21 USC § 379j–11 - Definitions
For purposes of this subpart:
(1)
The term “animal drug application” means an application for approval of any new animal drug submitted under section
360b
(b)(1) of this title. Such term does not include either a new animal drug application submitted under section
360b
(b)(2) of this title or a supplemental animal drug application.
(2)
The term “supplemental animal drug application” means—
(3)
The term “animal drug product” means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an animal drug application or a supplemental animal drug application has been approved.
(4)
The term “animal drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.
(5)
The term “investigational animal drug submission” means—
(6)
The term “animal drug sponsor” means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.
(7)
The term “final dosage form” means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.
(8)
The term “process for the review of animal drug applications” means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions:
(A)
The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(B)
The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval.
(C)
The inspection of animal drug establishments and other facilities undertaken as part of the Secretary’s review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(D)
Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(9)
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—
(A)
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,
(C)
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
(D)
collecting fees under section
379j–12 of this title and accounting for resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
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For purposes of this subpart:
(1)
The term “animal drug application” means an application for approval of any new animal drug submitted under section
360b
(b)(1) of this title. Such term does not include either a new animal drug application submitted under section
360b
(b)(2) of this title or a supplemental animal drug application.
(2)
The term “supplemental animal drug application” means—
(3)
The term “animal drug product” means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an animal drug application or a supplemental animal drug application has been approved.
(4)
The term “animal drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.
(5)
The term “investigational animal drug submission” means—
(6)
The term “animal drug sponsor” means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.
(7)
The term “final dosage form” means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.
(8)
The term “process for the review of animal drug applications” means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions:
(A)
The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(B)
The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval.
(C)
The inspection of animal drug establishments and other facilities undertaken as part of the Secretary’s review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(D)
Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
(9)
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—
(A)
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,
(C)
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
(D)
collecting fees under section
379j–12 of this title and accounting for resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
Source
(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.)
Amendment of Section
For termination of amendment by section 108(a) ofPub. L. 110–316, see Effective and Termination Dates of 2008 Amendment note below.
Termination of Section
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.
Amendments
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.
2007—Pub. L. 110–85, § 109(a), substituted “subpart” for “part” in introductory provisions.
Par. (11). Pub. L. 110–85, § 109(b), substituted “379g(11)” for “379g(9)”.
Effective and Termination Dates of 2008 Amendment
Pub. L. 110–316, title I, § 107,Aug. 14, 2008, 122 Stat. 3514, provided that: “The amendments made by sections
102,
103, and
104 [enacting section
379j–13 of this title and amending this section and section
379j–12 of this title] shall take effect on October 1, 2008, and fees under 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 amended by this title, shall be assessed for all animal drug applications and supplemental animal drug applications received on or after such date, regardless of the date of the enactment of this title [Aug. 14, 2008].”
Pub. L. 110–316, title I, § 108,Aug. 14, 2008, 122 Stat. 3515, provided that:
“(a) Authorization.—The amendments made by sections
102 and
103 [amending this section and section
379j–12 of this title] cease to be effective October 1, 2013.
“(b) Reporting Requirements.—The amendment made by section
104 [enacting section
379j–13 of this title] ceases to be effective January 31, 2014.”
Effective Date of 2007 Amendment
Amendment by Pub. L. 110–85effective Oct. 1, 2007, see section 107 ofPub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section
379g of this title.
Termination Date
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.”
Savings Provisions
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.”
Findings
Pub. L. 110–316, title I, § 101(b),Aug. 14, 2008, 122 Stat. 3509, provided that: “Congress finds that the fees authorized by the amendments made in this title [enacting section
379j–13 of this title and amending this section and sections
360b and
379j–12 of this title] will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified, for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.”
Pub. L. 108–130, § 2,Nov. 18, 2003, 117 Stat. 1361, provided that: “Congress finds as follows:
“(1) Prompt approval of safe and effective new animal drugs is critical to the improvement of animal health and the public health.
“(2) Animal health and the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of new animal drug applications.
“(3) The fees authorized by this Act [enacting this subpart and provisions set out as notes under this section and section
301 of this title] will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified, for purposes of part 4 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 Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.”
Accountability and Reports
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.
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