tion and provide the person, on request, an opportunity for an informal hearing with respect to such determination.

(B) If at any time the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that

(i) the holder of an approved application under paragraph (2) is exporting a drug from the United States to an importer, (ii) such importer is exporting the drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), and

(iii) such export presents an imminent hazard to the public health in such country,

the Secretary shall immediately prohibit the export of the drug to such importer, give the person exporting the drug from the United States prompt notice of the determination, and afford such person an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary.

(C) If the Secretary, or in the absence of the Secretary the individual acting as the Secretary, determines that the holder of an approved application under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), and that the export of the drug presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug to such country, give the holder prompt notice of the determination, and afford the holder an opportunity for an expedited hearing. A determination by the Secretary under this subparagraph may not be stayed pending final action by a reviewing court. The authority conferred by this subparagraph shall not be delegated by the Secretary.

(D) If the Secretary receives credible evidence that the holder of an application approved under paragraph (2) is exporting a drug to a country for which the Secretary cannot make a finding under paragraph (1)(A), the Secretary shall give the holder 60 days to provide information to the Secretary respecting such evidence and shall provide the holder an opportunity for an informal hearing on such evidence. Upon the expiration of such 60 days the Secretary 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 (1)(A).

(E) If the Secretary receives credible evidence that an importer is 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.

OFFICE OF INTERNATIONAL RELATIONS

SEC. 803. [383] (a) There is established in the Department of Health 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.

CHAPTER IX-MISCELLANEOUS

SEPARABILITY CLAUSE

SEC. 901. [391] If any provision of this Act is declared unconstitutional, or the applicability thereof to any person or circumstances is held invalid, the constitutionality of the remainder of the Act and the applicability thereof to other persons and circumstances shall not be affected thereby.

EFFECTIVE DATE AND REPEALS

SEC. 902. [392] (a) This Act shall take effect twelve months after the date of its enactment. The Federal Food and Drug Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15), shall remain in force until such effective date, and except as otherwise provided in this subsection, is hereby repealed effective upon such date: Provided, That the provisions of section 701 shall become effective on the enactment of this Act, and thereafter the Secretary [of Agriculture] is authorized hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or after the effective date of this Act as the Secretary [of Agriculture] shall direct, and (2) designate prior to the effective date of this Act food having common or usual names and exempt such food from the requirements of clause (2) of section 403(i) for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401: Provided further, That sections 502(j), 505, and 601(a), and all other provisions of this Act to the extent that they may relate to the enforcement of such sections, shall take effect on the date of the enactment of this Act, except that in the case of a cosmetic to which the proviso of section 601(a) relates, such cosmetic

shall not, prior to the ninetieth day after such date of enactment, be deemed adulterated by reason of the failure of its label to bear the legend prescribed in such proviso: Provided further, That the Act of March 4, 1923 (U.S.C., 1945 ed., title 21, sec. 321a; 32 Stat. 1500, ch. 268), defining butter and providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1946 ed., title 21, sec. 321b; 41 Stat. 271, ch. 26), defining wrapped meats as in package form; and the amendment to the Food and Drug Act, section 10A, approved August 27, 1935 (U.S.C., 1946 ed., title 21, sec. 372a [49 Stat. 871, ch. 739]), shall remain in force and effect and be applicable to the provisions of this Act.

(b) Meats and meat food products shall be exempt from the provisions of this Act to the extent of the application or the extension thereto of the Meat Inspection Act, approved March 4, 1907, as amended (U.S.C., 1946 ed., title 21, secs. 71-96; 34 Stat. 1260 et seq.).

(c) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of section 351 of Public Health Service Act (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913 (37 Stat. 832-833); the Filled Cheese Act of June 6, 1896 (U.S.C., 1946 ed., title 26, ch. 17, secs. 2350-2362); the Filled Milk Act of March 4, 1923 (U.S.C. 1946 ed., title 21, ch. 3, secs. 61-64); or the Import Milk Act of February 15, 1927 (U.S.C., 1946 ed., title 21, ch. 4, secs. 141-149).

SEC. 903. [393] FOOD AND DRUG ADMINISTRATION.

(a) IN GENERAL.-There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the "Administration"). (b) COMMISSIONER.

(1) APPOINTMENT.-There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the "Commissioner") who shall be appointed by the President by and with the advice and consent of the Senate.

(2) GENERAL POWERS.-The Secretary, through the Commissioner, shall be responsible for executing this Act and for

(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all administrative entities within the Administration;

(C) research relating to foods, drugs, cosmetics, and devices in carrying out this Act;

(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and

(E) performing such other functions as the Secretary may prescribe.

(c) TECHNICAL AND SCIENTIFIC REVIEW GROUPS.-The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under the Federal Food, Drug, and Cosmetic Act, and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

SEC. 903.1 [394] SCIENTIFIC REVIEW GROUPS.

Without regard to the provisions of title 5, United States Code, governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may

(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this Act); and

(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

1Public Law 101-635 added a new section 903. Probably should have been designated as "904".