[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.102]
[Page 294-296]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 56 INSTITUTIONAL REVIEW BOARDS--Table of Contents
Subpart A General Provisions
Sec. 56.102 Definitions.
As used in this part:
(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) Application for research or marketing permit includes:
(1) A color additive petition, described in part 71.
(2) Data and information regarding a substance submitted as part of
the procedures for establishing that a substance is generally recognized
as safe for a use which 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. 170.35.
[[Page 295]]
(3) A food additive petition, described in part 171.
(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) Data and information regarding a substance submitted as part of
the procedures for establishing a tolerance for unavoidable contaminants
in food and food-packaging materials, described in section 406 of the
act.
(6) An investigational new drug application, described in part 312
of this chapter.
(7) A new drug application, described in part 314.
(8) Data and information regarding the bioavailability or
bioequivalence of drugs for human use submitted as part of the
procedures for issuing, amending, or repealing a bioequivalence
requirement, described in part 320.
(9) 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.
(10) An application for a biologics license, described in part 601
of this chapter.
(11) Data and information regarding a biological product submitted
as part of the procedures for determining that licensed biological
products are safe and effective and not misbranded, as described in part
601 of this chapter.
(12) An Application for an Investigational Device Exemption,
described in parts 812 and 813.
(13) Data and information regarding a medical device for human use
submitted as part of the procedures for classifying such devices,
described in part 860.
(14) Data and information regarding a medical device for human use
submitted as part of the procedures for establishing, amending, or
repealing a standard for such device, described in part 861.
(15) An application for premarket approval of a medical device for
human use, described in section 515 of the act.
(16) A product development protocol for a medical device for human
use, described in section 515 of the act.
(17) Data and information regarding an electronic product submitted
as part of the procedures for establishing, amending, or repealing a
standard for such products, described in section 358 of the Public
Health Service Act.
(18) 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.
(19) Data and information regarding an electronic product submitted
as part of the procedures for granting, amending, or extending an
exemption from a radiation safety performance standard, as described in
Sec. 1010.5.
(20) 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.
(21) Data and information about a clinical study of an infant
formula when submitted as part of an infant formula notification under
section 412(c) of the Federal Food, Drug, and Cosmetic Act.
(22) Data and information submitted in a petition for a nutrient
content claim, described in Sec. 101.69 of this chapter, and for a
health claim, described in Sec. 101.70 of this chapter.
(23) Data and information from investigations involving children
submitted in a new dietary ingredient notification, described in Sec.
190.6 of this chapter.
(c) Clinical investigation means any experiment that involves a test
article and one or more human subjects, and that either must meet the
requirements for prior submission to the Food and Drug Administration
under section 505(i) or 520(g) of the act, or need not meet the
requirements for prior submission to the Food and Drug Administration
under these sections of the act, but the results of which are intended
to be later submitted to, or held for inspection by, the Food and Drug
Administration as part of an application for a research or marketing
permit. The
[[Page 296]]
term does not include experiments that must meet the provisions of part
58, regarding nonclinical laboratory studies. The terms research,
clinical research, clinical study, study, and clinical investigation are
deemed to be synonymous for purposes of this part.
(d) Emergency use means the use of a test article on a human subject
in a life-threatening situation in which no standard acceptable
treatment is available, and in which there is not sufficient time to
obtain IRB approval.
(e) Human subject means an individual who is or becomes a
participant in research, either as a recipient of the test article or as
a control. A subject may be either a healthy individual or a patient.
(f) Institution means any public or private entity or agency
(including Federal, State, and other agencies). The term facility as
used in section 520(g) of the act is deemed to be synonymous with the
term institution for purposes of this part.
(g) Institutional Review Board (IRB) means any board, committee, or
other group formally designated by an institution to review, to approve
the initiation of, and to conduct periodic review of, biomedical
research involving human subjects. The primary purpose of such review is
to assure the protection of the rights and welfare of the human
subjects. The term has the same meaning as the phrase institutional
review committee as used in section 520(g) of the act.
(h) Investigator means an individual who actually conducts a
clinical investigation (i.e., under whose immediate direction the test
article is administered or dispensed to, or used involving, a subject)
or, in the event of an investigation conducted by a team of individuals,
is the responsible leader of that team.
(i) Minimal risk means that the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.
(j) Sponsor means a person or other entity that initiates a clinical
investigation, but that does not actually conduct the investigation,
i.e., the test article is administered or dispensed to, or used
involving, a subject under the immediate direction of another
individual. A person other than an individual (e.g., a corporation or
agency) that uses one or more of its own employees to conduct an
investigation that it has initiated is considered to be a sponsor (not a
sponsor-investigator), and the employees are considered to be
investigators.
(k) Sponsor-investigator means an individual who both initiates and
actually conducts, alone or with others, a clinical investigation, i.e.,
under whose immediate direction the test article is administered or
dispensed to, or used involving, a subject. The term does not include
any person other than an individual, e.g., it does not include a
corporation or agency. The obligations of a sponsor-investigator under
this part include both those of a sponsor and those of an investigator.
(l) Test article means any drug for human use, biological product
for human use, medical device for human use, human food additive, color
additive, electronic product, or any other article subject to regulation
under the act or under sections 351 or 354-360F of the Public Health
Service Act.
(m) IRB approval means the determination of the IRB that the
clinical investigation has been reviewed and may be conducted at an
institution within the constraints set forth by the IRB and by other
institutional and Federal requirements.
[46 FR 8975, Jan. 27, 1981, as amended at 54 FR 9038, Mar. 3, 1989; 56
FR 28028, June 18, 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct. 20,
1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599, Apr. 24, 2001]
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