Source: https://www.law.cornell.edu/uscode/text/21/379j%E2%80%9341
Timestamp: 2019-10-14 23:18:48
Document Index: 229364815

Matched Legal Cases: ['§ 379', 'art 7', '§ 379', '§ 379', '§\u202f379', '§\u202f744', '§\u202f302', '§\u202f302', '§\u202f125', '§\u202f302', '§\u202f302', '§\u202f306', 'art 7', '§\u202f305', '§\u202f304', '§\u202f305', '§\u202f305', '§\u202f307', 'art 7', '§\u202f301', 'art 7', '§\u202f301', 'art 7']

21 U.S. Code § 379j–41 - Definitions | US Law | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 7 › § 379j–41
21 U.S. Code § 379j–41 - Definitions
§ 379j–41.
(1) The term “abbreviated new drug application”—
means an application submitted under section 355(j) of this title, an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and
(B) does not include an application—
for a positron emission tomography drug; or
submitted by a State or Federal governmental entity for a drug that is not distributed commercially.
(2) The term “active pharmaceutical ingredient” means—
(4) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
The term “contract manufacturing organization facility” means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.
(A) The term “facility”—
(i) means a business or other entity—
(B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—
(7) The term “finished dosage form” means—
(9) The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:
(B) The issuance of—
(C) The issuance of letters related to Type II active pharmaceutical drug master files which—
Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications.
The term “positron emission tomography drug” has the meaning given to the term “compounded positron emission tomography drug” in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply.
(12) The term “resources allocated for human generic drug activities” means the expenses for—
(June 25, 1938, ch. 675, § 744A, as added Pub. L. 112–144, title III, § 302, July 9, 2012, 126 Stat. 1008; amended Pub. L. 115–52, title III, § 302, Aug. 18, 2017, 131 Stat. 1020.)
For termination of section by section 305(a) of Pub. L. 115–52, see Effective and Termination Dates note set out below.
Section 357 of this title, referred to in par. (1)(A), was repealed by Pub. L. 105–115, title I, § 125(b)(1), Nov. 21, 1997, 111 Stat. 2325.
2017—Par. (1)(B). Pub. 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). Pub. L. 115–52, § 302(2), (3), added par. (5) and redesignated former pars. (5) to (12) as (6) to (13), respectively.
Pub. 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 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 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.”
Pub. L. 115–52, title III, § 305(a), Aug. 18, 2017, 131 Stat. 1027, 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, 2022.”
Pub. L. 112–144, title III, § 304(a), July 9, 2012, 126 Stat. 1024, which provided thatthis section and section 379j–42 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title III, § 305(c)(1), Aug. 18, 2017, 131 Stat. 1027, effective Oct. 1, 2017.
Pub. 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.”
Pub. 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.”
Pub. L. 115–52, title III, § 301(b), 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.”
Pub. L. 112–144, title III, § 301(b), 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.”