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
PL 115-52 (H.R.2430), enacted 08/18/2017

131 STAT. 1005 
PUBLIC LAW 115–52—AUG. 18, 2017 
Public Law 115–52 
115th Congress 
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. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Reauthorization Act of 
2017’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—FEES RELATING TO DRUGS 
Sec. 101. Short title; finding. 
Sec. 102. Authority to assess and use drug fees. 
Sec. 103. Reauthorization; reporting requirements. 
Sec. 104. Sunset dates. 
Sec. 105. Effective date. 
Sec. 106. Savings clause. 
TITLE II—FEES RELATING TO DEVICES 
Sec. 201. Short title; finding. 
Sec. 202. Definitions. 
Sec. 203. Authority to assess and use device fees. 
Sec. 204. Reauthorization; reporting requirements. 
Sec. 205. Conformity assessment pilot program. 
Sec. 206. Reauthorization of review. 
Sec. 207. Electronic format for submissions. 
Sec. 208. Savings clause. 
Sec. 209. Effective date. 
Sec. 210. Sunset dates. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 301. Short title; finding. 
Sec. 302. Definitions. 
Sec. 303. Authority to assess and use human generic drug fees. 
Sec. 304. Reauthorization; reporting requirements. 
Sec. 305. Sunset dates. 
Sec. 306. Effective date. 
Sec. 307. Savings clause. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 
Sec. 401. Short title; finding. 
Sec. 402. Definitions. 
Sec. 403. Authority to assess and use biosimilar fees. 
Sec. 404. Reauthorization; reporting requirements. 
Sec. 405. Sunset dates. 
Sec. 406. Effective date. 
FDA 
Reauthorization 
Act of 2017. 
21 USC 301 note. 
Aug. 18, 2017 
[H.R. 2430] 
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131 STAT. 1006 
PUBLIC LAW 115–52—AUG. 18, 2017 
Sec. 407. Savings clause. 
TITLE V—PEDIATRIC DRUGS AND DEVICES 
Sec. 501. Best pharmaceuticals for children. 
Sec. 502. Pediatric devices. 
Sec. 503. Early meeting on pediatric study plan. 
Sec. 504. Development of drugs and biological products for pediatric cancers. 
Sec. 505. Additional provisions on development of drugs and biological products for 
pediatric use. 
TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS 
Sec. 601. Reauthorization of provision relating to exclusivity of certain drugs con-
taining single enantiomers. 
Sec. 602. Reauthorization of the critical path public-private partnerships. 
Sec. 603. Reauthorization of orphan grants program. 
Sec. 604. Protecting and strengthening the drug supply chain. 
Sec. 605. Patient experience data. 
Sec. 606. Communication plans. 
Sec. 607. Orphan drugs. 
Sec. 608. Pediatric information added to labeling. 
Sec. 609. Sense of Congress on lowering the cost of prescription drugs. 
Sec. 610. Expanded access. 
Sec. 611. Tropical disease product application. 
TITLE VII—DEVICE INSPECTION AND REGULATORY IMPROVEMENTS 
Sec. 701. Risk-based inspections for devices. 
Sec. 702. Improvements to inspections process for device establishments. 
Sec. 703. Reauthorization of inspection program. 
Sec. 704. Certificates to foreign governments for devices. 
Sec. 705. Facilitating international harmonization. 
Sec. 706. Fostering innovation in medical imaging. 
Sec. 707. Risk-based classification of accessories. 
Sec. 708. Device pilot projects. 
Sec. 709. Regulation of over-the-counter hearing aids. 
Sec. 710. Report on servicing of devices. 
TITLE VIII—IMPROVING GENERIC DRUG ACCESS 
Sec. 801. Priority review of generic drugs. 
Sec. 802. Enhancing regulatory transparency to enhance generic competition. 
Sec. 803. Competitive generic therapies. 
Sec. 804. Accurate information about drugs with limited competition. 
Sec. 805. Suitability petitions. 
Sec. 806. Inspections. 
Sec. 807. Reporting on pending generic drug applications and priority review appli-
cations. 
Sec. 808. Incentivizing competitive generic drug development. 
Sec. 809. GAO study of issues regarding first cycle approvals of generic medicines. 
TITLE IX—ADDITIONAL PROVISIONS 
Sec. 901. Technical corrections. 
Sec. 902. Annual report on inspections. 
Sec. 903. Streamlining and improving consistency in performance reporting. 
Sec. 904. Analysis of use of funds. 
Sec. 905. Facilities management. 
TITLE I—FEES RELATING TO DRUGS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 
Drug User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated toward expe-
diting the drug development process and the process for the review 
of human drug applications, including postmarket drug safety 
activities, as set forth in the goals identified for purposes of part 
2 of subchapter C of chapter VII of the Federal Food, Drug, and 
21 USC 379g 
note. 
21 USC 301 note. 
Prescription 
Drug User Fee 
Amendments 
of 2017. 
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131 STAT. 1007 
PUBLIC LAW 115–52—AUG. 18, 2017 
Cosmetic Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—Section 736(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(a)) is amended— 
(A) in the matter preceding paragraph (1), by striking 
‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 2018’’; 
(B) in the heading of paragraph (1), by striking ‘‘AND 
SUPPLEMENT’’; 
(C) in paragraph (1), by striking ‘‘or a supplement’’ 
and ‘‘or supplement’’ each place either appears; 
(D) in paragraph (1)(A)— 
(i) in clause (i), by striking ‘‘(c)(4)’’ and inserting 
‘‘(c)(5)’’; and 
(ii) in clause (ii), by striking ‘‘A fee established’’ 
and all that follows through ‘‘are required.’’ and 
inserting the following: ‘‘A fee established under sub-
section (c)(5) for a human drug application for which 
clinical data (other than bioavailability or bioequiva-
lence studies) with respect to safety or effectiveness 
are not required for approval.’’; 
(E) in the heading of paragraph (1)(C), by striking 
‘‘OR SUPPLEMENT’’; 
(F) in paragraph (1)(F)— 
(i) in the heading, by striking ‘‘OR INDICATION’’; 
and 
(ii) by striking the second sentence; 
(G) by striking paragraph (2) (relating to a prescription 
drug establishment fee); 
(H) by redesignating paragraph (3) as paragraph (2); 
(I) in the heading of paragraph (2), as so redesignated, 
by striking ‘‘PRESCRIPTION
DRUG
PRODUCT
FEE’’ and 
inserting ‘‘PRESCRIPTION DRUG PROGRAM FEE’’; 
(J) in subparagraph (A) of such paragraph (2), by 
amending the first sentence to read as follows: ‘‘Except 
as provided in subparagraphs (B) and (C), each person 
who is named as the applicant in a human drug application, 
and who, after September 1, 1992, had pending before 
the Secretary a human drug application or supplement, 
shall pay the annual prescription drug program fee estab-
lished for a fiscal year under subsection (c)(5) for each 
prescription drug product that is identified in such a human 
drug application approved as of October 1 of such fiscal 
year.’’; 
(K) in subparagraph (B) of such paragraph (2)— 
(i) in the heading of subparagraph (B), by inserting 
after 
‘‘EXCEPTION’’ 
the 
following: 
‘‘FOR
CERTAIN 
PRESCRIPTION DRUG PRODUCTS’’; and 
(ii) by striking ‘‘A prescription drug product shall 
not be assessed a fee’’ and inserting ‘‘A prescription 
drug program fee shall not be assessed for a prescrip-
tion drug product’’; and 
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131 STAT. 1008 
PUBLIC LAW 115–52—AUG. 18, 2017 
(L) by adding at the end of such paragraph (2) the 
following: 
‘‘(C) LIMITATION.—A person who is named as the 
applicant in an approved human drug application shall 
not be assessed more than 5 prescription drug program 
fees for a fiscal year for prescription drug products identi-
fied in such approved human drug application.’’. 
(2) CONFORMING AMENDMENT.—Subparagraph (C) of section 
740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–12(a)(3)) is amended to read as follows: 
‘‘(C) LIMITATION.—An establishment shall be assessed 
only one fee per fiscal year under this section.’’. 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 736 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is 
amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 2018 through 
2022, fees under subsection (a) shall, except as provided in 
subsections (c), (d), (f), and (g), be established to generate 
a total revenue amount under such subsection that is equal 
to the sum of— 
‘‘(A) the annual base revenue for the fiscal year (as 
determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the capacity planning 
adjustment for the fiscal year (as determined under sub-
section (c)(2)); 
‘‘(D) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(3)); 
‘‘(E) the dollar amount equal to the additional direct 
cost adjustment for the fiscal year (as determined under 
subsection (c)(4)); and 
‘‘(F) additional dollar amounts for each fiscal year as 
follows: 
‘‘(i) $20,077,793 for fiscal year 2018. 
‘‘(ii) $21,317,472 for fiscal year 2019. 
‘‘(iii) $16,953,329 for fiscal year 2020. 
‘‘(iv) $5,426,896 for fiscal year 2021. 
‘‘(v) $2,769,609 for fiscal year 2022. 
‘‘(2) TYPES OF FEES.—Of the total revenue amount deter-
mined for a fiscal year under paragraph (1)— 
‘‘(A) 20 percent shall be derived from human drug 
application fees under subsection (a)(1); and 
‘‘(B) 80 percent shall be derived from prescription drug 
program fees under subsection (a)(2). 
‘‘(3) ANNUAL BASE REVENUE.—For purposes of paragraph 
(1), the dollar amount of the annual base revenue for a fiscal 
year shall be— 
‘‘(A) for fiscal year 2018, $878,590,000; and 
‘‘(B) for fiscal years 2019 through 2022, the dollar 
amount of the total revenue amount established under 
paragraph (1) for the previous fiscal year, not including 
any adjustments made under subsection (c)(3) or (c)(4).’’. 
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131 STAT. 1009 
PUBLIC LAW 115–52—AUG. 18, 2017 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Subsection (c) of sec-
tion 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h) is amended to read as follows: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of subsection (b)(1)(B), 
the dollar amount of the inflation adjustment to the annual 
base revenue for each fiscal year shall be equal to the 
product of— 
‘‘(i) such annual base revenue for the fiscal year 
under subsection (b)(1)(A); and 
‘‘(ii) the inflation adjustment percentage under 
subparagraph (B). 
‘‘(B) INFLATION ADJUSTMENT PERCENTAGE.—The infla-
tion adjustment percentage under this subparagraph for 
a fiscal year is equal to the sum of— 
‘‘(i) the average annual percent change in the cost, 
per full-time equivalent position of the Food and Drug 
Administration, of all personnel compensation and 
benefits paid with respect to such positions for the 
first 3 years of the preceding 4 fiscal years, multiplied 
by the proportion of personnel compensation and bene-
fits costs to total costs of the process for the review 
of human drug applications (as defined in section 
735(6)) for the first 3 years of the preceding 4 fiscal 
years; and 
‘‘(ii) the average annual percent change that 
occurred in the Consumer Price Index for urban con-
sumers (Washington-Baltimore, DC–MD–VA–WV; Not 
Seasonally Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 4 years of available 
data multiplied by the proportion of all costs other 
than personnel compensation and benefits costs to total 
costs of the process for the review of human drug 
applications (as defined in section 735(6)) for the first 
3 years of the preceding 4 fiscal years. 
‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each fiscal year, after the 
annual base revenue established in subsection (b)(1)(A) 
is adjusted for inflation in accordance with paragraph (1), 
such revenue shall be adjusted further for such fiscal year, 
in accordance with this paragraph, to reflect changes in 
the resource capacity needs of the Secretary for the process 
for the review of human drug applications. 
‘‘(B) INTERIM METHODOLOGY.— 
‘‘(i) IN
GENERAL.—Until the capacity planning 
methodology described in subparagraph (C) is effective, 
the adjustment under this paragraph for a fiscal year 
shall be based on the product of— 
‘‘(I) the annual base revenue for such year, 
as adjusted for inflation under paragraph (1); and 
‘‘(II) the adjustment percentage under clause 
(ii). 
‘‘(ii) ADJUSTMENT
PERCENTAGE.—The adjustment 
percentage under this clause for a fiscal year is the 
weighted change in the 3-year average ending in the 
Time period. 
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131 STAT. 1010 
PUBLIC LAW 115–52—AUG. 18, 2017 
most recent year for which data are available, over 
the 3-year average ending in the previous year, for— 
‘‘(I) the total number of human drug applica-
tions, efficacy supplements, and manufacturing 
supplements submitted to the Secretary; 
‘‘(II) the total number of active commercial 
investigational new drug applications; and 
‘‘(III) the total number of formal meetings 
scheduled by the Secretary, and written responses 
issued by the Secretary in lieu of such formal 
meetings, as identified in section I.H of the letters 
described in section 101(b) of the Prescription Drug 
User Fee Amendments of 2017. 
‘‘(C) CAPACITY PLANNING METHODOLOGY.— 
‘‘(i) DEVELOPMENT; EVALUATION AND REPORT.—The 
Secretary shall obtain, through a contract with an 
independent accounting or consulting firm, a report 
evaluating options and recommendations for a new 
methodology to accurately assess changes in the 
resource and capacity needs of the process for the 
review of human drug applications. The capacity plan-
ning methodological options and recommendations pre-
sented in such report shall utilize and be informed 
by personnel time reporting data as an input. The 
report shall be published for public comment no later 
than the end of fiscal year 2020. 
‘‘(ii) ESTABLISHMENT AND IMPLEMENTATION.—After 
review of the report described in clause (i) and any 
public comments thereon, the Secretary shall establish 
a capacity planning methodology for purposes of this 
paragraph, which shall— 
‘‘(I) replace the interim methodology under 
subparagraph (B); 
‘‘(II) 
incorporate 
such 
approaches 
and 
attributes as the Secretary determines appro-
priate; and 
‘‘(III) be effective beginning with the first fiscal 
year for which fees are set after such capacity 
planning methodology is established. 
‘‘(D) LIMITATION.—Under no circumstances shall an 
adjustment under this paragraph result in fee revenue 
for a fiscal year that is less than the sum of the amounts 
under subsections (b)(1)(A) (the annual base revenue for 
the fiscal year) and (b)(1)(B) (the dollar amount of the 
inflation adjustment for the fiscal year). 
‘‘(E) PUBLICATION
IN
FEDERAL
REGISTER.—The Sec-
retary shall publish in the Federal Register notice under 
paragraph (5) of the fee revenue and fees resulting from 
the adjustment and the methodologies under this para-
graph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INCREASE.—For fiscal year 2018 and subsequent 
fiscal years, the Secretary may, in addition to adjustments 
under paragraphs (1) and (2), further increase the fee rev-
enue and fees if such an adjustment is necessary to provide 
Time period. 
Effective date. 
Publication. 
Public 
information. 
Deadline. 
Contracts. 
Recommenda- 
tions. 
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131 STAT. 1011 
PUBLIC LAW 115–52—AUG. 18, 2017 
for not more than 14 weeks of operating reserves of carry-
over user fees for the process for the review of human 
drug applications. 
‘‘(B) DECREASE.—If the Secretary has carryover bal-
ances for such process in excess of 14 weeks of such oper-
ating reserves, the Secretary shall decrease such fee rev-
enue and fees to provide for not more than 14 weeks 
of such operating reserves. 
‘‘(C) NOTICE OF RATIONALE.—If an adjustment under 
subparagraph (A) or (B) is made, the rationale for the 
amount of the increase or decrease (as applicable) in fee 
revenue and fees shall be contained in the annual Federal 
Register notice under paragraph (5) establishing fee rev-
enue and fees for the fiscal year involved. 
‘‘(4) ADDITIONAL DIRECT COST ADJUSTMENT.— 
‘‘(A) IN GENERAL.—The Secretary shall, in addition to 
adjustments under paragraphs (1), (2), and (3), further 
increase the fee revenue and fees— 
‘‘(i) for fiscal year 2018, by $8,730,000; and 
‘‘(ii) for fiscal year 2019 and subsequent fiscal 
years, by the amount determined under subparagraph 
(B). 
‘‘(B) AMOUNT.—The amount determined under this 
subparagraph is— 
‘‘(i) $8,730,000, multiplied by 
‘‘(ii) the Consumer Price Index for urban con-
sumers (Washington-Baltimore, DC–MD–VA–WV; Not 
Seasonally Adjusted; All Items; Annual Index) for the 
most recent year of available data, divided by such 
Index for 2016. 
‘‘(5) ANNUAL FEE SETTING.—The Secretary shall, not later 
than 60 days before the start of each fiscal year that begins 
after September 30, 2017— 
‘‘(A) establish, for each such fiscal year, human drug 
application fees and prescription drug program fees under 
subsection (a), based on the revenue amounts established 
under subsection (b) and the adjustments provided under 
this subsection; and 
‘‘(B) publish such fee revenue and fees in the Federal 
Register. 
‘‘(6) LIMIT.—The total amount of fees charged, as adjusted 
under this subsection, for a fiscal year may not exceed the 
total costs for such fiscal year for the resources allocated for 
the process for the review of human drug applications.’’. 
(d) FEE WAIVER OR REDUCTION.—Section 736(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended— 
(1) in paragraph (1)— 
(A) by inserting ‘‘or’’ at the end of subparagraph (B); 
(B) by striking subparagraph (C); and 
(C) by redesignating subparagraph (D) as subpara-
graph (C); 
(2) by striking paragraph (3) (relating to use of standard 
costs); 
(3) by redesignating paragraph (4) as paragraph (3); and 
(4) in paragraph (3), as so redesignated— 
(A) in subparagraphs (A) and (B), by striking ‘‘para-
graph (1)(D)’’ and inserting ‘‘paragraph (1)(C)’’; and 
Federal Register, 
publication. 
Deadline. 
Time period. 
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131 STAT. 1012 
PUBLIC LAW 115–52—AUG. 18, 2017 
(B) in subparagraph (B)— 
(i) by striking clause (ii); 
(ii) by striking ‘‘shall pay’’ through ‘‘(i) application 
fees’’ and inserting ‘‘shall pay application fees’’; and 
(iii) by striking ‘‘; and’’ at the end and inserting 
a period. 
(e) EFFECT OF FAILURE TO PAY FEES.—Section 736(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is 
amended by striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 
(f) LIMITATIONS.—Section 736(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 
‘‘supplements, prescription drug establishments, and prescription 
drug products’’ and inserting ‘‘prescription drug program fees’’. 
(g) CREDITING AND AVAILABILITY OF FEES.—Section 736(g) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) 
is amended— 
(1) in paragraph (3)— 
(A) by striking ‘‘2013 through 2017’’ and inserting 
‘‘2018 through 2022’’; and 
(B) by striking ‘‘and paragraph (4) of this subsection’’; 
and 
(2) by striking paragraph (4). 
(h) ORPHAN DRUGS.—Section 736(k) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking 
‘‘product and establishment fees’’ each place it appears and inserting 
‘‘prescription drug program fees’’. 
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h–2) is amended— 
(1) in subsection (a)(1)— 
(A) in the matter before subparagraph (A), by striking 
‘‘2013’’ and inserting ‘‘2018’’; and 
(B) in subparagraph (A), by striking ‘‘Prescription Drug 
User Fee Amendments of 2012’’ and inserting ‘‘Prescription 
Drug User Fee Amendments of 2017’’; 
(2) in subsection (b), by striking ‘‘2013’’ and inserting 
‘‘2018’’; and 
(3) in subsection (d), by striking ‘‘2017’’ each place it 
appears and inserting ‘‘2022’’. 
SEC. 104. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to 
be effective October 1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 736B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to 
be effective January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2017, 
subsections (a) and (b) of section 105 of the Food and Drug Adminis-
tration Safety and Innovation Act (Public Law 112–144) are 
repealed. 
SEC. 105. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2017, or the date of the enactment of this Act, whichever is 
later, except that fees under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
21 USC 379g 
note. 
Effective date. 
Repeal. 
21 USC 379g 
note, 379h–2 
note. 
21 USC 379h–2 
note. 
21 USC 379g 
note. 
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131 STAT. 1013 
PUBLIC LAW 115–52—AUG. 18, 2017 
for all human drug applications received on or after October 1, 
2017, regardless of the date of the enactment of this Act. 
SEC. 106. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 2 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as in effect on the day before the date of the enact-
ment of this title, shall continue to be in effect with respect to 
human drug applications and supplements (as defined in such part 
as of such day) that on or after October 1, 2012, but before October 
1, 2017, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required 
by such part for a fiscal year prior to fiscal year 2018. 
TITLE II—FEES RELATING TO DEVICES 
SEC. 201. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 
Device User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees authorized 
under the amendments made by this title will be dedicated toward 
expediting the process for the review of device applications and 
for assuring the safety and effectiveness of devices, as set forth 
in the goals identified for purposes of part 3 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cosmetic Act in 
the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Committee on 
Energy and Commerce of the House of Representatives, as set 
forth in the Congressional Record. 
SEC. 202. DEFINITIONS. 
(a) IN GENERAL.—Section 737 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379i) is amended— 
(1) by redesignating paragraphs (8) through (13) as para-
graphs (9) through (14), respectively; 
(2) by inserting after paragraph (7) the following new para-
graph: 
‘‘(8) The term ‘de novo classification request’ means a 
request made under section 513(f)(2)(A) with respect to the 
classification of a device.’’; 
(3) in subparagraph (D) of paragraph (10) (as redesignated 
by paragraph (1)), by striking ‘‘and submissions’’ and inserting 
‘‘submissions, and de novo classification requests’’; and 
(4) in paragraph (11) (as redesignated by paragraph (1)), 
by striking ‘‘2011’’ and inserting ‘‘2016’’. 
(b) CONFORMING AMENDMENT.—Section 714(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3(b)(1)) is amended 
by striking ‘‘737(8)’’ and inserting ‘‘737(9)’’. 
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.—Section 738(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j(a)) is amended— 
(1) in paragraph (1), by striking ‘‘fiscal year 2013’’ and 
inserting ‘‘fiscal year 2018’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
21 USC 379i 
note. 
21 USC 301 note. 
Medical Device 
User Fee 
Amendments 
of 2017. 
Continuation. 
Time period. 
21 USC 379g 
note. 
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131 STAT. 1014 
PUBLIC LAW 115–52—AUG. 18, 2017 
(i) in the matter preceding clause (i), by striking 
‘‘October 1, 2012’’ and inserting ‘‘October 1, 2017’’; 
(ii) in clause (viii), by striking ‘‘2’’ and inserting 
‘‘3.4’’; and 
(iii) by adding at the end the following new clause: 
‘‘(xi) For a de novo classification request, a fee 
equal to 30 percent of the fee that applies under clause 
(i).’’; and 
(B) in subparagraph (B)(v)(I), by striking ‘‘or premarket 
notification submission’’ and inserting ‘‘premarket notifica-
tion submission, or de novo classification request’’. 
(b) FEE AMOUNTS.—Section 738(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows: 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsections (c), (d), (e), and 
(h), for each of fiscal years 2018 through 2022, fees under 
subsection (a) shall be derived from the base fee amounts 
specified in paragraph (2), to generate the total revenue 
amounts specified in paragraph (3). 
‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of para-
graph (1), the base fee amounts specified in this paragraph 
are as follows: 
‘‘Fee Type 
Fiscal 
Year 
2018 
Fiscal 
Year 
2019 
Fiscal 
Year 
2020 
Fiscal 
Year 
2021 
Fiscal 
Year 
2022 
Premarket Application ....
$294,000 
$300,000 
$310,000 
$328,000 
$329,000 
Establishment Registra-
tion ................................
$4,375 
$4,548 
$4,760 
$4,975 
$4,978 
‘‘(3) TOTAL
REVENUE
AMOUNTS
SPECIFIED.—For purposes 
of paragraph (1), the total revenue amounts specified in this 
paragraph are as follows: 
‘‘(A) $183,280,756 for fiscal year 2018. 
‘‘(B) $190,654,875 for fiscal year 2019. 
‘‘(C) $200,132,014 for fiscal year 2020. 
‘‘(D) $211,748,789 for fiscal year 2021. 
‘‘(E) $213,687,660 for fiscal year 2022.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 738(c) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is 
amended— 
(1) in paragraph (1), by striking ‘‘2012’’ and inserting 
‘‘2017’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘2014’’ and 
inserting ‘‘2018’’; 
(B) by striking subparagraph (B) and inserting the 
following new subparagraph: 
‘‘(B) 
APPLICABLE
INFLATION
ADJUSTMENT.—The 
applicable inflation adjustment for fiscal year 2018 and 
each subsequent fiscal year is the product of— 
‘‘(i) the base inflation adjustment under subpara-
graph (C) for such fiscal year; and 
‘‘(ii) the product of the base inflation adjustment 
under subparagraph (C) for each of the fiscal years 
preceding such fiscal year, beginning with fiscal year 
2016.’’; 
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131 STAT. 1015 
PUBLIC LAW 115–52—AUG. 18, 2017 
(C) in subparagraph (C), in the heading, by striking 
‘‘TO TOTAL REVENUE AMOUNTS’’; and 
(D) by amending subparagraph (D) to read as follows: 
‘‘(D) ADJUSTMENT TO BASE FEE AMOUNTS.—For each 
of fiscal years 2018 through 2022, the Secretary shall— 
‘‘(i) adjust the base fee amounts specified in sub-
section (b)(2) for such fiscal year by multiplying such 
amounts by the applicable inflation adjustment under 
subparagraph (B) for such year; and 
‘‘(ii) if the Secretary determines necessary, increase 
(in addition to the adjustment under clause (i)) such 
base fee amounts, on a uniform proportionate basis, 
to generate the total revenue amounts under sub-
section (b)(3), as adjusted for inflation under subpara-
graph (A).’’; and 
(3) in paragraph (3)— 
(A) by striking ‘‘2014 through 2017’’ and inserting 
‘‘2018 through 2022’’; and 
(B) by striking ‘‘further adjusted’’ and inserting 
‘‘increased’’. 
(d) SMALL BUSINESSES; FEE WAIVER
AND FEE REDUCTION 
REGARDING PREMARKET APPROVAL FEES.—Section 738(d) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is amended— 
(1) in paragraph (1), by striking ‘‘specified in clauses (i) 
through (v) and clauses (vii), (ix), and (x)’’ and inserting ‘‘speci-
fied in clauses (i) through (vii) and clauses (ix), (x), and (xi)’’; 
and 
(2) in paragraph (2)(C)— 
(A) by striking ‘‘supplement, or’’ and inserting ‘‘supple-
ment,’’; and 
(B) by inserting ‘‘, or a de novo classification request’’ 
after ‘‘class III device’’. 
(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET 
NOTIFICATION SUBMISSIONS.—Section 738(e)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended 
by striking ‘‘50’’ and inserting ‘‘25’’. 
(f) FEE WAIVER OR REDUCTION.— 
(1) REPEAL.—Section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection 
(f). 
(2) CONFORMING AMENDMENTS.— 
(A) Section 515(c)(4)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by 
striking ‘‘738(h)’’ and inserting ‘‘738(g)’’. 
(B) Section 738 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j), as amended by paragraph (1), 
is further amended— 
(i) by redesignating subsections (g) through (l) as 
subsections (f) through (k); 
(ii) in subsection (a)(2)(A), by striking ‘‘(d), (e), 
and (f)’’ and inserting ‘‘(d) and (e)’’; and 
(iii) in subsection (a)(3)(A), by striking ‘‘and sub-
section (f)’’. 
(g) EFFECT OF FAILURE TO PAY FEES.—Subsection (f)(1), as 
so redesignated, of section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended— 
Determination. 
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131 STAT. 1016 
PUBLIC LAW 115–52—AUG. 18, 2017 
(1) by striking ‘‘or periodic reporting concerning a class 
III device’’ and inserting ‘‘periodic reporting concerning a class 
III device, or de novo classification request’’; and 
(2) by striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 
(h) CONDITIONS.—Subsection (g)(1)(A), as so redesignated, of 
section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j) is amended by striking ‘‘$280,587,000’’ and inserting 
‘‘$320,825,000’’. 
(i) CREDITING AND AVAILABILITY OF FEES.—Subsection (h), as 
so redesignated, of section 738 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j) is amended— 
(1) in paragraph (3)— 
(A) by striking ‘‘2013 through 2017’’ and inserting 
‘‘2018 through 2022’’; and 
(B) by striking ‘‘subsection (c)’’ and all that follows 
through the period at the end and inserting ‘‘subsection 
(c).’’; and 
(2) by striking paragraph (4). 
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) PERFORMANCE REPORTS.—Section 738A(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘2013’’ and inserting ‘‘2018’’; and 
(ii) by striking ‘‘the Medical Device User Fee 
Amendments of 2012’’ and inserting ‘‘the Medical 
Device User Fee Amendments of 2017’’; and 
(B) in subparagraph (B), by striking ‘‘the Medical 
Device User Fee Amendments Act of 2012’’ and inserting 
‘‘the Medical Device User Fee Amendments of 2017’’; and 
(2) in paragraph (2), by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’. 
(b) REAUTHORIZATION.—Section 738A(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended— 
(1) in paragraph (1), by striking ‘‘2017’’ and inserting 
‘‘2022’’; and 
(2) in paragraph (5), by striking ‘‘2017’’ and inserting 
‘‘2022’’. 
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 
(a) IN GENERAL.—Section 514 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end 
the following: 
‘‘(d) PILOT ACCREDITATION SCHEME FOR CONFORMITY ASSESS-
MENT.— 
‘‘(1) IN
GENERAL.—The Secretary shall establish a pilot 
program under which— 
‘‘(A) testing laboratories may be accredited, by accredi-
tation bodies meeting criteria specified by the Secretary, 
to assess the conformance of a device with certain stand-
ards recognized under this section; and 
‘‘(B) subject to paragraph (2), determinations by testing 
laboratories so accredited that a device conforms with such 
standard or standards shall be accepted by the Secretary 
for purposes of demonstrating such conformity under this 
section unless the Secretary finds that a particular such 
determination shall not be so accepted. 
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131 STAT. 1017 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(2) SECRETARIAL
REVIEW
OF
ACCREDITED
LABORATORY 
DETERMINATIONS.—The Secretary may— 
‘‘(A) review determinations by testing laboratories 
accredited pursuant to this subsection, including by con-
ducting periodic audits of such determinations or processes 
of accredited bodies or testing laboratories and, following 
such review, taking additional measures under this Act, 
such as suspension or withdrawal of accreditation of such 
testing laboratory under paragraph (1)(A) or requesting 
additional information with respect to such device, as the 
Secretary determines appropriate; and 
‘‘(B) if the Secretary becomes aware of information 
materially bearing on safety or effectiveness of a device 
assessed for conformity by a testing laboratory so accred-
ited, take such additional measures under this Act as the 
Secretary determines appropriate, such as suspension or 
withdrawal of accreditation of such testing laboratory 
under paragraph (1)(A), or requesting additional informa-
tion with regard to such device. 
‘‘(3) IMPLEMENTATION AND REPORTING.— 
‘‘(A) PUBLIC MEETING.—The Secretary shall publish in 
the Federal Register a notice of a public meeting to be 
held no later than September 30, 2018, to discuss and 
obtain input and recommendations from stakeholders 
regarding the goals and scope of, and a suitable framework 
and procedures and requirements for, the pilot program 
under this subsection. 
‘‘(B) PILOT PROGRAM GUIDANCE.—The Secretary shall— 
‘‘(i) not later than September 30, 2019, issue draft 
guidance regarding the goals and implementation of 
the pilot program under this subsection; and 
‘‘(ii) not later than September 30, 2021, issue final 
guidance with respect to the implementation of such 
program. 
‘‘(C) PILOT PROGRAM INITIATION.—Not later than Sep-
tember 30, 2020, the Secretary shall initiate the pilot pro-
gram under this subsection. 
‘‘(D) REPORT.—The Secretary shall make available on 
the internet website of the Food and Drug Administration 
an annual report on the progress of the pilot program 
under this subsection. 
‘‘(4) SUNSET.—As of October 1, 2022— 
‘‘(A) the authority for accreditation bodies to accredit 
testing laboratories pursuant to paragraph (1)(A) shall 
cease to have force or effect; 
‘‘(B) the Secretary— 
‘‘(i) may not accept a determination pursuant to 
paragraph (1)(B) made by a testing laboratory after 
such date; and 
‘‘(ii) may accept such a determination made prior 
to such date; 
‘‘(C) except for purposes of accepting a determination 
described in subparagraph (B)(ii), the Secretary shall not 
continue to recognize the accreditation of testing labora-
tories accredited under paragraph (1)(A); and 
‘‘(D) the Secretary may take actions in accordance with 
paragraph (2) with respect to the determinations made 
Web posting. 
Federal Register, 
publication. 
Notice. 
Deadlines. 
Audits. 
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131 STAT. 1018 
PUBLIC LAW 115–52—AUG. 18, 2017 
prior to such date and recognition of the accreditation 
of testing laboratories pursuant to determinations made 
prior to such date.’’. 
SEC. 206. REAUTHORIZATION OF REVIEW. 
Section 523 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360m) is amended— 
(1) in subsection (a)(3)— 
(A) in subparagraph (A), by striking clauses (ii) and 
(iii) and inserting the following: 
‘‘(ii) a device classified under section 513(f)(2) or 
designated under section 515C(d); 
‘‘(iii) a device that is intended to be permanently 
implantable, life sustaining, or life supporting, unless 
otherwise determined by the Secretary in accordance 
with subparagraph (B)(i)(II) and listed as eligible for 
review under subparagraph (B)(iii); or 
‘‘(iv) a device that is of a type, or subset of a 
type, listed as not eligible for review under subpara-
graph (B)(iii).’’; 
(B) by striking subparagraph (B) and inserting the 
following: 
‘‘(B) DESIGNATION FOR REVIEW.—The Secretary shall— 
‘‘(i) issue draft guidance on the factors the Sec-
retary will use in determining whether a class I or 
class II device type, or subset of such device types, 
is eligible for review by an accredited person, 
including— 
‘‘(I) the risk of the device type, or subset of 
such device type; and 
‘‘(II) whether the device type, or subset of such 
device type, is permanently implantable, life sus-
taining, or life supporting, and whether there is 
a detailed public health justification for permitting 
the review by an accredited person of such device 
type or subset; 
‘‘(ii) not later than 24 months after the date on 
which the Secretary issues such draft guidance, finalize 
such guidance; and 
‘‘(iii) beginning on the date such guidance is final-
ized, designate and post on the internet website of 
the Food and Drug Administration, an updated list 
of class I and class II device types, or subsets of such 
device types, and the Secretary’s determination with 
respect to whether each such device type, or subset 
of a device type, is eligible or not eligible for review 
by an accredited person under this section based on 
the factors described in clause (i).’’; and 
(C) by adding at the end the following: 
‘‘(C) INTERIM
RULE.—Until the date on which the 
updated list is designated and posted in accordance with 
subparagraph (B)(iii), the list in effect on the date of enact-
ment the Medical Device User Fee Amendments of 2017 
shall be in effect.’’; 
(2) in subsection (b)— 
(A) in paragraph (2)— 
(i) by striking subparagraph (D); and 
Lists. 
Effective date. 
Web posting. 
Lists. 
Determination. 
Deadline. 
Guidance. 
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131 STAT. 1019 
PUBLIC LAW 115–52—AUG. 18, 2017 
(ii) by redesignating subparagraph (E) as subpara-
graph (D); and 
(B) in paragraph (3)— 
(i) by redesignating subparagraph (E) as subpara-
graph (F); 
(ii) in subparagraph (F) (as so redesignated), by 
striking ‘‘The operations of’’ and all that follows 
through ‘‘it will—’’ and inserting ‘‘Such person shall 
agree, at a minimum, to include in its request for 
accreditation a commitment to, at the time of accredita-
tion, and at any time it is performing any review 
pursuant to this section—’’; and 
(iii) by inserting after subparagraph (D) the fol-
lowing new subparagraph: 
‘‘(E) The operations of such person shall be in accord-
ance with generally accepted professional and ethical busi-
ness practices.’’; and 
(3) in subsection (c), by striking ‘‘2017’’ and inserting 
‘‘2022’’. 
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379k–1(b)) is amended by adding at the end the following 
new paragraph: 
‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLELY IN ELEC-
TRONIC FORMAT.— 
‘‘(A) IN GENERAL.—Beginning on such date as the Sec-
retary specifies in final guidance issued under subpara-
graph (C), presubmissions and submissions for devices 
described in paragraph (1) (and any appeals of action taken 
by the Secretary with respect to such presubmissions or 
submissions) shall be submitted solely in such electronic 
format as specified by the Secretary in such guidance. 
‘‘(B) DRAFT GUIDANCE.—The Secretary shall, not later 
than October 1, 2019, issue draft guidance providing for— 
‘‘(i) any further standards for the submission by 
electronic format required under subparagraph (A); 
‘‘(ii) a timetable for the establishment by the Sec-
retary of such further standards; and 
‘‘(iii) criteria for waivers of and exemptions from 
the requirements of this subsection. 
‘‘(C) FINAL GUIDANCE.—The Secretary shall, not later 
than 1 year after the close of the public comment period 
on the draft guidance issued under subparagraph (B), issue 
final guidance.’’. 
SEC. 208. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 3 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day 
before the date of the enactment of this title, shall continue to 
be in effect with respect to the submissions listed in section 
738(a)(2)(A) of such Act (as defined in such part as of such day) 
that on or after October 1, 2012, but before October 1, 2017, were 
accepted by the Food and Drug Administration for filing with 
respect to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2018. 
Continuation. 
Time period. 
21 USC 379i 
note. 
Criteria. 
Effective date. 
Deadline. 
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131 STAT. 1020 
PUBLIC LAW 115–52—AUG. 18, 2017 
SEC. 209. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2017, or the date of the enactment of this Act, whichever is 
later, except that fees under part 3 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all submissions listed in section 738(a)(2)(A) of such Act received 
on or after October 1, 2017, regardless of the date of the enactment 
of this Act. 
SEC. 210. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 737 and 738 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be 
effective October 1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 738A (21 U.S.C. 739j– 
1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthor-
ization and reporting requirements) shall cease to be effective 
January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2017, 
section 207(a) of the Food and Drug Administration Safety and 
Innovation Act (Public Law 112–144) is repealed. 
TITLE III—FEES RELATING TO GENERIC 
DRUGS 
SEC. 301. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Generic 
Drug User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated to human 
generic drug activities, as set forth in the goals identified for pur-
poses of part 7 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act, in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Chairman of the Committee on Energy and Commerce of the House 
of Representatives, as set forth in the Congressional Record. 
SEC. 302. DEFINITIONS. 
Section 744A of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–41) is amended— 
(1) in paragraph (1)(B), by striking ‘‘application for a 
positron emission tomography drug.’’ and inserting ‘‘applica-
tion— 
‘‘(i) for a positron emission tomography drug; or 
‘‘(ii) submitted by a State or Federal governmental 
entity for a drug that is not distributed commercially.’’; 
(2) by redesignating paragraphs (5) through (12) as para-
graphs (6) through (13), respectively; and 
(3) by inserting after paragraph (4) the following: 
‘‘(5) The term ‘contract manufacturing organization facility’ 
means a manufacturing facility of a finished dosage form of 
a drug approved pursuant to an abbreviated new drug applica-
tion, where such manufacturing facility is not identified in 
an approved abbreviated new drug application held by the 
owner of such facility or an affiliate of such owner or facility.’’. 
21 USC 379j–41 
note. 
21 USC 301 note. 
Generic Drug 
User Fee 
Amendments 
of 2017. 
Effective date. 
Repeal. 
21 USC 379i 
note. 
21 USC 379j–1 
note. 
21 USC 378i 
note. 
21 USC 379i 
note. 
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131 STAT. 1021 
PUBLIC LAW 115–52—AUG. 18, 2017 
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
FEES. 
(a) TYPES OF FEES.—Section 744B(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–42(a)) is amended— 
(1) in the matter preceding paragraph (1), by striking ‘‘fiscal 
year 2013’’ and inserting ‘‘fiscal year 2018’’; 
(2) in paragraph (1), by adding at the end the following: 
‘‘(E) SUNSET.—This paragraph shall cease to be effec-
tive October 1, 2022.’’; 
(3) in paragraph (2)— 
(A) by amending subparagraph (C) to read as follows: 
‘‘(C) NOTICE.—Not later than 60 days before the start 
of each of fiscal years 2018 through 2022, the Secretary 
shall publish in the Federal Register the amount of the 
drug master file fee established by this paragraph for such 
fiscal year.’’; and 
(B) in subparagraph (E)— 
(i) in clause (i)— 
(I) by striking ‘‘no later than the date’’ and 
inserting ‘‘on the earlier of— 
‘‘(I) the date’’; 
(II) by striking the period and inserting ‘‘; 
or’’; and 
(III) by adding at the end the following: 
‘‘(II) the date on which the drug master file 
holder requests the initial completeness assess-
ment.’’; and 
(ii) in clause (ii), by striking ‘‘notice provided for 
in clause (i) or (ii) of subparagraph (C), as applicable’’ 
and inserting ‘‘notice provided for in subparagraph (C)’’; 
(4) in paragraph (3)— 
(A) in the heading, by striking ‘‘AND PRIOR APPROVAL 
SUPPLEMENT’’; 
(B) in subparagraph (A), by striking ‘‘or a prior 
approval supplement to an abbreviated new drug applica-
tion’’; 
(C) by amending subparagraphs (B) and (C) to read 
as follows: 
‘‘(B) NOTICE.—Not later than 60 days before the start 
of each of fiscal years 2018 through 2022, the Secretary 
shall publish in the Federal Register the amount of the 
fees under subparagraph (A) for such fiscal year. 
‘‘(C) FEE DUE DATE.—The fees required by subpara-
graphs (A) and (F) shall be due no later than the date 
of submission of the abbreviated new drug application or 
prior approval supplement for which such fee applies.’’; 
(D) in subparagraph (D)— 
(i) in the heading, by inserting ‘‘, IS WITHDRAWN 
PRIOR TO BEING RECEIVED, OR IS NO LONGER RECEIVED’’ 
after ‘‘RECEIVED’’; and 
(ii) by striking ‘‘The Secretary shall’’ and all that 
follows through the period and inserting the following: 
‘‘(i) APPLICATIONS NOT CONSIDERED TO HAVE BEEN 
RECEIVED
AND
APPLICATIONS
WITHDRAWN
PRIOR
TO 
BEING RECEIVED.—The Secretary shall refund 75 per-
cent of the fee paid under subparagraph (A) for any 
abbreviated new drug application that the Secretary 
Deadline. 
Applicability. 
Deadline. 
Time period. 
Federal Register, 
publication. 
Deadline. 
Time period. 
Federal Register, 
publication. 
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131 STAT. 1022 
PUBLIC LAW 115–52—AUG. 18, 2017 
considers not to have been received within the meaning 
of section 505(j)(5)(A) for a cause other than failure 
to pay fees, or that has been withdrawn prior to being 
received within the meaning of section 505(j)(5)(A). 
‘‘(ii) APPLICATIONS NO LONGER RECEIVED.—The Sec-
retary shall refund 100 percent of the fee paid under 
subparagraph (A) for any abbreviated new drug 
application if the Secretary initially receives the 
application under section 505(j)(5)(A) and subsequently 
determines that an exclusivity period for a listed drug 
should have prevented the Secretary from receiving 
such application, such that the abbreviated new drug 
application is no longer received within the meaning 
of section 505(j)(5)(A).’’; 
(E) in subparagraph (E), by striking ‘‘or prior approval 
supplement’’; and 
(F) in the matter preceding clause (i) of subparagraph 
(F)— 
(i) by striking ‘‘2012’’ and inserting ‘‘2017’’; and 
(ii) by striking ‘‘subsection (d)(3)’’ and inserting 
‘‘subsection (d)(2)’’; 
(5) in paragraph (4)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i) and in clause 
(iii), by striking ‘‘, or intended to be identified, in 
at least one generic drug submission that is pending 
or’’ and inserting ‘‘in at least one generic drug submis-
sion that is’’; 
(ii) in clause (i), by striking ‘‘or intended to be 
identified in at least one generic drug submission that 
is pending or’’ and inserting ‘‘in at least one generic 
drug submission that is’’; 
(iii) in clause (ii), by striking ‘‘produces,’’ and all 
that follows through ‘‘such a’’ and inserting ‘‘is identi-
fied in at least one generic drug submission in which 
the facility is approved to produce one or more active 
pharmaceutical ingredients or in a Type II active 
pharmaceutical ingredient drug master file referenced 
in at least one such’’; and 
(iv) in clause (iii), by striking ‘‘to fees under both 
such clauses’’ and inserting ‘‘only to the fee attributable 
to the manufacture of the finished dosage forms’’; and 
(B) by amending subparagraphs (C) and (D) to read 
as follows: 
‘‘(C) NOTICE.—Within the timeframe specified in sub-
section (d)(1), the Secretary shall publish in the Federal 
Register the amount of the fees under subparagraph (A) 
for such fiscal year. 
‘‘(D) FEE DUE DATE.—For each of fiscal years 2018 
through 2022, the fees under subparagraph (A) for such 
fiscal year shall be due on the later of— 
‘‘(i) the first business day on or after October 1 
of each such year; or 
‘‘(ii) the first business day after the enactment 
of an appropriations Act providing for the collection 
and obligation of fees for such year under this section 
for such year.’’; 
Time period. 
Deadlines. 
Federal Register, 
publication. 
Refunds. 
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131 STAT. 1023 
PUBLIC LAW 115–52—AUG. 18, 2017 
(6) by redesignating paragraph (5) as paragraph (6); and 
(7) by inserting after paragraph (4) the following: 
‘‘(5) GENERIC DRUG APPLICANT PROGRAM FEE.— 
‘‘(A) IN GENERAL.—A generic drug applicant program 
fee shall be assessed annually as described in subsection 
(b)(2)(E). 
‘‘(B) AMOUNT.—The amount of fees established under 
subparagraph (A) shall be established under subsection 
(d). 
‘‘(C) NOTICE.—Within the timeframe specified in sub-
section (d)(1), the Secretary shall publish in the Federal 
Register the amount of the fees under subparagraph (A) 
for such fiscal year. 
‘‘(D) FEE DUE DATE.—For each of fiscal years 2018 
through 2022, the fees under subparagraph (A) for such 
fiscal year shall be due on the later of— 
‘‘(i) the first business day on or after October 1 
of each such fiscal year; or 
‘‘(ii) the first business day after the date of enact-
ment of an appropriations Act providing for the collec-
tion and obligation of fees for such fiscal year under 
this section for such fiscal year.’’. 
(b) FEE REVENUE AMOUNTS.—Section 744B(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(b)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) in the heading, by striking ‘‘2013’’ and inserting 
‘‘2018’’; 
(ii) by striking ‘‘2013’’ and inserting ‘‘2018’’; 
(iii) by striking ‘‘$299,000,000’’ and inserting 
‘‘$493,600,000’’; and 
(iv) by striking ‘‘Of that amount’’ and all that 
follows through the end of clause (ii); and 
(B) in subparagraph (B)— 
(i) in the heading, by striking ‘‘2014 THROUGH 2017’’ 
and inserting ‘‘2019 THROUGH 2022’’; 
(ii) by striking ‘‘2014 through 2017’’ and inserting 
‘‘2019 through 2022’’; 
(iii) by striking ‘‘paragraphs (2) through (4)’’ and 
inserting ‘‘paragraphs (2) through (5)’’; and 
(iv) by striking ‘‘$299,000,000’’ and inserting 
‘‘$493,600,000’’; and 
(2) in paragraph (2)— 
(A) in the matter preceding subparagraph (A)— 
(i) by striking ‘‘paragraph (1)(A)(ii) for fiscal year 
2013 and paragraph (1)(B) for each of fiscal years 
2014 through 2017’’ and inserting ‘‘such paragraph 
for a fiscal year’’; and 
(ii) by striking ‘‘through (4)’’ and inserting ‘‘through 
(5)’’; 
(B) in subparagraph (A), by striking ‘‘Six percent’’ and 
inserting ‘‘Five percent’’; 
(C) by amending subparagraphs (B) and (C) to read 
as follows: 
‘‘(B) Thirty-three percent shall be derived from fees 
under subsection (a)(3) (relating to abbreviated new drug 
applications). 
Time period. 
Deadlines. 
Federal Register, 
publication. 
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131 STAT. 1024 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(C) Twenty percent shall be derived from fees under 
subsection (a)(4)(A)(i) (relating to generic drug facilities). 
The amount of the fee for a contract manufacturing 
organization facility shall be equal to one-third the amount 
of the fee for a facility that is not a contract manufacturing 
organization facility. The amount of the fee for a facility 
located outside the United States and its territories and 
possessions shall be $15,000 higher than the amount of 
the fee for a facility located in the United States and 
its territories and possessions.’’; 
(D) in subparagraph (D)— 
(i) by striking ‘‘Fourteen percent’’ and inserting 
‘‘Seven percent’’; 
(ii) by striking ‘‘not less than $15,000 and not 
more than $30,000’’ and inserting ‘‘$15,000’’; and 
(iii) by striking ‘‘, as determined’’ and all that 
follows through the period at the end and inserting 
a period; and 
(E) by adding at the end the following: 
‘‘(E)(i) Thirty-five percent shall be derived from fees 
under subsection (a)(5) (relating to generic drug applicant 
program fees). For purposes of this subparagraph, if a 
person has affiliates, a single program fee shall be assessed 
with respect to that person, including its affiliates, and 
may be paid by that person or any one of its affiliates. 
The Secretary shall determine the fees as follows: 
‘‘(I) If a person (including its affiliates) owns at 
least one but not more than 5 approved abbreviated 
new drug applications on the due date for the fee 
under this subsection, the person (including its affili-
ates) shall be assessed a small business generic drug 
applicant program fee equal to one-tenth of the large 
size operation generic drug applicant program fee. 
‘‘(II) If a person (including its affiliates) owns at 
least 6 but not more than 19 approved abbreviated 
new drug applications on the due date for the fee 
under this subsection, the person (including its affili-
ates) shall be assessed a medium size operation generic 
drug applicant program fee equal to two-fifths of the 
large size operation generic drug applicant program 
fee. 
‘‘(III) If a person (including its affiliates) owns 
20 or more approved abbreviated new drug applications 
on the due date for the fee under this subsection, 
the person (including its affiliates) shall be assessed 
a large size operation generic drug applicant program 
fee. 
‘‘(ii) For purposes of this subparagraph, an abbreviated 
new drug application shall be deemed not to be approved 
if the applicant has submitted a written request for with-
drawal of approval of such abbreviated new drug applica-
tion by April 1 of the previous fiscal year.’’. 
(c) ADJUSTMENTS.—Section 744B(c) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘2014’’ and inserting ‘‘2019’’; 
Deadline. 
Determination. 
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131 STAT. 1025 
PUBLIC LAW 115–52—AUG. 18, 2017 
(B) by inserting ‘‘to equal the product of the total 
revenues established in such notice for the prior fiscal 
year multiplied’’ after ‘‘a fiscal year,’’; and 
(C) by striking the flush text following subparagraph 
(C); and 
(2) in paragraph (2)— 
(A) by striking ‘‘2017’’ each place it appears and 
inserting ‘‘2022’’; 
(B) by striking ‘‘the first 3 months of fiscal year 2018’’ 
and inserting ‘‘the first 3 months of fiscal year 2023’’; 
and 
(C) by striking ‘‘Such fees may only be used in fiscal 
year 2018.’’. 
(d) ANNUAL FEE SETTING.—Section 744B(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–42(d)) is amended— 
(1) by striking paragraphs (1) and (2) and inserting the 
following: 
‘‘(1) FISCAL YEARS 2018 THROUGH 2022.—Not more than 60 
days before the first day of each of fiscal years 2018 through 
2022, the Secretary shall establish the fees described in para-
graphs (2) through (5) of subsection (a), based on the revenue 
amounts established under subsection (b) and the adjustments 
provided under subsection (c).’’; 
(2) by redesignating paragraph (3) as paragraph (2); and 
(3) in paragraph (2) (as so redesignated), in the matter 
preceding subparagraph (A), by striking ‘‘fees under paragraphs 
(1) and (2)’’ and inserting ‘‘fee under paragraph (1)’’. 
(e) IDENTIFICATION OF FACILITIES.—Section 744B(f) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(f)) is 
amended— 
(1) by striking paragraph (1); 
(2) by redesignating paragraphs (2) through (4) as para-
graphs (1) through (3), respectively; 
(3) in paragraph (1) (as so redesignated)— 
(A) by striking ‘‘paragraph (4)’’ and inserting ‘‘para-
graph (3)’’; and 
(B) by striking ‘‘Such information shall’’ and all that 
follows through the end of subparagraph (B) and inserting 
‘‘Such information shall, for each fiscal year, be submitted, 
updated, or reconfirmed on or before June 1 of the previous 
fiscal year.’’; and 
(4) in paragraph (2), as so redesignated— 
(A) in the heading, by striking ‘‘CONTENTS OF NOTICE’’ 
and inserting ‘‘INFORMATION REQUIRED TO BE SUBMITTED’’; 
(B) in the matter preceding subparagraph (A), by 
striking ‘‘paragraph (2)’’ and inserting ‘‘paragraph (1)’’; 
(C) in subparagraph (A), by striking ‘‘or intended to 
be identified’’; 
(D) in subparagraph (D), by striking ‘‘and’’ at the end; 
(E) in subparagraph (E), by striking the period and 
inserting ‘‘; and’’; and 
(F) by adding at the end the following: 
‘‘(F) whether the facility is a contract manufacturing 
organization facility.’’. 
(f) EFFECT OF FAILURE TO PAY FEES.—Section 744B(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(g)) is 
amended— 
Deadline. 
Time period. 
Deadline. 
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131 STAT. 1026 
PUBLIC LAW 115–52—AUG. 18, 2017 
(1) in paragraph (1), by adding at the end the following: 
‘‘This paragraph shall cease to be effective on October 1, 2022.’’; 
(2) in paragraph (2)(C)(ii), by striking ‘‘of 505(j)(5)(A)’’ and 
inserting ‘‘of section 505(j)(5)(A)’’; and 
(3) by adding at the end the following: 
‘‘(5) GENERIC DRUG APPLICANT PROGRAM FEE.— 
‘‘(A) IN GENERAL.—A person who fails to pay a fee 
as required under subsection (a)(5) by the date that is 
20 calendar days after the due date, as specified in subpara-
graph (D) of such subsection, shall be subject to the fol-
lowing: 
‘‘(i) The Secretary shall place the person on a pub-
licly available arrears list. 
‘‘(ii) Any abbreviated new drug application sub-
mitted by the generic drug applicant or an affiliate 
of such applicant shall not be received, within the 
meaning of section 505(j)(5)(A). 
‘‘(iii) All drugs marketed pursuant to any abbre-
viated new drug application held by such applicant 
or an affiliate of such applicant shall be deemed mis-
branded under section 502(aa). 
‘‘(B) APPLICATION OF PENALTIES.—The penalties under 
subparagraph (A) shall apply until the fee required under 
subsection (a)(5) is paid.’’. 
(g) LIMITATIONS.—Section 744B(h)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–42(h)(2)) is amended by striking 
‘‘for Type II active pharmaceutical ingredient drug master files, 
abbreviated new drug applications and prior approval supplements, 
and generic drug facilities and active pharmaceutical ingredient 
facilities’’. 
(h) CREDITING AND AVAILABILITY OF FEES.—Section 744B(i) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(i)) 
is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘subparagraphs 
(C) and (D)’’ and inserting ‘‘subparagraph (C)’’; 
(B) by striking subparagraph (C) (relating to fee collec-
tion during first program year); 
(C) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN
SUBSEQUENT 
YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 2013)’’; and 
(D) by redesignating subparagraph (D) as subpara-
graph (C); and 
(2) in paragraph (3), by striking ‘‘fiscal years 2013 through 
2017’’ and inserting ‘‘fiscal years 2018 through 2022’’. 
(i) INFORMATION
ON ABBREVIATED NEW DRUG APPLICATIONS 
OWNED BY APPLICANTS AND THEIR AFFILIATES.—Section 744B of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) 
is amended by adding at the end the following: 
‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG APPLICATIONS 
OWNED BY APPLICANTS AND THEIR AFFILIATES.— 
‘‘(1) IN GENERAL.—By April 1 of each year, each person 
that owns an abbreviated new drug application, or a designated 
affiliate of such person, shall submit, on behalf of the person 
and the affiliates of such person, to the Secretary a list of— 
Deadline. 
Lists. 
Public 
information. 
Lists. 
Deadline. 
Time period. 
Termination 
date. 
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131 STAT. 1027 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(A) all approved abbreviated new drug applications 
owned by such person; and 
‘‘(B) if any affiliate of such person also owns an abbre-
viated new drug application, all affiliates that own any 
such abbreviated new drug application and all approved 
abbreviated new drug applications owned by any such affil-
iate. 
‘‘(2) FORMAT
AND
METHOD.—The Secretary shall specify 
in guidance the format and method for submission of lists 
under this subsection.’’. 
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744C of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–43) is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘2013’’ and inserting ‘‘2018’’; and 
(B) by striking ‘‘Generic Drug User Fee Amendments 
of 2012’’ and inserting ‘‘Generic Drug User Fee Amend-
ments of 2017’’; 
(2) in subsection (b), by striking ‘‘2013’’ and inserting 
‘‘2018’’; and 
(3) in subsection (d), by striking ‘‘2017’’ each place it 
appears and inserting ‘‘2022’’. 
SEC. 305. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744A and 744B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall 
cease to be effective October 1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 744C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to 
be effective January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN GENERAL.—Effective October 1, 2017, section 304 
of the Food and Drug Administration Safety and Innovation 
Act (Public Law 112–144) is repealed. 
(2) CONFORMING
AMENDMENT.—The Food and Drug 
Administration Safety and Innovation Act (Public Law 112– 
144) is amended in the table of contents in section 2 by striking 
the item relating to section 304. 
SEC. 306. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2017, or the date of the enactment of this Act, whichever is 
later, except that fees under part 7 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all abbreviated new drug applications received on or after 
October 1, 2017, regardless of the date of the enactment of this 
Act. 
SEC. 307. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 7 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as in effect on the day before the date of the enact-
ment of this title, shall continue to be in effect with respect to 
abbreviated new drug applications (as defined in such part as 
of such day) that were received by the Food and Drug Administra-
tion within the meaning of section 505(j)(5)(A) of such Act (21 
21 USC 379j–41 
note. 
21 USC 379j–41 
note. 
Effective date. 
Repeal. 
21 USC 379j–41 
note, 379j–43 
note. 
21 USC 379j–43 
note. 
21 USC 379j–41 
note. 
Guidance. 
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131 STAT. 1028 
PUBLIC LAW 115–52—AUG. 18, 2017 
U.S.C. 355(j)(5)(A)), prior approval supplements that were sub-
mitted, and drug master files for Type II active pharmaceutical 
ingredients that were first referenced on or after October 1, 2012, 
but before October 1, 2017, with respect to assessing and collecting 
any fee required by such part for a fiscal year prior to fiscal 
year 2018. 
TITLE IV—FEES RELATING TO 
BIOSIMILAR BIOLOGICAL PRODUCTS 
SEC. 401. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Biosimilar 
User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated to expediting 
the process for the review of biosimilar biological product applica-
tions, including postmarket safety activities, as set forth in the 
goals identified for purposes of part 8 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act, in the letters 
from the Secretary of Health and Human Services to the Chairman 
of the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Chairman of the Committee on Energy and 
Commerce of the House of Representatives, as set forth in the 
Congressional Record. 
SEC. 402. DEFINITIONS. 
(a) ADJUSTMENT FACTOR.—Section 744G(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read 
as follows: 
‘‘(1) The term ‘adjustment factor’ applicable to a fiscal 
year is the Consumer Price Index for urban consumers (Wash-
ington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; 
All items) for October of the preceding fiscal year divided by 
such Index for October 2011.’’. 
(b) BIOSIMILAR BIOLOGICAL PRODUCT.—Section 744G(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(3)) is 
amended by striking ‘‘means a product’’ and inserting ‘‘means a 
specific strength of a biological product in final dosage form’’. 
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES. 
(a) TYPES OF FEES.—Section 744H(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–52(a)) is amended— 
(1) in the matter preceding paragraph (1), by striking ‘‘fiscal 
year 2013’’ and inserting ‘‘fiscal year 2018’’; 
(2) in the heading of paragraph (1), by striking ‘‘BIO-
SIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGICAL PRODUCT’’; 
(3) in paragraph (1)(A)(i), by striking ‘‘(b)(1)(A)’’ and 
inserting ‘‘(c)(5)’’; 
(4) in paragraph (1)(B)(i), by striking ‘‘(b)(1)(B) for bio-
similar biological product development’’ and inserting ‘‘(c)(5) 
for the biosimilar biological product development program’’; 
(5) in paragraph (1)(B)(ii), by striking ‘‘annual biosimilar 
biological product development program fee’’ and inserting 
‘‘annual biosimilar biological product development fee’’; 
21 USC 379j–51 
note. 
21 USC 301 note. 
Biosimilar User 
Fee Amendments 
of 2017. 
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131 STAT. 1029 
PUBLIC LAW 115–52—AUG. 18, 2017 
(6) in paragraph (1)(B)(iii), by striking ‘‘annual biosimilar 
development program fee’’ and inserting ‘‘annual biosimilar 
biological product development fee’’; 
(7) in paragraph (1)(B), by adding at the end the following: 
‘‘(iv) REFUND.—If a person submits a marketing 
application for a biosimilar biological product before 
October 1 of a fiscal year and such application is 
accepted for filing on or after October 1 of such fiscal 
year, the person may request a refund equal to the 
annual biosimilar biological product development fee 
paid by the person for the product for such fiscal year. 
To qualify for consideration for a refund under this 
clause, a person shall submit to the Secretary a written 
request for such refund not later than 180 days after 
the marketing application is accepted for filing.’’; 
(8) in paragraph (1)(C), by striking ‘‘for a product effective 
October 1 of a fiscal year by,’’ and inserting ‘‘for a product, 
effective October 1 of a fiscal year, by,’’; 
(9) in paragraph (1)(D)— 
(A) in clause (i) in the matter preceding subclause 
(I), by inserting ‘‘, if the person seeks to resume participa-
tion in such program,’’ before ‘‘pay a fee’’; 
(B) in clause (i)(I), by inserting after ‘‘grants a request’’ 
the following: ‘‘by such person’’; and 
(C) in clause (i)(II), by inserting after ‘‘discontinued)’’ 
the following: ‘‘by such person’’; 
(10) in the heading of paragraph (1)(E), by striking ‘‘BIO-
SIMILAR DEVELOPMENT PROGRAM’’; 
(11) in paragraph (1)(F)— 
(A) in the subparagraph heading, by striking ‘‘BIO-
SIMILAR DEVELOPMENT PROGRAM’’; and 
(B) by amending clause (i) to read as follows: 
‘‘(i) REFUNDS.—Except as provided in subpara-
graph (B)(iv), the Secretary shall not refund any initial 
or annual biosimilar biological product development 
fee paid under subparagraph (A) or (B), or any reactiva-
tion fee paid under subparagraph (D).’’; 
(12) in paragraph (2)— 
(A) in the paragraph heading, by striking ‘‘AND SUPPLE-
MENT’’; 
(B) by amending subparagraphs (A) and (B) to read 
as follows: 
‘‘(A) IN GENERAL.—Each person that submits, on or 
after October 1, 2017, a biosimilar biological product 
application shall be subject to the following fees: 
‘‘(i) A fee established under subsection (c)(5) for 
a biosimilar biological product application for which 
clinical data (other than comparative bioavailability 
studies) with respect to safety or effectiveness are 
required for approval. 
‘‘(ii) A fee established under subsection (c)(5) for 
a biosimilar biological product application for which 
clinical data (other than comparative bioavailability 
studies) with respect to safety or effectiveness are not 
required for approval. Such fee shall be equal to half 
of the amount of the fee described in clause (i). 
Deadline. 
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131 STAT. 1030 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(B) RULE OF APPLICABILITY; TREATMENT OF CERTAIN 
PREVIOUSLY PAID FEES.—Any person who pays a fee under 
subparagraph (A), (B), or (D) of paragraph (1) for a product 
before October 1, 2017, but submits a biosimilar biological 
product application for that product after such date, shall— 
‘‘(i) be subject to any biosimilar biological product 
application fees that may be assessed at the time when 
such biosimilar biological product application is sub-
mitted; and 
‘‘(ii) be entitled to no reduction of such application 
fees based on the amount of fees paid for that product 
before October 1, 2017, under such subparagraph (A), 
(B), or (D).’’; 
(C) in the heading of subparagraph (D), by striking 
‘‘OR SUPPLEMENT’’; 
(D) in subparagraphs (C) through (F), by striking ‘‘or 
supplement’’ each place it appears; and 
(E) in subparagraph (D), by striking ‘‘or a supplement’’; 
(13) by amending paragraph (3) to read as follows: 
‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEE.— 
‘‘(A) IN GENERAL.—Each person who is named as the 
applicant in a biosimilar biological product application shall 
pay the annual biosimilar biological product program fee 
established for a fiscal year under subsection (c)(5) for 
each biosimilar biological product that— 
‘‘(i) is identified in such a biosimilar biological 
product application approved as of October 1 of such 
fiscal year; and 
‘‘(ii) as of October 1 of such fiscal year, does not 
appear on a list, developed and maintained by the 
Secretary, of discontinued biosimilar biological prod-
ucts. 
‘‘(B) DUE DATE.—The biosimilar biological product pro-
gram fee for a fiscal year shall be due on the later of— 
‘‘(i) the first business day on or after October 1 
of each such year; or 
‘‘(ii) the first business day after the enactment 
of an appropriations Act providing for the collection 
and obligation of fees for such year under this section. 
‘‘(C) ONE FEE PER PRODUCT PER YEAR.—The biosimilar 
biological product program fee shall be paid only once for 
each product for each fiscal year. 
‘‘(D) LIMITATION.—A person who is named as the 
applicant in a biosimilar biological product application shall 
not be assessed more than 5 biosimilar biological product 
program fees for a fiscal year for biosimilar biological prod-
ucts identified in such biosimilar biological product applica-
tion.’’. 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) FISCAL YEAR 2018.—For fiscal year 2018, fees under 
subsection (a) shall be established to generate a total revenue 
amount equal to the sum of— 
‘‘(A) $45,000,000; and 
Deadlines. 
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131 STAT. 1031 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(B) the dollar amount equal to the fiscal year 2018 
adjustment (as determined under subsection (c)(4)). 
‘‘(2) SUBSEQUENT
FISCAL
YEARS.—For each of the fiscal 
years 2019 through 2022, fees under subsection (a) shall, except 
as provided in subsection (c), be established to generate a 
total revenue amount equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal year (as 
determined under paragraph (4)); 
‘‘(B) the dollar amount equal to the inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the capacity planning 
adjustment for the fiscal year (as determined under sub-
section (c)(2)); and 
‘‘(D) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(3)). 
‘‘(3) ALLOCATION OF REVENUE AMOUNT AMONG FEES; LIMITA-
TIONS ON FEE AMOUNTS.— 
‘‘(A) ALLOCATION.—The Secretary shall determine the 
percentage of the total revenue amount for a fiscal year 
to be derived from, respectively— 
‘‘(i) initial and annual biosimilar biological product 
development fees and reactivation fees under sub-
section (a)(1); 
‘‘(ii) biosimilar biological product application fees 
under subsection (a)(2); and 
‘‘(iii) biosimilar biological product program fees 
under subsection (a)(3). 
‘‘(B) LIMITATIONS ON FEE AMOUNTS.—Until the first 
fiscal year for which the capacity planning adjustment 
under subsection (c)(2) is effective, the amount of any fee 
under subsection (a) for a fiscal year after fiscal year 2018 
shall not exceed 125 percent of the amount of such fee 
for fiscal year 2018. 
‘‘(C) BIOSIMILAR
BIOLOGICAL
PRODUCT
DEVELOPMENT 
FEES.—The initial biosimilar biological product develop-
ment fee under subsection (a)(1)(A) for a fiscal year shall 
be equal to the annual biosimilar biological product 
development fee under subsection (a)(1)(B) for that fiscal 
year. 
‘‘(D) REACTIVATION FEE.—The reactivation fee under 
subsection (a)(1)(D) for a fiscal year shall be equal to twice 
the amount of the annual biosimilar biological product 
development fee under subsection (a)(1)(B) for that fiscal 
year. 
‘‘(4) ANNUAL BASE REVENUE.—For purposes of paragraph 
(2), the dollar amount of the annual base revenue for a fiscal 
year shall be the dollar amount of the total revenue amount 
for the previous fiscal year, excluding any adjustments to such 
revenue amount under subsection (c)(3).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 744H of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is 
amended— 
(1) by redesignating subsections (c) through (h) as sub-
sections (d) through (i), respectively; 
Determination. 
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131 STAT. 1032 
PUBLIC LAW 115–52—AUG. 18, 2017 
(2) in subsections (a)(2)(F) and (h) (as redesignated by 
paragraph (1)), by striking ‘‘subsection (c)’’ and inserting ‘‘sub-
section (d)’’; 
(3) in subsection (a)(4)(A), by striking ‘‘subsection (b)(1)(F)’’ 
and inserting ‘‘subsection (c)(5)’’; and 
(4) by inserting after subsection (b) the following: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of subsection (b)(2)(B), 
the dollar amount of the inflation adjustment to the annual 
base revenue for each fiscal year shall be equal to the 
product of— 
‘‘(i) such annual base revenue for the fiscal year 
under subsection (b); and 
‘‘(ii) the inflation adjustment percentage under 
subparagraph (B). 
‘‘(B) INFLATION ADJUSTMENT PERCENTAGE.—The infla-
tion adjustment percentage under this subparagraph for 
a fiscal year is equal to the sum of— 
‘‘(i) the average annual percent change in the cost, 
per full-time equivalent position of the Food and Drug 
Administration, of all personnel compensation and 
benefits paid with respect to such positions for the 
first 3 years of the preceding 4 fiscal years, multiplied 
by the proportion of personnel compensation and bene-
fits costs to total costs of the process for the review 
of biosimilar biological product applications (as defined 
in section 744G(13)) for the first 3 years of the pre-
ceding 4 fiscal years; and 
‘‘(ii) the average annual percent change that 
occurred in the Consumer Price Index for urban con-
sumers (Washington-Baltimore, DC–MD–VA–WV; Not 
Seasonally Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 4 years of available 
data multiplied by the proportion of all costs other 
than personnel compensation and benefits costs to total 
costs of the process for the review of biosimilar 
biological product applications (as defined in section 
744G(13)) for the first 3 years of the preceding 4 fiscal 
years. 
‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—Beginning with the fiscal year 
described in subparagraph (B)(ii)(II), the Secretary shall, 
in addition to the adjustment under paragraph (1), further 
increase the fee revenue and fees under this section for 
a fiscal year to reflect changes in the resource capacity 
needs of the Secretary for the process for the review of 
biosimilar biological product applications. 
‘‘(B) CAPACITY PLANNING METHODOLOGY.— 
‘‘(i) DEVELOPMENT; EVALUATION AND REPORT.—The 
Secretary shall obtain, through a contract with an 
independent accounting or consulting firm, a report 
evaluating options and recommendations for a new 
methodology to accurately assess changes in the 
resource and capacity needs of the process for the 
review of biosimilar biological product applications. The 
Contracts. 
Effective date. 
Time periods. 
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131 STAT. 1033 
PUBLIC LAW 115–52—AUG. 18, 2017 
capacity planning methodological options and rec-
ommendations presented in such report shall utilize 
and be informed by personnel time reporting data as 
an input. The report shall be published for public com-
ment not later than September 30, 2020. 
‘‘(ii) ESTABLISHMENT AND IMPLEMENTATION.—After 
review of the report described in clause (i) and receipt 
and review of public comments thereon, the Secretary 
shall establish a capacity planning methodology for 
purposes of this paragraph, which shall— 
‘‘(I) 
incorporate 
such 
approaches 
and 
attributes as the Secretary determines appro-
priate; and 
‘‘(II) be effective beginning with the first fiscal 
year for which fees are set after such capacity 
planning methodology is established. 
‘‘(C) LIMITATION.—Under no circumstances shall an 
adjustment under this paragraph result in fee revenue 
for a fiscal year that is less than the sum of the amounts 
under subsections (b)(2)(A) (the annual base revenue for 
the fiscal year) and (b)(2)(B) (the dollar amount of the 
inflation adjustment for the fiscal year). 
‘‘(D) PUBLICATION
IN
FEDERAL
REGISTER.—The Sec-
retary shall publish in the Federal Register notice under 
paragraph (5) the fee revenue and fees resulting from the 
adjustment and the methodologies under this paragraph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INTERIM APPLICATION; FEE REDUCTION.—Until the 
first fiscal year for which the capacity planning adjustment 
under paragraph (2) is effective, the Secretary may, in 
addition to the adjustment under paragraph (1), reduce 
the fee revenue and fees under this section for a fiscal 
year as the Secretary determines appropriate for long- 
term financial planning purposes. 
‘‘(B) GENERAL
APPLICATION
AND
METHODOLOGY.— 
Beginning with the first fiscal year for which the capacity 
planning adjustment under paragraph (2) is effective, the 
Secretary may, in addition to the adjustments under para-
graphs (1) and (2)— 
‘‘(i) reduce the fee revenue and fees under this 
section as the Secretary determines appropriate for 
long-term financial planning purposes; or 
‘‘(ii) increase the fee revenue and fees under this 
section if such an adjustment is necessary to provide 
for not more than 21 weeks of operating reserves of 
carryover user fees for the process for the review of 
biosimilar biological product applications. 
‘‘(C) FEDERAL
REGISTER
NOTICE.—If an adjustment 
under subparagraph (A) or (B) is made, the rationale for 
the amount of the increase or decrease (as applicable) 
in fee revenue and fees shall be contained in the annual 
Federal Register notice under paragraph (5)(B) establishing 
fee revenue and fees for the fiscal year involved. 
‘‘(4) FISCAL YEAR 2018 ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2018, the Secretary 
shall adjust the fee revenue and fees under this section 
in such amount (if any) as needed to reflect an updated 
Assessment. 
Time period. 
Effective date. 
Notice. 
Effective date. 
Publication. 
Public 
information. 
Deadline. 
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131 STAT. 1034 
PUBLIC LAW 115–52—AUG. 18, 2017 
assessment of the workload for the process for the review 
of biosimilar biological product applications. 
‘‘(B) METHODOLOGY.—The Secretary shall publish 
under paragraph (5)(B) a description of the methodology 
used to calculate the fiscal year 2018 adjustment under 
this paragraph in the Federal Register notice establishing 
fee revenue and fees for fiscal year 2018. 
‘‘(C) LIMITATION.—No adjustment under this paragraph 
shall result in an increase in fee revenue and fees under 
this section in excess of $9,000,000. 
‘‘(5) ANNUAL FEE SETTING.—For fiscal year 2018 and each 
subsequent fiscal year, the Secretary shall, not later than 60 
days before the start of each such fiscal year— 
‘‘(A) establish, for the fiscal year, initial and annual 
biosimilar biological product development fees and reactiva-
tion fees under subsection (a)(1), biosimilar biological 
product application fees under subsection (a)(2), and bio-
similar biological product program fees under subsection 
(a)(3), based on the revenue amounts established under 
subsection (b) and the adjustments provided under this 
subsection; and 
‘‘(B) publish such fee revenue and fees in the Federal 
Register. 
‘‘(6) LIMIT.—The total amount of fees assessed for a fiscal 
year under this section may not exceed the total costs for 
such fiscal year for the resources allocated for the process 
for the review of biosimilar biological product applications.’’. 
(d) APPLICATION FEE WAIVER FOR SMALL BUSINESS.—Subsection 
(d)(1) of section 744H of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–52), as redesignated by subsection (c)(1), is 
amended— 
(1) by striking subparagraph (B); 
(2) by striking ‘‘; and’’ at the end of subparagraph (A) 
and inserting a period; and 
(3) by striking ‘‘shall pay—’’ and all that follows through 
‘‘application fees’’ and inserting ‘‘shall pay application fees’’. 
(e) EFFECT OF FAILURE TO PAY FEES.—Subsection (e) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–52), as redesignated by subsection (c)(1), is amended by 
striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Subsection (f) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–52), as redesignated by subsection (c)(1), is amended— 
(1) in paragraph (2)— 
(A) by striking subparagraph (C) (relating to fee collec-
tion during first program year) and inserting the following: 
‘‘(C) COMPLIANCE.—The Secretary shall be considered 
to have met the requirements of subparagraph (B) in any 
fiscal year if the costs described in such subparagraph 
are not more than 15 percent below the level specified 
in such subparagraph.’’; and 
(B) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN
SUBSEQUENT 
YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 2013)’’; and 
(2) in paragraph (3), by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’. 
Federal Register, 
publication. 
Time period. 
Deadline. 
Federal Register, 
publication. 
Notice. 
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131 STAT. 1035 
PUBLIC LAW 115–52—AUG. 18, 2017 
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744I of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–53) is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘2013’’ and inserting ‘‘2018’’; and 
(B) by striking ‘‘Biosimilar User Fee Act of 2012’’ and 
inserting ‘‘Biosimilar User Fee Amendments of 2017’’; 
(2) in subsection (b), by striking ‘‘2013’’ and inserting 
‘‘2018’’; 
(3) by striking subsection (d); 
(4) by redesignating subsection (e) as subsection (d); and 
(5) in subsection (d), as so redesignated, by striking ‘‘2017’’ 
each place it appears and inserting ‘‘2022’’. 
SEC. 405. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H of the Federal 
Food, Drug, and Cosmetic Act shall cease to be effective October 
1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 744I of the Federal 
Food, Drug, and Cosmetic Act shall cease to be effective January 
31, 2023. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN GENERAL.—Effective October 1, 2017, section 404 
of the Food and Drug Administration Safety and Innovation 
Act (Public Law 112–144) is repealed. 
(2) CONFORMING
AMENDMENT.—The Food and Drug 
Administration Safety and Innovation Act (Public Law 112– 
144) is amended in the table of contents in section 2 by striking 
the item relating to section 404. 
SEC. 406. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2017, or the date of the enactment of this Act, whichever is 
later, except that fees under part 8 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all biosimilar biological product applications received on or after 
October 1, 2017, regardless of the date of the enactment of this 
Act. 
SEC. 407. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 8 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as in effect on the day before the date of the enact-
ment of this title, shall continue to be in effect with respect to 
biosimilar biological product applications and supplements (as 
defined in such part as of such day) that were accepted by the 
Food and Drug Administration for filing on or after October 1, 
2012, but before October 1, 2017, with respect to assessing and 
collecting any fee required by such part for a fiscal year prior 
to fiscal year 2018. 
Continuation. 
Time period. 
21 USC 379j–51 
note. 
21 USC 379j–51 
note. 
Effective date. 
Repeal. 
21 USC 379j–51 
note, 379j–53 
note. 
21 USC 379j–53 
note. 
21 USC 379j–51 
note. 
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131 STAT. 1036 
PUBLIC LAW 115–52—AUG. 18, 2017 
TITLE V—PEDIATRIC DRUGS AND 
DEVICES 
SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN. 
Section 409I of the Public Health Service Act (42 U.S.C. 284m) 
is amended— 
(1) in subsection (a)(2)(A)(ii), by inserting ‘‘and identifica-
tion of biomarkers for such diseases, disorders, or conditions,’’ 
after ‘‘biologics,’’; 
(2) in subsection (c)— 
(A) in paragraph (6)— 
(i) by amending subparagraph (B) to read as fol-
lows: 
‘‘(B) AVAILABILITY OF REPORTS.— 
‘‘(i) IN
GENERAL.—Each report submitted under 
subparagraph (A) shall be considered to be in the public 
domain (subject to section 505A(d)(4) of the Federal 
Food, Drug, and Cosmetic Act) and not later than 
90 days after submission of such report, shall be— 
‘‘(I) posted on the internet website of the 
National Institutes of Health in a manner that 
is accessible and consistent with all applicable Fed-
eral laws and regulations, including such laws and 
regulations for the protection of— 
‘‘(aa) 
human 
research 
participants, 
including with respect to privacy, security, 
informed 
consent, 
and 
protected 
health 
information; and 
‘‘(bb) proprietary interests, confidential 
commercial information, and intellectual prop-
erty rights; and 
‘‘(II) assigned a docket number by the Commis-
sioner of Food and Drugs and made available for 
the submission of public comments. 
‘‘(ii) SUBMISSION
OF
COMMENTS.—An interested 
person may submit written comments concerning such 
pediatric studies to the Commissioner of Food and 
Drugs, and the submitted comments shall become part 
of the docket file with respect to each of the drugs.’’; 
and 
(ii) in subparagraph (C), by striking ‘‘appropriate 
action’’ and all that follows through the period and 
inserting ‘‘action in a timely and appropriate manner 
in response to the reports submitted under subpara-
graph (A), and shall begin such action upon receipt 
of the report under subparagraph (A), in accordance 
with paragraph (7).’’; and 
(B) in paragraph (7)— 
(i) in the matter preceding subparagraph (A), by 
striking ‘‘During’’ and inserting ‘‘Within’’; 
(ii) in subparagraph (C)(i), by striking ‘‘place’’ and 
all that follows through ‘‘and of’’ and inserting ‘‘include 
in the public docket file a reference to the location 
of the report on the internet website of the National 
Institutes of Health and a copy of’’; and 
Public 
information. 
Web posting. 
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131 STAT. 1037 
PUBLIC LAW 115–52—AUG. 18, 2017 
(iii) in clause (ii), by striking ‘‘in the Federal Reg-
ister and’’; 
(3) by striking subsection (d); 
(4) by redesignating subsection (e) as subsection (d); and 
(5) in paragraph (1) of subsection (d), as so redesignated, 
by striking ‘‘2013 through 2017’’ and inserting ‘‘2018 through 
2022’’. 
SEC. 502. PEDIATRIC DEVICES. 
(a) PEDIATRIC USE OF DEVICES.—Section 515A(a)(3) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(3)) is 
amended— 
(1) by redesignating subparagraphs (B) through (D) as sub-
paragraphs (D) through (F), respectively; 
(2) by inserting after subparagraph (A) the following: 
‘‘(B) any information, based on a review of data avail-
able to the Secretary, regarding devices used in pediatric 
patients but not labeled for such use for which the Sec-
retary determines that approved pediatric labeling could 
confer a benefit to pediatric patients; 
‘‘(C) the number of pediatric devices that receive a 
humanitarian use exemption under section 520(m);’’; 
(3) in subparagraph (E), as so redesignated, by striking 
‘‘; and’’ and inserting ‘‘;’’; 
(4) in subparagraph (F) (as so redesignated), by striking 
‘‘(B), and (C).’’ and inserting ‘‘(C), (D), and (E);’’; and 
(5) by adding at the end the following: 
‘‘(G) the number of devices for which the Secretary 
relied on data with respect to adults to support a deter-
mination of a reasonable assurance of safety and effective-
ness in pediatric patients; and 
‘‘(H) the number of devices for which the Secretary 
relied on data from one pediatric subpopulation to support 
a determination of a reasonable assurance of safety and 
effectiveness in another pediatric subpopulation. 
For the items described in this paragraph, such report shall 
disaggregate the number of devices by pediatric subpopula-
tion.’’. 
(b) HUMANITARIAN DEVICE EXEMPTION.—Section 520(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 
amended— 
(1) in paragraph (4)— 
(A) in subparagraph (B), by inserting ‘‘or an appro-
priate local committee’’ after ‘‘review committee’’ each place 
such term appears; and 
(B) in the matter following subparagraph (B), by 
inserting ‘‘or an appropriate local committee’’ after ‘‘review 
committee’’ each place such term appears; and 
(2) in paragraph (6)(A)(iv), by striking ‘‘2017’’ and inserting 
‘‘2022’’. 
(c) DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC AVAIL-
ABILITY.—Section 305 of the Pediatric Medical Device Safety and 
Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note)) 
is amended— 
(1) in subsection (c)— 
(A) in paragraph (4), by striking ‘‘and’’ at the end; 
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131 STAT. 1038 
PUBLIC LAW 115–52—AUG. 18, 2017 
(B) in paragraph (5), by striking the period and 
inserting ‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(6) providing regulatory consultation to device sponsors 
in support of the submission of an application for a pediatric 
device, where appropriate.’’; and 
(2) in subsection (e), by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’. 
(d) MEETING ON PEDIATRIC DEVICE DEVELOPMENT.— 
(1) IN
GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and Human 
Services shall convene a public meeting on the development, 
approval or clearance, and labeling of pediatric medical devices. 
The Secretary shall invite to such meeting representatives from 
the medical device industry, academia, recipients of funding 
under section 305 of the Pediatric Medical Device Safety and 
Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 
note), medical provider organizations, and organizations rep-
resenting patients and consumers. 
(2) TOPICS.—The meeting described in paragraph (1) shall 
include consideration of ways to— 
(A) improve research infrastructure and research net-
works to facilitate the conduct of clinical studies of devices 
for pediatric populations that would result in the approval 
or clearance, and labeling, of medical devices for such popu-
lations; 
(B) appropriately use extrapolation under section 
515A(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e–1(b)); 
(C) enhance the appropriate use of postmarket reg-
istries and data to increase pediatric medical device 
labeling; 
(D) increase Food and Drug Administration assistance 
to medical device manufacturers in developing devices for 
pediatric populations that are approved or cleared, and 
labeled, for their use; and 
(E) identify current barriers to pediatric device develop-
ment and incentives to address such barriers. 
(3) 
REPORT.—The 
report 
submitted 
under 
section 
515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e–1(a)(3)) with respect to the calendar year in which 
the meeting described in paragraph (1) is held shall include 
a summary of, and responses to, recommendations raised in 
such meeting. 
SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN. 
(a) IN GENERAL.—Clause (i) of section 505B(e)(2)(C) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) 
is amended to read as follows: 
‘‘(i) shall meet with the applicant— 
‘‘(I) if requested by the applicant with respect 
to a drug or biological product that is intended 
to treat a serious or life-threatening disease or 
condition, to discuss preparation of the initial pedi-
atric study plan, not later than the end-of-Phase 
1 meeting (as such term is used in section 
312.82(b) of title 21, Code of Federal Regulations, 
Deadlines. 
Deadline. 
Public 
information. 
Consultation. 
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131 STAT. 1039 
PUBLIC LAW 115–52—AUG. 18, 2017 
or successor regulations) or within 30 calendar 
days of receipt of such request, whichever is later; 
‘‘(II) to discuss the initial pediatric study plan 
as soon as practicable, but not later than 90 cal-
endar days after the receipt of such plan under 
subparagraph (A); and 
‘‘(III) to discuss the bases for the deferral 
under subsection (a)(4) or a full or partial waiver 
under subsection (a)(5);’’. 
(b) CONFORMING CHANGES.—Section 505B(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended— 
(1) in the heading of paragraph (2), by striking ‘‘MEETING’’ 
and inserting ‘‘MEETINGS’’; 
(2) in the heading of paragraph (2)(C), by striking 
‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 
(3) in clauses (ii) and (iii) of paragraph (2)(C), by striking 
‘‘no meeting’’ each place it appears and inserting ‘‘no meeting 
under clause (i)(II)’’; and 
(4) in paragraph (3) by striking ‘‘meeting under paragraph 
(2)(C)(i)’’ and inserting ‘‘meeting under paragraph (2)(C)(i)(II)’’. 
SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR 
PEDIATRIC CANCERS. 
(a) MOLECULAR
TARGETS
REGARDING
CANCER
DRUGS
AND 
BIOLOGICAL PRODUCTS.—Section 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) by redesignating subparagraphs (A) and (B) 
as clauses (i) and (ii), respectively, and adjusting the 
margins accordingly; 
(ii) by striking ‘‘A person’’ and inserting the fol-
lowing: 
‘‘(A) GENERAL REQUIREMENTS.—Except with respect to 
an application for which subparagraph (B) applies, a per-
son’’; 
(iii) in clause (i), as so redesignated, by striking 
‘‘, or’’ at the end and inserting ‘‘; or’’; and 
(iv) by adding after subparagraph (A), as so des-
ignated by clause (ii), the following: 
‘‘(B) CERTAIN MOLECULARLY TARGETED CANCER INDICA-
TIONS.—A person that submits, on or after the date that 
is 3 years after the date of enactment of the FDA Reauthor-
ization Act of 2017, an original application for a new active 
ingredient under section 505 of this Act or section 351 
of the Public Health Service Act, shall submit with the 
application reports on the investigation described in para-
graph (3) if the drug or biological product that is the 
subject of the application is— 
‘‘(i) intended for the treatment of an adult cancer; 
and 
‘‘(ii) directed at a molecular target that the Sec-
retary determines to be substantially relevant to the 
growth or progression of a pediatric cancer.’’; 
(B) in paragraph (2)(A), by striking ‘‘paragraph (1)’’ 
and inserting ‘‘paragraph (1)(A)’’; 
Time period. 
Reports. 
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131 STAT. 1040 
PUBLIC LAW 115–52—AUG. 18, 2017 
(C) by redesignating paragraphs (3) and (4) as para-
graphs (4) and (5), respectively; 
(D) by inserting after paragraph (2) the following: 
‘‘(3) MOLECULARLY TARGETED PEDIATRIC CANCER INVESTIGA-
TION.— 
‘‘(A) IN GENERAL.—With respect to a drug or biological 
product described in paragraph (1)(B), the investigation 
described in this paragraph is a molecularly targeted pedi-
atric cancer investigation, which shall be designed to yield 
clinically meaningful pediatric study data, gathered using 
appropriate formulations for each age group for which the 
study is required, regarding dosing, safety, and preliminary 
efficacy to inform potential pediatric labeling. 
‘‘(B) EXTRAPOLATION OF DATA.—Paragraph (2)(B) shall 
apply to investigations described in this paragraph to the 
same extent and in the same manner as paragraph (2)(B) 
applies with respect to the assessments required under 
paragraph (1)(A). 
‘‘(C) DEFERRALS AND WAIVERS.—Deferrals and waivers 
under paragraphs (4) and (5) shall apply to investigations 
described in this paragraph to the same extent and in 
the same manner as such deferrals and waivers apply 
with respect to the assessments under paragraph (2)(B).’’; 
(E) in paragraph (4), as so redesignated— 
(i) by striking ‘‘assessments required under para-
graph (1)’’ each place it appears and inserting ‘‘assess-
ments required under paragraph (1)(A) or reports on 
the investigation required under paragraph (1)(B)’’; 
(ii) in subparagraph (A)(ii)(I), by inserting ‘‘or 
reports on the investigation’’ after ‘‘assessments’’; 
(iii) in subparagraph (B)(ii), by striking ‘‘assess-
ment under paragraph (1)’’ and inserting ‘‘assessment 
under paragraph (1)(A) or reports on the investigation 
under paragraph (1)(B)’’; and 
(iv) in subparagraph (C)(ii)(II), by inserting ‘‘or 
investigation’’ after ‘‘assessment’’; and 
(F) in paragraph (5), as so redesignated, by inserting 
‘‘or reports on the investigation’’ after ‘‘assessments’’ each 
place it appears; 
(2) in subsection (d)— 
(A) by striking ‘‘subsection (a)(3)’’ each place it appears 
and inserting ‘‘subsection (a)(4)’’; 
(B) by inserting ‘‘AND REPORTS ON THE INVESTIGATION’’ 
after ‘‘SUBMISSION OF ASSESSMENTS’’ in the heading; and 
(C) by inserting ‘‘or the investigation described in sub-
section (a)(3)’’ after ‘‘assessment described in subsection 
(a)(2)’’ each place it appears; 
(3) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘or the investigation 
described in subsection (a)(3)’’ after ‘‘under subsection 
(a)(2)’’; and 
(B) in paragraph (2)(A)(i), by inserting ‘‘or the inves-
tigation described in subsection (a)(3)’’ after ‘‘under sub-
section (a)(2)’’; and 
(4) by adding at the end the following: 
‘‘(m) LIST OF PRIMARY MOLECULAR TARGETS.— 
Applicability. 
Applicability. 
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131 STAT. 1041 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(1) IN GENERAL.—Within one year of the date of enactment 
of the FDA Reauthorization Act of 2017, the Secretary shall 
establish and update regularly, and shall publish on the inter-
net website of the Food and Drug Administration— 
‘‘(A) a list of molecular targets considered, on the basis 
of data the Secretary determines to be adequate, to be 
substantially relevant to the growth and progression of 
a pediatric cancer, and that may trigger the requirements 
under this section; and 
‘‘(B) a list of molecular targets of new cancer drugs 
and biological products in development for which pediatric 
cancer study requirements under this section will be auto-
matically waived. 
‘‘(2) CONSULTATION.—In establishing the lists described in 
paragraph (1), the Secretary shall consult the National Cancer 
Institute, members of the internal committee under section 
505C, and the Pediatric Oncology Subcommittee of the Onco-
logic Drugs Advisory Committee, and shall take into account 
comments from the meeting under subsection (c). 
‘‘(3) RULE OF CONSTRUCTION.—Nothing in paragraph (1) 
shall be construed— 
‘‘(A) to require the inclusion of a molecular target on 
the list published under such paragraph as a condition 
for triggering the requirements under subsection (a)(1)(B) 
with respect to a drug or biological product directed at 
such molecular target; or 
‘‘(B) to authorize the disclosure of confidential commer-
cial information, as prohibited under section 301(j) of this 
Act or section 1905 of title 18, United States Code.’’. 
(b) ORPHAN DRUGS.—Section 505B(k) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows: 
‘‘(k) RELATION TO ORPHAN DRUGS.— 
‘‘(1) IN GENERAL; EXEMPTION FOR ORPHAN INDICATIONS.— 
Unless the Secretary requires otherwise by regulation and 
except as provided in paragraph (2), this section does not apply 
to any drug or biological product for an indication for which 
orphan designation has been granted under section 526. 
‘‘(2) APPLICABILITY DESPITE ORPHAN DESIGNATION OF CER-
TAIN INDICATIONS.—This section shall apply with respect to 
a drug or biological product for which an indication has been 
granted orphan designation under 526 if the investigation 
described in subsection (a)(3) applies to the drug or biological 
product as described in subsection (a)(1)(B).’’. 
(c) MEETING, CONSULTATION, AND GUIDANCE.— 
(1) MEETING.—The Secretary of Health and Human Serv-
ices (referred to in this subsection as the ‘‘Secretary’’), acting 
through the Commissioner of Food and Drugs and in collabora-
tion with the Director of the National Cancer Institute, shall 
convene a public meeting not later than 1 year after the date 
of enactment of this Act to solicit feedback from physicians 
and researchers (including pediatric oncologists and rare dis-
ease specialists), patients, and other stakeholders to provide 
input on development of the guidance under paragraph (2) 
and the list under subsection (m) of section 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as added by 
subsection (a). The Secretary shall seek input at such meeting 
on— 
Deadline. 
21 USC 355c 
note. 
Waiver. 
Deadline. 
Update. 
Web posting. 
Lists. 
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131 STAT. 1042 
PUBLIC LAW 115–52—AUG. 18, 2017 
(A) the data necessary to determine that there is sci-
entific evidence that a drug or biological product is directed 
at a molecular target that is considered to be substantially 
relevant to the growth or progression of a pediatric cancer; 
(B) the data necessary to determine that there is sci-
entific evidence that a molecular target is considered to 
be substantially relevant to the growth or progression of 
a pediatric cancer; 
(C) the data needed to meet the requirement of con-
ducting an investigation described in section 505B(a)(3) 
of the Federal Food, Drug, and Cosmetic Act, as amended 
by subsection (a); 
(D) considerations when developing the list under sec-
tion 505B(m) of the Federal Food, Drug, and Cosmetic 
Act that contains molecular targets shared between dif-
ferent tumor types; 
(E) the process the Secretary shall utilize to update 
regularly a list of molecular targets that may trigger a 
pediatric study under section 505B of the Federal Food, 
Drug, and Cosmetic Act, as so amended, and how often 
such updates shall occur; 
(F) how to overcome the challenges related to pediatric 
cancer drug and biological product development, including 
issues related to the ethical, practical, and other barriers 
to conducting clinical trials in pediatric cancer with small 
patient populations; 
(G) scientific or operational challenges associated with 
performing 
an 
investigation 
described 
in 
section 
505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic 
Act, including the effect on pediatric studies currently 
underway in a pediatric patient population, treatment of 
a pediatric patient population, and the ability to complete 
adult clinical trials; 
(H) the advantages and disadvantages of innovative 
clinical trial designs in addressing the development of 
cancer drugs or biological products directed at molecular 
targets in pediatric cancer patients; 
(I) the ways in which the Secretary can improve the 
current process outlined under sections 505A and 505B 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a, 355c) to encourage additional research and develop-
ment of pediatric cancer treatments; 
(J) the ways in which the Secretary might streamline 
and improve the written request process, including when 
studies contained in a request under such section 505A 
are not feasible due to the ethical, practical, or other bar-
riers to conducting clinical trials in pediatric cancer popu-
lations; 
(K) how the Secretary will facilitate collaboration 
among pediatric networks, academic centers and experts 
in pediatric cancer to conduct an investigation described 
in such section 505B(a)(3); 
(L) how the Secretary may facilitate collaboration 
among sponsors of same-in-class drugs and biological prod-
ucts that would be subject to the requirements for an 
investigation under such section 505B based on shared 
molecular targets; and 
Lists. 
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131 STAT. 1043 
PUBLIC LAW 115–52—AUG. 18, 2017 
(M) the ways in which the Secretary will help to miti-
gate the risks, if any, of discouraging the research and 
development of orphan drugs when implementing such sec-
tion 505B as amended. 
(2) GUIDANCE.—Not later than 2 years after the date of 
enactment of this Act, the Secretary, acting through the 
Commissioner of Food and Drugs, shall issue final guidance 
on implementation of the amendments to section 505B of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) 
regarding molecularly targeted cancer drugs made by this sec-
tion, including— 
(A) the scientific criteria, types of data, and regulatory 
considerations for determining whether a molecular target 
is substantially relevant to the growth or progression of 
a pediatric cancer and would trigger an investigation under 
section 505B of the Federal Food, Drug, and Cosmetic 
Act, as amended; 
(B) the process by which the Secretary will engage 
with sponsors to discuss determinations, investigation 
requirements, deferrals, waivers, and any other issues that 
need to be resolved to ensure that any required investiga-
tion based on a molecular target can be reasonably con-
ducted; 
(C) the scientific or operational challenges for which 
the Secretary may issue deferrals or waivers for an inves-
tigation described in subsection (a)(3) of such section 505B, 
including adverse impacts on current pediatric studies 
underway in a pediatric patient population, studies 
involving drugs designated as orphan drugs, treatment of 
a pediatric patient population, or the ability to complete 
adult clinical trials; 
(D) how the Secretary and sponsors will facilitate 
collaboration among pediatric networks, academic centers, 
and experts in pediatric cancer to conduct an investigation 
described in subsection (a)(3) of such section 505B; 
(E) scientific and regulatory considerations for study 
designs, including the applicability of innovative clinical 
trial designs for pediatric cancer drug and biological 
product developments under sections 505A and 505B of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 
355c); 
(F) approaches to streamline and improve the amend-
ment process, including when studies contained in a 
request under such section 505A are not feasible due to 
the ethical, practical, or other barriers to conducting clinical 
trials in pediatric cancer populations; 
(G) the process for submission of an initial pediatric 
study plan for the investigation described in section 
505B(a)(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(a)(3)), including the process for a sponsor 
to meet and reach agreement with the Secretary on the 
initial pediatric study plan; and 
(H) considerations for implementation of such section 
505B, as so amended, and waivers of the requirements 
of such section 505B with regard to molecular targets for 
which several drugs or biological products may be under 
investigation. 
Plan. 
Criteria. 
Deadline. 
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131 STAT. 1044 
PUBLIC LAW 115–52—AUG. 18, 2017 
(d) REPORT
TO CONGRESS.—Section 508(b) of the Food and 
Drug Administration Safety and Innovation Act (21 U.S.C. 355c– 
1(b)) is amended— 
(1) in paragraph (10), by striking ‘‘; and’’ and inserting 
‘‘;’’; and 
(2) by striking paragraph (11) and inserting the following: 
‘‘(11) an assessment of the impact of the amendments to 
such section 505B made by the FDA Reauthorization Act of 
2017 on pediatric research and labeling of drugs and biological 
products and pediatric labeling of molecularly targeted drugs 
and biological products for the treatment of cancer; 
‘‘(12) an assessment of the efforts of the Secretary to imple-
ment the plan developed under section 505C–1 of the Federal 
Food, Drug, and Cosmetic Act, regarding earlier submission 
of pediatric studies under sections 505A and 505B of such 
Act and section 351(m) of the Public Health Service Act, 
including— 
‘‘(A) the average length of time after the approval 
of an application under section 505(b)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or sec-
tion 351(a) of the Public Health Service Act (42 U.S.C. 
262(a)) before studies conducted pursuant to such section 
505A, 505B, or section 351(m) are completed, submitted, 
and incorporated into labeling; 
‘‘(B) the average length of time after the receipt of 
a proposed pediatric study request before the Secretary 
responds to such request; 
‘‘(C) the average length of time after the submission 
of a proposed pediatric study request before the Secretary 
issues a written request for such studies; 
‘‘(D) the number of written requests issued for each 
investigational new drug or biological product prior to the 
submission of an application under section 505(b)(1) of 
the Federal Food, Drug, and Cosmetic Act or section 351(a) 
of the Public Health Service Act; and 
‘‘(E) the average number, and range of numbers, of 
amendments to written requests issued, and the time the 
Secretary requires to review and act on proposed amend-
ments to written requests; 
‘‘(13) a list of sponsors of applications or holders of approved 
applications who received exclusivity under such section 505A 
or such section 351(m) after receiving a letter issued under 
such section 505B(d)(1) for any drug or biological product before 
the studies referred to in such letter were completed and sub-
mitted; 
‘‘(14) a list of assessments and investigations required 
under such section 505B; 
‘‘(15) how many requests under such section 505A for molec-
ular targeted cancer drugs, as defined by subsection (a)(1)(B) 
of such section 505B, approved prior to 3 years after the date 
of enactment of the FDA Reauthorization Act of 2017, have 
been issued by the Food and Drug Administration, and how 
many such requests have been completed; and 
‘‘(16) the Secretary’s assessment of the overall impact of 
the amendments made by section 504 of the FDA Reauthoriza-
tion Act of 2017 on the conduct and effectiveness of pediatric 
Assessment. 
Lists. 
Lists. 
Assessment. 
Assessment. 
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131 STAT. 1045 
PUBLIC LAW 115–52—AUG. 18, 2017 
cancer research and the orphan drug program, as well any 
subsequent recommendations.’’. 
(e) RULE OF CONSTRUCTION.—Nothing in this section, including 
the amendments made by this section, shall limit the authority 
of the Secretary of Health and Human Services to issue written 
requests under section 505A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355a) or section 351(m) of the Public Health 
Service Act (42 U.S.C. 262(m)), or to negotiate or implement amend-
ments to such requests proposed by the an applicant. 
(f) GAO REPORT.— 
(1) IN GENERAL.—Beginning on the date that is 5 years 
after the date of enactment of this Act, the Comptroller General 
of the United States shall conduct a study of the effectiveness 
of requiring assessments and investigations described in section 
505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c), as amended by this section, in the development of drugs 
and biological products for pediatric cancer indications. The 
Comptroller General shall examine— 
(A) the indications and associated molecular targets 
studied in assessments and investigations required for 
drugs or biological products intended for the treatment 
of an adult cancer; 
(B) the indication for which the study was requested 
as compared to the indication requested under the new 
drug application filed by the sponsor; 
(C) the number of pediatric cancer indications for which 
assessments and investigations have been required under 
such section 505B; 
(D) the number of requests for deferral and waiver 
of pediatric assessments and investigations required under 
such section and the number of such deferral and waiver 
requests granted and denied; 
(E) the number of orphan-designated indications for 
drugs and biological products for which assessments and 
investigations were required under such section; 
(F) the number of drugs and biological products 
approved for the treatment of cancer in the pediatric popu-
lation for which the supportive studies were required to 
be conducted under such section; 
(G) the number of written requests made under section 
505A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a) relating to investigations required under sub-
section (a)(1)(B) of such section 505B; and 
(H) any additional considerations by the Secretary 
regarding the effectiveness of requiring pediatric assess-
ments described in such section 505B in the development 
of drugs and biological products for pediatric cancer indica-
tions. 
(2) REVIEW.—The study under paragraph (1) shall include 
a review of the Food and Drug Administration’s use of the 
authority under section 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c), as amended by this section, 
including the amendments to the deferral and waiver criteria 
under such section and how such criteria have been applied. 
(3) CONSULTATION.—In conducting the study under para-
graph (1), the Comptroller General of the United States shall 
consult with appropriate stakeholders that may be required 
Criteria. 
Examination. 
Effective date. 
Time period. 
Study. 
21 USC 355c 
note. 
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131 STAT. 1046 
PUBLIC LAW 115–52—AUG. 18, 2017 
to conduct the trials under section 505B of the Federal Food, 
Drug, and Cosmetic Act, and the ability of such stakeholders 
to adhere to the requests issued by the Food and Drug Adminis-
tration. 
(4) REPORT.—Not later than the date that is 6 years after 
the date of enactment of this Act, the Comptroller General 
of the United States shall submit a report containing the results 
of the study under paragraph (1) to the Secretary of Health 
and Human Services, the Committee on Health, Education, 
Labor, and Pensions of the Senate, and the Committee on 
Energy and Commerce of the House of Representatives. 
SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND 
BIOLOGICAL PRODUCTS FOR PEDIATRIC USE. 
(a) INFORMING INTERNAL REVIEW COMMITTEE.—Section 505A(f) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) 
is amended by adding at the end the following: 
‘‘(7) INFORMING INTERNAL REVIEW COMMITTEE.—The Sec-
retary shall provide to the committee referred to in paragraph 
(1) any response issued to an applicant or holder with respect 
to a proposed pediatric study request.’’. 
(b) ACTION ON SUBMISSIONS.— 
(1) IN
GENERAL.—Section 505A(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a(d)) is amended— 
(A) by redesignating paragraphs (3) through (5) as 
paragraphs (4) through (6), respectively; and 
(B) by inserting after paragraph (2) the following: 
‘‘(3) ACTION ON SUBMISSIONS.—The Secretary shall review 
and act upon a submission by a sponsor or holder of a proposed 
pediatric study request or a proposed amendment to a written 
request for pediatric studies within 120 calendar days of the 
submission.’’. 
(2) CONFORMING AMENDMENTS.— 
(A) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Section 
505A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a), as amended by paragraph (1), is further 
amended by striking subsection ‘‘(d)(3)’’ each place it 
appears and inserting ‘‘(d)(4)’’. 
(B) PUBLIC HEALTH SERVICE ACT.—Paragraphs (2), (3), 
and (4) of section 351(m) of the Public Health Service 
Act (42 U.S.C. 262(m)) are amended by striking ‘‘section 
505A(d)(3)’’ each place it appears and inserting ‘‘section 
505A(d)(4)’’. 
(c) PLAN.—The Secretary of Health and Human Services, acting 
through the internal review committee established under section 
505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355d) shall, not later than one year after the date of enactment 
of this Act, develop and implement a plan to achieve, when appro-
priate, earlier submission of pediatric studies under section 505A 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 
or section 351(m) of the Public Health Service Act (42 U.S.C. 
262(m)). Such plan shall include recommendations to achieve— 
(1) earlier discussion of proposed pediatric study requests 
and written requests with sponsors, and if appropriate, discus-
sion of such requests at the meeting required under section 
505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a); 
Recommenda- 
tions. 
Deadline. 
21 USC 355a 
note. 
Deadline. 
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131 STAT. 1047 
PUBLIC LAW 115–52—AUG. 18, 2017 
(2) earlier issuance of written requests for a pediatric study 
under such section 505A, including for investigational new 
drugs prior to the submission of an application under section 
505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and 
(3) shorter timelines, when appropriate, for the completion 
of studies pursuant to a written request under such section 
505A or such section 351(m). 
(d) NEONATOLOGY EXPERTISE.— 
(1) IN GENERAL.—Section 6(d) of the Best Pharmaceuticals 
for Children Act (21 U.S.C. 393a(d)) is amended by striking 
‘‘For the 5-year period beginning on the date of enactment 
of this subsection, at’’ and inserting ‘‘At’’. 
(2) DRAFT GUIDANCE.—Not later than 2 years after the 
date of enactment of this Act, the Secretary shall issue draft 
guidance on clinical pharmacology considerations for neonatal 
studies for drugs and biological products. 
(e) SUBMISSION OF ASSESSMENTS.—Section 505B(d)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is 
amended by adding at the end the following: ‘‘The Secretary shall 
inform the Pediatric Advisory Committee of letters issued under 
this paragraph and responses to such letters.’’. 
(f) INTERNAL COMMITTEE.—Section 505C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355d) is amended by inserting 
‘‘or pediatric rare diseases’’ after ‘‘psychiatry’’. 
(g) REPORT ON LABELING OF ORPHAN DRUGS.— 
(1) IN GENERAL.—Not later than 2 years after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on Health, 
Education, Labor and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Representa-
tives, and make publicly available, including through posting 
on the internet website of the Food and Drug Administration, 
a report on the lack of information in the labeling of drugs 
for indications that have received an orphan designation under 
section 526 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb) with respect to the use of such drugs pediatric 
populations. 
(2) CONTENTS.—The report described in paragraph (1) shall 
include— 
(A) a list of drugs for which— 
(i) an indication was granted an orphan designa-
tion under section 526 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb); 
(ii) 
an 
application 
described 
under 
section 
505B(a)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)(1)) for such indication was sub-
mitted to the Secretary of Health and Human Services 
on or after April 1, 1999; and 
(iii) the labeling for such indication lacks impor-
tant pediatric information, including information 
related to safety, dosing, and effectiveness; 
(B) a description of the lack of information referred 
to in subparagraph (A)(iii) for each drug for an indication 
on such list; and 
(C) Federal policy recommendations to improve the 
labeling of drugs for indications that have received an 
Recommenda- 
tions. 
Lists. 
Public 
information. 
Web posting. 
Deadline. 
21 USC 355a 
note. 
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131 STAT. 1048 
PUBLIC LAW 115–52—AUG. 18, 2017 
orphan designation under such section 526 with respect 
to the use of such drugs pediatric populations.’’ 
TITLE VI—REAUTHORIZATIONS AND 
IMPROVEMENTS RELATED TO DRUGS 
SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLU-
SIVITY 
OF 
CERTAIN 
DRUGS 
CONTAINING 
SINGLE 
ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(u)(4)) is amended by striking ‘‘2017’’ and 
inserting ‘‘2022’’. 
SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
PARTNERSHIPS. 
Section 566(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–5(f)) is amended by striking ‘‘2013 through 2017’’ 
and inserting ‘‘2018 through 2022’’. 
SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM. 
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is 
amended by striking ‘‘2013 through 2017’’ and inserting ‘‘2018 
through 2022’’. 
SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY 
CHAIN. 
(a) DIVERTED DRUGS.—Paragraph (1) of section 801(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is 
amended— 
(1) by striking ‘‘(d)(1) Except as’’ and inserting ‘‘(d)(1)(A) 
Except as’’; and 
(2) by adding at the end the following: 
‘‘(B) Except as authorized by the Secretary in the case of 
a drug that appears on the drug shortage list under section 506E 
or in the case of importation pursuant to section 804, no drug 
that is subject to section 503(b)(1) may be imported into the United 
States for commercial use if such drug is manufactured outside 
the United States, unless the manufacturer has authorized the 
drug to be marketed in the United States and has caused the 
drug to be labeled to be marketed in the United States.’’. 
(b) COUNTERFEIT DRUGS.—Subsection (b) of section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended 
by adding at the end the following: 
‘‘(8) Notwithstanding subsection (a), any person who violates 
section 301(i)(3) by knowingly making, selling or dispensing, or 
holding for sale or dispensing, a counterfeit drug shall be imprisoned 
for not more than 10 years or fined in accordance with title 18, 
United States Code, or both.’’. 
SEC. 605. PATIENT EXPERIENCE DATA. 
Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is amended by striking ‘‘impact 
of such disease or condition, or a related therapy,’’ and inserting 
‘‘impact (including physical and psychosocial impacts) of such dis-
ease or condition, or a related therapy or clinical investigation’’. 
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131 STAT. 1049 
PUBLIC LAW 115–52—AUG. 18, 2017 
SEC. 606. COMMUNICATION PLANS. 
Section 505–1(e)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355–1(e)(3)) is amended— 
(1) in subparagraph (B), by striking ‘‘; or’’; 
(2) in subparagraph (C), by striking the period and 
inserting ‘‘; or’’; and 
(3) by adding at the end the following: 
‘‘(D) disseminating information to health care providers 
about drug formulations or properties, including informa-
tion about the limitations or patient care implications of 
such formulations or properties, and how such formulations 
or properties may be related to serious adverse drug events 
associated with use of the drug.’’. 
SEC. 607. ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following paragraph 
(2), by striking ‘‘such drug for such disease or condition’’ and 
inserting ‘‘the same drug for the same disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘If an application’’ and all that follows through ‘‘such license 
if’’ and inserting ‘‘During the 7-year period described in 
subsection (a) for an approved application under section 
505 or license under section 351 of the Public Health 
Service Act, the Secretary may approve an application or 
issue a license for a drug that is otherwise the same, 
as determined by the Secretary, as the already approved 
drug for the same rare disease or condition if’’; 
(B) in paragraph (1), by striking ‘‘notice’’ and all that 
follows through ‘‘assure’’ and inserting ‘‘of exclusive 
approval or licensure notice and opportunity for the submis-
sion of views, that during such period the holder of the 
exclusive approval or licensure cannot ensure’’; and 
(C) in paragraph (2), by striking ‘‘such holder provides’’ 
and inserting ‘‘the holder provides’’; and 
(3) by adding at the end the following: 
‘‘(c) CONDITION OF CLINICAL SUPERIORITY.— 
‘‘(1) IN GENERAL.—If a sponsor of a drug that is designated 
under section 526 and is otherwise the same, as determined 
by the Secretary, as an already approved or licensed drug 
is seeking exclusive approval or exclusive licensure described 
in subsection (a) for the same rare disease or condition as 
the already approved drug, the Secretary shall require such 
sponsor, as a condition of such exclusive approval or licensure, 
to demonstrate that such drug is clinically superior to any 
already approved or licensed drug that is the same drug. 
‘‘(2) DEFINITION.—For purposes of paragraph (1), the term 
‘clinically superior’ with respect to a drug means that the 
drug provides a significant therapeutic advantage over and 
above an already approved or licensed drug in terms of greater 
efficacy, greater safety, or by providing a major contribution 
to patient care. 
‘‘(d) REGULATIONS.—The Secretary may promulgate regulations 
for the implementation of subsection (c). Beginning on the date 
of enactment of the FDA Reauthorization Act of 2017, until such 
Applicability. 
Time period. 
Determination. 
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131 STAT. 1050 
PUBLIC LAW 115–52—AUG. 18, 2017 
time as the Secretary promulgates regulations in accordance with 
this subsection, the Secretary may apply any definitions set forth 
in regulations that were promulgated prior to such date of enact-
ment, to the extent such definitions are not inconsistent with the 
terms of this section, as amended by such Act. 
‘‘(e) DEMONSTRATION OF CLINICAL SUPERIORITY STANDARD.— 
To assist sponsors in demonstrating clinical superiority as described 
in subsection (c), the Secretary— 
‘‘(1) upon the designation of any drug under section 526, 
shall notify the sponsor of such drug in writing of the basis 
for the designation, including, as applicable, any plausible 
hypothesis offered by the sponsor and relied upon by the Sec-
retary that the drug is clinically superior to a previously 
approved drug; and 
‘‘(2) upon granting exclusive approval or licensure under 
subsection (a) on the basis of a demonstration of clinical superi-
ority as described in subsection (c), shall publish a summary 
of the clinical superiority findings.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in the amendments made 
by subsection (a) shall affect any determination under sections 
526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bb, 360cc) made prior to the date of enactment of the 
FDA Reauthorization Act of 2017. 
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING. 
Section 505A(o) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a(o)) is amended— 
(1) in the subsection heading, by striking ‘‘UNDER SECTION 
505(j)’’; 
(2) in paragraph (1)— 
(A) by striking ‘‘under section 505(j)’’ and inserting 
‘‘under subsection (b)(2) or (j) of section 505’’; and 
(B) by striking ‘‘or by exclusivity under clause (iii) 
or (iv) of section 505(j)(5)(F)’’ and inserting ‘‘, or by exclu-
sivity under clause (iii) or (iv) of section 505(j)(5)(F), clause 
(iii) or (iv) of section 505(c)(3)(E), or section 527(a), or 
by an extension of such exclusivity under this section or 
section 505E’’; 
(3) in paragraph (2), in the matter preceding subparagraph 
(A)— 
(A) by inserting ‘‘clauses (iii) and (iv) of section 
505(c)(3)(E), or section 527,’’ after ‘‘section 505(j)(5)(F),’’; 
and 
(B) by striking ‘‘drug approved under section 505(j)’’ 
and inserting ‘‘drug approved pursuant to an application 
submitted under subsection (b)(2) or (j) of section 505’’; 
and 
(4) by amending paragraph (3) to read as follows: 
‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND EXTEN-
SIONS.—This subsection does not affect— 
‘‘(A) the availability or scope of exclusivity under— 
‘‘(i) this section; 
‘‘(ii) section 505 for pediatric formulations; or 
‘‘(iii) section 527; 
‘‘(B) the availability or scope of an extension to any 
such exclusivity, including an extension under this section 
or section 505E; 
21 USC 360cc 
note. 
Publication. 
Summary. 
Notification. 
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131 STAT. 1051 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(C) the question of the eligibility for approval under 
section 505 of any application described in subsection (b)(2) 
or (j) of such section that omits any other aspect of labeling 
protected by exclusivity under— 
‘‘(i) clause (iii) or (iv) of section 505(j)(5)(F); 
‘‘(ii) clause (iii) or (iv) of section 505(c)(3)(E); or 
‘‘(iii) section 527(a); or 
‘‘(D) except as expressly provided in paragraphs (1) 
and (2), the operation of section 505 or section 527.’’. 
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIP-
TION DRUGS. 
It is the sense of the Congress that the Secretary of Health 
and Human Services should commit to engaging with the House 
of Representatives and the Senate to take administrative actions 
and enact legislative changes that— 
(1) will lower the cost of prescription drugs for consumers 
and reduce the burden of such cost on taxpayers; and 
(2) in lowering such cost, will— 
(A) balance the need to encourage innovation with 
the need to improve affordability; and 
(B) strive to increase competition in the pharmaceutical 
market, prevent anticompetitive behavior, and promote the 
timely availability of affordable, high-quality generic drugs 
and biosimilars. 
SEC. 610. EXPANDED ACCESS. 
(a) PATIENT ACCESS TO INVESTIGATIONAL DRUGS.— 
(1) PUBLIC MEETING.— 
(A) IN GENERAL.—The Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), 
acting through the Commissioner of Food and Drugs, in 
coordination with the Director of the National Institutes 
of Health, and in consultation with patients, health care 
providers, drug sponsors, bioethicists, and other stake-
holders, shall, not later than 270 days after the date of 
enactment of this Act, convene a public meeting to discuss 
clinical trial inclusion and exclusion criteria to inform the 
guidance under paragraph (3). The Secretary shall inform 
the Comptroller General of the United States of the date 
when the public meeting will take place. 
(B) TOPICS.—The Secretary shall make available on 
the internet website of the Food and Drug Administration 
a report on the topics discussed at the meeting described 
in subparagraph (A) within 90 days of such meeting. Such 
topics shall include discussion of— 
(i) the rationale for, and potential barriers for 
patients created by, research clinical trial inclusion 
and exclusion criteria; 
(ii) how appropriate patient populations can ben-
efit from the results of trials that employ alternative 
designs; 
(iii) barriers to participation in clinical trials, 
including— 
(I) information regarding any potential risks 
and benefits of participation; 
(II) 
regulatory, 
geographical, 
and 
socio-
economic barriers; and 
Web posting. 
Reports. 
Deadline. 
Coordination. 
Consultation. 
Deadline. 
21 USC 360bbb 
note. 
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131 STAT. 1052 
PUBLIC LAW 115–52—AUG. 18, 2017 
(III) the impact of exclusion criteria on the 
enrollment in clinical trials of particular popu-
lations, including infants and children, pregnant 
and lactating women, seniors, individuals with 
advanced disease, and individuals with co-morbid 
conditions; 
(iv) clinical trial designs and methods, including 
expanded access trials, that increase enrollment of 
more diverse patient populations, when appropriate, 
while facilitating the collection of data to establish 
safe use and support substantial evidence of effective-
ness, including data obtained from expanded access 
trials; and 
(v) how changes to clinical trial inclusion and 
exclusion criteria may impact the complexity and 
length of clinical trials, the data necessary to dem-
onstrate safety and effectiveness, and potential 
approaches to mitigating those impacts. 
(2) REPORT.—Not later than 1 year after the Secretary 
issues the report under paragraph (1)(B), the Comptroller Gen-
eral of the United States shall report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives on individual access to investigational drugs 
through the expanded access program under section 561(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb(b)). The report shall include— 
(A) a description of actions taken by manufacturers 
and distributors under section 561A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–0); 
(B) consideration of whether Form FDA 3926 and the 
guidance documents titled ‘‘Expanded Access to Investiga-
tional Drugs for Treatment Use—Questions and Answers’’ 
and ‘‘Individual Patient Expanded Access Applications: 
Form FDA 3926’’, issued by the Food and Drug Administra-
tion in June 2016, have reduced application burden with 
respect to individuals and physicians seeking access to 
investigational new drugs pursuant to section 561(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb) and improved clarity for patients, physicians, and 
drug manufacturers about such process; 
(C) consideration of whether the guidance or regula-
tions issued to implement section 561 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved 
access for individual patients to investigational drugs who 
do not qualify for clinical trials of such investigational 
drugs, and what barriers to such access remain; 
(D) an assessment of methods patients and health 
care providers use to engage with the Food and Drug 
Administration or drug sponsors on expanded access; and 
(E) an analysis of the Secretary’s report under para-
graph (1)(B). 
(3) GUIDANCE.— 
(A) IN
GENERAL.—Not later than 1 year after the 
publication of the report under paragraph (1)(B), the Sec-
retary, acting through the Commissioner of Food and 
Drugs, shall issue one or more draft guidances regarding 
Deadlines. 
Analysis. 
Assessment. 
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131 STAT. 1053 
PUBLIC LAW 115–52—AUG. 18, 2017 
eligibility criteria for clinical trials. Not later than 1 year 
after the public comment period on each such draft guid-
ance ends, the Secretary shall issue a revised draft guid-
ance or final guidance. 
(B) CONTENTS.—The guidance documents described in 
subparagraph (A) shall address methodological approaches 
that a manufacturer or sponsor of an investigation of a 
new drug may take to— 
(i) broaden eligibility criteria for clinical trials and 
expanded access trials, especially with respect to drugs 
for the treatment of serious and life-threatening condi-
tions or diseases for which there is an unmet medical 
need; 
(ii) develop eligibility criteria for, and increase trial 
recruitment to, clinical trials so that enrollment in 
such trials more accurately reflects the patients most 
likely to receive the drug, as applicable and as appro-
priate, while establishing safe use and supporting 
findings of substantial evidence of effectiveness; and 
(iii) use the criteria described in clauses (i) and 
(ii) in a manner that is appropriate for drugs intended 
for the treatment of rare diseases or conditions. 
(b) IMPROVING
INSTITUTIONAL
REVIEW
BOARD
REVIEW
OF 
SINGLE PATIENT EXPANDED ACCESS PROTOCOL.—Not later than 1 
year after the date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs, shall issue guidance 
or regulations, or revise existing guidance or regulations, to stream-
line the institutional review board review of individual patient 
expanded access protocols submitted under 561(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate 
the use of expanded access protocols, any guidance or regulations 
so issued or revised may include a description of the process for 
any person acting through a physician licensed in accordance with 
State law to request that an institutional review board chair (or 
designated member of the institutional review board) review a 
single patient expanded access protocol submitted under such sec-
tion 561(b) for a drug. The Secretary shall update any relevant 
forms associated with individual patient expanded access requests 
under such section 561(b) as necessary. 
(c) EXPANDED ACCESS POLICY TRANSPARENCY.—Section 561A(f) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 
0(f)) is amended— 
(1) in the matter preceding paragraph (1), by striking 
‘‘later’’ and inserting ‘‘earlier’’; 
(2) by striking paragraph (1); 
(3) by redesignating paragraph (2) as paragraph (1); 
(4) in paragraph (1) as so redesignated, by striking the 
period at the end and inserting ‘‘; or’’; and 
(5) by adding at the end the following: 
‘‘(2) as applicable, 15 days after the drug receives a designa-
tion as a breakthrough therapy, fast track product, or regenera-
tive advanced therapy under subsection (a), (b), or (g), respec-
tively, of section 506.’’. 
Time period. 
Update. 
Deadline. 
Guidance. 
21 USC 360bbb 
note. 
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131 STAT. 1054 
PUBLIC LAW 115–52—AUG. 18, 2017 
SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION. 
(a) IN GENERAL.—Subparagraph (A) of section 524(a)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is 
amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; and 
(2) by adding at the end the following: 
‘‘(iii) that contains reports of one or more new 
clinical 
investigations 
(other 
than 
bioavailability 
studies) that are essential to the approval of the 
application and conducted or sponsored by the sponsor 
of such application; and 
‘‘(iv) that contains an attestation from the sponsor 
of the application that such reports were not submitted 
as part of an application for marketing approval or 
licensure by a regulatory authority in India, Brazil, 
Thailand, or any country that is a member of the 
Pharmaceutical Inspection Convention or the Pharma-
ceutical Inspection Cooperation Scheme prior to Sep-
tember 27, 2007.’’. 
(b) EFFECTIVE DATE.—The amendments made by subsection 
(a) shall apply to human drug applications submitted after Sep-
tember 30, 2017. 
TITLE VII—DEVICE INSPECTION AND 
REGULATORY IMPROVEMENTS 
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES. 
(a) IN GENERAL.—Section 510(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(h)) is amended— 
(1) by striking paragraph (2) and inserting the following: 
‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 
‘‘(A) IN GENERAL.—The Secretary, acting through one 
or more officers or employees duly designated by the Sec-
retary, shall inspect establishments described in paragraph 
(1) that are engaged in the manufacture, propagation, 
compounding, or processing of a device or devices (referred 
to in this subsection as ‘device establishments’) in accord-
ance with a risk-based schedule established by the Sec-
retary. 
‘‘(B) FACTORS AND CONSIDERATIONS.—In establishing 
the risk-based schedule under subparagraph (A), the Sec-
retary shall— 
‘‘(i) apply, to the extent applicable for device 
establishments, the factors identified in paragraph (4); 
and 
‘‘(ii) consider the participation of the device 
establishment, as applicable, in international device 
audit programs in which the United States participates 
or the United States recognizes for purposes of 
inspecting device establishments.’’; and 
(2) in paragraph (4)— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘paragraph (3)’’ and inserting ‘‘paragraph (2) or 
(3)’’; and 
Applicability. 
21 USC 360n 
note. 
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131 STAT. 1055 
PUBLIC LAW 115–52—AUG. 18, 2017 
(B) in subparagraph (C), by inserting ‘‘or device’’ after 
‘‘drug’’. 
(b) FOREIGN INSPECTIONS.—Section 809(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended 
by striking ‘‘section 510(h)(3)’’ and inserting ‘‘paragraph (2) or (3) 
of section 510(h)’’. 
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE 
ESTABLISHMENTS. 
(a) IN GENERAL.—Section 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end 
the following: 
‘‘(h)(1) In the case of inspections other than for-cause inspec-
tions, the Secretary shall review processes and standards applicable 
to inspections of domestic and foreign device establishments in 
effect as of the date of the enactment of this subsection, and 
update such processes and standards through the adoption of uni-
form processes and standards applicable to such inspections. Such 
uniform processes and standards shall provide for— 
‘‘(A) exceptions to such processes and standards, as appro-
priate; 
‘‘(B) announcing the inspection of the establishment within 
a reasonable time before such inspection occurs, including by 
providing to the owner, operator, or agent in charge of the 
establishment a notification regarding the type and nature 
of the inspection; 
‘‘(C) a reasonable estimate of the timeframe for the inspec-
tion, an opportunity for advance communications between the 
officers or employees carrying out the inspection under sub-
section (a)(1) and the owner, operator, or agent in charge of 
the establishment concerning appropriate working hours during 
the inspection, and, to the extent feasible, advance notice of 
some records that will be requested; and 
‘‘(D) regular communications during the inspection with 
the owner, operator, or agent in charge of the establishment 
regarding inspection status, which may be recorded by either 
party with advance notice and mutual consent. 
‘‘(2)(A) The Secretary shall, with respect to a request described 
in subparagraph (B), provide nonbinding feedback with respect 
to such request not later than 45 days after the Secretary receives 
such request. 
‘‘(B) A request described in this subparagraph is a request 
for feedback— 
‘‘(i) that is made by the owner, operator, or agent in charge 
of such establishment in a timely manner; and 
‘‘(ii) with respect to actions proposed to be taken by a 
device establishment in a response to a report received by 
such establishment pursuant to subsection (b) that involve a 
public health priority, that implicate systemic or major actions, 
or relate to emerging safety issues (as determined by the Sec-
retary). 
‘‘(3) Nothing in this subsection affects the authority of the 
Secretary to conduct inspections otherwise permitted under this 
Act in order to ensure compliance with this Act.’’. 
(b) GUIDANCE.— 
(1) DRAFT GUIDANCE.—Not later than 18 months after the 
date of enactment of this Act, the Secretary of Health and 
Deadline. 
21 USC 374 note. 
Deadline. 
Review. 
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131 STAT. 1056 
PUBLIC LAW 115–52—AUG. 18, 2017 
Human Services, acting through the Commissioner of Food 
and Drugs, shall issue draft guidance that— 
(A) specifies how the Food and Drug Administration 
will implement the processes and standards described in 
paragraph (1) of subsection (h) of section 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added 
by subsection (a), and the requirements described in para-
graph (2) of such subsection (h); 
(B) provides for standardized methods for communica-
tions described in such paragraphs; 
(C) establishes, with respect to inspections of both 
domestic and foreign device establishments (as referred 
to in section 510(h)(2) of the Federal Food, Drug, and 
Cosmetic Act, as amended by subsection (a)), a standard 
timeframe for such inspections— 
(i) that occurs over consecutive days; and 
(ii) to which each investigator conducting such an 
inspection shall adhere unless the investigator identi-
fies to the establishment involved a reason that more 
time is needed to conduct such investigation; and 
(D) identifies practices for investigators and device 
establishments to facilitate the continuity of inspections 
of such establishments. 
(2) FINAL GUIDANCE.—Not later than 1 year after providing 
notice and opportunity for public comment on the draft guidance 
issued under paragraph (1), the Secretary of Health and Human 
Services shall issue final guidance to implement subsection 
(h) of section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374), as added by subsection (a). 
(c) ADULTERATED DEVICES.—Subsection (j) of section 501 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is 
amended by inserting ‘‘or device’’ after ‘‘drug’’. 
SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘October 1, 2017’’ 
and inserting ‘‘October 1, 2022’’. 
SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES. 
Subsection (e)(4) of section 801 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— 
(1) by adding at the end the following: 
‘‘(E)(i)(I) If the Secretary denies a request for certification under 
subparagraph (A)(ii) with respect to a device manufactured in an 
establishment (foreign or domestic) registered under section 510, 
the Secretary shall provide in writing to the person seeking such 
certification the basis for such denial, and specifically identify the 
finding upon which such denial is based. 
‘‘(II) If the denial of a request as described in subclause (I) 
is based on grounds other than an injunction proceeding pursuant 
to section 302, seizure action pursuant to section 304, or a recall 
designated Class I or Class II pursuant to part 7, title 21, Code 
of Federal Regulations, and is based on the facility being out of 
compliance with part 820 of title 21, Code of Federal Regulations, 
the Secretary shall provide a substantive summary of the specific 
grounds for noncompliance identified by the Secretary. 
‘‘(III) With respect to a device manufactured in an establish-
ment that has received a report under section 704(b), the Secretary 
Summary. 
Deadline. 
Notice. 
Public 
information. 
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131 STAT. 1057 
PUBLIC LAW 115–52—AUG. 18, 2017 
shall not deny a request for certification as described in subclause 
(I) with respect to a device based solely on the issuance of that 
report if the owner, operator, or agent in charge of such establish-
ment has agreed to a plan of correction in response to such report. 
‘‘(ii)(I) The Secretary shall provide a process for a person who 
is denied a certification as described in clause (i)(I) to request 
a review that conforms to the standards of section 517A(b). 
‘‘(II) Notwithstanding any previous review conducted pursuant 
to subclause (I), a person who has been denied a certification 
as described in clause (i)(I) may at any time request a review 
in order to present new information relating to actions taken by 
such person to address the reasons identified by the Secretary 
for the denial of certification, including evidence that corrective 
actions are being or have been implemented to address grounds 
for noncompliance identified by the Secretary. 
‘‘(III) Not later than 1 year after the date of enactment of 
the FDA Reauthorization Act of 2017, the Secretary shall issue 
guidance providing for a process to carry out this subparagraph. 
Not later than 1 year after the close of the comment period for 
such guidance, the Secretary shall issue final guidance. 
‘‘(iii)(I) Subject to subclause (II), this subparagraph applies 
to requests for certification on behalf of any device establishment 
registered under section 510, whether the establishment is located 
inside or outside of the United States, and regardless of whether 
such devices are to be exported from the United States. 
‘‘(II) If an establishment described in subclause (I) is not located 
within the United States and does not demonstrate that the devices 
manufactured, prepared, propagated, compounded, or processed at 
such establishment are to be exported from the United States, 
this subparagraph shall apply only if— 
‘‘(aa) the establishment has been inspected by the Secretary 
within 3 years of the date of the request; or 
‘‘(bb) the establishment participates in an audit program 
in which the United States participates or the United States 
recognizes, an audit under such program has been conducted, 
and the findings of such audit are provided to the Secretary 
within 3 years of the date of the request.’’; and 
(2) by moving the margins of subparagraphs (C) and (D) 
4 ems to the left. 
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION. 
Section 704(g) of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 374) is amended by adding at the end the following: 
‘‘(15)(A) Notwithstanding any other provision of this subsection, 
the Secretary may recognize auditing organizations that are recog-
nized by organizations established by governments to facilitate 
international harmonization for purposes of conducting inspections 
of— 
‘‘(i) establishments that manufacture, prepare, propagate, 
compound, or process devices (other than types of devices 
licensed under section 351 of the Public Health Service Act), 
as required under section 510(h); or 
‘‘(ii) establishments required to register pursuant to section 
510(i). 
‘‘(B) Nothing in this paragraph affects— 
‘‘(i) the authority of the Secretary to inspect any device 
establishment pursuant to this Act; or 
Audits. 
Applicability. 
Deadlines. 
Applicability. 
Deadlines. 
Guidance. 
Review. 
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131 STAT. 1058 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(ii) the authority of the Secretary to determine the official 
classification of an inspection.’’. 
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING. 
(a) APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MED-
ICAL IMAGING DEVICES.—Section 520 of the Federal Food, Drug, 
and Cosmetic Act (42 U.S.C. 360j) is amended by adding at the 
end the following: 
‘‘(p) DIAGNOSTIC IMAGING DEVICES INTENDED FOR USE WITH 
CONTRAST AGENTS.— 
‘‘(1) IN GENERAL.—The Secretary may, subject to the suc-
ceeding provisions of this subsection, approve an application 
(or a supplement to such an application) submitted under sec-
tion 515 with respect to an applicable medical imaging device, 
or, in the case of an applicable medical imaging device for 
which a notification is submitted under section 510(k), may 
make a substantial equivalence determination with respect to 
an applicable medical imaging device, or may grant a request 
submitted under section 513(f)(2) for an applicable medical 
imaging device, if such application, notification, or request 
involves the use of a contrast agent that is not— 
‘‘(A) in a concentration, rate of administration, or route 
of administration that is different from those described 
in the approved labeling of the contrast agent, except that 
the Secretary may approve such application, make such 
substantial equivalence determination, or grant such 
request if the Secretary determines that such differences 
in concentration, rate of administration, or route of 
administration exist but do not adversely affect the safety 
and effectiveness of the contrast agent when used with 
the device; 
‘‘(B) in a region, organ, or system of the body that 
is different from those described in the approved labeling 
of the contrast agent, except that the Secretary may 
approve such application, make such substantial equiva-
lence determination, or grant such request if the Secretary 
determines that such differences in region, organ, or system 
of the body exist but do not adversely affect the safety 
and effectiveness of the contrast agent when used with 
the device; 
‘‘(C) in a patient population that is different from those 
described in the approved labeling of the contrast agent, 
except that the Secretary may approve such application, 
make such substantial equivalence determination, or grant 
such request if the Secretary determines such differences 
in patient population exist but do not adversely affect the 
safety and effectiveness of the contrast agent when used 
with the device; or 
‘‘(D) in an imaging modality that is different from 
those described in the approved labeling of the contrast 
agent. 
‘‘(2) PREMARKET REVIEW.—The agency center charged with 
premarket review of devices shall have primary jurisdiction 
with respect to the review of an application, notification, or 
request described in paragraph (1). In conducting such review, 
such agency center may— 
Determinations. 
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131 STAT. 1059 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(A) consult with the agency center charged with the 
premarket review of drugs or biological products; and 
‘‘(B) review information and data provided to the Sec-
retary by the sponsor of a contrast agent in an application 
submitted under section 505 of this Act or section 351 
of the Public Health Service Act, so long as the sponsor 
of such contrast agent has provided to the sponsor of the 
applicable medical imaging device that is the subject of 
such review a right of reference and the application is 
submitted in accordance with this subsection. 
‘‘(3) APPLICABLE REQUIREMENTS.—An application submitted 
under section 515, a notification submitted under section 510(k), 
or a request submitted under section 513(f)(2), as described 
in paragraph (1), with respect to an applicable medical imaging 
device shall be subject to the requirements of such respective 
section. Such application, notification, or request shall only 
be subject to the requirements of this Act applicable to devices. 
‘‘(4) DEFINITIONS.—For purposes of this subsection— 
‘‘(A) the term ‘applicable medical imaging device’ means 
a device intended to be used in conjunction with a contrast 
agent (or class of contrast agents) for an imaging use 
that is not described in the approved labeling of such 
contrast agent (or the approved labeling of any contrast 
agent in the same class as such contrast agent); and 
‘‘(B) the term ‘contrast agent’ means a drug that is 
approved under section 505 or licensed under section 351 
of the Public Health Service Act, is intended for use in 
conjunction with an applicable medical imaging device, 
and— 
‘‘(i) is a diagnostic radiopharmaceutical, as defined 
in section 315.2 and 601.31 of title 21, Code of Federal 
Regulations (or any successor regulations); or 
‘‘(ii) is a diagnostic agent that improves the visual-
ization of structure or function within the body by 
increasing the relative difference in signal intensity 
within the target tissue, structure, or fluid.’’. 
(b) APPLICATIONS
FOR
APPROVAL
OF
CONTRAST
AGENTS 
INTENDED FOR USE WITH CERTAIN DIAGNOSTIC MEDICAL IMAGING 
DEVICES.—Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the following: 
‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH APPLICABLE 
MEDICAL IMAGING DEVICES.— 
‘‘(1) IN GENERAL.—The sponsor of a contrast agent for which 
an application has been approved under this section may submit 
a supplement to the application seeking approval for a new 
use following the authorization of a premarket submission for 
an applicable medical imaging device for that use with the 
contrast agent pursuant to section 520(p)(1). 
‘‘(2) REVIEW OF SUPPLEMENT.—In reviewing a supplement 
submitted under this subsection, the agency center charged 
with the premarket review of drugs may— 
‘‘(A) consult with the center charged with the pre-
market review of devices; and 
‘‘(B) review information and data submitted to the 
Secretary by the sponsor of an applicable medical imaging 
device pursuant to section 515, 510(k), or 513(f)(2) so long 
as the sponsor of such applicable medical imaging device 
Consultation. 
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131 STAT. 1060 
PUBLIC LAW 115–52—AUG. 18, 2017 
has provided to the sponsor of the contrast agent a right 
of reference. 
‘‘(3) DEFINITIONS.—For purposes of this subsection— 
‘‘(A) the term ‘new use’ means a use of a contrast 
agent that is described in the approved labeling of an 
applicable medical imaging device described in section 
520(p), but that is not described in the approved labeling 
of the contrast agent; and 
‘‘(B) the terms ‘applicable medical imaging device’ and 
‘contrast agent’ have the meanings given such terms in 
section 520(p).’’. 
SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES. 
(a) IN GENERAL.—Subsection (f) of section 513 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
adding at the end the following new paragraph: 
‘‘(6)(A) Subject to the succeeding subparagraphs of this para-
graph, the Secretary shall, by written order, classify an accessory 
under this section based on the risks of the accessory when used 
as intended and the level of regulatory controls necessary to provide 
a reasonable assurance of safety and effectiveness of the accessory, 
notwithstanding the classification of any other device with which 
such accessory is intended to be used. 
‘‘(B) The classification of any accessory distinct from another 
device by regulation or written order issued prior to December 
13, 2016, shall continue to apply unless and until the accessory 
is reclassified by the Secretary, notwithstanding the classification 
of any other device with which such accessory is intended to be 
used. Nothing in this paragraph shall preclude the Secretary’s 
authority to initiate the classification of an accessory through regu-
lation or written order, as appropriate. 
‘‘(C)(i) In the case of a device intended to be used with an 
accessory, where the accessory has been included in an application 
for premarket approval of such device under section 515 or a report 
under section 510(k) for clearance of such device and the Secretary 
has not classified such accessory distinctly from another device 
in accordance with subparagraph (A), the person filing the applica-
tion or report (as applicable) at the time such application or report 
is filed— 
‘‘(I) may include a written request for the proper classifica-
tion of the accessory pursuant to subparagraph (A); 
‘‘(II) shall include in any such request such information 
as may be necessary for the Secretary to evaluate, based on 
the least burdensome approach, the appropriate class for the 
accessory under subsection (a); and 
‘‘(III) shall, if the request under subclause (I) is requesting 
classification of the accessory in class II, include in the applica-
tion an initial draft proposal for special controls, if special 
controls would be required pursuant to subsection (a)(1)(B). 
‘‘(ii) The Secretary’s response under section 515(d) or section 
510(n) (as applicable) to an application or report described in clause 
(i) shall also contain the Secretary’s granting or denial of the 
request for classification of the accessory involved. 
‘‘(iii) The Secretary’s evaluation of an accessory under clause 
(i) shall constitute an order establishing a new classification for 
Evaluation. 
Applicability. 
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131 STAT. 1061 
PUBLIC LAW 115–52—AUG. 18, 2017 
such accessory for the specified intended use or uses of such acces-
sory and for any accessory with the same intended use or uses 
as such accessory. 
‘‘(D) For accessories that have been granted marketing 
authorization as part of a submission for another device with which 
the accessory involved is intended to be used, through an application 
for such other device under section 515(c), a report under section 
510(k), or a request for classification under paragraph (2) of this 
subsection, the following shall apply: 
‘‘(i) Not later than the date that is one year after the 
date of enactment of the FDA Reauthorization Act of 2017 
and at least once every 5 years thereafter, and as the Secretary 
otherwise determines appropriate, pursuant to this paragraph, 
the Secretary shall publish in the Federal Register a notice 
proposing a list of such accessories that the Secretary deter-
mines may be suitable for a distinct classification in class 
I and the proposed regulations for such classifications. In devel-
oping such list, the Secretary shall consider recommendations 
from sponsors of device submissions and other stakeholders 
for accessories to be included on such list. The notices shall 
provide for a period of not less than 60 calendar days for 
public comment. Within 180 days after the end of the comment 
period, the Secretary shall publish in the Federal Register 
a final action classifying such suitable accessories into class 
I. 
‘‘(ii) A manufacturer or importer of an accessory that has 
been granted such marketing authorization may submit to the 
Secretary a written request for the appropriate classification 
of the accessory based on the risks and appropriate level of 
regulatory controls as described in subparagraph (A), and shall, 
if the request is requesting classification of the accessory in 
class II, include in the submission an initial draft proposal 
for special controls, if special controls would be required pursu-
ant to subsection (a)(1)(B). Such request shall include such 
information as may be necessary for the Secretary to evaluate, 
based on the least burdensome approach, the appropriate class 
for the accessory under subsection (a). The Secretary shall 
provide an opportunity for a manufacturer or importer to meet 
with appropriate personnel of the Food and Drug Administra-
tion to discuss the appropriate classification of such accessory 
prior to submitting a written request under this clause for 
classification of the accessory. 
‘‘(iii) The Secretary shall respond to a request made under 
clause (ii) not later than 85 calendar days after receiving such 
request by issuing a written order classifying the accessory 
or denying the request. If the Secretary does not agree with 
the recommendation for classification submitted by the manu-
facturer or importer, the response shall include a detailed 
description and justification for such determination. Within 
30 calendar days after granting such a request, the Secretary 
shall publish a notice in the Federal Register announcing such 
response. 
‘‘(E) Nothing in this paragraph may be construed as precluding 
a manufacturer of an accessory of a new type from using the 
classification process described in subsection (f)(2) to obtain classi-
fication of such accessory in accordance with the criteria and 
requirements set forth in that subsection.’’. 
Federal Register, 
publication. 
Notice. 
Determination. 
Deadlines. 
Evaluation. 
Notices. 
Time period. 
Public 
information. 
Recommenda- 
tions. 
Deadlines. 
Federal Register, 
publication. 
Notice. 
Lists. 
Applicability. 
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131 STAT. 1062 
PUBLIC LAW 115–52—AUG. 18, 2017 
(b) CONFORMING CHANGE.—Section 513(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking 
paragraph (9) (relating to classification of an accessory). 
(c) EFFECTIVE DATE.—The amendments made by subsections 
(a) and (b) shall take effect on the date that is 60 days after 
the date of enactment of this Act. 
SEC. 708. DEVICE PILOT PROJECTS. 
(a) POSTMARKET PILOT.—Section 519 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360i) is amended by adding at the 
end the following: 
‘‘(i) POSTMARKET PILOT.— 
‘‘(1) IN GENERAL.—In order to provide timely and reliable 
information on the safety and effectiveness of devices approved 
under section 515, cleared under section 510(k), or classified 
under section 513(f)(2), including responses to adverse events 
and malfunctions, and to advance the objectives of part 803 
of title 21, Code of Federal Regulations (or successor regula-
tions), and advance the objectives of, and evaluate innovative 
new methods of compliance with, this section and section 522, 
the Secretary shall, within one year of the date of enactment 
of the FDA Reauthorization Act of 2017, initiate one or more 
pilot projects for voluntary participation by a manufacturer 
or manufacturers of a device or device type, or continue existing 
projects, in accordance with paragraph (3), that— 
‘‘(A) are designed to efficiently generate reliable and 
timely safety and active surveillance data for use by the 
Secretary or manufacturers of the devices that are involved 
in the pilot project; 
‘‘(B) inform the development of methods, systems, data 
criteria, and programs that could be used to support safety 
and active surveillance activities for devices included or 
not included in such project; 
‘‘(C) may be designed and conducted in coordination 
with a comprehensive system for evaluating medical device 
technology that operates under a governing board with 
appropriate representation of stakeholders, including 
patient groups and device manufacturers; 
‘‘(D) use electronic health data including claims data, 
patient survey data, or any other data, as the Secretary 
determines appropriate; and 
‘‘(E) prioritize devices and device types that meet one 
or more of the following criteria: 
‘‘(i) Devices and device types for which the collec-
tion and analysis of real world evidence regarding a 
device’s safety and effectiveness is likely to advance 
public health. 
‘‘(ii) Devices and device types that are widely used. 
‘‘(iii) Devices and device types, the failure of which 
has significant health consequences. 
‘‘(iv) Devices and device types for which the Sec-
retary— 
‘‘(I) has received public recommendations in 
accordance with paragraph (2)(B); and 
‘‘(II) has determined to meet one or more of 
the criteria under clause (i), (ii), or (iii) and is 
appropriate for such a pilot project. 
Deadline. 
21 USC 360c 
note. 
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131 STAT. 1063 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(2) PARTICIPATION.—The Secretary shall establish the 
conditions and processes— 
‘‘(A) under which a manufacturer of a device may vol-
untarily participate in a pilot project described in para-
graph (1); and 
‘‘(B) for facilitating public recommendations for devices 
to be prioritized under such a pilot project, including 
requirements for the data necessary to support such a 
recommendation. 
‘‘(3) CONTINUATION OF ONGOING PROJECTS.—The Secretary 
may continue or expand projects, with respect to providing 
timely and reliable information on the safety and effectiveness 
of devices approved under section 515, cleared under section 
510(k), or classified under section 513(f)(2), that are being car-
ried out as of the date of the enactment of the FDA Reauthoriza-
tion Act of 2017. The Secretary shall, beginning on such date 
of enactment, take such steps as may be necessary— 
‘‘(A) to ensure such projects meet the requirements 
of subparagraphs (A) through (E) of paragraph (1); and 
‘‘(B) to increase the voluntary participation in such 
projects of manufacturers of devices and facilitate public 
recommendations for any devices prioritized under such 
a project. 
‘‘(4) IMPLEMENTATION.— 
‘‘(A) CONTRACTING
AUTHORITY.—The Secretary may 
carry out a pilot project meeting the criteria specified in 
subparagraphs (A) through (E) of paragraph (1) or a project 
continued or expanded under paragraph (3) by entering 
into contracts, cooperative agreements, grants, or other 
appropriate agreements with public or private entities that 
have a significant presence in the United States and meet 
the following conditions: 
‘‘(i) If such an entity is a component of another 
organization, the entity and the organization have 
established an agreement under which appropriate 
security measures are implemented to maintain the 
confidentiality and privacy of the data described in 
paragraph (1)(D) and such agreement ensures that 
the entity will not make an unauthorized disclosure 
of such data to the other components of the organiza-
tion in breach of requirements with respect to confiden-
tiality and privacy of such data established under such 
security measures. 
‘‘(ii) In the case of the termination or nonrenewal 
of such a contract, cooperative agreement, grant, or 
other appropriate agreement, the entity or entities 
involved shall comply with each of the following: 
‘‘(I) The entity or entities shall continue to 
comply with the requirements with respect to con-
fidentiality and privacy referred to in clause (i) 
with respect to all data disclosed to the entity 
under such an agreement. 
‘‘(II) The entity or entities shall return any 
data disclosed to such entity pursuant to this sub-
section and to which it would not otherwise have 
access or, if returning such data is not practicable, 
destroy the data. 
Effective date. 
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131 STAT. 1064 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(iii) The entity or entities shall have one or more 
qualifications with respect to— 
‘‘(I) research, statistical, epidemiologic, or clin-
ical capability and expertise to conduct and com-
plete the activities under this subsection, including 
the capability and expertise to provide the Sec-
retary access to de-identified data consistent with 
the requirements of this subsection; 
‘‘(II) an information technology infrastructure 
to support electronic data and operational stand-
ards to provide security for such data, as appro-
priate; 
‘‘(III) experience with, and expertise on, the 
development of research on, and surveillance of, 
device safety and effectiveness using electronic 
health data; or 
‘‘(IV) such other expertise which the Secretary 
determines necessary to carry out such a project. 
‘‘(B) REVIEW OF CONTRACT IN THE EVENT OF A MERGER 
OR ACQUISITION.—The Secretary shall review any contract, 
cooperative agreement, grant, or other appropriate agree-
ment entered into under this paragraph with an entity 
meeting the conditions specified in subparagraph (A) in 
the event of a merger or acquisition of the entity in order 
to ensure that the requirements specified in this subsection 
will continue to be met. 
‘‘(5) COMPLIANCE
WITH
REQUIREMENTS
FOR
RECORDS
OR 
REPORTS ON DEVICES.—The participation of a manufacturer in 
pilot projects under this subsection or a project continued or 
expanded under paragraph (3) shall not affect the eligibility 
of such manufacturer to participate in any quarterly reporting 
program with respect to devices carried out under this section 
519 or section 522. The Secretary may determine that, for 
a specified time period to be determined by the Secretary, 
a manufacturer’s participation in a pilot project under this 
subsection or a project continued or expanded under paragraph 
(3) may meet the applicable requirements of this section or 
section 522, if— 
‘‘(A) the project has demonstrated success in capturing 
relevant adverse event information; and 
‘‘(B) the Secretary has established procedures for 
making adverse event and safety information collected from 
such project public, to the extent possible. 
‘‘(6) PRIVACY REQUIREMENTS.—With respect to the disclo-
sure of any health information collected through a project con-
ducted under this subsection— 
‘‘(A) individually identifiable health information so col-
lected shall not be disclosed when presenting any informa-
tion from such project; and 
‘‘(B) any such disclosure shall be made in compliance 
with regulations issued pursuant to section 264(c) of the 
Health Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note) and sections 552 and 552a 
of title 5, United States Code. 
‘‘(7) LIMITATIONS.—No pilot project under this subsection, 
or in coordination with the comprehensive system described 
in paragraph (1)(C), may allow for an entity participating in 
Determination. 
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131 STAT. 1065 
PUBLIC LAW 115–52—AUG. 18, 2017 
such project, other than the Secretary, to make determinations 
of safety or effectiveness, or substantial equivalence, for pur-
poses of this Act. 
‘‘(8) OTHER PROJECTS REQUIRED TO COMPLY.—Paragraphs 
(1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with 
respect to any pilot project undertaken in coordination with 
the comprehensive system described in paragraph (1)(C) that 
relates to the use of real world evidence for devices in the 
same manner and to the same extent as such paragraphs 
apply with respect to pilot projects conducted under this sub-
section. 
‘‘(9) REPORT TO CONGRESS.—Not later than 18 months after 
the date of enactment of this Act, and annually thereafter, 
the Secretary shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee 
on Health, Education, Labor and Pensions of the Senate a 
report containing a description of the pilot projects being con-
ducted under this subsection and projects continued or 
expanded pursuant to paragraph (3), including for each such 
project— 
‘‘(A) how the project is being implemented in accord-
ance with paragraph (4), including how such project is 
being implemented through a contract, cooperative agree-
ment, grant, or other appropriate agreement, if applicable; 
‘‘(B) the number of manufacturers that have agreed 
to participate in such project; 
‘‘(C) the data sources used to conduct such project; 
‘‘(D) the devices or device categories involved in such 
project; 
‘‘(E) the number of patients involved in such project; 
and 
‘‘(F) the findings of the project in relation to device 
safety, including adverse events, malfunctions, and other 
safety information. 
‘‘(10) SUNSET.—The Secretary may not carry out a pilot 
project initiated by the Secretary under this subsection after 
October 1, 2022.’’. 
(b) REPORT.—Not later than January 31, 2021, the Secretary 
of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall conduct a review through an independent 
third party to evaluate the strengths, limitations, and appropriate 
use of evidence collected pursuant to real world evidence pilot 
projects described in the letters described in section 201(b) of the 
Medical Device User Fee Amendments of 2017 and subsection (i) 
of section 519 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i), as amended by subsection (a), for informing premarket 
and postmarket decisionmaking for multiple device types, and to 
determine whether the methods, systems, and programs in such 
pilot projects efficiently generate reliable and timely evidence about 
the effectiveness or safety surveillance of devices. 
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS. 
(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further 
amended by adding at the end the following: 
‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING AIDS.— 
‘‘(1) DEFINITION.— 
Review. 
Determination. 
Applicability. 
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PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(A) IN GENERAL.—In this subsection, the term ‘over- 
the-counter hearing aid’ means a device that— 
‘‘(i) uses the same fundamental scientific tech-
nology as air conduction hearing aids (as defined in 
section 874.3300 of title 21, Code of Federal Regula-
tions) (or any successor regulation) or wireless air 
conduction hearing aids (as defined in section 874.3305 
of title 21, Code of Federal Regulations) (or any suc-
cessor regulation); 
‘‘(ii) is intended to be used by adults age 18 and 
older to compensate for perceived mild to moderate 
hearing impairment; 
‘‘(iii) through tools, tests, or software, allows the 
user to control the over-the-counter hearing aid and 
customize it to the user’s hearing needs; 
‘‘(iv) may— 
‘‘(I) use wireless technology; or 
‘‘(II) include tests for self-assessment of 
hearing loss; and 
‘‘(v) is available over-the-counter, without the 
supervision, prescription, or other order, involvement, 
or intervention of a licensed person, to consumers 
through in-person transactions, by mail, or online. 
‘‘(B) EXCEPTION.—Such term does not include a per-
sonal sound amplification product intended to amplify 
sound for nonhearing impaired consumers in situations 
including hunting and bird-watching. 
‘‘(2) REGULATION.—An over-the-counter hearing aid shall 
be subject to the regulations promulgated in accordance with 
section 709(b) of the FDA Reauthorization Act of 2017 and 
shall be exempt from sections 801.420 and 801.421 of title 
21, Code of Federal Regulations (or any successor regulations).’’. 
(b) REGULATIONS TO ESTABLISH CATEGORY.— 
(1) IN
GENERAL.—The Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), not 
later than 3 years after the date of enactment of this Act, 
shall promulgate proposed regulations to establish a category 
of over-the-counter hearing aids, as defined in subsection (q) 
of section 520 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j) as amended by subsection (a), and, not later 
than 180 days after the date on which the public comment 
period on the proposed regulations closes, shall issue such 
final regulations. 
(2) REQUIREMENTS.—In promulgating the regulations under 
paragraph (1), the Secretary shall— 
(A) include requirements that provide reasonable 
assurances of the safety and effectiveness of over-the- 
counter hearing aids; 
(B) include requirements that establish or adopt output 
limits appropriate for over-the-counter hearing aids; 
(C) include requirements for appropriate labeling of 
over-the-counter hearing aids, including requirements that 
such labeling include a conspicuous statement that the 
device is only intended for adults age 18 and older, informa-
tion on how consumers may report adverse events, informa-
tion on any contraindications, conditions, or symptoms of 
medically treatable causes of hearing loss, and advisements 
Deadlines. 
21 USC 360j 
note. 
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131 STAT. 1067 
PUBLIC LAW 115–52—AUG. 18, 2017 
to consult promptly with a licensed health care practitioner; 
and 
(D) describe the requirements under which the sale 
of over-the-counter hearing aids is permitted, without the 
supervision, prescription, or other order, involvement, or 
intervention of a licensed person, to consumers through 
in-person transactions, by mail, or online. 
(3) PREMARKET NOTIFICATION.—The Secretary shall make 
findings under section 510(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(m)) to determine whether over- 
the-counter hearing aids (as defined in section 520(q) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
amended by subsection (a)) require a report under section 
510(k) to provide reasonable assurance of safety and effective-
ness. 
(4) EFFECT ON STATE LAW.—No State or local government 
shall establish or continue in effect any law, regulation, order, 
or other requirement specifically related to hearing products 
that would restrict or interfere with the servicing, marketing, 
sale, dispensing, use, customer support, or distribution of over- 
the-counter hearing aids (as defined in section 520(q) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
amended by subsection (a)) through in-person transactions, by 
mail, or online, that is different from, in addition to, or other-
wise not identical to, the regulations promulgated under this 
subsection, including any State or local requirement for the 
supervision, prescription, or other order, involvement, or inter-
vention of a licensed person for consumers to access over- 
the-counter hearing aids. 
(5) NO
EFFECT
ON
PRIVATE
REMEDIES.—Nothing in this 
section shall be construed to modify or otherwise affect the 
ability of any person to exercise a private right of action under 
any State or Federal product liability, tort, warranty, contract, 
or consumer protection law. 
(c) NEW GUIDANCE ISSUED.—Not later than the date on which 
final regulations are issued under subsection (b), the Secretary 
shall update and finalize the draft guidance of the Department 
of Health and Human Services entitled ‘‘Regulatory Requirements 
for Hearing Aid Devices and Personal Sound Amplification Prod-
ucts’’, issued on November 7, 2013. Such updated and finalized 
guidance shall clarify which products, on the basis of claims or 
other marketing, advertising, or labeling material, meet the defini-
tion of a device in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) and which products meet the definition 
of a personal sound amplification product, as set forth in such 
guidance. 
(d) REPORT.—Not later than 2 years after the date on which 
the final regulations described in subsection (b)(1) are issued, the 
Secretary of Health and Human Services shall submit to Congress 
a report analyzing any adverse events relating to over-the-counter 
hearing aids (as defined in subsection (q)(1) of section 520 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)). 
SEC. 710. REPORT ON SERVICING OF DEVICES. 
(a) IN GENERAL.—Not later than 270 days after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall post 
Deadline. 
Update. 
Determination. 
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131 STAT. 1068 
PUBLIC LAW 115–52—AUG. 18, 2017 
on the internet website of the Food and Drug Administration a 
report on the continued quality, safety, and effectiveness of devices 
(as defined in section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(h))) with respect to servicing (as defined 
in subsection (c)). 
(b) CONTENTS.—The report submitted under subsection (a) shall 
contain— 
(1) the status of, and findings to date, with respect to, 
the proposed rule entitled ‘‘Refurbishing, Reconditioning, 
Rebuilding, Remarketing, Remanufacturing, and Servicing of 
Medical Devices Performed by Third-Party Entities and 
Original Equipment Manufacturers; Request for Comments’’ 
published in the Federal Register by the Food and Drug 
Administration on March 4, 2016 (81 Fed. Reg. 11477); 
(2) information presented during the October 2016 public 
workshop entitled ‘‘Refurbishing, Reconditioning, Rebuilding, 
Remarketing, Remanufacturing, and Servicing of Medical 
Devices Performed by Third-Party Entities and Original Equip-
ment Manufacturers’’; 
(3) a description of the statutory and regulatory authority 
of the Food and Drug Administration with respect to the serv-
icing of devices conducted by any entity, including original 
equipment manufacturers and third party entities; 
(4) details regarding how the Food and Drug Administra-
tion currently regulates devices with respect to servicing to 
ensure safety and effectiveness, how the agency could improve 
such regulation using the authority described in paragraph 
(3), and whether additional authority is recommended; 
(5) information on actions the Food and Drug Administra-
tion could take under the authority described in paragraphs 
(3) and (4) to assess the servicing of devices, including the 
size, scope, location, and composition of third party entities; 
(6) information on actions the Food and Drug Administra-
tion could take to track adverse events caused by servicing 
errors performed by any entity, including original equipment 
manufacturers and third party entities; 
(7) information regarding the regulation by States, the 
Joint Commission, or other regulatory bodies of device servicing 
performed by any entity, including original equipment manufac-
turers and third party entities; and 
(8) any additional information determined by the Secretary 
(acting through the Commissioner) to be relevant to ensuring 
the quality, safety, and effectiveness of devices with respect 
to servicing. 
(c) SERVICING DEFINED.—In this section, the term ‘‘servicing’’ 
includes, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, repairing, remanufacturing, or other serv-
icing of the device. 
TITLE VIII—IMPROVING GENERIC DRUG 
ACCESS 
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS. 
Section 505(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)) is amended by adding at the end the following: 
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131 STAT. 1069 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(11)(A) Subject to subparagraph (B), the Secretary shall 
prioritize the review of, and act within 8 months of the date of 
the submission of, an original abbreviated new drug application 
submitted for review under this subsection that is for a drug— 
‘‘(i) for which there are not more than 3 approved 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 paragraph, 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 pharma-
ceutical ingredients drug master files referenced in an application 
and sites or organizations involved in bioequivalence and clinical 
studies used to support the application, 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 requirements for such submission 
and that is not the only facility intended to conduct one or more 
unit operations in commercial production. Information provided by 
an applicant under this subparagraph shall not be considered the 
submission of an application under this subsection. 
‘‘(C) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to manufacture 
a drug described in subparagraph (A). 
‘‘(D) Nothing in this paragraph shall prevent the Secretary 
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 Cosmetic 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 subsection, the Secretary 
shall, as appropriate, provide review status updates indicating the 
categorical status of the applications by each relevant review dis-
cipline.’’. 
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 amended by inserting after 
section 506G the following: 
Review. 
Updates. 
Web posting. 
Update. 
Deadline. 
Lists. 
Determination. 
Deadlines. 
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131 STAT. 1070 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘SEC. 506H. COMPETITIVE GENERIC THERAPIES. 
‘‘(a) IN GENERAL.—The Secretary may, at the request of an 
applicant of a drug that is designated as a competitive generic 
therapy pursuant to subsection (b), expedite 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 generic 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 application for the drug under 
section 505(j). 
‘‘(3) CRITERIA.—A drug is eligible for designation as a 
competitive generic therapy under this section if the Secretary 
determines that there is inadequate generic competition. 
‘‘(4) DESIGNATION.—Not later than 60 calendar days after 
the receipt of a request under paragraph (1), the Secretary 
may— 
‘‘(A) determine whether the drug that is the subject 
of the request meets the criteria described 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 Secretary 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 communica-
tion with, the applicant regarding the development of the drug 
to ensure that the development program to gather the data 
necessary for approval is as efficient as practicable. 
‘‘(3) Involve senior managers and experienced review staff, 
as appropriate, in a collaborative, coordinated review of such 
application, including with 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 inspec-
tions; 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 commerce 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 described in section 505(j)(7)(A) (not 
Deadline. 
21 USC 356h. 
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131 STAT. 1071 
PUBLIC LAW 115–52—AUG. 18, 2017 
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. 
21 USC 356i. 
Deadlines. 
21 USC 356h 
note. 
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131 STAT. 1072 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(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. 
Deadline. 
Lists. 
Deadline. 
Lists. 
Review. 
Notification. 
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131 STAT. 1073 
PUBLIC LAW 115–52—AUG. 18, 2017 
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 
Web posting. 
Time period. 
Applicability. 
Deadline. 
Protocols. 
Review. 
21 USC 374 note. 
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131 STAT. 1074 
PUBLIC LAW 115–52—AUG. 18, 2017 
(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 
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131 STAT. 1075 
PUBLIC LAW 115–52—AUG. 18, 2017 
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. 
Assessment. 
Time period. 
Determination. 
Deadline. 
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131 STAT. 1076 
PUBLIC LAW 115–52—AUG. 18, 2017 
(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)— 
Effective date. 
21 USC 360e–3 
and note. 
21 USC 355. 
Time period. 
Reports. 
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131 STAT. 1077 
PUBLIC LAW 115–52—AUG. 18, 2017 
(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, 
Web postings. 
Time periods. 
Web posting. 
21 USC 355 note. 
21 USC 360e–3. 
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131 STAT. 1078 
PUBLIC LAW 115–52—AUG. 18, 2017 
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— 
Effective date. 
Effective date. 
Analysis. 
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131 STAT. 1079 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(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 
Effective date. 
Analysis. 
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131 STAT. 1080 
PUBLIC LAW 115–52—AUG. 18, 2017 
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.’’. 
Effective date. 
Analysis. 
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131 STAT. 1081 
PUBLIC LAW 115–52—AUG. 18, 2017 
(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 
Effective date. 
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131 STAT. 1082 
PUBLIC LAW 115–52—AUG. 18, 2017 
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 
Effective date. 
Determinations. 
Determination. 
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131 STAT. 1083 
PUBLIC LAW 115–52—AUG. 18, 2017 
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: 
Deadline. 
Public 
information. 
Recommenda- 
tions. 
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131 STAT. 1084 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(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 
Recommenda- 
tions. 
Effective date. 
Determinations. 
Determination. 
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131 STAT. 1085 
PUBLIC LAW 115–52—AUG. 18, 2017 
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. 
Deadline. 
Public 
information. 
Summary. 
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131 STAT. 1086 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(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. 
Recommenda- 
tions. 
Effective date. 
Determinations. 
Determination. 
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131 STAT. 1087 
PUBLIC LAW 115–52—AUG. 18, 2017 
‘‘(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 
Effective date. 
Determinations. 
Determination. 
Deadline. 
Public 
information. 
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131 STAT. 1088 
PUBLIC LAW 115–52—AUG. 18, 2017 
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; 
Review. 
Time period. 
Deadline. 
Public 
information. 
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131 STAT. 1089 
PUBLIC LAW 115–52—AUG. 18, 2017 
(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.— 
Consultation. 
Analysis. 
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131 STAT. 1090 
PUBLIC LAW 115–52—AUG. 18, 2017 
LEGISLATIVE HISTORY—H.R. 2430 (S. 934): 
HOUSE REPORTS: No. 115–201 (Comm. on Energy and Commerce). 
CONGRESSIONAL RECORD, Vol. 163 (2017): 
July 12, considered and passed House. 
Aug. 3, considered and passed Senate. 
(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.’’. 
Approved August 18, 2017. 
Effective date. 
Effective date. 
Effective date. 
Effective date. 
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