#### § 558.68 Avilamycin.

(a) *Specifications.* Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin.

(b) *Sponsor.* See No. 058198 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)).

(c) *Related tolerances.* See [§ 556.60 of this chapter](/on/2024-09-23/title-21/section-556.60).

(d) *Special considerations.*

(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See [§ 558.6](/on/2024-09-23/title-21/section-558.6) for additional requirements.

(2) The expiration date of VFDs for avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.

(e) *Conditions of use.* Administer in feed as follows:

(1) *Chickens* —

| Avilamycin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 13.6 to 40.9 | | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with *Clostridium perfringens* in broiler chickens | Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age | 058198 |
| (ii) 13.6 to 40.9 | Monensin, 90 to 110 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with *Clostridium perfringens;* and as an aid in the prevention of coccidiosis caused by *Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,* and *E. maxima* | Feed this complete Type C medicated feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. See [§ 558.355(d) of this chapter](/on/2024-09-23/title-21/section-558.355#p-558.355(d)). Monensin as provided by No. 058198 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 058198 |
| (iii) 13.6 to 40.9 | Narasin, 54 to 90 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with *Clostridium perfringens*; and for the prevention of coccidiosis caused by *Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,* and *E. maxima*. | Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with *Clostridium perfringens*. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by No. 058198 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)). | 058198 |
| (iv) 13.6 to 40.9 | Narasin, 27 to 45 plus nicarbazin, 27 to 45 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with *Clostridium perfringens;* and for the prevention of coccidiosis caused by *Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,* and *E. maxima* | Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with *Clostridium perfringens.* Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to chickens producing eggs for human consumption. Narasin and nicarbazin as provided by No. 058198 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)) | 058198 |
| (v) 13.6 to 40.9 | Salinomycin sodium, 40 to 60 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with *Clostridium perfringens*; and for the prevention of coccidiosis caused by *Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,* and *E. mivati*. | Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with *Clostridium perfringens*. Not approved for use with pellet binders. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Do not feed to laying hens producing eggs for human consumption. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592 in [§ 510.600(c) of this chapter](/on/2024-09-23/title-21/section-510.600#p-510.600(c)). | 058198 |

(2) *Swine* —

| Avilamycin in grams/ton | Combinationin grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 73 | | Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic *Escherichia coli* in groups of weaned pigs | Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older | 058198 |
| (ii) [Reserved] | | | | |

[[80 FR 61297](https://www.federalregister.gov/citation/80-FR-61297), Oct. 13, 2015, as amended at [80 FR 76387](https://www.federalregister.gov/citation/80-FR-76387), Dec. 9, 2015; [81 FR 17609](https://www.federalregister.gov/citation/81-FR-17609), Mar. 30, 2016; [81 FR 48703](https://www.federalregister.gov/citation/81-FR-48703), July 26, 2016; [81 FR 59134](https://www.federalregister.gov/citation/81-FR-59134), Aug. 29, 2016; [81 FR 67152](https://www.federalregister.gov/citation/81-FR-67152), Sept. 30, 2016; [82 FR 11509](https://www.federalregister.gov/citation/82-FR-11509), Feb. 24, 2017; [83 FR 14587](https://www.federalregister.gov/citation/83-FR-14587), Apr. 5, 2018; [83 FR 64741](https://www.federalregister.gov/citation/83-FR-64741), Dec. 18, 2018; [84 FR 8974](https://www.federalregister.gov/citation/84-FR-8974), Mar. 13, 2019; [84 FR 33001](https://www.federalregister.gov/citation/84-FR-33001), July 11, 2019; [85 FR 4209](https://www.federalregister.gov/citation/85-FR-4209), Jan. 24, 2020; [85 FR 45308](https://www.federalregister.gov/citation/85-FR-45308), July 28, 2020; [86 FR 13188](https://www.federalregister.gov/citation/86-FR-13188), Mar. 8, 2021; [86 FR 14821](https://www.federalregister.gov/citation/86-FR-14821), Mar. 19, 2021; [88 FR 55567](https://www.federalregister.gov/citation/88-FR-55567), Aug. 16, 2023]