21 USC § 383 - Office of International Relations

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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) 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—

(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.

(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.

(4) The Secretary shall, not later than 180 days after November 21, 1997, make public a plan that establishes a framework for achieving mutual recognition of good manufacturing practices inspections.

(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 321 (ff) of this title.

Source

(June 25, 1938, ch. 675, § 803, as added Pub. L. 101–629, § 15(a),Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105–115, title IV, § 410(b),Nov. 21, 1997, 111 Stat. 2373.)

Amendments

1997—Subsec. (c). Pub. L. 105–115added subsec. (c).

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as a note under section 321 of this title.

Report on Activities of Office of International Relations

Section 15(b) ofPub. L. 101–629directed Secretary of Health and Human Services, not later than 2 years after Nov. 28, 1990, to prepare and submit to the appropriate committees of Congress a report on the activities of the Office of International Relations under 21 U.S.C. 383.

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Wednesday, December 26, 2012

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

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21 USC	Description of Change	Session Year	Public Law	Statutes at Large
§ 383		2012	112-144 [Sec.] 609, 610	126 Stat. 1059

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

21 CFR - Food and Drugs

21 CFR 5 - ORGANIZATION

21 CFR 7 - ENFORCEMENT POLICY

21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR 20 - PUBLIC INFORMATION

21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

21 CFR 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

21 CFR 820 - QUALITY SYSTEM REGULATION

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21 USC § 383 - Office of International Relations

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