195 
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-
196 
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
197 
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—
198 
(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
199 
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
200 
‘‘(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