H. R. 6833—47 
to assessing and collecting any fee required by such part for a 
fiscal year prior to fiscal year 2023. 
TITLE IV—FEES RELATING TO 
BIOSIMILAR BIOLOGICAL PRODUCTS 
SEC. 4001. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Biosimilar 
User Fee Amendments of 2022’’. 
(b) FINDING.—Congress finds that the fees authorized by the 
amendments made by this title will be dedicated to expediting 
the process for the review of biosimilar biological product applica-
tions, including postmarket safety activities, as set forth in the 
goals identified for purposes of part 8 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
51 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 Com-
mittee on Energy and Commerce of the House of Representatives, 
as set forth in the Congressional Record. 
SEC. 4002. DEFINITIONS. 
(a) ADJUSTMENT FACTOR.—Section 744G(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read 
as follows: 
‘‘(1) The term ‘adjustment factor’ applicable to a fiscal 
year is the Consumer Price Index for urban consumers (Wash-
ington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally 
Adjusted; All items) for September of the preceding fiscal year 
divided by such Index for September 2011.’’. 
(b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION.—Section 
744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–51(4)(B)(iii)) is amended— 
(1) by striking subclause (II) (relating to an allergenic 
extract product); and 
(2) by redesignating subclauses (III) and (IV) as subclauses 
(II) and (III), respectively. 
SEC. 4003. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL 
PRODUCT FEES. 
(a) TYPES OF FEES.— 
(1) IN GENERAL.—The matter preceding paragraph (1) in 
section 744H(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–52(a)) is amended by striking ‘‘fiscal year 2018’’ 
and inserting ‘‘fiscal year 2023’’. 
(2) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT 
FEE.—Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(a)(1)(A)) are each amended by striking ‘‘5 days’’ and inserting 
‘‘7 days’’. 
(3) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT 
FEE.—Section 744H(a)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–52(a)(1)(B)) is amended— 
(A) in clause (i), by inserting before the period at 
the end the following: ‘‘, except that, in the case that 
such product (including, where applicable, ownership of
H. R. 6833—48 
the relevant investigational new drug application) is trans-
ferred to a licensee, assignee, or successor of such person, 
and written notice of such transfer is provided to the Sec-
retary, such licensee, assignee, or successor shall pay the 
annual biosimilar biological product development fee’’; 
(B) in clause (iii)— 
(i) in subclause (I), by striking ‘‘or’’ at the end; 
(ii) in subclause (II), by striking the period at 
the end and inserting ‘‘; or’’; and 
(iii) by adding at the end the following: 
‘‘(III) been administratively removed from the 
biosimilar biological product development program 
for the product under subparagraph (E)(v).’’; and 
(C) in clause (iv), by striking ‘‘is accepted for filing 
on or after October 1 of such fiscal year’’ and inserting 
‘‘is subsequently accepted for filing’’. 
(4) REACTIVATION FEE.—Section 744H(a)(1)(D) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(D)) 
is amended to read as follows: 
‘‘(D) REACTIVATION FEE.— 
‘‘(i) IN GENERAL.—A person that has discontinued 
participation in the biosimilar biological product 
development program for a product under subpara-
graph (C), or who has been administratively removed 
from such program for a product under subparagraph 
(E)(v), shall, if the person seeks to resume participation 
in such program, pay all annual biosimilar biological 
product development fees previously assessed for such 
product and still owed and a fee (referred to in this 
section as ‘reactivation fee’) by the earlier of the fol-
lowing: 
‘‘(I) Not later than 7 days after the Secretary 
grants a request by such person for a biosimilar 
biological product development meeting for the 
product (after the date on which such participation 
was discontinued or the date of administrative 
removal, as applicable). 
‘‘(II) Upon the date of submission (after the 
date on which such participation was discontinued 
or 
the 
date 
of 
administrative 
removal, 
as 
applicable) by such person of an investigational 
new drug application describing an investigation 
that the Secretary determines is intended to sup-
port a biosimilar biological product application for 
that product. 
‘‘(ii) APPLICATION OF ANNUAL FEE.—A person that 
pays a reactivation fee for a product shall pay for 
such product, beginning in the next fiscal year, the 
annual biosimilar biological product development fee 
under subparagraph (B), except that, in the case that 
such product (including, where applicable, ownership 
of the relevant investigational new drug application) 
is transferred to a licensee, assignee, or successor of 
such person, and written notice of such transfer is 
provided to the Secretary, such licensee, assignee, or 
successor shall pay the annual biosimilar biological 
product development fee.’’.
H. R. 6833—49 
(5) EFFECT OF FAILURE TO PAY FEES.—Section 744H(a)(1)(E) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(a)(1)(E)) is amended by adding at the end the following: 
‘‘(v) ADMINISTRATIVE
REMOVAL
FROM
THE
BIO-
SIMILAR
BIOLOGICAL
PRODUCT
DEVELOPMENT
PRO-
GRAM.—If a person has failed to pay an annual bio-
similar biological product development fee for a product 
as required under subparagraph (B) for a period of 
2 consecutive fiscal years, the Secretary may adminis-
tratively remove such person from the biosimilar 
biological product development program for the 
product. At least 30 days prior to administratively 
removing a person from the biosimilar biological 
product development program for a product under this 
clause, the Secretary shall provide written notice to 
such person of the intended administrative removal.’’. 
(6) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEE.— 
Section 744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–52(a)(2)(D)) is amended by inserting after 
‘‘or was withdrawn’’ the following: ‘‘prior to approval’’. 
(7) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEE.—Sec-
tion 744H(a)(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–52(a)(3)) is amended— 
(A) in subparagraph (A)— 
(i) in clause (i), by striking ‘‘and’’ at the end; 
(ii) by redesignating clause (ii) as clause (iii); and 
(iii) by inserting after clause (i) the following: 
‘‘(ii) may be dispensed only under prescription 
pursuant to section 503(b); and’’; and 
(B) by adding at the end the following: 
‘‘(E) MOVEMENT TO DISCONTINUED LIST.— 
‘‘(i) DATE OF INCLUSION.—If a written request to 
place a product on the list referenced in subparagraph 
(A) of discontinued biosimilar biological products is 
submitted to the Secretary on behalf of an applicant, 
and the request identifies the date the product is, 
or will be, withdrawn from sale, then for purposes 
of assessing the biosimilar biological product program 
fee, the Secretary shall consider such product to have 
been included on such list on the later of— 
‘‘(I) the date such request was received; or 
‘‘(II) if the product will be withdrawn from 
sale on a future date, such future date when the 
product is withdrawn from sale. 
‘‘(ii) TREATMENT AS WITHDRAWN FROM SALE.—For 
purposes of clause (i), a product shall be considered 
withdrawn from sale once the applicant has ceased 
its own distribution of the product, whether or not 
the applicant has ordered recall of all previously 
distributed lots of the product, except that a routine, 
temporary interruption in supply shall not render a 
product withdrawn from sale. 
‘‘(iii) SPECIAL RULE FOR PRODUCTS REMOVED FROM 
DISCONTINUED LIST.—If a biosimilar biological product 
that is identified in a biosimilar biological product 
application approved as of October 1 of a fiscal year 
appears, as of October 1 of such fiscal year, on the