§379j–22. Reauthorization; reporting requirements — Inbound Citations

Citations to 21 U.S.C. § 379j–22 as a whole

• 21 U.S.C. § 379j–21(k)

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  (k) In this section and section 379j–22 of this title:

  (1) The terms “abbreviated application for a generic new animal drug” and “abbreviated application” mean an abbreviated application for the approval of any generic new animal drug submitted under section 360b(b)(2) of this title. Such term does not include a supplemental abbreviated application for a generic new animal drug.

  (2) The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by—

  (A) for purposes of subsection (f)(1), such Index for October 2002; and

  (B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.

  (3) The term “costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs” means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs 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 abbreviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;

  (B) management of information, and the acquisition, maintenance, and repair of computer resources;

  (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 this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

  (4) The term “final dosage form” means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.

  (5) The term “generic new animal drug” means a new animal drug that is the subject of an abbreviated application.

  (6) The term “generic new 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 abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.

  (7) The term “generic new animal drug sponsor” means either an applicant named in an abbreviated application for a generic new animal drug 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 submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.

  (8) The term “generic investigational new animal drug meeting request” means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.

  (9) The terms “investigational submission for a generic new animal drug” and “investigational submission” mean—

  (A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or

  (B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug.

  (10) The term “person” includes an affiliate thereof (as such term is defined in section 379g(11) of this title).

  (11) The term “process for the review of abbreviated applications for generic new animal drugs” means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions:

  (A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

  (B) The issuance of action letters which approve abbreviated applications or supplemental abbreviated applications or which set forth in detail the specific deficiencies in abbreviated applications, supplemental abbreviated applications, or investigational submissions and, where appropriate, the actions necessary to place such applications, supplemental applications, or submissions in condition for approval.

  (C) The inspection of generic new animal drug establishments and other facilities undertaken as part of the Secretary’s review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions.

  (D) Monitoring of research conducted in connection with the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

  (E) The development of regulations and policy related to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

  (F) Development of standards for products subject to review.

  (G) Meetings between the agency and the generic new animal drug sponsor.

  (H) Review of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application, but not after such application has been approved.

  (I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.

  (12) The term “request to establish a generic investigational new animal drug file” means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.

  (13) The terms “supplemental abbreviated application for a generic new animal drug” and “supplemental abbreviated application” mean a request to the Secretary to approve a change in an approved abbreviated application.