II 

117TH CONGRESS 

2D SESSION S. 4535 

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

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

drugs, and biosimilar biological products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 14, 2022 

Mr. BURR introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

revise and extend the user-fee programs for prescription 

drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Food and Drug Administration Simple Reauthorization 

6 Act of 2022’’ or the ‘‘FDASRA Act of 2022’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use drug fees. 

Sec. 104. Reauthorization; reporting requirement. 

Sec. 105. Sunset dates. 

Sec. 106. Effective date. 

Sec. 107. 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 requirement. 

Sec. 205. Accreditation programs. 

Sec. 206. Sunset dates. 

Sec. 207. Effective date. 

Sec. 208. Savings clause. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title; finding. 

Sec. 302. Authority to assess and use human generic drug fees. 

Sec. 303. Reauthorization; reporting requirements. 

Sec. 304. Sunset dates. 

Sec. 305. Effective date. 

Sec. 306. 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 biological product fees. 

Sec. 404. Reauthorization; reporting requirements. 

Sec. 405. Sunset dates. 

Sec. 406. Effective date. 

Sec. 407. Savings clause. 

TITLE V—OTHER REAUTHORIZATIONS 

Sec. 501. Reauthorization of the critical path public-private partnership. 

Sec. 502. Reauthorization of the best pharmaceuticals for children program. 

Sec. 503. Reauthorization of the humanitarian device exemption incentive. 

Sec. 504. Reauthorization of the pediatric device consortia program. 

Sec. 505. Reauthorization of provision pertaining to drugs containing single 

enantiomers. 

Sec. 506. Reauthorization of orphan drug grants. 

Sec. 507. Reauthorization of certain device inspections. 


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1 TITLE I—FEES RELATING TO 

2 DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

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

5 ‘‘Prescription Drug User Fee Amendments of 2022’’. 

6 (b) FINDING.—Congress finds that the fees author7 ized by the amendments made in this title will be dedi8 cated toward expediting the drug development process and 

9 the process for the review of human drug applications, in10 cluding postmarket drug safety activities, as set forth in 

11 the goals identified for purposes of part 2 of subchapter 

12 C of chapter VII of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 379g et seq.), in the letters from the Sec14 retary of Health and Human Services to the Chairman 

15 of the Committee on Health, Education, Labor, and Pen16 sions of the Senate and the Chairman of the Committee 

17 on Energy and Commerce of the House of Representa18 tives, as set forth in the Congressional Record. 

19 SEC. 102. DEFINITIONS. 

20 Section 735 of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379g) is amended— 

22 (1) in paragraph (1), in the matter following 

23 subparagraph (B), by striking ‘‘an allergenic extract 

24 product, or’’ and inserting ‘‘does not include an ap25 plication with respect to an allergenic extract prodVerDate Sep 11 2014 23:43 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4535.IS S4535

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1 uct licensed before October 1, 2022, does not include 

2 an application with respect to a standardized aller3 genic extract product submitted pursuant to a notifi4 cation to the applicant from the Secretary regarding 

5 the existence of a potency test that measures the al6 lergenic activity of an allergenic extract product li7 censed by the applicant before October 1, 2022, does 

8 not include an application with respect to’’; 

9 (2) in paragraph (3), in the matter following 

10 subparagraph (C)— 

11 (A) by inserting ‘‘licensed before October 

12 1, 2022, a standardized allergenic extract prod13 uct submitted pursuant to a notification to the 

14 applicant from the Secretary regarding the ex15 istence of a potency test that measures the al16 lergenic activity of an allergenic extract product 

17 licensed by the applicant before October 1, 

18 2022,’’ after ‘‘an allergenic extract product’’; 

19 and 

20 (B) by adding at the end the following: ‘‘If 

21 a written request to place a product in the dis22 continued section of either of the lists described 

23 in subparagraph (C) is submitted to the Sec24 retary on behalf of an applicant, and the re25 quest identifies the date the product is, or will 


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1 be, withdrawn from sale, then, for purposes of 

2 assessing the prescription drug program fee 

3 under section 736(a)(2), the Secretary shall 

4 consider such product to have been included in 

5 the discontinued section on the later of (i) the 

6 date such request was received, or (ii) if the 

7 product will be withdrawn from sale on a future 

8 date, such future date when the product is 

9 withdrawn from sale. For purposes of subpara10 graph (C), a product shall be considered with11 drawn from sale once the applicant has ceased 

12 its own distribution of the product, whether or 

13 not the applicant has ordered recall of all pre14 viously distributed lots of the product, except 

15 that a routine, temporary interruption in supply 

16 shall not render a product withdrawn from 

17 sale.’’; and 

18 (3) by adding at the end the following: 

19 ‘‘(12) The term ‘skin-test diagnostic product’— 

20 ‘‘(A) means a product— 

21 ‘‘(i) for prick, scratch, intradermal, or 

22 subcutaneous administration; 

23 ‘‘(ii) expected to produce a limited, 

24 local reaction at the site of administration 

25 (if positive), rather than a systemic effect; 


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1 ‘‘(iii) not intended to be a preventive 

2 or therapeutic intervention; and 

3 ‘‘(iv) intended to detect an immediate 

4 or delayed-type skin hypersensitivity reac5 tion to aid in the diagnosis of— 

6 ‘‘(I) an allergy to an anti7 microbial agent; 

8 ‘‘(II) an allergy that is not to an 

9 antimicrobial agent, if the diagnostic 

10 product was authorized for marketing 

11 prior to October 1, 2022; or 

12 ‘‘(III) infection with fungal or 

13 mycobacterial pathogens; and 

14 ‘‘(B) includes positive and negative con15 trols required to interpret the results of a prod16 uct described in subparagraph (A).’’. 

17 SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 

18 (a) TYPES OF FEES.—Section 736(a) of the Federal 

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

20 amended— 

21 (1) in the matter preceding paragraph (1), by 

22 striking ‘‘2018’’ and inserting ‘‘2023’’; 

23 (2) in paragraph (1)— 


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1 (A) in subparagraph (A), by striking ‘‘sub2 section (c)(5)’’ each place it appears and insert3 ing ‘‘subsection (c)(6)’’; 

4 (B) in subparagraph (C), by inserting 

5 ‘‘prior to approval’’ after ‘‘or was withdrawn’’; 

6 and 

7 (C) by adding at the end the following: 

8 ‘‘(H) EXCEPTION FOR SKIN-TEST DIAG9 NOSTIC PRODUCTS.—A human drug application 

10 for a skin-test diagnostic product shall not be 

11 subject to a fee under subparagraph (A).’’; and 

12 (3) in paragraph (2)— 

13 (A) in subparagraph (A)— 

14 (i) by striking ‘‘subsection (c)(5)’’ and 

15 inserting ‘‘subsection (c)(6)’’; 

16 (ii) by striking ‘‘Except as provided’’ 

17 and inserting the following: 

18 ‘‘(i) PAYMENT OF FEES.—Except as 

19 provided’’; and 

20 (iii) by adding at the end the fol21 lowing: 

22 ‘‘(ii) PREVIOUSLY DISCONTINUED

23 DRUG PRODUCTS.—If a drug product that 

24 is identified in a human drug application 

25 approved as of October 1 of a fiscal year 


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1 is not a prescription drug product as of 

2 that date because the drug product is in 

3 the discontinued section of a list identified 

4 in section 735(3), and on any subsequent 

5 day during such fiscal year the drug prod6 uct is a prescription drug product, then ex7 cept as provided in subparagraphs (B) and 

8 (C), each person who is named as the ap9 plicant in a human drug application with 

10 respect to such product, and who, after 

11 September 1, 1992, had pending before the 

12 Secretary a human drug application or 

13 supplement, shall pay the annual prescrip14 tion drug program fee established for a fis15 cal year under subsection (c)(6) for such 

16 prescription drug product. Such fee shall 

17 be due on the last business day of such fis18 cal year and shall be paid only once for 

19 each product for a fiscal year in which the 

20 fee is payable.’’; and 

21 (B) by amending subparagraph (B) to read 

22 as follows: 

23 ‘‘(B) EXCEPTION FOR CERTAIN PRESCRIP24 TION DRUG PRODUCTS.—A prescription drug 

25 program fee shall not be assessed for a preVerDate Sep 11 2014 23:43 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4535.IS S4535

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1 scription drug product under subparagraph (A) 

2 if such product is— 

3 ‘‘(i) a large volume parenteral product 

4 (a sterile aqueous drug product packaged 

5 in a single-dose container with a volume 

6 greater than or equal to 100 mL, not in7 cluding powders for reconstitution or phar8 macy bulk packages) identified on the list 

9 compiled under section 505(j)(7); 

10 ‘‘(ii) pharmaceutically equivalent (as 

11 defined in section 314.3 of title 21, Code 

12 of Federal Regulations (or any successor 

13 regulations)), to another product on the 

14 list of products compiled under section 

15 505(j)(7) (not including the discontinued 

16 section of such list); or 

17 ‘‘(iii) a skin-test diagnostic product.’’. 

18 (b) FEE REVENUE AMOUNTS.—Section 736(b) of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 379h(b)) is amended— 

21 (1) in paragraph (1)— 

22 (A) in the matter preceding subparagraph 

23 (A), by striking ‘‘2018 through 2022’’ and in24 serting ‘‘2023 through 2027’’; 


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1 (B) by redesignating subparagraphs (C) 

2 through (F) as subparagraphs (D) through (G), 

3 respectively; 

4 (C) by inserting after subparagraph (B) 

5 the following: 

6 ‘‘(C) The dollar amount equal to the stra7 tegic hiring and retention adjustment for the 

8 fiscal year (as determined under subsection 

9 (c)(2));’’; 

10 (D) in subparagraph (D), as so redesig11 nated, by striking ‘‘(c)(2)’’ and inserting 

12 ‘‘(c)(3)’’; 

13 (E) in subparagraph (E), as so redesig14 nated, by striking ‘‘(c)(3)’’ and inserting 

15 ‘‘(c)(4)’’; 

16 (F) in subparagraph (F), as so redesig17 nated, by striking ‘‘(c)(4)’’ and inserting 

18 ‘‘(c)(5)’’; and 

19 (G) in subparagraph (G), as so redesig20 nated, by striking clauses (i) through (v) and 

21 inserting the following: 

22 ‘‘(i) $65,773,693 for fiscal year 2023. 

23 ‘‘(ii) $25,097,671 for fiscal year 2024. 

24 ‘‘(iii) $14,154,169 for fiscal year 

25 2025. 


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1 ‘‘(iv) $4,864,860 for fiscal year 2026. 

2 ‘‘(v) $1,314,620 for fiscal year 

3 2027.’’; and 

4 (2) in paragraph (3)— 

5 (A) in subparagraph (A), by striking 

6 ‘‘2018, $878,590,000’’ and inserting ‘‘2023, 

7 $1,151,522,958’’; and 

8 (B) in subparagraph (B)— 

9 (i) by striking ‘‘2019 through 2022’’ 

10 and inserting ‘‘2024 through 2027’’; and 

11 (ii) by striking ‘‘subsection (c)(3) or 

12 (c)(4)’’ and inserting ‘‘subsection (c)(4) or 

13 (c)(5)’’. 

14 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

15 736(c) of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 379h(c)) is amended— 

17 (1) in paragraph (1)(B)(ii), by striking ‘‘Wash18 ington-Baltimore, DC–MD–VA–WV’’ and inserting 

19 ‘‘Washington–Arlington–Alexandria, DC–VA–MD– 

20 WV’’; 

21 (2) by redesignating paragraphs (2) through 

22 (6) as paragraphs (3) through (7), respectively; 

23 (3) by inserting after paragraph (1) the fol24 lowing: 


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1 ‘‘(2) STRATEGIC HIRING AND RETENTION AD2 JUSTMENT.—For each fiscal year, after the annual 

3 base revenue established in subsection (b)(1)(A) is 

4 adjusted for inflation in accordance with paragraph 

5 (1), the Secretary shall further increase the fee rev6 enue and fees— 

7 ‘‘(A) for fiscal year 2023, by $9,000,000; 

8 and 

9 ‘‘(B) for fiscal year 2024 and each subse10 quent fiscal year, by $4,000,000.’’; 

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

12 (A) in subparagraph (A)— 

13 (i) by striking ‘‘for inflation’’; and 

14 (ii) by striking ‘‘paragraph (1)’’ and 

15 inserting ‘‘paragraphs (1) and (2)’’; 

16 (B) by amending subparagraph (B) to read 

17 as follows: 

18 ‘‘(B) METHODOLOGY.—For purposes of 

19 this paragraph, the Secretary shall employ the 

20 capacity planning methodology utilized by the 

21 Secretary in setting fees for fiscal year 2021, as 

22 described in the notice titled ‘Prescription Drug 

23 User Fee Rates for Fiscal Year 2021’ (85 Fed. 

24 Reg. 46651; August 3, 2020). The workload 

25 categories used in forecasting shall include only 


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1 the activities described in such notice and, as 

2 feasible, additional activities that are directly 

3 related to the direct review of applications and 

4 supplements, including additional formal meet5 ing types, the direct review of postmarketing 

6 commitments and requirements, the direct re7 view of risk evaluation and mitigation strate8 gies, and the direct review of annual reports for 

9 approved prescription drug products. Subject to 

10 the exceptions in the preceding sentence, the 

11 Secretary shall not include as workload cat12 egories in forecasting any non-core review ac13 tivities, including any activities that the Sec14 retary referenced for potential future use in 

15 such notice but did not utilize in the setting 

16 fees for fiscal year 2021.’’; 

17 (C) by striking subparagraph (C); 

18 (D) by redesignating subparagraphs (D) 

19 and (E) as subparagraphs (C) and (D), respec20 tively; 

21 (E) in subparagraph (C), as so redesig22 nated— 

23 (i) by striking ‘‘year) and’’ and insert24 ing ‘‘year),’’; and 


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1 (ii) by striking the period and insert2 ing ‘‘, and subsection (b)(1)(C) (the dollar 

3 amount of the strategic hiring and reten4 tion adjustment).’’; and 

5 (F) in subparagraph (D), as so redesig6 nated, by striking ‘‘paragraph (5)’’ and insert7 ing ‘‘paragraph (6)’’; 

8 (5) in paragraph (4), as so redesignated— 

9 (A) by amending subparagraph (A) to read 

10 as follows: 

11 ‘‘(A) INCREASE.—For fiscal year 2023 and 

12 subsequent fiscal years, the Secretary shall, in 

13 addition to adjustments under paragraphs (1), 

14 (2), and (3), further increase the fee revenue 

15 and fees if such an adjustment is necessary to 

16 provide for at least the following amounts of op17 erating reserves of carryover user fees for the 

18 process for the review of human drug applica19 tions for each fiscal year, as follows: 

20 ‘‘(i) For fiscal year 2023, at least 8 

21 weeks of operating reserves. 

22 ‘‘(ii) For fiscal year 2024, at least 9 

23 weeks of operating reserves. 


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1 ‘‘(iii) For fiscal year 2025 and subse2 quent fiscal years, at least 10 weeks of op3 erating reserves.’’; and 

4 (B) in subparagraph (C), by striking 

5 ‘‘paragraph (5)’’ and inserting ‘‘paragraph 

6 (6)’’; 

7 (6) by amending paragraph (5), as so redesig8 nated, to read as follows: 

9 ‘‘(5) ADDITIONAL DIRECT COST ADJUST10 MENT.—The Secretary shall, in addition to adjust11 ments under paragraphs (1), (2), (3), and (4), fur12 ther increase the fee revenue and fees— 

13 ‘‘(A) for fiscal year 2023, by $44,386,150; 

14 and 

15 ‘‘(B) for fiscal years 2024 through 2027, 

16 by the amount set forth in clauses (i) through 

17 (iv), as applicable, multiplied by the Consumer 

18 Price Index for urban consumers (Washington– 

19 Arlington–Alexandria, DC–VA–MD–WV; Not 

20 Seasonally Adjusted; All Items; Annual Index) 

21 for the most recent year of available data, di22 vided by such Index for 2021— 

23 ‘‘(i) for fiscal year 2024, $60,967,993; 

24 ‘‘(ii) for fiscal year 2025, 

25 $35,799,314; 


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1 ‘‘(iii) for fiscal year 2026, 

2 $35,799,314; and 

3 ‘‘(iv) for fiscal year 2027, 

4 $35,799,314.’’; and 

5 (7) in paragraph (6), as so redesignated, by 

6 striking ‘‘2017’’ and inserting ‘‘2022’’. 

7 (d) CREDITING AND AVAILABILITY OF FEES.—Sec8 tion 736(g)(3) of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 379h(g)(3)) is amended by striking ‘‘2018 

10 through 2022’’ and inserting ‘‘2023 through 2027’’. 

11 (e) WRITTEN REQUESTS FOR WAIVERS, REDUC12 TIONS, AND REFUNDS.—Section 736(i) of the Federal 

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

14 amended to read as follows: 

15 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC16 TIONS, EXEMPTIONS, AND RETURNS; DISPUTES CON17 CERNING FEES.—To qualify for consideration for a waiver 

18 or reduction under subsection (d), an exemption under 

19 subsection (k), or the return of any fee paid under this 

20 section, including if the fee is claimed to have been paid 

21 in error, a person shall submit to the Secretary a written 

22 request justifying such waiver, reduction, exemption, or 

23 return not later than 180 days after such fee is due. A 

24 request submitted under this paragraph shall include any 

25 legal authorities under which the request is made.’’. 


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1 (f) ORPHAN DRUGS.—Section 736(k) of the Federal 

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

3 amended— 

4 (1) in paragraph (1)(B), by striking ‘‘during 

5 the previous year’’ and inserting ‘‘, as determined 

6 under paragraph (2)’’; and 

7 (2) in paragraph (2), by striking ‘‘that its gross 

8 annual revenues’’ and all that follows through the 

9 period at the end and inserting ‘‘supported by tax 

10 returns submitted to the Internal Revenue Service, 

11 or, as necessary, by other appropriate financial in12 formation, that its gross annual revenues did not ex13 ceed $50,000,000 for the last calendar year ending 

14 prior to the fiscal year for which the exemption is 

15 requested.’’. 

16 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENT. 

17 Section 736B of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 379h–2) is amended— 

19 (1) by striking ‘‘2018’’ each place it appears 

20 and inserting ‘‘2023’’; 

21 (2) by striking ‘‘Prescription Drug User Fee 

22 Amendments of 2017’’ each place it appears and in23 serting ‘‘Prescription Drug User Fee Amendments 

24 of 2022’’; 


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1 (3) in subsection (a)(4), by striking ‘‘2020’’ and 

2 inserting ‘‘2023’’; and 

3 (4) in subsection (f), by striking ‘‘2022’’ each 

4 place it appears and inserting ‘‘2027’’. 

5 SEC. 105. SUNSET DATES. 

6 (a) AUTHORIZATION.—Sections 735 and 736 of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 

8 379h) shall cease to be effective October 1, 2027. 

9 (b) REPORTING REQUIREMENTS.—Section 736B of 

10 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 379h–2) shall cease to be effective January 31, 2028. 

12 (c) PREVIOUS SUNSET PROVISION.—Effective Octo13 ber 1, 2022, subsections (a) and (b) of section 104 of the 

14 FDA Reauthorization Act of 2017 (Public Law 115–52) 

15 are repealed. 

16 SEC. 106. EFFECTIVE DATE. 

17 The amendments made by this title shall take effect 

18 on October 1, 2022, or the date of the enactment of this 

19 Act, whichever is later, except that fees under part 2 of 

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

21 and Cosmetic Act (21 U.S.C. 379g et seq.) shall be as22 sessed for all human drug applications received on or after 

23 October 1, 2022, regardless of the date of the enactment 

24 of this Act. 


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1 SEC. 107. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

3 part 2 of subchapter C of chapter VII of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in 

5 effect on the day before the date of the enactment of this 

6 title, shall continue to be in effect with respect to human 

7 drug applications and supplements (as defined in such 

8 part as of such day) that were accepted by the Food and 

9 Drug Administration for filing on or after October 1, 

10 2017, but before October 1, 2022, with respect to assess11 ing and collecting any fee required by such part for a fiscal 

12 year prior to fiscal year 2023. 

13 TITLE II—FEES RELATING TO 

14 DEVICES 

15 SEC. 201. SHORT TITLE; FINDING. 

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

17 ‘‘Medical Device User Fee Amendments of 2022’’. 

18 (b) FINDING.—Congress finds that the fees author19 ized under the amendments made by this title will be dedi20 cated toward expediting the process for the review of de21 vice applications and for assuring the safety and effective22 ness of devices, as set forth in the goals identified for pur23 poses of part 3 of subchapter C of chapter VII of the Fed24 eral Food, Drug, and Cosmetic Act in the letters from the 

25 Secretary of Health and Human Services to the Chairman 

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1 sions of the Senate and the Chairman of the Committee 

2 on Energy and Commerce of the House of Representa3 tives, as set forth in the Congressional Record. 

4 SEC. 202. DEFINITIONS. 

5 Section 737 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 379i) is amended— 

7 (1) in paragraph (9)— 

8 (A) in the matter preceding subparagraph 

9 (A), by striking ‘‘and premarket notification 

10 submissions’’ and inserting ‘‘premarket notifica11 tion submissions, and de novo classification re12 quests’’; 

13 (B) in subparagraph (D), by striking ‘‘and 

14 submissions’’ and inserting ‘‘submissions, and 

15 de novo classification requests’’; 

16 (C) in subparagraph (F), by striking ‘‘and 

17 premarket notification submissions’’ and insert18 ing ‘‘premarket notification submissions, and de 

19 novo classification requests’’; 

20 (D) in subparagraphs (G) and (H), by 

21 striking ‘‘or submissions’’ each place it appears 

22 and inserting ‘‘submissions, or requests’’; and 

23 (E) in subparagraph (K), by striking ‘‘or 

24 premarket notification submissions’’ and insertVerDate Sep 11 2014 23:43 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S4535.IS S4535

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1 ing ‘‘premarket notification submissions, or de 

2 novo classification requests’’; and 

3 (2) in paragraph (11), by striking ‘‘2016’’ and 

4 inserting ‘‘2021’’. 

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

6 (a) TYPES OF FEES.—Section 738(a) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 

8 amended— 

9 (1) in paragraph (1), by striking ‘‘2018’’ and 

10 inserting ‘‘2023’’; and 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A)— 

13 (i) in the matter preceding clause (i), 

14 by striking ‘‘2017’’ and inserting ‘‘2022’’; 

15 (ii) in clause (iii), by striking ‘‘75 per16 cent’’ and inserting ‘‘80 percent’’; and 

17 (iii) in clause (viii), by striking ‘‘3.4 

18 percent’’ and inserting ‘‘4.5 percent’’; 

19 (B) in subparagraph (B)(iii), by striking 

20 ‘‘or premarket notification submission’’ and in21 serting ‘‘premarket notification submission, or 

22 de novo classification request’’; and 

23 (C) in subparagraph (C), by striking ‘‘or 

24 periodic reporting concerning a class III device’’ 

25 and inserting ‘‘periodic reporting concerning a 


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1 class III device, or de novo classification re2 quest’’. 

3 (b) FEE AMOUNTS.—Section 738(b) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is 

5 amended— 

6 (1) in paragraph (1), by striking ‘‘2018 

7 through 2022’’ and inserting ‘‘2023 through 2027’’; 

8 (2) by amending the table in paragraph (2) to 

9 read as follows: 

‘‘Fee Type 

Fiscal 

Year 

2023 

Fiscal 

Year 

2024 

Fiscal 

Year 

2025 

Fiscal 

Year 

2026 

Fiscal 

Year 

2027 

Premarket Application ........ $425,000 $435,000 $445,000 $455,000 $470,000

Establishment 

Registration .. $6,250 $6,875 $7,100 $7,575 $8,465’’; 

10 and 

11 (3) in paragraph (3), by amending subpara12 graphs (A) through (E) to read as follows: 

13 ‘‘(A) $312,606,000 for fiscal year 2023. 

14 ‘‘(B) $335,750,000 for fiscal year 2024. 

15 ‘‘(C) $350,746,400 for fiscal year 2025. 

16 ‘‘(D) $366,486,300 for fiscal year 2026. 

17 ‘‘(E) $418,343,000 for fiscal year 2027.’’. 

18 (c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 

19 738(c) of the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 379j(c)) is amended— 


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

2 inserting ‘‘2022’’; 

3 (2) in paragraph (2)— 

4 (A) by striking ‘‘2018’’ each place it ap5 pears and inserting ‘‘2023’’; 

6 (B) in subparagraph (B)(ii), by striking 

7 ‘‘2016’’ and inserting ‘‘2022’’; 

8 (C) in subparagraph (C)(i)(II), by striking 

9 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ 

10 and inserting ‘‘Washington–Arlington–Alexan11 dria, DC–VA–MD–WV’’; and 

12 (D) in subparagraph (D), by striking 

13 ‘‘2022’’ and inserting ‘‘2027’’; 

14 (3) in paragraph (3), by striking ‘‘2018 

15 through 2022’’ and inserting ‘‘2023 through 2027’’; 

16 (4) by redesignating paragraphs (4) and (5) as 

17 paragraphs (7) and (8), respectively; and 

18 (5) by inserting after paragraph (3) the fol19 lowing: 

20 ‘‘(4) PERFORMANCE IMPROVEMENT ADJUST21 MENT.— 

22 ‘‘(A) IN GENERAL.—For each of fiscal 

23 years 2025 through 2027, after the adjustment 

24 under paragraph (3), the base establishment 

25 registration fee amounts for such fiscal year 


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1 shall be increased to reflect changes in the re2 source needs of the Secretary due to improved 

3 review performance goals for the process for the 

4 review of device applications identified in the 

5 letters described in section 201(b) of the Med6 ical Device User Fee Amendments of 2022, as 

7 the Secretary determines necessary to achieve 

8 an increase in total fee collections for such fis9 cal year, equal to the following amounts, as ap10 plicable: 

11 ‘‘(i) For fiscal year 2025, the product 

12 of— 

13 ‘‘(I) the amount determined 

14 under subparagraph (B)(i)(I); and 

15 ‘‘(II) the applicable inflation ad16 justment under paragraph (2)(B) for 

17 such fiscal year. 

18 ‘‘(ii) For fiscal year 2026, the product 

19 of— 

20 ‘‘(I) the sum of the amounts de21 termined under subparagraphs 

22 (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); 

23 and 


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1 ‘‘(II) the applicable inflation ad2 justment under paragraph (2)(B) for 

3 such fiscal year. 

4 ‘‘(iii) For fiscal year 2027, the prod5 uct of— 

6 ‘‘(I) the sum of the amounts de7 termined under subparagraphs 

8 (B)(i)(III), (B)(ii)(II), and 

9 (B)(iii)(II); and 

10 ‘‘(II) the applicable inflation ad11 justment under paragraph (2)(B) for 

12 such fiscal year. 

13 ‘‘(B) AMOUNTS.— 

14 ‘‘(i) PRESUBMISSION AMOUNT.—For 

15 purposes of subparagraph (A), with respect 

16 to the presubmission written feedback goal, 

17 the amounts determined under this sub18 paragraph are as follows: 

19 ‘‘(I) For fiscal year 2025, 

20 $15,396,600 if the goal for fiscal year 

21 2023 is met. 

22 ‘‘(II) For fiscal year 2026— 

23 ‘‘(aa) $15,396,600 if the 

24 goal for fiscal year 2023 is met 


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1 and the goal for fiscal year 2024 

2 is missed; or 

3 ‘‘(bb) $36,792,200 if the 

4 goal for fiscal year 2024 is met. 

5 ‘‘(III) For fiscal year 2027— 

6 ‘‘(aa) $15,396,600 if the 

7 goal for fiscal year 2023 is met 

8 and the goal for each of fiscal 

9 years 2024 and 2025 is missed; 

10 ‘‘(bb) $36,792,200 if the 

11 goal for fiscal year 2024 is met 

12 and the goal for fiscal year 2025 

13 is missed; or 

14 ‘‘(cc) $40,572,600 if the 

15 goal for fiscal year 2025 is met. 

16 ‘‘(ii) DE NOVO CLASSIFICATION RE17 QUEST AMOUNT.—For purposes of sub18 paragraph (A), with respect to the de novo 

19 decision goal, the amounts determined 

20 under this subparagraph are as follows: 

21 ‘‘(I) For fiscal year 2026, 

22 $6,323,500 if the goal for fiscal year 

23 2023 is met. 

24 ‘‘(II) For fiscal year 2027— 


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1 ‘‘(aa) $6,323,500 if the goal 

2 for fiscal year 2023 is met and 

3 the goal for fiscal year 2024 is 

4 missed; or 

5 ‘‘(bb) $11,765,400 if the 

6 goal for fiscal year 2024 is met. 

7 ‘‘(iii) PREMARKET NOTIFICATION AND

8 PREMARKET APPROVAL AMOUNT.—For 

9 purposes of subparagraph (A), with respect 

10 to the 510(k) decision goal, 510(k) shared 

11 outcome total time to decision goal, PMA 

12 decision goal, and PMA shared outcome 

13 total time to decision goal, the amounts de14 termined under this subparagraph are as 

15 follows: 

16 ‘‘(I) For fiscal year 2026, 

17 $1,020,000 if the 4 goals for fiscal 

18 year 2023 are met. 

19 ‘‘(II) For fiscal year 2027— 

20 ‘‘(aa) $1,020,000 if the 4 

21 goals for fiscal year 2023 are met 

22 and one or more of the 4 goals 

23 for fiscal year 2024 is missed; or 


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1 ‘‘(bb) $3,906,000 if the 4 

2 goals for fiscal year 2024 are 

3 met. 

4 ‘‘(C) PERFORMANCE CALCULATION.—For 

5 purposes of this paragraph, performance of the 

6 following goals shall be determined as specified 

7 in the letters described in section 201(b) of the 

8 Medical Device User Fee Amendments of 2022 

9 and based on data available as of the applicable 

10 dates as follows: 

11 ‘‘(i) The performance of the pre12 submission written feedback goal— 

13 ‘‘(I) for fiscal year 2023, shall be 

14 based on data available as of March 

15 31, 2024; 

16 ‘‘(II) for fiscal year 2024, shall 

17 be based on data available as of 

18 March 31, 2025; and 

19 ‘‘(III) for fiscal year 2025, shall 

20 be based on data available as of 

21 March 31, 2026. 

22 ‘‘(ii) The performance of the de novo 

23 decision goal, 510(k) decision goal, 510(k) 

24 shared outcome total time to decision goal, 


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1 PMA decision goal, and PMA shared out2 come total time to decision goal— 

3 ‘‘(I) for fiscal year 2023, shall be 

4 based on data available as of March 

5 31, 2025; and 

6 ‘‘(II) for fiscal year 2024, shall 

7 be based on data available as of 

8 March 31, 2026. 

9 ‘‘(D) DEFINITIONS.—For purposes of this 

10 paragraph, the terms ‘presubmission written 

11 feedback goal’, ‘de novo decision goal’, ‘510(k) 

12 decision goal’, ‘510(k) shared outcome total 

13 time to decision goal’, ‘PMA decision goal’, and 

14 ‘PMA shared outcome total time to decision 

15 goal’ have the meanings given such terms in the 

16 goals identified in the letters described in sec17 tion 201(b) of the Medical Device User Fee 

18 Amendments of 2022. 

19 ‘‘(5) HIRING ADJUSTMENT.— 

20 ‘‘(A) IN GENERAL.—For each of fiscal 

21 years 2025 through 2027, after the adjust22 ments under paragraphs (3) and (4), if applica23 ble, the base establishment registration fee 

24 amounts shall be decreased as the Secretary de25 termines necessary to achieve a reduction in 


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1 total fee collections equal to the hiring adjust2 ment amount under subparagraph (B), if the 

3 number of hires to support the process for the 

4 review of device applications falls below the fol5 lowing thresholds for the applicable fiscal years: 

6 ‘‘(i) For fiscal year 2025, 85 percent 

7 of the hiring goal specified in subpara8 graph (C) for fiscal year 2023. 

9 ‘‘(ii) For fiscal year 2026, 90 percent 

10 of the hiring goal specified in subpara11 graph (C) for fiscal year 2024. 

12 ‘‘(iii) For fiscal year 2027, 90 percent 

13 of the hiring goal specified in subpara14 graph (C) for fiscal year 2025. 

15 ‘‘(B) HIRING ADJUSTMENT AMOUNT.—The 

16 hiring adjustment amount for fiscal year 2025 

17 and each subsequent fiscal year is the product 

18 of— 

19 ‘‘(i) the number of hires by which the 

20 hiring goal specified in subparagraph (C) 

21 for the fiscal year before the prior fiscal 

22 year was missed; 

23 ‘‘(ii) $72,877; and 


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1 ‘‘(iii) the applicable inflation adjust2 ment under paragraph (2)(B) for the fiscal 

3 year for which the hiring goal was missed. 

4 ‘‘(C) HIRING GOALS.— 

5 ‘‘(i) IN GENERAL.—For purposes of 

6 subparagraph (B), the hiring goals for 

7 each of fiscal years 2023 through 2025 are 

8 as follows: 

9 ‘‘(I) For fiscal year 2023, 144 

10 hires. 

11 ‘‘(II) For fiscal year 2024, 42 

12 hires. 

13 ‘‘(III) For fiscal year 2025— 

14 ‘‘(aa) 24 hires if the base es15 tablishment registration fees are 

16 not increased by the amount de17 termined under paragraph 

18 (4)(A)(i); or 

19 ‘‘(bb) 83 hires if the base 

20 establishment registration fees 

21 are increased by the amount de22 termined under paragraph 

23 (4)(A)(i). 

24 ‘‘(ii) NUMBER OF HIRES.—For pur25 poses of this paragraph, the number of 


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1 hires for a fiscal year shall be determined 

2 by the Secretary, as set forth in the letters 

3 described in section 201(b) of the Medical 

4 Device User Fee Amendments of 2022. 

5 ‘‘(6) OPERATING RESERVE ADJUSTMENT.— 

6 ‘‘(A) IN GENERAL.—For each of fiscal 

7 years 2023 through 2027, after the adjust8 ments under paragraphs (3), (4), and (5), if ap9 plicable, if the Secretary has operating reserves 

10 of carryover user fees for the process for the re11 view of device applications in excess of the des12 ignated amount in subparagraph (B), the Sec13 retary shall decrease the base establishment 

14 registration fee amounts to provide for not 

15 more than such designated amount of operating 

16 reserves. 

17 ‘‘(B) DESIGNATED AMOUNT.—Subject to 

18 subparagraph (C), for each fiscal year, the des19 ignated amount in this subparagraph is equal 

20 to the sum of— 

21 ‘‘(i) 13 weeks of operating reserves of 

22 carryover user fees; and 

23 ‘‘(ii) the 1 month of operating re24 serves described in paragraph (8). 


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1 ‘‘(C) EXCLUDED AMOUNT.—For the period 

2 of fiscal years 2023 through 2026, a total 

3 amount equal to $118,000,000 shall not be con4 sidered part of the designated amount under 

5 subparagraph (B) and shall not be subject to 

6 the decrease under subparagraph (A).’’. 

7 (d) CONDITIONS.—Section 738(g) of the Federal 

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

9 amended— 

10 (1) in paragraph (1)(A), by striking 

11 ‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; and 

12 (2) in paragraph (2), by inserting ‘‘de novo 

13 classification requests,’’ after ‘‘class III device,’’. 

14 (e) AUTHORIZATION OF APPROPRIATIONS.—Section 

15 738(h)(3) of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 379j(h)(3)) is amended to read as follows: 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 ‘‘(A) IN GENERAL.—For each of the fiscal 

19 years 2023 through 2027, there is authorized to 

20 be appropriated for fees under this section an 

21 amount equal to the revenue amount deter22 mined in subparagraph (B), less the amount of 

23 reductions determined in subparagraph (C). 


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1 ‘‘(B) REVENUE AMOUNT.—For purposes of 

2 this paragraph, the revenue amount for each 

3 fiscal year is the sum of— 

4 ‘‘(i) the total revenue amount under 

5 subsection (b)(3) for the fiscal year, as ad6 justed under subsection (c)(2); and 

7 ‘‘(ii) the performance improvement 

8 adjustment amount for the fiscal year 

9 under subsection (c)(4)(A), if applicable. 

10 ‘‘(C) AMOUNT OF REDUCTIONS.—For pur11 poses of this paragraph, the amount of reduc12 tions for each fiscal year is the sum of— 

13 ‘‘(i) the hiring adjustment amount for 

14 the fiscal year under subsection (c)(5), if 

15 applicable; and 

16 ‘‘(ii) the operating reserve adjustment 

17 amount for the fiscal year under sub18 section (c)(6), if applicable.’’. 

19 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENT. 

20 (a) PERFORMANCE REPORTS.—Section 738A(a) of 

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

22 379j–1(a)) is amended— 

23 (1) by striking ‘‘fiscal year 2018’’ each place it 

24 appears and inserting ‘‘fiscal year 2023’’; 


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1 (2) by striking ‘‘Medical Device User Fee 

2 Amendments of 2017’’ each place it appears and in3 serting ‘‘Medical Device User Fee Amendments of 

4 2022’’; 

5 (3) in paragraph (1)— 

6 (A) in subparagraph (A), by redesignating 

7 the second clause (iv) (relating to analysis) as 

8 clause (v); and 

9 (B) in subparagraph (A)(iv) (relating to 

10 rationale for MDUFA program changes), by 

11 striking ‘‘fiscal year 2020’’ and inserting ‘‘fiscal 

12 year 2023’’; and 

13 (4) in paragraph (4), by striking ‘‘2018 

14 through 2022’’ and inserting ‘‘2023 through 2027’’. 

15 (b) REAUTHORIZATION.—Section 738A(b) of the 

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

17 1(b)) is amended— 

18 (1) in paragraph (1), by striking ‘‘2022’’ and 

19 inserting ‘‘2027’’; and 

20 (2) in paragraph (5), by striking ‘‘2022’’ and 

21 inserting ‘‘2027’’. 

22 SEC. 205. ACCREDITATION PROGRAMS. 

23 (a) ACCREDITATION SCHEME FOR CONFORMITY AS24 SESSMENT.—Section 514(d) of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 360d(d)) is amended— 


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1 (1) in the subsection heading, by striking 

2 ‘‘PILOT’’; 

3 (2) in paragraph (1)— 

4 (A) in the matter preceding subparagraph 

5 (A), by striking ‘‘pilot’’; 

6 (B) in subparagraph (A)— 

7 (i) by inserting ‘‘meeting criteria spec8 ified by the Secretary in guidance’’ after 

9 ‘‘testing laboratories’’; 

10 (ii) by inserting ‘‘in guidance’’ after 

11 ‘‘by the Secretary’’; and 

12 (iii) by striking ‘‘assess the conform13 ance of a device with’’ and inserting ‘‘con14 duct testing to support the assessment of 

15 the conformance of a device to’’; and 

16 (C) in subparagraph (B)— 

17 (i) by striking ‘‘determinations’’ and 

18 inserting ‘‘results’’; 

19 (ii) by inserting ‘‘to support’’ after 

20 ‘‘so accredited’’; and 

21 (iii) by striking ‘‘a particular such de22 termination’’ and inserting ‘‘particular 

23 such results’’; 

24 (3) in paragraph (2)— 


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1 (A) in the paragraph heading, by striking 

2 ‘‘DETERMINATIONS’’ and inserting ‘‘RESULTS’’; 

3 (B) in subparagraph (A)— 

4 (i) by striking ‘‘determinations by 

5 testing laboratories’’ and all that follows 

6 through ‘‘such determinations or’’ and in7 serting ‘‘results by testing laboratories ac8 credited pursuant to this subsection, in9 cluding by conducting periodic audits of 

10 such results or of the’’; 

11 (ii) by inserting a comma after ‘‘or 

12 testing laboratories’’; 

13 (iii) by inserting ‘‘or recognition of an 

14 accreditation body’’ after ‘‘accreditation of 

15 such testing laboratory’’; and 

16 (iv) by striking ‘‘such device’’ and in17 serting ‘‘a device’’; and 

18 (C) in subparagraph (B)— 

19 (i) by striking ‘‘by a testing labora20 tory so accredited’’ and inserting ‘‘under 

21 this subsection’’; and 

22 (ii) by inserting ‘‘or recognition of an 

23 accreditation body’’ before ‘‘under para24 graph (1)(A)’’; 

25 (4) in paragraph (3)(C)— 


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1 (A) in the subparagraph heading, by in2 serting ‘‘AND TRANSITION’’ after ‘‘INITIATION’’; 

3 and 

4 (B) by adding at the end the following: 

5 ‘‘After September 30, 2023, such pilot program 

6 will be considered to be completed, and the Sec7 retary shall have the authority to continue oper8 ating a program consistent with this sub9 section.’’; and 

10 (5) by striking paragraph (4). 

11 (b) ACCREDITED PERSONS.—Section 523(c) of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 360m(c)) is amended by striking ‘‘2022’’ and inserting 

14 ‘‘2027’’. 

15 SEC. 206. SUNSET DATES. 

16 (a) AUTHORIZATION.—Sections 737 and 738 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 

18 379fj) shall cease to be effective October 1, 2027. 

19 (b) REPORTING REQUIREMENTS.—Section 738A of 

20 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 379j–1) shall cease to be effective January 31, 2028. 

22 (c) PREVIOUS SUNSET PROVISION.—Effective Octo23 ber 1, 2022, subsections (a) and (b) of section 210 of the 

24 FDA Reauthorization Act of 2017 (Public Law 115–52) 

25 are repealed. 


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1 SEC. 207. EFFECTIVE DATE. 

2 The amendments made by this title shall take effect 

3 on October 1, 2022, or the date of the enactment of this 

4 Act, whichever is later, except that fees under part 3 of 

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

6 and Cosmetic Act (21 U.S.C. 379i et seq.) shall be as7 sessed for all submissions listed in section 738(a)(2)(A) 

8 of such Act received on or after October 1, 2022, regard9 less of the date of the enactment of this Act. 

10 SEC. 208. SAVINGS CLAUSE. 

11 Notwithstanding the amendments made by this title, 

12 part 3 of subchapter C of chapter VII of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in 

14 effect on the day before the date of the enactment of this 

15 title, shall continue to be in effect with respect to the sub16 missions listed in section 738(a)(2)(A) of such Act (as de17 fined in such part as of such day) that on or after October 

18 1, 2017, but before October 1, 2022, were received by the 

19 Food and Drug Administration with respect to assessing 

20 and collecting any fee required by such part for a fiscal 

21 year prior to fiscal year 2023. 

22 TITLE III—FEES RELATING TO 

23 GENERIC DRUGS 

24 SEC. 301. SHORT TITLE; FINDING. 

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

26 ‘‘Generic Drug User Fee Amendments of 2022’’. 


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1 (b) FINDING.—The Congress finds that the fees au2 thorized by the amendments made in this title will be dedi3 cated to human generic drug activities, as set forth in the 

4 goals identified for purposes of part 7 of subchapter C 

5 of chapter VII of the Federal Food, Drug, and Cosmetic 

6 Act, in the letters from the Secretary of Health and 

7 Human Services to the Chairman of the Committee on 

8 Health, Education, Labor, and Pensions of the Senate and 

9 the Chairman of the Committee on Energy and Commerce 

10 of the House of Representatives, as set forth in the Con11 gressional Record. 

12 SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE13 NERIC DRUG FEES. 

14 (a) TYPES OF FEES.—Section 744B(a) of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

16 42(a)) is amended— 

17 (1) in the matter preceding paragraph (1), by 

18 striking ‘‘2018’’ and inserting ‘‘2023’’; 

19 (2) in paragraph (2)(C), by striking ‘‘fiscal 

20 years 2018 through 2022’’ and inserting ‘‘fiscal 

21 years 2023 through 2027’’; 

22 (3) in paragraph (3)(B), by striking ‘‘fiscal 

23 years 2018 through 2022’’ and inserting ‘‘fiscal 

24 years 2023 through 2027’’; 


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1 (4) in paragraph (4)(D), by striking ‘‘fiscal 

2 years 2018 through 2022’’ and inserting ‘‘fiscal 

3 years 2023 through 2027’’; and 

4 (5) in paragraph (5)(D), by striking ‘‘fiscal 

5 years 2018 through 2022’’ and inserting ‘‘fiscal 

6 years 2023 through 2027’’. 

7 (b) FEE REVENUE AMOUNTS.—Section 744B(b) of 

8 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 379j–42(b)) is amended— 

10 (1) in paragraph (1)— 

11 (A) in subparagraph (A)— 

12 (i) in the heading, by striking ‘‘2018’’ 

13 and inserting ‘‘2023’’; 

14 (ii) by striking ‘‘2018’’ and inserting 

15 ‘‘2023’’; and 

16 (iii) by striking ‘‘$493,600,000’’ and 

17 inserting ‘‘$582,500,000’’; and 

18 (B) in subparagraph (B)— 

19 (i) in the heading, by striking ‘‘2019

20 THROUGH 2022’’ and inserting ‘‘2024

21 THROUGH 2027’’; 

22 (ii) by striking ‘‘For each’’ and insert23 ing the following: 

24 ‘‘(i) IN GENERAL.—For each’’; 


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1 (iii) by striking ‘‘2019 through 2022’’ 

2 and inserting ‘‘2024 through 2027’’; 

3 (iv) by striking ‘‘$493,600,000’’ and 

4 inserting ‘‘the base revenue amount under 

5 clause (ii)’’; and 

6 (v) by adding at the end the following: 

7 ‘‘(ii) BASE REVENUE AMOUNT.—The 

8 base revenue amount for a fiscal year is 

9 the total revenue amount established under 

10 this paragraph for the previous fiscal year, 

11 not including any adjustments made for 

12 such previous fiscal year under subsection 

13 (c)(3).’’; and 

14 (2) in paragraph (2)— 

15 (A) in subparagraph (C), by striking ‘‘one16 third the amount’’ and inserting ‘‘24 percent’’; 

17 (B) in subparagraph (D), by striking 

18 ‘‘Seven’’ and inserting ‘‘Six’’; and 

19 (C) in subparagraph (E)(i), by striking 

20 ‘‘Thirty-five’’ and inserting ‘‘Thirty-six’’. 

21 (c) ADJUSTMENTS.—Section 744B(c) of the Federal 

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

23 amended— 

24 (1) in paragraph (1)— 


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1 (A) in the matter preceding subparagraph 

2 (A)— 

3 (i) by striking ‘‘2019’’ and inserting 

4 ‘‘2024’’; and 

5 (ii) by striking ‘‘the product of the 

6 total revenues established in such notice 

7 for the prior fiscal year’’ and inserting 

8 ‘‘the base revenue amount for the fiscal 

9 year determined under subsection 

10 (b)(1)(B)(ii)’’; and 

11 (B) in subparagraph (C), by striking 

12 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ 

13 and inserting ‘‘Washington-Arlington-Alexan14 dria, DC–VA–MD–WV’’; and 

15 (2) by striking paragraph (2) and inserting the 

16 following: 

17 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

18 ‘‘(A) IN GENERAL.—Beginning with fiscal 

19 year 2024, the Secretary shall, in addition to 

20 the adjustment under paragraph (1), further in21 crease the fee revenue and fees under this sec22 tion for a fiscal year, in accordance with this 

23 paragraph, to reflect changes in the resource 

24 capacity needs of the Secretary for human ge25 neric drug activities. 


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1 ‘‘(B) CAPACITY PLANNING METHOD2 OLOGY.—The Secretary shall establish a capac3 ity planning methodology for purposes of this 

4 paragraph, which shall— 

5 ‘‘(i) be derived from the methodology 

6 and recommendations made in the report 

7 titled ‘Independent Evaluation of the 

8 GDUFA Resource Capacity Planning Ad9 justment Methodology: Evaluation and 

10 Recommendations’ as announced in the 

11 Federal Register on August 3, 2020 (85 

12 Fed. Reg. 46658); and 

13 ‘‘(ii) incorporate approaches and at14 tributes determined appropriate by the 

15 Secretary, including those made in such re16 port recommendations, except the workload 

17 categories used in forecasting resources 

18 shall only be those specified in section 

19 VIII.B.2.e. of the letters described in sec20 tion 301(b) of the Generic Drug User Fee 

21 Amendments of 2022. 

22 ‘‘(C) LIMITATIONS.— 

23 ‘‘(i) IN GENERAL.—Under no cir24 cumstances shall an adjustment under this 

25 paragraph result in fee revenue for a fiscal 


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1 year that is less than the sum of the 

2 amounts under subsection (b)(1)(B)(ii) 

3 (the base revenue amount for the fiscal 

4 year) and paragraph (1) (the dollar 

5 amount of the inflation adjustment for the 

6 fiscal year). 

7 ‘‘(ii) ADDITIONAL LIMITATION.—An 

8 adjustment under this paragraph shall not 

9 exceed 3 percent of the sum described in 

10 clause (i) for the fiscal year, except that 

11 such limitation shall be 4 percent if— 

12 ‘‘(I) for purposes of an adjust13 ment for fiscal year 2024, the Sec14 retary determines that, during the pe15 riod from April 1, 2021, through 

16 March 31, 2023— 

17 ‘‘(aa) the total number of 

18 abbreviated new drug applica19 tions submitted was greater than 

20 or equal to 2,000; or 

21 ‘‘(bb) thirty-five percent or 

22 more of abbreviated new drug ap23 plications submitted related to 

24 complex products (as that term is 

25 defined in section XI of the letVerDate Sep 11 2014 23:43 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6201 E:\BILLS\S4535.IS S4535

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1 ters described in section 301(b) 

2 of the Generic Drug User Fee 

3 Amendments of 2022); 

4 ‘‘(II) for purposes of an adjust5 ment for fiscal year 2025, the Sec6 retary determines that, during the pe7 riod from April 1, 2022, through 

8 March 31, 2024— 

9 ‘‘(aa) the total number of 

10 abbreviated new drug applica11 tions submitted was greater than 

12 or equal to 2,300; or 

13 ‘‘(bb) thirty-five percent or 

14 more of abbreviated new drug ap15 plications submitted related to 

16 complex products (as so defined); 

17 ‘‘(III) for purposes of an adjust18 ment for fiscal year 2026, the Sec19 retary determines that, during the pe20 riod from April 1, 2023, through 

21 March 31, 2025— 

22 ‘‘(aa) the total number of 

23 abbreviated new drug applica24 tions submitted was greater than 

25 or equal to 2,300; or 


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1 ‘‘(bb) thirty-five percent or 

2 more of abbreviated new drug ap3 plications submitted related to 

4 complex products (as so defined); 

5 and 

6 ‘‘(IV) for purposes of an adjust7 ment for fiscal year 2027, the Sec8 retary determines that, during the pe9 riod from April 1, 2024, through 

10 March 31, 2026— 

11 ‘‘(aa) the total number of 

12 abbreviated new drug applica13 tions submitted was greater than 

14 or equal to 2,300; or 

15 ‘‘(bb) thirty-five percent or 

16 more of abbreviated new drug ap17 plications submitted related to 

18 complex products (as so defined). 

19 ‘‘(D) PUBLICATION IN FEDERAL REG20 ISTER.—The Secretary shall publish in the Fed21 eral Register notice under subsection (a), the 

22 fee revenue and fees resulting from the adjust23 ment and the methodology under this para24 graph. 

25 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 


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1 ‘‘(A) IN GENERAL.—For fiscal year 2024 

2 and subsequent fiscal years, the Secretary may, 

3 in addition to adjustments under paragraphs 

4 (1) and (2), further increase the fee revenue 

5 and fees under this section if such an adjust6 ment is necessary to provide operating reserves 

7 of carryover user fees for human generic drug 

8 activities for not more than the number of 

9 weeks specified in subparagraph (B). 

10 ‘‘(B) NUMBER OF WEEKS.—The number of 

11 weeks specified in this subparagraph is— 

12 ‘‘(i) 8 weeks for fiscal year 2024; 

13 ‘‘(ii) 9 weeks for fiscal year 2025; and 

14 ‘‘(iii) 10 weeks for each of fiscal year 

15 2026 and 2027. 

16 ‘‘(C) DECREASE.—If the Secretary has 

17 carryover balances for human generic drug ac18 tivities in excess of 12 weeks of the operating 

19 reserves referred to in subparagraph (A), the 

20 Secretary shall decrease the fee revenue and 

21 fees referred to in such subparagraph to provide 

22 for not more than 12 weeks of such operating 

23 reserves. 

24 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

25 an adjustment under this paragraph is made, 


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1 the rationale for the amount of the increase or 

2 decrease (as applicable) in fee revenue and fees 

3 shall be contained in the annual Federal Reg4 ister notice under subsection (a) publishing the 

5 fee revenue and fees for the fiscal year in6 volved.’’. 

7 (d) ANNUAL FEE SETTING.—Section 744B(d)(1) of 

8 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 379j–42(d)(1)) is amended— 

10 (1) in the heading, by striking ‘‘2018 THROUGH

11 2022’’ and inserting ‘‘2023 THROUGH 2027’’; 

12 (2) by striking ‘‘more’’ and inserting ‘‘later’’; 

13 and 

14 (3) by striking ‘‘2018 through 2022’’ and in15 serting ‘‘2023 through 2027’’. 

16 (e) EFFECT OF FAILURE TO PAY FEES.—The head17 ing of paragraph (3) of section 744B(g) of the Federal 

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

19 amended by striking ‘‘AND PRIOR APPROVAL SUPPLEMENT

20 FEE’’. 

21 (f) CREDITING AND AVAILABILITY OF FEES.—Sec22 tion 744B(i)(3) of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 379j–42(i)(3)) is amended by striking 

24 ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

25 2027’’. 


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1 SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 744C of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379j–43) is amended— 

4 (1) in subsection (a)— 

5 (A) by striking ‘‘2018’’ each place it ap6 pears and inserting ‘‘2023’’; and 

7 (B) by striking ‘‘Generic Drug User Fee 

8 Amendments of 2017’’ each place it appears 

9 and inserting ‘‘Generic Drug User Fee Amend10 ments of 2022’’; 

11 (2) in subsection (b), by striking ‘‘2018’’ and 

12 inserting ‘‘2023’’; 

13 (3) in subsection (c)— 

14 (A) by striking ‘‘2018’’ and inserting 

15 ‘‘2023’’; and 

16 (B) by striking ‘‘Generic Drug User Fee 

17 Amendments of 2017’’ each place it appears 

18 and inserting ‘‘Generic Drug User Fee Amend19 ments of 2022’’; and 

20 (4) in subsection (f)— 

21 (A) in paragraph (1), by striking ‘‘2022’’ 

22 and inserting ‘‘2027’’; and 

23 (B) in paragraph (5), by striking ‘‘January 

24 15, 2022’’ and inserting ‘‘January 15, 2027’’. 


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1 SEC. 304. SUNSET DATES. 

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

3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 379j–41; 379j–42) shall cease to be effective October 1, 

5 2027. 

6 (b) REPORTING REQUIREMENTS.—Section 744C of 

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 379j–43) shall cease to be effective January 31, 2028. 

9 (c) PREVIOUS SUNSET PROVISION.—Effective Octo10 ber 1, 2022, subsections (a) and (b) of section 305 of the 

11 FDA Reauthorization Act of 2017 (Public Law 115–52) 

12 are repealed. 

13 SEC. 305. EFFECTIVE DATE. 

14 The amendments made by this title shall take effect 

15 on October 1, 2022, or the date of the enactment of this 

16 Act, whichever is later, except that fees under part 7 of 

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

18 and Cosmetic Act (21 U.S.C. 379j–41 et seq.) shall be 

19 assessed for all abbreviated new drug applications received 

20 on or after October 1, 2022, regardless of the date of the 

21 enactment of this Act. 

22 SEC. 306. SAVINGS CLAUSE. 

23 Notwithstanding the amendments made by this title, 

24 part 7 of subchapter C of chapter VII of the Federal Food, 

25 Drug, and Cosmetic Act, as in effect on the day before 

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


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1 be in effect with respect to abbreviated new drug applica2 tions (as defined in such part as of such day) that were 

3 received by the Food and Drug Administration within the 

4 meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 

5 355(j)(5)(A)), prior approval supplements that were sub6 mitted, and drug master files for Type II active pharma7 ceutical ingredients that were first referenced on or after 

8 October 1, 2017, but before October 1, 2022, with respect 

9 to assessing and collecting any fee required by such part 

10 for a fiscal year prior to fiscal year 2023. 

11 TITLE IV—FEES RELATING TO 

12 BIOSIMILAR BIOLOGICAL 

13 PRODUCTS 

14 SEC. 401. SHORT TITLE; FINDING. 

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

16 ‘‘Biosimilar User Fee Amendments of 2022’’. 

17 (b) FINDING.—Congress finds that the fees author18 ized by the amendments made in this title will be dedi19 cated to expediting the process for the review of biosimilar 

20 biological product applications, including postmarket safe21 ty activities, as set forth in the goals identified for pur22 poses of part 8 of subchapter C of chapter VII of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 

24 et seq.), in the letters from the Secretary of Health and 

25 Human Services to the Chairman of the Committee on 


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1 Health, Education, Labor, and Pensions of the Senate and 

2 the Chairman of the Committee on Energy and Commerce 

3 of the House of Representatives, as set forth in the Con4 gressional Record. 

5 SEC. 402. DEFINITIONS. 

6 Section 744G of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 379j–51) is amended— 

8 (1) in paragraph (1)— 

9 (A) by striking ‘‘Washington-Baltimore, 

10 DC–MD–VA–WV’’ and inserting ‘‘Washington– 

11 Arlington–Alexandria, DC–VA–MD–WV’’; 

12 (B) by striking ‘‘October of’’ and inserting 

13 ‘‘September of’’; and 

14 (C) by striking ‘‘October 2011’’ and insert15 ing ‘‘September 2011’’; and 

16 (2) in paragraph (4)(B)(iii)— 

17 (A) by striking subclause (II); and 

18 (B) by redesignating subclauses (III) and 

19 (IV) as subclauses (II) and (III), respectively. 

20 SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIO21 LOGICAL PRODUCT FEES. 

22 (a) TYPES OF FEES.—Section 744H(a) of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

24 52(a)) is amended— 


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

2 striking ‘‘2018’’ and inserting ‘‘2023’’; 

3 (2) in paragraph (1)— 

4 (A) in subparagraph (A)— 

5 (i) in clause (iv)(I), by striking ‘‘5 

6 days’’ and inserting ‘‘7 days’’; and 

7 (ii) in clause (v)(II), by striking ‘‘5 

8 days’’ and inserting ‘‘7 days’’; 

9 (B) in subparagraph (B)— 

10 (i) in clause (i), by inserting ‘‘, except 

11 that, in the case that such product (includ12 ing, where applicable, ownership of the rel13 evant investigational new drug application) 

14 is transferred to a licensee, assignee, or 

15 successor of such person, and written no16 tice of such transfer is provided to the Sec17 retary, such licensee, assignee or successor 

18 shall pay the annual biosimilar biological 

19 product development fee’’ before the pe20 riod; 

21 (ii) in clause (iii)— 

22 (I) in subclause (I), by striking 

23 ‘‘; or’’ and inserting a semicolon; 

24 (II) in subclause (II), by striking 

25 the period and inserting ‘‘; or’’; and 


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1 (III) by adding at the end the 

2 following: 

3 ‘‘(III) been administratively re4 moved from the biosimilar biological 

5 product development program for the 

6 product under subparagraph (E)(v).’’; 

7 and 

8 (iii) in clause (iv), by striking ‘‘accept9 ed for filing on or after October 1 of such 

10 fiscal year’’ and inserting ‘‘subsequently 

11 accepted for filing’’; 

12 (C) in subparagraph (D)— 

13 (i) in clause (i)— 

14 (I) in the matter preceding sub15 clause (I), by striking ‘‘shall, if the 

16 person seeks to resume participation 

17 in such program, pay’’ and inserting 

18 ‘‘or who has been administratively re19 moved from such program for a prod20 uct under subparagraph (E)(v) shall, 

21 if the person seeks to resume partici22 pation in such program, pay all an23 nual biosimilar biological product de24 velopment fees previously assessed for 

25 such product and still owed and’’; 


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1 (II) in subclause (I)— 

2 (aa) by striking ‘‘5 days’’ 

3 and inserting ‘‘7 days’’; and 

4 (bb) by inserting ‘‘or the 

5 date of administrative removal, 

6 as applicable’’ after ‘‘discon7 tinued’’; and 

8 (III) in subclause (II), by insert9 ing ‘‘or the date of administrative re10 moval, as applicable’’ after ‘‘discon11 tinued’’; and 

12 (ii) in clause (ii), by inserting ‘‘, ex13 cept that, in the case that such product 

14 (including, where applicable, ownership of 

15 the relevant investigational new drug appli16 cation) is transferred to a licensee, as17 signee, or successor of such person, and 

18 written notice of such transfer is provided 

19 to the Secretary, such licensee, assignee or 

20 successor shall pay the annual biosimilar 

21 biological product development fee’’ before 

22 the period at the end; and 

23 (D) in subparagraph (E), by adding at the 

24 end the following: 


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1 ‘‘(v) ADMINISTRATIVE REMOVAL FROM

2 THE BIOSIMILAR BIOLOGICAL PRODUCT

3 DEVELOPMENT PROGRAM.—If a person has 

4 failed to pay an annual biosimilar biologi5 cal product development fee for a product 

6 as required under subparagraph (B) for a 

7 period of 2 consecutive fiscal years, the 

8 Secretary may administratively remove 

9 such person from the biosimilar biological 

10 product development program for the prod11 uct. At least 30 days prior to administra12 tively removing a person from the bio13 similar biological product development pro14 gram for a product under this clause, the 

15 Secretary shall provide written notice to 

16 such person of the intended administrative 

17 removal.’’; 

18 (3) in paragraph (2)(D), by inserting ‘‘prior to 

19 approval’’ after ‘‘withdrawn’’; 

20 (4) in paragraph (3)— 

21 (A) in subparagraph (A)— 

22 (i) in clause (i), by striking ‘‘; and’’ 

23 and inserting a semicolon; 

24 (ii) by redesignating clause (ii) as 

25 clause (iii); and 


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1 (iii) by inserting the following after 

2 clause (i): 

3 ‘‘(ii) may be dispensed only under pre4 scription pursuant to section 503(b); and’’; 

5 and 

6 (B) by adding at the end the following: 

7 ‘‘(E) MOVEMENT TO DISCONTINUED

8 LIST.— 

9 ‘‘(i) WRITTEN REQUEST TO PLACE ON

10 DISCONTINUED LIST.— 

11 ‘‘(I) IN GENERAL.—If a written 

12 request to place a product on the list 

13 of discontinued biosimilar biological 

14 products referred to in subparagraph 

15 (A)(iii) is submitted to the Secretary 

16 on behalf of an applicant, and the re17 quest identifies the date the product 

18 is, or will be, withdrawn from sale, 

19 then for purposes of assessing the bio20 similar biological product program fee, 

21 the Secretary shall consider such 

22 product to have been included on such 

23 list on the later of— 

24 ‘‘(aa) the date such request 

25 was received; or 


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1 ‘‘(bb) if the product will be 

2 withdrawn from sale on a future 

3 date, such future date when the 

4 product is withdrawn from sale. 

5 ‘‘(II) WITHDRAWN FROM SALE

6 DEFINED.—For purposes of this 

7 clause, a product shall be considered 

8 withdrawn from sale once the appli9 cant has ceased its own distribution of 

10 the product, whether or not the appli11 cant has ordered recall of all pre12 viously distributed lots of the product, 

13 except that a routine, temporary 

14 interruption in supply shall not render 

15 a product withdrawn from sale. 

16 ‘‘(ii) PRODUCTS REMOVED FROM DIS17 CONTINUED LIST.—If a biosimilar biologi18 cal product that is identified in a bio19 similar biological product application ap20 proved as of October 1 of a fiscal year ap21 pears, as of October 1 of such fiscal year, 

22 on the list of discontinued biosimilar bio23 logical products referred to in subpara24 graph (A)(iii), and on any subsequent day 

25 during such fiscal year the biosimilar bioVerDate Sep 11 2014 23:43 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S4535.IS S4535

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1 logical product does not appear on such 

2 list, except as provided in subparagraph 

3 (D), each person who is named as the ap4 plicant in the biosimilar biological product 

5 application shall pay the annual biosimilar 

6 biological product program fee established 

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

8 such biosimilar biological product. Not9 withstanding subparagraph (B), such fee 

10 shall be due on the last business day of 

11 such fiscal year and shall be paid only once 

12 for each product for each fiscal year.’’; and 

13 (5) by striking paragraph (4). 

14 (b) FEE REVENUE AMOUNTS.—Section 744H(b) of 

15 the Federal Food, Drug, and Cosmetic Act ((21 U.S.C. 

16 379j–52(b)) is amended— 

17 (1) by striking paragraph (1); 

18 (2) by redesignating paragraphs (2) through 

19 (4) as paragraphs (1) through (3), respectively; 

20 (3) in paragraph (1), as so redesignated— 

21 (A) in the paragraph heading, by striking 

22 ‘‘SUBSEQUENT FISCAL YEARS’’ and inserting 

23 ‘‘IN GENERAL’’; 


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1 (B) in the matter preceding subparagraph 

2 (A), by striking ‘‘2019 through 2022’’ and in3 serting ‘‘2023 through 2027’’; 

4 (C) in subparagraph (A), by striking 

5 ‘‘paragraph (4)’’ and inserting ‘‘paragraph 

6 (3)’’; 

7 (D) by redesignating subparagraphs (C) 

8 and (D) as subparagraphs (D) and (E), respec9 tively; 

10 (E) by inserting after subparagraph (B) 

11 the following: 

12 ‘‘(C) the dollar amount equal to the stra13 tegic hiring and retention adjustment (as deter14 mined under subsection (c)(2));’’; 

15 (F) in subparagraph (D), as so redesig16 nated, by striking ‘‘subsection (c)(2)); and’’ and 

17 inserting ‘‘subsection (c)(3));’’; 

18 (G) in subparagraph (E), as so redesig19 nated, by striking ‘‘subsection (c)(3)).’’ and in20 serting ‘‘subsection (c)(4)); and’’; and 

21 (H) by adding at the end the following: 

22 ‘‘(F) for fiscal years 2023 and 2024, addi23 tional dollar amounts equal to— 

24 ‘‘(i) $4,428,886 for fiscal year 2023; 

25 and 


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1 ‘‘(ii) $320,569 for fiscal year 2024.’’; 

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

3 (A) in the paragraph heading, by striking 

4 ‘‘; LIMITATIONS ON FEE AMOUNTS’’; 

5 (B) by striking subparagraph (B); and 

6 (C) by redesignating subaparagraphs (C) 

7 and (D) as subparagraphs (B) and (C), respec8 tively; and 

9 (5) by amending paragraph (3), as so redesig10 nated, to read as follows: 

11 ‘‘(3) ANNUAL BASE REVENUE.—For purposes 

12 of paragraph (1), the dollar amount of the annual 

13 base revenue for a fiscal year shall be— 

14 ‘‘(A) for fiscal year 2023, $43,376,922; 

15 and 

16 ‘‘(B) for fiscal years 2024 through 2027, 

17 the dollar amount of the total revenue amount 

18 established under paragraph (1) for the pre19 vious fiscal year, excluding any adjustments to 

20 such revenue amount under subsection (c)(4).’’. 

21 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

22 744H(c) of the Federal Food, Drug, and Cosmetic Act 

23 ((21 U.S.C. 379j–52(c)) is amended— 

24 (1) in paragraph (1)— 

25 (A) in subparagraph (A)— 


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1 (i) in the matter preceding clause (i), 

2 by striking ‘‘subsection (b)(2)(B)’’ and in3 serting ‘‘subsection (b)(1)(B)’’; and 

4 (ii) in clause (i), by striking ‘‘sub5 section (b)’’ and inserting ‘‘subsection 

6 (b)(1)(A)’’; and 

7 (B) in subparagraph (B)(ii), by striking 

8 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ 

9 and inserting ‘‘Washington–Arlington–Alexan10 dria, DC–VA–MD–WV’’; 

11 (2) by striking paragraph (4); 

12 (3) by redesignating paragraphs (2) and (3) as 

13 paragraphs (3) and (4), respectively; 

14 (4) by inserting after paragraph (1) the fol15 lowing: 

16 ‘‘(2) STRATEGIC HIRING AND RETENTION AD17 JUSTMENT.—For each fiscal year beginning in fiscal 

18 year 2023, after the annual base revenue under sub19 section (b)(1)(A) is adjusted for inflation in accord20 ance with paragraph (1), the Secretary shall further 

21 increase the fee revenue and fees by $150,000.’’; 

22 (5) in paragraph (3), as so redesignated— 

23 (A) in subparagraph (A)— 

24 (i) by striking ‘‘Beginning with the 

25 fiscal year described in subparagraph 


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1 (B)(ii)(II)’’ and inserting ‘‘For each fiscal 

2 year’’; and 

3 (ii) by striking ‘‘adjustment under 

4 paragraph (1), further increase’’ and in5 serting ‘‘adjustments under paragraphs (1) 

6 and (2), further adjust’’; 

7 (B) by amending subparagraph (B) to read 

8 as follows: 

9 ‘‘(B) METHODOLOGY.—For purposes of 

10 this paragraph, the Secretary shall employ the 

11 capacity planning methodology utilized by the 

12 Secretary in setting fees for fiscal year 2021, as 

13 described in the notice titled ‘Biosimilar User 

14 Fee Rates for Fiscal Year 2021’ (85 Fed. Reg. 

15 47220; August 4, 2020). The workload cat16 egories used in forecasting shall include only 

17 the activities described in such notice and, as 

18 feasible, additional activities that are also di19 rectly related to the direct review of biosimilar 

20 biological product applications and supplements, 

21 including additional formal meeting types and 

22 the direct review of postmarketing commitments 

23 and requirements, the direct review of risk eval24 uation and mitigation strategies, and the direct 

25 review of annual reports for approved biosimilar 


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1 biological products. Subject to the exceptions in 

2 the preceding sentence, the Secretary shall not 

3 include as workload categories in forecasting 

4 any non-core review activities, including any ac5 tivities that the Secretary referenced for poten6 tial future use in such notice but did not utilize 

7 in setting fees for fiscal year 2021.’’; and 

8 (C) in subparagraph (C)— 

9 (i) by striking ‘‘subsections (b)(2)(A)’’ 

10 and inserting ‘‘subsections (b)(1)(A)’’; 

11 (ii) by striking ‘‘and (b)(2)(B)’’ and 

12 inserting ‘‘, (b)(1)(B)’’; and 

13 (iii) by inserting ‘‘, and (b)(1)(C) (the 

14 dollar amount of the strategic hiring and 

15 retention adjustment)’’ before the period at 

16 the end; 

17 (6) by amending paragraph (4), as so redesig18 nated, to read as follows: 

19 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

20 ‘‘(A) INCREASE.—For fiscal year 2023 and 

21 subsequent fiscal years, the Secretary shall, in 

22 addition to adjustments under paragraphs (1), 

23 (2), and (3), further increase the fee revenue 

24 and fees if such an adjustment is necessary to 

25 provide for at least 10 weeks of operating reVerDate Sep 11 2014 23:43 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6201 E:\BILLS\S4535.IS S4535

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1 serves of carryover user fees for the process for 

2 the review of biosimilar biological product appli3 cations. 

4 ‘‘(B) DECREASE.— 

5 ‘‘(i) FISCAL YEAR 2023.—For fiscal 

6 year 2023, if the Secretary has carryover 

7 balances for the process for the review of 

8 biosimilar biological product applications in 

9 excess of 33 weeks of such operating re10 serves, the Secretary shall decrease such 

11 fee revenue and fees to provide for not 

12 more than 33 weeks of such operating re13 serves. 

14 ‘‘(ii) FISCAL YEAR 2024.—For fiscal 

15 year 2024, if the Secretary has carryover 

16 balances for the process for the review of 

17 biosimilar biological product applications in 

18 excess of 27 weeks of such operating re19 serves, the Secretary shall decrease such 

20 fee revenue and fees to provide for not 

21 more than 27 weeks of such operating re22 serves. 

23 ‘‘(iii) FISCAL YEAR 2025 AND SUBSE24 QUENT FISCAL YEARS.—For fiscal year 

25 2025 and subsequent fiscal years, if the 


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1 Secretary has carryover balances for the 

2 process for the review of biosimilar biologi3 cal product applications in excess of 21 

4 weeks of such operating reserves, the Sec5 retary shall decrease such fee revenue and 

6 fees to provide for not more than 21 weeks 

7 of such operating reserves. 

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

9 adjustment under subparagraph (A) or (B) is 

10 made, the rationale for the amount of the in11 crease or decrease (as applicable) in fee revenue 

12 and fees shall be contained in the annual Fed13 eral Register notice under paragraph (5)(B) es14 tablishing fee revenue and fees for the fiscal 

15 year involved.’’; and 

16 (7) in paragraph (5), in the matter preceding 

17 subparagraph (A), by striking ‘‘2018’’ and inserting 

18 ‘‘2023’’. 

19 (d) CREDITING AND AVAILABILITY OF FEES.—Sec20 tion 744H(f)(3) of the Federal Food, Drug, and Cosmetic 

21 Act ((21 U.S.C. 379j–52(f)(3)) is amended by striking 

22 ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

23 2027’’. 

24 (e) WRITTEN REQUESTS FOR WAIVERS AND RE25 FUNDS.—Subsection (h) of section 744H of the Federal 


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

2 amended to read as follows: 

3 ‘‘(h) WRITTEN REQUESTS FOR WAIVERS AND RE4 TURNS; DISPUTES CONCERNING FEES.—To qualify for 

5 consideration for a waiver under subsection (d), or the re6 turn of any fee paid under this section, including if the 

7 fee is claimed to have been paid in error, a person shall 

8 submit to the Secretary a written request justifying such 

9 waiver or return and, except as otherwise specified in this 

10 section, such written request shall be submitted to the Sec11 retary not later than 180 days after such fee is due. A 

12 request submitted under this paragraph shall include any 

13 legal authorities under which the request is made.’’. 

14 SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 

15 Section 744I of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 379j–53) is amended— 

17 (1) by striking ‘‘2018’’ each place it appears 

18 and inserting ‘‘2023’’; 

19 (2) by striking ‘‘Biosimilar User Fee Amend20 ments of 2017’’ each place it appears and inserting 

21 ‘‘Biosimilar User Fee Amendments of 2022’’; 

22 (3) in subsection (a)(4), by striking ‘‘2020’’ and 

23 inserting ‘‘2023’’; and 

24 (4) in subsection (f), by striking ‘‘2022’’ each 

25 place it appears and inserting ‘‘2027’’. 


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1 SEC. 405. SUNSET DATES. 

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

3 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 379j–51, 379j–52) shall cease to be effective October 1, 

5 2027. 

6 (b) REPORTING REQUIREMENTS.—Section 744I of 

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

8 379j–53) shall cease to be effective January 31, 2028. 

9 (c) PREVIOUS SUNSET PROVISION.—Effective Octo10 ber 1, 2022, subsections (a) and (b) of section 405 of the 

11 FDA Reauthorization Act of 2017 (Public Law 115–52) 

12 are repealed. 

13 SEC. 406. EFFECTIVE DATE. 

14 The amendments made by this title shall take effect 

15 on October 1, 2022, or the date of the enactment of this 

16 Act, whichever is later, except that fees under part 8 of 

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

18 and Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be 

19 assessed for all biosimilar biological product applications 

20 received on or after October 1, 2022, regardless of the 

21 date of the enactment of this Act. 

22 SEC. 407. SAVINGS CLAUSE. 

23 Notwithstanding the amendments made by this title, 

24 part 8 of subchapter C of chapter VII of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as 

26 in effect on the day before the date of the enactment of 


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1 this title, shall continue to be in effect with respect to bio2 similar biological product applications and supplements 

3 (as defined in such part as of such day) that were accepted 

4 by the Food and Drug Administration for filing on or after 

5 October 1, 2017, but before October 1, 2022, with respect 

6 to assessing and collecting any fee required by such part 

7 for a fiscal year prior to fiscal year 2023. 

8 TITLE V—OTHER 

9 REAUTHORIZATIONS 

10 SEC. 501. REAUTHORIZATION OF THE CRITICAL PATH PUB11 LIC-PRIVATE PARTNERSHIP. 

12 Section 566(f) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 

14 ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

15 2027’’. 

16 SEC. 502. REAUTHORIZATION OF THE BEST PHARMA17 CEUTICALS FOR CHILDREN PROGRAM. 

18 Section 409I(d)(1) of the Public Health Service Act 

19 (42 U.S.C. 284m(d)(1)) is amended by striking ‘‘2018 

20 through 2022’’ and inserting ‘‘2023 through 2027’’. 

21 SEC. 503. REAUTHORIZATION OF THE HUMANITARIAN DE22 VICE EXEMPTION INCENTIVE. 

23 Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

25 amended by striking ‘‘2022’’ and inserting ‘‘2027’’. 


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1 SEC. 504. REAUTHORIZATION OF THE PEDIATRIC DEVICE 

2 CONSORTIA PROGRAM. 

3 Section 305(e) of the Food and Drug Administration 

4 Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 

5 282 note) is amended by striking ‘‘$5,250,000 for each 

6 of fiscal years 2018 through 2022’’ and inserting 

7 ‘‘$7,000,000 for each of fiscal years 2023 through 2027’’. 

8 SEC. 505. REAUTHORIZATION OF PROVISION PERTAINING 

9 TO DRUGS CONTAINING SINGLE 

10 ENANTIOMERS. 

11 Section 505(u)(4) of the Federal Food, Drug, and 

12 Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by strik13 ing ‘‘October 1, 2022’’ and inserting ‘‘October 1, 2027’’. 

14 SEC. 506. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 

15 Section 5(c) of the Orphan Drug Act (21 U.S.C. 

16 360ee(c)) is amended by striking ‘‘2018 through 2022’’ 

17 and inserting ‘‘2023 through 2027’’. 

18 SEC. 507. REAUTHORIZATION OF CERTAIN DEVICE INSPEC19 TIONS. 

20 Section 704(g)(11) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik22 ing ‘‘2022’’ and inserting ‘‘2027’’. 

Æ 


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