H. R. 2430—67 
including drugs on the discontinued section of such list) that 
is— 
‘‘(A) the reference listed drug; or 
‘‘(B) a generic drug with the same reference listed 
drug as the drug for which designation as a competitive 
generic therapy is sought. 
‘‘(3) The term ‘reference listed drug’ means the listed drug 
(as such term is used in section 505(j)) for the drug involved.’’. 
(b) GUIDANCE; AMENDED REGULATIONS.— 
(1) IN GENERAL.— 
(A) ISSUANCE.—The Secretary of Health and Human 
Services shall— 
(i) not later than 18 months after the date of 
enactment of this Act, issue draft guidance on section 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comment period for the draft guidance, issue final guid-
ance on such section 506H. 
(B) CONTENTS.—The guidance issued under this para-
graph shall— 
(i) specify the process and criteria by which the 
Secretary makes a designation under section 506H of 
the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (a); 
(ii) specify the actions the Secretary may take 
to expedite the development and review of a competi-
tive 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 applica-
tion 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 prac-
ticable but not 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 propri-
etary name, if any; 
‘‘(3) new drug application number or abbreviated applica-
tion 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.
H. R. 2430—68 
‘‘(b) NOTIFICATION OF DRUG NOT AVAILABLE FOR SALE.—The 
holder of an application approved under subsection (c) or (j) shall 
notify the Secretary in writing within 180 calendar days of the 
date of approval of the drug if the drug will not be available 
for sale within 180 calendar days of such date of approval. The 
holder shall include with such notice the— 
‘‘(1) identity of the drug by established name and by propri-
etary name, if any; 
‘‘(2) new drug application number or abbreviated applica-
tion number; 
‘‘(3) strength of the drug; 
‘‘(4) date on which the drug will be available for sale, 
if known; and 
‘‘(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 section 505 shall review 
the information in the list published under subsection 505(j)(7)(A) 
and shall notify the Secretary 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 holder of an 
approved application fails to submit the information required under 
subsection (a), (b), or (c), the Secretary 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 determines 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 information provided 
under subsections (a), (b), and (c) by moving drugs that are not 
available for sale from the active 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 requirement under section 
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
H. R. 2430—69 
355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regu-
lations, 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 section 
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 substantive 
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 imple-
ment a protocol for expediting review of timely responses to reports 
of observations from an inspection under section 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall— 
(1) apply to responses to such reports pertaining to applica-
tions 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 remedi-
ation of conditions identified in the report; 
(B) for which concerns related to observations 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 section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
that reference 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 appro-
priate; and 
(3) establish a 6-month timeline for completion of review 
of such responses to such reports. 
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS 
AND PRIORITY REVIEW APPLICATIONS. 
Not later than 180 calendar days after the date of enactment 
of this Act, and quarterly thereafter until October 1, 2022, the 
Secretary of Health and Human Services 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 section 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 numbers 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
H. R. 2430—70 
(C) approved by the Secretary; 
(2) the number of applications filed under section 505(j) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
and prior approval supplements withdrawn in each month; 
(3) the mean and median approval and tentative approval 
times and the number of review cycles for such applications; 
(4) the number and type of meetings requested and held 
under such section 506H (as added by section 803); and 
(5) the number of such applications on which the Secretary 
has taken action pursuant to subsection (c) of such section 
506H (as added by section 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 DEVELOP-
MENT. 
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 COMPETITIVE GENERIC 
THERAPIES.— 
‘‘(I) 
EFFECTIVENESS
OF
APPLICATION.—Subject 
to 
subparagraph (D)(iv), if the application is for a drug that 
is the same as a competitive generic therapy for which 
any first approved applicant has commenced commercial 
marketing, the application shall be made effective on the 
date that is 180 days after the date of the first commercial 
marketing of the competitive generic therapy (including 
the commercial marketing of the listed drug) by any first 
approved applicant. 
‘‘(II) LIMITATION.—The exclusivity period under sub-
clause (I) shall not apply with respect to a competitive 
generic therapy that has previously received an exclusivity 
period under subclause (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 section 506H; and 
‘‘(BB) for which there are no unexpired patents 
or exclusivities on the list of products described 
in section 505(j)(7)(A) at the time of submission. 
‘‘(bb) The term ‘first approved applicant’ means 
any applicant that has submitted an application that— 
‘‘(AA) is for a competitive generic therapy that 
is approved on the first day on which any applica-
tion 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 
generic therapy; and 
‘‘(CC) is not for a drug for which all drug 
versions have forfeited eligibility for a 180-day
H. R. 2430—71 
exclusivity period under clause (iv) pursuant to 
subparagraph (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 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 tentative approvals 
for applications submitted under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the 
period beginning on October 1, 2012, and ending on September 
30, 2017. The rate of first cycle approvals and tentative 
approvals shall be determined and reported per each GDUFA 
cohort year during this period. 
(2) If the rate determined pursuant to paragraph (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 approvals for generic drug applications shall be 
itemized, assessed, and reported. In making the assessment 
required by this paragraph, the Comptroller General shall con-
sider, among other things, the role played by— 
(A) the Food and Drug Administration’s implementa-
tion of approval standards for generic drug applications; 
(B) the extent to which those approval standards are 
communicated clearly to industry and applied consistently 
during the review process; 
(C) the procedures for reviewing generic drug applica-
tions, including timelines for review activities by the Food 
and Drug Administration; 
(D) the extent to which those procedures are followed 
consistently (and those timelines are met) by the Food 
and Drug Administration; 
(E) the processes and practices for communication 
between the Food and Drug Administration and sponsors 
of generic drug applications; and 
(F) the completeness and quality of original generic 
drug applications submitted to the Food and Drug Adminis-
tration. 
(3) Taking into account the determinations made pursuant 
to paragraphs (1) and (2) and any review process improvements 
implemented pursuant to this Act, whether there are ways 
the review process for generic drugs could be improved to 
increase the rate of first cycle approvals and tentative approvals 
for generic drug applications. In making this determination, 
the Comptroller General shall consider, among other things, 
options for increasing review efficiency and communication 
effectiveness.
H. R. 2430—72 
(b) COMPLETION DATE.—Not later than the expiration of the 
2-year period beginning on the date of enactment of this Act, 
the Comptroller General shall complete the study under subsection 
(a) and submit a report describing the findings and conclusions 
of the study to the Secretary, the Committee on Energy and Com-
merce 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 abbre-
viated new drug application for the approval of a generic drug 
under section 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)). 
(4) The term ‘‘Secretary’’ means the Secretary of Health 
and Human Services. 
(5)(A) The term ‘‘first cycle approvals and tentative 
approvals’’ means the approval or tentative approval of a 
generic drug application after the Food and Drug Administra-
tion’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 communication 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 
deficiencies that the Administration has identified in the 
generic drug application (including pending amendments) or 
drug master file that must be satisfactorily 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— 
(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 Cos-
metic 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 striking ‘‘February 1’’ 
and replacing with ‘‘May 1’’. 
(f) Effective as of the enactment of the 21st Century Cures 
Act (Public Law 114–255)—
H. R. 2430—73 
(1) section 3051(a) of such Act is amended by striking 
‘‘by inserting after section 515B’’ and inserting ‘‘by inserting 
after section 515A’’; and 
(2) section 515C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e–3), as inserted by such section 3051(a), 
is redesignated as section 515B. 
(g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e–3(f)(2)), as redesignated by subsection (e)(2) 
of this section, is amended by striking ‘‘a proposed guidance’’ and 
inserting ‘‘a draft version of that guidance’’. 
(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 clearance 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 following: 
(1) The median time following a request from staff of the 
Food and Drug Administration reviewing 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 report 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 regu-
latory or enforcement action was indicated. 
(3) The median time from the sending of a warning letter, 
issuance of an import alert, or holding of a regulatory meeting 
to resolution of the regulatory or enforcement action indicated 
for inspections 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. 
SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORM-
ANCE 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 calendar days 
after the end of 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 Secretary shall 
post the data described in subparagraph (B) on the internet 
website of the Food and Drug Administration for such 
quarter and on a cumulative basis for such fiscal year,
H. R. 2430—74 
and may remove 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 guid-
ance on topics related to the process for the review 
of human drug applications, and whether such guid-
ances were issued as required by statute or pursuant 
to a commitment under the letters described in section 
101(b) of the Prescription Drug User Fee Amendments 
of 2017. 
‘‘(ii) The number and titles of public meetings held 
on topics related to the process for the review of human 
drug applications, and whether such meetings were 
required by statute or pursuant to a commitment under 
the letters described in section 101(b) of the Prescrip-
tion Drug User Fee Amendments of 2017. 
‘‘(iii) The number of new drug applications and 
biological licensing applications approved. 
‘‘(iv) The number of new drug applications 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 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 Evaluation and Research, the Office of Regu-
latory Affairs, 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 Evaluation and 
Research, the Center for Biologics Evaluation and 
Research, the Office of Regulatory Affairs, and the Office 
of the Commissioner, the number of employees for whom 
time reporting is required and the number of employees 
for whom time reporting is not required.’’. 
(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 amended— 
(1) by striking ‘‘Beginning with’’ and inserting the following: 
‘‘(i) GENERAL
REQUIREMENTS.—Beginning with’’; 
and 
(2) by adding at the end the following: 
‘‘(ii) ADDITIONAL
INFORMATION.—Beginning with 
fiscal year 2018, the annual report under this subpara-
graph shall include the progress of the Center for 
Devices and Radiological Health in achieving the goals, 
and future plans for meeting the goals, including—
H. R. 2430—75 
‘‘(I) the number of premarket applications filed 
under section 515 per fiscal year for each review 
division; 
‘‘(II) the number of reports submitted under 
section 510(k) per fiscal year for each review divi-
sion; and 
‘‘(III) the number of expedited development 
and priority review designations under section 
515C per fiscal year. 
‘‘(iii) REAL TIME REPORTING.— 
‘‘(I) IN GENERAL.—Not later than 30 calendar 
days after the end of 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 Secretary 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 remove duplicative data from the 
annual report under this subparagraph. 
‘‘(II) DATA.—The Secretary shall post the fol-
lowing 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 whether such 
guidances were issued as required by statute 
or pursuant to the letters described in section 
201(b) of the Medical Device User Fee Amend-
ments of 2017; and 
‘‘(bb) The number and titles of public 
meetings held on topics related to the process 
for the review of devices, and if such meetings 
were required by statute or pursuant to a 
commitment under the letters described in sec-
tion 201(b) of the Medical Device User Fee 
Amendments of 2017. 
‘‘(iv) RATIONALE FOR MDUFA PROGRAM CHANGES.— 
Beginning with fiscal year 2020, the Secretary shall 
include in the annual report under paragraph (1)— 
‘‘(I) data, analysis, and discussion of the 
changes in the number of full-time equivalents 
hired as agreed upon in the letters described in 
section 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 Research, 
the Office of Regulatory Affairs, and the Office 
of the Commissioner; 
‘‘(II) data, analysis, and discussion of the 
changes in the fee revenue amounts and costs 
for the process for the review of devices, including 
identifying 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
H. R. 2430—76 
Affairs, and the Office of the Commissioner, 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: 
‘‘(2) REAL TIME REPORTING.— 
‘‘(A) IN GENERAL.—Not later than 30 calendar days 
after the end of 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 Secretary shall 
post the data described in subparagraph (B) on the internet 
website of the Food and Drug Administration, 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 guid-
ance 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 
pursuant to a commitment under the letters described 
in section 301(b) of the Generic Drug User Fee Amend-
ments 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 division within 
the Center for Drug Evaluation and Research, the Center 
for Biologics Evaluation and Research, the Office of Regu-
latory Affairs, 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 Evaluation and 
Research, the Center for Biologics Evaluation and 
Research, the Office of Regulatory Affairs, and the Office 
of the Commissioner, the number of employees for whom 
time reporting is required and the number of employees 
for whom time reporting is not required.’’.
H. R. 2430—77 
(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 subsection shall include the progress 
of the Food and Drug Administration in achieving the goals, 
and future plans for meeting the goals, including— 
‘‘(A) information on all previous cohorts for which the 
Secretary has not given a complete response on all bio-
similar biological product applications and supplements in 
the cohort; 
‘‘(B) the number of original biosimilar biological 
product applications filed per fiscal year, 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 letters issued by the agency for 
such applications. 
‘‘(3) REAL TIME REPORTING.— 
‘‘(A) IN GENERAL.—Not later than 30 calendar days 
after the end of 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 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 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 guid-
ance on topics related to the process for the review 
of biosimilars, and whether such guidances were 
required by statute or pursuant to a commitment under 
the letters described in section 401(b) of the Biosimilar 
User Fee Amendments of 2017. 
‘‘(ii) The number and titles of public meetings held 
on topics related to the process 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 Amendments 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 division within the 
Center for Drug Evaluation and Research, the Center for
H. R. 2430—78 
Biologics Evaluation and Research, the Office of Regulatory 
Affairs, 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 biological product applications, 
including identifying drivers of such changes; and 
‘‘(C) for each of the Center for Drug Evaluation and 
Research, the Center for Biologics Evaluation and 
Research, the Office of Regulatory Affairs, and the Office 
of the Commissioner, the number of employees for whom 
time reporting is required and the number of employees 
for whom time reporting is not required.’’. 
SEC. 904. ANALYSIS OF USE OF FUNDS. 
(a) PDUFA REPORTS.— 
(1) ANALYSIS
IN
PDUFA
PERFORMANCE
REPORTS.—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 Secretary shall 
include in the report under paragraph (1) an analysis of the 
following: 
‘‘(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 applications for each 
fiscal year that did not meet the goals identified in 
the letters described in section 101(b) of the Prescrip-
tion Drug User Fee Amendments of 2017 for the 
applicable fiscal year. 
‘‘(B) Relevant data to determine whether the Center 
for Drug Evaluation and Research and the Center for Bio-
logics Evaluation and Research have met performance 
enhancement goals identified in the letters described in 
section 101(b) of the Prescription Drug User Fee Amend-
ments 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 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 section 101(b) of the Prescription Drug 
User Fee Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
REPORTS.—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 sub-
sections (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
H. R. 2430—79 
report to the Committee on Energy and Commerce and the Com-
mittee on Appropriations of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions and the 
Committee 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 in the letters described in section 
101(b) of the Prescription Drug User Fee 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 human drug 
application review process. 
‘‘(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 correc-
tive action report shall include— 
‘‘(A) a detailed justification for such determination 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 enhancement 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.— 
‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, 
as applicable and requested, representatives from the Centers 
with expertise in the review of human drugs shall meet with 
representatives from the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee 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
HEARING.—Each 
fiscal year, as applicable and requested, representatives from 
the Food and Drug Administration shall participate in a public 
hearing before the Committee on Health, Education, Labor, 
and Pensions of the Senate 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.’’. 
(b) MDUFA REPORTS.— 
(1) ANALYSIS IN MDUFA PERFORMANCE REPORTS.—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 
further amended by adding at the end the following: 
‘‘(iv) ANALYSIS.—For each fiscal year, the Secretary 
shall include in the report under clause (i) an analysis 
of the following:
H. R. 2430—80 
‘‘(I) The difference between the aggregate 
number of premarket applications filed under sec-
tion 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 agency, 
accounting for— 
‘‘(aa) the number of applications filed and 
reports submitted during one fiscal year for 
which a decision is not scheduled to be made 
until the following fiscal year; and 
‘‘(bb) the aggregate number of applications 
for each fiscal year that did not meet the 
goals as identified by the letters described in 
section 201(b) of the Medical Device User Fee 
Amendments of 2017 for the applicable fiscal 
year. 
‘‘(II) Relevant data to determine whether the 
Center for Devices and Radiological Health has 
met performance enhancement goals identified by 
the letters described in section 201(b) of the Med-
ical Device User Fee Amendments of 2017 for the 
applicable fiscal year. 
‘‘(III) The most common causes and trends 
for external or other circumstances affecting the 
ability of the Center for Devices and Radiological 
Health, the Office of Regulatory Affairs, or the 
Food and Drug Administration to meet review time 
and performance enhancement goals identified by 
the letters described in section 201(b) of the Med-
ical Device User Fee Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
REPORTS.—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 para-
graphs (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 Com-
merce and the Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, 
Labor, and Pensions and the Committee on Appropriations 
of the Senate. The report shall include the following informa-
tion, 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 section 201(b) of the Medical Device User 
Fee 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 section 201(b) of the Medical
H. R. 2430—81 
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 include— 
‘‘(i) a justification for such determination; 
‘‘(ii) a description of the types of circumstances, 
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 review goal was missed; 
and 
‘‘(iv) the performance enhancement goals that were 
not achieved during the previous fiscal year and 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. 
‘‘(3) ENHANCED COMMUNICATION.— 
‘‘(A) COMMUNICATIONS
WITH
CONGRESS.—Each fiscal 
year, as applicable and requested, 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 Commerce of the House of Rep-
resentatives 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 public hearing before the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Represent-
atives, 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 REPORTS.—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 Secretary 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 
‘‘(ii) the aggregate number of applications 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 applicable 
fiscal year.
H. R. 2430—82 
‘‘(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 affected the ability of the Sec-
retary to meet review time and performance enhancement 
goals identified by the letters described in section 301(b) 
of the Generic Drug User Fee Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
REPORTS.—Section 
744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–43) is amended— 
(A) by redesignating subsections (c) and (d) as sub-
sections (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 Energy and Commerce and the Com-
mittee on Appropriations of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions and the 
Committee 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 applicable 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 determines to not have been met, the correc-
tive action report shall include— 
‘‘(A) a detailed justification for such determination 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 enhancement goals 
that were not achieved, a detailed 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.— 
‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, 
as applicable and requested, representatives from the Centers 
with expertise in the review of human drugs shall meet with 
representatives from the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives to report 
on the contents described in the reports under this section.
H. R. 2430—83 
‘‘(2) PARTICIPATION
IN
CONGRESSIONAL
HEARING.—Each 
fiscal year, as applicable and requested, representatives from 
the Food and Drug Administration shall participate in a public 
hearing before the Committee on Health, Education, Labor, 
and Pensions of the Senate 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.’’. 
(d) BSUFA REPORTS.— 
(1) ANALYSIS
IN
BSUFA
PERFORMANCE
REPORTS.—Section 
744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–53(a)) as amended by section 903(d) is further amended 
by adding at the end the following: 
‘‘(5) ANALYSIS.—For each fiscal year, the Secretary shall 
include in the report an analysis of the following: 
‘‘(A) The difference between the aggregate number of 
biosimilar biological product applications and supplements 
filed and the aggregate number of approvals 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 
‘‘(ii) the aggregate number of applications 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 applicable fiscal 
year. 
‘‘(B) Relevant data to determine whether the Center 
for Drug Evaluation and Research and the Center for Bio-
logics Evaluation and Research have met the performance 
enhancement 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 by the letters described in section 401(b) of the 
Biosimilar User Fee Amendments of 2017.’’. 
(2) ISSUANCE
OF
CORRECTIVE
ACTION
REPORTS.—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 sub-
sections (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 Appropriations of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions and Committee 
on Appropriations of the Senate. The report shall include the fol-
lowing 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
H. R. 2430—84 
401(b) of the Biosimilar User Fee 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 biosimilar biological 
product application review process. 
‘‘(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 determines to not have been met, the corrective 
action report shall include— 
‘‘(A) a justification for such determination and a 
description of the types of circumstances and trends, as 
applicable, under which biosimilar 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 enhancement 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.— 
‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, 
as applicable and requested, representatives from the Centers 
with expertise in the review of human drugs shall meet with 
representatives from the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee 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
HEARING.—Each 
fiscal year, as applicable and requested, representatives from 
the Food and Drug Administration shall participate in a public 
hearing before the Committee on Health, Education, Labor, 
and Pensions of the Senate 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.’’. 
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 related 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 resources authorized by the 
Food and Drug Administration Safety and Innovation Act 
(Public Law 112–144) and this Act, as applicable, that 
contributed to— 
(i) the maintenance of scientific equipment and 
any existing facility plan or plans to maintain pre-
viously purchased scientific equipment;
H. R. 2430—85 
(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 ren-
ovation including the need for the renovation; 
(iii) the assets purchased or repaired under the 
‘‘repair of facilities and acquisition’’ 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.); 
(iv) the maintenance and repair of facilities and 
fixtures, including a description of any unanticipated 
repairs and maintenance as well as scheduled repairs 
maintenance, and the budget plan for the scheduled 
or anticipated maintenance; 
(v) the acquisition of furniture, a description of 
the furniture purchased, and the purpose of the fur-
niture including purchases 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 Administration’s 
ability to further its public health mission and review 
medical products by incurring the expenses listed in clauses 
(i) through (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 maintenance and renovation for the agency. 
(2) REPORT.— 
(A) IN GENERAL.—The Comptroller General shall issue 
a report to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce 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 rec-
ommendations, as applicable, on methods through which 
the Food and Drug Administration may improve planning 
for— 
(i) the maintenance, renovation, and repair of 
facilities; 
(ii) the purchase of furniture or other acquisitions; 
and 
(iii) ways the Food and Drug Administration may 
allocate the expenses described in clauses (i) and (ii) 
of paragraph (1)(A), as informed by the analysis under 
paragraph (1)(B). 
(b) ADMINISTRATION.—
H. R. 2430—86 
(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 expendi-
tures 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 equipment.’’. 
(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’’; 
(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 striking ‘‘LIMITA-
TION’’ and inserting ‘‘LIMITATIONS’’; 
(B) by striking ‘‘The fees authorized’’ and inserting 
the following: 
‘‘(i) IN GENERAL.—The fees authorized’’; and 
(C) by adding at the end the following: 
‘‘(ii) LEASING AND NECESSARY EQUIPMENT.—Begin-
ning on October 1, 2023, the authorities under section 
744G(9)(C) shall include only leasing and necessary 
scientific equipment.’’. 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.