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21 U.S.C. § 383 — Office of International Relations
Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** There is established in the Department of Health and Human Services an Office of International Relations.
**(b) Agreements with foreign countries** In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this chapter. In such agreements, the Secretary shall encourage the mutual recognition of—
(1) good manufacturing practice regulations promulgated under [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f&num=0&edition=prelim), and
(2) other regulations and testing protocols as the Secretary determines to be appropriate.
**(c) Harmonizing regulatory requirements**
(1) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this chapter.
(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States.
(3)
(A) The Secretary shall regularly participate in meetings with representatives of other foreign gov
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Source location: Title 21, Chapter 9, § 383; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Establishment** There is established in the Department of Health and Human Services an Office of International Relations.
**(b) Agreements with foreign countries** In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this chapter. In such agreements, the Secretary shall encourage the mutual recognition of—
(1) good manufacturing practice regulations promulgated under [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f&num=0&edition=prelim), and
(2) other regulations and testing protocols as the Secretary determines to be appropriate.
**(c) Harmonizing regulatory requirements**
(1) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the Secretary determines that such harmonization continues consumer protections consistent with the purposes of this chapter.
(2) The Secretary shall support the Office of the United States Trade Representative, in consultation with the Secretary of Commerce, in efforts to move toward the acceptance of mutual recognition agreements relating to the regulation of drugs, biological products, devices, foods, food additives, and color additives, and the regulation of good manufacturing practices, between the European Union and the United States.
(3)
(A) The Secretary shall regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements.
(B) In carrying out subparagraph (A), the Secretary may participate in appropriate fora, including the International Medical Device Regulators Forum, and may—
(i) provide guidance to such fora on strategies, policies, directions, membership, and other activities of a forum as appropriate;
(ii) to the extent appropriate, solicit, review, and consider comments from industry, academia, health care professionals, and patient groups regarding the activities of such fora; and
(iii) to the extent appropriate, inform the public of the Secretary’s activities within such fora, and share with the public any documentation relating to a forum’s strategies, policies, and other activities of such fora.
(4) With respect to devices, the Secretary may, when appropriate, enter into arrangements with nations regarding methods and approaches to harmonizing regulatory requirements for activities, including inspections and common international labeling symbols.
(5) Paragraphs (1) through (4) shall not apply with respect to products defined in [section 321(ff) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/ff&num=0&edition=prelim).
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
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Federal law — U.S. Code and appendices · legal_authorities
Page 652
TITLE 21—FOOD AND DRUGS
§ 383
suit of drug approval or licensing, application for ex-
port, contents, approval or disapproval, list of eligible
countries for export, and criteria for list change, report
to Secretary by holder of approved application, events
requiring report, and annual report to Secretary on
pursuit of approval of drug, export of drug under ap-
proved application prohibited under certain conditions,
determination by Secretary of noncompliance, failure
of active pursuit of drug approval, imminent hazard of
drug to public health, or exportation of drug to non-
eligible country, notices, hearings, and prohibition on
exportation of drug under certain circumstances, drugs
used in prevention or treatment of tropical disease, and
reference to Secretary and holder of application.
Subsec. (f)(5). Pub. L. 104–180 substituted ‘‘if the la-
beling of the drug or device is not’’ for ‘‘if the drug or
device is not labeled’’.
§ 383. Office of International Relations
(a) Establishment
There is established in the Department of
Health and Human Services an Office of Inter-
national Relations.
(b) Agreements with foreign countries
In carrying out the functions of the office
under subsection (a), the Secretary may enter
into agreements with foreign countries to facili-
tate commerce in devices between the United
States and such countries consistent with the
requirements of this chapter. In such agree-
ments, the Secretary shall encourage the mu-
tual recognition of—
(1) good manufacturing practice regulations
promulgated under section 360j(f) of this title,
and
(2) other regulations and testing protocols as
the Secretary determines to be appropriate.
(c) Harmonizing regulatory requirements
(1) The Secretary shall support the Office of
t
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 383
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