201 
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:
202 
‘‘(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-
203 
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-
204 
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,
205 
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
206 
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-
207 
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:
208 
‘‘(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
209 
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
210 
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
211 
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.—
212 
(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
213 
‘‘(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
214 
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
215 
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
216 
‘‘(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
217 
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
218 
‘‘(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
220 
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
221 
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
222 
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
223 
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
224 
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.—
225 
‘‘(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-
226 
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-
227 
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
228 
(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
229 
(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’’;
230 
(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
231 
744G(9)(C) shall include only leasing and 
necessary scientific equipment.’’. 
Passed the House of Representatives July 12, 2017. 
Attest: 
Clerk.
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.