
‘‘(B) A template for requests under sub-
section (b). 
‘‘(C) The criteria the Secretary will use in 
evaluating a request for priority review. 
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182 
‘‘(D) The standards the Secretary will use 
in assigning a team of staff, including team 
leaders, to review devices designated for priority 
review, including any training required for such 
personnel on effective and efficient review. 
‘‘(2) PROCESS.—Prior to finalizing the guidance 
under paragraph (1), the Secretary shall propose such 
guidance for public comment. 
‘‘(f) CONSTRUCTION.— 
‘‘(1) PURPOSE.—This section is intended to en-
courage the Secretary and provide the Secretary suffi-
cient authorities to apply efficient and flexible ap-
proaches to expedite the development of, and prioritize 
the agency’s review of, devices that represent break-
through technologies. 
‘‘(2) CONSTRUCTION.—Nothing in this section 
shall be construed to alter the criteria and standards 
for evaluating an application pursuant to section 
515(c), a report and request for classification under 
section 513(f)(2), or a report under section 510(k), in-
cluding the recognition of valid scientific evidence as 
described in section 513(a)(3)(B), and consideration 
of the least burdensome means of evaluating device ef-
fectiveness or demonstrating substantial equivalence 
between devices with differing technological character-
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183 
istics, as applicable. Nothing in this section alters the 
authority of the Secretary to act on an application 
pursuant to section 515(d) before completion of an es-
tablishment inspection, as the Secretary deems appro-
priate.’’. 
(b) CONFORMING AMENDMENT RELATED TO DESIGNA-
TION DETERMINATIONS.—Section 517A(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is 
amended by inserting ‘‘a request for designation under sec-
tion 515B,’’ after ‘‘an application under section 515,’’. 
Subtitle M—Medical Device 
Regulatory Process Improvements 
SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
(a) ESTABLISHMENT OF THIRD-PARTY QUALITY SYS-
TEM ASSESSMENT PROGRAM.—Chapter V of the Federal 
Food, Drug, and Cosmetic Act is amended by inserting after 
section 524A (21 U.S.C. 360n–1) the following new section: 
‘‘SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
‘‘(a) ACCREDITATION AND ASSESSMENT.— 
‘‘(1) IN
GENERAL; CERTIFICATION
OF
DEVICE 
QUALITY SYSTEM.—The Secretary shall, in accordance 
with this section, establish a third-party quality sys-
tem assessment program— 
‘‘(A) to accredit persons to assess whether a 
requestor’s quality system, including its design 
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controls, can reasonably assure the safety and ef-
fectiveness of in-scope devices subject to device-re-
lated changes; 
‘‘(B) under which accredited persons shall 
(as applicable) certify that a requestor’s quality 
system meets the criteria included in the guid-
ance issued under paragraph (5) with respect to 
the in-scope devices at issue; and 
‘‘(C) under which the Secretary shall rely 
on such certifications for purposes of deter-
mining the safety and effectiveness (or as appli-
cable, substantial equivalence) of in-scope devices 
subject to the device-related changes involved, in 
lieu of compliance with the following submission 
requirements: 
‘‘(i) A premarket notification. 
‘‘(ii) A thirty-day notice. 
‘‘(iii) A Special PMA supplement. 
‘‘(2) DEFINITIONS.—For purposes of this sec-
tionƒ 
‘‘(A) the term ‘device-related changes’ means 
changes made by a requestor with respect to in- 
scope devices, which are— 
‘‘(i) changes to a device found to be 
substantially 
equivalent 
under 
sections 
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513(i) and 510(k) to a predicate device, 
that— 
‘‘(I) would otherwise be subject to 
a premarket notification; and 
‘‘(II) do not alter— 
‘‘(aa) the intended use of the 
changed device; or 
‘‘(bb) the fundamental sci-
entific technology of such device; 
‘‘(ii) manufacturing changes subject to 
a 30-day notice; 
‘‘(iii) changes that qualify for a Spe-
cial PMA Supplement; and 
‘‘(iv) such other changes relating to the 
devices or the device manufacturing process 
as the Secretary determines appropriate; 
‘‘(B) the term ‘in-scope device’ means a de-
vice within the scope of devices agreed to by the 
requestor and the accredited person for purposes 
of a request for certification under this section; 
‘‘(C) the term ‘premarket notification’ 
means a premarket notification under section 
510(k); 
‘‘(D) the term ‘quality system’ means the 
methods used in, and the facilities and controls 
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186 
used for, the design, manufacture, packaging, la-
beling, storage, installation, and servicing of de-
vices, as described in section 520(f); 
‘‘(E) the term ‘requestor’ means a device 
manufacturer that is seeking certification under 
this section of a quality system used by such 
manufacturer; 
‘‘(F) the term ‘Special PMA’ means a Spe-
cial PMA supplement under section 814.39(d) of 
title 21, Code of Federal Regulations (or any 
successor regulations); and 
‘‘(G) the term ‘thirty-day notice’ means a 
notice described in section 515(d)(6). 
‘‘(3) ACCREDITATION PROCESS; ACCREDITATION 
RENEWAL.—Except as inconsistent with this section, 
the process and qualifications for accreditation of per-
sons and renewal of such accreditation under section 
704(g) shall apply with respect to accreditation of 
persons and renewal of such accreditation under this 
section. 
‘‘(4) USE OF ACCREDITED PARTIES TO CONDUCT 
ASSESSMENTS.— 
‘‘(A) INITIATION
OF
ASSESSMENT
SERV-
ICES.— 
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‘‘(i) DATE
ASSESSMENTS
AUTHOR-
IZED.—Beginning after the date on which 
the final guidance is issued under para-
graph (5), an accredited person may con-
duct an assessment under this section. 
‘‘(ii) INITIATION OF ASSESSMENTS.— 
Use of one or more accredited persons to as-
sess a requestor’s quality system under this 
section with respect to in-scope devices shall 
be at the initiation of the person who reg-
isters and lists the devices at issue under 
section 510. 
‘‘(B) COMPENSATION.—Compensation for 
such accredited persons shall— 
‘‘(i) be determined by agreement be-
tween the accredited person and the person 
who engages the services of the accredited 
person; and 
‘‘(ii) be paid by the person who en-
gages such services. 
‘‘(C) ACCREDITED
PERSON
SELECTION.— 
Each person who chooses to use an accredited 
person to assess a requestor’s quality system, as 
described in this section, shall select the accred-
ited person from a list of such persons published 
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by the Secretary in accordance with section 
704(g)(4). 
‘‘(5) 
GUIDANCE; 
CRITERIA
FOR
CERTIFI-
CATION.— 
‘‘(A) IN GENERAL.—The criteria for certifi-
cation of a quality system under this section 
shall be as specified by the Secretary in guidance 
issued under this paragraph. 
‘‘(B) 
CONTENTS; 
CERTIFICATION
CRI-
TERIA.—The guidance under this paragraph 
shall include specification of— 
‘‘(i) evaluative criteria to be used by 
an accredited person to assess and, as ap-
plicable, certify a requestor’s quality system 
under this section with respect to in-scope 
devices; and 
‘‘(ii) criteria for accredited persons to 
apply for a waiver of, and exemptions from, 
the certification criteria under clause (i). 
‘‘(C) 
TIMEFRAME
FOR
ISSUING
GUID-
ANCE.—The Secretary shall issue under this 
paragraph— 
‘‘(i) draft guidance not later than 12 
months after the enactment of the 21st Cen-
tury Cures Act; and 
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‘‘(ii) final guidance not later than 12 
months after issuance of the draft guidance 
under clause (i). 
‘‘(b) USE OF THIRD-PARTY ASSESSMENT.— 
‘‘(1) ASSESSMENT SUMMARY; CERTIFICATION.— 
‘‘(A) SUBMISSION OF ASSESSMENT TO SEC-
RETARY.—An accredited person who assesses a 
requestor’s quality system under subsection (a) 
shall submit to the Secretary a summary of the 
assessment— 
‘‘(i) within 30 days of the assessment; 
and 
‘‘(ii) which shall include (as applica-
ble)— 
‘‘(I) the accredited person’s certifi-
cation that the requestor has satisfied 
the criteria specified in the guidance 
issued under subsection (a)(5) for qual-
ity system certification with respect to 
the in-scope devices at issue; and 
‘‘(II) any waivers or exemptions 
from such criteria applied by the ac-
credited person. 
‘‘(B) TREATMENT OF ASSESSMENTS.—Sub-
ject to action by the Secretary under subpara-
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graph (C), with respect to assessments which in-
clude a certification under this section— 
‘‘(i) the Secretary’s review of the as-
sessment summary shall be deemed complete 
on the day that is 30 days after the date on 
which the Secretary receives the summary 
under subparagraph (A); and 
‘‘(ii) the assessment summary and cer-
tification of the quality system of a re-
questor shall be deemed accepted by the Sec-
retary on such 30th day. 
‘‘(C) ACTIONS BY SECRETARY.— 
‘‘(i) IN GENERAL.—Within 30 days of 
receiving an assessment summary and cer-
tification under subparagraph (A), the Sec-
retary may, by written notice to the accred-
ited person submitting such assessment cer-
tification, deem any such certification to be 
provisional beyond such 30-day period, sus-
pended pending further review by the Sec-
retary, or otherwise qualified or cancelled, 
based on the Secretary’s determination that 
(as applicable)— 
‘‘(I) additional information is 
needed to support such certification; 
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‘‘(II) such assessment or certifi-
cation is unwarranted; or 
‘‘(III) such action with regard to 
the certification is otherwise justified 
according to such factors and criteria 
as the Secretary finds appropriate. 
‘‘(ii) 
ACCEPTANCE
OF
CERTIFI-
CATION.—If following action by the Sec-
retary under clause (i) with respect to a 
certification, the Secretary determines that 
such certification is acceptable, the Sec-
retary shall issue written notice to the ap-
plicable accredited person indicating such 
acceptance. 
‘‘(2) NOTIFICATIONS
TO
SECRETARY
BY
CER-
TIFIED REQUESTORS OR ACCREDITED PERSONS FOR 
PROGRAM EVALUATION PURPOSES.— 
‘‘(A) ANNUAL SUMMARY REPORT FOR DE-
VICE-RELATED
CHANGES
OTHERWISE
SUBJECT 
TO
PREMARKET
NOTIFICATION.—A requestor 
whose quality system is certified under this sec-
tion that effectuates device-related changes with 
respect to in-scope devices, without prior submis-
sion of a premarket notification, shall ensure 
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that an annual summary report is submitted to 
the Secretary by the accredited person which— 
‘‘(i) describes the changes made to the 
in-scope device; and 
‘‘(ii) indicates the effective dates of 
such changes. 
‘‘(B) PERIODIC
NOTIFICATION
FOR
MANU-
FACTURING CHANGES OTHERWISE SUBJECT TO 
THIRTY-DAY NOTICE.—A requestor whose quality 
system is certified under this section that effec-
tuates device-related changes with respect to in- 
scope devices, without prior submission of a thir-
ty-day notice, shall provide notification to the 
Secretary of such changes in the requestor’s next 
periodic report under section 814.84(b) of title 
21, Code of Federal Regulations (or any suc-
cessor regulation). Such notification shall— 
‘‘(i) describe the changes made; and 
‘‘(ii) indicate the effective dates of such 
changes. 
‘‘(C) PERIODIC NOTIFICATION FOR DEVICE- 
RELATED
CHANGES
OTHERWISE
SUBJECT
TO 
SPECIAL PMA SUPPLEMENT.—A requestor whose 
quality system is certified under this section that 
effectuates device-related changes with respect to 
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in-scope devices, without prior submission of a 
Special PMA Supplement, shall provide notifica-
tion to the Secretary of such changes in the re-
questor’s next periodic report under section 
814.84(b) of title 21, Code of Federal Regulations 
(or any successor regulation). Such notification 
shall— 
‘‘(i) describe the changes made, includ-
ing a full explanation of the basis for the 
changes; and 
‘‘(ii) indicate the effective dates of such 
changes. 
‘‘(D) USE OF NOTIFICATIONS FOR PROGRAM 
EVALUATION PURPOSES.—Information submitted 
to the Secretary under subparagraphs (A) 
through (C) shall be used by the Secretary for 
purposes of the program evaluation under sub-
section (d). 
‘‘(c) DURATION AND EFFECT OF CERTIFICATION.—A 
certification under this section— 
‘‘(1) shall remain in effect for a period of 2 years 
from the date such certification is accepted by the 
Secretary, subject to paragraph (6); 
‘‘(2) may be renewed through the process de-
scribed in subsection (a)(3); 
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‘‘(3) shall continue to apply with respect to de-
vice-related changes made during such 2-year period, 
provided the certification remains in effect, irrespec-
tive of whether such certification is renewed after such 
2-year period; 
‘‘(4) shall have no effect on the need to comply 
with applicable submission requirements specified in 
subsection (a)(1)(C) with respect to any change per-
taining to in-scope devices which is not a device-re-
lated change under subsection (a)(2); 
‘‘(5) shall have no effect on the authority of the 
Secretary to conduct an inspection or otherwise deter-
mine whether the requestor has complied with the ap-
plicable requirements of this Act; and 
‘‘(6) may be revoked by the Secretary upon a de-
termination that the requestor’s quality system no 
longer meets the certification criteria specified in the 
guidance issued under subsection (a)(5) with respect 
to the in-scope devices at issue. 
‘‘(d) NOTICE OF REVOCATION.—The Secretary shall 
provide written notification to the requestor of a revocation 
pursuant to subsection (c)(6) not later than 10 business 
days after the determination described in such subsection. 
Upon receipt of the written notification, the requestor shall 
satisfy the applicable submission requirements specified in 
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subsection (a)(1)(C) for any device-related changes effec-
tuated after the date of such determination. After such rev-
ocation, such requestor is eligible to seek re-certification 
under this section of its quality system. 
‘‘(e) PROGRAM EVALUATION; SUNSET.— 
‘‘(1) PROGRAM EVALUATION AND REPORT.— 
‘‘(A) EVALUATION.—The Secretary shall 
complete an evaluation of the third-party quality 
system assessment program under this section no 
later than January 31, 2021, based on— 
‘‘(i) analysis of information from a 
representative group of device manufactur-
ers obtained from notifications provided by 
certified requestors or accredited persons 
under subsection (b)(2); and 
‘‘(ii) such other available information 
and data as the Secretary determines ap-
propriate. 
‘‘(B) REPORT.—No later than 1 year after 
completing the evaluation under subparagraph 
(A), the Secretary shall issue a report of the eval-
uation’s findings on the website of the Food and 
Drug Administration, which shall include the 
Secretary’s recommendations with respect to con-
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tinuation and as applicable expansion of the 
program under this section to encompass— 
‘‘(i) device submissions beyond those 
identified in subsection (a)(1)(C); and 
‘‘(ii) device changes beyond those de-
scribed in subsection (a)(2)(A). 
‘‘(2) SUNSET.—This section shall cease to be ef-
fective October 1, 2022. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to limit the authority of the Sec-
retary to request and review the complete assessment of a 
certified requestor under this section on a for-cause basis.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) REQUIREMENTS FOR PREMARKET APPROVAL 
SUPPLEMENTS.—Section 515(d)(5)(A)(i) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360e(d)(5)(A)(i)), as redesignated by section 2201, is 
further amended by inserting ‘‘, subject to section 
524B’’ after ‘‘that affects safety or effectiveness’’. 
(2) REQUIREMENTS FOR THIRTY-DAY NOTICE.— 
Section 515(d)(5)(A)(ii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(ii)), as 
redesignated by section 2201, is further amended by 
inserting ‘‘, subject to section 524B’’ after ‘‘the date 
on which the Secretary receives the notice’’. 
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(3) REQUIREMENTS FOR PREMARKET NOTIFICA-
TION; TECHNICAL
CORRECTION
TO
REFERENCE
TO 
SECTION 510(K).—Section 510(l) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amend-
ed by striking ‘‘of this subsection under subsection 
(m)’’ and inserting ‘‘of subsection (k) under sub-
section (m) or section 524B’’. 
(4) MISBRANDED
DEVICES.—Section 502(t) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352(t)) is amended by inserting ‘‘or 524B’’ after ‘‘sec-
tion 519’’. 
SEC. 2222. VALID SCIENTIFIC EVIDENCE. 
Section 513(a)(3)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended— 
(1) by redesignating clauses (i) and (ii) as sub-
clauses (I) and (II), respectively; 
(2) by striking ‘‘(B) If the Secretary’’ and insert-
ing ‘‘(B)(i) If the Secretary’’; and 
(3) by adding at the end the following: 
‘‘(ii) For purposes of clause (i), valid scientific evi-
dence may include— 
‘‘(I) evidence described in well-documented case 
histories, including registry data, that are collected 
and monitored under an acceptable protocol; 
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‘‘(II) studies published in peer-reviewed journals; 
and 
‘‘(III) data collected in countries other than the 
United States so long as such data otherwise meet the 
criteria specified in this subparagraph. 
‘‘(iii) In the case of a study published in a peer-re-
viewed journal that is offered as valid scientific evidence 
for purposes of clause (i), the Secretary may request data 
underlying the study if— 
‘‘(I) the Secretary, in making such request, com-
plies with the requirement of subparagraph (D)(ii) to 
consider the least burdensome appropriate means of 
evaluating device effectiveness or subsection (i)(1)(D) 
to consider the least burdensome means of deter-
mining substantial equivalence, as applicable; 
‘‘(II) the Secretary furnishes a written rationale 
for so requesting the underlying data together with 
such request; and 
‘‘(III) if the requested underlying data for such 
a study are unavailable, the Secretary shall consider 
such study to be part of the totality of the evidence 
with respect to the device, as the Secretary determines 
appropriate.’’. 
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