Page:United States Statutes at Large Volume 100 Part 5.djvu/277

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3751

shall prohibit the export of such drug to such country if the Secretary determines the holder is exporting the drug to a country for which the Secretary cannot make a finding under paragraph (I)(A). "(E) If the Secretary receives credible evidence that an importer is Reports. exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), the Secretary shall notify the holder of the application authorizing the export of such drug of such evidence and shall require the holder to investigate the export by such importer and to report to the Secretary within 14 days of the receipt of such notice the findings of the holder. If the Secretary determines that the importer has exported a drug to such a country, the Secretary shall prohibit such holder from exporting such drug to the importer unless the Secretary determines that the export by the importer was unintentional. "(g) For purposes of this section— "(1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Virus-Serum Toxin Act be considered to be a reference to the Secretary of Agriculture, and "(2) a reference in paragraph (3), (4), (5), or (6) of subsection (e) and in subparagraph (B), (C), (D), or (E) of subsection (f)(4) to the holder of an application shall be considered a reference to any person which is under common control with holder, is controlled by the holder, controls the holder, is owned by the holder, or owns the holder.". SEC. 103. ENFORCEMENT.

For the fines authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act, see section 3623 of title 18, United States Code, for the period ending October 31, 1986, and sections 3559 and 3571 of such title for the period beginning November 1, 1986.

21 USC 333 note. 21 USC 333.

SEC. 104. TROPICAL DISEASES.

Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following: "(c) The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.".

Research and development. Grants. Contracts.

SEC. 105. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

(a) AMENDMENT.—Section 351 of the Public Health Service Act (42 U.S.C 262) is amended by adding at the end the following: Post, p. 3783. "(h)(1)(A) A partially processed biological product which is not in a Labeling. form applicable to the prevention, treatment, or cure of diseases or injuries of man, which is not intended for sale in the United States, and which is intended for further manufacture into final dosage form outside the United States in a country listed under section 802(b)(A) of the Federal Food, Drug, and Cosmetic Act may, upon Ante, p. 3743. approval of an application meeting the requirements of subparagraph (B), be exported to a country listed under section 802(b)(4) of the Federal Food, Drug, and Cosmetic Act. The Secretary may not approve an application to export such a product unless the Secretary determines that the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and the outside of the shipping package is labeled with the

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