Page:United States Statutes at Large Volume 98 Part 2.djvu/441

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PUBLIC LAW 98-000—MMMM. DD, 1984

PUBLIC LAW 98-417—SEPT. 24, 1984

98 STAT. 1601

Cosmetic Act and the Public Health Service Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient. "(3) The term 'major health or environmental effects test' means a test which is reasonably related to the evaluation of the health or environmental effects of a product, which requires at least six months to conduct, and the data from which is submitted to receive permission for commercial marketing or use. Periods of analysis or evaluation of test results are not to be included in determining if the conduct of a test required at least six months. "(4)(A) Any reference to section 351 is a reference to section 351 of the Public Health Service Act. "(B) Any reference to section 503, 505, 507, or 515 is a reference to section 503, 505, 507, or 515 of the Federal Food, Drug, and Cosmetic Act. "(5) The term 'informal hearing' has the meaning prescribed for such term by section 201(y) of the Federal Food, Drug, and Cosmetic Act. "(6) The term 'patent' means a patent issued by the United States Patent and Trademark Office. "(g) For purposes of this section, the term 'regulatory review period' has the following meanings: "(I)(A) In the case of a product which is a human drug product, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a human drug product is the sum of— "(i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 became effective for the approved humsin drug product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507, and "(ii) the period beginning on the date the application was initially submitted for the approved human drug product under section 351, subsection (b) of section 505, or section 507 and ending on the date such application was approved under such section. "(2)(A) In the case of a product which is a food additive or color additive, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a food or color additive is the sum of—"(i) the period beginning on the date a major health or environmental effects test on the additive was initiated and ending on the date a petition was initially submitted with respect to the product under the Federal Fodd, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and "(ii) the period beginning on the date a petition was initially submitted with respect to the product under the Federal Food, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and ending on the date such regulation became effective or, if objections were filed to such regulation, ending on the date such objections were resolved and commercial marketing was

21 USC 301; 42 USC 201 note.

42 USC 262. 21 USC 353, 355, ^57,360e. 21 USC 321.

21 USC 355, 357.

Ante, pp. 1592, i^^^.

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