---
kind: "section"
citation: "21 C.F.R. § 514.105"
title: "21"
number: "514.105"
heading: "Approval of applications."
url: "https://uscodex.org/cfr/21/514.105"
---

# §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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 360ddd, 360ddd-1, 371, 379e, 381.

### Source

Source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.

### Amendments

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