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‘‘(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-
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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-
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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. 
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‘‘(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 
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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 
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‘‘(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, 
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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 
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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 
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‘‘(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-
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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, 
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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; 
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(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 
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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; 
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(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 
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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— 
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‘‘(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 
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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— 
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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-
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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 
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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: 
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(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. 
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SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY 
IN PERFORMANCE REPORTING. 
(a) PDUFA.—Section 736B(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as 
amended by section 103, is further amended by inserting 
after paragraph (2) the following: 
‘‘(3) REAL TIME REPORTING.— 
‘‘(A) IN GENERAL.—Not later than 30 cal-
endar days after the end of the second quarter 
of fiscal year 2018, and not later than 30 cal-
endar days after the end of each quarter of 
each fiscal year thereafter, the Secretary shall 
post the data described in subparagraph (B) on 
the internet website of the Food and Drug Ad-
ministration for such quarter and on a cumu-
lative basis for such fiscal year, and may re-
move duplicative data from the annual perform-
ance report under this subsection. 
‘‘(B) DATA.—The Secretary shall post the 
following data in accordance with subparagraph 
(A): 
‘‘(i) The number and titles of draft 
and final guidance on topics related to the 
process for the review of human drug ap-
plications, and whether such guidances 
were issued as required by statute or pur-
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suant to a commitment under the letters 
described in section 101(b) of the Prescrip-
tion Drug User Fee Amendments of 2017. 
‘‘(ii) The number and titles of public 
meetings held on topics related to the proc-
ess for the review of human drug applica-
tions, and whether such meetings were re-
quired by statute or pursuant to a commit-
ment under the letters described in section 
101(b) of the Prescription Drug User Fee 
Amendments of 2017. 
‘‘(iii) The number of new drug appli-
cations and biological licensing applications 
approved. 
‘‘(iv) The number of new drug appli-
cations and biological licensing applications 
filed. 
‘‘(4) 
RATIONALE
FOR
PDUFA
PROGRAM 
CHANGES.—Beginning with fiscal year 2020, the 
Secretary shall include in the annual report under 
paragraph (1)— 
‘‘(A) data, analysis, and discussion of the 
changes in the number of full-time equivalents 
hired as agreed upon in the letters described in 
section 101(b) of the Prescription Drug User 
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Fee Amendments of 2017 and the number of 
full time equivalents funded by budget authority 
at the Food and Drug Administration by each 
division within the Center for Drug Evaluation 
and Research, the Center for Biologics Evalua-
tion and Research, the Office of Regulatory Af-
fairs, and the Office of the Commissioner; 
‘‘(B) data, analysis, and discussion of the 
changes in the fee revenue amounts and costs 
for the process for the review of human drugs, 
including identifying drivers of such changes; 
and 
‘‘(C) for each of the Center for Drug Eval-
uation and Research, the Center for Biologics 
Evaluation and Research, the Office of Regu-
latory Affairs, and the Office of the Commis-
sioner, the number of employees for whom time 
reporting is required and the number of em-
ployees for whom time reporting is not re-
quired.’’. 
(b) MDUFA.—Section 738A(a)(1)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
1(a)(1)(A)), as amended by section 204, is further amend-
ed— 
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(1) by striking ‘‘Beginning with’’ and inserting 
the following: 
‘‘(i) GENERAL
REQUIREMENTS.—Be-
ginning with’’; and 
(2) by adding at the end the following: 
‘‘(ii) ADDITIONAL
INFORMATION.— 
Beginning with fiscal year 2018, the an-
nual report under this subparagraph shall 
include the progress of the Center for De-
vices and Radiological Health in achieving 
the goals, and future plans for meeting the 
goals, including— 
‘‘(I) the number of premarket ap-
plications filed under section 515 per 
fiscal year for each review division; 
‘‘(II) the number of reports sub-
mitted under section 510(k) per fiscal 
year for each review division; and 
‘‘(III) the number of expedited 
development and priority review des-
ignations under section 515C per fis-
cal year. 
‘‘(iii) REAL TIME REPORTING.— 
‘‘(I) IN
GENERAL.—Not later 
than 30 calendar days after the end of 
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the second quarter of fiscal year 
2018, and not later than 30 calendar 
days after the end of each quarter of 
each fiscal year thereafter, the Sec-
retary shall post the data described in 
subclause (II) on the internet website 
of the Food and Drug Administration 
for such quarter and on a cumulative 
basis for such fiscal year, and may re-
move duplicative data from the annual 
report under this subparagraph. 
‘‘(II) DATA.—The Secretary shall 
post the following data in accordance 
with subclause (I): 
‘‘(aa) The number and titles 
of draft and final guidance on 
topics related to the process for 
the review of devices, and wheth-
er such guidances were issued as 
required by statute or pursuant 
to the letters described in section 
201(b) of the Medical Device 
User Fee Amendments of 2017; 
and 
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‘‘(bb) The number and titles 
of public meetings held on topics 
related to the process for the re-
view of devices, and if such meet-
ings were required by statute or 
pursuant to a commitment under 
the letters described in section 
201(b) of the Medical Device 
User Fee Amendments of 2017. 
‘‘(iv) RATIONALE
FOR
MDUFA
PRO-
GRAM
CHANGES.—Beginning with fiscal 
year 2020, the Secretary shall include in 
the annual report under paragraph (1)— 
‘‘(I) data, analysis, and discus-
sion of the changes in the number of 
full-time equivalents hired as agreed 
upon in the letters described in sec-
tion 201(b) of the Medical Device 
User Fee Amendments of 2017 and 
the number of full time equivalents 
funded by budget authority at the 
Food and Drug Administration by 
each division within the Center for 
Devices and Radiological Health, the 
Center for Biologics Evaluation and 
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Research, the Office of Regulatory Af-
fairs, and the Office of the Commis-
sioner; 
‘‘(II) data, analysis, and discus-
sion of the changes in the fee revenue 
amounts and costs for the process for 
the review of devices, including identi-
fying drivers of such changes; and 
‘‘(III) for each of the Center for 
Devices and Radiological Health, the 
Center for Biologics Evaluation and 
Research, the Office of Regulatory Af-
fairs, and the Office of the Commis-
sioner, the number of employees for 
whom time reporting is required and 
the number of employees for whom 
time reporting is not required.’’. 
(c) GDUFA.—Section 744C(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as 
amended by section 304, is further amended— 
(1) by striking ‘‘Beginning with’’ and inserting 
the following: 
‘‘(1) 
GENERAL
REQUIREMENTS.—Beginning 
with’’; and 
(2) by adding at the end the following: 
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‘‘(2) REAL TIME REPORTING.— 
‘‘(A) IN GENERAL.—Not later than 30 cal-
endar days after the end of the second quarter 
of fiscal year 2018, and not later than 30 cal-
endar days after the end of each quarter of 
each fiscal year thereafter, the Secretary shall 
post the data described in subparagraph (B) on 
the internet website of the Food and Drug Ad-
ministration, and may remove duplicative data 
from the annual report under this subsection. 
‘‘(B) DATA.—The Secretary shall post the 
following data in accordance with subparagraph 
(A): 
‘‘(i) The number and titles of draft 
and final guidance on topics related to 
human generic drug activities and whether 
such guidances were issued as required by 
statute or pursuant to a commitment 
under the letters described in section 
301(b) of the Generic Drug User Fee 
Amendments of 2017. 
‘‘(ii) The number and titles of public 
meetings held on topics related to human 
generic drug activities and whether such 
meetings were required by statute or pur-
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suant to a commitment under the letters 
described in section 301(b) of the Generic 
Drug User Fee Amendments of 2017. 
‘‘(3) 
RATIONALE
FOR
GDUFA
PROGRAM 
CHANGES.—Beginning with fiscal year 2020, the 
Secretary shall include in the annual report under 
paragraph (1)— 
‘‘(A) data, analysis, and discussion of the 
changes in the number of full-time equivalents 
hired as agreed upon in the letters described in 
section 301(b) of the Generic Drug User Fee 
Amendments of 2017 and the number of full 
time equivalents funded by budget authority at 
the Food and Drug Administration by each di-
vision within the Center for Drug Evaluation 
and Research, the Center for Biologics Evalua-
tion and Research, the Office of Regulatory Af-
fairs, and the Office of the Commissioner; 
‘‘(B) data, analysis, and discussion of the 
changes in the fee revenue amounts and costs 
for human generic drug activities, including 
identifying drivers of such changes; and 
‘‘(C) for each of the Center for Drug Eval-
uation and Research, the Center for Biologics 
Evaluation and Research, the Office of Regu-
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latory Affairs, and the Office of the Commis-
sioner, the number of employees for whom time 
reporting is required and the number of em-
ployees for whom time reporting is not re-
quired.’’. 
(d) BSUFA.—Section 744I(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)), as 
amended by section 404, is further amended— 
(1) by striking ‘‘Beginning with’’ and inserting 
the following: 
‘‘(1) 
GENERAL
REQUIREMENTS.—Beginning 
with’’; and 
(2) by adding at the end the following: 
‘‘(2) ADDITIONAL
INFORMATION.—Beginning 
with fiscal year 2018, the report under this sub-
section shall include the progress of the Food and 
Drug Administration in achieving the goals, and fu-
ture plans for meeting the goals, including— 
‘‘(A) information on all previous cohorts 
for which the Secretary has not given a com-
plete response on all biosimilar biological prod-
uct applications and supplements in the cohort; 
‘‘(B) the number of original biosimilar bio-
logical product applications filed per fiscal year, 
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and the number of approvals issued by the 
agency for such applications; and 
‘‘(C) the number of resubmitted original 
biosimilar biological product applications filed 
per fiscal year and the number of approvals let-
ters issued by the agency for such applications. 
‘‘(3) REAL TIME REPORTING.— 
‘‘(A) IN GENERAL.—Not later than 30 cal-
endar days after the end of the second quarter 
of fiscal year 2018, and not later than 30 cal-
endar days after the end of each quarter of 
each fiscal year thereafter, the Secretary shall 
post the data described in subparagraph (B) for 
such quarter and on a cumulative basis for the 
fiscal year on the internet website of the Food 
and Drug Administration, and may remove du-
plicative data from the annual report under this 
subsection. 
‘‘(B) DATA.—The Secretary shall post the 
following data in accordance with subparagraph 
(A): 
‘‘(i) The number and titles of draft 
and final guidance on topics related to the 
process for the review of biosimilars, and 
whether such guidances were required by 
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statute or pursuant to a commitment 
under the letters described in section 
401(b) of the Biosimilar User Fee Amend-
ments of 2017. 
‘‘(ii) The number and titles of public 
meetings held on topics related to the proc-
ess for the review of biosimilars, and 
whether such meetings were required by 
statute or pursuant to a commitment 
under the letters described in section 
401(b) of the Biosimilar User Fee Amend-
ments of 2017. 
‘‘(4) 
RATIONALE
FOR
BSUFA
PROGRAM 
CHANGES.—Beginning with fiscal year 2020, the 
Secretary shall include in the annual report under 
paragraph (1)— 
‘‘(A) data, analysis, and discussion of the 
changes in the number of full-time equivalents 
hired as agreed upon in the letters described in 
section 401(b) of the Biosimilar User Fee 
Amendments of 2017 and the number of full 
time equivalents funded by budget authority at 
the Food and Drug Administration by each di-
vision within the Center for Drug Evaluation 
and Research, the Center for Biologics Evalua-
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tion and Research, the Office of Regulatory Af-
fairs, and the Office of the Commissioner; 
‘‘(B) data, analysis, and discussion of the 
changes in the fee revenue amounts and costs 
for the process for the review of biosimilar bio-
logical product applications, including identi-
fying drivers of such changes; and 
‘‘(C) for each of the Center for Drug Eval-
uation and Research, the Center for Biologics 
Evaluation and Research, the Office of Regu-
latory Affairs, and the Office of the Commis-
sioner, the number of employees for whom time 
reporting is required and the number of em-
ployees for whom time reporting is not re-
quired.’’. 
SEC. 904. ANALYSIS OF USE OF FUNDS. 
(a) PDUFA REPORTS.— 
(1) ANALYSIS
IN
PDUFA
PERFORMANCE
RE-
PORTS.—Section 736B(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as 
amended by section 903(a), is further amended by 
adding at the end the following: 
‘‘(5) ANALYSIS.—For each fiscal year, the Sec-
retary shall include in the report under paragraph 
(1) an analysis of the following: 
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‘‘(A) The difference between the aggregate 
number of human drug applications filed and 
the aggregate number of approvals, accounting 
for— 
‘‘(i) such applications filed during one 
fiscal year for which a decision is not 
scheduled to be made until the following 
fiscal year; 
‘‘(ii) the aggregate number of applica-
tions for each fiscal year that did not meet 
the goals identified in the letters described 
in section 101(b) of the Prescription Drug 
User Fee Amendments of 2017 for the ap-
plicable fiscal year. 
‘‘(B) Relevant data to determine whether 
the Center for Drug Evaluation and Research 
and the Center for Biologics Evaluation and 
Research have met performance enhancement 
goals identified in the letters described in sec-
tion 101(b) of the Prescription Drug User Fee 
Amendments of 2017 for the applicable fiscal 
year. 
‘‘(C) The most common causes and trends 
of external or other circumstances affecting the 
ability of the Center for Drug Evaluation and 
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Research, the Center for Biologics Evaluation 
and Research, Office of Regulatory Affairs, and 
the Food and Drug Administration to meet the 
review time and performance enhancement 
goals identified in the letters described in sec-
tion 101(b) of the Prescription Drug User Fee 
Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
RE-
PORTS.—Section 736B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h–2) is amended— 
(A) by redesignating subsections (c) and 
(d) as subsections (e) and (f), respectively; and 
(B) by inserting after subsection (b) the 
following: 
‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 
fiscal year 2018, for each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and 
submit a corrective action report to the Committee on En-
ergy and Commerce and the Committee on Appropriations 
of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate. The report shall 
include the following information, as applicable: 
‘‘(1) GOALS MET.—For each fiscal year, if the 
Secretary determines, based on the analysis under 
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subsection (a)(5), that each of the goals identified in 
the letters described in section 101(b) of the Pre-
scription Drug User Fee Amendments of 2017 for 
the applicable fiscal year have been met, the correc-
tive action report shall include recommendations on 
ways in which the Secretary can improve and 
streamline the human drug application review proc-
ess. 
‘‘(2) GOALS
MISSED.—For any of the goals 
identified in the letters described in section 101(b) 
of the Prescription Drug User Fee Amendments of 
2017 for the applicable fiscal year that the Secretary 
determines to not have been met, the corrective ac-
tion report shall include— 
‘‘(A) a detailed justification for such deter-
mination and a description, as applicable, of the 
types of circumstances and trends under which 
human drug applications that missed the review 
goal time were approved during the first cycle 
review, or application review goals were missed; 
and 
‘‘(B) with respect to performance enhance-
ment goals that were not achieved, a description 
of efforts the Food and Drug Administration 
has put in place for the fiscal year in which the 
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report is submitted to improve the ability of 
such agency to meet each such goal for the 
such fiscal year. 
‘‘(d) ENHANCED COMMUNICATION.— 
‘‘(1) COMMUNICATIONS
WITH
CONGRESS.— 
Each fiscal year, as applicable and requested, rep-
resentatives from the Centers with expertise in the 
review of human drugs shall meet with representa-
tives from the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives to report on the contents described 
in the reports under this section. 
‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR-
ING.—Each fiscal year, as applicable and requested, 
representatives from the Food and Drug Adminis-
tration shall participate in a public hearing before 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representa-
tives, to report on the contents described in the re-
ports under this section. Such hearing shall occur 
not later than 120 days after the end of each fiscal 
year for which fees are collected under this part.’’. 
(b) MDUFA REPORTS.— 
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(1) ANALYSIS
IN
MDUFA
PERFORMANCE
RE-
PORTS.—Section 738A(a)(1)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
1(a)(1)(A)), as amended by section 903(b), is fur-
ther amended by adding at the end the following: 
‘‘(iv) 
ANALYSIS.—For 
each 
fiscal 
year, the Secretary shall include in the re-
port under clause (i) an analysis of the fol-
lowing: 
‘‘(I) The difference between the 
aggregate number of premarket appli-
cations filed under section 515 and 
aggregate reports submitted under 
section 510(k) and the aggregate 
number of major deficiency letters, 
not approvable letters, and denials for 
such applications issued by the agen-
cy, accounting for— 
‘‘(aa) the number of applica-
tions filed and reports submitted 
during one fiscal year for which a 
decision is not scheduled to be 
made until the following fiscal 
year; and 
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‘‘(bb) the aggregate number 
of applications for each fiscal 
year that did not meet the goals 
as identified by the letters de-
scribed in section 201(b) of the 
Medical Device User Fee Amend-
ments of 2017 for the applicable 
fiscal year. 
‘‘(II) Relevant data to determine 
whether the Center for Devices and 
Radiological Health has met perform-
ance enhancement goals identified by 
the letters described in section 201(b) 
of the Medical Device User Fee 
Amendments of 2017 for the applica-
ble fiscal year. 
‘‘(III) The most common causes 
and trends for external or other cir-
cumstances affecting the ability of the 
Center for Devices and Radiological 
Health, the Office of Regulatory Af-
fairs, or the Food and Drug Adminis-
tration to meet review time and per-
formance enhancement goals identi-
fied by the letters described in section 
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201(b) of the Medical Device User 
Fee Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
RE-
PORTS.—Section 738A(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is 
amended— 
(A) by redesignating paragraphs (2) and 
(3) as paragraphs (4) and (5), respectively; and 
(B) by inserting after paragraph (1) the 
following: 
‘‘(2) CORRECTIVE ACTION REPORT.—Beginning 
with fiscal year 2018, for each fiscal year for which 
fees are collected under this part, the Secretary shall 
prepare and submit a corrective action report to the 
Committee on Energy and Commerce and the Com-
mittee on Appropriations of the House of Represent-
atives and the Committee on Health, Education, 
Labor, and Pensions and the Committee on Appro-
priations of the Senate. The report shall include the 
following information, as applicable: 
‘‘(A) GOALS MET.—For each fiscal year, if 
the Secretary determines, based on the analysis 
under paragraph (1)(A)(iv), that each of the 
goals identified by the letters described in sec-
tion 201(b) of the Medical Device User Fee 
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Amendments of 2017 for the applicable fiscal 
year have been met, the corrective action report 
shall include recommendations on ways in which 
the Secretary can improve and streamline the 
medical device application review process. 
‘‘(B) GOALS
MISSED.—For each of the 
goals identified by the letters described in sec-
tion 201(b) of the Medical Device User Fee 
Amendments of 2017 for the applicable fiscal 
year that the Secretary determines to not have 
been met, the corrective action report shall in-
clude— 
‘‘(i) a justification for such determina-
tion; 
‘‘(ii) a description of the types of cir-
cumstances, in the aggregate, under which 
applications or reports submitted under 
section 515 or notifications submitted 
under section 510(k) missed the review 
goal times but were approved during the 
first cycle review, as applicable; 
‘‘(iii) a summary and any trends with 
regard to the circumstances for which a re-
view goal was missed; and 
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‘‘(iv) the performance enhancement 
goals that were not achieved during the 
previous fiscal year and a description of ef-
forts the Food and Drug Administration 
has put in place for the fiscal year in 
which the report is submitted to improve 
the ability of such agency to meet each 
such goal for the such fiscal year. 
‘‘(3) ENHANCED COMMUNICATION.— 
‘‘(A) 
COMMUNICATIONS
WITH
CON-
GRESS.—Each fiscal year, as applicable and re-
quested, representatives from the Centers with 
expertise in the review of devices shall meet 
with representatives from the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives to report 
on the contents described in the reports under 
this section. 
‘‘(B) PARTICIPATION
IN
CONGRESSIONAL 
HEARING.—Each fiscal year, as applicable and 
requested, representatives from the Food and 
Drug Administration shall participate in a pub-
lic hearing before the Committee on Health, 
Education, Labor, and Pensions of the Senate 
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and the Committee on Energy and Commerce 
of the House of Representatives, to report on 
the contents described in the reports under this 
section. Such hearing shall occur not later than 
120 days after the end of each fiscal year for 
which fees are collected under this part.’’. 
(c) GDUFA REPORTS.— 
(1) ANALYSIS
IN
GDUFA
PERFORMANCE
RE-
PORTS.—Section 744C(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as 
amended by section 903(c) is further amended by 
adding at the end the following: 
‘‘(4) ANALYSIS.—For each fiscal year, the Sec-
retary shall include in the report an analysis of the 
following: 
‘‘(A) The difference between the aggregate 
number of abbreviated new drug applications 
filed and the aggregate number of approvals or 
aggregate number of complete response letters 
issued by the agency, accounting for— 
‘‘(i) such applications filed during one 
fiscal year for which a decision is not 
scheduled to be made until the following 
fiscal year; and 
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‘‘(ii) the aggregate number of applica-
tions for each fiscal year that did not meet 
the goals identified by the letters described 
in section 301(b) of the Generic Drug User 
Fee Amendments of 2017 for the applica-
ble fiscal year. 
‘‘(B) Relevant data to determine whether 
the Food and Drug Administration has met the 
performance enhancement goals identified by 
the letters described in section 301(b) of the 
Generic Drug User Fee Amendments of 2017 
for the applicable fiscal year. 
‘‘(C) The most common causes and trends 
for external or other circumstances that af-
fected the ability of the Secretary to meet re-
view time and performance enhancement goals 
identified by the letters described in section 
301(b) of the Generic Drug User Fee Amend-
ments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
RE-
PORTS.—Section 744C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–43) is amend-
ed— 
(A) by redesignating subsections (c) and 
(d) as subsections (e) and (f), respectively; and 
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(B) by inserting after subsection (b) the 
following: 
‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 
fiscal year 2018, for each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and 
submit a corrective action report to the Committee on En-
ergy and Commerce and the Committee on Appropriations 
of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate. The report shall 
include the following information, as applicable: 
‘‘(1) GOALS MET.—For each fiscal year, if the 
Secretary determines, based on the analysis under 
subsection (a)(4), that each of the goals identified by 
the letters described in section 301(b) of the Generic 
Drug User Fee Amendments of 2017 for the appli-
cable fiscal year have been met, the corrective action 
report shall include recommendations on ways in 
which the Secretary can improve and streamline the 
abbreviated new drug application review process. 
‘‘(2) GOALS MISSED.—For each of the goals 
identified by the letters described in section 301(b) 
of the Generic Drug User Fee Amendments of 2017 
for the applicable fiscal year that the Secretary de-
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termines to not have been met, the corrective action 
report shall include— 
‘‘(A) a detailed justification for such deter-
mination and a description, as applicable, of the 
types of circumstances and trends under which 
abbreviated new drug applications missed the 
review goal times but were approved during the 
first cycle review, or review goals were missed; 
and 
‘‘(B) with respect to performance enhance-
ment goals that were not achieved, a detailed 
description of efforts the Food and Drug Ad-
ministration has put in place for the fiscal year 
in which the report is submitted to improve the 
ability of such agency to meet each such goal 
for the such fiscal year. 
‘‘(d) ENHANCED COMMUNICATION.— 
‘‘(1) COMMUNICATIONS
WITH
CONGRESS.— 
Each fiscal year, as applicable and requested, rep-
resentatives from the Centers with expertise in the 
review of human drugs shall meet with representa-
tives from the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
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Representatives to report on the contents described 
in the reports under this section. 
‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR-
ING.—Each fiscal year, as applicable and requested, 
representatives from the Food and Drug Adminis-
tration shall participate in a public hearing before 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representa-
tives, to report on the contents described in the re-
ports under this section. Such hearing shall occur 
not later than 120 days after the end of each fiscal 
year for which fees are collected under this part.’’. 
(d) BSUFA REPORTS.— 
(1) ANALYSIS
IN
BSUFA
PERFORMANCE
RE-
PORTS.—Section 744I(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–53(a)) as amend-
ed by section 903(d) is further amended by adding 
at the end the following: 
‘‘(5) ANALYSIS.—For each fiscal year, the Sec-
retary shall include in the report an analysis of the 
following: 
‘‘(A) The difference between the aggregate 
number of biosimilar biological product applica-
tions and supplements filed and the aggregate 
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number of approvals issued by the agency, ac-
counting for— 
‘‘(i) such applications filed during one 
fiscal year for which a decision is not 
scheduled to be made until the following 
fiscal year; and 
‘‘(ii) the aggregate number of applica-
tions for each fiscal year that did not meet 
the goals identified by the letters described 
in section 401(b) of the Biosimilar User 
Fee Amendments of 2017 for the applica-
ble fiscal year. 
‘‘(B) Relevant data to determine whether 
the Center for Drug Evaluation and Research 
and the Center for Biologics Evaluation and 
Research have met the performance enhance-
ment goals identified by the letters described in 
section 401(b) of the Biosimilar User Fee 
Amendments of 2017 for the applicable fiscal 
year. 
‘‘(C) The most common causes and trends 
for external or other circumstances affecting 
the ability of the Secretary to meet review time 
and performance enhancement goals identified 
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by the letters described in section 401(b) of the 
Biosimilar User Fee Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
RE-
PORTS.—Section 744I of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–53), as amended 
by section 404, is further amended— 
(A) by redesignating subsections (c) and 
(d) as subsections (e) and (f), respectively; and 
(B) by inserting after subsection (b) the 
following: 
‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 
fiscal year 2018, and for each fiscal year for which fees 
are collected under this part, the Secretary shall prepare 
and submit a corrective action report to the Committee 
on Energy and Commerce and Committee on Appropria-
tions of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions and Com-
mittee on Appropriations of the Senate. The report shall 
include the following information, as applicable: 
‘‘(1) GOALS MET.—For each fiscal year, if the 
Secretary determines, based on the analysis under 
subsection (a)(5), that each of the goals identified by 
the letters described in section 401(b) of the Bio-
similar User Fee Amendments of 2017 for the appli-
cable fiscal year have been met, the corrective action 
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report shall include recommendations on ways in 
which the Secretary can improve and streamline the 
biosimilar biological product application review proc-
ess. 
‘‘(2) GOALS MISSED.—For each of the goals 
identified by the letters described in section 401(b) 
of the Biosimilar User Fee Amendments of 2017 for 
the applicable fiscal year that the Secretary deter-
mines to not have been met, the corrective action re-
port shall include— 
‘‘(A) a justification for such determination 
and a description of the types of circumstances 
and trends, as applicable, under which bio-
similar biological product applications missed 
the review goal times but were approved during 
the first cycle review, or review goals were 
missed; and 
‘‘(B) with respect to performance enhance-
ment goals that were not achieved, a description 
of efforts the Food and Drug Administration 
has put in place for the fiscal year in which the 
report is submitted to improve the ability of 
such agency to meet each such goal for the 
such fiscal year. 
‘‘(d) ENHANCED COMMUNICATION.— 
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‘‘(1) COMMUNICATIONS
WITH
CONGRESS.— 
Each fiscal year, as applicable and requested, rep-
resentatives from the Centers with expertise in the 
review of human drugs shall meet with representa-
tives from the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives to report on the contents described 
in the reports under this section. 
‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR-
ING.—Each fiscal year, as applicable and requested, 
representatives from the Food and Drug Adminis-
tration shall participate in a public hearing before 
the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on En-
ergy and Commerce of the House of Representa-
tives, to report on the contents described in the re-
ports under this section. Such hearing shall occur 
not later than 120 days after the end of each fiscal 
year for which fees are collected under this part.’’. 
SEC. 905. FACILITIES MANAGEMENT. 
(a) EVALUATION.— 
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study on the expenses 
incurred by the Food and Drug Administration re-
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lated to facility maintenance and renovation in fiscal 
years 2012 through 2019. The study under this 
paragraph shall include the following: 
(A) A review of purchases and expenses 
differentiated by appropriated funds, and re-
sources authorized by the Food and Drug Ad-
ministration Safety and Innovation Act (Public 
Law 112–144) and this Act, as applicable, that 
contributed to— 
(i) the maintenance of scientific equip-
ment and any existing facility plan or 
plans to maintain previously purchased sci-
entific equipment; 
(ii) the renovation of facilities in the 
Center for Drug Evaluation and Research, 
the Center for Biologics Evaluation and 
Research, and the Center for Devices and 
Radiological Health, and the purpose of 
such renovation including the need for the 
renovation; 
(iii) the assets purchased or repaired 
under the ‘‘repair of facilities and acquisi-
tion’’ authority under parts 2, 3, 7, and 8 
of subchapter C of chapter VII of the Fed-
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eral Food, Drug, and Cosmetic Act (21 
U.S.C. 379f et seq.); 
(iv) the maintenance and repair of fa-
cilities and fixtures, including a description 
of any unanticipated repairs and mainte-
nance as well as scheduled repairs mainte-
nance, and the budget plan for the sched-
uled or anticipated maintenance; 
(v) the acquisition of furniture, a de-
scription of the furniture purchased, and 
the purpose of the furniture including pur-
chases for the Center for Drug Evaluation 
and Research, the Center for Biologics 
Evaluation and Research, and the Center 
for Devices and Radiological Health; and 
(vi) the acquisition of other necessary 
materials and supplies by product category 
under the authority under parts 2, 3, 7, 
and 8 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379f et seq.). 
(B) An analysis of the Food and Drug Ad-
ministration’s ability to further its public health 
mission and review medical products by incur-
ring the expenses listed in clauses (i) through 
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(vi) of subparagraph (A). In conducting the 
analysis, the Comptroller General shall request 
information from and consult with appropriate 
employees, including staff and those responsible 
for the fiscal decisions regarding facility main-
tenance and renovation for the agency. 
(2) REPORT.— 
(A) IN GENERAL.—The Comptroller Gen-
eral shall issue a report to the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives not later 
than July 30, 2020, containing the results of 
the study under paragraph (1). 
(B) RECOMMENDATIONS.—As part of the 
report under this paragraph, the Comptroller 
General may provide recommendations, as ap-
plicable, on methods through which the Food 
and Drug Administration may improve plan-
ning for— 
(i) the maintenance, renovation, and 
repair of facilities; 
(ii) the purchase of furniture or other 
acquisitions; and 
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(iii) ways the Food and Drug Admin-
istration may allocate the expenses de-
scribed in clauses (i) and (ii) of paragraph 
(1)(A), as informed by the analysis under 
paragraph (1)(B). 
(b) ADMINISTRATION.— 
(1) PDUFA.—Section 736(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) 
is amended by adding at the end the following: 
‘‘(3) LIMITATION.—Beginning on October 1, 
2023, the authorities under section 735(7)(C) shall 
include only expenditures for leasing and necessary 
scientific equipment.’’. 
(2) MDUFA.—Section 738(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) 
is amended by adding at the end the following: 
‘‘(3) LIMITATION.—Beginning on October 1, 
2023, the authorities under section 737(9)(C) shall 
include only leasing and necessary scientific equip-
ment.’’. 
(3) GDUFA.—Section 744B(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
42(e)) is amended— 
(A) in the subsection heading, by striking 
‘‘LIMIT’’ and inserting ‘‘LIMITATIONS’’; 
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(B) by striking ‘‘The total amount’’ and 
inserting the following: 
‘‘(1) IN GENERAL.—The total amount’’; and 
(C) by adding at the end the following: 
‘‘(2) LEASING AND NECESSARY EQUIPMENT.— 
Beginning on October 1, 2023, the authorities under 
section 744A(11)(C) shall include only leasing and 
necessary scientific equipment.’’. 
(4) BSUFA.—Section 744H(e)(2)(B) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–52(e)(2)(B)) is amended— 
(A) in the subparagraph heading, by strik-
ing ‘‘LIMITATION’’ and inserting ‘‘LIMITA-
TIONS’’; 
(B) by striking ‘‘The fees authorized’’ and 
inserting the following: 
‘‘(i) IN GENERAL.—The fees author-
ized’’; and 
(C) by adding at the end the following: 
‘‘(ii) 
LEASING
AND
NECESSARY 
EQUIPMENT.—Beginning on October 1, 
2023, 
the 
authorities 
under 
section 
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744G(9)(C) shall include only leasing and 
necessary scientific equipment.’’. 
Passed the House of Representatives July 12, 2017. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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Calendar No. 174 
115TH CONGRESS 
1ST SESSION 
H. R. 2430 
AN ACT 
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 17, 2017 
Read the second time and placed on the calendar 
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