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.
Please note that 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
Cattle are defined as animals of the Bos genus, either Bos taurus taurus or Bos taurus indicus. There are three major subclasses of cattle: veal calves, beef cattle, and dairy cattle.
Veal Calves
Veal calves are typically dairy breeds of immature male or female cattle that are raised to produce meat (veal) for human consumption. Most are pre-ruminating; but, depending on management, age, and diet, they may be ruminating.
The following subclass of veal calves may be used to further define this major subclass:
| Subclass | Definition |
|---|---|
| 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.
The following subclasses of beef cattle may be used to further define this major subclass:
A. Beef Calves
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.
The following variants of beef calves may be used to further define this subclass:
| Variant | Definition |
|---|---|
| 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 2 months of age and older | Beef calves considered ruminating and nursing their dams from 2 months of age to weaning. |
B. Beef Steers
Weaned castrated male cattle (beef and dairy breeds) intended for slaughter, housed in any setting and receiving their diet from any source(s).
The following variants and subsets of variants of beef steers may be used to further define this subclass:
| Variant | Subset | Definition |
|---|---|---|
| Growing Beef Steers on Pasture (stocker, feeder, and slaughter) | No subsets | Weaned growing beef steers (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. |
| Growing Beef Steers in a Dry Lot | No subsets | Weaned growing beef steers (beef and dairy breeds) maintained in a dry lot. They receive the majority of their diet from harvested forage (possibly with a supplement). |
| Growing Beef Steers Fed in Confinement for Slaughter | Includes all subsets | Weaned growing and finishing beef steers (beef and dairy breeds) intended only for slaughter 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. Includes growing beef steers in a grow yard (see definition below). |
| Growing Beef Steers Fed in Confinement for Slaughter | Growing Beef Steers in a Grow Yard | A subset population of growing beef steers fed in confinement for slaughter, these are weaned growing beef steers (beef and dairy breeds) confined in group pens and fed a moderate- to high-roughage diet ad libitum as their sole ration prior to the finishing stage. Grow yards may also be referred to as starter yards or backgrounding yards in the industry. |
C. Beef Heifers
Weaned female beef cattle intended for breeding (beef breeds) or slaughter (beef and dairy breeds) that have not yet calved, housed in any setting and receiving their diet from any source(s).
The following variants and subsets of variants of beef heifers may be used to further define this subclass:
| Variant | Subset | Definition |
|---|---|---|
| Replacement Beef Heifers | Includes all subsets | 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 1 year will apply. |
| Replacement 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 1 year will apply. |
| Growing Beef Heifers on Pasture (stocker, feeder, and slaughter) | No subsets | Weaned growing beef heifers (beef and 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. |
| Growing Beef Heifers in a Dry Lot | No subsets | Weaned growing beef heifers (beef and dairy breeds) maintained in a dry lot. They receive the majority of their diet from harvested forage (possibly with a supplement). |
| Growing Beef Heifers Fed in Confinement for Slaughter | Includes all subsets | Weaned growing and finishing beef heifers (beef and 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. Includes growing beef heifers in a grow yard (see definition below). |
| Growing Beef Heifers Fed in Confinement for Slaughter | Growing Beef Heifers in a Grow Yard | A subset population of growing beef heifers fed in confinement for slaughter, these are weaned growing beef heifers (beef and dairy breeds) confined in group pens and fed a moderate- to high-roughage diet ad libitum as their sole ration prior to the finishing stage. Grow yards may also be referred to as starter yards or backgrounding yards in the industry. |
D. Beef Bulls
Weaned intact male beef cattle intended for breeding (beef breeds) or slaughter (beef and dairy breeds), housed in any setting and receiving their diet from any source(s).
The following variants of beef bulls may be used to further define this subclass:
| Variant | Definition |
|---|---|
| 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 Intended for Slaughter | Weaned intact male beef cattle intended only for slaughter (beef and dairy breeds). |
E. Beef Cows
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.
The following subclasses of dairy cattle may be used to further define this major subclass:
A. Dairy Calves
Pre-ruminating dairy cattle from birth until weaning being fed a ration that includes milk or liquid milk replacer. Excludes veal calves.
B. Replacement Dairy Heifers
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 1 year will apply.
The following variants of replacement dairy heifers may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Periparturient Replacement Dairy Heifers | Replacement dairy heifers approximately 3 weeks before calving. After calving they become periparturient dairy cows. |
| Replacement Dairy Heifers on Pasture | Weaned replacement dairy heifers maintained on pasture and receiving the majority of their diet from grazing. |
C. Dairy Bulls
Weaned intact male dairy cattle intended for breeding. If reproductive safety is not evaluated, an age restriction of less than 1 year will apply.
D. Dairy Cows
Female dairy cattle that have calved.
The following variants of dairy cows may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Lactating Dairy Cows | Dairy cows that are producing milk for human food. |
| 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). |
| 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. |
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.
The following subclasses of swine may be used to further define this class:
A. Nursing Piglets
Swine from birth until weaning. May be referred to as weanling pigs, baby pigs, or suckling piglets in the industry.
B. Nursery Swine
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.
C. Growing Swine
Swine intended for slaughter, from approximately 40 to 70 lbs (18 to 32 kg) to 120 to 150 lbs (55 to 68 kg).
D. Finishing Swine
Swine intended for slaughter, from approximately 120 to 150 lbs (55 to 68 kg) to market weight.
E. Boars
Intact male swine intended for breeding or slaughter.
The following variants of boars may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Boars Intended for Breeding | Boars intended for breeding. |
| 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. |
F. Barrows
Surgically castrated male swine intended for slaughter.
G. Gilts
Female swine intended for breeding or slaughter that have never farrowed a litter.
The following variants of gilts may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Replacement Gilts | Gilts intended for breeding. |
| Gestating Replacement Gilts | Replacement gilts that are pregnant. |
| Gilts Intended for Slaughter | Gilts intended for slaughter. |
H. Sows
Female swine that have farrowed.
The following variants of sows may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Gestating Sows | Sows that are pregnant. |
| Lactating Sows | Sows that are producing milk. |
| Weaned Sows | Sows that have farrowed and completed nursing a litter. |
| Sows Intended for Slaughter | Sows that have been removed from breeding service. May also be referred to as culled sows in the industry. |
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.
The following subclasses of chickens may be used to further define this class:
A. Embryonated Chicken Eggs
Eggs containing a chicken embryo at any stage of embryonic development.
B. Chicks
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.
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).
C. Broiler Chickens
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.
D. Replacement Chickens
Chickens raised from hatch to sexual maturity and intended to become laying hens or breeder chickens.
The following variants of replacement chickens may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Breeder Replacement Chickens | Male and female chickens intended to become breeder chickens. |
| Laying Hen Replacement Chickens | Female chickens intended to become laying hens. |
E. Laying Hens
Mature female chickens that produce non-fertilized eggs for consumption.
F. Breeder Chickens
Sexually mature male and female chickens intended to produce fertilized eggs for hatching.
The following variants of breeder chickens may be used to further define this subclass:
| Variant | Definition |
|---|---|
| Broiler Breeder Chickens | Chickens intended to produce fertilized eggs for hatching into broiler chickens or broiler breeder replacement chickens. |
| Layer Breeder Chickens | Chickens intended to produce fertilized eggs for hatching into laying hen replacement chickens or layer breeder replacement chickens. |
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.
The following subclasses of turkeys may be used to further define this class:
A. Embryonated Turkey Eggs
Eggs containing a turkey embryo at any stage of embryonic development.
B. Turkey Poults
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.
C. Growing Turkeys
Turkeys raised from hatch and growing to a marketable weight and intended for meat production. Includes fryer-roaster, young turkey, and yearling turkey.
D. Breeder Replacement Turkeys
Turkeys raised from hatch to sexual maturity and intended to become breeder turkeys.
E. Breeder Turkeys
Sexually mature male and female turkeys intended to produce fertilized eggs for hatching into growing turkeys or breeder replacement turkeys.