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  1. New Animal Drug Applications

Classes of Major Food-Producing Animals for New Animal Drug Applications

FDA is providing the tables of Appendix III in Guidance for Industry (GFI) #191, "Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs," below so that users can more easily access the information.

The labeling for some approved animal drugs includes “legacy terms” that have been used since before FDA established the terminology in these tables; therefore, the tables do not encompass all terminology for all classes of major food-producing animals.

Cattle
    Veal Calves
    Beef Cattle
    Dairy Cattle
Swine
Chickens
Turkeys

Cattle

Veal Calves

Veal calves are typically dairy breeds of calves that are raised to produce meat for human consumption.

Major Subclass Subclass Definition
Veal Calves none Immature male or female cattle intended for slaughter for veal production. Most are pre-ruminating; but depending on management, age and diet, may be ruminating.
Veal Calves Bob Veal Veal calves less than 2 weeks of age and pre-ruminating.

Beef Cattle

Beef cattle are defined as cattle that are raised primarily to produce meat (either beef or dairy breeds) for human consumption or to produce offspring (beef breeds) that will produce meat intended for human consumption.

Subclass Variant Definition
Beef Calves none Beef cattle (beef breeds only) nursing their dams from birth until weaning. May be pre-ruminating or ruminating. Formerly referred to as “suckling beef calves”. Excludes veal calves.
Beef Calves Beef Calves less than 2 months of age Beef calves considered pre-ruminating and nursing their dams from birth until 2 months of age.
Beef Calves Beef Calves 2 months of age and older Beef calves considered ruminating and nursing their dams from 2 months of age to weaning. 
Beef Steers none Weaned castrated male cattle (either beef and dairy breeds) intended for slaughter, housed in any setting and receiving their diet from any source(s).
Beef Steers Growing Beef Steers on Pasture (stocker, feeder, and slaughter)

Weaned growing beef steers (either beef and dairy breeds) maintained on pasture and receiving the majority of their diet from grazing. Refers to cattle considered to be “stocker, feeder, and slaughter” cattle, and these words are always included in the parenthetical portion of the class name. 

“Stocker” refers to weaned growing cattle grazing pasture prior to finishing and slaughter; they are usually younger, weigh less, and are of lower condition (finish) than “feeder” cattle.

Feeder” refers to weaned growing cattle grazing pasture and of sufficient weight and maturity to be placed on high-energy rations for finishing; they are generally older, weigh more, and carry more condition (finish) than “stocker” cattle. 

Slaughter” refers to weaned growing cattle grazing pasture and suitable for slaughter.

Beef Steers Growing Beef Steers in Dry Lot Weaned growing beef steers (beef and dairy breeds) maintained in dry lot. They receive the majority of their diet from harvested forage (possibly with a supplement).
Beef Steers Growing Beef Steers in Grow Yard Weaned growing beef steers (beef and dairy breeds) maintained in group pens. They receive their diet as a complete ration. May also be referred to as starter yards or backgrounding yards in the industry.
Beef Steers Growing Beef Steers Fed in Confinement for Slaughter Weaned growing and finishing beef steers (either beef and dairy breeds) confined in group pens and fed a progressively high-energy diet ad libitum as their sole ration until slaughter. May also be referred to as feed yard or feedlot cattle in the industry. Excludes cattle intended to be returned to pasture or other feeding settings prior to slaughter. 
Beef Heifers none Weaned female beef cattle intended for breeding (beef breeds) or slaughter (either beef or dairy breeds) that have not yet calved, housed in any setting and receiving their diet from any source(s).
Beef Heifers Replacement Beef Heifers

Weaned female beef heifers (beef breeds only) that are intended only for breeding to produce calves for meat production.

If reproductive safety is not evaluated, an age restriction of less than one year will apply.

Beef Heifers Replacement Beef Heifers on Pasture

Weaned replacement beef heifers maintained on pasture and receiving the majority of their diet from grazing.

If reproductive safety is not evaluated, an age restriction of less than one year will apply.

Beef Heifers Growing Beef Heifers on Pasture (stocker, feeder, and slaughter)

Weaned growing beef heifers (either beef or dairy breeds) intended only for slaughter (i.e., not for reproductive purposes) maintained on pasture and receiving the majority of their diet from grazing. Refers to cattle considered to be “stocker, feeder, and slaughter” cattle, and these words are always included in the parenthetical portion of the class name. 

Stocker” refers to weaned growing cattle grazing pasture prior to finishing and slaughter; they are usually younger, weigh less, and are of lower condition (finish) than “feeder” cattle.

Feeder” refers to weaned growing cattle grazing pasture and of sufficient weight and maturity to be placed on high-energy rations for finishing; they are generally older, weigh more, and carry more condition (finish) than “stocker” cattle. 

Slaughter” refers to weaned growing cattle grazing pasture and suitable for slaughter.

Beef Heifers Growing Beef Heifers in Dry Lot Weaned growing beef heifers (beef and dairy breeds) maintained in dry lot. They receive the majority of their diet from harvested forage (possibly with a supplement).
Beef Heifers Growing Beef Heifers in Grow Yard Weaned growing beef heifers (beef and dairy breeds) maintained in group pens. They receive their diet as a complete ration. May also be referred to as starter yards or backgrounding yards in the industry.
Beef Heifers Growing Beef Heifers Fed in Confinement for Slaughter Weaned growing and finishing beef heifers (either beef or dairy breeds) intended only for slaughter (i.e., not for reproductive purposes) and confined in group pens and fed a progressively high-energy diet ad libitum as their sole ration until slaughter. May also be referred to as feed yard or feedlot cattle in the industry. Excludes cattle intended to be returned to pasture or other feeding settings prior to slaughter.
Beef Bulls none Weaned intact male beef cattle intended for breeding (beef breeds) or slaughter (either beef or dairy breeds), housed in any setting and receiving their diet from any source(s).
Beef Bulls Beef Bulls Intended for Breeding

Weaned intact male beef bulls (beef breeds only) intended only for breeding. 

If reproductive safety is not evaluated, an age restriction of less than one year will apply.

Beef Bulls Beef Bulls Intended for Slaughter Weaned intact male beef cattle intended only for slaughter (either beef or dairy breeds).
Beef Cows none Beef breed female cattle that have calved.

Dairy Cattle

Dairy cattle are defined as cattle that are raised primarily to produce milk for human consumption and/or to produce offspring that will produce milk or meat (including veal) for human consumption.

Subclass Variant Definition
Dairy Calves none Pre-ruminating dairy cattle from birth until weaning being fed a ration that includes milk or liquid milk replacer. Excludes veal calves.
Replacement Dairy Heifers none

Weaned female dairy cattle that have not yet calved and are intended only for breeding and future milk production, housed in any setting and receiving their diet from any source(s).

If reproductive safety is not evaluated, an age restriction of less than one year will apply.

Replacement Dairy Heifers Periparturient Replacement Dairy Heifers Replacement dairy heifers approximately 3 weeks before calving. After calving they become periparturient dairy cows.
Replacement Dairy Heifers Replacement Dairy Heifers on Pasture Weaned replacement dairy heifers maintained on pasture and receiving the majority of their diet from grazing.
Dairy Bulls none

Weaned intact male dairy cattle intended for breeding.

If reproductive safety is not evaluated, an age restriction of less than one year will apply.

Dairy Cows none Female dairy cattle that have calved.
Dairy Cows Lactating Dairy Cows Dairy cows that are producing milk for human food.
Dairy Cows Dry Dairy Cows Dairy cows that have previously lactated, but which are not currently producing milk for human food (i.e., dairy cows between two lactations).
Dairy Cows Periparturient Dairy Cows Dairy cows that have previously lactated, and are in the transition period from approximately 3 weeks before to approximately 3 weeks after calving

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Swine

Swine are defined as animals of the Sus genus, either Sus scrofa domesticus or Sus domesticus, that are raised primarily to produce meat for human consumption or to produce offspring that will produce meat for human consumption.

Subclass Variant Definition
Nursing Piglets none Swine from birth until weaning. May be referred to as weanling pigs, baby pigs, or suckling piglets in the industry.
Nursery Swine none Swine intended for slaughter, from weaning to end of nursery phase at approximately 40 to 70 lbs (18 to 32 kg). May be referred to as starter pigs in the industry.
Growing Swine none Swine intended for slaughter, from approximately 40 to 70 lbs (18 to 32 kg) to 120 to 150 lbs (55 to 68 kg).
Finishing Swine none Swine intended for slaughter, from approximately 120 to 150 lbs (55 to 68 kg) to market weight.
Boars none Intact male swine intended for breeding or slaughter.
Boars Boars Intended for Breeding Boars intended for breeding
Boars Boars Intended for Slaughter Boars intended for slaughter, including chemically castrated males and those removed from breeding service. May also be referred to as culled boars in the industry.
Barrows none Surgically castrated male swine intended for slaughter.
Gilts none Female swine intended for breeding or slaughter that have never farrowed a litter.
Gilts Replacement Gilts Gilts intended for breeding.
Gilts Gestating Replacement Gilts Replacement gilts that are pregnant.
Gilts Gilts Intended for Slaughter Gilts intended for slaughter
Sows none Female swine that have farrowed.
Sows Gestating Sows Sows that are pregnant.
Sows Lactating Sows Sows that are producing milk.
Sows Weaned Sows Sows that have farrowed and completed nursing a litter.
Sows Sows Intended for Slaughter Sows that have been removed from breeding service. May also be referred to as culled sows in the industry.

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Chickens

Chickens are defined as animals of the subspecies Gallus gallus domesticus that are raised primarily to produce meat and/or eggs for human consumption or to produce offspring that will produce meat and/or eggs for human consumption. 

Subclass Variant Definition
Embryonated Chicken Eggs none Eggs containing a chicken embryo at any stage of embryonic development.
Chicks1 none Chickens from hatch until they are able to survive in ambient temperature (no longer brooded). This is the initial post-hatch phase of the subclasses identified in the remainder of this table.
Broiler Chickens none Chickens raised from hatch, grown to a marketable weight, and intended for meat production.  Includes Rock Cornish game hen or Cornish game hen, broiler or fryer, roaster or roasting chicken, and capon.
Replacement Chickens none Chickens raised from hatch to sexual maturity and intended to become laying hens or breeder chickens.
Replacement Chickens Breeder Replacement Chickens Male and female chickens intended to become breeder chickens.
Replacement Chickens Laying Hen Replacement Chickens Female chickens intended to become laying hens.
Laying Hens none Mature female chickens that produce non-fertilized eggs for consumption.
Breeder Chickens none Sexually mature male and female chickens intended to produce fertilized eggs for hatching.
Breeder Chickens Broiler Breeder Chickens Chickens intended to produce fertilized eggs for hatching into broiler chickens or broiler breeder replacement chickens.
Breeder Chickens Layer Breeder Chickens Chickens intended to produce fertilized eggs for hatching into laying hen replacement chickens or layer breeder replacement chickens.

1 When used on approved labeling, the term “chicks” only refers to chicks of the chicken species. If a drug product is approved for use in chicks of another species, the labeling should clearly state “(species) chicks” (e.g., quail chicks).

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Turkeys

Turkeys are defined as animals of the species Meleagris gallopavo that are commonly raised primarily to produce meat for human consumption or to produce offspring that will produce meat for human consumption.

Subclass Variant Definition
Embryonated Turkey Eggs none Eggs containing a turkey embryo at any stage of embryonic development.
Turkey Poults none Turkeys from hatch until they are able to survive in ambient temperature (no longer brooded). This is the initial post-hatch phase of the subclasses identified in the remainder of this table.
Growing Turkeys none Turkeys raised from hatch and growing to a marketable weight and intended for meat production.  Includes fryer-roaster, young turkey, and yearling turkey.
Breeder Replacement Turkeys none Turkeys raised from hatch to sexual maturity and intended to become breeder turkeys.
Breeder Turkeys none Sexually mature male and female turkeys intended to produce fertilized eggs for hatching into growing turkeys or breeder replacement turkeys.

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