U.S. Code
- Title 1 General Provisions
- Title 2 The Congress
- Title 3 The President
- Title 4 Flag and Seal, Seat Of Government,and the States
- Title 5 Government Organization and Employees
- Appendix to Title 5
- Title 6 Domestic Security
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- Appendix to Title 10 (Rules of Court of Appeals for the Armed Forces)
- Title 11 Bankruptcy
- Appendix to Title 11
- Title 12 Banks and Banking
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- Appendix to Title 18
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- Title 22 Foreign Relations and Intercourse
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- Appendix to Title 26
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- Title 34 Navy (repealed)
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- Title 38 Veterans' Benefits
- Appendix to Title 38 (Rules of Court of Appeals for Veterans Claims()
- Title 39 Postal Service
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- Appendix to Title 46
- Title 47 Telegraphs, Telephones, and Radiotelegraphs
- Title 48 Territories and Insular Possessions
- Title 49 Transportation
- Title 50 War and National Defense
- Appendix to Title 50
§ 383. Office of International Relations
(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) of this section, 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—
(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)
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.
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