131 
interpretive criteria standards in accordance with 
paragraph (2) (referred to in this section as the ‘In-
terpretive Criteria Website’). 
‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTER-
PRETIVE CRITERIA STANDARDS.— 
‘‘(A) IN GENERAL.—The list described in 
paragraph (1) shall consist of any new or up-
dated susceptibility test interpretive criteria 
standards that are— 
‘‘(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-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00131
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
132 
other similar source acceptable to the 
Secretary; and 
‘‘(ii) recognized in whole, or in part, 
by the Secretary under subsection (c). 
‘‘(B) OTHER LIST.—The Interpretive Cri-
teria Website shall, in addition to the list de-
scribed in subparagraph (A), include a list of 
interpretive criteria, if any, that the Secretary 
has determined to be appropriate with respect 
to 
legally 
marketed 
antimicrobial 
drugs, 
where— 
‘‘(i) the Secretary does not recognize, 
in whole or in part, an interpretive criteria 
standard described under subparagraph 
(A) otherwise applicable to such a drug; 
‘‘(ii) the Secretary withdraws under 
subsection (c)(1)(B) recognition of a 
standard, in whole or in part, otherwise 
applicable to such a drug; 
‘‘(iii) the Secretary approves an appli-
cation under section 505 of this Act or sec-
tion 351 of the Public Health Service Act, 
as applicable, with respect to marketing of 
such a drug for which there are no rel-
evant interpretive criteria included in a 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00132
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
133 
standard recognized by the Secretary 
under subsection (c); or 
‘‘(iv) because the characteristics of 
such a drug differ from other drugs with 
the same active ingredient, the interpretive 
criteria with respect to such drug— 
‘‘(I) differ from otherwise appli-
cable interpretive criteria included in 
a standard listed under subparagraph 
(A) or interpretive criteria otherwise 
listed under this subparagraph; and 
‘‘(II) are determined by the Sec-
retary to be appropriate for the drug. 
‘‘(C) REQUIRED STATEMENTS OF LIMITA-
TIONS OF INFORMATION.—The Interpretive Cri-
teria Website shall include the following: 
‘‘(i) A statement that— 
‘‘(I) the website provides infor-
mation about the susceptibility of bac-
teria, fungi, or other microorganisms 
to a certain drug (or drugs); and 
‘‘(II) the safety and efficacy of 
the drug in treating clinical infections 
due to such bacteria, fungi, or other 
microorganisms may not have been es-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00133
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
134 
tablished in adequate and well-con-
trolled clinical trials and the clinical 
significance of such susceptibility in-
formation in such trials is unknown. 
‘‘(ii) A statement that directs health 
care practitioners to consult the approved 
product labeling for specific drugs to deter-
mine the uses for which the Food and 
Drug Administration has approved the 
product. 
‘‘(iii) Any other statement that the 
Secretary determines appropriate to ade-
quately convey the limitations of the data 
supporting susceptibility test interpretive 
criteria standard listed on the website. 
‘‘(3) NOTICE.—Not later than the date on 
which the Interpretive Criteria Website is estab-
lished, the Secretary shall publish a notice of that 
establishment in the Federal Register. 
‘‘(4) INAPPLICABILITY OF MISBRANDING PROVI-
SION.—The inclusion in the approved labeling of an 
antimicrobial drug of a reference or hyperlink to the 
Interpretive Criteria Website, in and of itself, shall 
not cause the drug to be misbranded in violation of 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00134
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
135 
section 502, or the regulations promulgated there-
under. 
‘‘(5) TRADE SECRETS AND CONFIDENTIAL IN-
FORMATION.—Nothing in this section shall be con-
strued as authorizing the Secretary to disclose any 
information that is a trade secret or confidential in-
formation subject to section 552(b)(4) of title 5, 
United States Code. 
‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER-
PRETIVE CRITERIA FROM STANDARD DEVELOPMENT OR-
GANIZATIONS.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
the establishment of the Interpretive Criteria 
Website, and at least every 6 months thereafter, the 
Secretary shall— 
‘‘(A) evaluate any appropriate new or up-
dated susceptibility test interpretive criteria 
standards established by a nationally or inter-
nationally recognized standard development or-
ganization described in subsection (b)(2)(A)(i); 
and 
‘‘(B) publish on the public website of the 
Food and Drug Administration a notice— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00135
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
136 
‘‘(i) withdrawing recognition of any 
different susceptibility test interpretive cri-
teria standard, in whole or in part; 
‘‘(ii) recognizing the new or updated 
standards; 
‘‘(iii) recognizing one or more parts of 
the new or updated interpretive criteria 
specified in such a standard and declining 
to recognize the remainder of such stand-
ard; and 
‘‘(iv) making any necessary updates to 
the lists under subsection (b)(2). 
‘‘(2) BASES FOR UPDATING INTERPRETIVE CRI-
TERIA STANDARDS.—In evaluating new or updated 
susceptibility test interpretive criteria standards 
under paragraph (1)(A), the Secretary may con-
sider— 
‘‘(A) the Secretary’s determination that 
such a standard is not applicable to a particular 
drug because the characteristics of the drug dif-
fer from other drugs with the same active in-
gredient; 
‘‘(B) information provided by interested 
third parties, including public comment on the 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00136
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
137 
annual compilation of notices published under 
paragraph (3); 
‘‘(C) any bases used to identify suscepti-
bility test interpretive criteria under subsection 
(a)(2); and 
‘‘(D) such other information or factors as 
the Secretary determines appropriate. 
‘‘(3) ANNUAL
COMPILATION
OF
NOTICES.— 
Each year, the Secretary shall compile the notices 
published under paragraph (1)(B) and publish such 
compilation in the Federal Register and provide for 
public comment. If the Secretary receives comments, 
the Secretary will review such comments and, if the 
Secretary determines appropriate, update pursuant 
to this subsection susceptibility test interpretive cri-
teria standards— 
‘‘(A) recognized by the Secretary under 
this subsection; or 
‘‘(B) otherwise listed on the Interpretive 
Criteria Website under subsection (b)(2). 
‘‘(4) RELATION TO SECTION 514(c).—Any sus-
ceptibility test interpretive standard recognized 
under this subsection or any criteria otherwise listed 
under subsection (b)(2)(B) shall be deemed to be 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00137
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
138 
recognized as a standard by the Secretary under sec-
tion 514(c)(1). 
‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRI-
TERIA.—Nothing in this section prohibits a person 
from seeking approval or clearance of a drug or de-
vice, or changes to the drug or the device, on the 
basis of susceptibility test interpretive criteria stand-
ards which differ from those recognized pursuant to 
paragraph (1). 
‘‘(d) ANTIMICROBIAL DRUG LABELING.— 
‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH-
MENT OF INTERPRETIVE CRITERIA WEBSITE.—With 
respect to an antimicrobial drug lawfully introduced 
or delivered for introduction into interstate com-
merce for commercial distribution before the estab-
lishment of the Interpretive Criteria Website, a hold-
er of an approved application under section 505 or 
section 351 of the Public Health Service Act, as ap-
plicable, for each such drug— 
‘‘(A) not later than 1 year after establish-
ment of the Interpretive Criteria Website, shall 
submit to the Secretary a supplemental applica-
tion for purposes of changing the drug’s label-
ing to substitute a reference or hyperlink to 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00138
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
139 
such Website for any susceptibility test inter-
pretive criteria and related information; and 
‘‘(B) may begin distribution of the drug in-
volved upon receipt by the Secretary of the sup-
plemental application for such change. 
‘‘(2) DRUGS MARKETED SUBSEQUENT TO ES-
TABLISHMENT
OF
INTERPRETIVE
CRITERIA 
WEBSITE.—With respect to antimicrobial drugs law-
fully introduced or delivered for introduction into 
interstate commerce for commercial distribution on 
or after the date of the establishment of the Inter-
pretive Criteria Website, the labeling for such a drug 
shall include, in lieu of susceptibility test interpretive 
criteria and related information, a reference to such 
Website. 
‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTI-
MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— 
‘‘(1) IN
GENERAL.—Notwithstanding sections 
501, 502, 510, 513, and 515, if the conditions speci-
fied in paragraph (2) are met (in addition to other 
applicable provisions under this chapter) with re-
spect to an antimicrobial susceptibility testing device 
described in subsection (f)(1), the Secretary may au-
thorize the marketing of such device for a use de-
scribed in such subsection. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00139
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
140 
‘‘(2) 
CONDITIONS
APPLICABLE
TO
ANTI-
MICROBIAL
SUSCEPTIBILITY
TESTING
DEVICES.— 
The conditions specified in this paragraph are the 
following: 
‘‘(A) The device is used to make a deter-
mination of susceptibility using susceptibility 
test interpretive criteria that are— 
‘‘(i) included in a standard recognized 
by the Secretary under subsection (c); or 
‘‘(ii) otherwise listed on the Interpre-
tive Criteria Website under subsection 
(b)(2). 
‘‘(B) The labeling of such device promi-
nently and conspicuously— 
‘‘(i) includes a statement that— 
‘‘(I) the device provides informa-
tion about the susceptibility of bac-
teria and fungi to certain drugs; and 
‘‘(II) the safety and efficacy of 
such drugs in treating clinical infec-
tions due to such bacteria or fungi 
may not have been established in ade-
quate and well-controlled clinical trials 
and the clinical significance of such 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00140
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
141 
susceptibility information in those in-
stances is unknown; 
‘‘(ii) includes a statement directing 
health care practitioners to consult the ap-
proved labeling for drugs tested using such 
a device, to determine the uses for which 
the Food and Drug Administration has ap-
proved such drugs; and 
‘‘(iii) includes any other statement the 
Secretary determines appropriate to ade-
quately convey the limitations of the data 
supporting the interpretive criteria de-
scribed in subparagraph (A). 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘antimicrobial susceptibility test-
ing device’ means a device that utilizes susceptibility 
test interpretive criteria to determine and report the 
in vitro susceptibility of certain microorganisms to a 
drug (or drugs). 
‘‘(2) The term ‘qualified infectious disease 
product’ means a qualified infectious disease product 
designated under section 505E(d). 
‘‘(3) The term ‘susceptibility test interpretive 
criteria’ means— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00141
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
142 
‘‘(A) one or more specific numerical values 
which characterize the susceptibility of bacteria 
or other microorganisms to the drug tested; and 
‘‘(B) related categorizations of such sus-
ceptibility, including categorization of the drug 
as susceptible, intermediate, resistant, or such 
other term as the Secretary determines appro-
priate. 
‘‘(4)(A) The term ‘antimicrobial drug’ means, 
subject to subparagraph (B), a systemic anti-
bacterial or antifungal drug that— 
‘‘(i) is intended for human use in the treat-
ment of a disease or condition caused by a bac-
terium or fungus; 
‘‘(ii) may include a qualified infectious dis-
ease product designated under section 505E(d); 
and 
‘‘(iii) is subject to section 503(b)(1). 
‘‘(B) If provided by the Secretary through regu-
lations, such term may include— 
‘‘(i) drugs other than systemic anti-
bacterial and antifungal drugs; and 
‘‘(ii) biological products (as such term is 
defined in section 351 of the Public Health 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00142
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
143 
Service Act) to the extent such products exhibit 
antimicrobial activity. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed— 
‘‘(1) to alter the standards of evidence— 
‘‘(A) under subsection (c) or (d) of section 
505, including the substantial evidence stand-
ard in section 505(d), or under section 351 of 
the Public Health Service Act (as applicable); 
or 
‘‘(B) with respect to marketing authoriza-
tion for devices, under section 510, 513, or 515; 
‘‘(2) to apply with respect to any drug, device, 
or biological product, in any context other than— 
‘‘(A) an antimicrobial drug; or 
‘‘(B) an antimicrobial susceptibility testing 
device that uses susceptibility test interpretive 
criteria to characterize and report the in vitro 
susceptibility of certain bacteria, fungi, or other 
microorganisms to antimicrobial drugs in ac-
cordance with this section; or 
‘‘(3) unless specifically stated, to have any ef-
fect on authorities provided under other sections of 
this Act, including any regulations issued under such 
sections.’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00143
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
144 
(b) CONFORMING AMENDMENTS.— 
(1) REPEAL OF RELATED AUTHORITY.—Section 
1111 of the Food and Drug Administration Amend-
ments Act of 2007 (42 U.S.C. 247d–5a; relating to 
identification of clinically susceptible concentrations 
of antimicrobials) is repealed. 
(2) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352), as 
amended by section 2121, is further amended by 
adding at the end the following: 
‘‘(ee) If it is an antimicrobial drug and its labeling 
fails to conform with the requirements under section 
511(d).’’. 
(3) RECOGNITION OF INTERPRETIVE CRITERIA 
AS DEVICE STANDARD.—Section 514(c)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360d(c)(1)(A)) is amended by inserting after ‘‘the 
Secretary shall, by publication in the Federal Reg-
ister’’ the following: ‘‘(or, with respect to suscepti-
bility test interpretive criteria or standards recog-
nized or otherwise listed under section 511, by post-
ing on the Interpretive Criteria Website in accord-
ance with such section)’’. 
(c) REPORT
TO CONGRESS.—Not later than two 
years after the date of enactment of this Act, the Sec-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00144
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
145 
retary of Health and Human Services shall submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, 
Labor and Pensions of the Senate a report on the progress 
made in implementing section 511 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360a), as amended 
by this section. 
(d) REQUESTS FOR UPDATES TO INTERPRETIVE CRI-
TERIA WEBSITE.—Chapter 35 of title 44, United States 
Code, shall not apply to the collection of information from 
interested parties regarding the updating of lists under 
paragraph (2) of subsection (b) section 511 of the Federal 
Food, Drug, and Cosmetic Act (as amended by subsection 
(a)) and posted on the Interpretive Criteria Website estab-
lished under paragraph (1) of such subsection (b). 
(e) NO EFFECT
ON HEALTH CARE PRACTICE.— 
Nothing in this subtitle (including the amendments made 
by this subtitle) shall be construed to restrict, in any man-
ner, the prescribing or administering of antibiotics or 
other products by health care practitioners, or to limit the 
practice of health care. 
SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF 
NEW ANTIMICROBIAL DRUGS. 
(a) 
ADDITIONAL
PAYMENT
FOR
NEW
ANTI-
MICROBIAL DRUGS UNDER MEDICARE.— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00145
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
146 
(1) IN GENERAL.—Section 1886(d)(5) of the 
Social Security Act (42 U.S.C. 1395ww(d)(5)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(M)(i)(I) Effective for discharges beginning on or 
after October 1, 2017, the Secretary shall, after notice and 
opportunity for public comment (in the publications re-
quired by subsection (e)(5) for a fiscal year or otherwise), 
provide for additional payment to be made under this sub-
section in accordance with the provisions of this subpara-
graph with respect to discharges by eligible hospitals that 
involve new antimicrobial drugs in the amount, subject to 
clause (vi), provided for under section 1847A. 
‘‘(II) Additional payments to be made under this sub-
section shall be with respect to discharges involving a new 
antimicrobial drug that occur during the four-fiscal-year 
period beginning on which an inpatient hospital code is 
issued with respect to the drug. 
‘‘(ii) 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— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00146
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
147 
‘‘(aa) is intended to treat an infection 
caused by, or likely to be caused by, a quali-
fying pathogen (as defined under section 
505E(f) of the Federal Food, Drug, and Cos-
metic 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; 
‘‘(II) is intended to treat an infection for which 
there is an ‘unmet medical need’; and 
‘‘(III) is intended to treat an infection associ-
ated with high rates of mortality or significant pa-
tient morbidity, as determined in consultation with 
the infectious disease professional community. 
‘‘(iii) For purposes of this subparagraph, the term 
‘eligible hospital’ means a hospital that participates in the 
National Healthcare Safety Network of the Centers for 
Disease Control and Prevention (or, to the extent a similar 
surveillance system reporting program that includes re-
porting about antimicrobial drugs is determined by the 
Secretary to be available to such hospitals, such similar 
surveillance system as the Secretary may specify). 
‘‘(iv) The Secretary may only revoke a determination 
of a product under this subparagraph as a new anti-
microbial drug if the Secretary finds that the request for 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00147
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
148 
such determination contained an untrue statement of ma-
terial fact. 
‘‘(v) Not later than October 1, 2017, the Secretary 
shall first publish in the Federal Register a list of the new 
antimicrobial drugs. Each fiscal year thereafter, the Sec-
retary shall publish a list of the new antimicrobial drugs 
for such fiscal year as part of the annual rulemaking 
under this subsection. 
‘‘(vi)(I) The total of the additional payments made 
under this subsection pursuant to this subparagraph for 
discharges in a fiscal year (as estimated by the Secretary 
as part of the rulemaking under this subsection for the 
fiscal year) may not exceed the applicable percentage 
(specified in subclause (II)) of the total program payments 
estimated to be made under this subsection for all dis-
charges in such fiscal year (as calculated by the Secretary 
as part of the rulemaking under this subsection for the 
fiscal year). For purposes of the preceding sentence, in 
the case that, with respect to a fiscal year, such additional 
payments are made only with respect to discharges during 
a portion of such fiscal year, the reference to ‘all dis-
charges in such fiscal year’ shall be considered a reference 
to all discharges during such portion of such fiscal year. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00148
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
149 
‘‘(II) For purposes of subclause (I), the term ‘appli-
cable percentage’ means, for fiscal year 2018 and each fis-
cal year thereafter, 0.06807 percent. 
‘‘(III) If the Secretary estimates before the beginning 
of a fiscalyear that the amount of the additional payments 
under this subsection pursuant to this subparagraph for 
the fiscal year (or portion thereof) as determined under 
subclause (I) will exceed the limit established under such 
subclause, the Secretary shall reduce pro rata the amount 
of each of the additional payments under this subsection 
pursuant to this subparagraph for such fiscal year (or por-
tion thereof) in order to ensure that the aggregate addi-
tional payments under this subsection pursuant to this 
paragraph (as so estimated) do not exceed such limit.’’. 
(2) CONFORMING AMENDMENTS.— 
(A) NO DUPLICATIVE NTAP PAYMENTS.— 
Section 1886(d)(5)(K)(i) of the Social Security 
Act (42 U.S.C. 1395ww(d)(5)(K)(i)) is amend-
ed by inserting ‘‘and with respect to which an 
additional payment is not made pursuant to 
subparagraph (M),’’ after ‘‘2001,’’. 
(B) ACCESS
TO
PRICE
INFORMATION.— 
Section 1927(b)(3)(A)(iii) of the Social Security 
Act 
(42 
U.S.C. 
1396r–8(b)(3)(A)(iii)) 
is 
amended— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00149
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
150 
(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.— 
(1) STUDY.—The Comptroller General of the 
United States shall 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)); and 
(B) develop recommendations for actions 
to be taken in order to overcome any barriers 
identified under subparagraph (A). 
(2) 
CONSIDERATION.—In 
conducting 
such 
study, the Comptroller General shall take into ac-
count the perspectives of the Director of the Na-
tional Institutes of Health, the Commissioner of the 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00150
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
151 
Food and Drugs, and the Director of the Centers for 
Disease Control and Prevention. 
(3) 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). 
Subtitle H—Vaccine Access, 
Certainty, and Innovation 
SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY 
COMMITTEE ON IMMUNIZATION PRACTICES. 
Section 2102(a) of the Public Health Service Act (42 
U.S.C. 300aa–2(a)) is amended by adding at the end the 
following: 
‘‘(10) ADVISORY COMMITTEE ON IMMUNIZATION 
PRACTICES.— 
‘‘(A) STANDARD
PERIODS
OF
TIME
FOR 
MAKING RECOMMENDATIONS.—Upon the licen-
sure of any vaccine or any new indication for a 
vaccine, the Director of the Program shall di-
rect the Advisory Committee on Immunization 
Practices, at its next regularly scheduled meet-
ing, to consider the use of the vaccine. 
‘‘(B) EXPEDITED REVIEW PURSUANT TO 
REQUEST BY SPONSOR OR MANUFACTURER.—If 
the Advisory Committee does not make rec-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00151
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
152 
ommendations with respect to the use of a vac-
cine at the Advisory Committee’s first regularly 
scheduled meeting after the licensure of the 
vaccine or any new indication for the vaccine, 
the Advisory Committee, at the request of the 
sponsor of the vaccine, shall make such rec-
ommendations on an expedited basis. 
‘‘(C) EXPEDITED
REVIEW
FOR
BREAK-
THROUGH
THERAPIES
AND
FOR
USE
DURING 
PUBLIC HEALTH EMERGENCIES.—If a vaccine 
is designated as a breakthrough therapy under 
section 506 of the Federal Food, Drug, and 
Cosmetic Act and is licensed under section 351 
of this Act, the Advisory Committee shall make 
recommendations with respect to the use of the 
vaccine on an expedited basis. 
‘‘(D) DEFINITION.—In this paragraph, the 
terms ‘Advisory Committee on Immunization 
Practices’ and ‘Advisory Committee’ mean the 
advisory committee on immunization practices 
established by the Secretary pursuant to section 
222, acting through the Director of the Centers 
for Disease Control and Prevention.’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00152
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
153 
SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF 
ACIP RECOMMENDATIONS. 
(a) REVIEW.—The Director of the Centers for Dis-
ease Control and Prevention shall conduct a review of the 
process used by the Advisory Committee on Immunization 
Practices to evaluate consistency in formulating and 
issuing recommendations pertaining to vaccines. 
(b) CONSIDERATIONS.—The review under subsection 
(a) shall include assessment of— 
(1) the criteria used to evaluate new and exist-
ing vaccines; 
(2) the Grading of Recommendations, Assess-
ment, Development, and Evaluation (GRADE) ap-
proach to the review and analysis of scientific and 
economic data, including the scientific basis for such 
approach; and 
(3) the extent to which the processes used by 
the working groups of the Advisory Committee on 
Immunization 
Practices 
are 
consistent 
among 
groups. 
(c) STAKEHOLDERS.—In carrying out the review 
under subsection (a), the Director of the Centers for Dis-
ease Control and Prevention shall solicit input from vac-
cine stakeholders. 
(d) REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Director of the Centers 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00153
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
154 
for Disease Control and Prevention shall submit to the 
appropriate committees of the Congress and make publicly 
available a report on the results of the review under sub-
section (a), including recommendations on improving the 
consistency of the process described in such subsection. 
(e) DEFINITION.—In this section, the term ‘‘Advisory 
Committee on Immunization Practices’’ means the advi-
sory committee on immunization practices established by 
the Secretary of Health and Human Services pursuant to 
section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Dis-
ease Control and Prevention. 
SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVEL-
OPERS. 
Section 310 of the Public Health Service Act (42 
U.S.C. 242o) is amended by adding at the end the fol-
lowing: 
‘‘(c)(1) In this subsection, the term ‘vaccine devel-
oper’ means a nongovernmental entity engaged in— 
‘‘(A)(i) the development of a vaccine with the 
intent to pursue licensing of the vaccine by the Food 
and Drug Administration; or 
‘‘(ii) the production of a vaccine licensed by the 
Food and Drug Administration; and 
‘‘(B) vaccine research. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00154
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
155 
‘‘(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 
developer and experts from the Centers for Disease Con-
trol and Prevention in immunization programs, epidemi-
ology, and other relevant areas at which the Director (or 
the Director’s designee), for the purpose of informing the 
vaccine developer’s understanding of public health needs 
and priorities, shall provide the perspectives of the Centers 
for Disease Control and Prevention and other 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 de-
velopment planning. 
‘‘(B) In addition to the representatives specified in 
subparagraph (A), the Secretary may, with the agreement 
of the vaccine developer requesting a meeting under such 
subparagraph, include in such meeting representatives 
of— 
‘‘(i) the Food and Drug Administration; and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00155
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
156 
‘‘(ii) the National Vaccine Program. 
‘‘(C) The Secretary shall convene a meeting re-
quested under subparagraph (A) not later than 120 days 
after receipt of the request for the meeting. 
‘‘(3)(A) Upon the submission of a written request by 
a vaccine developer, the Secretary, acting through the Di-
rector of the Centers for Disease Control and Prevention, 
shall provide to the vaccine developer any age-based or 
other demographically assessed disease epidemiological 
analyses or data that— 
‘‘(i) are specified in the request; 
‘‘(ii) have been published; 
‘‘(iii) have been performed by or are in the pos-
session of the Centers; 
‘‘(iv) are not a trade secret or commercial or fi-
nancial information that is privileged or confidential 
and subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United 
States Code; and 
‘‘(v) do not contain individually identifiable in-
formation. 
‘‘(B) The Secretary shall provide analyses requested 
by a vaccine manufacturer under subparagraph (A) not 
later than 120calendar days after receipt of the request 
for the analyses. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00156
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
157 
‘‘(4) The Secretary shall promptly notify a vaccine 
developer 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 
‘‘(ii) provided by the Secretary to the vac-
cine developer in one or more analyses under 
paragraph (3); and 
‘‘(B) the change may have implications for the 
vaccine developer’s vaccine research and develop-
ment.’’. 
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 section 2063, is 
further amended by inserting after section 505F of such 
Act the following: 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00157
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
158 
‘‘SEC. 505G. EXTENSION OF EXCLUSIVITY PERIODS FOR A 
DRUG APPROVED FOR A NEW INDICATION 
FOR A RARE DISEASE OR CONDITION. 
‘‘(a) DESIGNATION.— 
‘‘(1) IN GENERAL.—The Secretary shall des-
ignate a drug as a drug approved for a new indica-
tion to prevent, diagnose, or treat a rare disease or 
condition for purposes of granting the extensions 
under subsection (b) if— 
‘‘(A) prior to approval of an application or 
supplemental application for the new indication, 
the drug was approved or licensed for mar-
keting under section 505(c) of this Act or sec-
tion 351(a) of the Public Health Service Act, 
but was not so approved or licensed for the new 
indication; 
‘‘(B)(i) the sponsor of the approved or li-
censed drug files an application or a supple-
mental application for approval of the new indi-
cation for use of the drug to prevent, diagnose, 
or treat the rare disease or condition; and 
‘‘(ii) the Secretary approves the application 
or supplemental application; and 
‘‘(C) the application or supplemental appli-
cation for the new indication contains the con-
sent of the applicant to notice being given by 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00158
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
159 
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 this 
subsection shall not be revoked for any reason. 
‘‘(B) EXCEPTION.—The Secretary may re-
voke a designation of a drug under paragraph 
(1) if the Secretary finds that the application or 
supplemental application resulting in such des-
ignation contained an untrue statement of ma-
terial fact. 
‘‘(3) NOTIFICATION PRIOR TO DISCONTINUANCE 
OF
PRODUCTION
FOR
SOLELY
COMMERCIAL
REA-
SONS.—A designation of a drug under paragraph (1) 
shall be subject to the condition that the sponsor of 
the drug will notify the Secretary of any discontinu-
ance of the production of the drug for solely com-
mercial reasons at least one year before such dis-
continuance. 
‘‘(4) NOTICE
TO
PUBLIC.—Notice respecting 
the designation of a drug under paragraph (1) shall 
be made available to the public. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00159
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
160 
‘‘(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 7 1⁄2-year periods de-
scribed in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) 
of section 505, the 3-year periods described in 
clauses (iii) and (iv) of subsection (c)(3)(E) and 
clauses (iii) and (iv) of subsection (j)(5)(F) of sec-
tion 505, and the 7-year period described in section 
527, as applicable, shall be extended by 6 months; 
or 
‘‘(B) the 4- and 12-year periods described in 
subparagraphs (A) and (B) of section 351(k)(7) of 
the Public Health Service Act and the 7-year period 
described in section 527, as applicable, shall be ex-
tended by 6 months; and 
‘‘(2)(A) if the drug is the subject of a listed 
patent for which a certification has been submitted 
under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 
section 505 or a listed patent for which a certifi-
cation has been submitted under subsections 
(b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, 
the period during which an application may not be 
approved 
under 
section 
505(c)(3) 
or 
section 
505(j)(5)(B) shall be extended by a period of 6 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00160
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
161 
months after the date the patent 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 sec-
tion 505, and in the patent infringement litigation 
resulting from the certification the court determines 
that the patent is valid and would be infringed, the 
period during which an application may not be ap-
proved 
under 
section 
505(c)(3) 
or 
section 
505(j)(5)(B) shall be extended by a period of 6 
months after the date the patent expires (including 
any patent extensions). 
‘‘(c) RELATION TO PEDIATRIC AND QUALIFIED IN-
FECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any exten-
sion 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 
subsection (a)(1) has previously received an extension by 
operation of subsection (b). 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00161
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
162 
‘‘(e) DEFINITION.—In this section, the term ‘rare 
disease 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 appli-
cation 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.— 
(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 
APPROVED FOR A NEW INDICATION FOR A RARE DIS-
EASE
OR
CONDITION.—Notwithstanding the ref-
erences in subsection (b)(1) to the lengths of the ex-
clusivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in sub-
section (b)(1) shall be in addition to any extensions 
under section 505G.’’; and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00162
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
163 
(B) in subsection (c), by adding at the end 
the following: 
‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG 
APPROVED FOR A NEW INDICATION FOR A RARE DIS-
EASE
OR
CONDITION.—Notwithstanding the ref-
erences in subsection (c)(1) to the lengths of the ex-
clusivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in sub-
section (c)(1) shall be in addition to any extensions 
under section 505G.’’. 
(2) RELATION
TO
EXCLUSIVITY
FOR
NEW 
QUALIFIED
INFECTIOUS
DISEASE
PRODUCTS
THAT 
ARE DRUGS.—Subsection (b) of section 505E of the 
Federal 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 pe-
riod under section 505A’’ and inserting ‘‘any 
extension of the periods under sections 505A 
and 505G, as applicable,’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00163
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
164 
(3) RELATION TO PEDIATRIC EXCLUSIVITY FOR 
BIOLOGICAL
PRODUCTS.—Section 351(m) of the 
Public Health Service Act (42 U.S.C. 262(m)) is 
amended by adding at the end the following: 
‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO-
LOGICAL PRODUCT APPROVED FOR A NEW INDICA-
TION FOR A RARE DISEASE OR CONDITION.—Not-
withstanding the references in paragraphs (2)(A), 
(2)(B), (3)(A), and (3)(B) to the lengths of the ex-
clusivity periods after application of pediatric exclu-
sivity, the 6-month extensions described in such 
paragraphs shall be in addition to any extensions 
under section 505G.’’. 
SEC. 2152. REAUTHORIZATION OF RARE PEDIATRIC DIS-
EASE PRIORITY REVIEW VOUCHER INCEN-
TIVE 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 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00164
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
165 
groups often called neonates, infants, children, 
and adolescents.’’; and 
(B) in paragraph (4)(A)— 
(i) in subparagraph (E), by striking 
‘‘and’’; 
(ii) in subparagraph (F), by striking 
the period 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 
(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 
development of drugs that treat or prevent rare pe-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00165
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
166 
diatric diseases that would not otherwise have been 
developed. In conducting such study, the Comp-
troller General shall examine the following: 
(A) The indications for which each drug 
for which a priority review voucher was award-
ed under such section 529 was approved under 
section 505 of such Act (21 U.S.C. 355) or sec-
tion 351 of the Public Health Service Act (42 
U.S.C. 262). 
(B) Whether the priority review voucher 
impacted a sponsor’s decision to invest in devel-
oping a drug to treat or prevent a rare pedi-
atric 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 Pub-
lic 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— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00166
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
167 
(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 
(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; 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00167
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
168 
(ii) the impact of the priority review 
voucher program on the public health as a 
result of the expedited review of applica-
tions 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 towards providing 
incentives for the development of clinically 
important drugs that— 
(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 Com-
merce of the House of Representatives and the Com-
mittee on Health, Education, Labor and Pensions of 
the Senate a report containing the results of the 
study of conducted under paragraph (1). 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00168
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
169 
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 edu-
cation and nonprofit organizations for the purpose of 
studying and recommending improvements to the process 
of continuous manufacturing of drugs and biological prod-
ucts and similar innovative monitoring and control tech-
niques. 
(b) DEFINITIONS.—In this section: 
(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 
meaning 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 $5,000,000 for each of fis-
cal years 2016 through 2020 to carry out this section. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00169
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
170 
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 
controlled 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 
(iii) by adding at the end the fol-
lowing: 
‘‘(B) Subsequent to any re-exportation de-
scribed in subparagraph (A), a controlled substance 
may continue to be exported from any country that 
is a member of the European Economic Area to any 
other such country, provided that— 
‘‘(i) the conditions applicable with respect 
to the first country under paragraphs (1), (2), 
(3), (4), (6), and (7) are met by each subse-
quent country from which the controlled sub-
stance is exported pursuant to this paragraph; 
and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00170
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
171 
‘‘(ii) the conditions applicable with respect 
to the second country under such paragraphs 
are met by each subsequent country to which 
the controlled substance is exported pursuant to 
this paragraph.’’; and 
(B) in paragraph (6)— 
(i) by striking ‘‘(6)’’ and inserting 
‘‘(6)(A)’’; and 
(ii) by adding at the end the fol-
lowing: 
‘‘(B) In the case of re-exportation among mem-
bers of the European Economic Area, within 30 
days after each re-exportation, the person who ex-
ported the controlled substance from the United 
States delivers to the Attorney General— 
‘‘(i) documentation certifying that such re- 
exportation has occurred; and 
‘‘(ii) information concerning the consignee, 
country, and product.’’; and 
(2) by adding at the end the following: 
‘‘(g) LIMITATION.—The Attorney General shall not 
promulgate nor enforce any regulation, subregulatory 
guidance, or enforcement policy which impedes re-expor-
tation among European Economic Area countries (as pro-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00171
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
172 
vided in subsection (f)(5)), including by promulgating or 
enforcing any requirement that— 
‘‘(1) re-exportation from the first country to the 
second country or re-exportation from the second 
country to another country (as such terms are used 
in subsection (f)) occur within a specified period of 
time; or 
‘‘(2) information concerning the consignee, 
country, and product be provided prior to expor-
tation of the controlled substance from the United 
States or prior to each re-exportation among mem-
bers of the European Economic Area.’’. 
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 
adding 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 comment, review and up-
date the guidance periodically.’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00172
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
173 
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: 
‘‘SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DE-
VICES. 
‘‘(a) IN GENERAL.—In order to provide for more ef-
fective treatment or diagnosis of life-threatening or irre-
versibly debilitating human diseases or conditions, the 
Secretary shall establish a program to provide priority re-
view for devices— 
‘‘(1) representing breakthrough technologies; 
‘‘(2) for which no approved alternatives exist; 
‘‘(3) offering significant advantages over exist-
ing approved or cleared alternatives, including the 
potential to, compared to existing approved or 
cleared alternatives, reduce or eliminate the need for 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00173
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
174 
hospitalization, improve patient quality of life, facili-
tate patients’ ability to manage their own care (such 
as through self-directed personal assistance), or es-
tablish long-term clinical efficiencies; or 
‘‘(4) the availability of which is in the best in-
terest of patients. 
‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 
device may request that the Secretary designate the device 
for priority review under this section. Any such request 
for designation may be made at any time prior to the sub-
mission of an application under section 515(c), a petition 
for classification under section 513(f)(2), or a notification 
under section 510(k). 
‘‘(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 
described in subsection (a). If the Secretary deter-
mines that the device meets the criteria, the Sec-
retary 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 
composed of experienced staff and managers of the 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00174
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
175 
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 
determination 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 accord-
ance with section 517A(b)— 
‘‘(i) based upon the submission of 
documents by such person; or 
‘‘(ii) based upon such documents and 
a meeting or teleconference. 
‘‘(B) RESPONSE.—Reconsideration of a 
designation 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 des-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00175
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
176 
ignation based on the fact that the criteria specified 
in subsection (a) are no longer met because of the 
subsequent 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-
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 effi-
cient development of the device and the efficient 
review of any submission described in sub-
section (b) for the device; 
‘‘(C) adopt an efficient process for timely 
dispute resolution; 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00176
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
177 
‘‘(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 
(including in response to the request of the 
sponsor); and 
‘‘(H) assign staff to be available within a 
reasonable time to address questions by institu-
tional review committees concerning the condi-
tions and clinical testing requirements applica-
ble 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 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00177
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
178 
expediting the development and review of devices 
designated under subsection (c), the Secretary, in 
collaboration 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 statistics, to the extent scientifically 
appropriate; 
‘‘(C) facilitate, to the extent scientifically 
appropriate, expedited and efficient develop-
ment and review of the device through utiliza-
tion of timely postmarket data collection, with 
regard to applications for approval under sec-
tion 515(c); and 
‘‘(D) agree to clinical protocols that the 
Secretary will consider binding on the Secretary 
and the sponsor, subject to— 
‘‘(i) changes agreed to by the sponsor 
and the Secretary; 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00178
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
179 
‘‘(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 
guidance on the implementation of this section. Such 
guidance shall include the following: 
‘‘(A) The process for a person to seek a 
priority 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. 
‘‘(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 guid-
ance under paragraph (1), the Secretary shall pro-
pose such guidance for public comment. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00179
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
180 
‘‘(f) CONSTRUCTION.— 
‘‘(1) PURPOSE.—This section is intended to en-
courage the Secretary and provide the Secretary suf-
ficient authorities to apply efficient and flexible ap-
proaches to expedite the development of, and 
prioritize the agency’s review of, devices that rep-
resent breakthrough 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), 
including the recognition of valid scientific evidence 
as described in section 513(a)(3)(B), and consider-
ation of the least burdensome means of evaluating 
device effectiveness or demonstrating substantial 
equivalence between devices with differing techno-
logical characteristics, 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 establishment inspection, as the 
Secretary deems appropriate.’’. 
(b) CONFORMING AMENDMENT RELATED TO DES-
IGNATION DETERMINATIONS.—Section 517A(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g– 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00180
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
181 
1(a)(1)) is amended by inserting ‘‘a request for designa-
tion under section 515B,’’ after ‘‘an application under sec-
tion 515,’’. 
Subtitle M—Medical Device 
Regulatory Process Improvements 
SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
(a) ESTABLISHMENT
OF THIRD-PARTY QUALITY 
SYSTEM ASSESSMENT PROGRAM.—Chapter V of the Fed-
eral Food, Drug, and Cosmetic Act is amended by insert-
ing 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 accord-
ance with this section, establish a third-party quality 
system assessment program— 
‘‘(A) to accredit persons to assess whether 
a requestor’s quality system, including its de-
sign controls, can reasonably assure the safety 
and effectiveness of in-scope devices subject to 
device-related changes (as defined in paragraph 
(2)); 
‘‘(B) under which accredited persons shall, 
as applicable, certify that a requestor’s quality 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00181
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
182 
system meets the criteria issued under para-
graph (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 of in-scope 
devices subject to the device-related changes in-
volved, in lieu of compliance with the following 
submission requirements: 
‘‘(i) A thirty-day notice (as defined in 
paragraph (2)). 
‘‘(ii) A Special PMA supplement (as 
defined in paragraph (2)). 
‘‘(2) DEFINITIONS.—For purposes of this sec-
tionƒ 
‘‘(A) the term ‘device-related changes’ 
means changes made by a requestor with re-
spect to in-scope devices, which are— 
‘‘(i) manufacturing changes subject to 
a 30-day notice; 
‘‘(ii) changes that qualify for a Spe-
cial PMA supplement; and 
‘‘(iii) such other changes relating to 
the devices or the device manufacturing 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00182
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
183 
process as the Secretary determines appro-
priate; 
‘‘(B) the term ‘in-scope device’ means a 
device within the scope of devices agreed to by 
the requestor and the accredited person for pur-
poses of a request for certification under this 
section; 
‘‘(C) the term ‘quality system’ means a 
quality system described in section 520(f); 
‘‘(D) the term ‘requestor’ means a device 
manufacturer that is seeking certification under 
this section of a quality system used by such 
manufacturer; 
‘‘(E) 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 
‘‘(F) 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 
persons and renewal of such accreditation under sec-
tion 704(g) shall apply with respect to accreditation 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00183
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
184 
of persons and renewal of such accreditation under 
this section. 
‘‘(4) USE OF ACCREDITED PARTIES TO CON-
DUCT ASSESSMENTS.— 
‘‘(A) INITIATION
OF
ASSESSMENT
SERV-
ICES.— 
‘‘(i) DATE
ASSESSMENTS
AUTHOR-
IZED.—Beginning after issuance of the 
final guidance under paragraph (5), an ac-
credited person may conduct an assess-
ment under this section. 
‘‘(ii) INITIATION OF ASSESSMENTS.— 
Use of one or more accredited persons to 
assess a requestor’s quality system under 
this section with respect to in-scope devices 
shall be at the initiation of the person who 
registers 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 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00184
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
185 
‘‘(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 ac-
credited person from a list of such persons pub-
lished by the Secretary in accordance with sec-
tion 704(g)(4). 
‘‘(5) 
GUIDANCE; 
CRITERIA
FOR
CERTIFI-
CATION.— 
‘‘(A) IN GENERAL.—The criteria for cer-
tification of a quality system under this section 
shall be as specified by the Secretary in guid-
ance 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 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00185
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
186 
‘‘(ii) criteria for accredited persons to 
apply 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 
Century Cures Act; and 
‘‘(ii) final guidance not later than 12 
months after issuance of the draft guid-
ance under clause (i). 
‘‘(b) USE OF THIRD-PARTY ASSESSMENT.— 
‘‘(1) 
ASSESSMENT
SUMMARY; 
CERTIFI-
CATION.— 
‘‘(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 as applicable shall in-
clude— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00186
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
187 
‘‘(I) the accredited person’s cer-
tification that the requestor has satis-
fied the criteria issued under sub-
section (a)(5) for quality system cer-
tification 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.— 
Subject to action by the Secretary under sub-
paragraph (C), with respect to assessments 
which include a certification under this sec-
tion— 
‘‘(i) the Secretary’s review of the as-
sessment summary shall be deemed com-
plete 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 
certification of the requestor shall be 
deemed accepted by the Secretary on such 
30th day. 
‘‘(C) ACTIONS BY SECRETARY.— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00187
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
188 
‘‘(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 ac-
credited person submitting such assess-
ment certification, deem any such certifi-
cation to be provisional beyond such 30- 
day period, suspended pending further re-
view by the Secretary, or otherwise quali-
fied or cancelled, based on the Secretary’s 
determination that (as applicable)— 
‘‘(I) additional information is 
needed to support such certification; 
‘‘(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-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00188
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
189 
plicable accredited person indicating such 
acceptance. 
‘‘(2) NOTIFICATIONS TO SECRETARY BY CER-
TIFIED
MANUFACTURERS
FOR
PROGRAM
EVALUA-
TION PURPOSES.— 
‘‘(A) PERIODIC NOTIFICATION FOR MANU-
FACTURING CHANGES OTHERWISE SUBJECT TO 
THIRTY-DAY
NOTICE.—A requestor certified 
under this section that effectuates device-re-
lated changes with respect to in-scope devices, 
without prior submission of a thirty-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 successor regu-
lation). Such notification shall— 
‘‘(i) describe the changes made; and 
‘‘(ii) indicate the effective dates of 
such changes. 
‘‘(B) PERIODIC
NOTIFICATION
FOR
DE-
VICE-RELATED CHANGES OTHERWISE SUBJECT 
TO
SPECIAL
PMA
SUPPLEMENT.—A requestor 
certified under this section that effectuates de-
vice-related changes with respect to in-scope de-
vices, without prior submission of a Special 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00189
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
190 
PMA Supplement, 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 
successor regulation). Such notification shall— 
‘‘(i) describe the changes made, in-
cluding a full explanation of the basis for 
the changes; and 
‘‘(ii) indicate the effective dates of 
such changes. 
‘‘(C) USE
OF
NOTIFICATIONS
FOR
PRO-
GRAM
EVALUATION
PURPOSES.—Information 
submitted to the Secretary under subpara-
graphs (A) and (B) shall be used by the Sec-
retary for purposes of the program evaluation 
under subsection (d). 
‘‘(c) DURATION AND EFFECT OF CERTIFICATION.— 
A certification under this section— 
‘‘(1) shall remain in effect for a period of two 
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); 
‘‘(3) shall continue to apply with respect to de-
vice-related changes made during such 2-year period, 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00190
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
191 
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 de-
termine the requestor’s conformance with the appli-
cable requirements of this Act; and 
‘‘(6) shall be considered to be revoked if the 
Secretary provides written notification to the cer-
tified requestor that its quality system does not sat-
isfy the certification criteria issued under subsection 
(a)(5) with respect to the in-scope devices at issue, 
such that the applicable submission requirements 
specified in subsection (a)(1)(C) must be met for 
changes made after receipt of such written notifica-
tion, with respect to such devices. 
‘‘(d) PROGRAM EVALUATION; SUNSET.— 
‘‘(1) PROGRAM EVALUATION AND REPORT.— 
‘‘(A) EVALUATION.—The Secretary shall 
complete an evaluation of the third-party qual-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00191
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
192 
ity system assessment program under this sec-
tion 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 
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 
evaluation’s findings on the website of the Food 
and Drug Administration, which shall include 
the Secretary’s recommendations with respect 
to continuation and as applicable expansion of 
the program under this section to include addi-
tional types of submissions and additional types 
of changes beyond those identified in subsection 
(a)(1)(C), including changes to devices cleared 
under section 510(k). At the discretion of the 
Secretary, the program may be expanded prior 
to January 31, 2021. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00192
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
193 
‘‘(2) SUNSET.—This section shall cease to be 
effective October 1, 2022. 
‘‘(e) 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
AP-
PROVAL SUPPLEMENTS.—Section 515(d)(6)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ‘‘, 
subject to section 524B,’’ after ‘‘that affects safety 
or effectiveness’’. 
(2) REQUIREMENTS
FOR
THIRTY-DAY
NO-
TICE.—Section 515(d)(6)(A)(ii) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360e(d)(6)(A)(ii)) is amended by inserting ‘‘, subject 
to section 524B,’’ after ‘‘the date on which the Sec-
retary receives the notice’’. 
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; 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00193
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
194 
(2) by striking ‘‘(B) If the Secretary’’ and in-
serting ‘‘(B)(i) If the Secretary’’; and 
(3) by adding at the end the following: 
‘‘(ii) Valid scientific evidence for purposes 
of clause (i) may include: 
‘‘(I) evidence described in well-docu-
mented case histories, including registry 
data, that are collected and monitored 
under an acceptable protocol; 
‘‘(II) studies published in peer-re-
viewed journals; and 
‘‘(III) data collected in countries other 
than the United States so long as such 
data otherwise meets the criteria specified 
in this subparagraph. 
‘‘(iii) In the case of a study published in 
a peer-reviewed 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 re-
quest, complies with the requirement of 
subparagraph (D)(ii) to consider the least 
burdensome appropriate means of evalu-
ating device effectiveness or subsection 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00194
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
195 
(i)(1)(D) to consider the least burdensome 
means of determining substantial equiva-
lence, 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 Sec-
retary shall consider such study to be part 
of the totality of the evidence with respect 
to the device, as the Secretary determines 
appropriate.’’. 
SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT. 
(a) IN GENERAL.—Section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
inserting after subsection (i) the following: 
‘‘(j) TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT.— 
‘‘(1) TRAINING.—Each employee of the Food 
and Drug Administration who is involved in the re-
view of premarket submissions under section 515 or 
section 510(k), including supervisors, shall receive 
training regarding the meaning and implementation 
of the least burdensome appropriate means concept 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00195
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
196 
in the context of the use of that term in subsections 
(a)(3)(D) and (i)(1)(D) of this section and in section 
515(c)(5). 
‘‘(2) GUIDANCE DOCUMENTS.— 
‘‘(A) DRAFT
UPDATED
GUIDANCE.—Not 
later than 12 months after the date of enact-
ment of the 21st Century Cures Act, the Sec-
retary shall issue a draft guidance document 
updating the October 4, 2002, guidance docu-
ment entitled ‘The Least Burdensome Provision 
of the FDA Modernization Act of 1997: Con-
cept and Principles; Final Guidance for FDA 
and Industry’. 
‘‘(B) MEETING
OF
STAKEHOLDERS.—In 
developing such draft guidance document, the 
Secretary shall convene a meeting of stake-
holders to ensure a full record to support the 
publication of such document. 
‘‘(3) OMBUDSMAN AUDIT.—Not later than 18 
months after the date of issuance of final version of 
the draft guidance under paragraph (2), the om-
budsman for the organizational unit of the Food and 
Drug Administration responsible for the premarket 
review of devices shall— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00196
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
197 
‘‘(A) conduct, or have conducted, an audit 
of the training described in paragraph (1); and 
‘‘(B) include in such audit interviews with 
a representative sample of persons from indus-
try regarding their experience in the device pre-
market review process.’’. 
(b) ADDITIONAL INFORMATION REGARDING PRE-
MARKET APPLICATIONS.—Subsection (c) of section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 
29 360e) is amended by adding at the end the follows: 
‘‘(5)(A) Whenever the Secretary requests additional 
information from an applicant regarding an application 
under paragraph (1), the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate 
device safety and effectiveness, and request information 
accordingly. 
‘‘(B) For purposes of subparagraph (A), the term 
‘necessary’ means the minimum required information that 
would support a determination by the Secretary that an 
application provides a reasonable assurance of the safety 
and effectiveness of the device. 
‘‘(C) Nothing in this paragraph alters the standards 
for premarket approval of a device.’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00197
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
198 
SEC. 2224. RECOGNITION OF STANDARDS. 
Section 514(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360d(c)) is amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (B) the following new subparagraphs: 
‘‘(C)(i) Any person may submit a request 
for recognition under subparagraph (A) of all 
or part of an appropriate standard established 
by a nationally or internationally recognized 
standard organization. 
‘‘(ii) Not later than 60 days after the Sec-
retary receives such a request, the Secretary 
shall— 
‘‘(I) make a determination to recog-
nize all, part, or none of the standard that 
is the subject of the request; and 
‘‘(II) issue to the person who sub-
mitted such request a response in writing 
that states the Secretary’s rationale for 
that determination, including the scientific, 
technical, regulatory, or other basis for 
such determination; 
‘‘(iii) The Secretary shall make a response 
issued under clause (ii)(II) publicly available, in 
such manner as the Secretary determines ap-
propriate. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00198
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
199 
‘‘(iv) The Secretary shall take such actions 
as may be necessary to implement all or part of 
a standard recognized under subclause (I), in 
accordance with subparagraph (A). 
‘‘(D) The Secretary shall make publicly 
available, in such manner as the Secretary de-
termines appropriate, the rationale for recogni-
tion under subparagraph (A) of part of a stand-
ard, including the scientific, technical, regu-
latory, or other basis for such recognition.’’; 
and 
(2) by adding at the end the following new 
paragraphs: 
‘‘(4) TRAINING ON USE OF STANDARDS.—The 
Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket sub-
missions for devices periodic training on the concept 
and use of recognized standards for purposes of 
meeting a premarket submission requirement or 
other applicable requirement under this Act, includ-
ing standards relevant to an employee’s area of de-
vice review. 
‘‘(5) GUIDANCE.— 
‘‘(A) DRAFT
GUIDANCE.—The Secretary 
shall publish guidance identifying the principles 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00199
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
200 
for recognizing standards under this section. In 
publishing such guidance, the Secretary shall 
consider the experience with, and reliance on, a 
standard by other Federal regulatory authori-
ties and the device industry, and whether rec-
ognition of a standard will promote harmoni-
zation among regulatory authorities in the regu-
lation of devices. 
‘‘(B) TIMING.—The Secretary shall pub-
lish— 
‘‘(i) draft guidance under subpara-
graph (A) not later than 12 months after 
the date of the enactment of the 21st Cen-
tury Cures Act; and 
‘‘(ii) final guidance not later than 12 
months of the close of the public comment 
period for the draft guidance under clause 
(i).’’. 
SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT 
TO CERTAIN CLASS I AND CLASS II DEVICES. 
(a) CLASS I DEVICES.—Section 510(l) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
amended— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00200
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
201 
(1) by striking ‘‘A report under subsection (k)’’ 
and inserting ‘‘(1) A report under subsection (k)’’; 
and 
(2) by adding at the end the following new 
paragraph: 
‘‘(2) Not later than 120 days after the date of the 
enactment of the 21st Century Cures Act, the Secretary 
shall identify, through publication in the Federal Register, 
any type of class I device that the Secretary determines 
no longer requires a report under subsection (k) to provide 
reasonable assurance of safety and effectiveness. Upon 
such publication— 
‘‘(A) each type of class I device so identified 
shall be exempt from the requirement for a report 
under subsection (k); and 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended 
to incorporate such exemption.’’. 
(b) CLASS II DEVICES.—Section 510(m) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) 
is amended— 
(1) by striking paragraph (1) and inserting the 
following new paragraph: 
‘‘(1) The Secretary shall— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00201
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
202 
‘‘(A) not later than 60 days after the date of 
the enactment of the 21st Century Cures Act— 
‘‘(i) publish in the Federal Register a no-
tice that contains a list of each type of class II 
device that the Secretary determines no longer 
requires a report under subsection (k) to pro-
vide reasonable assurance of safety and effec-
tiveness; and 
‘‘(ii) provide for a period of not less than 
60 days for public comment beginning on the 
date of the publication of such notice; and 
‘‘(B) not later than 180 days after the date of 
the enactment of 21st Century Cures Act, publish in 
the Federal Register a list representing the Sec-
retary’s final determination with respect to the de-
vices contained in the list published under subpara-
graph (A).’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘1 day after the date of 
publication of a list under this subsection,’’ and 
inserting ‘‘1 day after the date of publication of 
the final list under paragraph (1)(B),’’; and 
(B) by striking ‘‘30-day period’’ and in-
serting ‘‘60-day period’’; and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00202
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
203 
(3) by adding at the end the following new 
paragraph: 
‘‘(3) Upon the publication of the final list under para-
graph (1)(B)— 
‘‘(A) each type of class II device so listed shall 
be exempt from the requirement for a report under 
subsection (k); and 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended 
to incorporate such exemption.’’. 
SEC. 2226. ADVISORY COMMITTEE PROCESS. 
(a) CLASSIFICATION PANELS.—Paragraph (5) of sec-
tion 513(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(b)) is amended— 
(1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 
and 
(2) by adding at the end the following: 
‘‘(B) When a device is specifically the sub-
ject of review by a classification panel, the Sec-
retary shall— 
‘‘(i) ensure that adequate expertise is 
represented on the classification panel to 
assess— 
‘‘(I) the disease or condition 
which the device is intended to cure, 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00203
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
204 
treat, mitigate, prevent, or diagnose; 
and 
‘‘(II) the technology of the de-
vice; and 
‘‘(ii) as part of the process to ensure 
adequate expertise under clause (i), give 
due consideration to the recommendations 
of the person whose premarket submission 
is subject to panel review on the expertise 
needed among the voting members of the 
panel. 
‘‘(C) For review by a classification panel of 
a premarket submission for a device, the Sec-
retary shall— 
‘‘(i) provide an opportunity for the 
person whose premarket submission is sub-
ject to panel review to provide rec-
ommendations on the expertise needed 
among the voting members of the panel; 
and 
‘‘(ii) give due consideration to such 
recommendations and ensure that adequate 
expertise is represented on advisory panels 
to assess— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00204
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
205 
‘‘(I) the disease or condition for 
which the device is intended to cure, 
treat, mitigate, prevent, or diagnose; 
and 
‘‘(II) the technology of the de-
vice. 
‘‘(D) 
For 
purposes 
of 
subparagraph 
(B)(ii), the term ‘adequate expertise’ means 
that the membership of the classification panel 
reviewing a premarket submission includes— 
‘‘(i) two or more voting members, with 
a specialty or other expertise clinically rel-
evant to the device under review; and 
‘‘(ii) at least one voting member who 
is knowledgeable about the technology of 
the device.’’. 
(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c(b)(6)) is amended— 
(1) in subparagraph (A)(iii), by inserting before 
the period at the end ‘‘, including by designating a 
representative who will be provided a time during 
the panel meeting to address the panel individually 
(or accompanied by experts selected by such rep-
resentative) 
for 
the 
purpose 
of 
correcting 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00205
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
206 
misstatements of fact or providing clarifying infor-
mation, subject to the discretion of panel chair-
person.’’. 
(2) by striking subparagraph (B) and inserting 
the following new subparagraph: 
‘‘(B)(i) Any meeting of a classification 
panel for a device that is specifically the subject 
of review shall— 
‘‘(I) provide adequate time for initial 
presentations by the person whose device is 
specifically the subject of a classification 
panel review and by the Secretary; and 
‘‘(II) encourage free and open partici-
pation by all interested persons. 
‘‘(ii) Following the initial presentations de-
scribed in clause (i), the panel may— 
‘‘(I) pose questions to a designated 
representative described in subparagraph 
(A)(iii); and 
‘‘(II) consider the responses to such 
questions in the panel’s review of the de-
vice that is specifically the subject of re-
view by the classification panel.’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00206
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
207 
SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICA-
TION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amend-
ed— 
(1) in paragraph (1) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; 
(2) in paragraph (2)(A) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; and 
(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ 
and inserting ‘‘8,000’’ 
(b) GUIDANCE DOCUMENT
ON PROBABLE BEN-
EFIT.—Not later than 18 months after the date of enact-
ment of this Act, the Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall publish a draft guidance document that de-
fines the criteria for establishing ‘‘probable benefit’’ as 
that term is used in section 520(m)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)). 
SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN 
VITRO DIAGNOSTICS. 
(a) DRAFT REVISED GUIDANCE.—Not later than 12 
months after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall publish a 
draft guidance that— 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00207
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
208 
(1) revises section V ‘‘Demonstrating Insignifi-
cant Risk of an Erroneous Result—‘Accuracy’ ’’ of 
the guidance entitled ‘‘Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 
(CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices’’ and dated January 30, 
2008; and 
(2) includes guidance on the appropriate use of 
comparable performance between a waived user and 
a moderately complex laboratory user to dem-
onstrate accuracy. 
(b) FINAL REVISED GUIDANCE.—The Secretary of 
Health and Human Services shall finalize the draft guid-
ance published under subsection (a) not later than 12 
months after the comment period for such draft guidance 
closes. 
Subtitle N—Sensible Oversight for 
Technology 
Which 
Advances 
Regulatory Efficiency 
SEC. 2241. HEALTH SOFTWARE. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(ss)(1) The term ‘health software’ means software 
that does not, through use of an in vitro diagnostic device 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00208
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
209 
or signal acquisition system, acquire, process, or analyze 
an image or physiological signal, is not an accessory, is 
not an integral part of a device necessary to support the 
use of the device, is not used in the manufacture and 
transfusion of blood and blood components to assist in the 
prevention of disease in humans, and— 
‘‘(A) is intended for use for administrative 
or operational support or the processing and 
maintenance of financial records; 
‘‘(B) is intended for use in clinical, labora-
tory, or administrative workflow and related 
recordkeeping; 
‘‘(C)(i) is intended for use solely in the 
transfer, aggregation, conversion (in accordance 
with a present specification), storage, manage-
ment, retrieval, or transmission of data or in-
formation; 
‘‘(ii) utilizes a connectivity software plat-
form, electronic or electrical hardware, or a 
physical communications infrastructure; and 
‘‘(iii) is not intended for use— 
‘‘(I) in active patient monitoring; or 
‘‘(II) in controlling or altering the 
functions or parameters of a device that is 
connected to such software; 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00209
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
210 
‘‘(D) is intended for use to organize and 
present information for health or wellness edu-
cation or for use in maintaining a healthy life-
style, including medication adherence and 
health management tools; 
‘‘(E) is intended for use to analyze infor-
mation to provide general health information 
that does not include patient-specific rec-
ommended options to consider in the preven-
tion, diagnosis, treatment, cure, or mitigation of 
a particular disease or condition; or 
‘‘(F) is intended for use to analyze infor-
mation to provide patient-specific recommended 
options to consider in the prevention, diagnosis, 
treatment, cure, or mitigation of a particular 
disease or condition. 
‘‘(2) The term ‘accessory’ means a product that— 
‘‘(A) is intended for use with one or more par-
ent devices; 
‘‘(B) is intended to support, supplement, or 
augment the performance of one or more parent de-
vices; and 
‘‘(C) shall be classified by the Secretary— 
‘‘(i) according to its intended use; and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00210
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
211 
‘‘(ii) independently of any classification of 
any parent device with which it is used.’’. 
SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGU-
LATION. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. HEALTH SOFTWARE. 
‘‘(a) INAPPLICABILITY OF REGULATION TO HEALTH 
SOFTWARE.—Except as provided in subsection (b), health 
software shall not be subject to regulation under this Act. 
‘‘(b) EXCEPTION.— 
‘‘(1) IN
GENERAL.—Subsection (a) shall not 
apply with respect to a software product— 
‘‘(A) of a type described in subparagraph 
(F) of section 201(ss)(1); and 
‘‘(B) that the Secretary determines poses a 
significant risk to patient safety. 
‘‘(2) CONSIDERATIONS.—In making a deter-
mination under subparagraph (B) of paragraph (1) 
with respect to a product to which such paragraph 
applies, the Secretary shall consider the following: 
‘‘(A) The likelihood and severity of patient 
harm if the product were to not perform as in-
tended. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00211
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
212 
‘‘(B) The extent to which the product is 
intended to support the clinical judgment of a 
medical professional. 
‘‘(C) Whether there is a reasonable oppor-
tunity for a medical professional to review the 
basis of the information or treatment rec-
ommendation provided by the product. 
‘‘(D) The intended user and user environ-
ment, such as whether a medical professional 
will use a software product of a type described 
in subparagraph (F) of section 201(ss)(1). 
‘‘(c) DELEGATION.—The Secretary shall delegate pri-
mary jurisdiction for regulating a software product deter-
mined under subsection (b) to be subject to regulation 
under this Act to the center at the Food and Drug Admin-
istration charged with regulating devices. 
‘‘(d) REGULATION OF SOFTWARE.— 
‘‘(1) IN GENERAL.—The Secretary shall review 
existing regulations and guidance regarding the reg-
ulation of software under this Act. The Secretary 
may implement a new framework for the regulation 
of software and shall, as appropriate, modify such 
regulations and guidance or issue new regulations or 
guidance. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00212
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
213 
‘‘(2) ISSUANCE
BY
ORDER.—Notwithstanding 
subchapter II of chapter 5 of title 5, United States 
Code, the Secretary may modify or issue regulations 
for the regulation of software under this Act by ad-
ministrative order published in the Federal Register 
following the publication of a proposed order. 
‘‘(3) AREAS UNDER REVIEW.—The review of ex-
isting regulations and guidance under paragraph (1) 
may include review of the following areas: 
‘‘(A) Classification of software. 
‘‘(B) Standards for development of soft-
ware. 
‘‘(C) 
Standards 
for 
validation 
and 
verification of software. 
‘‘(D) Review of software. 
‘‘(E) Modifications to software. 
‘‘(F) Manufacturing of software. 
‘‘(G) Quality systems for software. 
‘‘(H) Labeling requirements for software. 
‘‘(I) Postmarketing requirements for re-
porting of adverse events. 
‘‘(4) PROCESS FOR ISSUING PROPOSED REGU-
LATIONS, 
ADMINISTRATIVE
ORDER, 
AND
GUID-
ANCE.—Not later than 18 months after the date of 
enactment of this section, the Secretary shall consult 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00213
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
214 
with external stakeholders (including patients, indus-
try, health care providers, academia, and govern-
ment) to gather input before issuing regulations, an 
administrative order, and guidance under this sub-
section. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as providing the Secretary with the 
authority to regulate under this Act any health software 
product of the type described in subparagraph (F) of sec-
tion 201(ss)(1) unless and until the Secretary has made 
a determination described in subsection (b)(1)(B) with re-
spect to such product.’’. 
SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE. 
Section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in subparagraph (2), by striking ‘‘or’’ after 
‘‘or other animals,’’; 
(2) in subparagraph (3), by striking ‘‘and’’ and 
inserting ‘‘or’’; and 
(3) by inserting after subparagraph (3) the fol-
lowing: 
‘‘(4) is not health software (other than software 
determined to be a risk to patient safety under sec-
tion 524B(b)), and’’. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00214
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
215 
Subtitle O—Streamlining Clinical 
Trials 
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RE-
SEARCH; APPLICABILITY OF RULES. 
(a) IN GENERAL.—In order to simplify and facilitate 
compliance by researchers with applicable regulations for 
protection of human subjects in research, the Secretary 
of Health and Human Services shall, to the extent possible 
and consistent with other statutory provisions, harmonize 
differences between the HHS Human Subject Regulations 
and the FDA Human Subject Regulations in accordance 
with subsection (b). 
(b) AVOIDING REGULATORY DUPLICATION AND UN-
NECESSARY DELAYS.— 
(1) IN GENERAL.—The Secretary shall— 
(A) make such modifications to the provi-
sions of the HHS Human Subject Regulations 
and the vulnerable-populations rules as may be 
necessary— 
(i) to reduce regulatory duplication 
and unnecessary delays; 
(ii) to modernize such provisions in 
the context of multisite and cooperative re-
search projects; and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00215
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
216 
(iii) to incorporate local consider-
ations, community values, and mechanisms 
to protect vulnerable populations; and 
(B) ensure that human subject research 
that is subject to the HHS Human Subject 
Regulations or to the FDA Human Subject 
Regulations may— 
(i) use joint or shared review; 
(ii) rely upon the review of— 
(I) an independent institutional 
review board; or 
(II) an institutional review board 
of an entity other than the sponsor of 
the research; or 
(iii) use similar arrangements to avoid 
duplication of effort. 
(2) REGULATIONS AND GUIDANCE.—Not later 
than 12 months after the date of enactment of this 
Act, the Secretary, acting through the relevant agen-
cies and offices of the Department of Health and 
Human Services, including the Office for Human 
Research Protections and relevant agencies and of-
fices of the Food and Drug Administration, shall 
issue such regulations and guidance and take such 
other actions as may be necessary to implement this 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00216
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
217 
section and help facilitate the broader use of single, 
central, or lead institutional review boards. Such 
regulations and guidance shall include clarification 
of requirements and policies relating to the fol-
lowing: 
(A) Arrangements to avoid duplication de-
scribed in paragraph (1)(A)(i), including— 
(i) delineating the roles of institu-
tional review boards in multisite or cooper-
ative, multisite studies where one or more 
local institutional review boards are relied 
upon, or similar arrangements are used; 
(ii) the risks and benefits to human 
subjects; 
(iii) standardization of informed con-
sent and other processes and legal docu-
ments; and 
(iv) incorporating community values 
through the use of local institutional re-
view boards while continuing to use central 
or lead institutional review boards. 
(B) Concerns about regulatory and legal li-
ability contributing to decisions by the sponsors 
of research to rely on local institutional review 
boards for multisite research. 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00217
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
218 
(3) CONSULTATION.—In issuing regulations or 
guidance pursuant to paragraph (2), the Secretary 
shall consult with stakeholders (including research-
ers, academic organizations, hospitals, institutional 
research boards, pharmaceutical, biotechnology and 
medical device developers, clinical research organiza-
tions, patient groups, and others). 
(c) TIMING.—The Secretary shall complete the har-
monization described in subsection (a) not later than 36 
months after the date of enactment of this Act. 
(d) PROGRESS REPORT.—Not later than 24 months 
after the date of enactment of this Act, the Secretary shall 
submit to Congress a report on the progress made towards 
completing such harmonization. 
(d) DEFINITIONS.— 
(1) HUMAN SUBJECT REGULATIONS.—In this 
section: 
(A) 
FDA 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘FDA Human Subject Reg-
ulations’’ means the provisions of parts 50, 56, 
312, and 812 of title 21, Code of Federal Regu-
lations (or any successor regulations). 
(B) HHS 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘HHS Human Subject Reg-
ulations’’ subject to clause (ii), means the provi-
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00218
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
219 
sions of subpart A of part 46 of title 45, Code 
of Federal Regulations (or any successor regu-
lations). 
(C) VULNERABLE-POPULATIONS RULES.— 
The term ‘‘vulnerable-populations rules’’— 
(i) subject to clause (ii), means the 
provisions of subparts B through D of 
such part 46 (or any successor regula-
tions); or 
(ii) as applicable to the human sub-
jects involved in research described in sub-
paragraph (B), means the provisions appli-
cable to vulnerable populations under part 
56 of such title 21 (or any successor regu-
lations) and subpart D of part 50 of such 
title 21 (or any successor regulations). 
(2) HUMAN SUBJECT RESEARCH.— 
(A) Except as provided in subparagraph 
(B), the term ‘‘human subject research’’ means 
research, as defined in subpart A of part 46 of 
title 45, Code of Federal Regulations (or any 
successor regulations), that involves a human 
subject, as defined in such subpart A (or any 
successor regulations); and 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00219
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS
220 
(B) In the case of an investigation that is 
subject to the provisions of part 50 of title 21, 
Code of Federal Regulations (or any successor 
regulations), the term ‘‘human subject’’ has the 
meaning given such term in such part 50, and 
the term ‘‘human subject research’’ means a 
clinical investigation as defined in such part 50. 
(3) OTHER DEFINITIONS.—In this section: 
(A) INSTITUTIONAL REVIEW BOARD.—The 
term ‘‘institutional review board’’ has the mean-
ing that applies to the term ‘‘institutional re-
view board’’ under the HHS Human Subject 
Regulations. 
(B) 
LEAD
INSTITUTIONAL
REVIEW 
BOARD.—The term ‘‘lead institutional review 
board’’ means an institutional review board that 
otherwise meets the requirements of the HHS 
Human Subject Regulations and enters into a 
written agreement with an institution, another 
institutional review board, a sponsor, or a prin-
cipal investigator to approve and oversee human 
subject research that is conducted at multiple 
locations. References to an institutional review 
board include an institutional review board that 
VerDate Sep 11 2014 
01:31 May 20, 2015
Jkt 049200
PO 00000
Frm 00220
Fmt 6652
Sfmt 6201
E:\BILLS\H6.IH
H6
SSpencer on DSK4SPTVN1PROD with BILLS