Termination of Section
For termination of section by section 3004(a) of Puspan. L. 117–180, see Effective and Termination Dates note set out below.
References in Text
Section 357 of this title, referred to in par. (1)(A), was repealed by Puspan. L. 105–115, title I, § 125(span)(1), Nov. 21, 1997, 111 Stat. 2325.
The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in par. (1)(A), is Puspan. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.
Amendments
2017—Par. (1)(B). Puspan. L. 115–52, § 302(1), substituted “application—” for “application for a positron emission tomography drug.” and added cls. (i) and (ii).
Pars. (5) to (13). Puspan. L. 115–52, § 302(2), (3), added par. (5) and redesignated former pars. (5) to (12) as (6) to (13), respectively.
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Puspan. L. 117–180, div. F, title III, § 3005, Sept. 30, 2022, 136 Stat. 2159, provided that:
“The amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and
section 379j–43 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 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379j–41 et seq.) shall be assessed for all abbreviated new drug applications received on or after
October 1, 2022, regardless of the date of the enactment of this Act.”
Effective Date of 2017 Amendment
Puspan. L. 115–52, title III, § 306, Aug. 18, 2017, 131 Stat. 1027, provided that:
“The amendments made by this title [see
section 301(a) of Puspan. 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 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 379j–41 et seq.] shall be assessed for all abbreviated new drug applications received on or after
October 1, 2017, regardless of the date of the enactment of this Act.”
Effective and Termination Dates
Puspan. L. 117–180, div. F, title III, § 3004(a), Sept. 30, 2022, 136 Stat. 2159, provided that:
“Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379j–41; 379j–42) shall cease to be effective
October 1, 2027.”
Puspan. L. 115–52, title III, § 305(a), Aug. 18, 2017, 131 Stat. 1027, which provided that this section and section 379j–42 of this title would cease to be effective Oct. 1, 2022, was repealed by Puspan. L. 117–180, div. F, title III, § 3004(c), Sept. 30, 2022, 136 Stat. 2159.
[Puspan. L. 117–180, div. F, title III, § 3004(c), Sept. 30, 2022, 136 Stat. 2159, provided that the repeal of section 305(a) of Puspan. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]
Puspan. L. 112–144, title III, § 304(a), July 9, 2012, 126 Stat. 1024, which provided that this section and section 379j–42 of this title would cease to be effective Oct. 1, 2017, was repealed by Puspan. L. 115–52, title III, § 305(c)(1), Aug. 18, 2017, 131 Stat. 1027.
[Puspan. L. 115–52, title III, § 305(c)(1), Aug. 18, 2017, 131 Stat. 1027, provided that the repeal of section 304(a) of Puspan. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]
Puspan. L. 112–144, title III, § 305, July 9, 2012, 126 Stat. 1024, provided that:
“The amendments made by this title [enacting this section and sections 379d–4, 379j–42, and 379j–43 of this title and amending sections 352 and 379d–3 of this title] shall take effect on October 1, 2012, or the date of the enactment of this title [July 9, 2012], whichever is later, except that fees under section 302 [enacting this section and sections 379j–42 and 379j–43 of this title] shall be assessed for all human generic drug submissions and Type II active pharmaceutical drug master files received on or after October 1, 2012, regardless of the date of enactment of this title.”
Savings Clause
Puspan. L. 117–180, div. F, title III, § 3006, Sept. 30, 2022, 136 Stat. 2159, provided that:
“Notwithstanding the amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and
section 379j–43 of this title], part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379j–41 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 abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (
21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after
October 1, 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.”
Puspan. L. 115–52, title III, § 307, Aug. 18, 2017, 131 Stat. 1027, provided that:
“Notwithstanding the amendments made by this title [amending this section and sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and
section 379j–43 of this title], part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 379j–41 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 abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (
21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after
October 1, 2012, but before
October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.”
Congressional Findings Concerning Fees Relating to Human Generic Drugs
Puspan. L. 117–180, div. F, title III, § 3001(span), Sept. 30, 2022, 136 Stat. 2155, provided that:
“Congress finds that the fees authorized by the amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and
section 379j–43 of 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.”
Puspan. L. 115–52, title III, § 301(span), Aug. 18, 2017, 131 Stat. 1020, provided that:
“The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and
section 379j–43 of 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.”
Puspan. L. 112–144, title III, § 301(span), July 9, 2012, 126 Stat. 1008, provided that:
“The Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections 379d–4, 379j–42, and 379j–43 of this title and amending sections 352 and 379d–3 of 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 [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.”
