§ 383. Office of International Relations

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pub. L. 101–629 § 15(a) · 104 Stat. 4469

   Enacted · 21 U.S.C. § 383

   June 25, 1938, ch. 675, § 803, as added Pub. L. 101–629, § 15(a), Nov. 28, 1990, 104 Stat. 4525

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 803, as added Pub. L. 101–629, § 15(a), Nov. 28, 1990, 104 Stat. 4525

   Enacted provision · exact public law section
   (a) Office.— Title VIII is amended by adding at the end the following: “Sec. 803. “office of international relations (a) There is established in the Department of Health 21 USC 383. and Human Services an Office of International Relations. “(b) 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 Act. In such agreements, the Secretary shall encourage the mutual recognition of— “(1) good manufacturing practice regulations promulgated under section 520(f), and “(2) other regulations and testing protocols as the Secretary determines to be appropriate.”

2. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 title IV § 410(b) · 111 Stat. 2296

   Added · 21 U.S.C. § 383(c)

   Pub. L. 105–115 added subsec. (c)

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 105–115 added subsec. (c).

   Enacted provision · exact public law section
   (b) Harmonization Efforts.— Section 803 (21 U.S.C. 383) is amended by adding at the end the following: “(c) (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 Act. “(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 the date of enactment of the Food and Drug Administration Modernization Act of 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 201(ff).”.

   Effective date note
   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.

3. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 610 · 126 Stat. 993

   1. Amended · 21 U.S.C. § 383(c)(3)

      Pub. L. 112–144, § 610, designated existing provisions as subpar. (A)

   2. Added · 21 U.S.C. § 383(c)(3)

      Pub. L. 112–144, § 610, added subpar. (B)

   Source evidence

   Code amendment note
   Subsec. (c)(3). Pub. L. 112–144, § 610, designated existing provisions as subpar. (A) and added subpar. (B).

   Enacted provision · exact public law section
   SEC. 610. PARTICIPATION IN INTERNATIONAL FORA.   Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is amended— (1) by striking “(3)” and inserting “(3)(A)”; and (2) by adding at the end the following: “(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. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 609 · 126 Stat. 993

   Amended · 21 U.S.C. § 383(c)(4)

   Pub. L. 112–144, § 609, amended par. (4) generally. Prior to amendment, par. (4) read as follows: “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.”

   Source evidence

   Code amendment note
   Subsec. (c)(4). Pub. L. 112–144, § 609, amended par. (4) generally. Prior to amendment, par. (4) read as follows: “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.”

   Enacted provision · exact public law section
   SEC. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW, INSPECTION, AND LABELING SYMBOLS.   Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is amended to read as follows: “(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 of 5 references resolved to an enrolled provision