and shall be available in accordance with appropriation Acts until expended without fiscal year limitation. (2) COLLECTIONS AND APPROPRIATION ACTS.-The fees authorized by this section (A) shall be collected in each fiscal year in an amount equal to the amount specified in appropriation Acts for such fiscal year, and (B) shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of fulltime equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs for fiscal year 1992 multiplied by the adjustment factor. (3) AUTHORIZATION OF APPROPRIATIONS.-There are authorized to be appropriated for fees under this section (A) $36,000,000 for fiscal year 1993, as adjusted to reflect increases in the total fee revenues made (h) COLLECTION OF UNPAID FEES.-In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code. (i) CONSTRUCTION.-This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged. CHAPTER VIII-IMPORTS AND EXPORTS IMPORTS AND EXPORTS SEC. 801. [381] (a) The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 510 and shall request that if any drugs or devices manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs or devices be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 520(f), or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 505, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled Substances Import and Export Act. (b) Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Secretary of Health and Human Services that an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, device, or cosmetic, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Secretary's authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Department of Health and Human Services designated by the Secretary, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury. (c) All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee and, in de fault of such payment, shall constitute a lien against any future importations made by such owner or consignee. (d)(1) Except as provided in paragraph (2), no drug subject to section 503(b) which is manufactured in a State and exported may be imported into the United States unless the drug is imported by the manufacturer of the drug. (2) The Secretary may authorize the importation of a drug the importation of which is prohibited by paragraph (1) if the drug is required for emergency medical care. (e)(1) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (A) accords to the specifications of the foreign purchaser, (B) is not in conflict with the laws of the country to which it is intended for export, (C) is labeled on the outside of the shipping package that it is intended for export, and (D) is not sold or offered for sale in domestic commerce. This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 512. (2) Paragraph (1) does not apply to any device (A) which does not comply with an applicable requirement of section 514 or 515, (B) which under section 520(g) is exempt from either such section, or (C) which is a banned device under section 516, unless, in addition to the requirements of paragraph (1), the Secretary has determined that the exportation of the device is not contrary to public health and safety and has the approval of the country to which it is intended for export. EXPORTS OF CERTAIN UNAPPROVED PRODUCTS SEC. 802. [382] (a) A drug (including a biological product) intended for human or animal use (1) which (A) requires approval by the Secretary under section 505 or section 512, or (B) requires licensing by the Secretary under section 351 of the Public Health Service Act or by the Secretary of Agriculture under the Act of March 4, 1913 (known as the Virus Serum Toxin Act), before it may be introduced or delivered for introduction into interstate commerce to a country, and (2) which does not have such approval or license, which is not exempt from such sections or Act, and which is introduced or delivered for introduction into interstate commerce to a country, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug is authorized under subsection (b). (b)(1) A drug (including a biological product) may, upon approval of an application submitted under paragraph (3), be exported if (A) the drug contains the same active ingredient as a- (I) which has an exemption under section 505(i), and (II) for which approval is actively being pursued by the person who has the exemption, (ii) biological product for human use and (I) which has an exemption under section 505(i), (II) for which licensing of the biological product under section 351 of the Public Health Service Act is actively being pursued by the person who has the exemption, (iii) biological product for animal use (I) for which authority has been granted under the Virus-Serum Toxin Act for the preparation of an experimental drug product, and (II) for which the licensing of the biological product under such Act is actively being pursued by the person who has the authority, or (iv) new animal drug and (I) which has an exemption under section 512(j), (II) for which approval is actively being pursued by the person who has the exemption, (B) except as provided in paragraph (2), the drug is exported to a country which is listed under paragraph (4) and in which the drug is approved and has not been withdrawn from sale, (C) an application for the drug under section 505 or 512, section 351 of the Public Health Service Act, or the VirusSerum Toxin Act has not been disapproved by an order of the Secretary under section 505(d) or 512(d) or 351 of the Public Health Service Act or by the Secretary of Agriculture in the case of an application under the Virus-Serum Toxin Act, (D) the drug is manufactured, processed, packaged, and held in conformity with current good manufacturing practice and is not adulterated under paragraph1 (a)(1), ̄(a)(2)(A), (a)(3), (c), or (d) of section 501, (E) the outside of the shipping package is labeled with the following statement: "This drug may be sold or offered for sale only in the following countries: the blank space being filled with a list of the countries to which export of the drug is authorized under this subsection, (F) the drug is not the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the manufacture of the drug in the United States for export to a country is contrary to the public health and safety of the United States, (G) the requirements of subparagraphs (A) through (D) of section 801(d)(1) have been met. 1 Probably should be "subsection". The Secretary shall determine that an applicant is actively pursuing the approval or licensing of a drug if the applicant has demonstrated that degree of attention and continuous directed effort as may reasonably be expected from, and are ordinarily exercised by, a person before approval or licensing of a drug, such as the preparation for and the conduct of preclinical or clinical investigations, the analysis of the results of such investigations, conferences on such investigations with government officials, and the preparation of an application of approval or licensing for the drug. (2) The Secretary may permit the export of a drug under paragraph (1) to a country which is listed under paragraph (4) and in which the drug is not approved if the drug is exported to such country solely for the purpose of further export to a country listed in paragraph (4) in which the drug is approved. (3)(A) Any person may apply to have a drug exported under paragraph (1). Such an application shall be filed at least 90 days before the date the applicant proposes to export the drug for which the application is submitted. Before the expiration of 10 days from the date of the submission of such an application, the Secretary shall publish a notice in the Federal Register which identifies the applicant under such application, the drug proposed to be exported under such application, and the country to which the drug is proposed to be exported. (B) An application for the export of a drug shall— (i) identify the drug to be exported, (ii) list each country to which the drug is to be exported and list the persons in each such country to which the drug is to be exported, (iii) contain a certification by the applicant that— (I) the applicant will export the drug only to a country which is listed in paragraph (4) and in which the drug is approved unless the drug is authorized to be exported under paragraph (2) and will export only those quantities of the drug which may reasonably be sold in each country to which it is to be exported, (II) the drug is approved by each country to which it is to be exported unless the drug is authorized to be exported under paragraph (2) and the drug has not been withdrawn from sale in such country, (III) the drug meets the requirements of paragraph (1)(D), (IV) the drug will be labeled in accordance with paragraph (1)(E), and (V) the drug meets the requirements of paragraphs (1)(C) and (1)(G), (iv) contain a certification by the holder of the exemption or authority for such drug described in paragraph (1)(A) that the holder will actively pursue the approval or licensing of the drug, (v) identify the exemption or authority for an experimental drug product in effect for such drug under the laws referred to in paragraph (1)(A), (vi) identify the establishments in which the drug is manufactured, and |