Editorial Notes
Amendments
2022—Par. (1). Pub. L. 117–180, § 4002(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011.”
Par. (4)(B)(iii)(II)–(IV). Pub. L. 117–180, § 4002(b), redesignated subcls. (III) and (IV) as (II) and (III), respectively, and struck out former subcl. (II) which read as follows: “an allergenic extract product;”.
2017—Par. (1). Pub. L. 115–52, § 402(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “The term ‘adjustment factor’ applicable to a fiscal year that is the Consumer Price Index for all urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such Index for September 2011.”
Par. (3). Pub. L. 115–52, § 402(b), substituted “means a specific strength of a biological product in final dosage form” for “means a product”.
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Pub. L. 117–180, div. F, title IV, § 4006, Sept. 30, 2022, 136 Stat. 2166, provided that:
“The amendments made by this title [see
section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under
section 301 of this title] shall take effect on
October 1, 2022, or the date of the enactment of this Act [
Sept. 30, 2022], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379j–51 et seq.) shall be assessed for all
biosimilar biological product applications received on or after
October 1, 2022, regardless of the date of the enactment of this Act.”
Effective Date of 2017 Amendment
Pub. L. 115–52, title IV, § 406, Aug. 18, 2017, 131 Stat. 1035, provided that:
“The amendments made by this title [see
section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under
section 301 of this title] shall take effect on
October 1, 2017, or the date of the enactment of this Act [
Aug. 18, 2017], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 379j–51 et seq.] shall be assessed for all
biosimilar biological product applications received on or after
October 1, 2017, regardless of the date of the enactment of this Act.”
Effective and Termination Dates
Pub. L. 117–180, div. F, title IV, § 4005(a), Sept. 30, 2022, 136 Stat. 2166, provided that:
“Sections 744G and 744H of the
Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379j–51, 379j–52) shall cease to be effective
October 1, 2027.”
Pub. L. 115–52, title IV, § 405(a), Aug. 18, 2017, 131 Stat. 1035, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title IV, § 4005(c), Sept. 30, 2022, 136 Stat. 2166.
[Pub. L. 117–180, div. F, title IV, § 4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]
Pub. L. 112–144, title IV, § 404(a), July 9, 2012, 126 Stat. 1038, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title IV, § 405(c)(1), Aug. 18, 2017, 131 Stat. 1035.
[Pub. L. 115–52, title III, § 405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]
Pub. L. 112–144, title IV, § 405, July 9, 2012, 126 Stat. 1039, provided that:
“(a) In General.—Except as provided under subsection (b), the amendments made by this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] shall take effect on the later of—
“(2)
the date of the enactment of this title [July 9, 2012].
Savings
Pub. L. 117–180, div. F, title IV, § 4007, Sept. 30, 2022, 136 Stat. 2167, provided that:
“Notwithstanding the amendments made by this title [see
section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under
section 301 of this title], part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379j–51 et seq.), as in effect on the day before the date of the enactment of this title [
Sept. 30, 2022], shall continue to be in effect with respect to
biosimilar biological product applications and
supplements (as defined in such part as of such day) that were accepted by the
Food and Drug Administration for filing on or after
October 1, 2017, but before
October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.”
Pub. L. 115–52, title IV, § 407, Aug. 18, 2017, 131 Stat. 1035, provided that:
“Notwithstanding the amendments made by this title [see
section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under
section 301 of this title], part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 379j–51 et seq.], as in effect on the day before the date of the enactment of this title [
Aug. 18, 2017], shall continue to be in effect with respect to
biosimilar biological product applications and
supplements (as defined in such part as of such day) that were accepted by the
Food and Drug Administration for filing on or after
October 1, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.”
Congressional Findings Concerning Fees Relating to Biosimilar Biological Products
Pub. L. 117–180, div. F, title IV, § 4001(b), Sept. 30, 2022, 136 Stat. 2160, provided that:
“
Congress finds that the fees authorized by the amendments made by this title [see
section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under
section 301 of this title] will be dedicated to expediting the
process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (
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 Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record.”
Pub. L. 115–52, title IV, § 401(b), Aug. 18, 2017, 131 Stat. 1028, provided that:
“The
Congress finds that the fees authorized by the amendments made in this title [see
section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under
section 301 of this title] will be dedicated to expediting the
process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [
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 Committee on Energy and Commerce of the
House of Representatives, as set forth in the Congressional Record.”
Pub. L. 112–144, title IV, § 401(b), July 9, 2012, 126 Stat. 1026, provided that:
“The
Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections
379j–52 and
379j–53 of this title and amending sections
379d–4 and
379g of this title] will be dedicated to expediting the
process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [this subpart], 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.”