19 U.S. Code § 2576b - Subpart definitions

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§ 2576b.
Subpart definitions
Notwithstanding section 2571 of this title, for purposes of this subpart—
(1) Approval procedure

The term “approval procedure” means any registration, notification, or other mandatory administrative procedure for granting permission for a good or service to be produced, marketed, or used for a stated purpose or under stated conditions.

(2) Conformity assessment procedure

The term “conformity assessment procedure” means any procedure used, directly or indirectly, to determine that a technical regulation or standard is fulfilled, including sampling, testing, inspection, evaluation, verification, monitoring, auditing, assurance of conformity, accreditation, registration, or approval used for such a purpose, but does not mean an approval procedure.

(3) ObjectiveThe term “objective” includes—
protection of human, animal, or plant life or health, the environment or consumers, including matters relating to quality and identifiability of goods or services, and
sustainable development,
but does not include the protection of domestic production.
(4) Service

The term “service” means a land transportation service or a telecommunications service.

(5) StandardThe term “standard” means—
characteristics for a good or a service,
(B) characteristics, rules, or guidelines for—
processes or production methods relating to such good, or
operating methods relating to such service, and
(C) provisions specifying terminology, symbols, packaging, marking, or labelling for—
a good or its related process or production methods, or
a service or its related operating methods,
for common and repeated use, including explanatory and other related provisions set out in a document approved by a standardizing body, with which compliance is not mandatory.
(6) Standards-related measure

The term “standards-related measure” means a standard, technical regulation, or conformity assessment procedure.

(7) Technical regulationThe term “technical regulation” means—
characteristics or their related processes and production methods for a good,
characteristics for a service or its related operating methods, or
(C) provisions specifying terminology, symbols, packaging, marking, or labelling for—
a good or its related process or production method, or
a service or its related operating method,
set out in a document, including applicable administrative, explanatory, and other related provisions, with which compliance is mandatory.
(8) Telecommunications service

The term “telecommunications service” means a service provided by means of the transmission and reception of signals by any electromagnetic means, but does not mean the cable, broadcast, or other electromagnetic distribution of radio or television programming to the public generally.

(Pub. L. 96–39, title IV, § 473, as added Pub. L. 103–182, title III, § 351(a), Dec. 8, 1993, 107 Stat. 2120.)

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21 CFR - Food and Drugs



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