[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: 21CFR60.3]
[Page 317-318]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 60 PATENT TERM RESTORATION--Table of Contents
Subpart A General Provisions
Sec. 60.3 Definitions.
(a) The definitions contained in 35 U.S.C. 156 apply to those terms
when used in this part.
(b) The following definitions of terms apply to this part:
(1) The term Act means the Federal Food, Drug, and Cosmetic Act
(secs. 201-901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)).
(2) Active ingredient means any component that is intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or to
affect the structure or any function of the body of man or of animals.
The term includes those components that may undergo chemical change in
the manufacture of the drug product and be present in the drug product
in a modified form intended to furnish the specified activity or effect.
(3) Applicant means any person who submits an application or an
amendment or supplement to an application under 35 U.S.C. 156 seeking
patent term restoration.
(4) Application means an application for patent term restoration
submitted under 35 U.S.C. 156.
(5) Clinical investigation or study means any experiment that
involves a test article and one or more subjects and that is either
subject to requirements for prior submission to the Food and Drug
Administration under section 505(i), 512(j), or 520(g) of the Federal
Food, Drug, and Cosmetic Act, or is not subject to the requirements for
prior submission to FDA under those sections of the Federal Food, Drug,
and Cosmetic Act, but the results of which are intended to be submitted
later to, or held for inspection by, FDA as part of an application for a
research or marketing permit. The term does not include experiments that
are subject to the provisions of part 58 regarding nonclinical
laboratory studies.
[[Page 318]]
(6) Color additive means any substance that meets the definition in
section 201(t) of the Act and which is subject to premarketing approval
under section 721 of the Act.
(7) Due diligence petition means a petition submitted under Sec.
60.30(a).
(8) FDA means the Food and Drug Administration.
(9) Food additive means any substance that meets the definition in
section 201(s) of the Act and which is subject to premarketing approval
under section 409 of the Act.
(10) Human drug product means the active ingredient of a new drug or
human biologic product (as those terms are used in the Act and the
Public Health Service Act), including any salt or ester of the active
ingredient, as a single entity or in combination with another active
ingredient.
(11) Marketing applicant means any person who submits an application
for premarketing approval by FDA under:
(i) Section 505(b) of the Act or section 351 of the Public Health
Service Act (human drug products);
(ii) Section 515 of the Act (medical devices);
(iii) Section 409 or 721 of the Act (food and color additives); or
(iv) Section 512 of the Act (animal drug products).
(12) Marketing application means an application for:
(i) Human drug products submitted under section 505(b) of the Act or
section 351 of the Public Health Service Act;
(ii) Medical devices submitted under section 515 of the Act;
(iii) Food and color additives submitted under section 409 or 721 of
the Act; or
(iv) Animal drug products submitted under section 512 of the Act.
(13) Medical device means any article that meets the definition in
section 201(h) of the Act and which is subject to premarketing approval
under section 515 of the Act.
(14) Product means a human drug product, animal drug product,
medical device, food additive, or color additive, as those terms are
defined in this section.
(15) PTO means the United States Patent and Trademark Office.
(16) Animal drug product means the active ingredient of a new animal
drug (as that term is used in the Act) that is not primarily
manufactured using recombinant deoxyribonucleic acid (DNA), recombinant
ribonucleic acid (RNA), hybridoma technology, or other processes
involving site-specific genetic manipulation techniques, including any
salt or ester of the active ingredient, as a single entity or in
combination with another active ingredient.
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992; 64
FR 399, Jan. 5, 1999]
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