[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.3]

[Page 38-39]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 510--NEW ANIMAL DRUGS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  510.3  Definitions and interpretations.


    As used in this part:
    (a) The term act means the Federal Food, Drug, and Cosmetic Act, as 
amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 
321-392).
    (b) Department means the Department of Health and Human Services.
    (c) Secretary means the Secretary of Health and Human Services.
    (d) Commissioner means the Commissioner of Food and Drugs.
    (e) Person means individuals, partnerships, corporations, and 
associations.
    (f) The definitions and interpretations of terms contained in 
section 201 of the act shall be applicable to such terms when used in 
the regulations in this part.
    (g) The term new animal drug means any drug intended for use for 
animals other than man, including any drug intended for use in animal 
feed but not including such animal feed:
    (1) The composition of which is such that such drug is not generally 
recognized, among experts qualified by scientific training and 
experience to evaluate the safety and effectiveness of animal drugs, as 
safe and effective for use under the conditions prescribed, recommended, 
or suggested in the labeling thereof; except that such a drug not so 
recognized shall not be deemed to be a new animal drug if at any time 
prior to June 25, 1938, it was subject to the Food and Drug Act of June 
30, 1906, as amended, and if at such time its labeling contained the 
same representations concerning the conditions of its use; or
    (2) The composition of which is such that such drug, as a result of 
investigations to determine its safety and effectiveness for use under 
such conditions, has become so recognized but which has not, otherwise 
than in such investigations, been used to a material extent or for a 
material time under such conditions.
    (h) The term animal feed means an article which is intended for use 
for food for animals other than man and which is intended for use as a 
substantial source of nutrients in the diet of the animal, and is not 
limited to a mixture intended to be the sole ration of the animal.
    (i) The newness of an animal drug, including a new animal drug 
intended for use in or on animal feed, may arise by reason of: (1) The 
newness for its intended drug use of any substance of which the drug is 
comprised, in whole or in part, whether it be an active substance or a 
menstruum, excipient, carrier, coating, or other component; (2) the 
newness for its intended drug use of a combination of two or more 
substances, none of which is itself a new animal drug; (3) the newness 
for its intended drug use of the proportion of a substance in a 
combination, even though such combination containing such substance in 
other proportion is not a new animal drug; (4) the newness for its 
intended drug use in a different species of animal; (5) the newness of 
its intended drug use in diagnosing, curing, mitigating, treating, or 
preventing

[[Page 39]]

a disease, or to affect a structure or function of the animal body, even 
though such drug is not a new animal drug when used in another disease 
or to affect another structure or function of the body; or (6) the 
newness of a dosage, or method or duration of administration or 
application, or any other condition of use prescribed, recommended, or 
suggested in the labeling of such drug, even though such drug or animal 
feed containing such drug when used in another dosage, or another method 
or duration of administration or application, or different condition, is 
not a new animal drug.
    (j) Animals used only for laboratory research and laboratory 
research animals mean individual animals or groups of animals intended 
for use and used solely for laboratory research purposes, regardless of 
species, and does not include animals intended to be used for any food 
purposes or animals intended to be kept as livestock.
    (k) The term sponsor means the person responsible for an 
investigation of a new animal drug, including responsibility for 
compliance with applicable provisions of the act and regulations. The 
sponsor may be an individual, partnership, corporation, or Government 
agency or may be a manufacturer, scientific institution, or an 
investigator regularly and lawfully engaged in the investigation of new 
animal drugs.

[40 FR 13807, Mar. 27, 1975, as amended at 50 FR 7517, Feb. 22, 1985; 54 
FR 22741, May 26, 1989; 64 FR 69190, Dec. 10, 1999]