21 CFR § 514.105 - Approval of applications.

---
identifier: "/us/cfr/t21/s514.105"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 514.105 - Approval of applications."
title_number: 21
title_name: "Food and Drugs"
section_number: "514.105"
section_name: "Approval of applications."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "514"
part_name: "NEW ANIMAL DRUG APPLICATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 360ddd, 360ddd-1, 371, 379e, 381."
regulatory_source: "40 FR 13825, Mar. 27, 1975, unless otherwise noted."
cfr_part: "514"
---


# 514.105 Approval of applications.

(a) The Commissioner shall forward for publication in the *Federal Register* a regulation prescribing the conditions under which the new animal drug may be used, including the name and address of the applicant; the conditions and indications for use covered by the application; any tolerance, withdrawal period, or other use restrictions; any tolerance required for the new animal drug substance or its metabolites in edible products of food-producing animals; and, if such new animal drug is intended for use in animal feed, appropriate purposes and conditions of use (including special labeling requirements) applicable to any animal feed; and such other information the Commissioner deems necessary to assure safe and effective use.

(b) He shall notify the applicant by sending him a copy of the proposed publication as described in paragraph (a)(1) of this section.

[40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, 1999]