118 
(f)(2) to obtain classification of such accessory in accord-
ance with the criteria and requirements set forth in that 
subsection.’’. 
(b) CONFORMING CHANGE.—Section 513(b) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is 
amended by striking paragraph (9) (relating to classifica-
tion of an accessory). 
(c) EFFECTIVE DATE.—The amendments made by sub-
sections (a) and (b) shall take effect on the date that is 60 
days after the date of enactment of this Act. 
TITLE VII—GENERIC DRUG 
ACCESS AND COMPETITION 
SEC. 701. COMPETITIVE GENERIC THERAPIES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 
by inserting after section 506G the following: 
‘‘SEC. 506H. COMPETITIVE GENERIC THERAPIES. 
‘‘(a) IN GENERAL.—The Secretary shall, at the request 
of the sponsor of a drug that is designated as a competitive 
generic therapy pursuant to subsection (b), expedite the de-
velopment and review of such drug pursuant to section 
505(j). 
‘‘(b) DESIGNATION PROCESS.— 
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‘‘(1) REQUEST.—The sponsor of a drug may re-
quest the Secretary to designate the drug as a com-
petitive generic therapy. 
‘‘(2) TIMING.—A request under paragraph (1) 
may be made concurrently with, or at any time prior 
to, the submission of an abbreviated new drug appli-
cation for the drug under section 505(j). 
‘‘(3) CRITERIA.—A drug is eligible for designa-
tion as a competitive generic therapy under this sec-
tion if the Secretary determines that there is inad-
equate generic competition. 
‘‘(4) DESIGNATION.—Not later than 60 calendar 
days after the receipt of a request under paragraph 
(1), the Secretary shall— 
‘‘(A) determine whether the drug that is the 
subject of the request meets the criteria described 
in paragraph (3); and 
‘‘(B) if the Secretary finds that the drug 
meets such criteria, designate the drug as a com-
petitive generic therapy. 
‘‘(c) ACTIONS.—In expediting the development and re-
view of a drug under subsection (a), the Secretary shall, 
as requested by the sponsor, take actions including the fol-
lowing: 
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‘‘(1) Hold meetings with the sponsor and the re-
view team throughout the development of the drug 
prior to submission of the application for such drug 
under section 505(j). 
‘‘(2) Provide timely advice to, and interactive 
communication with, the sponsor regarding the devel-
opment of the drug to ensure that the development 
program to gather the data necessary for approval is 
as efficient as practicable. 
‘‘(3) Involve senior managers and experienced re-
view staff, as appropriate, in a collaborative, coordi-
nated review, including with respect to drug-device 
combination products and other complex products. 
‘‘(4) Assign a cross-disciplinary project lead for 
the Food and Drug Administration review team— 
‘‘(A) to facilitate an efficient review of the 
development program and application, including 
manufacturing inspections; and 
‘‘(B) to serve as a scientific liaison between 
the review team and the sponsor. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘generic drug’ means a drug that 
is approved pursuant to section 505(j). 
‘‘(2) The term ‘inadequate generic competition’ 
means, with respect to a product, there is not more 
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than one approved drug product on the list of prod-
ucts described in section 505(j)(7)(A) (not including 
products on the discontinued section of such list) that 
is— 
‘‘(A) the reference listed drug; or 
‘‘(B) a generic drug with the same reference 
listed drug as the drug for which designation as 
a competitive generic therapy is sought. 
‘‘(3) The term ‘reference listed drug’ means the 
listed drug (as such term is used in section 505(j)) for 
the drug involved.’’. 
(b) GUIDANCE; AMENDED REGULATIONS.— 
(1) IN GENERAL.— 
(A) ISSUANCE.—The Secretary of Health 
and Human Services shall— 
(i) not later than 18 months after the 
date of enactment of this Act, issue draft 
guidance on the provisions of section 506H 
of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a); and 
(ii) not later than 1 year after the close 
of the comment period for the draft guid-
ance, issue final guidance on such provi-
sions. 
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(B) CONTENTS.—The guidance issued under 
this subsection shall— 
(i) specify the process and criteria by 
which the Secretary makes a designation 
under section 506H of the Federal Food, 
Drug, and Cosmetic Act, as added by sub-
section (a); 
(ii) specify the actions the Secretary 
will take to expedite the development and 
review of a competitive generic therapy pur-
suant to such a designation; and 
(iii) include good review management 
practices for competitive generic therapies. 
(2) AMENDED REGULATIONS.— 
(A) IN
GENERAL.—If the Secretary of 
Health and Human Services determines that it 
is necessary to amend the regulations under title 
21, Code of Federal Regulations, in order to im-
plement section 506H of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), 
the Secretary shall amend such regulations not 
later than 2 years after the date of enactment of 
this Act. 
(B) PROCEDURE.—In carrying out sub-
paragraph (A), and in issuing any other regula-
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tions to implement such section 506H, the Sec-
retary shall— 
(i) issue a notice of proposed rule-
making that includes the proposed regula-
tion; 
(ii) provide a period of not less than 
60 days for comments on the proposed regu-
lation; and 
(iii) publish the final regulation not 
less than 30 days before the effective date of 
the regulation. 
SEC. 702. ENHANCING REGULATORY TRANSPARENCY TO 
ENHANCE GENERIC COMPETITION. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355) is amended by adding at the 
end the following: 
‘‘(11) Upon the request of an applicant regarding one 
or more specified pending applications under this sub-
section, the Secretary shall— 
‘‘(A) by telephone or electronic mail, provide re-
view status updates; and 
‘‘(B) indicate in such updates the categorical 
status of the applications by each relevant review dis-
cipline.’’. 
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124 
SEC. 703. INCENTIVIZING COMPETITIVE GENERIC THERAPY 
DEVELOPMENT. 
Section 505(j)(5) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(5)) is amended— 
(1) in subparagraph (B), by adding at the end 
the following: 
‘‘(v) 180-DAY
EXCLUSIVITY
PERIOD
FOR
COM-
PETITIVE GENERIC THERAPIES.— 
‘‘(I) EFFECTIVENESS
OF
APPLICATION.— 
Subject to subparagraph (D)(iv), if the applica-
tion is for a drug that is the same as a competi-
tive generic therapy for which any first approved 
applicant has commenced commercial marketing, 
the application shall be made effective on the 
date that is 180 days after the date of the first 
commercial marketing of the competitive generic 
therapy (including the commercial marketing of 
the listed drug) by any first approved applicant. 
‘‘(II) LIMITATION.—The exclusivity period 
under subclause (I) shall not apply with respect 
to a competitive generic therapy that has pre-
viously received an exclusivity period under sub-
clause (I). 
‘‘(III) DEFINITIONS.—In this clause and 
subparagraph (D)(iv): 
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‘‘(aa) The term ‘competitive generic 
therapy’ means a drug— 
‘‘(AA) that is designated as a 
competitive generic therapy under sec-
tion 506H; and 
‘‘(BB) for which there are no un-
expired 
patents 
or 
blocking 
exclusivities on the list of products de-
scribed in section 505(j)(7)(A) at the 
time of approval. 
‘‘(bb) The term ‘first approved appli-
cant’ means any applicant that has sub-
mitted an application that— 
‘‘(AA) is for a competitive generic 
therapy that is approved on the first 
day on which any application for such 
competitive generic therapy is ap-
proved; 
‘‘(BB) is not eligible for a 180- 
day exclusivity period under clause 
(iv) for the drug that is the subject of 
the application for the competitive ge-
neric therapy; and 
‘‘(CC) is not for a drug for which 
all drug versions have forfeited eligi-
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bility for a 180-day exclusivity period 
under clause (iv) pursuant to subpara-
graph (D).’’; and 
(2) in subparagraph (D), by adding at the end 
the following: 
‘‘(iv) SPECIAL FORFEITURE RULE FOR 
COMPETITIVE GENERIC THERAPY.—The 180- 
day exclusivity period described in subpara-
graph (B)(v) shall be forfeited by a first ap-
proved applicant if the applicant fails to 
market the competitive generic therapy 
within 75 days after the date on which the 
approval of the first approved applicant’s 
application for the competitive generic ther-
apy is made effective.’’. 
SEC. 704. TROPICAL DISEASE PRODUCT APPLICATION. 
Subparagraph (A) of section 524(a)(4) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is 
amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; 
and 
(2) by adding at the end the following: 
‘‘(iii) that contains reports of one or 
more new clinical investigations (other than 
bioavailability studies) that are essential to 
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the approval of the application and con-
ducted or sponsored by the sponsor of such 
application; and 
‘‘(iv) that contains an attestation from 
the sponsor of the application that such re-
ports were not submitted as part of an ap-
plication for marketing approval or licen-
sure by a regulatory authority in India, 
Brazil, Thailand, or any country that is a 
member of the Pharmaceutical Inspection 
Convention or the Pharmaceutical Inspec-
tion Cooperation Scheme prior to Sep-
tember 27, 2007.’’. 
SEC. 705. GAO STUDY OF ISSUES REGARDING FIRST CYCLE 
APPROVALS OF GENERIC MEDICINES. 
(a) STUDY BY GAO.—The Comptroller General of the 
United States shall conduct a study to determine the fol-
lowing: 
(1) The rate of first cycle approvals and ten-
tative approvals for generic drug applications sub-
mitted during the period beginning on October 1, 
2012, and ending on September 30, 2017. The rate of 
first cycle approvals and tentative approvals shall be 
determined and reported per each GDUFA cohort 
year during this period. 
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(2) If the rate determined pursuant to para-
graph (1) for any GDUFA cohort year is lower than 
20 percent, the reasons contributing to the relatively 
low rate of first cycle approvals and tentative approv-
als for generic drug applications shall be itemized, as-
sessed, and reported. In making the assessment re-
quired by this paragraph, the Comptroller General 
shall consider, among other things, the role played 
by— 
(A) the Food and Drug Administration’s 
implementation of approval standards for ge-
neric drug applications; 
(B) the extent to which those approval 
standards are communicated clearly to industry 
and applied consistently during the review proc-
ess; 
(C) the procedures for reviewing generic 
drug applications, including timelines for review 
activities by the Food and Drug Administration; 
(D) the extent to which those procedures are 
followed consistently (and those timelines are 
met) by the Food and Drug Administration; 
(E) the processes and practices for commu-
nication between the Food and Drug Adminis-
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129 
tration and sponsors of generic drug applica-
tions; and 
(F) the completeness and quality of original 
generic drug applications submitted to the Food 
and Drug Administration. 
(3) Taking into account the determinations made 
pursuant to paragraphs (1) and (2) and any review 
process improvements implemented pursuant to this 
Act, whether there are ways the review process for ge-
neric drugs could be improved to increase the rate of 
first cycle approvals and tentative approvals for ge-
neric drug applications. In making this determina-
tion, the Comptroller General shall consider, among 
other things, options for increasing review efficiency 
and communication effectiveness. 
(b) COMPLETION DATE.—Not later than the expiration 
of the 2-year period beginning on the date of enactment of 
this Act, the Comptroller General shall complete the study 
under subsection (a) and submit a report describing the 
findings and conclusions of the study to the Secretary, the 
Committee on Energy and Commerce of the House of Rep-
resentatives, and the Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(c) DEFINITIONS.—For purposes of this section: 
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130 
(1) The term ‘‘GDUFA cohort year’’ means a fis-
cal year. 
(2) The term ‘‘generic drug’’ means a drug that 
is approved or is seeking approval under section 
505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)). 
(3) The term ‘‘generic drug application’’ means 
an abbreviated new drug application for the approval 
of a generic drug under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)). 
(4) The term ‘‘Secretary’’ means the Secretary of 
Health and Human Services. 
(5)(A) The term ‘‘first cycle approvals and ten-
tative approvals’’ means the approval or tentative ap-
proval of a generic drug application after the Food 
and Drug Administration’s complete review of the ap-
plication and without issuance of one or more com-
plete response letters. 
(B) For purposes of this paragraph, the term 
‘‘complete response letter’’ means a written commu-
nication to the sponsor of a generic drug application 
or holder of a drug master file (DMF) from the Food 
and Drug Administration describing all of the defi-
ciencies that the Administration has identified in the 
generic drug application (including pending amend-
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131 
ments) or drug master file that must be satisfactorily 
addressed before the generic drug application can be 
approved. 
TITLE VIII—FOSTERING INNOVA-
TION IN MEDICAL IMAGING 
SEC. 801. APPROVAL OF APPLICATIONS FOR CERTAIN DIAG-
NOSTIC MEDICAL IMAGING DEVICES. 
Section 520 of the Federal Food, Drug, and Cosmetic 
Act (42 U.S.C. 360j), as amended by section 613, is further 
amended by adding at the end the following: 
‘‘(q) DIAGNOSTIC IMAGING DEVICES INTENDED FOR 
USE WITH CONTRAST AGENTS.— 
‘‘(1) The Secretary may, subject to the succeeding 
provisions of this subsection, approve an application 
(or a supplement to such an application) submitted 
under section 515 with respect to an applicable med-
ical imaging device, or, in the case of an applicable 
medical imaging device for which a notification is 
submitted under section 510(k), may make a substan-
tial equivalence determination with respect to an ap-
plicable medical imaging device, or may grant a re-
quest submitted under section 513(f)(2) for an appli-
cable medical imaging device, if the indications and 
conditions of use proposed in such application, notifi-
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cation, or request involve the use of a contrast agent 
that is not— 
‘‘(A) in a concentration, rate of administra-
tion, or route of administration that is different 
from those described in the approved labeling of 
the contrast agent, except that the Secretary may 
approve such application, make such substantial 
equivalence determination, or grant such request 
if the Secretary determines that such differences 
in concentration, rate of administration, or 
route of administration exist but do not ad-
versely affect the safety and effectiveness of the 
contrast agent when used with the device; 
‘‘(B) in a region, organ, or system of the 
body that is different from those described in the 
approved labeling of the contrast agent, except 
that the Secretary may approve such applica-
tion, make such substantial equivalence deter-
mination, or grant such request if the Secretary 
determines that such differences in region, organ, 
or system of the body exist but do not adversely 
affect the safety and effectiveness of the contrast 
agent when used with the device; 
‘‘(C) in a patient population that is dif-
ferent from those described in the approved label-
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ing of the contrast agent, except that the Sec-
retary may approve such application, make such 
substantial equivalence determination, or grant 
such request if the Secretary determines such dif-
ferences in patient population exist but do not 
adversely affect the safety and effectiveness of the 
contrast agent when used with the device; or 
‘‘(D) in an imaging modality (such as an 
ultrasound, an x-ray, diagnostic radiopharma-
ceutical-based technologies, fluorescent imaging 
technology, or magnetic resonance) that is dif-
ferent from those described in the approved label-
ing of the contrast agent. 
‘‘(2) The agency center charged with premarket 
review of devices shall have primary jurisdiction with 
respect to the review of an application, notification, 
or request described in paragraph (1). In conducting 
such review, such agency center may— 
‘‘(A) consult with the agency center charged 
with the premarket review of drugs or biological 
products; and 
‘‘(B) review information and data provided 
to the Secretary by the sponsor of a contrast 
agent in an application submitted under section 
505 of this Act or section 351 of the Public 
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134 
Health Service Act, so long as the sponsor of 
such contrast agent has provided to the sponsor 
of the applicable medical imaging device that is 
the subject of such review a right of reference and 
the application is submitted in accordance with 
this subsection. 
‘‘(3) An application submitted under section 
515, a notification submitted under section 510(k), or 
a request submitted under section 513(f)(2), as de-
scribed in paragraph (1), with respect to an applica-
ble medical imaging device shall be subject to the re-
quirements of such respective section. Such applica-
tion, notification, or request shall only be subject to 
the requirements of this Act applicable to devices. 
‘‘(4) For purposes of this subsection and section 
505(y)— 
‘‘(A) the term ‘applicable medical imaging 
device’ means a device intended to be used in 
conjunction with a contrast agent (or class of 
contrast agents) for an imaging use that is not 
described in the approved labeling of such con-
trast agent (or the approved labeling of any con-
trast agent in the same class as such contrast 
agent); and 
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135 
‘‘(B) the term ‘contrast agent’ means a drug 
that is approved under section 505 or licensed 
under section 351 of the Public Health Service 
Act, is intended for use in conjunction with an 
applicable medical imaging device, and— 
‘‘(i) is a diagnostic radiopharma-
ceutical, as defined in section 315.2 and 
601.31 of title 21, Code of Federal Regula-
tions (or any successor regulations); or 
‘‘(ii) is a diagnostic agent that im-
proves the visualization of structure or func-
tion within the body by increasing the rel-
ative difference in signal intensity within 
the target tissue, structure, or fluid.’’. 
SEC. 802. APPLICATIONS FOR APPROVAL OF CONTRAST 
AGENTS INTENDED FOR USE WITH CERTAIN 
DIAGNOSTIC MEDICAL IMAGING DEVICES. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH 
APPLICABLE MEDICAL IMAGING DEVICES.— 
‘‘(1) The sponsor of a contrast agent for which 
an application has been approved under this section 
may submit a supplement to the application seeking 
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‘‘(B) the term ‘applicable medical imaging 
device’ and ‘contrast agent’ have the meanings 
given such terms in section 520(q).’’. 
TITLE IX—ADDITIONAL 
PROVISIONS 
SEC. 901. TECHNICAL CORRECTIONS. 
(a) Section 3075(a) of the 21st Century Cures Act 
(Public Law 114–255) is amended— 
(1) in the matter preceding paragraph (1), by 
striking ‘‘as amended by section 2074’’ and inserting 
‘‘as amended by section 3102’’; and 
(2) in paragraph (2), by striking ‘‘section 
2074(1)(C)’’ and inserting ‘‘section 3102(1)(C)’’. 
(b) Section 506G(b)(1)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by 
striking ‘‘identity’’ and inserting ‘‘identify’’. 
(c) Section 505F(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355g(b)) is amended by striking 
‘‘randomized’’ and inserting ‘‘traditional’’. 
(d) Section 505F(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355g(d)) is amended by striking 
‘‘2’’ and inserting ‘‘3’’. 
(e) Effective as of the enactment of the 21st Century 
Cures Act (Public Law 114–255)— 
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138 
(1) section 3051(a) of such Act is amended by 
striking ‘‘by inserting after section 515B’’ and insert-
ing ‘‘by inserting after section 515A’’; and 
(2) section 515C of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360e–3), as inserted by such 
section 3051(a), is redesignated as section 515B. 
(f) Section 515B(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360e–3(f)(2)), as redesignated by 
subsection (e)(2) of this section, is amended by striking ‘‘a 
proposed guidance’’ and inserting ‘‘a draft version of that 
guidance’’. 
(g) Section 513(b)(5)(D) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(b)(5)(D)) is amended by 
striking ‘‘medical device submissions’’ and inserting ‘‘med-
ical devices that may be specifically the subject of a review 
by a classification panel’’. 
SEC. 902. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIPS. 
Section 566(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 
‘‘2013 through 2017’’ and inserting ‘‘2018 through 2022’’. 
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Union Calendar No. 138 
115TH CONGRESS 
1ST SESSION 
H. R. 2430 
[Report No. 115–201] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs 
for prescription drugs, medical devices, generic 
drugs, and biosimilar biological products, and for 
other purposes. 
JULY 11, 2017 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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