§ 383. — Office of International Relations.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC383]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII--IMPORTS AND EXPORTS
Sec. 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--
(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 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.
(June 25, 1938, ch. 675, Sec. 803, as added Pub. L. 101-629, Sec. 15(a),
Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105-115, title IV,
Sec. 410(b), Nov. 21, 1997, 111 Stat. 2373.)
Amendments
1997--Subsec. (c). Pub. L. 105-115 added subsec. (c).
Effective Date of 1997 Amendment
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997,
except as otherwise provided, see section 501 of Pub. 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) of Pub. L. 101-629 directed 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.
Section Referred to in Other Sections
This section is referred to in sections 335a, 374 of this title.
