PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1005 

Public Law 115–52 

115th Congress 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 

user-fee programs for prescription drugs, medical devices, generic drugs, and 

biosimilar biological products, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘FDA Reauthorization Act of 

2017’’. 

SEC. 2. TABLE OF CONTENTS. 

The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Authority to assess and use drug fees. 

Sec. 103. Reauthorization; reporting requirements. 

Sec. 104. Sunset dates. 

Sec. 105. Effective date. 

Sec. 106. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; finding. 

Sec. 202. Definitions. 

Sec. 203. Authority to assess and use device fees. 

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Conformity assessment pilot program. 

Sec. 206. Reauthorization of review. 

Sec. 207. Electronic format for submissions. 

Sec. 208. Savings clause. 

Sec. 209. Effective date. 

Sec. 210. Sunset dates. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title; finding. 

Sec. 302. Definitions. 

Sec. 303. Authority to assess and use human generic drug fees. 

Sec. 304. Reauthorization; reporting requirements. 

Sec. 305. Sunset dates. 

Sec. 306. Effective date. 

Sec. 307. Savings clause. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Definitions. 

Sec. 403. Authority to assess and use biosimilar fees. 

Sec. 404. Reauthorization; reporting requirements. 

Sec. 405. Sunset dates. 

Sec. 406. Effective date. 

FDA 

Reauthorization 

Act of 2017. 

21 USC 301 note. 

Aug. 18, 2017 

[H.R. 2430] 

131 STAT. 1006 PUBLIC LAW 115–52—AUG. 18, 2017 

Sec. 407. Savings clause. 

TITLE V—PEDIATRIC DRUGS AND DEVICES 

Sec. 501. Best pharmaceuticals for children. 

Sec. 502. Pediatric devices. 

Sec. 503. Early meeting on pediatric study plan. 

Sec. 504. Development of drugs and biological products for pediatric cancers. 

Sec. 505. Additional provisions on development of drugs and biological products for 

pediatric use. 

TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS 

Sec. 601. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers. 

Sec. 602. Reauthorization of the critical path public-private partnerships. 

Sec. 603. Reauthorization of orphan grants program. 

Sec. 604. Protecting and strengthening the drug supply chain. 

Sec. 605. Patient experience data. 

Sec. 606. Communication plans. 

Sec. 607. Orphan drugs. 

Sec. 608. Pediatric information added to labeling. 

Sec. 609. Sense of Congress on lowering the cost of prescription drugs. 

Sec. 610. Expanded access. 

Sec. 611. Tropical disease product application. 

TITLE VII—DEVICE INSPECTION AND REGULATORY IMPROVEMENTS 

Sec. 701. Risk-based inspections for devices. 

Sec. 702. Improvements to inspections process for device establishments. 

Sec. 703. Reauthorization of inspection program. 

Sec. 704. Certificates to foreign governments for devices. 

Sec. 705. Facilitating international harmonization. 

Sec. 706. Fostering innovation in medical imaging. 

Sec. 707. Risk-based classification of accessories. 

Sec. 708. Device pilot projects. 

Sec. 709. Regulation of over-the-counter hearing aids. 

Sec. 710. Report on servicing of devices. 

TITLE VIII—IMPROVING GENERIC DRUG ACCESS 

Sec. 801. Priority review of generic drugs. 

Sec. 802. Enhancing regulatory transparency to enhance generic competition. 

Sec. 803. Competitive generic therapies. 

Sec. 804. Accurate information about drugs with limited competition. 

Sec. 805. Suitability petitions. 

Sec. 806. Inspections. 

Sec. 807. Reporting on pending generic drug applications and priority review applications. 

Sec. 808. Incentivizing competitive generic drug development. 

Sec. 809. GAO study of issues regarding first cycle approvals of generic medicines. 

TITLE IX—ADDITIONAL PROVISIONS 

Sec. 901. Technical corrections. 

Sec. 902. Annual report on inspections. 

Sec. 903. Streamlining and improving consistency in performance reporting. 

Sec. 904. Analysis of use of funds. 

Sec. 905. Facilities management. 

TITLE I—FEES RELATING TO DRUGS 

SEC. 101. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 

Drug User Fee Amendments of 2017’’. 

(b) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review 

of human drug applications, including postmarket drug safety 

activities, as set forth in the goals identified for purposes of part 

2 of subchapter C of chapter VII of the Federal Food, Drug, and 

21 USC 379g 

note. 

21 USC 301 note. 

Prescription 

Drug User Fee 

Amendments 

of 2017. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1007 

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. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 

(a) TYPES OF FEES.— (1) IN GENERAL.—Section 736(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379h(a)) is amended— 

(A) in the matter preceding paragraph (1), by striking 

‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 2018’’; 

(B) in the heading of paragraph (1), by striking ‘‘AND

SUPPLEMENT’’; 

(C) in paragraph (1), by striking ‘‘or a supplement’’ 

and ‘‘or supplement’’ each place either appears; 

(D) in paragraph (1)(A)— 

(i) in clause (i), by striking ‘‘(c)(4)’’ and inserting 

‘‘(c)(5)’’; and 

(ii) in clause (ii), by striking ‘‘A fee established’’ 

and all that follows through ‘‘are required.’’ and 

inserting the following: ‘‘A fee established under 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 approval.’’; 

(E) in the heading of paragraph (1)(C), by striking 

‘‘OR SUPPLEMENT’’; 

(F) in paragraph (1)(F)— 

(i) in the heading, by striking ‘‘OR INDICATION’’; 

and 

(ii) by striking the second sentence; 

(G) by striking paragraph (2) (relating to a prescription 

drug establishment fee); 

(H) by redesignating paragraph (3) as paragraph (2); 

(I) in the heading of paragraph (2), as so redesignated, 

by striking ‘‘PRESCRIPTION DRUG PRODUCT FEE’’ and 

inserting ‘‘PRESCRIPTION DRUG PROGRAM FEE’’; 

(J) in subparagraph (A) of such paragraph (2), by 

amending the first sentence to read as follows: ‘‘Except 

as provided in subparagraphs (B) and (C), each person 

who is named as the applicant in a human drug application, 

and who, after September 1, 1992, had pending before 

the Secretary a human drug application or supplement, 

shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each 

prescription drug product that is identified in such a human 

drug application approved as of October 1 of such fiscal 

year.’’; 

(K) in subparagraph (B) of such paragraph (2)— 

(i) in the heading of subparagraph (B), by inserting 

after ‘‘EXCEPTION’’ the following: ‘‘FOR CERTAIN

PRESCRIPTION DRUG PRODUCTS’’; and 

(ii) by striking ‘‘A prescription drug product shall 

not be assessed a fee’’ and inserting ‘‘A prescription 

drug program fee shall not be assessed for a prescription drug product’’; and 

131 STAT. 1008 PUBLIC LAW 115–52—AUG. 18, 2017 

(L) by adding at the end of such paragraph (2) the 

following: 

‘‘(C) LIMITATION.—A person who is named as the 

applicant in an approved human drug application shall 

not be assessed more than 5 prescription drug program 

fees for a fiscal year for prescription drug products 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.’’. 

(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 736 of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is 

amended to read as follows: 

‘‘(b) FEE REVENUE AMOUNTS.— 

‘‘(1) IN GENERAL.—For each of the fiscal years 2018 through 

2022, fees under subsection (a) shall, except as provided in 

subsections (c), (d), (f), and (g), be established to generate 

a total revenue amount under such subsection that is equal 

to the sum of— 

‘‘(A) the annual base revenue for the fiscal year (as 

determined under paragraph (3)); 

‘‘(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection 

(c)(1)); 

‘‘(C) the dollar amount equal to the capacity planning 

adjustment for the fiscal year (as determined under subsection (c)(2)); 

‘‘(D) the dollar amount equal to the operating reserve 

adjustment for the fiscal year, if applicable (as determined 

under subsection (c)(3)); 

‘‘(E) the dollar amount equal to the additional direct 

cost adjustment for the fiscal year (as determined under 

subsection (c)(4)); and 

‘‘(F) additional dollar amounts for each fiscal year as 

follows: 

‘‘(i) $20,077,793 for fiscal year 2018. 

‘‘(ii) $21,317,472 for fiscal year 2019. 

‘‘(iii) $16,953,329 for fiscal year 2020. 

‘‘(iv) $5,426,896 for fiscal year 2021. 

‘‘(v) $2,769,609 for fiscal year 2022. 

‘‘(2) TYPES OF FEES.—Of the total revenue amount 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 prescription drug 

program fees under subsection (a)(2). 

‘‘(3) ANNUAL BASE REVENUE.—For purposes of paragraph 

(1), the dollar amount of the annual base revenue for a fiscal 

year shall be— 

‘‘(A) for fiscal year 2018, $878,590,000; and 

‘‘(B) for fiscal years 2019 through 2022, the dollar 

amount of the total revenue amount established under 

paragraph (1) for the previous fiscal year, not including 

any adjustments made under subsection (c)(3) or (c)(4).’’. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1009 

(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379h) is amended to read as follows: 

‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 

‘‘(1) INFLATION ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For purposes of subsection (b)(1)(B), 

the dollar amount of the inflation adjustment to the annual 

base revenue for each fiscal year shall be equal to the 

product of— 

‘‘(i) such annual base revenue for the fiscal year 

under subsection (b)(1)(A); and 

‘‘(ii) the inflation adjustment percentage under 

subparagraph (B). 

‘‘(B) INFLATION ADJUSTMENT PERCENTAGE.—The 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, multiplied 

by the proportion of personnel compensation and benefits costs to total costs of the process for the review 

of human drug applications (as defined in section 

735(6)) for the first 3 years of the preceding 4 fiscal 

years; and 

‘‘(ii) the average annual percent change that 

occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not 

Seasonally Adjusted; All items; Annual Index) for the 

first 3 years of the preceding 4 years of available 

data multiplied by the proportion of all costs other 

than personnel compensation and benefits costs to total 

costs of the process for the review of human drug 

applications (as defined in section 735(6)) for the first 

3 years of the preceding 4 fiscal years. 

‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For each fiscal year, after the 

annual base revenue established in subsection (b)(1)(A) 

is adjusted for inflation in accordance with paragraph (1), 

such revenue shall be adjusted further for such fiscal year, 

in accordance with this paragraph, to reflect changes in 

the resource capacity needs of the Secretary for the process 

for the review of human drug applications. 

‘‘(B) INTERIM METHODOLOGY.— 

‘‘(i) IN GENERAL.—Until the capacity planning 

methodology described in subparagraph (C) is effective, 

the adjustment under this paragraph for a fiscal year 

shall be based on the product of— 

‘‘(I) the annual base revenue for such year, 

as adjusted for inflation under paragraph (1); and 

‘‘(II) the adjustment percentage under clause 

(ii). 

‘‘(ii) ADJUSTMENT PERCENTAGE.—The adjustment 

percentage under this clause for a fiscal year is the 

weighted change in the 3-year average ending in the 

Time period. 

131 STAT. 1010 PUBLIC LAW 115–52—AUG. 18, 2017 

most recent year for which data are available, over 

the 3-year average ending in the previous year, for— 

‘‘(I) the total number of human drug applications, efficacy supplements, and manufacturing 

supplements submitted to the Secretary; 

‘‘(II) the total number of active commercial 

investigational new drug applications; and 

‘‘(III) the total number of formal meetings 

scheduled by the Secretary, and written responses 

issued by the Secretary in lieu of such formal 

meetings, as identified in section I.H of the letters 

described in section 101(b) of the Prescription Drug 

User Fee Amendments of 2017. 

‘‘(C) CAPACITY PLANNING METHODOLOGY.— 

‘‘(i) DEVELOPMENT; EVALUATION AND REPORT.—The 

Secretary shall obtain, through a contract with an 

independent accounting or consulting firm, a report 

evaluating options and recommendations for a new 

methodology to accurately assess changes in the 

resource and capacity needs of the process for the 

review of human drug applications. The capacity 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 no later 

than the end of fiscal year 2020. 

‘‘(ii) ESTABLISHMENT AND IMPLEMENTATION.—After 

review of the report described in clause (i) and any 

public comments thereon, the Secretary shall establish 

a capacity planning methodology for purposes of this 

paragraph, which shall— 

‘‘(I) replace the interim methodology under 

subparagraph (B); 

‘‘(II) incorporate such approaches and 

attributes as the Secretary determines appropriate; and 

‘‘(III) be effective beginning with the first fiscal 

year for which fees are set after such capacity 

planning methodology is established. 

‘‘(D) LIMITATION.—Under no circumstances shall an 

adjustment under this paragraph result in fee revenue 

for a fiscal year that is less than the sum of the amounts 

under subsections (b)(1)(A) (the annual base revenue for 

the fiscal year) and (b)(1)(B) (the dollar amount of the 

inflation adjustment for the fiscal year). 

‘‘(E) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under 

paragraph (5) of the fee revenue and fees resulting from 

the adjustment and the methodologies under this 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 

Time period. 

Effective date. 

Publication. 

Public 

information. 

Deadline. 

Contracts. 

Recommendations. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1011 

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 carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks 

of such operating reserves. 

‘‘(C) NOTICE OF RATIONALE.—If an adjustment under 

subparagraph (A) or (B) is made, the rationale for the 

amount of the increase or decrease (as applicable) in fee 

revenue and fees shall be contained in the annual Federal 

Register notice under paragraph (5) establishing fee 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 subsequent fiscal 

years, by the amount determined under subparagraph 

(B). 

‘‘(B) AMOUNT.—The amount determined under this 

subparagraph is— 

‘‘(i) $8,730,000, multiplied by 

‘‘(ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not 

Seasonally Adjusted; All Items; Annual Index) for the 

most recent year of available data, divided by such 

Index for 2016. 

‘‘(5) ANNUAL FEE SETTING.—The Secretary shall, not later 

than 60 days before the start of each fiscal year that begins 

after September 30, 2017— 

‘‘(A) establish, for each such fiscal year, human drug 

application fees and prescription drug program fees under 

subsection (a), based on the revenue amounts established 

under subsection (b) and the adjustments provided under 

this subsection; and 

‘‘(B) publish such fee revenue and fees in the Federal 

Register. 

‘‘(6) LIMIT.—The total amount of fees charged, as adjusted 

under this subsection, for a fiscal year may not exceed the 

total costs for such fiscal year for the resources allocated for 

the process for the review of human drug applications.’’. 

(d) FEE WAIVER OR REDUCTION.—Section 736(d) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended— 

(1) in paragraph (1)— 

(A) by inserting ‘‘or’’ at the end of subparagraph (B); 

(B) by striking subparagraph (C); and 

(C) by redesignating subparagraph (D) as subparagraph (C); 

(2) by striking paragraph (3) (relating to use of standard 

costs); 

(3) by redesignating paragraph (4) as paragraph (3); and 

(4) in paragraph (3), as so redesignated— 

(A) in subparagraphs (A) and (B), by striking ‘‘paragraph (1)(D)’’ and inserting ‘‘paragraph (1)(C)’’; and 

Federal Register, 

publication. 

Deadline. 

Time period. 

131 STAT. 1012 PUBLIC LAW 115–52—AUG. 18, 2017 

(B) in subparagraph (B)— 

(i) by striking clause (ii); 

(ii) by striking ‘‘shall pay’’ through ‘‘(i) application 

fees’’ and inserting ‘‘shall pay application fees’’; and 

(iii) by striking ‘‘; and’’ at the end and inserting 

a period. 

(e) EFFECT OF FAILURE TO PAY FEES.—Section 736(e) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is 

amended by striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 

(f) LIMITATIONS.—Section 736(f)(2) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 

‘‘supplements, prescription drug establishments, and prescription 

drug products’’ and inserting ‘‘prescription drug program fees’’. 

(g) CREDITING AND AVAILABILITY OF FEES.—Section 736(g) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) 

is amended— 

(1) in paragraph (3)— 

(A) by striking ‘‘2013 through 2017’’ and inserting 

‘‘2018 through 2022’’; and 

(B) by striking ‘‘and paragraph (4) of this subsection’’; 

and 

(2) by striking paragraph (4). 

(h) ORPHAN DRUGS.—Section 736(k) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking 

‘‘product and establishment fees’’ each place it appears and inserting 

‘‘prescription drug program fees’’. 

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 736B of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379h–2) is amended— 

(1) in subsection (a)(1)— 

(A) in the matter before subparagraph (A), by striking 

‘‘2013’’ and inserting ‘‘2018’’; and 

(B) in subparagraph (A), by striking ‘‘Prescription Drug 

User Fee Amendments of 2012’’ and inserting ‘‘Prescription 

Drug User Fee Amendments of 2017’’; 

(2) in subsection (b), by striking ‘‘2013’’ and inserting 

‘‘2018’’; and 

(3) in subsection (d), by striking ‘‘2017’’ each place it 

appears and inserting ‘‘2022’’. 

SEC. 104. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to 

be effective October 1, 2022. 

(b) REPORTING REQUIREMENTS.—Section 736B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to 

be effective January 31, 2023. 

(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2017, 

subsections (a) and (b) of section 105 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) are 

repealed. 

SEC. 105. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2017, or the date of the enactment of this Act, whichever is 

later, except that fees under part 2 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

21 USC 379g 

note. 

Effective date. 

Repeal. 

21 USC 379g 

note, 379h–2 

note. 

21 USC 379h–2 

note. 

21 USC 379g 

note. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1013 

for all human drug applications received on or after October 1, 

2017, regardless of the date of the enactment of this Act. 

SEC. 106. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 2 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to 

human drug applications and supplements (as defined in such part 

as of such day) that on or after October 1, 2012, but before October 

1, 2017, were accepted by the Food and Drug Administration for 

filing with respect to assessing and collecting any fee required 

by such part for a fiscal year prior to fiscal year 2018. 

TITLE II—FEES RELATING TO DEVICES 

SEC. 201. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 

Device User Fee Amendments of 2017’’. 

(b) FINDING.—The Congress finds that the fees authorized 

under the amendments made by this title will be dedicated toward 

expediting the process for the review of device applications and 

for assuring the safety and effectiveness of devices, as set forth 

in the goals identified for purposes of part 3 of subchapter C 

of chapter VII of the Federal Food, Drug, and Cosmetic Act in 

the letters from the Secretary of Health and Human Services to 

the Chairman of the Committee on Health, Education, Labor, and 

Pensions of the Senate and the Chairman of the Committee on 

Energy and Commerce of the House of Representatives, as set 

forth in the Congressional Record. 

SEC. 202. DEFINITIONS. 

(a) IN GENERAL.—Section 737 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379i) is amended— 

(1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively; 

(2) by inserting after paragraph (7) the following 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 submissions’’ and inserting 

‘‘submissions, and de novo classification requests’’; and 

(4) in paragraph (11) (as redesignated by paragraph (1)), 

by striking ‘‘2011’’ and inserting ‘‘2016’’. 

(b) CONFORMING AMENDMENT.—Section 714(b)(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3(b)(1)) is amended 

by striking ‘‘737(8)’’ and inserting ‘‘737(9)’’. 

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

(a) TYPES OF FEES.—Section 738(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j(a)) is amended— 

(1) in paragraph (1), by striking ‘‘fiscal year 2013’’ and 

inserting ‘‘fiscal year 2018’’; and 

(2) in paragraph (2)— 

(A) in subparagraph (A)— 

21 USC 379i 

note. 

21 USC 301 note. 

Medical Device 

User Fee 

Amendments 

of 2017. 

Continuation. 

Time period. 

21 USC 379g 

note. 

131 STAT. 1014 PUBLIC LAW 115–52—AUG. 18, 2017 

(i) in the matter preceding clause (i), by striking 

‘‘October 1, 2012’’ and inserting ‘‘October 1, 2017’’; 

(ii) in clause (viii), by striking ‘‘2’’ and inserting 

‘‘3.4’’; and 

(iii) by adding at the end the following new clause: 

‘‘(xi) For a de novo classification request, a fee 

equal to 30 percent of the fee that applies under clause 

(i).’’; and 

(B) in subparagraph (B)(v)(I), by striking ‘‘or premarket 

notification submission’’ and inserting ‘‘premarket 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 paragraph (3). 

‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of paragraph (1), the base fee amounts specified in this paragraph 

are as follows: 

‘‘Fee Type 

Fiscal 

Year 

2018 

Fiscal 

Year 

2019 

Fiscal 

Year 

2020 

Fiscal 

Year 

2021 

Fiscal 

Year 

2022 

Premarket Application .... $294,000 $300,000 $310,000 $328,000 $329,000 

Establishment 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 inserting 

‘‘2017’’; 

(2) in paragraph (2)— 

(A) in subparagraph (A), by striking ‘‘2014’’ and 

inserting ‘‘2018’’; 

(B) by striking subparagraph (B) and inserting the 

following new subparagraph: 

‘‘(B) APPLICABLE INFLATION ADJUSTMENT.—The 

applicable inflation adjustment for fiscal year 2018 and 

each subsequent fiscal year is the product of— 

‘‘(i) the base inflation adjustment under 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.’’; 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1015 

(C) in subparagraph (C), in the heading, by striking 

‘‘TO TOTAL REVENUE AMOUNTS’’; and 

(D) by amending subparagraph (D) to read as follows: 

‘‘(D) ADJUSTMENT TO BASE FEE AMOUNTS.—For each 

of fiscal years 2018 through 2022, the Secretary shall— 

‘‘(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such 

amounts by the applicable inflation adjustment under 

subparagraph (B) for such year; and 

‘‘(ii) if the Secretary determines necessary, increase 

(in addition to the adjustment under clause (i)) such 

base fee amounts, on a uniform proportionate basis, 

to generate the total revenue amounts under 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 inserting 

‘‘increased’’. 

(d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION

REGARDING PREMARKET APPROVAL FEES.—Section 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 inserting ‘‘supplement,’’; and 

(B) by inserting ‘‘, or a de novo classification request’’ 

after ‘‘class III device’’. 

(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET

NOTIFICATION SUBMISSIONS.—Section 738(e)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended 

by striking ‘‘50’’ and inserting ‘‘25’’. 

(f) FEE WAIVER OR REDUCTION.— 

(1) REPEAL.—Section 738 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection 

(f). 

(2) CONFORMING AMENDMENTS.— 

(A) Section 515(c)(4)(A) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by 

striking ‘‘738(h)’’ and inserting ‘‘738(g)’’. 

(B) Section 738 of the Federal Food, Drug, and 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 striking ‘‘and subsection (f)’’. 

(g) EFFECT OF FAILURE TO PAY FEES.—Subsection (f)(1), as 

so redesignated, of section 738 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j) is amended— 

Determination. 

131 STAT. 1016 PUBLIC LAW 115–52—AUG. 18, 2017 

(1) by striking ‘‘or periodic reporting concerning a class 

III device’’ and inserting ‘‘periodic reporting concerning a class 

III device, or de novo classification request’’; and 

(2) by striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 

(h) CONDITIONS.—Subsection (g)(1)(A), as so redesignated, of 

section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j) is amended by striking ‘‘$280,587,000’’ and inserting 

‘‘$320,825,000’’. 

(i) CREDITING AND AVAILABILITY OF FEES.—Subsection (h), as 

so redesignated, of section 738 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j) is amended— 

(1) in paragraph (3)— 

(A) by striking ‘‘2013 through 2017’’ and inserting 

‘‘2018 through 2022’’; and 

(B) by striking ‘‘subsection (c)’’ and all that follows 

through the period at the end and inserting ‘‘subsection 

(c).’’; and 

(2) by striking paragraph (4). 

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) PERFORMANCE REPORTS.—Section 738A(a) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended— 

(1) in paragraph (1)— 

(A) in subparagraph (A)— 

(i) by striking ‘‘2013’’ and inserting ‘‘2018’’; and 

(ii) by striking ‘‘the Medical Device User Fee 

Amendments of 2012’’ and inserting ‘‘the Medical 

Device User Fee Amendments of 2017’’; and 

(B) in subparagraph (B), by striking ‘‘the Medical 

Device User Fee Amendments Act of 2012’’ and inserting 

‘‘the Medical Device User Fee Amendments of 2017’’; and 

(2) in paragraph (2), by striking ‘‘2013 through 2017’’ and 

inserting ‘‘2018 through 2022’’. 

(b) REAUTHORIZATION.—Section 738A(b) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended— 

(1) in paragraph (1), by striking ‘‘2017’’ and inserting 

‘‘2022’’; and 

(2) in paragraph (5), by striking ‘‘2017’’ and inserting 

‘‘2022’’. 

SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 

(a) IN GENERAL.—Section 514 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end 

the following: 

‘‘(d) PILOT ACCREDITATION SCHEME FOR CONFORMITY ASSESS- MENT.— ‘‘(1) IN GENERAL.—The Secretary shall establish a pilot 

program under which— 

‘‘(A) testing laboratories may be accredited, by 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), determinations by testing 

laboratories so accredited that a device conforms with such 

standard or standards shall be accepted by the Secretary 

for purposes of demonstrating such conformity under this 

section unless the Secretary finds that a particular such 

determination shall not be so accepted. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1017 

‘‘(2) SECRETARIAL REVIEW OF ACCREDITED LABORATORY

DETERMINATIONS.—The Secretary may— 

‘‘(A) review determinations by testing laboratories 

accredited pursuant to this subsection, including by conducting periodic audits of such determinations or processes 

of accredited bodies or testing laboratories and, following 

such review, taking additional measures under this Act, 

such as suspension or withdrawal of accreditation of such 

testing laboratory under paragraph (1)(A) or requesting 

additional information with respect to such device, as the 

Secretary determines appropriate; and 

‘‘(B) if the Secretary becomes aware of information 

materially bearing on safety or effectiveness of a device 

assessed for conformity by a testing laboratory so accredited, take such additional measures under this Act as the 

Secretary determines appropriate, such as suspension or 

withdrawal of accreditation of such testing laboratory 

under paragraph (1)(A), or requesting additional information with regard to such device. 

‘‘(3) IMPLEMENTATION AND REPORTING.— 

‘‘(A) PUBLIC MEETING.—The Secretary shall publish in 

the Federal Register a notice of a public meeting to be 

held no later than September 30, 2018, to discuss and 

obtain input and recommendations from stakeholders 

regarding the goals and scope of, and a suitable framework 

and procedures and requirements for, the pilot program 

under this subsection. 

‘‘(B) PILOT PROGRAM GUIDANCE.—The Secretary shall— 

‘‘(i) not later than September 30, 2019, issue draft 

guidance regarding the goals and implementation of 

the pilot program under this subsection; and 

‘‘(ii) not later than September 30, 2021, issue final 

guidance with respect to the implementation of such 

program. 

‘‘(C) PILOT PROGRAM INITIATION.—Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection. 

‘‘(D) REPORT.—The Secretary shall make available on 

the internet website of the Food and Drug Administration 

an annual report on the progress of the pilot program 

under this subsection. 

‘‘(4) SUNSET.—As of October 1, 2022— 

‘‘(A) the authority for accreditation bodies to accredit 

testing laboratories pursuant to paragraph (1)(A) shall 

cease to have force or effect; 

‘‘(B) the Secretary— 

‘‘(i) may not accept a determination pursuant to 

paragraph (1)(B) made by a testing laboratory after 

such date; and 

‘‘(ii) may accept such a determination made prior 

to such date; 

‘‘(C) except for purposes of accepting a determination 

described in subparagraph (B)(ii), the Secretary shall not 

continue to recognize the accreditation of testing laboratories accredited under paragraph (1)(A); and 

‘‘(D) the Secretary may take actions in accordance with 

paragraph (2) with respect to the determinations made 

Web posting. 

Federal Register, 

publication. 

Notice. 

Deadlines. 

Audits. 

131 STAT. 1018 PUBLIC LAW 115–52—AUG. 18, 2017 

prior to such date and recognition of the accreditation 

of testing laboratories pursuant to determinations made 

prior to such date.’’. 

SEC. 206. REAUTHORIZATION OF REVIEW. 

Section 523 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360m) is amended— 

(1) in subsection (a)(3)— 

(A) in subparagraph (A), by striking clauses (ii) and 

(iii) and inserting the following: 

‘‘(ii) a device classified under section 513(f)(2) or 

designated under section 515C(d); 

‘‘(iii) a device that is intended to be permanently 

implantable, life sustaining, or life supporting, unless 

otherwise determined by the Secretary in accordance 

with subparagraph (B)(i)(II) and listed as eligible for 

review under subparagraph (B)(iii); or 

‘‘(iv) a device that is of a type, or subset of a 

type, listed as not eligible for review under subparagraph (B)(iii).’’; 

(B) by striking subparagraph (B) and inserting the 

following: 

‘‘(B) DESIGNATION FOR REVIEW.—The Secretary shall— 

‘‘(i) issue draft guidance on the factors the Secretary will use in determining whether a class I or 

class II device type, or subset of such device types, 

is eligible for review by an accredited person, 

including— 

‘‘(I) the risk of the device type, or subset of 

such device type; and 

‘‘(II) whether the device type, or subset of such 

device type, is permanently implantable, life sustaining, or life supporting, and whether there is 

a detailed public health justification for permitting 

the review by an accredited person of such device 

type or subset; 

‘‘(ii) not later than 24 months after the date on 

which the Secretary issues such draft guidance, finalize 

such guidance; and 

‘‘(iii) beginning on the date such guidance is finalized, designate and post on the internet website of 

the Food and Drug Administration, an updated list 

of class I and class II device types, or subsets of such 

device types, and the Secretary’s determination with 

respect to whether each such device type, or subset 

of a device type, is eligible or not eligible for review 

by an accredited person under this section based on 

the factors described in clause (i).’’; and 

(C) by adding at the end the following: 

‘‘(C) INTERIM RULE.—Until the date on which the 

updated list is designated and posted in accordance with 

subparagraph (B)(iii), the list in effect on the date of 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 

Lists. 

Effective date. 

Web posting. 

Lists. 

Determination. 

Deadline. 

Guidance. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1019 

(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 redesignated), by 

striking ‘‘The operations of’’ and all that follows 

through ‘‘it will—’’ and inserting ‘‘Such person shall 

agree, at a minimum, to include in its request for 

accreditation a commitment to, at the time of accreditation, and at any time it is performing any review 

pursuant to this section—’’; and 

(iii) by inserting after subparagraph (D) the following new subparagraph: 

‘‘(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.’’; and 

(3) in subsection (c), by striking ‘‘2017’’ and inserting 

‘‘2022’’. 

SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379k–1(b)) is amended by adding at the end the following 

new paragraph: 

‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLELY IN 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 paragraph (1) (and any appeals of action taken 

by the Secretary with respect to such presubmissions or 

submissions) shall be submitted solely in such electronic 

format as specified by the Secretary in such guidance. 

‘‘(B) DRAFT GUIDANCE.—The Secretary shall, not later 

than October 1, 2019, issue draft guidance providing for— 

‘‘(i) any further standards for the submission by 

electronic format required under subparagraph (A); 

‘‘(ii) a timetable for the establishment by the Secretary of such further standards; and 

‘‘(iii) criteria for waivers of and exemptions from 

the requirements of this subsection. 

‘‘(C) FINAL GUIDANCE.—The Secretary shall, not later 

than 1 year after the close of the public comment period 

on the draft guidance issued under subparagraph (B), issue 

final guidance.’’. 

SEC. 208. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 3 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day 

before the date of the enactment of this title, shall continue to 

be in effect with respect to the submissions listed in section 

738(a)(2)(A) of such Act (as defined in such part as of such day) 

that on or after October 1, 2012, but before October 1, 2017, were 

accepted by the Food and Drug Administration for filing with 

respect to assessing and collecting any fee required by such part 

for a fiscal year prior to fiscal year 2018. 

Continuation. 

Time period. 

21 USC 379i 

note. 

Criteria. 

Effective date. 

Deadline. 

131 STAT. 1020 PUBLIC LAW 115–52—AUG. 18, 2017 

SEC. 209. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2017, or the date of the enactment of this Act, whichever is 

later, except that fees under part 3 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

for all submissions listed in section 738(a)(2)(A) of such Act received 

on or after October 1, 2017, regardless of the date of the enactment 

of this Act. 

SEC. 210. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 737 and 738 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be 

effective October 1, 2022. 

(b) REPORTING REQUIREMENTS.—Section 738A (21 U.S.C. 739j– 

1) of the Federal Food, Drug, and Cosmetic Act (regarding 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 Food and Drug Administration Safety and 

Innovation Act (Public Law 112–144) is repealed. 

TITLE III—FEES RELATING TO GENERIC 

DRUGS 

SEC. 301. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Generic 

Drug User Fee Amendments of 2017’’. 

(b) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated to human 

generic drug activities, as set forth in the goals identified for 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 ‘‘application for a 

positron emission tomography drug.’’ and inserting ‘‘application— 

‘‘(i) for a positron emission tomography drug; or 

‘‘(ii) submitted by a State or Federal governmental 

entity for a drug that is not distributed commercially.’’; 

(2) by redesignating paragraphs (5) through (12) as paragraphs (6) through (13), respectively; and 

(3) by inserting after paragraph (4) the following: 

‘‘(5) The term ‘contract manufacturing organization facility’ 

means a manufacturing facility of a finished dosage form of 

a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in 

an approved abbreviated new drug application held by the 

owner of such facility or an affiliate of such owner or facility.’’. 

21 USC 379j–41 

note. 

21 USC 301 note. 

Generic Drug 

User Fee 

Amendments 

of 2017. 

Effective date. 

Repeal. 

21 USC 379i 

note. 

21 USC 379j–1 

note. 

21 USC 378i 

note. 

21 USC 379i 

note. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1021 

SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 

FEES. 

(a) TYPES OF FEES.—Section 744B(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–42(a)) is amended— 

(1) in the matter preceding paragraph (1), by striking ‘‘fiscal 

year 2013’’ and inserting ‘‘fiscal year 2018’’; 

(2) in paragraph (1), by adding at the end the following: 

‘‘(E) SUNSET.—This paragraph shall cease to be effective October 1, 2022.’’; 

(3) in paragraph (2)— 

(A) by amending subparagraph (C) to read as follows: 

‘‘(C) NOTICE.—Not later than 60 days before the start 

of each of fiscal years 2018 through 2022, the Secretary 

shall publish in the Federal Register the amount of the 

drug master file fee established by this paragraph for such 

fiscal year.’’; and 

(B) in subparagraph (E)— 

(i) in clause (i)— 

(I) by striking ‘‘no later than the date’’ and 

inserting ‘‘on the earlier of— 

‘‘(I) the date’’; 

(II) by striking the period and inserting ‘‘; 

or’’; and 

(III) by adding at the end the following: 

‘‘(II) the date on which the drug master file 

holder requests the initial completeness assessment.’’; and 

(ii) in clause (ii), by striking ‘‘notice provided for 

in clause (i) or (ii) of subparagraph (C), as applicable’’ 

and inserting ‘‘notice provided for in subparagraph (C)’’; 

(4) in paragraph (3)— 

(A) in the heading, by striking ‘‘AND PRIOR APPROVAL

SUPPLEMENT’’; 

(B) in subparagraph (A), by striking ‘‘or a prior 

approval supplement to an abbreviated new drug application’’; 

(C) by amending subparagraphs (B) and (C) to read 

as follows: 

‘‘(B) NOTICE.—Not later than 60 days before the start 

of each of fiscal years 2018 through 2022, the Secretary 

shall publish in the Federal Register the amount of the 

fees under subparagraph (A) for such fiscal year. 

‘‘(C) FEE DUE DATE.—The fees required by subparagraphs (A) and (F) shall be due no later than the date 

of submission of the abbreviated new drug application or 

prior approval supplement for which such fee applies.’’; 

(D) in subparagraph (D)— 

(i) in the heading, by inserting ‘‘, IS WITHDRAWN

PRIOR TO BEING RECEIVED, OR IS NO LONGER RECEIVED’’ 

after ‘‘RECEIVED’’; and 

(ii) by striking ‘‘The Secretary shall’’ and all that 

follows through the period and inserting the following: 

‘‘(i) APPLICATIONS NOT CONSIDERED TO HAVE BEEN

RECEIVED AND APPLICATIONS WITHDRAWN PRIOR TO

BEING RECEIVED.—The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any 

abbreviated new drug application that the Secretary 

Deadline. 

Applicability. 

Deadline. 

Time period. 

Federal Register, 

publication. 

Deadline. 

Time period. 

Federal Register, 

publication. 

131 STAT. 1022 PUBLIC LAW 115–52—AUG. 18, 2017 

considers not to have been received within the meaning 

of section 505(j)(5)(A) for a cause other than failure 

to pay fees, or that has been withdrawn prior to being 

received within the meaning of section 505(j)(5)(A). 

‘‘(ii) APPLICATIONS NO LONGER RECEIVED.—The Secretary shall refund 100 percent of the fee paid under 

subparagraph (A) for any abbreviated new drug 

application if the Secretary initially receives the 

application under section 505(j)(5)(A) and subsequently 

determines that an exclusivity period for a listed drug 

should have prevented the Secretary from receiving 

such application, such that the abbreviated new drug 

application is no longer received within the meaning 

of section 505(j)(5)(A).’’; 

(E) in subparagraph (E), by striking ‘‘or prior approval 

supplement’’; and 

(F) in the matter preceding clause (i) of subparagraph 

(F)— 

(i) by striking ‘‘2012’’ and inserting ‘‘2017’’; and 

(ii) by striking ‘‘subsection (d)(3)’’ and inserting 

‘‘subsection (d)(2)’’; 

(5) in paragraph (4)— 

(A) in subparagraph (A)— 

(i) in the matter preceding clause (i) and in clause 

(iii), by striking ‘‘, or intended to be identified, in 

at least one generic drug submission that is pending 

or’’ and inserting ‘‘in at least one generic drug submission that is’’; 

(ii) in clause (i), by striking ‘‘or intended to be 

identified in at least one generic drug submission that 

is pending or’’ and inserting ‘‘in at least one generic 

drug submission that is’’; 

(iii) in clause (ii), by striking ‘‘produces,’’ and all 

that follows through ‘‘such a’’ and inserting ‘‘is 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 manufacture of the finished dosage forms’’; and 

(B) by amending subparagraphs (C) and (D) to read 

as follows: 

‘‘(C) NOTICE.—Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal 

Register the amount of the fees under subparagraph (A) 

for such fiscal year. 

‘‘(D) FEE DUE DATE.—For each of fiscal years 2018 

through 2022, the fees under subparagraph (A) for such 

fiscal year shall be due on the later of— 

‘‘(i) the first business day on or after October 1 

of each such year; or 

‘‘(ii) the first business day after the enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such year under this section 

for such year.’’; 

Time period. 

Deadlines. 

Federal Register, 

publication. 

Refunds. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1023 

(6) by redesignating paragraph (5) as paragraph (6); and 

(7) by inserting after paragraph (4) the following: 

‘‘(5) GENERIC DRUG APPLICANT PROGRAM FEE.— 

‘‘(A) IN GENERAL.—A generic drug applicant program 

fee shall be assessed annually as described in subsection 

(b)(2)(E). 

‘‘(B) AMOUNT.—The amount of fees established under 

subparagraph (A) shall be established under subsection 

(d). 

‘‘(C) NOTICE.—Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal 

Register the amount of the fees under subparagraph (A) 

for such fiscal year. 

‘‘(D) FEE DUE DATE.—For each of fiscal years 2018 

through 2022, the fees under subparagraph (A) for such 

fiscal year shall be due on the later of— 

‘‘(i) the first business day on or after October 1 

of each such fiscal year; or 

‘‘(ii) the first business day after the date of 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’’; 

(ii) by striking ‘‘2014 through 2017’’ and inserting 

‘‘2019 through 2022’’; 

(iii) by striking ‘‘paragraphs (2) through (4)’’ and 

inserting ‘‘paragraphs (2) through (5)’’; and 

(iv) by striking ‘‘$299,000,000’’ and inserting 

‘‘$493,600,000’’; and 

(2) in paragraph (2)— 

(A) in the matter preceding subparagraph (A)— 

(i) by striking ‘‘paragraph (1)(A)(ii) for fiscal year 

2013 and paragraph (1)(B) for each of fiscal years 

2014 through 2017’’ and inserting ‘‘such paragraph 

for a fiscal year’’; and 

(ii) by striking ‘‘through (4)’’ and inserting ‘‘through 

(5)’’; 

(B) in subparagraph (A), by striking ‘‘Six percent’’ and 

inserting ‘‘Five percent’’; 

(C) by amending subparagraphs (B) and (C) to read 

as follows: 

‘‘(B) Thirty-three percent shall be derived from fees 

under subsection (a)(3) (relating to abbreviated new drug 

applications). 

Time period. 

Deadlines. 

Federal Register, 

publication. 

131 STAT. 1024 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(C) Twenty percent shall be derived from fees under 

subsection (a)(4)(A)(i) (relating to generic drug facilities). 

The amount of the fee for a contract manufacturing 

organization facility shall be equal to one-third the amount 

of the fee for a facility that is not a contract manufacturing 

organization facility. The amount of the fee for a facility 

located outside the United States and its territories and 

possessions shall be $15,000 higher than the amount of 

the fee for a facility located in the United States and 

its territories and possessions.’’; 

(D) in subparagraph (D)— 

(i) by striking ‘‘Fourteen percent’’ and inserting 

‘‘Seven percent’’; 

(ii) by striking ‘‘not less than $15,000 and not 

more than $30,000’’ and inserting ‘‘$15,000’’; and 

(iii) by striking ‘‘, as determined’’ and all that 

follows through the period at the end and inserting 

a period; and 

(E) by adding at the end the following: 

‘‘(E)(i) Thirty-five percent shall be derived from fees 

under subsection (a)(5) (relating to generic drug applicant 

program fees). For purposes of this subparagraph, if a 

person has affiliates, a single program fee shall be assessed 

with respect to that person, including its affiliates, and 

may be paid by that person or any one of its affiliates. 

The Secretary shall determine the fees as follows: 

‘‘(I) If a person (including its affiliates) owns at 

least one but not more than 5 approved abbreviated 

new drug applications on the due date for the fee 

under this subsection, the person (including its affiliates) shall be assessed a small business generic drug 

applicant program fee equal to one-tenth of the large 

size operation generic drug applicant program fee. 

‘‘(II) If a person (including its affiliates) owns at 

least 6 but not more than 19 approved abbreviated 

new drug applications on the due date for the fee 

under this subsection, the person (including its 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. 

‘‘(III) If a person (including its affiliates) owns 

20 or more approved abbreviated new drug applications 

on the due date for the fee under this subsection, 

the person (including its affiliates) shall be assessed 

a large size operation generic drug applicant program 

fee. 

‘‘(ii) For purposes of this subparagraph, an abbreviated 

new drug application shall be deemed not to be approved 

if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.’’. 

(c) ADJUSTMENTS.—Section 744B(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended— 

(1) in paragraph (1)— 

(A) by striking ‘‘2014’’ and inserting ‘‘2019’’; 

Deadline. 

Determination. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1025 

(B) by inserting ‘‘to equal the product of the total 

revenues established in such notice for the prior fiscal 

year multiplied’’ after ‘‘a fiscal year,’’; and 

(C) by striking the flush text following subparagraph 

(C); and 

(2) in paragraph (2)— 

(A) by striking ‘‘2017’’ each place it appears and 

inserting ‘‘2022’’; 

(B) by striking ‘‘the first 3 months of fiscal year 2018’’ 

and inserting ‘‘the first 3 months of fiscal year 2023’’; 

and 

(C) by striking ‘‘Such fees may only be used in fiscal 

year 2018.’’. 

(d) ANNUAL FEE SETTING.—Section 744B(d) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–42(d)) is amended— 

(1) by striking paragraphs (1) and (2) and inserting the 

following: 

‘‘(1) FISCAL YEARS 2018 THROUGH 2022.—Not more than 60 

days before the first day of each of fiscal years 2018 through 

2022, the Secretary shall establish the fees described in 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 paragraph (2); and 

(3) in paragraph (2) (as so redesignated), in the matter 

preceding subparagraph (A), by striking ‘‘fees under paragraphs 

(1) and (2)’’ and inserting ‘‘fee under paragraph (1)’’. 

(e) IDENTIFICATION OF FACILITIES.—Section 744B(f) of the 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 inserting ‘‘paragraph (3)’’; and 

(B) by striking ‘‘Such information shall’’ and all that 

follows through the end of subparagraph (B) and inserting 

‘‘Such information shall, for each fiscal year, be submitted, 

updated, or reconfirmed on or before June 1 of the previous 

fiscal year.’’; and 

(4) in paragraph (2), as so redesignated— 

(A) in the heading, by striking ‘‘CONTENTS OF NOTICE’’ 

and inserting ‘‘INFORMATION REQUIRED TO BE SUBMITTED’’; 

(B) in the matter preceding subparagraph (A), by 

striking ‘‘paragraph (2)’’ and inserting ‘‘paragraph (1)’’; 

(C) in subparagraph (A), by striking ‘‘or intended to 

be identified’’; 

(D) in subparagraph (D), by striking ‘‘and’’ at the end; 

(E) in subparagraph (E), by striking the period and 

inserting ‘‘; and’’; and 

(F) by adding at the end the following: 

‘‘(F) whether the facility is a contract manufacturing 

organization facility.’’. 

(f) EFFECT OF FAILURE TO PAY FEES.—Section 744B(g) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(g)) is 

amended— 

Deadline. 

Time period. 

Deadline. 

131 STAT. 1026 PUBLIC LAW 115–52—AUG. 18, 2017 

(1) in paragraph (1), by adding at the end the following: 

‘‘This paragraph shall cease to be effective on October 1, 2022.’’; 

(2) in paragraph (2)(C)(ii), by striking ‘‘of 505(j)(5)(A)’’ and 

inserting ‘‘of section 505(j)(5)(A)’’; and 

(3) by adding at the end the following: 

‘‘(5) GENERIC DRUG APPLICANT PROGRAM FEE.— 

‘‘(A) IN GENERAL.—A person who fails to pay a fee 

as required under subsection (a)(5) by the date that is 

20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following: 

‘‘(i) The Secretary shall place the person on a publicly available arrears list. 

‘‘(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate 

of such applicant shall not be received, within the 

meaning of section 505(j)(5)(A). 

‘‘(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant 

or an affiliate of such applicant 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. 379j–42(h)(2)) is amended by striking 

‘‘for Type II active pharmaceutical ingredient drug master files, 

abbreviated new drug applications and prior approval supplements, 

and generic drug facilities and active pharmaceutical ingredient 

facilities’’. 

(h) CREDITING AND AVAILABILITY OF FEES.—Section 744B(i) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(i)) 

is amended— 

(1) in paragraph (2)— 

(A) in subparagraph (A), by striking ‘‘subparagraphs 

(C) and (D)’’ and inserting ‘‘subparagraph (C)’’; 

(B) by striking subparagraph (C) (relating to fee collection during first program year); 

(C) in subparagraph (D)— 

(i) in the heading, by striking ‘‘IN SUBSEQUENT

YEARS’’; and 

(ii) by striking ‘‘(after fiscal year 2013)’’; and 

(D) by redesignating subparagraph (D) as 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 APPLICATIONS

OWNED BY APPLICANTS AND THEIR AFFILIATES.—Section 744B of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) 

is amended by adding at the end the following: 

‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG APPLICATIONS

OWNED BY APPLICANTS AND THEIR AFFILIATES.— 

‘‘(1) IN GENERAL.—By April 1 of each year, each person 

that owns an abbreviated new drug application, or a designated 

affiliate of such person, shall submit, on behalf of the person 

and the affiliates of such person, to the Secretary a list of— 

Deadline. 

Lists. 

Public 

information. 

Lists. 

Deadline. 

Time period. 

Termination 

date. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1027 

‘‘(A) all approved abbreviated new drug applications 

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 application and all approved 

abbreviated new drug applications owned by any such affiliate. 

‘‘(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’’; 

(2) in subsection (b), by striking ‘‘2013’’ and inserting 

‘‘2018’’; and 

(3) in subsection (d), by striking ‘‘2017’’ each place it 

appears and inserting ‘‘2022’’. 

SEC. 305. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 744A and 744B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall 

cease to be effective October 1, 2022. 

(b) REPORTING REQUIREMENTS.—Section 744C of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to 

be effective January 31, 2023. 

(c) PREVIOUS SUNSET PROVISION.— 

(1) IN GENERAL.—Effective October 1, 2017, section 304 

of the Food and Drug Administration Safety and Innovation 

Act (Public Law 112–144) is repealed. 

(2) CONFORMING AMENDMENT.—The Food and Drug 

Administration Safety and Innovation Act (Public Law 112– 

144) is amended in the table of contents in section 2 by striking 

the item relating to section 304. 

SEC. 306. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2017, or the date of the enactment of this Act, whichever is 

later, except that fees under part 7 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

for all abbreviated new drug applications received on or after 

October 1, 2017, regardless of the date of the enactment of this 

Act. 

SEC. 307. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 7 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act, as in effect on the day before the date of the 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 were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 

21 USC 379j–41 

note. 

21 USC 379j–41 

note. 

Effective date. 

Repeal. 

21 USC 379j–41 

note, 379j–43 

note. 

21 USC 379j–43 

note. 

21 USC 379j–41 

note. 

Guidance. 

131 STAT. 1028 PUBLIC LAW 115–52—AUG. 18, 2017 

U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical 

ingredients that were first referenced on or after October 1, 2012, 

but before October 1, 2017, with respect to assessing and collecting 

any fee required by such part for a fiscal year prior to fiscal 

year 2018. 

TITLE IV—FEES RELATING TO 

BIOSIMILAR BIOLOGICAL PRODUCTS 

SEC. 401. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Biosimilar 

User Fee Amendments of 2017’’. 

(b) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated to expediting 

the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the 

goals identified for purposes of part 8 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act, in the letters 

from the Secretary of Health and Human Services to the Chairman 

of the Committee on Health, Education, Labor, and Pensions of 

the Senate and the Chairman of the Committee on Energy and 

Commerce of the House of Representatives, as set forth in the 

Congressional Record. 

SEC. 402. DEFINITIONS. 

(a) ADJUSTMENT FACTOR.—Section 744G(1) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read 

as follows: 

‘‘(1) The term ‘adjustment factor’ applicable to a fiscal 

year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; 

All items) for October of the preceding fiscal year divided by 

such Index for October 2011.’’. 

(b) BIOSIMILAR BIOLOGICAL PRODUCT.—Section 744G(3) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(3)) is 

amended by striking ‘‘means a product’’ and inserting ‘‘means a 

specific strength of a biological product in final dosage form’’. 

SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES. 

(a) TYPES OF FEES.—Section 744H(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–52(a)) is amended— 

(1) in the matter preceding paragraph (1), by striking ‘‘fiscal 

year 2013’’ and inserting ‘‘fiscal year 2018’’; 

(2) in the heading of paragraph (1), by striking ‘‘BIOSIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGICAL PRODUCT’’; 

(3) in paragraph (1)(A)(i), by striking ‘‘(b)(1)(A)’’ and 

inserting ‘‘(c)(5)’’; 

(4) in paragraph (1)(B)(i), by striking ‘‘(b)(1)(B) for biosimilar biological product development’’ and inserting ‘‘(c)(5) 

for the biosimilar biological product development program’’; 

(5) in paragraph (1)(B)(ii), by striking ‘‘annual biosimilar 

biological product development program fee’’ and inserting 

‘‘annual biosimilar biological product development fee’’; 

21 USC 379j–51 

note. 

21 USC 301 note. 

Biosimilar User 

Fee Amendments 

of 2017. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1029 

(6) in paragraph (1)(B)(iii), by striking ‘‘annual biosimilar 

development program fee’’ and inserting ‘‘annual biosimilar 

biological product development fee’’; 

(7) in paragraph (1)(B), by adding at the end the following: 

‘‘(iv) REFUND.—If a person submits a marketing 

application for a biosimilar biological product before 

October 1 of a fiscal year and such application is 

accepted for filing on or after October 1 of such fiscal 

year, the person may request a refund equal to the 

annual biosimilar biological product development fee 

paid by the person for the product for such fiscal year. 

To qualify for consideration for a refund under this 

clause, a person shall submit to the Secretary a written 

request for such refund not later than 180 days after 

the marketing application is accepted for filing.’’; 

(8) in paragraph (1)(C), by striking ‘‘for a product effective 

October 1 of a fiscal year by,’’ and inserting ‘‘for a product, 

effective October 1 of a fiscal year, by,’’; 

(9) in paragraph (1)(D)— 

(A) in clause (i) in the matter preceding subclause 

(I), by inserting ‘‘, if the person seeks to resume participation in such program,’’ before ‘‘pay a fee’’; 

(B) in clause (i)(I), by inserting after ‘‘grants a request’’ 

the following: ‘‘by such person’’; and 

(C) in clause (i)(II), by inserting after ‘‘discontinued)’’ 

the following: ‘‘by such person’’; 

(10) in the heading of paragraph (1)(E), by striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; 

(11) in paragraph (1)(F)— 

(A) in the subparagraph heading, by striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; and 

(B) by amending clause (i) to read as follows: 

‘‘(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 reactivation 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: 

‘‘(A) IN GENERAL.—Each person that submits, on or 

after October 1, 2017, a biosimilar biological product 

application shall be subject to the following fees: 

‘‘(i) A fee established under subsection (c)(5) for 

a biosimilar biological product application for which 

clinical data (other than comparative bioavailability 

studies) with respect to safety or effectiveness are 

required for approval. 

‘‘(ii) A fee established under subsection (c)(5) for 

a biosimilar biological product application for which 

clinical data (other than comparative bioavailability 

studies) with respect to safety or effectiveness are not 

required for approval. Such fee shall be equal to half 

of the amount of the fee described in clause (i). 

Deadline. 

131 STAT. 1030 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(B) RULE OF APPLICABILITY; TREATMENT OF CERTAIN

PREVIOUSLY PAID FEES.—Any person who pays a fee under 

subparagraph (A), (B), or (D) of paragraph (1) for a product 

before October 1, 2017, but submits a biosimilar biological 

product application for that product after such date, shall— 

‘‘(i) be subject to any biosimilar biological product 

application fees that may be assessed at the time when 

such biosimilar biological product application is 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 subparagraph (A), 

(B), or (D).’’; 

(C) in the heading of subparagraph (D), by striking 

‘‘OR SUPPLEMENT’’; 

(D) in subparagraphs (C) through (F), by striking ‘‘or 

supplement’’ each place it appears; and 

(E) in subparagraph (D), by striking ‘‘or a supplement’’; 

(13) by amending paragraph (3) to read as follows: 

‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEE.— 

‘‘(A) IN GENERAL.—Each person who is named as the 

applicant in a biosimilar biological product application shall 

pay the annual biosimilar biological product program fee 

established for a fiscal year under subsection (c)(5) for 

each biosimilar biological product that— 

‘‘(i) is identified in such a biosimilar biological 

product application approved as of October 1 of such 

fiscal year; and 

‘‘(ii) as of October 1 of such fiscal year, does not 

appear on a list, developed and maintained by the 

Secretary, of discontinued biosimilar biological 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 enactment 

of an appropriations Act providing for the collection 

and obligation of fees for such year under this section. 

‘‘(C) ONE FEE PER PRODUCT PER YEAR.—The biosimilar 

biological product program fee shall be paid only once for 

each product for each fiscal year. 

‘‘(D) LIMITATION.—A person who is named as the 

applicant in a biosimilar biological product application shall 

not be assessed more than 5 biosimilar biological product 

program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.’’. 

(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 744H 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

52) is amended to read as follows: 

‘‘(b) FEE REVENUE AMOUNTS.— 

‘‘(1) FISCAL YEAR 2018.—For fiscal year 2018, fees under 

subsection (a) shall be established to generate a total revenue 

amount equal to the sum of— 

‘‘(A) $45,000,000; and 

Deadlines. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1031 

‘‘(B) the dollar amount equal to the fiscal year 2018 

adjustment (as determined under subsection (c)(4)). 

‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of the fiscal 

years 2019 through 2022, fees under subsection (a) shall, except 

as provided in subsection (c), be established to generate a 

total revenue amount equal to the sum of— 

‘‘(A) the annual base revenue for the fiscal year (as 

determined under paragraph (4)); 

‘‘(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection 

(c)(1)); 

‘‘(C) the dollar amount equal to the capacity planning 

adjustment for the fiscal year (as determined under subsection (c)(2)); and 

‘‘(D) the dollar amount equal to the operating reserve 

adjustment for the fiscal year, if applicable (as determined 

under subsection (c)(3)). 

‘‘(3) ALLOCATION OF REVENUE AMOUNT AMONG FEES; LIMITATIONS ON FEE AMOUNTS.— 

‘‘(A) ALLOCATION.—The Secretary shall determine the 

percentage of the total revenue amount for a fiscal year 

to be derived from, respectively— 

‘‘(i) initial and annual biosimilar biological product 

development fees and reactivation fees under subsection (a)(1); 

‘‘(ii) biosimilar biological product application fees 

under subsection (a)(2); and 

‘‘(iii) biosimilar biological product program fees 

under subsection (a)(3). 

‘‘(B) LIMITATIONS ON FEE AMOUNTS.—Until the first 

fiscal year for which the capacity planning adjustment 

under subsection (c)(2) is effective, the amount of any fee 

under subsection (a) for a fiscal year after fiscal year 2018 

shall not exceed 125 percent of the amount of such fee 

for fiscal year 2018. 

‘‘(C) BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT

FEES.—The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall 

be equal to the annual biosimilar biological product 

development fee under subsection (a)(1)(B) for that fiscal 

year. 

‘‘(D) REACTIVATION FEE.—The reactivation fee under 

subsection (a)(1)(D) for a fiscal year shall be equal to twice 

the amount of the annual biosimilar biological product 

development fee under subsection (a)(1)(B) for that fiscal 

year. 

‘‘(4) ANNUAL BASE REVENUE.—For purposes of paragraph 

(2), the dollar amount of the annual base revenue for a fiscal 

year shall be the dollar amount of the total revenue amount 

for the previous fiscal year, excluding any adjustments to such 

revenue amount under subsection (c)(3).’’. 

(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 744H of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is 

amended— 

(1) by redesignating subsections (c) through (h) as subsections (d) through (i), respectively; 

Determination. 

131 STAT. 1032 PUBLIC LAW 115–52—AUG. 18, 2017 

(2) in subsections (a)(2)(F) and (h) (as redesignated by 

paragraph (1)), by striking ‘‘subsection (c)’’ and inserting ‘‘subsection (d)’’; 

(3) in subsection (a)(4)(A), by striking ‘‘subsection (b)(1)(F)’’ 

and inserting ‘‘subsection (c)(5)’’; and 

(4) by inserting after subsection (b) the following: 

‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 

‘‘(1) INFLATION ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For purposes of subsection (b)(2)(B), 

the dollar amount of the inflation adjustment to the annual 

base revenue for each fiscal year shall be equal to the 

product of— 

‘‘(i) such annual base revenue for the fiscal year 

under subsection (b); and 

‘‘(ii) the inflation adjustment percentage under 

subparagraph (B). 

‘‘(B) INFLATION ADJUSTMENT PERCENTAGE.—The 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, multiplied 

by the proportion of personnel compensation and benefits costs to total costs of the process for the review 

of biosimilar biological product applications (as defined 

in section 744G(13)) for the first 3 years of the preceding 4 fiscal years; and 

‘‘(ii) the average annual percent change that 

occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not 

Seasonally Adjusted; All items; Annual Index) for the 

first 3 years of the preceding 4 years of available 

data multiplied by the proportion of all costs other 

than personnel compensation and benefits costs to total 

costs of the process for the review of biosimilar 

biological product applications (as defined in section 

744G(13)) for the first 3 years of the preceding 4 fiscal 

years. 

‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

‘‘(A) IN GENERAL.—Beginning with the fiscal year 

described in subparagraph (B)(ii)(II), the Secretary shall, 

in addition to the adjustment under paragraph (1), further 

increase the fee revenue and fees under this section for 

a fiscal year to reflect changes in the resource capacity 

needs of the Secretary for the process for the review of 

biosimilar biological product applications. 

‘‘(B) CAPACITY PLANNING METHODOLOGY.— 

‘‘(i) DEVELOPMENT; EVALUATION AND REPORT.—The 

Secretary shall obtain, through a contract with an 

independent accounting or consulting firm, a report 

evaluating options and recommendations for a new 

methodology to accurately assess changes in the 

resource and capacity needs of the process for the 

review of biosimilar biological product applications. The 

Contracts. 

Effective date. 

Time periods. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1033 

capacity 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. 

‘‘(ii) ESTABLISHMENT AND IMPLEMENTATION.—After 

review of the report described in clause (i) and receipt 

and review of public comments thereon, the Secretary 

shall establish a capacity planning methodology for 

purposes of this paragraph, which shall— 

‘‘(I) incorporate such approaches and 

attributes as the Secretary determines appropriate; and 

‘‘(II) be effective beginning with the first fiscal 

year for which fees are set after such capacity 

planning methodology is established. 

‘‘(C) LIMITATION.—Under no circumstances shall an 

adjustment under this paragraph result in fee revenue 

for a fiscal year that is less than the sum of the amounts 

under subsections (b)(2)(A) (the annual base revenue for 

the fiscal year) and (b)(2)(B) (the dollar amount of the 

inflation adjustment for the fiscal year). 

‘‘(D) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under 

paragraph (5) the fee revenue and fees resulting from the 

adjustment and the methodologies under this paragraph. 

‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

‘‘(A) INTERIM APPLICATION; FEE REDUCTION.—Until the 

first fiscal year for which the capacity planning adjustment 

under paragraph (2) is effective, the Secretary may, in 

addition to the adjustment under paragraph (1), reduce 

the fee revenue and fees under this section for a fiscal 

year as the Secretary determines appropriate for longterm financial planning purposes. 

‘‘(B) GENERAL APPLICATION AND METHODOLOGY.— Beginning with the first fiscal year for which the capacity 

planning adjustment under paragraph (2) is effective, the 

Secretary may, in addition to the adjustments under paragraphs (1) and (2)— 

‘‘(i) reduce the fee revenue and fees under this 

section as the Secretary determines appropriate for 

long-term financial planning purposes; or 

‘‘(ii) increase the fee revenue and fees under this 

section if such an adjustment is necessary to provide 

for not more than 21 weeks of operating reserves of 

carryover user fees for the process for the review of 

biosimilar biological product applications. 

‘‘(C) FEDERAL REGISTER NOTICE.—If an adjustment 

under subparagraph (A) or (B) is made, the rationale for 

the amount of the increase or decrease (as applicable) 

in fee revenue and fees shall be contained in the annual 

Federal Register notice under paragraph (5)(B) establishing 

fee revenue and fees for the fiscal year involved. 

‘‘(4) FISCAL YEAR 2018 ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For fiscal year 2018, the Secretary 

shall adjust the fee revenue and fees under this section 

in such amount (if any) as needed to reflect an updated 

Assessment. 

Time period. 

Effective date. 

Notice. 

Effective date. 

Publication. 

Public 

information. 

Deadline. 

131 STAT. 1034 PUBLIC LAW 115–52—AUG. 18, 2017 

assessment of the workload for the process for the review 

of biosimilar biological product applications. 

‘‘(B) METHODOLOGY.—The Secretary shall publish 

under paragraph (5)(B) a description of the methodology 

used to calculate the fiscal year 2018 adjustment under 

this paragraph in the Federal Register notice establishing 

fee revenue and fees for fiscal year 2018. 

‘‘(C) LIMITATION.—No adjustment under this paragraph 

shall result in an increase in fee revenue and fees under 

this section in excess of $9,000,000. 

‘‘(5) ANNUAL FEE SETTING.—For fiscal year 2018 and each 

subsequent fiscal year, the Secretary shall, not later than 60 

days before the start of each such fiscal year— 

‘‘(A) establish, for the fiscal year, initial and annual 

biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological 

product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection 

(a)(3), based on the revenue amounts established under 

subsection (b) and the adjustments provided under this 

subsection; and 

‘‘(B) publish such fee revenue and fees in the Federal 

Register. 

‘‘(6) LIMIT.—The total amount of fees assessed for a fiscal 

year under this section may not exceed the total costs for 

such fiscal year for the resources allocated for the process 

for the review of biosimilar biological product applications.’’. 

(d) APPLICATION FEE WAIVER FOR SMALL BUSINESS.—Subsection 

(d)(1) of section 744H of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379j–52), as redesignated by subsection (c)(1), is 

amended— 

(1) by striking subparagraph (B); 

(2) by striking ‘‘; and’’ at the end of subparagraph (A) 

and inserting a period; and 

(3) by striking ‘‘shall pay—’’ and all that follows through 

‘‘application fees’’ and inserting ‘‘shall pay application fees’’. 

(e) EFFECT OF FAILURE TO PAY FEES.—Subsection (e) of section 

744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j–52), as redesignated by subsection (c)(1), is amended by 

striking ‘‘all fees’’ and inserting ‘‘all such fees’’. 

(f) CREDITING AND AVAILABILITY OF FEES.—Subsection (f) of 

section 744H of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379j–52), as redesignated by subsection (c)(1), is amended— 

(1) in paragraph (2)— 

(A) by striking subparagraph (C) (relating to fee collection during first program year) and inserting the following: 

‘‘(C) COMPLIANCE.—The Secretary shall be considered 

to have met the requirements of subparagraph (B) in any 

fiscal year if the costs described in such subparagraph 

are not more than 15 percent below the level specified 

in such subparagraph.’’; and 

(B) in subparagraph (D)— 

(i) in the heading, by striking ‘‘IN SUBSEQUENT

YEARS’’; and 

(ii) by striking ‘‘(after fiscal year 2013)’’; and 

(2) in paragraph (3), by striking ‘‘2013 through 2017’’ and 

inserting ‘‘2018 through 2022’’. 

Federal Register, 

publication. 

Time period. 

Deadline. 

Federal Register, 

publication. 

Notice. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1035 

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 744I of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379j–53) is amended— 

(1) in subsection (a)— 

(A) by striking ‘‘2013’’ and inserting ‘‘2018’’; and 

(B) by striking ‘‘Biosimilar User Fee Act of 2012’’ and 

inserting ‘‘Biosimilar User Fee Amendments of 2017’’; 

(2) in subsection (b), by striking ‘‘2013’’ and inserting 

‘‘2018’’; 

(3) by striking subsection (d); 

(4) by redesignating subsection (e) as subsection (d); and 

(5) in subsection (d), as so redesignated, by striking ‘‘2017’’ 

each place it appears and inserting ‘‘2022’’. 

SEC. 405. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 744G and 744H of the Federal 

Food, Drug, and Cosmetic Act shall cease to be effective October 

1, 2022. 

(b) REPORTING REQUIREMENTS.—Section 744I of the Federal 

Food, Drug, and Cosmetic Act shall cease to be effective January 

31, 2023. 

(c) PREVIOUS SUNSET PROVISION.— 

(1) IN GENERAL.—Effective October 1, 2017, section 404 

of the Food and Drug Administration Safety and Innovation 

Act (Public Law 112–144) is repealed. 

(2) CONFORMING AMENDMENT.—The Food and Drug 

Administration Safety and Innovation Act (Public Law 112– 

144) is amended in the table of contents in section 2 by striking 

the item relating to section 404. 

SEC. 406. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2017, or the date of the enactment of this Act, whichever is 

later, except that fees under part 8 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

for all biosimilar biological product applications received on or after 

October 1, 2017, regardless of the date of the enactment of this 

Act. 

SEC. 407. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 8 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to 

biosimilar biological product applications and supplements (as 

defined in such part as of such day) that were accepted by the 

Food and Drug Administration for filing on or after October 1, 

2012, but before October 1, 2017, with respect to assessing and 

collecting any fee required by such part for a fiscal year prior 

to fiscal year 2018. 

Continuation. 

Time period. 

21 USC 379j–51 

note. 

21 USC 379j–51 

note. 

Effective date. 

Repeal. 

21 USC 379j–51 

note, 379j–53 

note. 

21 USC 379j–53 

note. 

21 USC 379j–51 

note. 

131 STAT. 1036 PUBLIC LAW 115–52—AUG. 18, 2017 

TITLE V—PEDIATRIC DRUGS AND 

DEVICES 

SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN. 

Section 409I of the Public Health Service Act (42 U.S.C. 284m) 

is amended— 

(1) in subsection (a)(2)(A)(ii), by inserting ‘‘and identification of biomarkers for such diseases, disorders, or conditions,’’ 

after ‘‘biologics,’’; 

(2) in subsection (c)— 

(A) in paragraph (6)— 

(i) by amending subparagraph (B) to read as follows: 

‘‘(B) AVAILABILITY OF REPORTS.— 

‘‘(i) IN GENERAL.—Each report submitted under 

subparagraph (A) shall be considered to be in the public 

domain (subject to section 505A(d)(4) of the Federal 

Food, Drug, and Cosmetic Act) and not later than 

90 days after submission of such report, shall be— 

‘‘(I) posted on the internet website of the 

National Institutes of Health in a manner that 

is accessible and consistent with all applicable Federal laws and regulations, including such laws and 

regulations for the protection of— 

‘‘(aa) human research participants, 

including with respect to privacy, security, 

informed consent, and protected health 

information; and 

‘‘(bb) proprietary interests, confidential 

commercial information, and intellectual property rights; and 

‘‘(II) assigned a docket number by the Commissioner of Food and Drugs and made available for 

the submission of public comments. 

‘‘(ii) SUBMISSION OF COMMENTS.—An interested 

person may submit written comments concerning such 

pediatric studies to the Commissioner of Food and 

Drugs, and the submitted comments shall become part 

of the docket file with respect to each of the drugs.’’; 

and 

(ii) in subparagraph (C), by striking ‘‘appropriate 

action’’ and all that follows through the period and 

inserting ‘‘action in a timely and appropriate manner 

in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt 

of the report under subparagraph (A), in accordance 

with paragraph (7).’’; and 

(B) in paragraph (7)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘During’’ and inserting ‘‘Within’’; 

(ii) in subparagraph (C)(i), by striking ‘‘place’’ and 

all that follows through ‘‘and of’’ and inserting ‘‘include 

in the public docket file a reference to the location 

of the report on the internet website of the National 

Institutes of Health and a copy of’’; and 

Public 

information. 

Web posting. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1037 

(iii) in clause (ii), by striking ‘‘in the Federal Register and’’; 

(3) by striking subsection (d); 

(4) by redesignating subsection (e) as subsection (d); and 

(5) in paragraph (1) of subsection (d), as so redesignated, 

by striking ‘‘2013 through 2017’’ and inserting ‘‘2018 through 

2022’’. 

SEC. 502. PEDIATRIC DEVICES. 

(a) PEDIATRIC USE OF DEVICES.—Section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(3)) is 

amended— 

(1) by redesignating subparagraphs (B) through (D) as subparagraphs (D) through (F), respectively; 

(2) by inserting after subparagraph (A) the following: 

‘‘(B) any information, based on a review of data available to the Secretary, regarding devices used in pediatric 

patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could 

confer a benefit to pediatric patients; 

‘‘(C) the number of pediatric devices that receive a 

humanitarian use exemption under section 520(m);’’; 

(3) in subparagraph (E), as so redesignated, by striking 

‘‘; and’’ and inserting ‘‘;’’; 

(4) in subparagraph (F) (as so redesignated), by striking 

‘‘(B), and (C).’’ and inserting ‘‘(C), (D), and (E);’’; and 

(5) by adding at the end the following: 

‘‘(G) the number of devices for which the Secretary 

relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and 

‘‘(H) the number of devices for which the Secretary 

relied on data from one pediatric subpopulation to support 

a determination of a reasonable assurance of safety and 

effectiveness in another pediatric subpopulation. 

For the items described in this paragraph, such report shall 

disaggregate the number of devices by pediatric subpopulation.’’. 

(b) HUMANITARIAN DEVICE EXEMPTION.—Section 520(m) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 

amended— 

(1) in paragraph (4)— 

(A) in subparagraph (B), by inserting ‘‘or an appropriate local committee’’ after ‘‘review committee’’ each place 

such term appears; and 

(B) in the matter following subparagraph (B), by 

inserting ‘‘or an appropriate local committee’’ after ‘‘review 

committee’’ each place such term appears; and 

(2) in paragraph (6)(A)(iv), by striking ‘‘2017’’ and inserting 

‘‘2022’’. 

(c) DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC AVAILABILITY.—Section 305 of the Pediatric Medical Device Safety and 

Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note)) 

is amended— 

(1) in subsection (c)— 

(A) in paragraph (4), by striking ‘‘and’’ at the end; 

131 STAT. 1038 PUBLIC LAW 115–52—AUG. 18, 2017 

(B) in paragraph (5), by striking the period and 

inserting ‘‘; and’’; and 

(C) by adding at the end the following: 

‘‘(6) providing regulatory consultation to device sponsors 

in support of the submission of an application for a pediatric 

device, where appropriate.’’; and 

(2) in subsection (e), by striking ‘‘2013 through 2017’’ and 

inserting ‘‘2018 through 2022’’. 

(d) MEETING ON PEDIATRIC DEVICE DEVELOPMENT.— (1) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, the Secretary of Health and Human 

Services shall convene a public meeting on the development, 

approval or clearance, and labeling of pediatric medical devices. 

The Secretary shall invite to such meeting representatives from 

the medical device industry, academia, recipients of funding 

under section 305 of the Pediatric Medical Device Safety and 

Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 

note), medical provider organizations, and organizations representing patients and consumers. 

(2) TOPICS.—The meeting described in paragraph (1) shall 

include consideration of ways to— 

(A) improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices 

for pediatric populations that would result in the approval 

or clearance, and labeling, of medical devices for such populations; 

(B) appropriately use extrapolation under section 

515A(b) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360e–1(b)); 

(C) enhance the appropriate use of postmarket registries and data to increase pediatric medical device 

labeling; 

(D) increase Food and Drug Administration assistance 

to medical device manufacturers in developing devices for 

pediatric populations that are approved or cleared, and 

labeled, for their use; and 

(E) identify current barriers to pediatric device development and incentives to address such barriers. 

(3) REPORT.—The report submitted under section 

515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360e–1(a)(3)) with respect to the calendar year in which 

the meeting described in paragraph (1) is held shall include 

a summary of, and responses to, recommendations raised in 

such meeting. 

SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN. 

(a) IN GENERAL.—Clause (i) of section 505B(e)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) 

is amended to read as follows: 

‘‘(i) shall meet with the applicant— 

‘‘(I) if requested by the applicant with respect 

to a drug or biological product that is intended 

to treat a serious or life-threatening disease or 

condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 

1 meeting (as such term is used in section 

312.82(b) of title 21, Code of Federal Regulations, 

Deadlines. 

Deadline. 

Public 

information. 

Consultation. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1039 

or successor regulations) or within 30 calendar 

days of receipt of such request, whichever is later; 

‘‘(II) to discuss the initial pediatric study plan 

as soon as practicable, but not later than 90 calendar days after the receipt of such plan under 

subparagraph (A); and 

‘‘(III) to discuss the bases for the deferral 

under subsection (a)(4) or a full or partial waiver 

under subsection (a)(5);’’. 

(b) CONFORMING CHANGES.—Section 505B(e) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended— 

(1) in the heading of paragraph (2), by striking ‘‘MEETING’’ 

and inserting ‘‘MEETINGS’’; 

(2) in the heading of paragraph (2)(C), by striking 

‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 

(3) in clauses (ii) and (iii) of paragraph (2)(C), by striking 

‘‘no meeting’’ each place it appears and inserting ‘‘no meeting 

under clause (i)(II)’’; and 

(4) in paragraph (3) by striking ‘‘meeting under paragraph 

(2)(C)(i)’’ and inserting ‘‘meeting under paragraph (2)(C)(i)(II)’’. 

SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR 

PEDIATRIC CANCERS. 

(a) MOLECULAR TARGETS REGARDING CANCER DRUGS AND

BIOLOGICAL PRODUCTS.—Section 505B of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355c) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

(i) by redesignating subparagraphs (A) and (B) 

as clauses (i) and (ii), respectively, and adjusting the 

margins accordingly; 

(ii) by striking ‘‘A person’’ and inserting the following: 

‘‘(A) GENERAL REQUIREMENTS.—Except with respect to 

an application for which subparagraph (B) applies, a person’’; 

(iii) in clause (i), as so redesignated, by striking 

‘‘, or’’ at the end and inserting ‘‘; or’’; and 

(iv) by adding after subparagraph (A), as so designated by clause (ii), the following: 

‘‘(B) CERTAIN MOLECULARLY TARGETED CANCER INDICATIONS.—A person that submits, on or after the date that 

is 3 years after the date of enactment of the FDA Reauthorization Act of 2017, an original application for a new active 

ingredient under section 505 of this Act or section 351 

of the Public Health Service Act, shall submit with the 

application reports on the investigation described in paragraph (3) if the drug or biological product that is the 

subject of the application is— 

‘‘(i) intended for the treatment of an adult cancer; 

and 

‘‘(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the 

growth or progression of a pediatric cancer.’’; 

(B) in paragraph (2)(A), by striking ‘‘paragraph (1)’’ 

and inserting ‘‘paragraph (1)(A)’’; 

Time period. 

Reports. 

131 STAT. 1040 PUBLIC LAW 115–52—AUG. 18, 2017 

(C) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; 

(D) by inserting after paragraph (2) the following: 

‘‘(3) MOLECULARLY TARGETED PEDIATRIC CANCER INVESTIGATION.— 

‘‘(A) IN GENERAL.—With respect to a drug or biological 

product described in paragraph (1)(B), the investigation 

described in this paragraph is a molecularly targeted pediatric cancer investigation, which shall be designed to yield 

clinically meaningful pediatric study data, gathered using 

appropriate formulations for each age group for which the 

study is required, regarding dosing, safety, and preliminary 

efficacy to inform potential pediatric labeling. 

‘‘(B) EXTRAPOLATION OF DATA.—Paragraph (2)(B) shall 

apply to investigations described in this paragraph to the 

same extent and in the same manner as paragraph (2)(B) 

applies with respect to the assessments required under 

paragraph (1)(A). 

‘‘(C) DEFERRALS AND WAIVERS.—Deferrals and waivers 

under paragraphs (4) and (5) shall apply to investigations 

described in this paragraph to the same extent and in 

the same manner as such deferrals and waivers apply 

with respect to the assessments under paragraph (2)(B).’’; 

(E) in paragraph (4), as so redesignated— 

(i) by striking ‘‘assessments required under paragraph (1)’’ each place it appears and inserting ‘‘assessments required under paragraph (1)(A) or reports on 

the investigation required under paragraph (1)(B)’’; 

(ii) in subparagraph (A)(ii)(I), by inserting ‘‘or 

reports on the investigation’’ after ‘‘assessments’’; 

(iii) in subparagraph (B)(ii), by striking ‘‘assessment under paragraph (1)’’ and inserting ‘‘assessment 

under paragraph (1)(A) or reports on the investigation 

under paragraph (1)(B)’’; and 

(iv) in subparagraph (C)(ii)(II), by inserting ‘‘or 

investigation’’ after ‘‘assessment’’; and 

(F) in paragraph (5), as so redesignated, by inserting 

‘‘or reports on the investigation’’ after ‘‘assessments’’ each 

place it appears; 

(2) in subsection (d)— 

(A) by striking ‘‘subsection (a)(3)’’ each place it appears 

and inserting ‘‘subsection (a)(4)’’; 

(B) by inserting ‘‘AND REPORTS ON THE INVESTIGATION’’ 

after ‘‘SUBMISSION OF ASSESSMENTS’’ in the heading; and 

(C) by inserting ‘‘or the investigation described in subsection (a)(3)’’ after ‘‘assessment described in subsection 

(a)(2)’’ each place it appears; 

(3) in subsection (e)— 

(A) in paragraph (1), by inserting ‘‘or the investigation 

described in subsection (a)(3)’’ after ‘‘under subsection 

(a)(2)’’; and 

(B) in paragraph (2)(A)(i), by inserting ‘‘or the investigation described in subsection (a)(3)’’ after ‘‘under subsection (a)(2)’’; and 

(4) by adding at the end the following: 

‘‘(m) LIST OF PRIMARY MOLECULAR TARGETS.— 

Applicability. 

Applicability. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1041 

‘‘(1) IN GENERAL.—Within one year of the date of enactment 

of the FDA Reauthorization Act of 2017, the Secretary shall 

establish and update regularly, and shall publish on the internet website of the Food and Drug Administration— 

‘‘(A) a list of molecular targets considered, on the basis 

of data the Secretary determines to be adequate, to be 

substantially relevant to the growth and progression of 

a pediatric cancer, and that may trigger the requirements 

under this section; and 

‘‘(B) a list of molecular targets of new cancer drugs 

and biological products in development for which pediatric 

cancer study requirements under this section will be automatically waived. 

‘‘(2) CONSULTATION.—In establishing the lists described in 

paragraph (1), the Secretary shall consult the National Cancer 

Institute, members of the internal committee under section 

505C, and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, and shall take into account 

comments from the meeting under subsection (c). 

‘‘(3) RULE OF CONSTRUCTION.—Nothing in paragraph (1) 

shall be construed— 

‘‘(A) to require the inclusion of a molecular target on 

the list published under such paragraph as a condition 

for triggering the requirements under subsection (a)(1)(B) 

with respect to a drug or biological product directed at 

such molecular target; or 

‘‘(B) to authorize the disclosure of confidential commercial information, as prohibited under section 301(j) of this 

Act or section 1905 of title 18, United States Code.’’. 

(b) ORPHAN DRUGS.—Section 505B(k) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows: 

‘‘(k) RELATION TO ORPHAN DRUGS.— 

‘‘(1) IN GENERAL; EXEMPTION FOR ORPHAN INDICATIONS.— 

Unless the Secretary requires otherwise by regulation and 

except as provided in paragraph (2), this section does not apply 

to any drug or biological product for an indication for which 

orphan designation has been granted under section 526. 

‘‘(2) APPLICABILITY DESPITE ORPHAN DESIGNATION OF CERTAIN INDICATIONS.—This section shall apply with respect to 

a drug or biological product for which an indication has been 

granted orphan designation under 526 if the investigation 

described in subsection (a)(3) applies to the drug or biological 

product as described in subsection (a)(1)(B).’’. 

(c) MEETING, CONSULTATION, AND GUIDANCE.— 

(1) MEETING.—The Secretary of Health and Human Services (referred to in this subsection as the ‘‘Secretary’’), acting 

through the Commissioner of Food and Drugs and in collaboration with the Director of the National Cancer Institute, shall 

convene a public meeting not later than 1 year after the date 

of enactment of this Act to solicit feedback from physicians 

and researchers (including pediatric oncologists and rare disease specialists), patients, and other stakeholders to provide 

input on development of the guidance under paragraph (2) 

and the list under subsection (m) of section 505B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as added by 

subsection (a). The Secretary shall seek input at such meeting 

on— 

Deadline. 

21 USC 355c 

note. 

Waiver. 

Deadline. 

Update. 

Web posting. 

Lists. 

131 STAT. 1042 PUBLIC LAW 115–52—AUG. 18, 2017 

(A) the data necessary to determine that there is scientific evidence that a drug or biological product is directed 

at a molecular target that is considered to be substantially 

relevant to the growth or progression of a pediatric cancer; 

(B) the data necessary to determine that there is scientific evidence that a molecular target is considered to 

be substantially relevant to the growth or progression of 

a pediatric cancer; 

(C) the data needed to meet the requirement of conducting an investigation described in section 505B(a)(3) 

of the Federal Food, Drug, and Cosmetic Act, as amended 

by subsection (a); 

(D) considerations when developing the list under section 505B(m) of the Federal Food, Drug, and Cosmetic 

Act that contains molecular targets shared between different tumor types; 

(E) the process the Secretary shall utilize to update 

regularly a list of molecular targets that may trigger a 

pediatric study under section 505B of the Federal Food, 

Drug, and Cosmetic Act, as so amended, and how often 

such updates shall occur; 

(F) how to overcome the challenges related to pediatric 

cancer drug and biological product development, including 

issues related to the ethical, practical, and other barriers 

to conducting clinical trials in pediatric cancer with small 

patient populations; 

(G) scientific or operational challenges associated with 

performing an investigation described in section 

505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic 

Act, including the effect on pediatric studies currently 

underway in a pediatric patient population, treatment of 

a pediatric patient population, and the ability to complete 

adult clinical trials; 

(H) the advantages and disadvantages of innovative 

clinical trial designs in addressing the development of 

cancer drugs or biological products directed at molecular 

targets in pediatric cancer patients; 

(I) the ways in which the Secretary can improve the 

current process outlined under sections 505A and 505B 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355a, 355c) to encourage additional research and development of pediatric cancer treatments; 

(J) the ways in which the Secretary might streamline 

and improve the written request process, including when 

studies contained in a request under such section 505A 

are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations; 

(K) how the Secretary will facilitate collaboration 

among pediatric networks, academic centers and experts 

in pediatric cancer to conduct an investigation described 

in such section 505B(a)(3); 

(L) how the Secretary may facilitate collaboration 

among sponsors of same-in-class drugs and biological products that would be subject to the requirements for an 

investigation under such section 505B based on shared 

molecular targets; and 

Lists. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1043 

(M) the ways in which the Secretary will help to mitigate the risks, if any, of discouraging the research and 

development of orphan drugs when implementing such section 505B as amended. 

(2) GUIDANCE.—Not later than 2 years after the date of 

enactment of this Act, the Secretary, acting through the 

Commissioner of Food and Drugs, shall issue final guidance 

on implementation of the amendments to section 505B of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) 

regarding molecularly targeted cancer drugs made by this section, including— 

(A) the scientific criteria, types of data, and regulatory 

considerations for determining whether a molecular target 

is substantially relevant to the growth or progression of 

a pediatric cancer and would trigger an investigation under 

section 505B of the Federal Food, Drug, and Cosmetic 

Act, as amended; 

(B) the process by which the Secretary will engage 

with sponsors to discuss determinations, investigation 

requirements, deferrals, waivers, and any other issues that 

need to be resolved to ensure that any required investigation based on a molecular target can be reasonably conducted; 

(C) the scientific or operational challenges for which 

the Secretary may issue deferrals or waivers for an investigation described in subsection (a)(3) of such section 505B, 

including adverse impacts on current pediatric studies 

underway in a pediatric patient population, studies 

involving drugs designated as orphan drugs, treatment of 

a pediatric patient population, or the ability to complete 

adult clinical trials; 

(D) how the Secretary and sponsors will facilitate 

collaboration among pediatric networks, academic centers, 

and experts in pediatric cancer to conduct an investigation 

described in subsection (a)(3) of such section 505B; 

(E) scientific and regulatory considerations for study 

designs, including the applicability of innovative clinical 

trial designs for pediatric cancer drug and biological 

product developments under sections 505A and 505B of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 

355c); 

(F) approaches to streamline and improve the amendment process, including when studies contained in a 

request under such section 505A are not feasible due to 

the ethical, practical, or other barriers to conducting clinical 

trials in pediatric cancer populations; 

(G) the process for submission of an initial pediatric 

study plan for the investigation described in section 

505B(a)(3) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355c(a)(3)), including the process for a sponsor 

to meet and reach agreement with the Secretary on the 

initial pediatric study plan; and 

(H) considerations for implementation of such section 

505B, as so amended, and waivers of the requirements 

of such section 505B with regard to molecular targets for 

which several drugs or biological products may be under 

investigation. 

Plan. 

Criteria. 

Deadline. 

131 STAT. 1044 PUBLIC LAW 115–52—AUG. 18, 2017 

(d) REPORT TO CONGRESS.—Section 508(b) of the Food and 

Drug Administration Safety and Innovation Act (21 U.S.C. 355c– 

1(b)) is amended— 

(1) in paragraph (10), by striking ‘‘; and’’ and inserting 

‘‘;’’; and 

(2) by striking paragraph (11) and inserting the following: 

‘‘(11) an assessment of the impact of the amendments to 

such section 505B made by the FDA Reauthorization Act of 

2017 on pediatric research and labeling of drugs and biological 

products and pediatric labeling of molecularly targeted drugs 

and biological products for the treatment of cancer; 

‘‘(12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal 

Food, Drug, and Cosmetic Act, regarding earlier submission 

of pediatric studies under sections 505A and 505B of such 

Act and section 351(m) of the Public Health Service Act, 

including— 

‘‘(A) the average length of time after the approval 

of an application under section 505(b)(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 

262(a)) before studies conducted pursuant to such section 

505A, 505B, or section 351(m) are completed, submitted, 

and incorporated into labeling; 

‘‘(B) the average length of time after the receipt of 

a proposed pediatric study request before the Secretary 

responds to such request; 

‘‘(C) the average length of time after the submission 

of a proposed pediatric study request before the Secretary 

issues a written request for such studies; 

‘‘(D) the number of written requests issued for each 

investigational new drug or biological product prior to the 

submission of an application under section 505(b)(1) of 

the Federal Food, Drug, and Cosmetic Act or section 351(a) 

of the Public Health Service Act; and 

‘‘(E) the average number, and range of numbers, of 

amendments to written requests issued, and the time the 

Secretary requires to review and act on proposed amendments to written requests; 

‘‘(13) a list of sponsors of applications or holders of approved 

applications who received exclusivity under such section 505A 

or such section 351(m) after receiving a letter issued under 

such section 505B(d)(1) for any drug or biological product before 

the studies referred to in such letter were completed and submitted; 

‘‘(14) a list of assessments and investigations required 

under such section 505B; 

‘‘(15) how many requests under such section 505A for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) 

of such section 505B, approved prior to 3 years after the date 

of enactment of the FDA Reauthorization Act of 2017, have 

been issued by the Food and Drug Administration, and how 

many such requests have been completed; and 

‘‘(16) the Secretary’s assessment of the overall impact of 

the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric 

Assessment. 

Lists. 

Lists. 

Assessment. 

Assessment. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1045 

cancer research and the orphan drug program, as well any 

subsequent recommendations.’’. 

(e) RULE OF CONSTRUCTION.—Nothing in this section, including 

the amendments made by this section, shall limit the authority 

of the Secretary of Health and Human Services to issue written 

requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health 

Service Act (42 U.S.C. 262(m)), or to negotiate or implement amendments to such requests proposed by the an applicant. 

(f) GAO REPORT.— (1) IN GENERAL.—Beginning on the date that is 5 years 

after the date of enactment of this Act, the Comptroller General 

of the United States shall conduct a study of the effectiveness 

of requiring assessments and investigations described in section 

505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355c), as amended by this section, in the development of drugs 

and biological products for pediatric cancer indications. The 

Comptroller General shall examine— 

(A) the indications and associated molecular targets 

studied in assessments and investigations required for 

drugs or biological products intended for the treatment 

of an adult cancer; 

(B) the indication for which the study was requested 

as compared to the indication requested under the new 

drug application filed by the sponsor; 

(C) the number of pediatric cancer indications for which 

assessments and investigations have been required under 

such section 505B; 

(D) the number of requests for deferral and waiver 

of pediatric assessments and investigations required under 

such section and the number of such deferral and waiver 

requests granted and denied; 

(E) the number of orphan-designated indications for 

drugs and biological products for which assessments and 

investigations were required under such section; 

(F) the number of drugs and biological products 

approved for the treatment of cancer in the pediatric population for which the supportive studies were required to 

be conducted under such section; 

(G) the number of written requests made under section 

505A of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 355a) relating to investigations required under subsection (a)(1)(B) of such section 505B; and 

(H) any additional considerations by the Secretary 

regarding the effectiveness of requiring pediatric assessments described in such section 505B in the development 

of drugs and biological products for pediatric cancer indications. 

(2) REVIEW.—The study under paragraph (1) shall include 

a review of the Food and Drug Administration’s use of the 

authority under section 505B of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355c), as amended by this section, 

including the amendments to the deferral and waiver criteria 

under such section and how such criteria have been applied. 

(3) CONSULTATION.—In conducting the study under paragraph (1), the Comptroller General of the United States shall 

consult with appropriate stakeholders that may be required 

Criteria. 

Examination. 

Effective date. 

Time period. 

Study. 

21 USC 355c 

note. 

131 STAT. 1046 PUBLIC LAW 115–52—AUG. 18, 2017 

to conduct the trials under section 505B of the Federal Food, 

Drug, and Cosmetic Act, and the ability of such stakeholders 

to adhere to the requests issued by the Food and Drug Administration. 

(4) REPORT.—Not later than the date that is 6 years after 

the date of enactment of this Act, the Comptroller General 

of the United States shall submit a report containing the results 

of the study under paragraph (1) to the Secretary of Health 

and Human Services, the Committee on Health, Education, 

Labor, and Pensions of the Senate, and the Committee on 

Energy and Commerce of the House of Representatives. 

SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND 

BIOLOGICAL PRODUCTS FOR PEDIATRIC USE. 

(a) INFORMING INTERNAL REVIEW COMMITTEE.—Section 505A(f) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) 

is amended by adding at the end the following: 

‘‘(7) INFORMING INTERNAL REVIEW COMMITTEE.—The Secretary shall provide to the committee referred to in paragraph 

(1) any response issued to an applicant or holder with respect 

to a proposed pediatric study request.’’. 

(b) ACTION ON SUBMISSIONS.— 

(1) IN GENERAL.—Section 505A(d) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355a(d)) is amended— 

(A) by redesignating paragraphs (3) through (5) as 

paragraphs (4) through (6), respectively; and 

(B) by inserting after paragraph (2) the following: 

‘‘(3) ACTION ON SUBMISSIONS.—The Secretary shall review 

and act upon a submission by a sponsor or holder of a proposed 

pediatric study request or a proposed amendment to a written 

request for pediatric studies within 120 calendar days of the 

submission.’’. 

(2) CONFORMING AMENDMENTS.— 

(A) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Section 

505A of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 355a), as amended by paragraph (1), is further 

amended by striking subsection ‘‘(d)(3)’’ each place it 

appears and inserting ‘‘(d)(4)’’. 

(B) PUBLIC HEALTH SERVICE ACT.—Paragraphs (2), (3), 

and (4) of section 351(m) of the Public Health Service 

Act (42 U.S.C. 262(m)) are amended by striking ‘‘section 

505A(d)(3)’’ each place it appears and inserting ‘‘section 

505A(d)(4)’’. 

(c) PLAN.—The Secretary of Health and Human Services, acting 

through the internal review committee established under section 

505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355d) shall, not later than one year after the date of enactment 

of this Act, develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 

or section 351(m) of the Public Health Service Act (42 U.S.C. 

262(m)). Such plan shall include recommendations to achieve— 

(1) earlier discussion of proposed pediatric study requests 

and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section 

505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a); 

Recommendations. 

Deadline. 

21 USC 355a 

note. 

Deadline. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1047 

(2) earlier issuance of written requests for a pediatric study 

under such section 505A, including for investigational new 

drugs prior to the submission of an application under section 

505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and 

(3) shorter timelines, when appropriate, for the completion 

of studies pursuant to a written request under such section 

505A or such section 351(m). 

(d) NEONATOLOGY EXPERTISE.— 

(1) IN GENERAL.—Section 6(d) of the Best Pharmaceuticals 

for Children Act (21 U.S.C. 393a(d)) is amended by striking 

‘‘For the 5-year period beginning on the date of enactment 

of this subsection, at’’ and inserting ‘‘At’’. 

(2) DRAFT GUIDANCE.—Not later than 2 years after the 

date of enactment of this Act, the Secretary shall issue draft 

guidance on clinical pharmacology considerations for neonatal 

studies for drugs and biological products. 

(e) SUBMISSION OF ASSESSMENTS.—Section 505B(d)(1) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is 

amended by adding at the end the following: ‘‘The Secretary shall 

inform the Pediatric Advisory Committee of letters issued under 

this paragraph and responses to such letters.’’. 

(f) INTERNAL COMMITTEE.—Section 505C of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355d) is amended by inserting 

‘‘or pediatric rare diseases’’ after ‘‘psychiatry’’. 

(g) REPORT ON LABELING OF ORPHAN DRUGS.— 

(1) IN GENERAL.—Not later than 2 years after the date 

of the enactment of this Act, the Secretary of Health and 

Human Services shall submit to the Committee on Health, 

Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting 

on the internet website of the Food and Drug Administration, 

a report on the lack of information in the labeling of drugs 

for indications that have received an orphan designation under 

section 526 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb) with respect to the use of such drugs pediatric 

populations. 

(2) CONTENTS.—The report described in paragraph (1) shall 

include— 

(A) a list of drugs for which— 

(i) an indication was granted an orphan designation under section 526 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360bbb); 

(ii) an application described under section 

505B(a)(1) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355c(a)(1)) for such indication was submitted to the Secretary of Health and Human Services 

on or after April 1, 1999; and 

(iii) the labeling for such indication lacks important pediatric information, including information 

related to safety, dosing, and effectiveness; 

(B) a description of the lack of information referred 

to in subparagraph (A)(iii) for each drug for an indication 

on such list; and 

(C) Federal policy recommendations to improve the 

labeling of drugs for indications that have received an 

Recommendations. 

Lists. 

Public 

information. 

Web posting. 

Deadline. 

21 USC 355a 

note. 

131 STAT. 1048 PUBLIC LAW 115–52—AUG. 18, 2017 

orphan designation under such section 526 with respect 

to the use of such drugs pediatric populations.’’ 

TITLE VI—REAUTHORIZATIONS AND 

IMPROVEMENTS RELATED TO DRUGS 

SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 

ENANTIOMERS. 

Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(u)(4)) is amended by striking ‘‘2017’’ and 

inserting ‘‘2022’’. 

SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 

PARTNERSHIPS. 

Section 566(f) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360bbb–5(f)) is amended by striking ‘‘2013 through 2017’’ 

and inserting ‘‘2018 through 2022’’. 

SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM. 

Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is 

amended by striking ‘‘2013 through 2017’’ and inserting ‘‘2018 

through 2022’’. 

SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY 

CHAIN. 

(a) DIVERTED DRUGS.—Paragraph (1) of section 801(d) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is 

amended— 

(1) by striking ‘‘(d)(1) Except as’’ and inserting ‘‘(d)(1)(A) 

Except as’’; and 

(2) by adding at the end the following: 

‘‘(B) Except as authorized by the Secretary in the case of 

a drug that appears on the drug shortage list under section 506E 

or in the case of importation pursuant to section 804, no drug 

that is subject to section 503(b)(1) may be imported into the United 

States for commercial use if such drug is manufactured outside 

the United States, unless the manufacturer has authorized the 

drug to be marketed in the United States and has caused the 

drug to be labeled to be marketed in the United States.’’. 

(b) COUNTERFEIT DRUGS.—Subsection (b) of section 303 of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended 

by adding at the end the following: 

‘‘(8) Notwithstanding subsection (a), any person who violates 

section 301(i)(3) by knowingly making, selling or dispensing, or 

holding for sale or dispensing, a counterfeit drug shall be imprisoned 

for not more than 10 years or fined in accordance with title 18, 

United States Code, or both.’’. 

SEC. 605. PATIENT EXPERIENCE DATA. 

Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is amended by striking ‘‘impact 

of such disease or condition, or a related therapy,’’ and inserting 

‘‘impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation’’. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1049 

SEC. 606. COMMUNICATION PLANS. 

Section 505–1(e)(3) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355–1(e)(3)) is amended— 

(1) in subparagraph (B), by striking ‘‘; or’’; 

(2) in subparagraph (C), by striking the period and 

inserting ‘‘; or’’; and 

(3) by adding at the end the following: 

‘‘(D) disseminating information to health care providers 

about drug formulations or properties, including information about the limitations or patient care implications of 

such formulations or properties, and how such formulations 

or properties may be related to serious adverse drug events 

associated with use of the drug.’’. 

SEC. 607. ORPHAN DRUGS. 

(a) IN GENERAL.—Section 527 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360cc) is amended— 

(1) in subsection (a), in the matter following paragraph 

(2), by striking ‘‘such drug for such disease or condition’’ and 

inserting ‘‘the same drug for the same disease or condition’’; 

(2) in subsection (b)— 

(A) in the matter preceding paragraph (1), by striking 

‘‘If an application’’ and all that follows through ‘‘such license 

if’’ and inserting ‘‘During the 7-year period described in 

subsection (a) for an approved application under section 

505 or license under section 351 of the Public Health 

Service Act, the Secretary may approve an application or 

issue a license for a drug that is otherwise the same, 

as determined by the Secretary, as the already approved 

drug for the same rare disease or condition if’’; 

(B) in paragraph (1), by striking ‘‘notice’’ and all that 

follows through ‘‘assure’’ and inserting ‘‘of exclusive 

approval or licensure notice and opportunity for the submission of views, that during such period the holder of the 

exclusive approval or licensure cannot ensure’’; and 

(C) in paragraph (2), by striking ‘‘such holder provides’’ 

and inserting ‘‘the holder provides’’; and 

(3) by adding at the end the following: 

‘‘(c) CONDITION OF CLINICAL SUPERIORITY.— 

‘‘(1) IN GENERAL.—If a sponsor of a drug that is designated 

under section 526 and is otherwise the same, as determined 

by the Secretary, as an already approved or licensed drug 

is seeking exclusive approval or exclusive licensure described 

in subsection (a) for the same rare disease or condition as 

the already approved drug, the Secretary shall require such 

sponsor, as a condition of such exclusive approval or licensure, 

to demonstrate that such drug is clinically superior to any 

already approved or licensed drug that is the same drug. 

‘‘(2) DEFINITION.—For purposes of paragraph (1), the term 

‘clinically superior’ with respect to a drug means that the 

drug provides a significant therapeutic advantage over and 

above an already approved or licensed drug in terms of greater 

efficacy, greater safety, or by providing a major contribution 

to patient care. 

‘‘(d) REGULATIONS.—The Secretary may promulgate regulations 

for the implementation of subsection (c). Beginning on the date 

of enactment of the FDA Reauthorization Act of 2017, until such 

Applicability. 

Time period. 

Determination. 

131 STAT. 1050 PUBLIC LAW 115–52—AUG. 18, 2017 

time as the Secretary promulgates regulations in accordance with 

this subsection, the Secretary may apply any definitions set forth 

in regulations that were promulgated prior to such date of enactment, to the extent such definitions are not inconsistent with the 

terms of this section, as amended by such Act. 

‘‘(e) DEMONSTRATION OF CLINICAL SUPERIORITY STANDARD.— To assist sponsors in demonstrating clinical superiority as described 

in subsection (c), the Secretary— 

‘‘(1) upon the designation of any drug under section 526, 

shall notify the sponsor of such drug in writing of the basis 

for the designation, including, as applicable, any plausible 

hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously 

approved drug; and 

‘‘(2) upon granting exclusive approval or licensure under 

subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary 

of the clinical superiority findings.’’. 

(b) RULE OF CONSTRUCTION.—Nothing in the amendments made 

by subsection (a) shall affect any determination under sections 

526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bb, 360cc) made prior to the date of enactment of the 

FDA Reauthorization Act of 2017. 

SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING. 

Section 505A(o) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355a(o)) is amended— 

(1) in the subsection heading, by striking ‘‘UNDER SECTION

505(j)’’; 

(2) in paragraph (1)— 

(A) by striking ‘‘under section 505(j)’’ and inserting 

‘‘under subsection (b)(2) or (j) of section 505’’; and 

(B) by striking ‘‘or by exclusivity under clause (iii) 

or (iv) of section 505(j)(5)(F)’’ and inserting ‘‘, or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), clause 

(iii) or (iv) of section 505(c)(3)(E), or section 527(a), or 

by an extension of such exclusivity under this section or 

section 505E’’; 

(3) in paragraph (2), in the matter preceding subparagraph 

(A)— 

(A) by inserting ‘‘clauses (iii) and (iv) of section 

505(c)(3)(E), or section 527,’’ after ‘‘section 505(j)(5)(F),’’; 

and 

(B) by striking ‘‘drug approved under section 505(j)’’ 

and inserting ‘‘drug approved pursuant to an application 

submitted under subsection (b)(2) or (j) of section 505’’; 

and 

(4) by amending paragraph (3) to read as follows: 

‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND EXTENSIONS.—This subsection does not affect— 

‘‘(A) the availability or scope of exclusivity under— 

‘‘(i) this section; 

‘‘(ii) section 505 for pediatric formulations; or 

‘‘(iii) section 527; 

‘‘(B) the availability or scope of an extension to any 

such exclusivity, including an extension under this section 

or section 505E; 

21 USC 360cc 

note. 

Publication. 

Summary. 

Notification. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1051 

‘‘(C) the question of the eligibility for approval under 

section 505 of any application described in subsection (b)(2) 

or (j) of such section that omits any other aspect of labeling 

protected by exclusivity under— 

‘‘(i) clause (iii) or (iv) of section 505(j)(5)(F); 

‘‘(ii) clause (iii) or (iv) of section 505(c)(3)(E); or 

‘‘(iii) section 527(a); or 

‘‘(D) except as expressly provided in paragraphs (1) 

and (2), the operation of section 505 or section 527.’’. 

SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF 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— 

(1) will lower the cost of prescription drugs for consumers 

and reduce the burden of such cost on taxpayers; and 

(2) in lowering such cost, will— 

(A) balance the need to encourage innovation with 

the need to improve affordability; and 

(B) strive to increase competition in the pharmaceutical 

market, prevent anticompetitive behavior, and promote the 

timely availability of affordable, high-quality generic drugs 

and biosimilars. 

SEC. 610. EXPANDED ACCESS. 

(a) PATIENT ACCESS TO INVESTIGATIONAL DRUGS.— (1) PUBLIC MEETING.— (A) IN GENERAL.—The Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’), 

acting through the Commissioner of Food and Drugs, in 

coordination with the Director of the National Institutes 

of Health, and in consultation with patients, health care 

providers, drug sponsors, bioethicists, and other stakeholders, shall, not later than 270 days after the date of 

enactment of this Act, convene a public meeting to discuss 

clinical trial inclusion and exclusion criteria to inform the 

guidance under paragraph (3). The Secretary shall inform 

the Comptroller General of the United States of the date 

when the public meeting will take place. 

(B) TOPICS.—The Secretary shall make available on 

the internet website of the Food and Drug Administration 

a report on the topics discussed at the meeting described 

in subparagraph (A) within 90 days of such meeting. Such 

topics shall include discussion of— 

(i) the rationale for, and potential barriers for 

patients created by, research clinical trial inclusion 

and exclusion criteria; 

(ii) how appropriate patient populations can benefit from the results of trials that employ alternative 

designs; 

(iii) barriers to participation in clinical trials, 

including— 

(I) information regarding any potential risks 

and benefits of participation; 

(II) regulatory, geographical, and socioeconomic barriers; and 

Web posting. 

Reports. 

Deadline. 

Coordination. 

Consultation. 

Deadline. 

21 USC 360bbb 

note. 

131 STAT. 1052 PUBLIC LAW 115–52—AUG. 18, 2017 

(III) the impact of exclusion criteria on the 

enrollment in clinical trials of particular populations, including infants and children, pregnant 

and lactating women, seniors, individuals with 

advanced disease, and individuals with co-morbid 

conditions; 

(iv) clinical trial designs and methods, including 

expanded access trials, that increase enrollment of 

more diverse patient populations, when appropriate, 

while facilitating the collection of data to establish 

safe use and support substantial evidence of effectiveness, including data obtained from expanded access 

trials; and 

(v) how changes to clinical trial inclusion and 

exclusion criteria may impact the complexity and 

length of clinical trials, the data necessary to demonstrate safety and effectiveness, and potential 

approaches to mitigating those impacts. 

(2) REPORT.—Not later than 1 year after the Secretary 

issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on 

Health, Education, Labor, and Pensions of the Senate and 

the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs 

through the expanded access program under section 561(b) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

360bbb(b)). The report shall include— 

(A) a description of actions taken by manufacturers 

and distributors under section 561A of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360bbb–0); 

(B) consideration of whether Form FDA 3926 and the 

guidance documents titled ‘‘Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers’’ 

and ‘‘Individual Patient Expanded Access Applications: 

Form FDA 3926’’, issued by the Food and Drug Administration in June 2016, have reduced application burden with 

respect to individuals and physicians seeking access to 

investigational new drugs pursuant to section 561(b) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

360bbb) and improved clarity for patients, physicians, and 

drug manufacturers about such process; 

(C) consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved 

access for individual patients to investigational drugs who 

do not qualify for clinical trials of such investigational 

drugs, and what barriers to such access remain; 

(D) an assessment of methods patients and health 

care providers use to engage with the Food and Drug 

Administration or drug sponsors on expanded access; and 

(E) an analysis of the Secretary’s report under paragraph (1)(B). 

(3) GUIDANCE.— 

(A) IN GENERAL.—Not later than 1 year after the 

publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and 

Drugs, shall issue one or more draft guidances regarding 

Deadlines. 

Analysis. 

Assessment. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1053 

eligibility criteria for clinical trials. Not later than 1 year 

after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance. 

(B) CONTENTS.—The guidance documents described in 

subparagraph (A) shall address methodological approaches 

that a manufacturer or sponsor of an investigation of a 

new drug may take to— 

(i) broaden eligibility criteria for clinical trials and 

expanded access trials, especially with respect to drugs 

for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical 

need; 

(ii) develop eligibility criteria for, and increase trial 

recruitment to, clinical trials so that enrollment in 

such trials more accurately reflects the patients most 

likely to receive the drug, as applicable and as appropriate, while establishing safe use and supporting 

findings of substantial evidence of effectiveness; and 

(iii) use the criteria described in clauses (i) and 

(ii) in a manner that is appropriate for drugs intended 

for the treatment of rare diseases or conditions. 

(b) IMPROVING INSTITUTIONAL REVIEW BOARD REVIEW OF

SINGLE PATIENT EXPANDED ACCESS PROTOCOL.—Not later than 1 

year after the date of enactment of this Act, the Secretary, acting 

through the Commissioner of Food and Drugs, shall issue guidance 

or regulations, or revise existing guidance or regulations, to streamline the institutional review board review of individual patient 

expanded access protocols submitted under 561(b) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate 

the use of expanded access protocols, any guidance or regulations 

so issued or revised may include a description of the process for 

any person acting through a physician licensed in accordance with 

State law to request that an institutional review board chair (or 

designated member of the institutional review board) review a 

single patient expanded access protocol submitted under such section 561(b) for a drug. The Secretary shall update any relevant 

forms associated with individual patient expanded access requests 

under such section 561(b) as necessary. 

(c) EXPANDED ACCESS POLICY TRANSPARENCY.—Section 561A(f) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

0(f)) is amended— 

(1) in the matter preceding paragraph (1), by striking 

‘‘later’’ and inserting ‘‘earlier’’; 

(2) by striking paragraph (1); 

(3) by redesignating paragraph (2) as paragraph (1); 

(4) in paragraph (1) as so redesignated, by striking the 

period at the end and inserting ‘‘; or’’; and 

(5) by adding at the end the following: 

‘‘(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 506.’’. 

Time period. 

Update. 

Deadline. 

Guidance. 

21 USC 360bbb 

note. 

131 STAT. 1054 PUBLIC LAW 115–52—AUG. 18, 2017 

SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION. 

(a) IN GENERAL.—Subparagraph (A) of section 524(a)(4) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is 

amended— 

(1) in clause (i), by striking ‘‘and’’ at the end; and 

(2) by adding at the end the following: 

‘‘(iii) that contains reports of one or more new 

clinical investigations (other than bioavailability 

studies) that are essential to the approval of the 

application and conducted or sponsored by the sponsor 

of such application; and 

‘‘(iv) that contains an attestation from the sponsor 

of the application that such reports were not submitted 

as part of an application for marketing approval or 

licensure by a regulatory authority in India, Brazil, 

Thailand, or any country that is a member of the 

Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.’’. 

(b) EFFECTIVE DATE.—The amendments made by subsection 

(a) shall apply to human drug applications submitted after September 30, 2017. 

TITLE VII—DEVICE INSPECTION AND 

REGULATORY IMPROVEMENTS 

SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES. 

(a) IN GENERAL.—Section 510(h) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360(h)) is amended— 

(1) by striking paragraph (2) and inserting the following: 

‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 

‘‘(A) IN GENERAL.—The Secretary, acting through one 

or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph 

(1) that are engaged in the manufacture, propagation, 

compounding, or processing of a device or devices (referred 

to in this subsection as ‘device establishments’) in accordance with a risk-based schedule established by the Secretary. 

‘‘(B) FACTORS AND CONSIDERATIONS.—In establishing 

the risk-based schedule under subparagraph (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 international device 

audit programs in which the United States participates 

or the United States recognizes for purposes of 

inspecting device establishments.’’; and 

(2) in paragraph (4)— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘paragraph (3)’’ and inserting ‘‘paragraph (2) or 

(3)’’; and 

Applicability. 

21 USC 360n 

note. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1055 

(B) in subparagraph (C), by inserting ‘‘or device’’ after 

‘‘drug’’. 

(b) FOREIGN INSPECTIONS.—Section 809(a)(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended 

by striking ‘‘section 510(h)(3)’’ and inserting ‘‘paragraph (2) or (3) 

of section 510(h)’’. 

SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE 

ESTABLISHMENTS. 

(a) IN GENERAL.—Section 704 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 374) is amended by adding at the end 

the following: 

‘‘(h)(1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable 

to inspections of domestic and foreign device establishments in 

effect as of the date of the enactment of this subsection, and 

update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such 

uniform processes and standards shall provide for— 

‘‘(A) exceptions to such processes and standards, as appropriate; 

‘‘(B) announcing the inspection of the establishment within 

a reasonable time before such inspection occurs, including by 

providing to the owner, operator, or agent in charge of the 

establishment a notification regarding the type and nature 

of the inspection; 

‘‘(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the 

officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of 

the establishment concerning appropriate working hours during 

the inspection, and, to the extent feasible, advance notice of 

some records that will be requested; and 

‘‘(D) regular communications during the inspection with 

the owner, operator, or agent in charge of the establishment 

regarding inspection status, which may be recorded by either 

party with advance notice and mutual consent. 

‘‘(2)(A) The Secretary shall, with respect to a request described 

in subparagraph (B), provide nonbinding feedback with respect 

to such request not later than 45 days after the Secretary receives 

such request. 

‘‘(B) A request described in this subparagraph is a request 

for feedback— 

‘‘(i) that is made by the owner, operator, or agent in charge 

of such establishment in a timely manner; and 

‘‘(ii) with respect to actions proposed to be taken by a 

device establishment in a response to a report received by 

such establishment pursuant to subsection (b) that involve a 

public health priority, that implicate systemic or major actions, 

or relate to emerging safety issues (as determined by the Secretary). 

‘‘(3) Nothing in this subsection affects the authority of the 

Secretary to conduct inspections otherwise permitted under this 

Act in order to ensure compliance with this Act.’’. 

(b) GUIDANCE.— (1) DRAFT GUIDANCE.—Not later than 18 months after the 

date of enactment of this Act, the Secretary of Health and 

Deadline. 

21 USC 374 note. 

Deadline. 

Review. 

131 STAT. 1056 PUBLIC LAW 115–52—AUG. 18, 2017 

Human Services, acting through the Commissioner of Food 

and Drugs, shall issue draft guidance that— 

(A) specifies how the Food and Drug Administration 

will implement the processes and standards described in 

paragraph (1) of subsection (h) of section 704 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added 

by subsection (a), and the requirements described in paragraph (2) of such subsection (h); 

(B) provides for standardized methods for communications described in such paragraphs; 

(C) establishes, with respect to inspections of both 

domestic and foreign device establishments (as referred 

to in section 510(h)(2) of the Federal Food, Drug, and 

Cosmetic Act, as amended by subsection (a)), a standard 

timeframe for such inspections— 

(i) that occurs over consecutive days; and 

(ii) to which each investigator conducting such an 

inspection shall adhere unless the investigator identifies to the establishment involved a reason that more 

time is needed to conduct such investigation; and 

(D) identifies practices for investigators and device 

establishments to facilitate the continuity of inspections 

of such establishments. 

(2) FINAL GUIDANCE.—Not later than 1 year after providing 

notice and opportunity for public comment on the draft guidance 

issued under paragraph (1), the Secretary of Health and Human 

Services shall issue final guidance to implement subsection 

(h) of section 704 of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 374), as added by subsection (a). 

(c) ADULTERATED DEVICES.—Subsection (j) of section 501 of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is 

amended by inserting ‘‘or device’’ after ‘‘drug’’. 

SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM. 

Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘October 1, 2017’’ 

and inserting ‘‘October 1, 2022’’. 

SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES. 

Subsection (e)(4) of section 801 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended— 

(1) by adding at the end the following: 

‘‘(E)(i)(I) If the Secretary denies a request for certification under 

subparagraph (A)(ii) with respect to a device manufactured in an 

establishment (foreign or domestic) registered under section 510, 

the Secretary shall provide in writing to the person seeking such 

certification the basis for such denial, and specifically identify the 

finding upon which such denial is based. 

‘‘(II) If the denial of a request as described in subclause (I) 

is based on grounds other than an injunction proceeding pursuant 

to section 302, seizure action pursuant to section 304, or a recall 

designated Class I or Class II pursuant to part 7, title 21, Code 

of Federal Regulations, and is based on the facility being out of 

compliance with part 820 of title 21, Code of Federal Regulations, 

the Secretary shall provide a substantive summary of the specific 

grounds for noncompliance identified by the Secretary. 

‘‘(III) With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary 

Summary. 

Deadline. 

Notice. 

Public 

information. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1057 

shall not deny a request for certification as described in subclause 

(I) with respect to a device based solely on the issuance of that 

report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report. 

‘‘(ii)(I) The Secretary shall provide a process for a person who 

is denied a certification as described in clause (i)(I) to request 

a review that conforms to the standards of section 517A(b). 

‘‘(II) Notwithstanding any previous review conducted pursuant 

to subclause (I), a person who has been denied a certification 

as described in clause (i)(I) may at any time request a review 

in order to present new information relating to actions taken by 

such person to address the reasons identified by the Secretary 

for the denial of certification, including evidence that corrective 

actions are being or have been implemented to address grounds 

for noncompliance identified by the Secretary. 

‘‘(III) Not later than 1 year after the date of enactment of 

the FDA Reauthorization Act of 2017, the Secretary shall issue 

guidance providing for a process to carry out this subparagraph. 

Not later than 1 year after the close of the comment period for 

such guidance, the Secretary shall issue final guidance. 

‘‘(iii)(I) Subject to subclause (II), this subparagraph applies 

to requests for certification on behalf of any device establishment 

registered under section 510, whether the establishment is located 

inside or outside of the United States, and regardless of whether 

such devices are to be exported from the United States. 

‘‘(II) If an establishment described in subclause (I) is not located 

within the United States and does not demonstrate that the devices 

manufactured, prepared, propagated, compounded, or processed at 

such establishment are to be exported from the United States, 

this subparagraph shall apply only if— 

‘‘(aa) the establishment has been inspected by the Secretary 

within 3 years of the date of the request; or 

‘‘(bb) the establishment participates in an audit program 

in which the United States participates or the United States 

recognizes, an audit under such program has been conducted, 

and the findings of such audit are provided to the Secretary 

within 3 years of the date of the request.’’; and 

(2) by moving the margins of subparagraphs (C) and (D) 

4 ems to the left. 

SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION. 

Section 704(g) of the Federal Food, Drug and Cosmetic Act 

(21 U.S.C. 374) is amended by adding at the end the following: 

‘‘(15)(A) Notwithstanding any other provision of this subsection, 

the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate 

international harmonization for purposes of conducting inspections 

of— 

‘‘(i) establishments that manufacture, prepare, propagate, 

compound, or process devices (other than types of devices 

licensed under section 351 of the Public Health Service Act), 

as required under section 510(h); or 

‘‘(ii) establishments required to register pursuant to section 

510(i). 

‘‘(B) Nothing in this paragraph affects— 

‘‘(i) the authority of the Secretary to inspect any device 

establishment pursuant to this Act; or 

Audits. 

Applicability. 

Deadlines. 

Applicability. 

Deadlines. 

Guidance. 

Review. 

131 STAT. 1058 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(ii) the authority of the Secretary to determine the official 

classification of an inspection.’’. 

SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING. 

(a) APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDICAL IMAGING DEVICES.—Section 520 of the Federal Food, Drug, 

and Cosmetic Act (42 U.S.C. 360j) is amended by adding at the 

end the following: 

‘‘(p) DIAGNOSTIC IMAGING DEVICES INTENDED FOR USE WITH

CONTRAST AGENTS.— 

‘‘(1) IN GENERAL.—The Secretary may, subject to the succeeding provisions of this subsection, approve an application 

(or a supplement to such an application) submitted under section 515 with respect to an applicable medical imaging device, 

or, in the case of an applicable medical imaging device for 

which a notification is submitted under section 510(k), may 

make a substantial equivalence determination with respect to 

an applicable medical imaging device, or may grant a request 

submitted under section 513(f)(2) for an applicable medical 

imaging device, if such application, notification, or request 

involves the use of a contrast agent that is not— 

‘‘(A) in a concentration, rate of administration, or route 

of administration that is different from those described 

in the approved labeling of the contrast agent, except that 

the Secretary may approve such application, make such 

substantial equivalence determination, or grant such 

request if the Secretary determines that such differences 

in concentration, rate of administration, or route of 

administration exist but do not adversely affect the safety 

and effectiveness of the contrast agent when used with 

the device; 

‘‘(B) in a region, organ, or system of the body that 

is different from those described in the approved labeling 

of the contrast agent, except that the Secretary may 

approve such application, make such substantial equivalence determination, or grant such request if the Secretary 

determines that such differences in region, organ, or system 

of the body exist but do not adversely affect the safety 

and effectiveness of the contrast agent when used with 

the device; 

‘‘(C) in a patient population that is different from those 

described in the approved labeling of the contrast agent, 

except that the Secretary may approve such application, 

make such substantial equivalence determination, or grant 

such request if the Secretary determines such differences 

in patient population exist but do not adversely affect the 

safety and effectiveness of the contrast agent when used 

with the device; or 

‘‘(D) in an imaging modality that is different from 

those described in the approved labeling of the contrast 

agent. 

‘‘(2) PREMARKET REVIEW.—The agency center charged with 

premarket review of devices shall have primary jurisdiction 

with respect to the review of an application, notification, or 

request described in paragraph (1). In conducting such review, 

such agency center may— 

Determinations. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1059 

‘‘(A) consult with the agency center charged with the 

premarket review of drugs or biological products; and 

‘‘(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application 

submitted under section 505 of this Act or section 351 

of the Public Health Service Act, so long as the sponsor 

of such contrast agent has provided to the sponsor of the 

applicable medical imaging device that is the subject of 

such review a right of reference and the application is 

submitted in accordance with this subsection. 

‘‘(3) APPLICABLE REQUIREMENTS.—An application submitted 

under section 515, a notification submitted under section 510(k), 

or a request submitted under section 513(f)(2), as described 

in paragraph (1), with respect to an applicable medical imaging 

device shall be subject to the requirements of such respective 

section. Such application, notification, or request shall only 

be subject to the requirements of this Act applicable to devices. 

‘‘(4) DEFINITIONS.—For purposes of this subsection— 

‘‘(A) the term ‘applicable medical imaging device’ means 

a device intended to be used in conjunction with a contrast 

agent (or class of contrast agents) for an imaging use 

that is not described in the approved labeling of such 

contrast agent (or the approved labeling of any contrast 

agent in the same class as such contrast agent); and 

‘‘(B) the term ‘contrast agent’ means a drug that is 

approved under section 505 or licensed under section 351 

of the Public Health Service Act, is intended for use in 

conjunction with an applicable medical imaging device, 

and— 

‘‘(i) is a diagnostic radiopharmaceutical, as defined 

in section 315.2 and 601.31 of title 21, Code of Federal 

Regulations (or any successor regulations); or 

‘‘(ii) is a diagnostic agent that improves the visualization of structure or function within the body by 

increasing the relative difference in signal intensity 

within the target tissue, structure, or fluid.’’. 

(b) APPLICATIONS FOR APPROVAL OF CONTRAST AGENTS

INTENDED FOR USE WITH CERTAIN DIAGNOSTIC MEDICAL IMAGING

DEVICES.—Section 505 of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355) is amended by adding at the end the following: 

‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH APPLICABLE

MEDICAL IMAGING DEVICES.— 

‘‘(1) IN GENERAL.—The sponsor of a contrast agent for which 

an application has been approved under this section may submit 

a supplement to the application seeking approval for a new 

use following the authorization of a premarket submission for 

an applicable medical imaging device for that use with the 

contrast agent pursuant to section 520(p)(1). 

‘‘(2) REVIEW OF SUPPLEMENT.—In reviewing a supplement 

submitted under this subsection, the agency center charged 

with the premarket review of drugs may— 

‘‘(A) consult with the center charged with the premarket review of devices; and 

‘‘(B) review information and data submitted to the 

Secretary by the sponsor of an applicable medical imaging 

device pursuant to section 515, 510(k), or 513(f)(2) so long 

as the sponsor of such applicable medical imaging device 

Consultation. 

131 STAT. 1060 PUBLIC LAW 115–52—AUG. 18, 2017 

has provided to the sponsor of the contrast agent a right 

of reference. 

‘‘(3) DEFINITIONS.—For purposes of this subsection— 

‘‘(A) the term ‘new use’ means a use of a contrast 

agent that is described in the approved labeling of an 

applicable medical imaging device described in section 

520(p), but that is not described in the approved labeling 

of the contrast agent; and 

‘‘(B) the terms ‘applicable medical imaging device’ and 

‘contrast agent’ have the meanings given such terms in 

section 520(p).’’. 

SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES. 

(a) IN GENERAL.—Subsection (f) of section 513 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 

adding at the end the following new paragraph: 

‘‘(6)(A) Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory 

under this section based on the risks of the accessory when used 

as intended and the level of regulatory controls necessary to provide 

a reasonable assurance of safety and effectiveness of the accessory, 

notwithstanding the classification of any other device with which 

such accessory is intended to be used. 

‘‘(B) The classification of any accessory distinct from another 

device by regulation or written order issued prior to December 

13, 2016, shall continue to apply unless and until the accessory 

is reclassified by the Secretary, notwithstanding the classification 

of any other device with which such accessory is intended to be 

used. Nothing in this paragraph shall preclude the Secretary’s 

authority to initiate the classification of an accessory through regulation or written order, as appropriate. 

‘‘(C)(i) In the case of a device intended to be used with an 

accessory, where the accessory has been included in an application 

for premarket approval of such device under section 515 or a report 

under section 510(k) for clearance of such device and the Secretary 

has not classified such accessory distinctly from another device 

in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report 

is filed— 

‘‘(I) may include a written request for the proper classification of the accessory pursuant to subparagraph (A); 

‘‘(II) shall include in any such request such information 

as may be necessary for the Secretary to evaluate, based on 

the least burdensome approach, the appropriate class for the 

accessory under subsection (a); and 

‘‘(III) shall, if the request under subclause (I) is requesting 

classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special 

controls would be required pursuant to subsection (a)(1)(B). 

‘‘(ii) The Secretary’s response under section 515(d) or section 

510(n) (as applicable) to an application or report described in clause 

(i) shall also contain the Secretary’s granting or denial of the 

request for classification of the accessory involved. 

‘‘(iii) The Secretary’s evaluation of an accessory under clause 

(i) shall constitute an order establishing a new classification for 

Evaluation. 

Applicability. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1061 

such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses 

as such accessory. 

‘‘(D) For accessories that have been granted marketing 

authorization as part of a submission for another device with which 

the accessory involved is intended to be used, through an application 

for such other device under section 515(c), a report under section 

510(k), or a request for classification under paragraph (2) of this 

subsection, the following shall apply: 

‘‘(i) Not later than the date that is one year after the 

date of enactment of the FDA Reauthorization Act of 2017 

and at least once every 5 years thereafter, and as the Secretary 

otherwise determines appropriate, pursuant to this paragraph, 

the Secretary shall publish in the Federal Register a notice 

proposing a list of such accessories that the Secretary determines may be suitable for a distinct classification in class 

I and the proposed regulations for such classifications. In developing such list, the Secretary shall consider recommendations 

from sponsors of device submissions and other stakeholders 

for accessories to be included on such list. The notices shall 

provide for a period of not less than 60 calendar days for 

public comment. Within 180 days after the end of the comment 

period, the Secretary shall publish in the Federal Register 

a final action classifying such suitable accessories into class 

I. 

‘‘(ii) A manufacturer or importer of an accessory that has 

been granted such marketing authorization may submit to the 

Secretary a written request for the appropriate classification 

of the accessory based on the risks and appropriate level of 

regulatory controls as described in subparagraph (A), and shall, 

if the request is requesting classification of the accessory in 

class II, include in the submission an initial draft proposal 

for special controls, if special controls would be required pursuant to subsection (a)(1)(B). Such request shall include such 

information as may be necessary for the Secretary to evaluate, 

based on the least burdensome approach, the appropriate class 

for the accessory under subsection (a). The Secretary shall 

provide an opportunity for a manufacturer or importer to meet 

with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory 

prior to submitting a written request under this clause for 

classification of the accessory. 

‘‘(iii) The Secretary shall respond to a request made under 

clause (ii) not later than 85 calendar days after receiving such 

request by issuing a written order classifying the accessory 

or denying the request. If the Secretary does not agree with 

the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed 

description and justification for such determination. Within 

30 calendar days after granting such a request, the Secretary 

shall publish a notice in the Federal Register announcing such 

response. 

‘‘(E) Nothing in this paragraph may be construed as precluding 

a manufacturer of an accessory of a new type from using the 

classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and 

requirements set forth in that subsection.’’. 

Federal Register, 

publication. 

Notice. 

Determination. 

Deadlines. 

Evaluation. 

Notices. 

Time period. 

Public 

information. 

Recommendations. 

Deadlines. 

Federal Register, 

publication. 

Notice. 

Lists. 

Applicability. 

131 STAT. 1062 PUBLIC LAW 115–52—AUG. 18, 2017 

(b) CONFORMING CHANGE.—Section 513(b) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking 

paragraph (9) (relating to classification of an accessory). 

(c) EFFECTIVE DATE.—The amendments made by subsections 

(a) and (b) shall take effect on the date that is 60 days after 

the date of enactment of this Act. 

SEC. 708. DEVICE PILOT PROJECTS. 

(a) POSTMARKET PILOT.—Section 519 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360i) is amended by adding at the 

end the following: 

‘‘(i) POSTMARKET PILOT.— ‘‘(1) IN GENERAL.—In order to provide timely and reliable 

information on the safety and effectiveness of devices approved 

under section 515, cleared under section 510(k), or classified 

under section 513(f)(2), including responses to adverse events 

and malfunctions, and to advance the objectives of part 803 

of title 21, Code of Federal Regulations (or successor regulations), and advance the objectives of, and evaluate innovative 

new methods of compliance with, this section and section 522, 

the Secretary shall, within one year of the date of enactment 

of the FDA Reauthorization Act of 2017, initiate one or more 

pilot projects for voluntary participation by a manufacturer 

or manufacturers of a device or device type, or continue existing 

projects, in accordance with paragraph (3), that— 

‘‘(A) are designed to efficiently generate reliable and 

timely safety and active surveillance data for use by the 

Secretary or manufacturers of the devices that are involved 

in the pilot project; 

‘‘(B) inform the development of methods, systems, data 

criteria, and programs that could be used to support safety 

and active surveillance activities for devices included or 

not included in such project; 

‘‘(C) may be designed and conducted in coordination 

with a comprehensive system for evaluating medical device 

technology that operates under a governing board with 

appropriate representation of stakeholders, including 

patient groups and device manufacturers; 

‘‘(D) use electronic health data including claims data, 

patient survey data, or any other data, as the Secretary 

determines appropriate; and 

‘‘(E) prioritize devices and device types that meet one 

or more of the following criteria: 

‘‘(i) Devices and device types for which the collection and analysis of real world evidence regarding a 

device’s safety and effectiveness is likely to advance 

public health. 

‘‘(ii) Devices and device types that are widely used. 

‘‘(iii) Devices and device types, the failure of which 

has significant health consequences. 

‘‘(iv) Devices and device types for which the Secretary— 

‘‘(I) has received public recommendations in 

accordance with paragraph (2)(B); and 

‘‘(II) has determined to meet one or more of 

the criteria under clause (i), (ii), or (iii) and is 

appropriate for such a pilot project. 

Deadline. 

21 USC 360c 

note. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1063 

‘‘(2) PARTICIPATION.—The Secretary shall establish the 

conditions and processes— 

‘‘(A) under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph (1); and 

‘‘(B) for facilitating public recommendations for devices 

to be prioritized under such a pilot project, including 

requirements for the data necessary to support such a 

recommendation. 

‘‘(3) CONTINUATION OF ONGOING PROJECTS.—The Secretary 

may continue or expand projects, with respect to providing 

timely and reliable information on the safety and effectiveness 

of devices approved under section 515, cleared under section 

510(k), or classified under section 513(f)(2), that are being carried out as of the date of the enactment of the FDA Reauthorization Act of 2017. The Secretary shall, beginning on such date 

of enactment, take such steps as may be necessary— 

‘‘(A) to ensure such projects meet the requirements 

of subparagraphs (A) through (E) of paragraph (1); and 

‘‘(B) to increase the voluntary participation in such 

projects of manufacturers of devices and facilitate public 

recommendations for any devices prioritized under such 

a project. 

‘‘(4) IMPLEMENTATION.— 

‘‘(A) CONTRACTING AUTHORITY.—The Secretary may 

carry out a pilot project meeting the criteria specified in 

subparagraphs (A) through (E) of paragraph (1) or a project 

continued or expanded under paragraph (3) by entering 

into contracts, cooperative agreements, grants, or other 

appropriate agreements with public or private entities that 

have a significant presence in the United States and meet 

the following conditions: 

‘‘(i) If such an entity is a component of another 

organization, the entity and the organization have 

established an agreement under which appropriate 

security measures are implemented to maintain the 

confidentiality and privacy of the data described in 

paragraph (1)(D) and such agreement ensures that 

the entity will not make an unauthorized disclosure 

of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such 

security measures. 

‘‘(ii) In the case of the termination or nonrenewal 

of such a contract, cooperative agreement, grant, or 

other appropriate agreement, the entity or entities 

involved shall comply with each of the following: 

‘‘(I) The entity or entities shall continue to 

comply with the requirements with respect to confidentiality and privacy referred to in clause (i) 

with respect to all data disclosed to the entity 

under such an agreement. 

‘‘(II) The entity or entities shall return any 

data disclosed to such entity pursuant to this subsection and to which it would not otherwise have 

access or, if returning such data is not practicable, 

destroy the data. 

Effective date. 

131 STAT. 1064 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(iii) The entity or entities shall have one or more 

qualifications with respect to— 

‘‘(I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including 

the capability and expertise to provide the Secretary access to de-identified data consistent with 

the requirements of this subsection; 

‘‘(II) an information technology infrastructure 

to support electronic data and operational standards to provide security for such data, as appropriate; 

‘‘(III) experience with, and expertise on, the 

development of research on, and surveillance of, 

device safety and effectiveness using electronic 

health data; or 

‘‘(IV) such other expertise which the Secretary 

determines necessary to carry out such a project. 

‘‘(B) REVIEW OF CONTRACT IN THE EVENT OF A MERGER

OR ACQUISITION.—The Secretary shall review any contract, 

cooperative agreement, grant, or other appropriate agreement entered into under this paragraph with an entity 

meeting the conditions specified in subparagraph (A) in 

the event of a merger or acquisition of the entity in order 

to ensure that the requirements specified in this subsection 

will continue to be met. 

‘‘(5) COMPLIANCE WITH REQUIREMENTS FOR RECORDS OR

REPORTS ON DEVICES.—The participation of a manufacturer in 

pilot projects under this subsection or a project continued or 

expanded under paragraph (3) shall not affect the eligibility 

of such manufacturer to participate in any quarterly reporting 

program with respect to devices carried out under this section 

519 or section 522. The Secretary may determine that, for 

a specified time period to be determined by the Secretary, 

a manufacturer’s participation in a pilot project under this 

subsection or a project continued or expanded under paragraph 

(3) may meet the applicable requirements of this section or 

section 522, if— 

‘‘(A) the project has demonstrated success in capturing 

relevant adverse event information; and 

‘‘(B) the Secretary has established procedures for 

making adverse event and safety information collected from 

such project public, to the extent possible. 

‘‘(6) PRIVACY REQUIREMENTS.—With respect to the disclosure of any health information collected through a project conducted under this subsection— 

‘‘(A) individually identifiable health information so collected shall not be disclosed when 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 Portability and Accountability Act of 

1996 (42 U.S.C. 1320d–2 note) and sections 552 and 552a 

of title 5, United States Code. 

‘‘(7) LIMITATIONS.—No pilot project under this subsection, 

or in coordination with the comprehensive system described 

in paragraph (1)(C), may allow for an entity participating in 

Determination. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1065 

such project, other than the Secretary, to make determinations 

of safety or effectiveness, or substantial equivalence, for purposes of this Act. 

‘‘(8) OTHER PROJECTS REQUIRED TO COMPLY.—Paragraphs 

(1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with 

respect to any pilot project undertaken in coordination with 

the comprehensive system described in paragraph (1)(C) that 

relates to the use of real world evidence for devices in the 

same manner and to the same extent as such paragraphs 

apply with respect to pilot projects conducted under this 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, Education, Labor and Pensions of the Senate a 

report containing a description of the pilot projects being conducted under this subsection and projects continued or 

expanded pursuant to paragraph (3), including for each such 

project— 

‘‘(A) how the project is being implemented in 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; 

‘‘(D) the devices or device categories involved in such 

project; 

‘‘(E) the number of patients involved in such project; 

and 

‘‘(F) the findings of the project in relation to device 

safety, including adverse events, malfunctions, and other 

safety information. 

‘‘(10) SUNSET.—The Secretary may not carry out a pilot 

project initiated by the Secretary under this subsection after 

October 1, 2022.’’. 

(b) REPORT.—Not later than January 31, 2021, the Secretary 

of Health and Human Services, acting through the Commissioner 

of Food and Drugs, shall conduct a review through an independent 

third party to evaluate the strengths, limitations, and appropriate 

use of evidence collected pursuant to real world evidence pilot 

projects described in the letters described in section 201(b) of the 

Medical Device User Fee Amendments of 2017 and subsection (i) 

of section 519 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360i), as amended by subsection (a), for informing premarket 

and postmarket decisionmaking for multiple device types, and to 

determine whether the methods, systems, and programs in such 

pilot projects efficiently generate reliable and timely evidence about 

the effectiveness or safety surveillance of devices. 

SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS. 

(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further 

amended by adding at the end the following: 

‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING AIDS.— ‘‘(1) DEFINITION.— 

Review. 

Determination. 

Applicability. 

131 STAT. 1066 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(A) IN GENERAL.—In this subsection, the term ‘overthe-counter hearing aid’ means a device that— 

‘‘(i) uses the same fundamental scientific technology as air conduction hearing 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 section 874.3305 

of title 21, Code of Federal Regulations) (or any successor regulation); 

‘‘(ii) is intended to be used by adults age 18 and 

older to compensate for perceived mild to moderate 

hearing impairment; 

‘‘(iii) through tools, tests, or software, allows the 

user to control the over-the-counter hearing aid and 

customize it to the user’s hearing needs; 

‘‘(iv) may— 

‘‘(I) use wireless technology; or 

‘‘(II) include tests for self-assessment of 

hearing loss; and 

‘‘(v) is available over-the-counter, without the 

supervision, prescription, or other order, involvement, 

or intervention of a licensed person, to consumers 

through in-person transactions, by mail, or online. 

‘‘(B) EXCEPTION.—Such term does not include a personal sound amplification product intended to amplify 

sound for nonhearing impaired consumers in situations 

including hunting and bird-watching. 

‘‘(2) REGULATION.—An over-the-counter hearing aid shall 

be subject to the regulations promulgated in accordance with 

section 709(b) of the FDA Reauthorization Act of 2017 and 

shall be exempt from sections 801.420 and 801.421 of title 

21, Code of Federal Regulations (or any successor regulations).’’. 

(b) REGULATIONS TO ESTABLISH CATEGORY.— 

(1) IN GENERAL.—The Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’), not 

later than 3 years after the date of enactment of this Act, 

shall promulgate proposed regulations to establish a category 

of over-the-counter hearing aids, as defined in subsection (q) 

of section 520 of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360j) as amended by subsection (a), and, not later 

than 180 days after the date on which the public comment 

period on the proposed regulations closes, shall issue such 

final regulations. 

(2) REQUIREMENTS.—In promulgating the regulations under 

paragraph (1), the Secretary shall— 

(A) include requirements that provide reasonable 

assurances of the safety and effectiveness of over-thecounter hearing aids; 

(B) include requirements that establish or adopt output 

limits appropriate for over-the-counter hearing aids; 

(C) include requirements for appropriate labeling of 

over-the-counter hearing aids, including requirements that 

such labeling include a conspicuous statement that the 

device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of 

medically treatable causes of hearing loss, and advisements 

Deadlines. 

21 USC 360j 

note. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1067 

to consult promptly with a licensed health care practitioner; 

and 

(D) describe the requirements under which the sale 

of over-the-counter hearing aids is permitted, without the 

supervision, prescription, or other order, involvement, or 

intervention of a licensed person, to consumers through 

in-person transactions, by mail, or online. 

(3) PREMARKET NOTIFICATION.—The Secretary shall make 

findings under section 510(m) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360(m)) to determine whether overthe-counter hearing aids (as defined in section 520(q) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 

amended by subsection (a)) require a report under section 

510(k) to provide reasonable assurance of safety and effectiveness. 

(4) EFFECT ON STATE LAW.—No State or local government 

shall establish or continue in effect any law, regulation, order, 

or other requirement specifically related to hearing products 

that would restrict or interfere with the servicing, marketing, 

sale, dispensing, use, customer support, or distribution of overthe-counter hearing aids (as defined in section 520(q) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 

amended by subsection (a)) through in-person transactions, by 

mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this 

subsection, including any State or local requirement for the 

supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access overthe-counter hearing aids. 

(5) NO EFFECT ON PRIVATE REMEDIES.—Nothing in this 

section shall be construed to modify or otherwise affect the 

ability of any person to exercise a private right of action under 

any State or Federal product liability, tort, warranty, contract, 

or consumer protection law. 

(c) NEW GUIDANCE ISSUED.—Not later than the date on which 

final regulations are issued under subsection (b), the Secretary 

shall update and finalize the draft guidance of the Department 

of Health and Human Services entitled ‘‘Regulatory Requirements 

for Hearing Aid Devices and Personal Sound Amplification Products’’, issued on November 7, 2013. Such updated and finalized 

guidance shall clarify which products, on the basis of claims or 

other marketing, advertising, or labeling material, meet the 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 in subsection (q)(1) of section 520 of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)). 

SEC. 710. REPORT ON SERVICING OF DEVICES. 

(a) IN GENERAL.—Not later than 270 days after the date of 

enactment of this Act, the Secretary of Health and Human Services, 

acting through the Commissioner of Food and Drugs, shall post 

Deadline. 

Update. 

Determination. 

131 STAT. 1068 PUBLIC LAW 115–52—AUG. 18, 2017 

on the internet website of the Food and Drug Administration a 

report on the continued quality, safety, and effectiveness of devices 

(as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) with respect to servicing (as defined 

in subsection (c)). 

(b) CONTENTS.—The report submitted under subsection (a) shall 

contain— 

(1) the status of, and findings to date, with respect to, 

the proposed rule entitled ‘‘Refurbishing, Reconditioning, 

Rebuilding, Remarketing, Remanufacturing, and Servicing of 

Medical Devices Performed by Third-Party Entities and 

Original Equipment Manufacturers; Request for Comments’’ 

published in the Federal Register by the Food and Drug 

Administration on March 4, 2016 (81 Fed. Reg. 11477); 

(2) information presented during the October 2016 public 

workshop entitled ‘‘Refurbishing, Reconditioning, Rebuilding, 

Remarketing, Remanufacturing, and Servicing of Medical 

Devices Performed by Third-Party Entities and Original Equipment Manufacturers’’; 

(3) a description of the statutory and regulatory authority 

of the Food and Drug Administration with respect to the servicing of devices conducted by any entity, including original 

equipment manufacturers and third party entities; 

(4) details regarding how the Food and Drug Administration currently regulates devices with respect to servicing to 

ensure safety and effectiveness, how the agency could improve 

such regulation using the authority described in paragraph 

(3), and whether additional authority is recommended; 

(5) information on actions the Food and Drug Administration could take under the authority described in paragraphs 

(3) and (4) to assess the servicing of devices, including the 

size, scope, location, and composition of third party entities; 

(6) information on actions the Food and Drug Administration could take to track adverse events caused by servicing 

errors performed by any entity, including original equipment 

manufacturers and third party entities; 

(7) information regarding the regulation by States, the 

Joint Commission, or other regulatory bodies of device servicing 

performed by any entity, including original equipment manufacturers and third party entities; and 

(8) any additional information determined by the Secretary 

(acting through the Commissioner) to be relevant to ensuring 

the quality, safety, and effectiveness of devices with respect 

to servicing. 

(c) SERVICING DEFINED.—In this section, the term ‘‘servicing’’ 

includes, with respect to a device, refurbishing, reconditioning, 

rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device. 

TITLE VIII—IMPROVING GENERIC DRUG 

ACCESS 

SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS. 

Section 505(j) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(j)) is amended by adding at the end the following: 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1069 

‘‘(11)(A) Subject to subparagraph (B), the Secretary shall 

prioritize the review of, and act within 8 months of the date of 

the submission of, an original abbreviated new drug application 

submitted for review under this subsection that is for a drug— 

‘‘(i) for which there are not more than 3 approved drug 

products listed under paragraph (7) and for which there are 

no blocking patents and exclusivities; or 

‘‘(ii) that has been included on the list under section 506E. 

‘‘(B) To qualify for priority review under this paragraph, not 

later than 60 days prior to the submission of an application 

described in subparagraph (A) or that the Secretary may prioritize 

pursuant to subparagraph (D), the applicant shall provide complete, 

accurate information regarding facilities involved in manufacturing 

processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application 

and sites or organizations involved in bioequivalence and clinical 

studies used to support the application, to enable the Secretary 

to make a determination regarding whether an inspection of a 

facility is necessary. Such information shall include the relevant 

(as determined by the Secretary) sections of such application, which 

shall be unchanged relative to the date of the submission of such 

application, except to the extent that a change is made to such 

information to exclude a facility that was not used to generate 

data to meet any application requirements for such submission 

and that is not the only facility intended to conduct one or more 

unit operations in commercial production. Information provided by 

an applicant under this subparagraph shall not be considered the 

submission of an application under this subsection. 

‘‘(C) The Secretary may expedite an inspection or reinspection 

under section 704 of an establishment that proposes to manufacture 

a drug described in subparagraph (A). 

‘‘(D) Nothing in this paragraph shall prevent the Secretary 

from prioritizing the review of other applications as the Secretary 

determines appropriate. 

‘‘(12) The Secretary shall publish on the internet website of 

the Food and Drug Administration, and update at least once every 

6 months, a list of all drugs approved under subsection (c) for 

which all patents and periods of exclusivity under this Act have 

expired and for which no application has been approved under 

this subsection.’’. 

SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE 

GENERIC COMPETITION. 

Section 505(j) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355), as amended by section 801, is further amended 

by adding at the end the following: 

‘‘(13) Upon the request of an applicant regarding one or more 

specified pending applications under this subsection, the Secretary 

shall, as appropriate, provide review status updates indicating the 

categorical status of the applications by each relevant review discipline.’’. 

SEC. 803. COMPETITIVE GENERIC THERAPIES. 

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 

section 506G the following: 

Review. 

Updates. 

Web posting. 

Update. 

Deadline. 

Lists. 

Determination. 

Deadlines. 

131 STAT. 1070 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘SEC. 506H. COMPETITIVE GENERIC THERAPIES. 

‘‘(a) IN GENERAL.—The Secretary may, at the request of an 

applicant of a drug that is designated as a competitive generic 

therapy pursuant to subsection (b), expedite the development and 

review of an abbreviated new drug application under section 505(j) 

for such drug. 

‘‘(b) DESIGNATION PROCESS.— ‘‘(1) REQUEST.—The applicant may request the Secretary 

to designate the drug as a competitive generic therapy. 

‘‘(2) TIMING.—A request under paragraph (1) may be made 

concurrently with, or at any time prior to, the submission 

of an abbreviated new drug application for the drug under 

section 505(j). 

‘‘(3) CRITERIA.—A drug is eligible for designation as a 

competitive generic therapy under this section if the Secretary 

determines that there is inadequate generic competition. 

‘‘(4) DESIGNATION.—Not later than 60 calendar days after 

the receipt of a request under paragraph (1), the Secretary 

may— 

‘‘(A) determine whether the drug that is the subject 

of the request meets the criteria described in paragraph 

(3); and 

‘‘(B) if the Secretary finds that the drug meets such 

criteria, designate the drug as a competitive generic 

therapy. 

‘‘(c) ACTIONS.—In expediting the development and review of 

an application under subsection (a), the Secretary may, as requested 

by the applicant, take actions including the following: 

‘‘(1) Hold meetings with the applicant and the review team 

throughout the development of the drug prior to submission 

of the application for such drug under section 505(j). 

‘‘(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug 

to ensure that the development program to gather the data 

necessary for approval is as efficient as practicable. 

‘‘(3) Involve senior managers and experienced review staff, 

as appropriate, in a collaborative, coordinated review of such 

application, including with respect to drug-device combination 

products and other complex products. 

‘‘(4) Assign a cross-disciplinary project lead— 

‘‘(A) to facilitate an efficient review of the development 

program and application, including manufacturing inspections; and 

‘‘(B) to serve as a scientific liaison between the review 

team and the applicant. 

‘‘(d) REPORTING REQUIREMENT.—Not later than one year after 

the date of the approval of an application under section 505(j) 

with respect to a drug for which the development and review 

is expedited under this section, the sponsor of such drug shall 

report to the Secretary on whether the drug has been marketed 

in interstate commerce since the date of such approval. 

‘‘(e) DEFINITIONS.—In this section: 

‘‘(1) The term ‘generic drug’ means a drug that is approved 

pursuant to section 505(j). 

‘‘(2) The term ‘inadequate generic competition’ means, with 

respect to a drug, there is not more than one approved drugs 

on the list of drugs described in section 505(j)(7)(A) (not 

Deadline. 

21 USC 356h. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1071 

including drugs on the discontinued section of such list) that 

is— 

‘‘(A) the reference listed drug; or 

‘‘(B) a generic drug with the same reference listed 

drug as the drug for which designation as a competitive 

generic therapy is sought. 

‘‘(3) The term ‘reference listed drug’ means the listed drug 

(as such term is used in section 505(j)) for the drug involved.’’. 

(b) GUIDANCE; AMENDED REGULATIONS.— (1) IN GENERAL.— (A) ISSUANCE.—The Secretary of Health and Human 

Services shall— 

(i) not later than 18 months after the date of 

enactment of this Act, issue draft guidance on section 

506H of the Federal Food, Drug, and Cosmetic Act, 

as added by subsection (a); and 

(ii) not later than 1 year after the close of the 

comment period for the draft guidance, issue final guidance on such section 506H. 

(B) CONTENTS.—The guidance issued under this paragraph shall— 

(i) specify the process and criteria by which the 

Secretary makes a designation under section 506H of 

the Federal Food, Drug, and Cosmetic Act, as added 

by subsection (a); 

(ii) specify the actions the Secretary may take 

to expedite the development and review of a competitive generic therapy pursuant to such a designation; 

and 

(iii) include good review management practices for 

competitive generic therapies. 

(2) AMENDED REGULATIONS.—The Secretary of Health and 

Human Services shall issue or revise any regulations as may 

be necessary to carry out this section not later than 2 years 

after the date of enactment of this Act. 

SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED 

COMPETITION. 

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 351 et seq.) is amended by inserting after section 506H, 

as added by section 803, the following: 

‘‘SEC. 506I. PROMPT REPORTS OF MARKETING STATUS. 

‘‘(a) NOTIFICATION OF WITHDRAWAL.—The holder of an application approved under subsection (c) or (j) of section 505 shall notify 

the Secretary in writing 180 days prior to withdrawing the approved 

drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall 

include with such notice the— 

‘‘(1) National Drug Code; 

‘‘(2) identity of the drug by established name and by proprietary name, if any; 

‘‘(3) new drug application number or abbreviated application number; 

‘‘(4) strength of the drug; 

‘‘(5) date on which the drug is expected to no longer be 

available for sale; and 

‘‘(6) reason for withdrawal of the drug. 

21 USC 356i. 

Deadlines. 

21 USC 356h 

note. 

131 STAT. 1072 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(b) NOTIFICATION OF DRUG NOT AVAILABLE FOR SALE.—The 

holder of an application approved under subsection (c) or (j) shall 

notify the Secretary in writing within 180 calendar days of the 

date of approval of the drug if the drug will not be available 

for sale within 180 calendar days of such date of approval. The 

holder shall include with such notice the— 

‘‘(1) identity of the drug by established name and by proprietary name, if any; 

‘‘(2) new drug application number or abbreviated application number; 

‘‘(3) strength of the drug; 

‘‘(4) date on which the drug will be available for sale, 

if known; and 

‘‘(5) reason for not marketing the drug after approval. 

‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 days of the 

date of enactment of this section, all holders of applications 

approved under subsection (c) or (j) of section 505 shall review 

the information in the list published under subsection 505(j)(7)(A) 

and shall notify the Secretary in writing that— 

‘‘(1) all of the application holder’s drugs in the active section 

of the list published under subsection 505(j)(7)(A) are available 

for sale; or 

‘‘(2) one or more of the application holder’s drugs in the 

active section of the list published under subsection 505(j)(7)(A) 

have been withdrawn from sale or have never been available 

for sale, and include with such notice the information required 

pursuant to subsection (a) or (b), as applicable. 

‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a holder of an 

approved application fails to submit the information required under 

subsection (a), (b), or (c), the Secretary may move the application 

holder’s drugs from the active section of the list published under 

subsection 505(j)(7)(A) to the discontinued section of the list, except 

that the Secretary shall remove from the list in accordance with 

subsection 505(j)(7)(C) drugs the Secretary determines have been 

withdrawn from sale for reasons of safety of effectiveness. 

‘‘(e) UPDATES.—The Secretary shall update the list published 

under subsection 505(j)(7)(A) based on the information provided 

under subsections (a), (b), and (c) by moving drugs that are not 

available for sale from the active section to the discontinued section 

of the list, except that drugs the Secretary determines have been 

withdrawn from sale for reasons of safety or effectiveness shall 

be removed from the list in accordance with subsection 505(j)(7)(C). 

The Secretary shall make monthly updates to the list based on 

the information provided pursuant to subsections (a) and (b), and 

shall update the list based on the information provided under 

subsection (c) as soon as practicable. 

‘‘(f) LIMITATION ON USE OF NOTICES.—Any notice submitted 

under this section shall not be made public by the Secretary and 

shall be used solely for the purpose of the updates described in 

subsection (e).’’. 

SEC. 805. SUITABILITY PETITIONS. 

(a) IN GENERAL.—It is the sense of Congress that the Food 

and Drug Administration shall meet the requirement under section 

505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

Deadline. 

Lists. 

Deadline. 

Lists. 

Review. 

Notification. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1073 

355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of 

submission. 

(b) REPORT.—The Secretary of Health and Human Services 

shall include in the annual reports under section 807— 

(1) the number of pending petitions under section 

505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 355(j)(2)(C)); and 

(2) the number of such petitions pending a substantive 

response for more than 180 days from the date of receipt. 

SEC. 806. INSPECTIONS. 

Within 6 months of the date of enactment of this Act, the 

Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports 

of observations from an inspection under section 704 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall— 

(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355)— 

(A) for which the approval is dependent upon remediation of conditions identified in the report; 

(B) for which concerns related to observations from 

an inspection under such section 704 are the only barrier 

to approval; and 

(C) where the drug that is the subject of the application 

is a drug— 

(i) for which there are not more than 3 other 

approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 

that reference the same listed drug and for which 

there are less than 6 abbreviated new drug applications 

tentatively approved; or 

(ii) that is included on the list under section 506E 

of such Act (21 U.S.C. 356e); 

(2) address expedited re-inspection of facilities, as appropriate; and 

(3) establish a 6-month timeline for completion of review 

of such responses to such reports. 

SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS 

AND PRIORITY REVIEW APPLICATIONS. 

Not later than 180 calendar days after the date of enactment 

of this Act, and quarterly thereafter until October 1, 2022, the 

Secretary of Health and Human Services shall post on the internet 

website of the Food and Drug Administration a report that provides, 

with respect to the months covered by the report— 

(1) with respect to applications filed under section 505(j) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 

that, during the most recent calendar year, were subject to 

priority review under paragraph (11) of such section 505(j) 

(as added by section 801) or expedited development and review 

under section 506H of the Federal Food, Drug, and Cosmetic 

Act (as added by section 803), the numbers of such applications 

(with denotation of such applications that were filed prior to 

October 1, 2014) that are— 

(A) awaiting action by the applicant; 

(B) awaiting action by the Secretary; and 

Web posting. 

Time period. 

Applicability. 

Deadline. 

Protocols. 

Review. 

21 USC 374 note. 

131 STAT. 1074 PUBLIC LAW 115–52—AUG. 18, 2017 

(C) approved by the Secretary; 

(2) the number of applications filed under section 505(j) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 

and prior approval supplements withdrawn in each month; 

(3) the mean and median approval and tentative approval 

times and the number of review cycles for such applications; 

(4) the number and type of meetings requested and held 

under such section 506H (as added by section 803); and 

(5) the number of such applications on which the Secretary 

has taken action pursuant to subsection (c) of such section 

506H (as added by section 803) and any effect such section 

506H may have on the length of time for approval of applications under such section 505(j) and the number of review cycles 

for such approvals. 

SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT. 

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(j)(5)) is amended— 

(1) in subparagraph (B), by adding at the end the following: 

‘‘(v) 180-DAY EXCLUSIVITY PERIOD FOR COMPETITIVE GENERIC

THERAPIES.— 

‘‘(I) EFFECTIVENESS OF APPLICATION.—Subject to 

subparagraph (D)(iv), if the application is for a drug that 

is the same as a competitive generic therapy for which 

any first approved applicant has commenced commercial 

marketing, the application shall be made effective on the 

date that is 180 days after the date of the first commercial 

marketing of the competitive generic therapy (including 

the commercial marketing of the listed drug) by any first 

approved applicant. 

‘‘(II) LIMITATION.—The exclusivity period under subclause (I) shall not apply with respect to a competitive 

generic therapy that has previously received an exclusivity 

period under subclause (I). 

‘‘(III) DEFINITIONS.—In this clause and subparagraph 

(D)(iv): 

‘‘(aa) The term ‘competitive generic therapy’ means 

a drug— 

‘‘(AA) that is designated as a competitive 

generic therapy under section 506H; and 

‘‘(BB) for which there are no unexpired patents 

or exclusivities on the list of products described 

in section 505(j)(7)(A) at the time of submission. 

‘‘(bb) The term ‘first approved applicant’ means 

any applicant that has submitted an application that— 

‘‘(AA) is for a competitive generic therapy that 

is approved on the first day on which any application for such competitive generic therapy is 

approved; 

‘‘(BB) is not eligible for a 180-day exclusivity 

period under clause (iv) for the drug that is the 

subject of the application for the competitive 

generic therapy; and 

‘‘(CC) is not for a drug for which all drug 

versions have forfeited eligibility for a 180-day 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1075 

exclusivity period under clause (iv) pursuant to 

subparagraph (D).’’; and 

(2) in subparagraph (D), by adding at the end the following: 

‘‘(iv) SPECIAL FORFEITURE RULE FOR COMPETITIVE

GENERIC THERAPY.—The 180-day exclusivity period 

described in subparagraph (B)(v) shall be forfeited by 

a first approved applicant if the applicant fails to 

market the competitive generic therapy within 75 days 

after the date on which the approval of the first 

approved applicant’s application for the competitive 

generic therapy is made effective.’’. 

SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS 

OF GENERIC MEDICINES. 

(a) STUDY BY GAO.—The Comptroller General of the United 

States shall conduct a study to determine the following: 

(1) The rate of first cycle approvals and tentative approvals 

for applications submitted under section 505(j) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the 

period beginning on October 1, 2012, and ending on September 

30, 2017. The rate of first cycle approvals and tentative 

approvals shall be determined and reported per each GDUFA 

cohort year during this period. 

(2) If the rate determined pursuant to paragraph (1) for 

any GDUFA cohort year is lower than 20 percent, the reasons 

contributing to the relatively low rate of first cycle approvals 

and tentative approvals for generic drug applications shall be 

itemized, assessed, and reported. In making the assessment 

required by this paragraph, the Comptroller General shall consider, among other things, the role played by— 

(A) the Food and Drug Administration’s implementation of approval standards for generic drug applications; 

(B) the extent to which those approval standards are 

communicated clearly to industry and applied consistently 

during the review process; 

(C) the procedures for reviewing generic drug applications, including timelines for review activities by the Food 

and Drug Administration; 

(D) the extent to which those procedures are followed 

consistently (and those timelines are met) by the Food 

and Drug Administration; 

(E) the processes and practices for communication 

between the Food and Drug Administration and sponsors 

of generic drug applications; and 

(F) the completeness and quality of original generic 

drug applications submitted to the Food and Drug Administration. 

(3) Taking into account the determinations made pursuant 

to paragraphs (1) and (2) and any review process improvements 

implemented pursuant to this Act, whether there are ways 

the review process for generic drugs could be improved to 

increase the rate of first cycle approvals and tentative approvals 

for generic drug applications. In making this determination, 

the Comptroller General shall consider, among other things, 

options for increasing review efficiency and communication 

effectiveness. 

Assessment. 

Time period. 

Determination. 

Deadline. 

131 STAT. 1076 PUBLIC LAW 115–52—AUG. 18, 2017 

(b) COMPLETION DATE.—Not later than the expiration of the 

2-year period beginning on the date of enactment of this Act, 

the Comptroller General shall complete the study under subsection 

(a) and submit a report describing the findings and conclusions 

of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on 

Health, Education, Labor, and Pensions of the Senate. 

(c) DEFINITIONS.—For purposes of this section: 

(1) The term ‘‘GDUFA cohort year’’ means a fiscal year. 

(2) The term ‘‘generic drug’’ means a drug that is approved 

or is seeking approval under section 505(j) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355(j)). 

(3) The term ‘‘generic drug application’’ means an abbreviated new drug application for the approval of a generic drug 

under section 505(j) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(j)). 

(4) The term ‘‘Secretary’’ means the Secretary of Health 

and Human Services. 

(5)(A) The term ‘‘first cycle approvals and tentative 

approvals’’ means the approval or tentative approval of a 

generic drug application after the Food and Drug Administration’s complete review of the application and without issuance 

of one or more complete response letters. 

(B) For purposes of this paragraph, the term ‘‘complete 

response letter’’ means a written communication to the sponsor 

of a generic drug application or holder of a drug master file 

from the Food and Drug Administration describing all of the 

deficiencies that the Administration has identified in the 

generic drug application (including pending amendments) or 

drug master file that must be satisfactorily addressed before 

the generic drug application can be approved. 

TITLE IX—ADDITIONAL PROVISIONS 

SEC. 901. TECHNICAL CORRECTIONS. 

(a) Section 3075(a) of the 21st Century Cures Act (Public Law 

114–255) is amended— 

(1) in the matter preceding paragraph (1), by striking ‘‘as 

amended by section 2074’’ and inserting ‘‘as amended by section 

3102’’; and 

(2) in paragraph (2), by striking ‘‘section 2074(1)(C)’’ and 

inserting ‘‘section 3102(1)(C)’’. 

(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking ‘‘identity’’ 

and inserting ‘‘identify’’. 

(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355g(b)) is amended by striking ‘‘randomized’’ and 

inserting ‘‘traditional’’. 

(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355g(d)) is amended by striking ‘‘2’’ and inserting 

‘‘3’’. 

(e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360(h)(6)) is amended by striking ‘‘February 1’’ 

and replacing with ‘‘May 1’’. 

(f) Effective as of the enactment of the 21st Century Cures 

Act (Public Law 114–255)— 

Effective date. 

21 USC 360e–3 

and note. 

21 USC 355. 

Time period. 

Reports. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1077 

(1) section 3051(a) of such Act is amended by striking 

‘‘by inserting after section 515B’’ and inserting ‘‘by inserting 

after section 515A’’; and 

(2) section 515C of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360e–3), as inserted by such section 3051(a), 

is redesignated as section 515B. 

(g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360e–3(f)(2)), as redesignated by subsection (e)(2) 

of this section, is amended by striking ‘‘a proposed guidance’’ and 

inserting ‘‘a draft version of that guidance’’. 

(h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking ‘‘medical device 

submissions’’ and inserting ‘‘medical devices that may be specifically 

the subject of a review by a classification panel’’. 

SEC. 902. ANNUAL REPORT ON INSPECTIONS. 

Not later than March 1 of each year, the Secretary of Health 

and Human Services shall post on the internet website of the 

Food and Drug Administration information related to inspections 

of facilities necessary for approval of a drug under section 505 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), 

approval of a device under section 515 of such Act (21 U.S.C. 

360e), or clearance of a device under section 510(k) of such Act 

(21 U.S.C. 360(k)) that were conducted during the previous calendar 

year. Such information shall include the following: 

(1) The median time following a request from staff of the 

Food and Drug Administration reviewing an application or 

report to the beginning of the inspection, and the median time 

from the beginning of an inspection to the issuance of a report 

pursuant to section 704(b) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 374(b)). 

(2) The median time from the issuance of a report pursuant 

to such section 704(b) to the sending of a warning letter, 

issuance of an import alert, or holding of a regulatory meeting 

for inspections for which the Secretary concluded that regulatory or enforcement action was indicated. 

(3) The median time from the sending of a warning letter, 

issuance of an import alert, or holding of a regulatory meeting 

to resolution of the regulatory or enforcement action indicated 

for inspections for which the Secretary concluded that such 

action was indicated. 

(4) The number of times that a facility was issued a report 

pursuant to such section 704(b) and approval of an application 

was delayed due to the issuance of a withhold recommendation. 

SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING. 

(a) PDUFA.—Section 736B(a) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379h–2(a)), as amended by section 103, 

is further amended by inserting after paragraph (2) the following: 

‘‘(3) REAL TIME REPORTING.— 

‘‘(A) IN GENERAL.—Not later than 30 calendar days 

after the end of the second quarter of fiscal year 2018, 

and not later than 30 calendar days after the end of each 

quarter of each fiscal year thereafter, the Secretary shall 

post the data described in subparagraph (B) on the internet 

website of the Food and Drug Administration for such 

quarter and on a cumulative basis for such fiscal year, 

Web postings. 

Time periods. 

Web posting. 

21 USC 355 note. 

21 USC 360e–3. 

131 STAT. 1078 PUBLIC LAW 115–52—AUG. 18, 2017 

and may remove duplicative data from the annual performance report under this subsection. 

‘‘(B) DATA.—The Secretary shall post the following data 

in accordance with subparagraph (A): 

‘‘(i) The number and titles of draft and final guidance on topics related to the process for the review 

of human drug applications, and whether such guidances were issued as required by statute or pursuant 

to a commitment under the letters described in section 

101(b) of the Prescription Drug User Fee Amendments 

of 2017. 

‘‘(ii) The number and titles of public meetings held 

on topics related to the process for the review of human 

drug applications, and whether such meetings were 

required by statute or pursuant to a commitment under 

the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017. 

‘‘(iii) The number of new drug applications and 

biological licensing applications approved. 

‘‘(iv) The number of new drug applications and 

biological licensing applications filed. 

‘‘(4) RATIONALE FOR PDUFA PROGRAM CHANGES.—Beginning 

with fiscal year 2020, the Secretary shall include in the annual 

report under paragraph (1)— 

‘‘(A) data, analysis, and discussion of the changes in 

the number of full-time equivalents hired as agreed upon 

in the letters described in section 101(b) of the Prescription 

Drug User Fee Amendments of 2017 and the number of 

full time equivalents funded by budget authority at the 

Food and Drug Administration by each division within 

the Center for Drug Evaluation and Research, the Center 

for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; 

‘‘(B) data, analysis, and discussion of the changes in 

the fee revenue amounts and costs for the process for 

the review of human drugs, including identifying drivers 

of such changes; and 

‘‘(C) for each of the Center for Drug Evaluation and 

Research, the Center for Biologics Evaluation and 

Research, the Office of Regulatory Affairs, and the Office 

of the Commissioner, the number of employees for whom 

time reporting is required and the number of employees 

for whom time reporting is not required.’’. 

(b) MDUFA.—Section 738A(a)(1)(A) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), as amended by section 

204, is further amended— 

(1) by striking ‘‘Beginning with’’ and inserting the following: 

‘‘(i) GENERAL REQUIREMENTS.—Beginning with’’; 

and 

(2) by adding at the end the following: 

‘‘(ii) ADDITIONAL INFORMATION.—Beginning with 

fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for 

Devices and Radiological Health in achieving the goals, 

and future plans for meeting the goals, including— 

Effective date. 

Effective date. 

Analysis. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1079 

‘‘(I) the number of premarket applications filed 

under section 515 per fiscal year for each review 

division; 

‘‘(II) the number of reports submitted under 

section 510(k) per fiscal year for each review division; and 

‘‘(III) the number of expedited development 

and priority review designations under section 

515C per fiscal year. 

‘‘(iii) REAL TIME REPORTING.— ‘‘(I) IN GENERAL.—Not later than 30 calendar 

days after the end of the second quarter of fiscal 

year 2018, and not later than 30 calendar days 

after the end of each quarter of each fiscal year 

thereafter, the Secretary shall post the data 

described in subclause (II) on the internet website 

of the Food and Drug Administration for such 

quarter and on a cumulative basis for such fiscal 

year, and may remove duplicative data from the 

annual report under this subparagraph. 

‘‘(II) DATA.—The Secretary shall post the following data in accordance with subclause (I): 

‘‘(aa) The number and titles of draft and 

final guidance on topics related to the process 

for the review of devices, and whether such 

guidances were issued as required by statute 

or pursuant to the letters described in section 

201(b) of the Medical Device User Fee Amendments of 2017; and 

‘‘(bb) The number and titles of public 

meetings held on topics related to the process 

for the review of devices, and if such meetings 

were required by statute or pursuant to a 

commitment under the letters described in section 201(b) of the Medical Device User Fee 

Amendments of 2017. 

‘‘(iv) RATIONALE FOR MDUFA PROGRAM CHANGES.— 

Beginning with fiscal year 2020, the Secretary shall 

include in the annual report under paragraph (1)— 

‘‘(I) data, analysis, and discussion of the 

changes in the number of full-time equivalents 

hired as agreed upon in the letters described in 

section 201(b) of the Medical Device User Fee 

Amendments of 2017 and the number of full time 

equivalents funded by budget authority at the Food 

and Drug Administration by each division within 

the Center for Devices and Radiological Health, 

the Center for Biologics Evaluation and Research, 

the Office of Regulatory Affairs, and the Office 

of the Commissioner; 

‘‘(II) data, analysis, and discussion of the 

changes in the fee revenue amounts and costs 

for the process for the review of devices, including 

identifying drivers of such changes; and 

‘‘(III) for each of the Center for Devices and 

Radiological Health, the Center for Biologics 

Evaluation and Research, the Office of Regulatory 

Effective date. 

Analysis. 

131 STAT. 1080 PUBLIC LAW 115–52—AUG. 18, 2017 

Affairs, and the Office of the Commissioner, the 

number of employees for whom time reporting is 

required and the number of employees for whom 

time reporting is not required.’’. 

(c) GDUFA.—Section 744C(a) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j–43(a)), as amended by section 304, 

is further amended— 

(1) by striking ‘‘Beginning with’’ and inserting the following: 

‘‘(1) GENERAL REQUIREMENTS.—Beginning with’’; and 

(2) by adding at the end the following: 

‘‘(2) REAL TIME REPORTING.— 

‘‘(A) IN GENERAL.—Not later than 30 calendar days 

after the end of the second quarter of fiscal year 2018, 

and not later than 30 calendar days after the end of each 

quarter of each fiscal year thereafter, the Secretary shall 

post the data described in subparagraph (B) on the internet 

website of the Food and Drug Administration, and may 

remove duplicative data from the annual report under this 

subsection. 

‘‘(B) DATA.—The Secretary shall post the following data 

in accordance with subparagraph (A): 

‘‘(i) The number and titles of draft and final guidance on topics related to human generic drug activities 

and whether such guidances were issued as required 

by statute or pursuant to a commitment under the 

letters described in section 301(b) of the Generic Drug 

User Fee Amendments of 2017. 

‘‘(ii) The number and titles of public meetings held 

on topics related to human generic drug activities and 

whether such meetings were required by statute or 

pursuant to a commitment under the letters described 

in section 301(b) of the Generic Drug User Fee Amendments of 2017. 

‘‘(3) RATIONALE FOR GDUFA PROGRAM CHANGES.—Beginning 

with fiscal year 2020, the Secretary shall include in the annual 

report under paragraph (1)— 

‘‘(A) data, analysis, and discussion of the changes in 

the number of full-time equivalents hired as agreed upon 

in the letters described in section 301(b) of the Generic 

Drug User Fee Amendments of 2017 and the number of 

full time equivalents funded by budget authority at the 

Food and Drug Administration by each division within 

the Center for Drug Evaluation and Research, the Center 

for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; 

‘‘(B) data, analysis, and discussion of the changes in 

the fee revenue amounts and costs for human generic drug 

activities, including identifying drivers of such changes; 

and 

‘‘(C) for each of the Center for Drug Evaluation and 

Research, the Center for Biologics Evaluation and 

Research, the Office of Regulatory Affairs, and the Office 

of the Commissioner, the number of employees for whom 

time reporting is required and the number of employees 

for whom time reporting is not required.’’. 

Effective date. 

Analysis. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1081 

(d) BSUFA.—Section 744I(a) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j–53(a)), as amended by section 404, 

is further amended— 

(1) by striking ‘‘Beginning with’’ and inserting the following: 

‘‘(1) GENERAL REQUIREMENTS.—Beginning with’’; and 

(2) by adding at the end the following: 

‘‘(2) ADDITIONAL INFORMATION.—Beginning with fiscal year 

2018, the report under this subsection shall include the progress 

of the Food and Drug Administration in achieving the goals, 

and future plans for meeting the goals, including— 

‘‘(A) information on all previous cohorts for which the 

Secretary has not given a complete response on all biosimilar biological product applications and supplements in 

the cohort; 

‘‘(B) the number of original biosimilar biological 

product applications filed per fiscal year, and the number 

of approvals issued by the agency for such applications; 

and 

‘‘(C) the number of resubmitted original biosimilar 

biological product applications filed per fiscal year and 

the number of approvals letters issued by the agency for 

such applications. 

‘‘(3) REAL TIME REPORTING.— 

‘‘(A) IN GENERAL.—Not later than 30 calendar days 

after the end of the second quarter of fiscal year 2018, 

and not later than 30 calendar days after the end of each 

quarter of each fiscal year thereafter, the Secretary shall 

post the data described in subparagraph (B) for such 

quarter and on a cumulative basis for the fiscal year on 

the internet website of the Food and Drug Administration, 

and may remove duplicative data from the annual report 

under this subsection. 

‘‘(B) DATA.—The Secretary shall post the following data 

in accordance with subparagraph (A): 

‘‘(i) The number and titles of draft and final guidance on topics related to the process for the review 

of biosimilars, and whether such guidances were 

required by statute or pursuant to a commitment under 

the letters described in section 401(b) of the Biosimilar 

User Fee Amendments of 2017. 

‘‘(ii) The number and titles of public meetings held 

on topics related to the process for the review of 

biosimilars, and whether such meetings were required 

by statute or pursuant to a commitment under the 

letters described in section 401(b) of the Biosimilar 

User Fee Amendments of 2017. 

‘‘(4) RATIONALE FOR BSUFA PROGRAM CHANGES.—Beginning 

with fiscal year 2020, the Secretary shall include in the annual 

report under paragraph (1)— 

‘‘(A) data, analysis, and discussion of the changes in 

the number of full-time equivalents hired as agreed upon 

in the letters described in section 401(b) of the Biosimilar 

User Fee Amendments of 2017 and the number of full 

time equivalents funded by budget authority at the Food 

and Drug Administration by each division within the 

Center for Drug Evaluation and Research, the Center for 

Effective date. 

131 STAT. 1082 PUBLIC LAW 115–52—AUG. 18, 2017 

Biologics Evaluation and Research, the Office of Regulatory 

Affairs, and the Office of the Commissioner; 

‘‘(B) data, analysis, and discussion of the changes in 

the fee revenue amounts and costs for the process for 

the review of biosimilar biological product applications, 

including identifying drivers of such changes; and 

‘‘(C) for each of the Center for Drug Evaluation and 

Research, the Center for Biologics Evaluation and 

Research, the Office of Regulatory Affairs, and the Office 

of the Commissioner, the number of employees for whom 

time reporting is required and the number of employees 

for whom time reporting is not required.’’. 

SEC. 904. ANALYSIS OF USE OF FUNDS. 

(a) PDUFA REPORTS.— 

(1) ANALYSIS IN PDUFA PERFORMANCE REPORTS.—Section 

736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379h–2(a)), as amended by section 903(a), is further amended 

by adding at the end the following: 

‘‘(5) ANALYSIS.—For each fiscal year, the Secretary shall 

include in the report under paragraph (1) an analysis of the 

following: 

‘‘(A) The difference between the aggregate number of 

human drug applications filed and the aggregate number 

of approvals, accounting for— 

‘‘(i) such applications filed during one fiscal year 

for which a decision is not scheduled to be made until 

the following fiscal year; 

‘‘(ii) the aggregate number of applications for each 

fiscal year that did not meet the goals identified in 

the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the 

applicable fiscal year. 

‘‘(B) Relevant data to determine whether the Center 

for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance 

enhancement goals identified in the letters described in 

section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year. 

‘‘(C) The most common causes and trends of external 

or other circumstances affecting the ability of the Center 

for Drug Evaluation and Research, the Center for Biologics 

Evaluation and Research, Office of Regulatory Affairs, and 

the Food and Drug Administration to meet the review 

time and performance enhancement goals identified in the 

letters described in section 101(b) of the Prescription Drug 

User Fee Amendments of 2017.’’. 

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 

736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379h–2) is amended— 

(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and 

(B) by inserting after subsection (b) the following: 

‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with fiscal year 

2018, for each fiscal year for which fees are collected under this 

part, the Secretary shall prepare and submit a corrective action 

Effective date. 

Determinations. 

Determination. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1083 

report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the 

Committee on Health, Education, Labor, and Pensions and the 

Committee on Appropriations of the Senate. The report shall include 

the following information, as applicable: 

‘‘(1) GOALS MET.—For each fiscal year, if the Secretary 

determines, based on the analysis under subsection (a)(5), that 

each of the goals identified in the letters described in section 

101(b) of the Prescription Drug User Fee Amendments of 2017 

for the applicable fiscal year have been met, the corrective 

action report shall include recommendations on ways in which 

the Secretary can improve and streamline the human drug 

application review process. 

‘‘(2) GOALS MISSED.—For any of the goals identified in 

the letters described in section 101(b) of the Prescription Drug 

User Fee Amendments of 2017 for the applicable fiscal year 

that the Secretary determines to not have been met, the corrective action report shall include— 

‘‘(A) a detailed justification for such determination and 

a description, as applicable, of the types of circumstances 

and trends under which human drug applications that 

missed the review goal time were approved during the 

first cycle review, or application review goals were missed; 

and 

‘‘(B) with respect to performance enhancement goals 

that were not achieved, a description of efforts the Food 

and Drug Administration has put in place for the fiscal 

year in which the report is submitted to improve the ability 

of such agency to meet each such goal for the such fiscal 

year. 

‘‘(d) ENHANCED COMMUNICATION.— 

‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, 

as applicable and requested, representatives from the Centers 

with expertise in the review of human drugs shall meet with 

representatives from the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives to report 

on the contents described in the reports under this section. 

‘‘(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each 

fiscal year, as applicable and requested, representatives from 

the Food and Drug Administration shall participate in a public 

hearing before the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives, to report on 

the contents described in the reports under this section. Such 

hearing shall occur not later than 120 days after the end 

of each fiscal year for which fees are collected under this 

part.’’. 

(b) MDUFA REPORTS.— 

(1) ANALYSIS IN MDUFA PERFORMANCE REPORTS.—Section 

738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379j–1(a)(1)(A)), as amended by section 903(b), is 

further amended by adding at the end the following: 

‘‘(iv) ANALYSIS.—For each fiscal year, the Secretary 

shall include in the report under clause (i) an analysis 

of the following: 

Deadline. 

Public 

information. 

Recommendations. 

131 STAT. 1084 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(I) The difference between the aggregate 

number of premarket applications filed under section 515 and aggregate reports submitted under 

section 510(k) and the aggregate number of major 

deficiency letters, not approvable letters, and 

denials for such applications issued by the agency, 

accounting for— 

‘‘(aa) the number of applications filed and 

reports submitted during one fiscal year for 

which a decision is not scheduled to be made 

until the following fiscal year; and 

‘‘(bb) the aggregate number of applications 

for each fiscal year that did not meet the 

goals as identified by the letters described in 

section 201(b) of the Medical Device User Fee 

Amendments of 2017 for the applicable fiscal 

year. 

‘‘(II) Relevant data to determine whether the 

Center for Devices and Radiological Health has 

met performance enhancement goals identified by 

the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the 

applicable fiscal year. 

‘‘(III) The most common causes and trends 

for external or other circumstances affecting the 

ability of the Center for Devices and Radiological 

Health, the Office of Regulatory Affairs, or the 

Food and Drug Administration to meet review time 

and performance enhancement goals identified by 

the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.’’. 

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 

738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j–1(a)) is amended— 

(A) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and 

(B) by inserting after paragraph (1) the following: 

‘‘(2) CORRECTIVE ACTION REPORT.—Beginning with fiscal 

year 2018, for each fiscal year for which fees are collected 

under this part, the Secretary shall prepare and submit a 

corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of 

Representatives and the Committee on Health, Education, 

Labor, and Pensions and the Committee on Appropriations 

of the Senate. The report shall include the following information, as applicable: 

‘‘(A) GOALS MET.—For each fiscal year, if the Secretary 

determines, based on the analysis under paragraph 

(1)(A)(iv), that each of the goals identified by the letters 

described in section 201(b) of the Medical Device User 

Fee Amendments of 2017 for the applicable fiscal year 

have been met, the corrective action report shall include 

recommendations on ways in which the Secretary can 

improve and streamline the medical device application 

review process. 

‘‘(B) GOALS MISSED.—For each of the goals identified 

by the letters described in section 201(b) of the Medical 

Recommendations. 

Effective date. 

Determinations. 

Determination. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1085 

Device User Fee Amendments of 2017 for the applicable 

fiscal year that the Secretary determines to not have been 

met, the corrective action report shall include— 

‘‘(i) a justification for such determination; 

‘‘(ii) a description of the types of circumstances, 

in the aggregate, under which applications or reports 

submitted under section 515 or notifications submitted 

under section 510(k) missed the review goal times but 

were approved during the first cycle review, as 

applicable; 

‘‘(iii) a summary and any trends with regard to 

the circumstances for which a review goal was missed; 

and 

‘‘(iv) the performance enhancement goals that were 

not achieved during the previous fiscal year and a 

description of efforts the Food and Drug Administration 

has put in place for the fiscal year in which the report 

is submitted to improve the ability of such agency 

to meet each such goal for the such fiscal year. 

‘‘(3) ENHANCED COMMUNICATION.— 

‘‘(A) COMMUNICATIONS WITH CONGRESS.—Each fiscal 

year, as applicable and requested, representatives from 

the Centers with expertise in the review of devices shall 

meet with representatives from the Committee on Health, 

Education, Labor, and Pensions of the Senate and the 

Committee on Energy and Commerce of the House of Representatives to report on the contents described in the 

reports under this section. 

‘‘(B) PARTICIPATION IN CONGRESSIONAL HEARING.—Each 

fiscal year, as applicable and requested, representatives 

from the Food and Drug Administration shall participate 

in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports 

under this section. Such hearing shall occur not later than 

120 days after the end of each fiscal year for which fees 

are collected under this part.’’. 

(c) GDUFA REPORTS.— 

(1) ANALYSIS IN GDUFA PERFORMANCE REPORTS.—Section 

744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j–43(a)), as amended by section 903(c) is further amended 

by adding at the end the following: 

‘‘(4) ANALYSIS.—For each fiscal year, the Secretary shall 

include in the report an analysis of the following: 

‘‘(A) The difference between the aggregate number of 

abbreviated new drug applications filed and the aggregate 

number of approvals or aggregate number of complete 

response letters issued by the agency, accounting for— 

‘‘(i) such applications filed during one fiscal year 

for which a decision is not scheduled to be made until 

the following fiscal year; and 

‘‘(ii) the aggregate number of applications for each 

fiscal year that did not meet the goals identified by 

the letters described in section 301(b) of the Generic 

Drug User Fee Amendments of 2017 for the applicable 

fiscal year. 

Deadline. 

Public 

information. 

Summary. 

131 STAT. 1086 PUBLIC LAW 115–52—AUG. 18, 2017 

‘‘(B) Relevant data to determine whether the Food 

and Drug Administration has met the performance 

enhancement goals identified by the letters described in 

section 301(b) of the Generic Drug User Fee Amendments 

of 2017 for the applicable fiscal year. 

‘‘(C) The most common causes and trends for external 

or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement 

goals identified by the letters described in section 301(b) 

of the Generic Drug User Fee Amendments of 2017.’’. 

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 

744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j–43) is amended— 

(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and 

(B) by inserting after subsection (b) the following: 

‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with fiscal year 

2018, for each fiscal year for which fees are collected under this 

part, the Secretary shall prepare and submit a corrective action 

report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the 

Committee on Health, Education, Labor, and Pensions and the 

Committee on Appropriations of the Senate. The report shall include 

the following information, as applicable: 

‘‘(1) GOALS MET.—For each fiscal year, if the Secretary 

determines, based on the analysis under subsection (a)(4), that 

each of the goals identified by the letters described in section 

301(b) of the Generic Drug User Fee Amendments of 2017 

for the applicable fiscal year have been met, the corrective 

action report shall include recommendations on ways in which 

the Secretary can improve and streamline the abbreviated new 

drug application review process. 

‘‘(2) GOALS MISSED.—For each of the goals identified by 

the letters described in section 301(b) of the Generic Drug 

User Fee Amendments of 2017 for the applicable fiscal year 

that the Secretary determines to not have been met, the corrective action report shall include— 

‘‘(A) a detailed justification for such determination and 

a description, as applicable, of the types of circumstances 

and trends under which abbreviated new drug applications 

missed the review goal times but were approved during 

the first cycle review, or review goals were missed; and 

‘‘(B) with respect to performance enhancement goals 

that were not achieved, a detailed description of efforts 

the Food and Drug Administration has put in place for 

the fiscal year in which the report is submitted to improve 

the ability of such agency to meet each such goal for 

the such fiscal year. 

‘‘(d) ENHANCED COMMUNICATION.— 

‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, 

as applicable and requested, representatives from the Centers 

with expertise in the review of human drugs shall meet with 

representatives from the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives to report 

on the contents described in the reports under this section. 

Recommendations. 

Effective date. 

Determinations. 

Determination. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1087 

‘‘(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each 

fiscal year, as applicable and requested, representatives from 

the Food and Drug Administration shall participate in a public 

hearing before the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives, to report on 

the contents described in the reports under this section. Such 

hearing shall occur not later than 120 days after the end 

of each fiscal year for which fees are collected under this 

part.’’. 

(d) BSUFA REPORTS.— (1) ANALYSIS IN BSUFA PERFORMANCE REPORTS.—Section 

744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j–53(a)) as amended by section 903(d) is further amended 

by adding at the end the following: 

‘‘(5) ANALYSIS.—For each fiscal year, the Secretary shall 

include in the report an analysis of the following: 

‘‘(A) The difference between the aggregate number of 

biosimilar biological product applications and supplements 

filed and the aggregate number of approvals issued by 

the agency, accounting for— 

‘‘(i) such applications filed during one fiscal year 

for which a decision is not scheduled to be made until 

the following fiscal year; and 

‘‘(ii) the aggregate number of applications for each 

fiscal year that did not meet the goals identified by 

the letters described in section 401(b) of the Biosimilar 

User Fee Amendments of 2017 for the applicable fiscal 

year. 

‘‘(B) Relevant data to determine whether the Center 

for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance 

enhancement goals identified by the letters described in 

section 401(b) of the Biosimilar User Fee Amendments 

of 2017 for the applicable fiscal year. 

‘‘(C) The most common causes and trends for external 

or other circumstances affecting the ability of the Secretary 

to meet review time and performance enhancement goals 

identified by the letters described in section 401(b) of the 

Biosimilar User Fee Amendments of 2017.’’. 

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 

744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379j–53), as amended by section 404, is further amended— 

(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and 

(B) by inserting after subsection (b) the following: 

‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with fiscal year 

2018, and for each fiscal year for which fees are collected under 

this part, the Secretary shall prepare and submit a corrective action 

report to the Committee on Energy and Commerce and Committee 

on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee 

on Appropriations of the Senate. The report shall include the following information, as applicable: 

‘‘(1) GOALS MET.—For each fiscal year, if the Secretary 

determines, based on the analysis under subsection (a)(5), that 

each of the goals identified by the letters described in section 

Effective date. 

Determinations. 

Determination. 

Deadline. 

Public 

information. 

131 STAT. 1088 PUBLIC LAW 115–52—AUG. 18, 2017 

401(b) of the Biosimilar User Fee Amendments of 2017 for 

the applicable fiscal year have been met, the corrective action 

report shall include recommendations on ways in which the 

Secretary can improve and streamline the biosimilar biological 

product application review process. 

‘‘(2) GOALS MISSED.—For each of the goals identified by 

the letters described in section 401(b) of the Biosimilar User 

Fee Amendments of 2017 for the applicable fiscal year that 

the Secretary determines to not have been met, the corrective 

action report shall include— 

‘‘(A) a justification for such determination and a 

description of the types of circumstances and trends, as 

applicable, under which biosimilar biological product 

applications missed the review goal times but were 

approved during the first cycle review, or review goals 

were missed; and 

‘‘(B) with respect to performance enhancement goals 

that were not achieved, a description of efforts the Food 

and Drug Administration has put in place for the fiscal 

year in which the report is submitted to improve the ability 

of such agency to meet each such goal for the such fiscal 

year. 

‘‘(d) ENHANCED COMMUNICATION.— 

‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, 

as applicable and requested, representatives from the Centers 

with expertise in the review of human drugs shall meet with 

representatives from the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives to report 

on the contents described in the reports under this section. 

‘‘(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each 

fiscal year, as applicable and requested, representatives from 

the Food and Drug Administration shall participate in a public 

hearing before the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives, to report on 

the contents described in the reports under this section. Such 

hearing shall occur not later than 120 days after the end 

of each fiscal year for which fees are collected under this 

part.’’. 

SEC. 905. FACILITIES MANAGEMENT. 

(a) EVALUATION.— 

(1) STUDY.—The Comptroller General of the United States 

shall conduct a study on the expenses incurred by the Food 

and Drug Administration related to facility maintenance and 

renovation in fiscal years 2012 through 2019. The study under 

this paragraph shall include the following: 

(A) A review of purchases and expenses differentiated 

by appropriated funds, and resources authorized by the 

Food and Drug Administration Safety and Innovation Act 

(Public Law 112–144) and this Act, as applicable, that 

contributed to— 

(i) the maintenance of scientific equipment and 

any existing facility plan or plans to maintain previously purchased scientific equipment; 

Review. 

Time period. 

Deadline. 

Public 

information. 

PUBLIC LAW 115–52—AUG. 18, 2017 131 STAT. 1089 

(ii) the renovation of facilities in the Center for 

Drug Evaluation and Research, the Center for Biologics 

Evaluation and Research, and the Center for Devices 

and Radiological Health, and the purpose of such renovation including the need for the renovation; 

(iii) the assets purchased or repaired under the 

‘‘repair of facilities and acquisition’’ authority under 

parts 2, 3, 7, and 8 of subchapter C of chapter VII 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379f et seq.); 

(iv) the maintenance and repair of facilities and 

fixtures, including a description of any unanticipated 

repairs and maintenance as well as scheduled repairs 

maintenance, and the budget plan for the scheduled 

or anticipated maintenance; 

(v) the acquisition of furniture, a description of 

the furniture purchased, and the purpose of the furniture including purchases for the Center for Drug 

Evaluation and Research, the Center for Biologics 

Evaluation and Research, and the Center for Devices 

and Radiological Health; and 

(vi) the acquisition of other necessary materials 

and supplies by product category under the authority 

under parts 2, 3, 7, and 8 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379f et seq.). 

(B) An analysis of the Food and Drug Administration’s 

ability to further its public health mission and review 

medical products by incurring the expenses listed in clauses 

(i) through (vi) of subparagraph (A). In conducting the 

analysis, the Comptroller General shall request information 

from and consult with appropriate employees, including 

staff and those responsible for the fiscal decisions regarding 

facility maintenance and renovation for the agency. 

(2) REPORT.— 

(A) IN GENERAL.—The Comptroller General shall issue 

a report to the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives not later 

than July 30, 2020, containing the results of the study 

under paragraph (1). 

(B) RECOMMENDATIONS.—As part of the report under 

this paragraph, the Comptroller General may provide recommendations, as applicable, on methods through which 

the Food and Drug Administration may improve planning 

for— 

(i) the maintenance, renovation, and repair of 

facilities; 

(ii) the purchase of furniture or other acquisitions; 

and 

(iii) ways the Food and Drug Administration may 

allocate the expenses described in clauses (i) and (ii) 

of paragraph (1)(A), as informed by the analysis under 

paragraph (1)(B). 

(b) ADMINISTRATION.— 

Consultation. 

Analysis. 

131 STAT. 1090 PUBLIC LAW 115–52—AUG. 18, 2017 

LEGISLATIVE HISTORY—H.R. 2430 (S. 934): 

HOUSE REPORTS: No. 115–201 (Comm. on Energy and Commerce). 

CONGRESSIONAL RECORD, Vol. 163 (2017): 

July 12, considered and passed House. 

Aug. 3, considered and passed Senate. 

Æ 

(1) PDUFA.—Section 736(f) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding 

at the end the following: 

‘‘(3) LIMITATION.—Beginning on October 1, 2023, the 

authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.’’. 

(2) MDUFA.—Section 738(h) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding 

at the end the following: 

‘‘(3) LIMITATION.—Beginning on October 1, 2023, the 

authorities under section 737(9)(C) shall include only leasing 

and necessary scientific equipment.’’. 

(3) GDUFA.—Section 744B(e) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–42(e)) is amended— 

(A) in the subsection heading, by striking ‘‘LIMIT’’ and 

inserting ‘‘LIMITATIONS’’; 

(B) by striking ‘‘The total amount’’ and inserting the 

following: 

‘‘(1) IN GENERAL.—The total amount’’; and 

(C) by adding at the end the following: 

‘‘(2) LEASING AND NECESSARY EQUIPMENT.—Beginning on 

October 1, 2023, the authorities under section 744A(11)(C) shall 

include only leasing and necessary scientific equipment.’’. 

(4) BSUFA.—Section 744H(e)(2)(B) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–52(e)(2)(B)) is 

amended— 

(A) in the subparagraph heading, by striking ‘‘LIMITATION’’ and inserting ‘‘LIMITATIONS’’; 

(B) by striking ‘‘The fees authorized’’ and inserting 

the following: 

‘‘(i) IN GENERAL.—The fees authorized’’; and 

(C) by adding at the end the following: 

‘‘(ii) LEASING AND NECESSARY EQUIPMENT.—Beginning on October 1, 2023, the authorities under section 

744G(9)(C) shall include only leasing and necessary 

scientific equipment.’’. 

Approved August 18, 2017. 

Effective date. 

Effective date. 

Effective date. 

Effective date.