[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.3]
 
[Page 301-303]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 58.3  Definitions.
 
    As used in this part, the following terms shall have the meanings
specified:
    (a) 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) Test article means any food additive, color additive, drug,
biological product, electronic product, medical device for human use, or
any other article subject to regulation under the act or under sections
351 and 354-360F of the Public Health Service Act.
    (c) Control article means any food additive, color additive, drug,
biological product, electronic product, medical device for human use, or
any article other than a test article, feed, or water that is
administered to the test system in the course of a nonclinical
laboratory study for the purpose of establishing a basis for comparison
with the test article.
    (d) Nonclinical laboratory study means in vivo or in vitro
experiments in which test articles are studied prospectively in test
systems under laboratory conditions to determine their safety. The term
does not include studies utilizing human subjects or clinical studies or
field trials in animals. The term does not include basic exploratory
studies carried out to determine whether a test article has any
potential utility or to determine physical or chemical characteristics
of a test article.
    (e) Application for research or marketing permit includes:
    (1) A color additive petition, described in part 71.
    (2) A food additive petition, described in parts 171 and 571.
    (3) Data and information regarding a substance submitted as part of
the procedures for establishing that a substance is generally recognized
as safe for use, which use results or may reasonably be expected to
result, directly or indirectly, in its becoming a component or otherwise
affecting the characteristics of any food, described in Sec. Sec.
170.35 and 570.35.
    (4) Data and information regarding a food additive submitted as part
of the procedures regarding food additives permitted to be used on an
interim basis pending additional study, described in Sec. 180.1.
    (5) An investigational new drug application, described in part 312
of this chapter.
 
[[Page 302]]
 
    (6) A new drug application, described in part 314.
    (7) Data and information regarding an over-the-counter drug for
human use, submitted as part of the procedures for classifying such
drugs as generally recognized as safe and effective and not misbranded,
described in part 330.
    (8) Data and information about a substance submitted as part of the
procedures for establishing a tolerance for unavoidable contaminants in
food and food-packaging materials, described in parts 109 and 509.
    (9) [Reserved]
    (10) A Notice of Claimed Investigational Exemption for a New Animal
Drug, described in part 511.
    (11) A new animal drug application, described in part 514.
    (12) [Reserved]
    (13) An application for a biologics license, described in part 601
of this chapter.
    (14) An application for an investigational device exemption,
described in part 812.
    (15) An Application for Premarket Approval of a Medical Device,
described in section 515 of the act.
    (16) A Product Development Protocol for a Medical Device, described
in section 515 of the act.
    (17) Data and information regarding a medical device submitted as
part of the procedures for classifying such devices, described in part
860.
    (18) Data and information regarding a medical device submitted as
part of the procedures for establishing, amending, or repealing a
performance standard for such devices, described in part 861.
    (19) Data and information regarding an electronic product submitted
as part of the procedures for obtaining an exemption from notification
of a radiation safety defect or failure of compliance with a radiation
safety performance standard, described in subpart D of part 1003.
    (20) Data and information regarding an electronic product submitted
as part of the procedures for establishing, amending, or repealing a
standard for such product, described in section 358 of the Public Health
Service Act.
    (21) Data and information regarding an electronic product submitted
as part of the procedures for obtaining a variance from any electronic
product performance standard as described in Sec. 1010.4.
    (22) Data and information regarding an electronic product submitted
as part of the procedures for granting, amending, or extending an
exemption from any electronic product performance standard, as described
in Sec. 1010.5.
    (23) A premarket notification for a food contact substance,
described in part 170, subpart D, of this chapter.
    (f) Sponsor means:
    (1) A person who initiates and supports, by provision of financial
or other resources, a nonclinical laboratory study;
    (2) A person who submits a nonclinical study to the Food and Drug
Administration in support of an application for a research or marketing
permit; or
    (3) A testing facility, if it both initiates and actually conducts
the study.
    (g) Testing facility means a person who actually conducts a
nonclinical laboratory study, i.e., actually uses the test article in a
test system. Testing facility includes any establishment required to
register under section 510 of the act that conducts nonclinical
laboratory studies and any consulting laboratory described in section
704 of the act that conducts such studies. Testing facility encompasses
only those operational units that are being or have been used to conduct
nonclinical laboratory studies.
    (h) Person includes an individual, partnership, corporation,
association, scientific or academic establishment, government agency, or
organizational unit thereof, and any other legal entity.
    (i) Test system means any animal, plant, microorganism, or subparts
thereof to which the test or control article is administered or added
for study. Test system also includes appropriate groups or components of
the system not treated with the test or control articles.
    (j) Specimen means any material derived from a test system for
examination or analysis.
    (k) Raw data means any laboratory worksheets, records, memoranda,
notes, or exact copies thereof, that are
 
[[Page 303]]
 
the result of original observations and activities of a nonclinical
laboratory study and are necessary for the reconstruction and evaluation
of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact copy or
exact transcript may be substituted for the original source as raw data.
Raw data may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated observations, and
recorded data from automated instruments.
    (l) Quality assurance unit means any person or organizational
element, except the study director, designated by testing facility
management to perform the duties relating to quality assurance of
nonclinical laboratory studies.
    (m) Study director means the individual responsible for the overall
conduct of a nonclinical laboratory study.
    (n) Batch means a specific quantity or lot of a test or control
article that has been characterized according to Sec. 58.105(a).
    (o) Study initiation date means the date the protocol is signed by
the study director.
    (p) Study completion date means the date the final report is signed
by the study director.
 
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987;
54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May
21, 2002]