Source: http://www.law.cornell.edu/uscode/text/21/379j-11?quicktabs_8=2
Timestamp: 2013-05-25 19:28:38
Document Index: 84123983

Matched Legal Cases: ['§ 379', 'art 4', '§ 379', '§ 379', '§ 739', '§ 3', '§ 109', '§ 102', '§ 102', '§ 102', '§ 102', '§ 102', '§ 108', '§ 5', '§ 106', 'art 4', '§ 4']

21 USC § 379j–11 - Definitions | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 4 › § 379j–11	prevnext
21 USC § 379j–11 - Definitions
(j) of this title for a new animal drug intended to be the subject of an animal drug application or a supplemental animal drug application, or
The term “costs of resources allocated for the process for the review of animal drug applications” means the expenses incurred in connection with the process for the review of animal drug applications for—
officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific animal drug applications, supplemental animal drug applications, or investigational animal drug submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities,
(June 25, 1938, ch. 675, § 739, as added Pub. L. 108–130, § 3,Nov. 18, 2003, 117 Stat. 1361; amended Pub. L. 110–85, title I, § 109,Sept. 27, 2007, 121 Stat. 842; Pub. L. 110–316, title I, § 102,Aug. 14, 2008, 122 Stat. 3510.)
For termination of amendment by section 108(a) ofPub. L. 110–316, see Effective and Termination Dates of 2008 Amendment note below.
For termination of section by section 5 ofPub. L. 108–130, see Termination Date note below.
For savings provisions, see section 106 ofPub. L. 110–316, set out as a note below.
2008—Par. (6). Pub. L. 110–316, §§ 102(1), 108(a), temporarily substituted “that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary” for “, except for an approved application for which all subject products have been removed from listing under section 360 of this title”. See Effective and Termination Dates of 2008 Amendment note below.
Par. (8)(H). Pub. L. 110–316, §§ 102(2), 108(a), temporarily substituted “but not after such application has been approved” for “but not such activities after an animal drug has been approved”. See Effective and Termination Dates of 2008 Amendment note below.
Par. (10). Pub. L. 110–316, §§ 102(3), 108(a), temporarily substituted “month being October 2002” for “year being 2003”. See Effective and Termination Dates of 2008 Amendment note below.
Pars. (11), (12). Pub. L. 110–316, §§ 102(4), (5), 108(a), temporarily added par. (11) and redesignated former par. (11) as (12). See Effective and Termination Dates of 2008 Amendment note below.
Pub. L. 110–316, title I, § 108,Aug. 14, 2008, 122 Stat. 3515, provided that:
Pub. L. 108–130, § 5,Nov. 18, 2003, 117 Stat. 1371, provided that: “The amendments made by section 3 [enacting this subpart] shall not be in effect after October 1, 2008, and section 4 [enacting provisions set out as a note below] shall not be in effect after 120 days after such date.”
Pub. L. 110–316, title I, § 106,Aug. 14, 2008, 122 Stat. 3514, provided that: “Notwithstanding section 5 of the Animal Drug User Fee Act of 2003 [Pub. L. 108–130] (21 U.S.C. 379j–11 note), and notwithstanding the amendments made by this title [enacting section 379j–13 of this title and amending this section and sections 360b and 379j–12 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of the enactment of this title [Aug. 14, 2008], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after September 1, 2003, but before October 1, 2008, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2009.”
Pub. L. 108–130, § 4,Nov. 18, 2003, 117 Stat. 1370, which required the Secretary of Health and Human Services, after certain consultations, to develop recommendations relating to the review of animal drug applications after fiscal year 2008, to submit to congressional committees a report each fiscal year concerning the progress of the Food and Drug Administration in achieving certain goals toward expediting the animal drug development process and the review of the animal drug applications and investigational animal drug submissions, and to submit a report for each fiscal year to congressional committees on the implementation of the authority for the fees collected under this subpart during the fiscal year and the use, by the Food and Drug Administration, of the fees collected, ceased to be effective 120 days after Oct. 1, 2008. See Termination Date note above.