164 
ing aids (as defined in section 874.3300 of 
title 21, Code of Federal Regulations) (or 
any successor regulation) or wireless air 
conduction hearing aids (as defined in sec-
tion 874.3305 of title 21, Code of Federal 
Regulations) (or any successor regulation); 
‘‘(ii) is intended to be used by adults 
age 18 and older to compensate for per-
ceived mild to moderate hearing impair-
ment; 
‘‘(iii) through tools, tests, or software, 
allows the user to control the over-the- 
counter hearing aid and customize it to the 
user’s hearing needs; 
‘‘(iv) may— 
‘‘(I) use wireless technology; or 
‘‘(II) include tests for self-assess-
ment of hearing loss; and 
‘‘(v) 
is 
available 
over-the-counter, 
without the supervision, prescription, or 
other order, involvement, or intervention of 
a licensed person, to consumers through 
in-person transactions, by mail, or online. 
‘‘(B) EXCEPTION.—Such term does not in-
clude a personal sound amplification product in-
165 
tended to amplify sound for nonhearing im-
paired consumers in situations including hunt-
ing and bird-watching. 
‘‘(2) REGULATION.—An over-the-counter hear-
ing aid shall be subject to the regulations promul-
gated in accordance with section 709(b) of the FDA 
Reauthorization Act of 2017 and shall be exempt 
from sections 801.420 and 801.421 of title 21, Code 
of Federal Regulations (or any successor regula-
tions).’’. 
(b) REGULATIONS TO ESTABLISH CATEGORY.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’), not later than 3 years after the date 
of enactment of this Act, shall promulgate proposed 
regulations to establish a category of over-the- 
counter hearing aids, as defined in subsection (q) of 
section 520 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j) as amended by sub-
section (a), and, not later than 180 days after the 
date on which the public comment period on the pro-
posed regulations closes, shall issue such final regu-
lations. 
(2) REQUIREMENTS.—In promulgating the reg-
ulations under paragraph (1), the Secretary shall—
166 
(A) include requirements that provide rea-
sonable assurances of the safety and effective-
ness of over-the-counter hearing aids; 
(B) include requirements that establish or 
adopt output limits appropriate for over-the- 
counter hearing aids; 
(C) include requirements for appropriate 
labeling of over-the-counter hearing aids, in-
cluding requirements that such labeling include 
a conspicuous statement that the device is only 
intended for adults age 18 and older, informa-
tion on how consumers may report adverse 
events, information on any contraindications, 
conditions, or symptoms of medically treatable 
causes of hearing loss, and advisements to con-
sult promptly with a licensed health care practi-
tioner; and 
(D) describe the requirements under which 
the sale of over-the-counter hearing aids is per-
mitted, without the supervision, prescription, or 
other order, involvement, or intervention of a li-
censed person, to consumers through in-person 
transactions, by mail, or online. 
(3) PREMARKET
NOTIFICATION.—The Sec-
retary shall make findings under section 510(m) of
167 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(m)) to determine whether over-the- 
counter hearing aids (as defined in section 520(q) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j), as amended by subsection (a)) require 
a report under section 510(k) to provide reasonable 
assurance of safety and effectiveness. 
(4) EFFECT ON STATE LAW.—No State or local 
government shall establish or continue in effect any 
law, regulation, order, or other requirement specifi-
cally related to hearing products that would restrict 
or interfere with the servicing, marketing, sale, dis-
pensing, use, customer support, or distribution of 
over-the-counter hearing aids (as defined in section 
520(q) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j), as amended by subsection (a)) 
through in-person transactions, by mail, or online, 
that is different from, in addition to, or otherwise 
not identical to, the regulations promulgated under 
this subsection, including any State or local require-
ment for the supervision, prescription, or other 
order, involvement, or intervention of a licensed per-
son for consumers to access over-the-counter hearing 
aids.
168 
(5) NO EFFECT ON PRIVATE REMEDIES.—Noth-
ing in this section shall be construed to modify or 
otherwise affect the ability of any person to exercise 
a private right of action under any State or Federal 
product liability, tort, warranty, contract, or con-
sumer protection law. 
(c) NEW GUIDANCE ISSUED.—Not later than the 
date on which final regulations are issued under sub-
section (b), the Secretary shall update and finalize the 
draft guidance of the Department of Health and Human 
Services entitled ‘‘Regulatory Requirements for Hearing 
Aid Devices and Personal Sound Amplification Products’’, 
issued on November 7, 2013. Such updated and finalized 
guidance shall clarify which products, on the basis of 
claims or other marketing, advertising, or labeling mate-
rial, meet the definition of a device in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 
and which products meet the definition of a personal 
sound amplification product, as set forth in such guidance. 
(d) REPORT.—Not later than 2 years after the date 
on which the final regulations described in subsection 
(b)(1) are issued, the Secretary of Health and Human 
Services shall submit to Congress a report analyzing any 
adverse events relating to over-the-counter hearing aids
169 
(as defined in subsection (q)(1) of section 520 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360j)). 
SEC. 710. REPORT ON SERVICING OF DEVICES. 
(a) IN GENERAL.—Not later than 270 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall post on the internet website of the 
Food and Drug Administration a report on the continued 
quality, safety, and effectiveness of devices (as defined in 
section 201(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(h))) with respect to servicing (as de-
fined in subsection (c)). 
(b) CONTENTS.—The report submitted under sub-
section (a) shall contain— 
(1) the status of, and findings to date, with re-
spect to, the proposed rule entitled ‘‘Refurbishing, 
Reconditioning, Rebuilding, Remarketing, Remanu-
facturing, and Servicing of Medical Devices Per-
formed by Third-Party Entities and Original Equip-
ment Manufacturers; Request for Comments’’ pub-
lished in the Federal Register by the Food and Drug 
Administration on March 4, 2016 (81 Fed. Reg. 
11477); 
(2) information presented during the October 
2016 public workshop entitled ‘‘Refurbishing, Recon-
171 
(7) information regarding the regulation by 
States, the Joint Commission, or other regulatory 
bodies of device servicing performed by any entity, 
including original equipment manufacturers and 
third party entities; and 
(8) any additional information determined by 
the Secretary (acting through the Commissioner) to 
be relevant to ensuring the quality, safety, and effec-
tiveness of devices with respect to servicing. 
(c) SERVICING DEFINED.—In this section, the term 
‘‘servicing’’ includes, with respect to a device, refurbishing, 
reconditioning, rebuilding, remarketing, repairing, re-
manufacturing, or other servicing of the device. 
TITLE VIII—IMPROVING 
GENERIC DRUG ACCESS 
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) is amended by adding at the 
end the following: 
‘‘(11)(A) Subject to subparagraph (B), the Secretary 
shall prioritize the review of, and act within 8 months of 
the date of the submission of, an original abbreviated new 
drug application submitted for review under this sub-
section that is for a drug—
172 
‘‘(i) for which there are not more than 3 ap-
proved drug products listed under paragraph (7) and 
for which there are no blocking patents and 
exclusivities; or 
‘‘(ii) that has been included on the list under 
section 506E. 
‘‘(B) To qualify for priority review under this para-
graph, not later than 60 days prior to the submission of 
an application described in subparagraph (A) or that the 
Secretary may prioritize pursuant to subparagraph (D), 
the applicant shall provide complete, accurate information 
regarding facilities involved in manufacturing processes 
and testing of the drug that is the subject of the applica-
tion, including facilities in corresponding Type II active 
pharmaceutical ingredients drug master files referenced in 
an application and sites or organizations involved in bio-
equivalence and clinical studies used to support the appli-
cation, to enable the Secretary to make a determination 
regarding whether an inspection of a facility is necessary. 
Such information shall include the relevant (as determined 
by the Secretary) sections of such application, which shall 
be unchanged relative to the date of the submission of 
such application, except to the extent that a change is 
made to such information to exclude a facility that was 
not used to generate data to meet any application require-
173 
ments for such submission and that is not the only facility 
intended to conduct one or more unit operations in com-
mercial production. Information provided by an applicant 
under this subparagraph shall not be considered the sub-
mission of an application under this subsection. 
‘‘(C) The Secretary may expedite an inspection or re-
inspection under section 704 of an establishment that pro-
poses to manufacture a drug described in subparagraph 
(A). 
‘‘(D) Nothing in this paragraph shall prevent the Sec-
retary from prioritizing the review of other applications 
as the Secretary determines appropriate. 
‘‘(12) The Secretary shall publish on the internet 
website of the Food and Drug Administration, and update 
at least once every 6 months, a list of all drugs approved 
under subsection (c) for which all patents and periods of 
exclusivity under this Act have expired and for which no 
application has been approved under this subsection.’’. 
SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO 
ENHANCE GENERIC COMPETITION. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355), as amended by section 801, 
is further amended by adding at the end the following: 
‘‘(13) Upon the request of an applicant regarding one 
or more specified pending applications under this sub-
174 
section, the Secretary shall, as appropriate, provide review 
status updates indicating the categorical status of the ap-
plications by each relevant review discipline.’’. 
SEC. 803. COMPETITIVE GENERIC THERAPIES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 506G the following: 
‘‘SEC. 506H. COMPETITIVE GENERIC THERAPIES. 
‘‘(a) IN GENERAL.—The Secretary may, at the re-
quest of an applicant of a drug that is designated as a 
competitive generic therapy pursuant to subsection (b), ex-
pedite the development and review of an abbreviated new 
drug application under section 505(j) for such drug. 
‘‘(b) DESIGNATION PROCESS.— 
‘‘(1) REQUEST.—The applicant may request the 
Secretary to designate the drug as a competitive ge-
neric 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.
175 
‘‘(4) DESIGNATION.—Not later than 60 cal-
endar days after the receipt of a request under para-
graph (1), the Secretary may— 
‘‘(A) determine whether the drug that is 
the subject of the request meets the criteria de-
scribed in paragraph (3); and 
‘‘(B) if the Secretary finds that the drug 
meets such criteria, designate the drug as a 
competitive generic therapy. 
‘‘(c) ACTIONS.—In expediting the development and 
review of an application under subsection (a), the Sec-
retary may, as requested by the applicant, take actions 
including the following: 
‘‘(1) Hold meetings with the applicant and the 
review 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 applicant regarding the de-
velopment of the drug to ensure that the develop-
ment program to gather the data necessary for ap-
proval is as efficient as practicable. 
‘‘(3) Involve senior managers and experienced 
review staff, as appropriate, in a collaborative, co-
ordinated review of such application, including with
176 
respect to drug-device combination products and 
other complex products. 
‘‘(4) Assign a cross-disciplinary project lead— 
‘‘(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 applicant. 
‘‘(d) REPORTING REQUIREMENT.—Not later than 
one year after the date of the approval of an application 
under section 505(j) with respect to a drug for which the 
development and review is expedited under this section, 
the sponsor of such drug shall report to the Secretary on 
whether the drug has been marketed in interstate com-
merce since the date of such approval. 
‘‘(e) 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 drug, there is not more 
than one approved drugs on the list of drugs de-
scribed in section 505(j)(7)(A) (not including drugs 
on the discontinued section of such list) that is— 
‘‘(A) the reference listed drug; or
177 
‘‘(B) a generic drug with the same ref-
erence listed drug as the drug for which des-
ignation 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 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 
guidance, issue final guidance on such sec-
tion 506H. 
(B) CONTENTS.—The guidance issued 
under this paragraph shall— 
(i) specify the process and criteria by 
which the Secretary makes a designation 
under section 506H of the Federal Food,
178 
Drug, and Cosmetic Act, as added by sub-
section (a); 
(ii) specify the actions the Secretary 
may take to expedite the development and 
review of a competitive generic therapy 
pursuant to such a designation; and 
(iii) include good review management 
practices for competitive generic therapies. 
(2) AMENDED
REGULATIONS.—The Secretary 
of Health and Human Services shall issue or revise 
any regulations as may be necessary to carry out 
this section not later than 2 years after the date of 
enactment of this Act. 
SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH 
LIMITED COMPETITION. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506H, as added by section 803, the following: 
‘‘SEC. 506I. PROMPT REPORTS OF MARKETING STATUS. 
‘‘(a) NOTIFICATION OF WITHDRAWAL.—The holder 
of an application approved under subsection (c) or (j) of 
section 505 shall notify the Secretary in writing 180 days 
prior to withdrawing the approved drug from sale, or if 
180 days is not practicable as soon as practicable but not
179 
later than the date of withdrawal. The holder shall include 
with such notice the— 
‘‘(1) National Drug Code; 
‘‘(2) identity of the drug by established name 
and by proprietary name, if any; 
‘‘(3) new drug application number or abbre-
viated application number; 
‘‘(4) strength of the drug; 
‘‘(5) date on which the drug is expected to no 
longer be available for sale; and 
‘‘(6) reason for withdrawal of the drug. 
‘‘(b) NOTIFICATION OF DRUG NOT AVAILABLE FOR 
SALE.—The holder of an application approved under sub-
section (c) or (j) shall notify the Secretary in writing with-
in 180 calendar days of the date of approval of the drug 
if the drug will not be available for sale within 180 cal-
endar days of such date of approval. The holder shall in-
clude with such notice the— 
‘‘(1) identity of the drug by established name 
and by proprietary name, if any; 
‘‘(2) new drug application number or abbre-
viated application number; 
‘‘(3) strength of the drug; 
‘‘(4) date on which the drug will be available 
for sale, if known; and
180 
‘‘(5) reason for not marketing the drug after 
approval. 
‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 
days of the date of enactment of this section, all holders 
of applications approved under subsection (c) or (j) of sec-
tion 505 shall review the information in the list published 
under subsection 505(j)(7)(A) and shall notify the Sec-
retary in writing that— 
‘‘(1) all of the application holder’s drugs in the 
active section of the list published under subsection 
505(j)(7)(A) are available for sale; or 
‘‘(2) one or more of the application holder’s 
drugs in the active section of the list published 
under subsection 505(j)(7)(A) have been withdrawn 
from sale or have never been available for sale, and 
include with such notice the information required 
pursuant to subsection (a) or (b), as applicable. 
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a hold-
er of an approved application fails to submit the informa-
tion required under subsection (a), (b), or (c), the Sec-
retary may move the application holder’s drugs from the 
active section of the list published under subsection 
505(j)(7)(A) to the discontinued section of the list, except 
that the Secretary shall remove from the list in accordance 
with subsection 505(j)(7)(C) drugs the Secretary deter-
181 
mines have been withdrawn from sale for reasons of safety 
of effectiveness. 
‘‘(e) UPDATES.—The Secretary shall update the list 
published under subsection 505(j)(7)(A) based on the in-
formation provided under subsections (a), (b), and (c) by 
moving drugs that are not available for sale from the ac-
tive section to the discontinued section of the list, except 
that drugs the Secretary determines have been withdrawn 
from sale for reasons of safety or effectiveness shall be 
removed from the list in accordance with subsection 
505(j)(7)(C). The Secretary shall make monthly updates 
to the list based on the information provided pursuant to 
subsections (a) and (b), and shall update the list based 
on the information provided under subsection (c) as soon 
as practicable. 
‘‘(f) LIMITATION ON USE OF NOTICES.—Any notice 
submitted under this section shall not be made public by 
the Secretary and shall be used solely for the purpose of 
the updates described in subsection (e).’’. 
SEC. 805. SUITABILITY PETITIONS. 
(a) IN GENERAL.—It is the sense of Congress that 
the Food and Drug Administration shall meet the require-
ment under section 505(j)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and sec-
tion 314.93(e) of title 21, Code of Federal Regulations,
182 
of responding to suitability petitions within 90 days of 
submission. 
(b) REPORT.—The Secretary of Health and Human 
Services shall include in the annual reports under section 
807— 
(1) the number of pending petitions under sec-
tion 505(j)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(2)(C)); and 
(2) the number of such petitions pending a sub-
stantive response for more than 180 days from the 
date of receipt. 
SEC. 806. INSPECTIONS. 
Within 6 months of the date of enactment of this Act, 
the Secretary of Health and Human Services shall develop 
and implement a protocol for expediting review of timely 
responses to reports of observations from an inspection 
under section 704 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374). Such protocol shall— 
(1) apply to responses to such reports per-
taining to applications submitted under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355)— 
(A) for which the approval is dependent 
upon remediation of conditions identified in the 
report;
183 
(B) for which concerns related to observa-
tions from an inspection under such section 704 
are the only barrier to approval; and 
(C) where the drug that is the subject of 
the application is a drug— 
(i) for which there are not more than 
3 other approved applications under sec-
tion 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) that ref-
erence the same listed drug and for which 
there are less than 6 abbreviated new drug 
applications tentatively approved; or 
(ii) that is included on the list under 
section 506E of such Act (21 U.S.C. 
356e); 
(2) address expedited re-inspection of facilities, 
as appropriate; and 
(3) establish a 6-month timeline for completion 
of review of such responses to such reports. 
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLI-
CATIONS AND PRIORITY REVIEW APPLICA-
TIONS. 
Not later than 180 calendar days after the date of 
enactment of this Act, and quarterly thereafter until Octo-
ber 1, 2022, the Secretary of Health and Human Services
184 
shall post on the internet website of the Food and Drug 
Administration a report that provides, with respect to the 
months covered by the report— 
(1) with respect to applications filed under sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)) that, during the most recent 
calendar year, were subject to priority review under 
paragraph (11) of such section 505(j) (as added by 
section 801) or expedited development and review 
under section 506H of the Federal Food, Drug, and 
Cosmetic Act (as added by section 803), the num-
bers of such applications (with denotation of such 
applications that were filed prior to October 1, 
2014) that are— 
(A) awaiting action by the applicant; 
(B) awaiting action by the Secretary; and 
(C) approved by the Secretary; 
(2) the number of applications filed under sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)) and prior approval supple-
ments withdrawn in each month; 
(3) the mean and median approval and ten-
tative approval times and the number of review cy-
cles for such applications;
185 
(4) the number and type of meetings requested 
and held under such section 506H (as added by sec-
tion 803); and 
(5) the number of such applications on which 
the Secretary has taken action pursuant to sub-
section (c) of such section 506H (as added by sec-
tion 803) and any effect such section 506H may 
have on the length of time for approval of applica-
tions under such section 505(j) and the number of 
review cycles for such approvals. 
SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG 
DEVELOPMENT. 
Section 505(j)(5) of the Federal Food, Drug, and 
Cosmetic 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 ap-
proved applicant has commenced commercial 
marketing, the application shall be made effec-
tive on the date that is 180 days after the date
186 
of the first commercial marketing of the com-
petitive generic therapy (including the commer-
cial 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): 
‘‘(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 exclusivities on the 
list of products described in section 
505(j)(7)(A) at the time of submis-
sion. 
‘‘(bb) The term ‘first approved appli-
cant’ means any applicant that has sub-
mitted an application that—
187 
‘‘(AA) is for a competitive ge-
neric therapy that is approved on the 
first day on which any application for 
such competitive generic therapy is 
approved; 
‘‘(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-
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 
subparagraph (B)(v) shall be forfeited by a 
first approved 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
188 
applicant’s application for the competitive 
generic therapy is made effective.’’. 
SEC. 809. 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 
following: 
(1) The rate of first cycle approvals and ten-
tative approvals for applications submitted under 
section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) during the period be-
ginning on October 1, 2012, and ending on Sep-
tember 30, 2017. The rate of first cycle approvals 
and tentative approvals shall be determined and re-
ported per each GDUFA cohort year during this pe-
riod. 
(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 ap-
provals for generic drug applications shall be 
itemized, assessed, and reported. In making the as-
sessment required by this paragraph, the Comp-
troller General shall consider, among other things, 
the role played by—
189 
(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 Administra-
tion; 
(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 com-
munication between the Food and Drug Admin-
istration and sponsors of generic drug applica-
tions; and 
(F) the completeness and quality of origi-
nal 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 proc-
190 
ess for generic drugs could be improved to increase 
the rate of first cycle approvals and tentative ap-
provals for generic drug applications. In making this 
determination, the Comptroller General shall con-
sider, among other things, options for increasing re-
view efficiency and communication effectiveness. 
(b) COMPLETION DATE.—Not later than the expira-
tion of the 2-year period beginning on the date of enact-
ment of this Act, the Comptroller General shall complete 
the study under subsection (a) and submit a report de-
scribing the findings and conclusions of the study to the 
Secretary, the Committee on Energy and Commerce of the 
House of Representatives, and the Committee on Health, 
Education, Labor, and Pensions of the Senate. 
(c) DEFINITIONS.—For purposes of this section: 
(1) The term ‘‘GDUFA cohort year’’ means a 
fiscal 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 Fed-
191 
eral 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 
approval of a generic drug application after the 
Food and Drug Administration’s complete review of 
the application and without issuance of one or more 
complete 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 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-
ments) or drug master file that must be satisfac-
torily addressed before the generic drug application 
can be approved. 
TITLE IX—ADDITIONAL 
PROVISIONS 
SEC. 901. TECHNICAL CORRECTIONS. 
(a) Section 3075(a) of the 21st Century Cures Act 
(Public Law 114–255) is amended—
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(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) Section 510(h)(6) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(h)(6)) is amended by strik-
ing ‘‘February 1’’ and replacing with ‘‘May 1’’. 
(f) Effective as of the enactment of the 21st Century 
Cures Act (Public Law 114–255)— 
(1) section 3051(a) of such Act is amended by 
striking ‘‘by inserting after section 515B’’ and in-
serting ‘‘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
193 
by such section 3051(a), is redesignated as section 
515B. 
(g) Section 515B(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e–3(f)(2)), as redesig-
nated by subsection (e)(2) of this section, is amended by 
striking ‘‘a proposed guidance’’ and inserting ‘‘a draft 
version of that guidance’’. 
(h) 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 
‘‘medical devices that may be specifically the subject of 
a review by a classification panel’’. 
SEC. 902. ANNUAL REPORT ON INSPECTIONS. 
Not later than March 1 of each year, the Secretary 
of Health and Human Services shall post on the internet 
website of the Food and Drug Administration information 
related to inspections of facilities necessary for approval 
of a drug under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355), approval of a device 
under section 515 of such Act (21 U.S.C. 360e), or clear-
ance of a device under section 510(k) of such Act (21 
U.S.C. 360(k)) that were conducted during the previous 
calendar year. Such information shall include the fol-
lowing:
194 
(1) The median time following a request from 
staff of the Food and Drug Administration review-
ing an application or report to the beginning of the 
inspection, and the median time from the beginning 
of an inspection to the issuance of a report pursuant 
to section 704(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(b)). 
(2) The median time from the issuance of a re-
port pursuant to such section 704(b) to the sending 
of a warning letter, issuance of an import alert, or 
holding of a regulatory meeting for inspections for 
which the Secretary concluded that regulatory or en-
forcement action was indicated. 
(3) The median time from the sending of a 
warning letter, issuance of an import alert, or hold-
ing of a regulatory meeting to resolution of the regu-
latory or enforcement action indicated for inspec-
tions for which the Secretary concluded that such 
action was indicated. 
(4) The number of times that a facility was 
issued a report pursuant to such section 704(b) and 
approval of an application was delayed due to the 
issuance of a withhold recommendation.