IB 
Union Calendar No. 138 
115TH CONGRESS 
1ST SESSION H. R. 2430 
[Report No. 115–201] 
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. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 16, 2017 
Mr. WALDEN (for himself, Mr. PALLONE, Mr. BURGESS, and Mr. GENE 
GREEN of Texas) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
JULY 11, 2017 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on May 16, 2017] 
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A BILL 
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 bio-
logical products, and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives 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; findings. 
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 clause. 
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. 
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Sec. 406. Effective date. 
Sec. 407. Savings clause. 
TITLE V—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO 
DRUGS 
Sec. 501. Reauthorization of provision relating to exclusivity of certain drugs 
containing single enantiomers. 
Sec. 502. Reauthorization of orphan grants program. 
Sec. 503. Reauthorization of pediatric study of drugs. 
Sec. 504. Protecting and strengthening the drug supply chain. 
Sec. 505. Sense of Congress on lowering the cost of prescription drugs. 
TITLE VI—DEVICE INSPECTION AND REGULATORY IMPROVEMENTS 
Subtitle A—Improving the Process for Inspections of Device Establishments 
Sec. 601. Risk-based inspections for devices. 
Sec. 602. Recognition of foreign government inspections. 
Sec. 603. Improvements to inspections process for device establishments. 
Sec. 604. Certificates to foreign governments for devices. 
Sec. 605. Facilitating international harmonization. 
Sec. 606. Reauthorization of inspection program. 
Subtitle B—Other Provisions 
Sec. 611. Reauthorization of pediatric humanitarian device exceptions. 
Sec. 612. Reauthorization of pediatric device consortia. 
Sec. 613. Regulation of over-the-counter hearing aids. 
Sec. 614. Report on ensuring quality, safety, and continued effectiveness of de-
vices that have been serviced. 
Sec. 615. Device pilot projects to generate reliable and timely safety and active 
surveillance data. 
Sec. 616. Risk-based classification of accessories. 
TITLE VII—GENERIC DRUG ACCESS AND COMPETITION 
Sec. 701. Competitive Generic Therapies. 
Sec. 702. Enhancing regulatory transparency To enhance generic competition. 
Sec. 703. Incentivizing competitive generic therapy development. 
Sec. 704. Tropical disease product application. 
Sec. 705. GAO study of issues regarding first cycle approvals of generic medi-
cines. 
TITLE VIII—FOSTERING INNOVATION IN MEDICAL IMAGING 
Sec. 801. Approval of applications for certain diagnostic medical imaging de-
vices. 
Sec. 802. Applications for approval of contrast agents intended for use with cer-
tain diagnostic medical imaging devices. 
TITLE IX—ADDITIONAL PROVISIONS 
Sec. 901. Technical corrections. 
Sec. 902. Reauthorization of the critical path public-private partnerships. 
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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 author-
ized by the amendments made in this title will be dedicated 
toward expediting the drug development process and the 
process for the review of human drug applications, includ-
ing 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 Cosmetic Act, 
in the letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Chair-
man of the Committee on Energy and Commerce of the 
House of Representatives, 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— 
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(A) in the matter preceding paragraph (1), 
by striking ‘‘fiscal year 2013’’ and inserting ‘‘fis-
cal 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 ei-
ther 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 subsection (c)(5) 
for a human drug application for which 
clinical data (other than bioavailability or 
bioequivalence studies) with respect to safety 
or effectiveness are not required for ap-
proval.’’; 
(E) in the heading of paragraph (1)(C), by 
striking ‘‘OR SUPPLEMENT’’; 
(F) in paragraph (1)(F)— 
(i) in the heading, by striking ‘‘OR IN-
DICATION’’; and 
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(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 fol-
lows: ‘‘Except as provided in subparagraphs (B) 
and (C), each person who is named as the appli-
cant in a human drug application, and who, 
after September 1, 1992, had pending before the 
Secretary a human drug application or supple-
ment, shall pay the annual prescription drug 
program fee established for a fiscal year under 
subsection (c)(5) for each prescription drug prod-
uct that is identified in such a human drug ap-
plication approved as of October 1 of such fiscal 
year.’’; 
(K) in subparagraph (B) of such paragraph 
(2)— 
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(i) in the heading of subparagraph 
(B), by inserting after ‘‘EXCEPTION’’ the fol-
lowing: ‘‘FOR CERTAIN PRESCRIPTION DRUG 
PRODUCTS’’; and 
(ii) by striking ‘‘A prescription drug 
product shall not be assessed a fee’’ and in-
serting ‘‘A prescription drug program fee 
shall not be assessed for a prescription drug 
product’’; and 
(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 identified 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.’’. 
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(b) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 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, ex-
cept 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 infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the capac-
ity planning adjustment for the fiscal year (as 
determined under subsection (c)(2)); 
‘‘(D) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(3)); 
‘‘(E) the dollar amount equal to the addi-
tional direct cost adjustment for the fiscal year 
(as determined under subsection (c)(4)); and 
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‘‘(F) additional dollar amounts for each fis-
cal 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 determined 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 pre-
scription 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 estab-
lished under paragraph (1) for the previous fis-
cal year, not including any adjustments made 
under subsection (c)(3) or (c)(4).’’. 
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(c) ADJUSTMENTS; ANNUAL
FEE
SETTING.—Sub-
section (c) of section 736 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h) is amended to read as fol-
lows: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of sub-
section (b)(1)(B), the dollar amount of the infla-
tion 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 percent-
age under subparagraph (B). 
‘‘(B) INFLATION
ADJUSTMENT
PERCENT-
AGE.—The 
inflation 
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, multi-
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plied by the proportion of personnel com-
pensation 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; and 
‘‘(ii) 
the 
average 
annual 
percent 
change that occurred in the Consumer Price 
Index for urban consumers (Washington- 
Baltimore, DC–MD–VA–WV; Not Season-
ally 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 compensa-
tion and benefits costs to total costs of the 
process for the review of human drug appli-
cations (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 sub-
section (b)(1)(A) is adjusted for inflation in ac-
cordance with paragraph (1), such revenue shall 
be adjusted further for such fiscal year, in ac-
cordance with this paragraph, to reflect changes 
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in the resource capacity needs of the Secretary 
for the process for the review of human drug ap-
plications. 
‘‘(B) INTERIM METHODOLOGY.— 
‘‘(i) IN GENERAL.—Until the capacity 
planning methodology described in subpara-
graph (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 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 applications, efficacy supple-
ments, and manufacturing supple-
ments submitted to the Secretary; 
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‘‘(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 meet-
ings, as identified in section I.H of the 
letters described in section 101(b) of the 
Prescription Drug User Fee Amend-
ments of 2017. 
‘‘(C) CAPACITY PLANNING METHODOLOGY.— 
‘‘(i) DEVELOPMENT; EVALUATION AND 
REPORT.—The 
Secretary 
shall 
obtain, 
through a contract with an independent ac-
counting or consulting firm, a report evalu-
ating 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 planning meth-
odological options and recommendations 
presented in such report shall utilize and be 
informed by personnel time reporting data 
as an input. The report shall be published 
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for public comment no later than the end of 
fiscal year 2020. 
‘‘(ii) ESTABLISHMENT AND IMPLEMEN-
TATION.—After review of the report de-
scribed in clause (i) and any public com-
ments thereon, the Secretary shall establish 
a capacity planning methodology for pur-
poses of this paragraph, which shall— 
‘‘(I) replace the interim method-
ology under subparagraph (B); 
‘‘(II) incorporate such approaches 
and attributes as the Secretary deter-
mines appropriate; and 
‘‘(III) be effective beginning with 
the first fiscal year for which fees are 
set after such capacity planning meth-
odology 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 in-
flation adjustment for the fiscal year). 
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‘‘(E) 
PUBLICATION
IN
FEDERAL
REG-
ISTER.—The Secretary shall publish in the Fed-
eral 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) 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 revenue and fees 
if such an adjustment is necessary to provide for 
not more than 14 weeks of operating reserves of 
carryover user fees for the process for the review 
of human drug applications. 
‘‘(B) DECREASE.—If the Secretary has car-
ryover balances for such process in excess of 14 
weeks of such operating reserves, the Secretary 
shall decrease such fee revenue and fees to pro-
vide for not more than 14 weeks of such oper-
ating reserves. 
‘‘(C) NOTICE OF RATIONALE.—If an adjust-
ment 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 Reg-
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ister notice under paragraph (5) establishing fee 
revenue 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 subse-
quent fiscal years, by the amount deter-
mined 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 consumers (Washington-Baltimore, 
DC–MD–VA–WV; Not Seasonally Adjusted; 
All Items; Annual Index) for the most re-
cent 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— 
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‘‘(A) establish, for the next 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 sub-
section; 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 subpara-
graph (B); 
(B) by striking subparagraph (C); and 
(C) by redesignating subparagraph (D) as 
subparagraph (C); 
(2) by striking paragraph (3) (relating to use of 
standard costs); 
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(3) by redesignating paragraph (4) as para-
graph (3); and 
(4) in paragraph (3), as so redesignated— 
(A) in subparagraphs (A) and (B), by strik-
ing ‘‘paragraph (1)(D)’’ and inserting ‘‘para-
graph (1)(C)’’; and 
(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 in-
serting ‘‘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 estab-
lishments, 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— 
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(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 ‘‘Pre-
scription Drug User Fee Amendments of 2012’’ 
and inserting ‘‘Prescription Drug User Fee 
Amendments of 2017’’; 
(2) in subsection (b), by striking ‘‘2013’’ and in-
serting ‘‘2018’’; and 
(3) in subsection (d), by striking ‘‘2017’’ each 
place it appears and inserting ‘‘2022’’. 
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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 Administration Safety and Innovation Act (Pub-
lic 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 sub-
chapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act shall be assessed for all human drug applica-
tions 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 enactment of this title, shall continue to be in 
effect with respect to human drug applications and supple-
ments (as defined in such part as of such day) that on or 
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after October 1, 2012, but before October 1, 2017, were ac-
cepted 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; FINDINGS. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Medical Device User Fee Amendments of 2017’’. 
(b) FINDINGS.—The Congress finds that the fees au-
thorized 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 effec-
tiveness 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 Chair-
man 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. 
Section 737 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379i) is amended— 
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(1) by redesignating paragraphs (8) through (13) 
as paragraphs (9) through (14), respectively; 
(2) by inserting after paragraph (7) the fol-
lowing new paragraph: 
‘‘(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 sub-
missions’’ and inserting ‘‘submissions, and de novo 
classification requests’’; and 
(4) in paragraph (11) (as redesignated by para-
graph (1)), by striking ‘‘2011’’ and inserting ‘‘2016’’. 
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)— 
(i) in the matter preceding clause (i), 
by striking ‘‘October 1, 2012’’ and inserting 
‘‘October 1, 2017’’; 
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(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 re-
quest, 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 in-
serting ‘‘premarket notification 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 para-
graph (3). 
‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For pur-
poses of paragraph (1), the base fee amounts specified 
in this paragraph are as follows: 
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‘‘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 Registration .........................
$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 in-
serting ‘‘2017’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking 
‘‘2014’’ and inserting ‘‘2018’’; 
(B) by striking subparagraph (B) and in-
serting the following new subparagraph: 
‘‘(B) 
APPLICABLE
INFLATION
ADJUST-
MENT.—The applicable inflation adjustment for 
fiscal year 2018 and each subsequent fiscal year 
is the product of— 
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‘‘(i) the base inflation adjustment 
under subparagraph (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.’’; 
(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 speci-
fied in subsection (b)(2) for such fiscal year 
by multiplying such amounts by the appli-
cable inflation adjustment under subpara-
graph (B) for such year; and 
‘‘(ii) if the Secretary determines nec-
essary, increase (in addition to the adjust-
ment under clause (i)) such base fee 
amounts, on a uniform proportionate basis, 
to generate the total revenue amounts under 
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subsection (b)(3), as adjusted for inflation 
under subparagraph (A).’’; and 
(3) in paragraph (3)— 
(A) by striking ‘‘2014 through 2017’’ and 
inserting ‘‘2018 through 2022’’; and 
(B) by striking ‘‘further adjusted’’ and in-
serting ‘‘increased’’. 
(d) SMALL BUSINESSES; FEE WAIVER AND FEE RE-
DUCTION REGARDING PREMARKET APPROVAL FEES.—Sec-
tion 738(d) of the Federal 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 ‘‘specified in clauses (i) through 
(vii) and clauses (ix), (x), and (xi)’’; and 
(2) in paragraph (2)(C)— 
(A) by striking ‘‘supplement, or’’ and in-
serting ‘‘supplement,’’; and 
(B) by inserting ‘‘, or a de novo classifica-
tion 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’’. 
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(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 CHANGES.— 
(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 Cosmetic 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 strik-
ing ‘‘and subsection (f)’’. 
(g) EFFECT OF FAILURE TO PAY FEES.—Subsection 
(f)(1), as redesignated, of section 738 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— 
(1) by striking ‘‘or periodic reporting concerning 
a class III device’’ and inserting ‘‘periodic reporting 
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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 redesig-
nated, of section 738 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j) is amended by striking 
‘‘$280,587,000’’ and inserting ‘‘$320,825,000’’. 
(i) CREDITING AND AVAILABILITY OF FEES.—Sub-
section (h), as redesignated, of section 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend-
ed— 
(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 insert-
ing ‘‘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)— 
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‘‘(1) IN GENERAL.—The Secretary shall establish 
a pilot program under which— 
‘‘(A) testing laboratories may be accredited, 
by accreditation bodies meeting criteria specified 
by the Secretary, to assess the conformance of a 
device with certain standards recognized under 
this section; and 
‘‘(B) subject to paragraph (2), determina-
tions 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 sec-
tion unless the Secretary finds that a particular 
such determination shall not be so accepted. 
‘‘(2) SECRETARIAL REVIEW OF ACCREDITED LAB-
ORATORY DETERMINATIONS.—The Secretary may— 
‘‘(A) review determinations by testing lab-
oratories accredited pursuant to this subsection, 
including by conducting periodic audits of such 
determinations or processes of accredited bodies 
or testing laboratories and, following such re-
view, taking additional measures under this Act, 
such as suspension or withdrawal of accredita-
tion of such testing laboratory under paragraph 
(1)(A) or requesting additional information with 
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respect to such device, as the Secretary deter-
mines appropriate; and 
‘‘(B) if the Secretary becomes aware of in-
formation materially bearing on safety or effec-
tiveness of a device assessed for conformity by a 
testing laboratory so accredited, take such addi-
tional measures under this Act as the Secretary 
determines appropriate, such as suspension or 
withdrawal of accreditation of such testing lab-
oratory under paragraph (1)(A), or requesting 
additional information with regard to such de-
vice. 
‘‘(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 Sep-
tember 30, 2018, to discuss and obtain input 
and recommendations from stakeholders regard-
ing the goals and scope of, and a suitable frame-
work and procedures and requirements for, the 
pilot program under this subsection. 
‘‘(B) PILOT PROGRAM GUIDANCE.—The Sec-
retary shall— 
‘‘(i) not later than September 30, 2019, 
issue draft guidance regarding the goals 
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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 September 30, 2020, the Secretary 
shall initiate the pilot program under this sub-
section. 
‘‘(D) REPORT.—The Secretary shall make 
available on the 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 para-
graph (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 de-
termination described in subparagraph (B)(ii), 
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the Secretary shall not continue to recognize the 
accreditation of testing laboratories accredited 
under paragraph (1)(A); and 
‘‘(D) the Secretary may take actions in ac-
cordance with paragraph (2) with respect to the 
determinations made prior to such date and rec-
ognition of the accreditation of testing labora-
tories 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); or 
‘‘(iii) a device that is of a type, or sub-
set of a type, listed as not eligible for review 
under subparagraph (B)(iii).’’; 
(B) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) DESIGNATION FOR REVIEW.—The Sec-
retary shall— 
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‘‘(i) issue draft guidance on the factors 
the Secretary will use in determining 
whether a class I or class II device type, or 
subset of such device types, is eligible for re-
view 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 perma-
nently implantable, life sustaining, or 
life supporting; 
‘‘(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 guid-
ance is finalized, designate and post on the 
internet website of the Food and Drug Ad-
ministration, an updated list of class I and 
class II device types, or subsets of such de-
vice types, and the Secretary’s determina-
tion with respect to whether each such de-
vice type, or subset of a device type, is eligi-
ble or not eligible for review by an accred-
ited person under this section based on the 
factors described in clause (i).’’; and 
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(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 enactment 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 
(ii) by redesignating subparagraph (E) 
as subparagraph (D); and 
(B) in paragraph (3)— 
(i) by redesignating subparagraph (E) 
as subparagraph (F); 
(ii) in subparagraph (F) (as so redes-
ignated), 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 ac-
creditation a commitment to, at the time of 
accreditation, and at any time it is per-
forming any review pursuant to this sec-
tion—’’; and 
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(iii) by inserting after subparagraph 
(D) the following new subparagraph: 
‘‘(E) The operations of such person shall be 
in accordance with generally accepted profes-
sional and ethical business practices.’’; and 
(3) in subsection (c), by striking ‘‘2017’’ and in-
serting ‘‘2022’’. 
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 
Section 745A(b) of the Federal Food, Drug, and Cos-
metic 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 ELECTRONIC FORMAT.— 
‘‘(A) IN GENERAL.—Beginning on such date 
as the Secretary specifies in final guidance 
issued under subparagraph (C), presubmissions 
and submissions for devices described in para-
graph (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— 
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‘‘(i) any further standards for the sub-
mission by electronic format required under 
subparagraph (A); 
‘‘(ii) a timetable for the establishment 
by the Secretary of such further standards; 
and 
‘‘(iii) criteria for waivers of and ex-
emptions from the requirements of this sub-
section. 
‘‘(C) 
FINAL
GUIDANCE.—The 
Secretary 
shall, not later than 12 months after the close of 
the public comment period on the draft guidance 
issued under subparagraph (B), issue final guid-
ance described in clauses (i) through (iii) of such 
subparagraph.’’. 
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 col-
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lecting any fee required by such part for a fiscal year prior 
to fiscal year 2018. 
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 sub-
chapter 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 CLAUSE. 
(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 reauthorization and reporting requirements) 
shall cease to be effective January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 
1, 2017, section 207(a) of the Medical Device User Fee 
Amendments of 2012 (Public Law 112–144) is repealed. 
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TITLE III—FEES RELATING TO 
GENERIC DRUGS 
SEC. 301. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Ge-
neric Drug User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees author-
ized by the amendments made in this title will be dedicated 
to human generic drug activities, as set forth in the goals 
identified for purposes 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 ‘‘applica-
tion for a positron emission tomography drug.’’ and 
inserting ‘‘application— 
‘‘(i) for a positron emission tomog-
raphy drug; or 
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‘‘(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 paragraphs (6) through (13), respectively; and 
(3) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) The term ‘contract manufacturing organiza-
tion facility’ means a manufacturing facility of a fin-
ished dosage form of a drug approved pursuant to an 
abbreviated new drug application, where such manu-
facturing facility is not identified in an approved ab-
breviated new drug application held by the owner of 
such facility or an affiliate of such owner or facil-
ity.’’. 
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GE-
NERIC 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: 
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‘‘(E) SUNSET.—This paragraph shall cease 
to be effective October 1, 2022.’’; 
(3) in paragraph (2)— 
(A) by amending subparagraph (C) to read 
as follows: 
‘‘(C) NOTICE.—Not later than 60 days be-
fore 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 in-
serting ‘‘; or’’; and 
(III) by adding at the end the fol-
lowing: 
‘‘(II) the date on which the drug 
master file holder requests the initial 
completeness assessment.’’; and 
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(ii) in clause (ii), by striking ‘‘notice 
provided for in clause (i) or (ii) of subpara-
graph (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 application’’; 
(C) by amending subparagraphs (B) and 
(C) to read as follows: 
‘‘(B) NOTICE.—Not later than 60 days be-
fore the start of each of fiscal years 2018 through 
2022, the Secretary shall publish in the Federal 
Register the amount of the fees under subpara-
graph (A) for such fiscal year. 
‘‘(C) FEE DUE DATE.—The fees required by 
subparagraphs (A) and (F) shall be due no later 
than the date of submission of the abbreviated 
new drug application or prior approval supple-
ment for which such fee applies.’’; 
(D) in subparagraph (D)— 
(i) in the heading, by inserting ‘‘, IS 
WITHDRAWN PRIOR TO BEING RECEIVED, OR 
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IS
NO
LONGER
RECEIVED’’ after ‘‘RE-
CEIVED’’; 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
APPLICA-
TIONS
WITHDRAWN
PRIOR
TO
BEING
RE-
CEIVED.—The Secretary shall refund 75 
percent of the fee paid under subparagraph 
(A) for any abbreviated new drug applica-
tion that the Secretary 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
RE-
CEIVED.—The Secretary shall refund 100 
percent of the fee paid under subparagraph 
(A) for any abbreviated new drug applica-
tion 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 pre-
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vented the Secretary from receiving such 
application, such that the abbreviated new 
drug application is no longer received with-
in 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 in-
tended to be identified, in at least one ge-
neric drug submission that is pending or’’ 
and inserting ‘‘in at least one generic drug 
submission that is’’; 
(ii) in clause (i), by striking ‘‘or in-
tended to be identified in at least one ge-
neric drug submission that is pending or’’ 
and inserting ‘‘in at least one generic drug 
submission that is’’; 
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(iii) in clause (ii), by striking ‘‘pro-
duces,’’ and all that follows through ‘‘such 
a’’ and inserting ‘‘is identified 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 manufac-
ture of the finished dosage forms’’; and 
(B) by amending subparagraphs (C) and 
(D) to read as follows: 
‘‘(C) NOTICE.—Within the timeframe speci-
fied in subsection (d)(1), the Secretary shall pub-
lish 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 subpara-
graph (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 
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‘‘(ii) the first business day after the en-
actment of an appropriations Act providing 
for the collection and obligation of fees for 
such year under this section for such year.’’; 
(6) by redesignating paragraph (5) as para-
graph (6); and 
(7) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) 
GENERIC
DRUG
APPLICANT
PROGRAM 
FEE.— 
‘‘(A) IN GENERAL.—A generic drug appli-
cant program fee shall be assessed annually as 
described in subsection (b)(2)(E). 
‘‘(B) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (d). 
‘‘(C) NOTICE.—Within the timeframe speci-
fied in subsection (d)(1), the Secretary shall pub-
lish 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 subpara-
graph (A) for such fiscal year shall be due on the 
later of— 
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‘‘(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 enactment of an appropriations Act 
providing for the collection 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’’; 
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(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 in-
serting ‘‘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 ab-
breviated new drug applications). 
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‘‘(C) Twenty percent shall be derived from 
fees under subsection (a)(4)(A)(i) (relating to ge-
neric 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 manufac-
turing 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 ter-
ritories 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 ge-
neric drug applicant program fees). For pur-
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poses of this subparagraph, if a person has affili-
ates, 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 affili-
ates) owns at least one but not more than 
5 approved abbreviated new drug applica-
tions on the due date for the fee under this 
subsection, the person (including its affili-
ates) shall be assessed a small business ge-
neric drug applicant program fee equal to 
one-tenth of the large size operation generic 
drug applicant program fee. 
‘‘(II) If a person (including its affili-
ates) owns at least 6 but not more than 19 
approved abbreviated new drug applications 
on the due date for the fee under this sub-
section, the person (including its affiliates) 
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. 
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‘‘(III) If a person (including its affili-
ates) owns 20 or more approved abbreviated 
new drug applications on the due date for 
the fee under this subsection, the person (in-
cluding 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 withdrawal 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’’; 
(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 sub-
paragraph (C); and 
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(2) in paragraph (2)— 
(A) by striking ‘‘2017’’ each place it ap-
pears 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 in-
serting the following: 
‘‘(1) FISCAL
YEARS
2018
THROUGH
2022.—Not 
more than 60 days before the first day of each of fis-
cal years 2018 through 2022, the Secretary shall es-
tablish the fees described in paragraphs (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 para-
graph (2); and 
(3) in paragraph (2) (as so redesignated), in the 
matter preceding subparagraph (A), by striking ‘‘fees 
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under paragraphs (1) and (2)’’ and inserting ‘‘fee 
under paragraph (1)’’. 
(e) IDENTIFICATION OF FACILITIES.—Section 744B(f) 
of the Federal 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 paragraphs (1) through (3), respectively; 
(3) in paragraph (1) (as so redesignated)— 
(A) by striking ‘‘paragraph (4)’’ and insert-
ing ‘‘paragraph (3)’’; and 
(B) by striking ‘‘Such information shall’’ 
and all that follows through the end of subpara-
graph (B) and inserting ‘‘Such information 
shall, for each fiscal year, be submitted, updated, 
or reconfirmed on or before June 1 of the pre-
vious fiscal year.’’; and 
(4) in paragraph (2), as so redesignated— 
(A) in the heading, by striking ‘‘CONTENTS 
OF NOTICE’’ and inserting ‘‘INFORMATION RE-
QUIRED TO BE SUBMITTED’’; 
(B) in the matter preceding subparagraph 
(A), by striking ‘‘paragraph (2)’’ and inserting 
‘‘paragraph (1)’’; 
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(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 man-
ufacturing organization facility.’’. 
(f) EFFECT
OF FAILURE TO PAY FEES.—Section 
744B(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379–42(g)) is amended— 
(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 
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date, as specified in subparagraph (D) of such 
subsection, shall be subject to the following: 
‘‘(i) The Secretary shall place the per-
son on a publicly available arrears list. 
‘‘(ii) Any abbreviated new drug appli-
cation submitted by the generic drug appli-
cant or an affiliate of such applicant shall 
not be received, within the meaning of sec-
tion 505(j)(5)(A). 
‘‘(iii) All drugs marketed pursuant to 
any abbreviated new drug application held 
by such applicant or an affiliate of such ap-
plicant shall be deemed misbranded 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. 379–42(h)(2)) is 
amended by striking ‘‘for Type II active pharmaceutical in-
gredient drug master files, abbreviated new drug applica-
tions and prior approval supplements, and generic drug fa-
cilities and active pharmaceutical ingredient facilities’’. 
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(h) CREDITING AND AVAILABILITY OF FEES.—Section 
744B(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379–42(i)) is amended— 
(1) in paragraph (2)— 
(A) by striking subparagraph (C) (relating 
to fee collection during first program year); 
(B) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN 
SUBSEQUENT YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 
2013)’’; and 
(C) by redesignating subparagraph (D) as 
subparagraph (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 APPLI-
CATIONS OWNED
BY APPLICANTS
AND THEIR AFFILI-
ATES.—Section 744B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379–42) is amended by adding at the 
end the following: 
‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG AP-
PLICATIONS OWNED BY APPLICANTS AND THEIR AFFILI-
ATES.— 
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‘‘(1) IN GENERAL.—By April 1 of each year, 
each person that owns an abbreviated new drug ap-
plication, or any affiliate of such person, shall sub-
mit, on behalf of the person and its affiliates, to the 
Secretary a list of— 
‘‘(A) all approved abbreviated new drug ap-
plications owned by such person; and 
‘‘(B) if any affiliate of such person also 
owns an abbreviated new drug application, all 
affiliates that own any such abbreviated new 
drug applications 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 Amendments of 2017’’; 
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(2) in subsection (b), by striking ‘‘2013’’ and in-
serting ‘‘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.—Effective October 
1, 2017, subsections (a) and (b) of section 304 of the Food 
and Drug Administration Safety and Innovation Act (Pub-
lic Law 112–144) are repealed. 
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 sub-
chapter 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. 
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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 enactment 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 on or after October 
1, 2012, but before October 1, 2017, were received by the 
Food and Drug Administration within the meaning of sec-
tion 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior 
approval supplements that were submitted, and drug mas-
ter files for Type II active pharmaceutical ingredients that 
were first referenced 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 author-
ized by the amendments made in this title will be dedicated 
to expediting the process for the review of biosimilar biologi-
cal product applications, including postmarket safety ac-
tivities, as set forth in the goals identified for purposes of 
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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 (Washington-Baltimore, DC–MD–VA–WV; 
Not Seasonally Adjusted; All items; Annual Index) 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 prod-
uct’’ and inserting ‘‘means a specific strength of a biological 
product in final dosage form’’. 
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(7) in paragraph (1)(B), by adding at the end 
the following: 
‘‘(iv) REFUND.—If a person submits a 
marketing application for a biosimilar bio-
logical 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 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 prod-
uct effective October 1 of a fiscal year by,’’ and insert-
ing ‘‘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 participation in such program,’’ before 
‘‘pay a fee’’; 
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(B) in clause (i)(I), by inserting after 
‘‘grants a request’’ the following: ‘‘by such per-
son’’; and 
(C) in clause (i)(II), by inserting after ‘‘dis-
continued)’’ the following: ‘‘by such person’’; 
(10) in the heading of paragraph (1)(E), by 
striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; 
(11) in paragraph (1)(F)— 
(A) in the subparagraph heading, by strik-
ing ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’ be-
fore ‘‘FEES’’; and 
(B) by amending clause (i) to read as fol-
lows: 
‘‘(i) REFUNDS.—Except as provided in 
subparagraph (B)(iv), the Secretary shall 
not refund any initial or annual biosimilar 
biological product development fee paid 
under subparagraph (A) or (B), or any re-
activation fee paid under subparagraph 
(D).’’; 
(12) in paragraph (2)— 
(A) in the paragraph heading, by striking 
‘‘AND SUPPLEMENT’’; 
(B) by amending subparagraphs (A) and 
(B) to read as follows: 
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‘‘(A) IN GENERAL.—Each person that sub-
mits, 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 re-
quired 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 de-
scribed in clause (i). 
‘‘(B) RULE OF APPLICABILITY; TREATMENT 
OF CERTAIN PREVIOUSLY PAID FEES.—Any per-
son who pays a fee under subparagraph (A), (B), 
or (D) of paragraph (1) for a product before Oc-
tober 1, 2017, but submits a biosimilar biological 
product application for that product after such 
date, shall— 
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‘‘(i) be subject to any biosimilar bio-
logical product application fees that may be 
assessed at the time when such biosimilar 
biological product application is submitted; 
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 subparagraphs (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 fol-
lows: 
‘‘(3) BIOSIMILAR
BIOLOGICAL
PRODUCT
PRO-
GRAM FEE.— 
‘‘(A) IN
GENERAL.—Each person who is 
named as the applicant in a biosimilar biologi-
cal product application shall pay the annual 
biosimilar biological product program fee estab-
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lished 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 discon-
tinued biosimilar biological products. 
‘‘(B) DUE DATE.—The biosimilar biological 
product program 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 en-
actment 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 prod-
uct application shall not be assessed more than 
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5 biosimilar biological product program fees for 
a fiscal year for biosimilar biological products 
identified in such biosimilar biological product 
application.’’. 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 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 gen-
erate a total revenue amount equal to the sum of— 
‘‘(A) $45,000,000; and 
‘‘(B) the dollar amount equal to the fiscal 
year 2018 adjustment (as determined under sub-
section (c)(4)). 
‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 
the fiscal years 2019 through 2022, fees under sub-
section (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 infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
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‘‘(C) the dollar amount equal to the capac-
ity planning adjustment for the fiscal year (as 
determined under subsection (c)(2)); and 
‘‘(D) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(3)). 
‘‘(3) ALLOCATION OF REVENUE AMOUNT AMONG 
FEES; LIMITATIONS ON FEE AMOUNTS.— 
‘‘(A) ALLOCATION.—The Secretary shall de-
termine the percentage of the total revenue 
amount for a fiscal year to be derived from, re-
spectively— 
‘‘(i) initial and annual biosimilar de-
velopment fees and reactivation fees under 
subsection (a)(1); 
‘‘(ii) biosimilar biological product ap-
plication 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 
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not exceed 125 percent of the amount of such fee 
for fiscal year 2018. 
‘‘(C) BIOSIMILAR BIOLOGICAL PRODUCT DE-
VELOPMENT FEES.—The initial biosimilar bio-
logical product development fee under subsection 
(a)(1)(A) for a fiscal year shall be equal to the 
annual biosimilar biological product develop-
ment fee under subsection (a)(1)(B) for that fis-
cal 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 subsections (d) through (i), respectively; 
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(2) in subsections (a)(2)(F) and (h) (as redesig-
nated by paragraph (1)), by striking ‘‘subsection (c)’’ 
and inserting ‘‘subsection (d)’’; 
(3) in subsection (a)(4)(A), by striking ‘‘sub-
section (b)(1)(F)’’ and inserting ‘‘subsection (c)(5)’’; 
and 
(4) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of sub-
section (b)(2)(B), the dollar amount of the infla-
tion 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 percent-
age under subparagraph (B). 
‘‘(B) INFLATION
ADJUSTMENT
PERCENT-
AGE.—The 
inflation 
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 
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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, multi-
plied by the proportion of personnel com-
pensation and benefits costs to total costs of 
the process for the review of biosimilar bio-
logical product applications (as defined in 
section 744G(13)) 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 consumers (Washington- 
Baltimore, DC–MD–VA–WV; Not Season-
ally 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 compensa-
tion and benefits costs to total costs of the 
process for the review of biosimilar biologi-
cal product applications (as defined in sec-
tion 744G(13)) for the first 3 years of the 
preceding 4 fiscal years. 
‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 
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‘‘(A) IN GENERAL.—Beginning with the fis-
cal year described in subparagraph (B)(ii)(II), 
the Secretary shall, in addition to the adjust-
ment under paragraph (1), further increase the 
fee revenue and fees under this section for a fis-
cal year to reflect changes in the resource capac-
ity needs of the Secretary for the process for the 
review of biosimilar biological product applica-
tions. 
‘‘(B) CAPACITY PLANNING METHODOLOGY.— 
‘‘(i) DEVELOPMENT; EVALUATION AND 
REPORT.—The 
Secretary 
shall 
obtain, 
through a contract with an independent ac-
counting or consulting firm, a report evalu-
ating 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 capac-
ity planning methodological options and 
recommendations presented in such report 
shall utilize and be informed by personnel 
time reporting data as an input. The report 
shall be published for public comment not 
later than September 30, 2020. 
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‘‘(ii) ESTABLISHMENT AND IMPLEMEN-
TATION.—After review of the report de-
scribed in clause (i) and receipt and review 
of public comments thereon, the Secretary 
shall establish a capacity planning method-
ology for purposes of this paragraph, which 
shall— 
‘‘(I) incorporate such approaches 
and attributes as the Secretary deter-
mines appropriate; and 
‘‘(II) be effective beginning with 
the first fiscal year for which fees are 
set after such capacity planning meth-
odology 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 in-
flation adjustment for the fiscal year). 
‘‘(D) 
PUBLICATION
IN
FEDERAL
REG-
ISTER.—The Secretary shall publish in the Fed-
eral Register notice under paragraph (5) the fee 
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revenue and fees resulting from the adjustment 
and the methodologies under this paragraph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INTERIM
APPLICATION; FEE
REDUC-
TION.—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 fis-
cal year as the Secretary determines appropriate 
for long-term financial planning purposes. 
‘‘(B) GENERAL APPLICATION AND METHOD-
OLOGY.—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 paragraphs 
(1) and (2)— 
‘‘(i) reduce the fee revenue and fees 
under this section as the Secretary deter-
mines 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 
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fees for the process for the review of bio-
similar biological product applications. 
‘‘(C) FEDERAL
REGISTER
NOTICE.—If an 
adjustment under subparagraph (A) or (B) is 
made, the rationale for the amount of the in-
crease or decrease (as applicable) in fee revenue 
and fees shall be contained in the annual Federal 
Register notice under paragraph (5) 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 of the 
workload for the process for the review of bio-
similar biological product applications. 
‘‘(B) METHODOLOGY.—The Secretary shall 
publish under paragraph (5) 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 
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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 devel-
opment fees and reactivation fees under sub-
section (a)(1), biosimilar biological product ap-
plication 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 adjust-
ments 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 allo-
cated for the process for the review of biosimilar bio-
logical product applications.’’. 
(d) APPLICATION FEE WAIVER
FOR SMALL BUSI-
NESS.—Subsection (d)(1) of section 744H of the Federal 
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Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as re-
designated by subsection (c)(1), is amended— 
(1) by striking subparagraph (B); 
(2) by striking ‘‘shall pay—’’ and all that fol-
lows through ‘‘application fees’’ and inserting ‘‘shall 
pay application fees’’; and 
(3) by striking ‘‘; and’’ at the end and inserting 
a period. 
(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.—Sub-
section (f) of section 744H of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–52), as redesignated by sub-
section (c)(1), is amended— 
(1) in paragraph (2)— 
(A) by striking subparagraph (C) (relating 
to fee collection during first program year) and 
inserting the following: 
‘‘(C) COMPLIANCE.—The Secretary shall be 
considered to have met the requirements of sub-
paragraph (B) in any fiscal year if the costs de-
scribed in such subparagraph are not more than 
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15 percent below the level specified in such sub-
paragraph.’’; 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’’. 
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 in-
serting ‘‘2018’’; 
(3) by striking subsection (d); 
(4) by redesignating subsection (e) as subsection 
(d); and 
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(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, as amended by sec-
tion 403 of this Act, shall cease to be effective October 1, 
2022. 
(b) REPORTING REQUIREMENTS.—Section 744I of the 
Federal Food, Drug, and Cosmetic Act, as amended by sec-
tion 404 of this Act, shall cease to be effective January 31, 
2023. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN GENERAL.—Effective October 1, 2017, sec-
tion 404 of the Food and Drug Administration Safety 
and Innovation Act (Public Law 112–144) is re-
pealed. 
(2) CONFORMING AMENDMENT.—The Food and 
Drug Administration Safety and Innovation Act 
(Public Law 112–144) is amended in the table of con-
tents in section 2 by striking the item relating to sec-
tion 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 
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Act, whichever is later, except that fees under part 8 of sub-
chapter 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 enactment of this title, shall continue to be in 
effect with respect to biosimilar biological product applica-
tions and supplements (as defined in such part as of such 
day) that were accepted by the Food and Drug Administra-
tion for filing on or after October 1, 2012, but before October 
1, 2017, with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2018. 
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TITLE 
V—REAUTHORIZATIONS 
AND 
IMPROVEMENTS 
RE-
LATED TO DRUGS 
SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(u)(4)) is amended by striking 
‘‘2017’’ and inserting ‘‘2022’’. 
SEC. 502. REAUTHORIZATION OF ORPHAN GRANTS PRO-
GRAM. 
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. 503. REAUTHORIZATION OF PEDIATRIC STUDY OF 
DRUGS. 
Section 409I(e)(1) of the Public Health Service Act (42 
U.S.C. 284m(e)(1)) is amended by striking ‘‘2013 through 
2017’’ and inserting ‘‘2018 through 2022’’. 
SEC. 504. 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— 
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(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 in effect 
under section 506E, no drug that would be subject to section 
503(b), and which is manufactured outside the United 
States and intended by the manufacturer or labeled to be 
marketed outside the United States, may be imported into 
the United States for sale or commercial use.’’. 
(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. 505. SENSE OF CONGRESS ON LOWERING THE COST OF 
PRESCRIPTION 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— 
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(1) will lower the cost of prescription drugs for 
consumers and reduce the burden of such cost on tax-
payers; and 
(2) in lowering such cost, will— 
(A) balance the need to encourage innova-
tion 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. 
TITLE VI—DEVICE INSPECTION 
AND REGULATORY IMPROVE-
MENTS 
Subtitle A—Improving the Process 
for Inspections of Device Estab-
lishments 
SEC. 601. RISK-BASED INSPECTIONS FOR DEVICES. 
Paragraph (2) of section 510(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended to 
read as follows: 
‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 
‘‘(A) IN GENERAL.—The Secretary, acting 
through one or more officers or employees duly 
designated by the Secretary, shall inspect estab-
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lishments 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 establish-
ments’) in accordance with a risk-based schedule 
established by the Secretary. 
‘‘(B) FACTORS AND CONSIDERATIONS.—In 
establishing the risk-based schedule under sub-
paragraph (A), the Secretary 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 inter-
national device audit programs in which 
the United States participates or which the 
United States recognizes for purposes of in-
specting device establishments.’’. 
SEC. 602. RECOGNITION OF FOREIGN GOVERNMENT IN-
SPECTIONS. 
Subsection (a)(1) of section 809 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended 
by inserting ‘‘or 510(h)(2) (as applicable)’’ before the semi-
colon at the end. 
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SEC. 603. 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 
inspections, the Secretary shall review processes and stand-
ards applicable to inspections of domestic and foreign de-
vice establishments in effect as of the date of the enactment 
of this subsection, and update such processes and standards 
through the adoption of uniform processes and standards 
applicable to such inspections. Such processes and stand-
ards shall provide for— 
‘‘(A) exceptions to such processes and standards, 
as appropriate; 
‘‘(B) announcing the inspection of the establish-
ment 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 inspection, an opportunity for advance commu-
nications between the officers or employees carrying 
out the inspection under subsection (a)(1) and the 
owner, operator, or agent in charge of the establish-
ment concerning appropriate working hours during 
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the inspection, and, to the extent feasible, advance no-
tice of some records that will be requested in order to 
expedite the inspection; and 
‘‘(D) regular communications during the inspec-
tion 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 feed-
back 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 re-
quest 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 re-
ceived by such establishment pursuant to subsection 
(b) that involve a public health priority, that impli-
cate systemic or major actions, or relate to emerging 
safety issues (as determined by the Secretary). 
‘‘(3) Nothing in this subsection limits the authority of 
the Secretary to conduct inspections otherwise permitted 
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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 section, the 
Secretary of Health and Human Services shall issue 
draft guidance that— 
(A) specifies how the Food and Drug Ad-
ministration will implement the process de-
scribed in paragraph (1) of subsection (h) of sec-
tion 704 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374), as added by sub-
section (a), and the requirements described in 
paragraph (2) of such subsection; 
(B) provides for standardized methods for 
communications described in such paragraphs; 
(C) establishes, with respect to inspections 
of both domestic and foreign device establish-
ments (as referred to in section 510(h)(2) of the 
Federal Food, Drug, and Cosmetic Act, as 
amended by subsection (a)), a standard time-
frame for such inspections— 
(i) that occurs over consecutive days; 
and 
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(ii) to which each investigator con-
ducting such an inspection shall adhere un-
less the investigator identifies to the estab-
lishment 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 para-
graph (1), the Secretary of Health and Human Serv-
ices shall issue final guidance to implement subsection 
(h) of section 704 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374), as added by subsection 
(a). 
SEC. 604. CERTIFICATES TO FOREIGN GOVERNMENTS FOR 
DEVICES. 
(a) IN GENERAL.—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) If the Secretary denies a request made under 
subparagraph (A)(ii) for certification with respect to a de-
vice, the Secretary shall provide, in writing, to the person 
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seeking such certification the basis for such denial, and spe-
cifically identify the finding upon which such denial is 
based. 
‘‘(ii) If the denial of a request as described in clause 
(i) is based on— 
‘‘(I) grounds other than an injunction pro-
ceeding pursuant to section 302, seizure action pursu-
ant to section 304, or a recall designated Class I or 
Class II pursuant to part 7, title 21, Code of Federal 
Regulations, and 
‘‘(II) an establishment being considered out of 
compliance with part 820, title 21, Code of Federal 
Regulations, 
the Secretary shall provide a substantive summary of the 
specific grounds for noncompliance so identified, if such 
grounds have not been previously communicated to the 
manufacturer. 
‘‘(iii) With respect to a device manufactured in an es-
tablishment that has received a report under section 704(b), 
the Secretary shall not deny a request for certification 
under subparagraph (A)(ii) based exclusively on the 
issuance of that report if the owner, operator, or agent in 
charge of such establishment has agreed to a plan of correc-
tion in response to such report. 
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‘‘(F)(i) The Secretary shall provide a process for a per-
son who is denied a certification as described in subpara-
graph (E)(i) to request a review that conforms to the stand-
ards of section 517A(b). 
‘‘(ii) Notwithstanding any previous review conducted 
pursuant to clause (i), a person who has been denied a cer-
tification for a device as described in subparagraph (E)(i) 
may, at any time, request a review of that denial in order 
to present new information relating to actions taken by 
such person to address the reasons identified by the Sec-
retary for such denial, including evidence that corrective 
actions are being or have been implemented to address the 
grounds for noncompliance identified by the Secretary 
under subparagraph (E)(ii). 
‘‘(G)(i) This paragraph applies to requests for certifi-
cation on behalf of any device establishment registered 
under section 510, whether the establishment is located in 
the United States or another country. 
‘‘(ii) The Secretary may charge a fee for the issuance 
of a certification described in clause (i), and such fee is 
subject to the same conditions and requirements as a fee 
charged under subparagraph (B) for a certification issued 
under such subparagraph.’’; and 
(2) by moving the margins of subparagraphs (C) 
and (D) 4 ems to the left. 
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(b) GUIDANCE.—Not later than 1 year after date of 
the enactment of this section, the Secretary of Health and 
Human Services shall issue guidance providing for a proc-
ess to carry out subparagraph (F) of section 801(e)(4) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(e)(4)), as added by subsection (a). Not later than 12 
months after the comment period closes for the draft guid-
ance, the Secretary shall issue final guidance. 
SEC. 605. FACILITATING INTERNATIONAL HARMONIZATION. 
Section 704(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374(g)) is amended by adding at the 
end the following: 
‘‘(15) Notwithstanding any other provision of this sub-
section, for purposes of conducting inspections of establish-
ments that manufacture, prepare, propagate, compound, or 
process devices except types of devices licensed under section 
351 of the Public Health Service Act, which inspections are 
required under section 510(h) or are inspections of such es-
tablishments required to register pursuant to section 510(i), 
the Secretary may recognize auditing organizations that 
are recognized by organizations established by governments 
to facilitate international harmonization. Nothing in this 
paragraph affects the authority of the Secretary to inspect 
any device establishment pursuant to this Act. Nothing in 
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this paragraph affects the authority of the Secretary to de-
termine the official classification of an inspection.’’. 
SEC. 606. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 374(g)(11)) is amended by striking 
‘‘October 1, 2017’’ and inserting ‘‘October 1, 2022’’. 
Subtitle B—Other Provisions 
SEC. 611. REAUTHORIZATION OF PEDIATRIC HUMANI-
TARIAN DEVICE EXCEPTIONS. 
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended 
by striking ‘‘2017’’ and inserting ‘‘2022’’. 
SEC. 612. REAUTHORIZATION OF PEDIATRIC DEVICE CON-
SORTIA. 
Section 305(e) of the Pediatric Medical Device Safety 
and Improvement Act of 2007 (Public Law 110–85; 42 
U.S.C. 282 note)) is amended by striking ‘‘2013 through 
2017’’ and inserting ‘‘2018 through 2022’’. 
SEC. 613. 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) is amended by 
adding at the end the following: 
‘‘(p) REGULATION OF OVER-THE-COUNTER HEARING 
AIDS.— 
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‘‘(1) DEFINITION.— 
‘‘(A) In this subsection, the term ‘over-the- 
counter hearing aid’ means a device— 
‘‘(i) that uses the same fundamental 
scientific technology as air conduction hear-
ing aids (as defined in section 874.3300 of 
title 21, Code of Federal Regulations) (or 
any successor regulation) or wireless air 
conduction hearing aids (as defined in sec-
tion 874.3305 of title 21, Code of Federal 
Regulations) (or any successor regulation); 
‘‘(ii) that is intended to be used by 
adults over the age of 18 to compensate for 
perceived mild to moderate hearing impair-
ment; 
‘‘(iii) that, through tools, tests, or soft-
ware, allows the user to control the over-the- 
counter hearing aid and customize it to the 
user’s hearing needs; 
‘‘(iv) that may— 
‘‘(I) use wireless technology; or 
‘‘(II) include tests for self-assess-
ment of hearing loss; and 
‘‘(v) that is available over-the-counter, 
without the supervision, prescription, or 
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other order, involvement, or intervention of 
a licensed person, to consumers through in- 
person transactions, by mail, or online. 
‘‘(B) Such term does not include a personal 
sound amplification product intended to amplify 
sound for nonhearing impaired consumers in sit-
uations including hunting and bird-watching. 
‘‘(2) REGULATION.—An over-the-counter hearing 
aid shall be subject to the regulations promulgated in 
accordance with section 613(b) of the FDA Reauthor-
ization Act of 2017 and shall be exempt from sections 
801.420 and 801.421 of title 21, Code of Federal Reg-
ulations (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 reg-
ulations to establish a category of over-the-counter 
hearing aids, as defined in subsection (p) 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. 
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(2) REQUIREMENTS.—In promulgating the regu-
lations under paragraph (1), the Secretary shall— 
(A) include requirements that provide rea-
sonable assurances of the safety and efficacy 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 la-
beling of the over-the-counter hearing aid, in-
cluding requirements that such labeling include 
a conspicuous statement that the device is only 
intended for adults over the age of 18, informa-
tion on how consumers may report adverse 
events, information on any contraindications, 
conditions, or symptoms of medically treatable 
causes of hearing loss, and advisements to con-
sult promptly with a licensed physician; and 
(D) describe the requirements under which 
the sale of over-the-counter hearing aids is per-
mitted, without the supervision, prescription, or 
other order, involvement, or intervention of a li-
censed person, to consumers through in-person 
transactions, by mail, or online. 
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(3) PREMARKET NOTIFICATION.—The Secretary 
shall make findings under section 510(m) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360(m)) to determine whether over-the-counter hear-
ing aids (as defined in section 520(p) 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 safe-
ty and effectiveness. 
(4) EFFECT ON STATE LAW.—No State or local 
government shall establish or continue in effect any 
law, regulation, order, or other requirement specifi-
cally related to hearing products that would restrict 
or interfere with the servicing, marketing, sale, dis-
pensing, use, customer support, or distribution of 
over-the-counter hearing aids (as defined in section 
520(p) 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 otherwise not 
identical to, the regulations promulgated under this 
subsection, including any State or local requirement 
for the supervision, prescription, or other order, in-
volvement, or intervention of a licensed person for 
consumers to access over-the-counter hearing aids. 
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(5) NO EFFECT ON PRIVATE REMEDIES.—Noth-
ing in this section shall be construed to modify or oth-
erwise affect the ability of any person to exercise a 
private right of action under any State or Federal 
product liability, tort, warranty, contract, or con-
sumer 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 Products’’, issued on Novem-
ber 7, 2013. Such updated and finalized guidance shall 
clarify which products, on the basis of claims or other mar-
keting, advertising, or labeling material, meet the definition 
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 
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in subsection (p)(1) of section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j)). 
SEC. 614. REPORT ON ENSURING QUALITY, SAFETY, AND 
CONTINUED 
EFFECTIVENESS 
OF 
DEVICES 
THAT HAVE BEEN SERVICED. 
(a) IN GENERAL.—Not later than 180 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 submit to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor and Pensions of the 
Senate a report on how the Food and Drug Administration 
intends to ensure the quality, safety, and continued effec-
tiveness of devices (as defined in section 201(h) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301(h))) with 
respect to which servicing (as defined in subsection (c)) has 
been performed by any entity engaging in such servicing. 
(b) CONTENTS.—The report submitted under sub-
section (a) shall contain— 
(1) the status of, and findings to date with re-
spect to, the notice entitled ‘‘Refurbishing, Recondi-
tioning, Rebuilding, Remarketing, Remanufacturing, 
and Servicing of Medical Devices Performed by 
Third-Party Entities and Original Equipment Manu-
facturers; Request for Comments’’ published by the 
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100 
Food and Drug Administration on April 25, 2016 (81 
Fed. Reg. 24041 et seq.), including how the Food and 
Drug Administration intends to define the specific ac-
tivities performed on a device by the manufacturer of 
the device or other entities; 
(2) a description of the statutory or regulatory 
authority of the Food and Drug Administration used 
to oversee and regulate servicing conducted with re-
spect to devices; 
(3) details on how the Food and Drug Adminis-
tration intends to protect the public health by ensur-
ing consistent quality, safety, and continued effective-
ness of devices with respect to which servicing has 
been performed by any entity engaging in such serv-
icing; 
(4) information on how the Food and Drug Ad-
ministration can better understand the device serv-
icing industry, including the size, scope, location, and 
composition of entities performing such servicing and 
the rate of adverse events related to such servicing; 
(5) information regarding the current regulation 
by States, the Joint Commission, or other regulatory 
bodies of servicing conducted with respect to devices 
by all entities, including original equipment manu-
facturers, third-party entities, and hospitals; and 
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101 
(6) any additional information determined by 
the Secretary (acting through the Commissioner) to be 
relevant to ensuring the quality, safety, and contin-
ued effectiveness of devices with respect to which serv-
icing has been performed, including whether addi-
tional Federal statutory authority is necessary to en-
sure such quality, safety, and continued effectiveness. 
(c) SERVICING DEFINED.—In this section, the term 
‘‘servicing’’ includes, with respect to a device, refurbishing, 
reconditioning, rebuilding, remarketing, remanufacturing, 
repairing, or other servicing of the device by a person other 
than the manufacturer of the device. 
SEC. 615. DEVICE PILOT PROJECTS TO GENERATE RELI-
ABLE AND TIMELY SAFETY AND ACTIVE SUR-
VEILLANCE DATA. 
(a) IN GENERAL.—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) PILOT PROJECTS TO GENERATE RELIABLE AND 
TIMELY SAFETY AND ACTIVE SURVEILLANCE DATA.— 
‘‘(1) IN
GENERAL.—The Secretary shall, not 
later than one year after the date of the enactment of 
the FDA Reauthorization Act of 2017, initiate one or 
more pilot projects relating to providing timely and 
reliable information on the safety and effectiveness of 
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102 
devices approved under section 515, cleared under sec-
tion 510(k), or classified under section 513(f)(2), in 
which a manufacturer or manufacturers of a device or 
device type voluntarily participate. Any such project 
shall meet each of the following criteria: 
‘‘(A) The project is 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) The project informs, to the extent ap-
plicable, the development of methods, systems, 
data criteria, and programs that could be used 
to support safety and active surveillance activi-
ties for any device. 
‘‘(C) The project shall be designed and con-
ducted in coordination with a comprehensive 
system for evaluating device technology that op-
erates under a governing board with appropriate 
representation of stakeholders, including patient 
groups and device manufacturers. 
‘‘(D) The project uses electronic health data 
including, as appropriate, claims data, patient 
survey data, and any other data, as the Sec-
retary determines appropriate. 
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103 
‘‘(E) The project prioritizes devices and de-
vice types that meet one or more of the following 
criteria: 
‘‘(i) Devices and device types for which 
the collection and analysis of real world evi-
dence regarding a device’s safety and effec-
tiveness 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 con-
sequences. 
‘‘(iv) Devices and device types for 
which the Secretary— 
‘‘(I) has received public rec-
ommendations 
in 
accordance 
with 
paragraph (2)(B); and 
‘‘(II) has determined to meet one 
of the criteria under clause (i), (ii), or 
(iii) and is appropriate for such a 
pilot project. 
‘‘(2) PARTICIPATION.—The Secretary shall estab-
lish the conditions and processes— 
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‘‘(A) under which a manufacturer of a de-
vice may voluntarily participate in a pilot 
project described in paragraph (1); and 
‘‘(B) for facilitating public recommenda-
tions 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 
Reauthorization Act of 2017. The Secretary shall, be-
ginning on such date of enactment, take such steps as 
may be necessary— 
‘‘(A) to ensure such projects meet the re-
quirements 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 de-
vices prioritized under such a project. 
‘‘(4) IMPLEMENTATION.— 
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‘‘(A) CONTRACTING AUTHORITY.—The Sec-
retary 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 pri-
vate entities that have a significant presence in 
the United States and meet the following condi-
tions: 
‘‘(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 confiden-
tiality and privacy of the data described in 
paragraph (1)(D) and such agreement en-
sures that the entity will not make an un-
authorized disclosure of such data to the 
other components of the organization in 
breach of requirements with respect to con-
fidentiality and privacy of such data estab-
lished under such security measures. 
‘‘(ii) In the case of the termination or 
nonrenewal of such a contract, cooperative 
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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 require-
ments with respect to confidentiality 
and privacy referred to in clause (i) 
under this subparagraph 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 enti-
ty pursuant to this subsection and to 
which it would not otherwise have ac-
cess or, if returning such data is not 
practicable, destroy the data. 
‘‘(iii) The entity or entities shall have 
one or more qualifications with respect to— 
‘‘(I) 
research, 
statistical, 
epi-
demiologic, or clinical capability and 
expertise to conduct and complete the 
activities under this subsection, includ-
ing the capability and expertise to pro-
vide the Secretary access to de-identi-
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fied data consistent with the require-
ments of this subsection; 
‘‘(II) an information technology 
infrastructure to support electronic 
data and operational standards to pro-
vide security for such data, as appro-
priate; 
‘‘(III) experience with, and exper-
tise 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 agreement entered 
into under this paragraph with an entity meet-
ing the conditions specified in subparagraph (A) 
in the event of a merger or acquisition of the en-
tity in order to ensure that the requirements 
specified in this subsection will continue to be 
met. 
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‘‘(5) COMPLIANCE
WITH
REQUIREMENTS
FOR 
RECORDS OR REPORTS ON DEVICES.—The participa-
tion of a manufacturer in pilot projects under this 
subsection shall not affect the eligibility of such man-
ufacturer to participate in any quarterly reporting 
program with respect to devices carried out under sec-
tion 519 or 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 applica-
ble requirements of section 519 or 522, if— 
‘‘(A) the project has demonstrated success in 
capturing relevant adverse event information; 
and 
‘‘(B) the Secretary has established proce-
dures for making adverse event and safety infor-
mation collected from such project public, to the 
extent possible. 
‘‘(6) PRIVACY REQUIREMENTS.—With respect to 
the disclosure of any health information collected 
through a project conducted under this subsection— 
‘‘(A) individually identifiable health infor-
mation so collected shall not be disclosed when 
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presenting any information 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 Port-
ability 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.— 
‘‘(A) IN GENERAL.—No pilot project under 
this subsection undertaken in coordination with 
the comprehensive system described in paragraph 
(1)(C), shall allow for an entity participating in 
such program, other than the Secretary or the 
Secretary’s designee, to make determinations of 
safety or effectiveness, or substantial equivalence, 
for purposes of the Act. 
‘‘(B) NO USE OF FEES.—Pilot projects ini-
tiated under this subsection may not primarily 
utilize funds collected pursuant to the Medical 
Device User Fee Amendments of 2017. 
‘‘(8) OTHER PROJECTS REQUIRED TO COMPLY.— 
Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), and (6) 
shall apply with respect to any pilot program under-
taken in coordination with the comprehensive system 
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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 
subsection. 
‘‘(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, Edu-
cation, Labor and Pensions of the Senate a report 
containing a description of the pilot projects being 
conducted under this subsection and projects contin-
ued or expanded pursuant to paragraph (3), includ-
ing for each such project— 
‘‘(A) how the project is being implemented 
in accordance with paragraph (4), including 
how such project is being implemented through a 
contract, cooperative agreement, 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; 
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‘‘(D) the devices or device categories in-
volved 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, mal-
functions, 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, may conduct a re-
view through an independent third party to evaluate the 
strengths, limitations, and appropriate use of evidence col-
lected pursuant to real world evidence pilot projects de-
scribed in the letters described in section 201(b) of the Med-
ical 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 added by subsection (a)— 
(1) for purposes of informing premarket and 
postmarket decisionmaking for multiple device types; 
and 
(2) to determine whether the methods, systems, 
and programs carried out through such pilot projects 
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approval for the use of the contrast agent for a new 
indication and conditions of use following the author-
ization of a premarket submission for an applicable 
medical imaging device for that use with the contrast 
agent pursuant to section 520(q)(1). 
‘‘(2) 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 premarket review of devices; and 
‘‘(B) review information and data sub-
mitted to the Secretary by the sponsor of an ap-
plicable medical imaging device pursuant to sec-
tion 515, 510(k), or 513(f)(2) so long as the 
sponsor of such applicable medical imaging de-
vice has provided to the sponsor of the contrast 
agent a right of reference. 
‘‘(3) For purposes of this subsection— 
‘‘(A) the term ‘new indication’ means a use 
of a contrast agent that is described in the ap-
proved labeling of an applicable medical imag-
ing device described in section 520(q), but that 
is not described in the approved labeling of the 
contrast agent; and 
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