H. R. 6833—39 
‘‘(C) HIRING ADJUSTMENT AMOUNT.—The hiring adjust-
ment amount for fiscal year 2025 and each subsequent 
fiscal year is the product of— 
‘‘(i) the number of hires by which the hiring goal 
specified in subparagraph (D) for the fiscal year before 
the prior fiscal year was not met; 
‘‘(ii) $72,877; and 
‘‘(iii) the applicable inflation adjustment under 
paragraph (2)(B) for the fiscal year for which the hiring 
goal was not met. 
‘‘(D) HIRING GOALS.—The hiring goals for each of fiscal 
years 2023 through 2025 are as follows: 
‘‘(i) For fiscal year 2023, 144 hires. 
‘‘(ii) For fiscal year 2024, 42 hires. 
‘‘(iii) For fiscal year 2025: 
‘‘(I) 24 hires if the base establishment registra-
tion fees are not increased by the amount deter-
mined under paragraph (4)(A)(i). 
‘‘(II) 83 hires if the base establishment reg-
istration fees are increased by the amount deter-
mined under paragraph (4)(A)(i). 
‘‘(E) NUMBER OF HIRES.—For purposes of this para-
graph, the number of hires for a fiscal year shall be deter-
mined by the Secretary as set forth in the letters described 
in section 2001(b) of the Medical Device User Fee Amend-
ments of 2022. 
‘‘(6) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—For each of fiscal years 2023 
through 2027, after the adjustments under paragraphs (2), 
(3), (4), and (5), if applicable, if the Secretary has operating 
reserves of carryover user fees for the process for the review 
of device applications in excess of the designated amount 
in subparagraph (B), the Secretary shall decrease the base 
establishment registration fee amounts to provide for not 
more than such designated amount of operating reserves. 
‘‘(B) DESIGNATED AMOUNT.—Subject to subparagraph 
(C), for each fiscal year, the designated amount in this 
subparagraph is equal to the sum of— 
‘‘(i) 13 weeks of operating reserves of carryover 
user fees; and 
‘‘(ii) 1 month of operating reserves maintained 
pursuant to paragraph (8). 
‘‘(C) EXCLUDED AMOUNT.—For the period of fiscal years 
2023 through 2026, a total amount equal to $118,000,000 
shall not be considered part of the designated amount 
under subparagraph (B) and shall not be subject to the 
decrease under subparagraph (A).’’. 
(d) CONDITIONS.—Section 738(g) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j(g)) is amended— 
(1) in paragraph (1)(A), by striking ‘‘$320,825,000’’ and 
inserting ‘‘$398,566,000’’; and 
(2) in paragraph (2), by inserting ‘‘de novo classification 
requests,’’ after ‘‘class III device,’’. 
(e) CREDITING AND AVAILABILITY OF FEES.—Section 738(h)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) 
is amended to read as follows: 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—
H. R. 6833—40 
‘‘(A) IN
GENERAL.—For each of fiscal years 2023 
through 2027, there is authorized to be appropriated for 
fees under this section an amount equal to the revenue 
amount determined under subparagraph (B), less the 
amount of reductions determined under subparagraph (C). 
‘‘(B) REVENUE
AMOUNT.—For purposes of this para-
graph, the revenue amount for each fiscal year is the 
sum of— 
‘‘(i) the total revenue amount under subsection 
(b)(3) for the fiscal year, as adjusted under paragraphs 
(2) and (3) of subsection (c); and 
‘‘(ii) the performance improvement adjustment 
amount for the fiscal year under subsection (c)(4), if 
applicable. 
‘‘(C) AMOUNT OF REDUCTIONS.—For purposes of this 
paragraph, the amount of reductions for each fiscal year 
is the sum of— 
‘‘(i) the hiring adjustment amount for the fiscal 
year under subsection (c)(5), if applicable; and 
‘‘(ii) the operating reserve adjustment amount for 
the fiscal year under subsection (c)(6), if applicable.’’. 
SEC. 2004. 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) by striking ‘‘fiscal year 2018’’ each place it appears 
and inserting ‘‘fiscal year 2023’’; 
(2) by striking ‘‘Medical Device User Fee Amendments of 
2017’’ each place it appears and inserting ‘‘Medical Device 
User Fee Amendments of 2022’’; 
(3) in paragraph (1)— 
(A) in subparagraph (A), by redesignating the second 
clause (iv) (relating to analysis) as clause (v); and 
(B) in subparagraph (A)(iv), by striking ‘‘fiscal year 
2020’’ and inserting ‘‘fiscal year 2023’’; and 
(4) in paragraph (4), by striking ‘‘2018 through 2022’’ and 
inserting ‘‘2023 through 2027’’. 
(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 ‘‘2022’’ and inserting 
‘‘2027’’; and 
(2) in paragraph (5), by striking ‘‘2022’’ and inserting 
‘‘2027’’. 
SEC. 2005. CONFORMITY ASSESSMENT PILOT PROGRAM. 
Section 514(d) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360d(d)) is amended to read as follows: 
‘‘(d) ACCREDITATION SCHEME FOR CONFORMITY ASSESSMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall establish a program 
under which— 
‘‘(A) testing laboratories meeting criteria specified in 
guidance by the Secretary may be accredited, by accredita-
tion bodies meeting criteria specified in guidance by the 
Secretary, to conduct testing to support the assessment 
of the conformity of a device to certain standards recognized 
under this section; and 
‘‘(B) subject to paragraph (2), results from tests con-
ducted to support the assessment of conformity of devices
H. R. 6833—41 
as described in subparagraph (A) conducted by testing lab-
oratories accredited pursuant to this subsection shall be 
accepted by the Secretary for purposes of demonstrating 
such conformity unless the Secretary finds that certain 
results of such tests should not be so accepted. 
‘‘(2) SECRETARIAL
REVIEW
OF
ACCREDITED
LABORATORY 
RESULTS.—The Secretary may— 
‘‘(A) review the results of tests conducted by testing 
laboratories 
accredited 
pursuant 
to 
this 
subsection, 
including by conducting periodic audits of such results or 
of the processes of accredited bodies or testing laboratories; 
‘‘(B) following such review, take additional measures 
under this Act, as the Secretary determines appropriate, 
such as— 
‘‘(i) suspension or withdrawal of accreditation of 
a testing laboratory or recognition of an accreditation 
body under paragraph (1)(A); or 
‘‘(ii) requesting additional information with respect 
to a device; and 
‘‘(C) if the Secretary becomes aware of information 
materially bearing on the safety or effectiveness of a device 
for which an assessment of conformity was supported by 
testing conducted by a testing laboratory accredited under 
this subsection, take such additional measures under this 
Act, as the Secretary determines appropriate, such as— 
‘‘(i) suspension or withdrawal of accreditation of 
a testing laboratory or recognition of an accreditation 
body under paragraph (1)(A); or 
‘‘(ii) requesting additional information with regard 
to such device. 
‘‘(3) REPORT.—The Secretary shall make available on the 
internet website of the Food and Drug Administration an 
annual report on the progress of the program under this sub-
section.’’. 
SEC. 2006. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM. 
Section 523(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360m(c)) is amended by striking ‘‘October 1’’ and 
inserting ‘‘December 17’’. 
SEC. 2007. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 737 and 738 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be 
effective October 1, 2027. 
(b) REPORTING REQUIREMENTS.—Section 738A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1) shall cease to 
be effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISIONS.—Effective October 1, 2022, 
subsections (a) and (b) of section 210 of the FDA Reauthorization 
Act of 2017 (Public Law 115–52) are repealed. 
SEC. 2008. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2022, 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 (21 U.S.C. 379i 
et seq.) shall be assessed for all submissions listed in section
H. R. 6833—42 
738(a)(2)(A) of such Act received on or after October 1, 2022, regard-
less of the date of the enactment of this Act. 
SEC. 2009. 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, 2017, but before October 1, 2022, were 
received by the Food and Drug Administration with respect to 
assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2023. 
TITLE III—FEES RELATING TO GENERIC 
DRUGS 
SEC. 3001. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Generic 
Drug User Fee Amendments of 2022’’. 
(b) FINDING.—Congress finds that the fees authorized by the 
amendments made by 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 (21 U.S.C. 379j–41 et seq.), 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. 3002. 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 
‘‘2018’’ and inserting ‘‘2023’’; 
(2) in paragraph (2)(C), by striking ‘‘2018 through 2022’’ 
and inserting ‘‘2023 through 2027’’; 
(3) in paragraph (3)(B), by striking ‘‘2018 through 2022’’ 
and inserting ‘‘2023 through 2027’’; 
(4) in paragraph (4)(D), by striking ‘‘2018 through 2022’’ 
and inserting ‘‘2023 through 2027’’; and 
(5) in paragraph (5)(D), by striking ‘‘2018 through 2022’’ 
and inserting ‘‘2023 through 2027’’. 
(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 ‘‘2018’’ and inserting 
‘‘2023’’; 
(ii) by striking ‘‘2018’’ and inserting ‘‘2023’’; and 
(iii) by striking ‘‘$493,600,000’’ and inserting 
‘‘$582,500,000’’; and 
(B) by amending subparagraph (B) to read as follows: