MANAGEMENT ACTIVITIES STUDY.

SEC. 205. MANAGEMENT ACTIVITIES STUDY. (a) Study.— The Comptroller General shall conduct a study of the management of activities of the Food and Drug Administration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances. (b) Contents.— In conducting the study, the Comptroller General shall examine, with respect to such activities— (1) the means by which the Food and Drug Administration makes a determination that a substance poses a risk to public health and safety that justifies the expenditure of resources by the agency; (2) the means by which the Food and Drug Administration makes a determination that a substance is adulterated, misbranded, or improperly manufactured; (3) the means by which the Food and Drug Administration makes a determination relating to the quantitative management of the agency response to specific issues, in order to adjust the efforts of the agency to be commensurate with the severity of the problem addressed by the agency; (4) the approach by which the Food and Drug Administration determines the adequacy of proof related to the risk posed by, or the safety of, a substance, and the adequacy of such approach; and (5) the relationship between— (A) (i) the number of hours devoted by Food and Drug Administration personnel, and the expertise of such personnel, in conducting such activities; (ii) the cost of conducting such activities; and 106 STAT. 4503 (iii) the cost to manufacturers of such supplements to achieve compliance with such activities; and (B) (i) the level of risk suspected to be posed by such supplements; and (ii) the level of risk determined to be posed by such supplements. (c) Approach.— In conducting the study, the Comptroller General shall analyze the current practices of the Food and Drug Administration and the practices of the agency within the 5 years prior to the date of enactment of this Act. (d) Analysis.— In conducting the study, the Comptroller General shall— (1) determine the relative proportion of resources devoted to Food and Drug Administration regulatory and enforcement activities that are related to— (A) dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances; (B) food additives that are not such dietary supplements; (C) foods that are not such dietary supplements; (D) drugs that are not such dietary supplements, and devices; or (E) cosmetics; and (2) determine, with respect to such supplements, with respect to food additives, and with respect to foods, the proportion of the resources devoted to such regulatory and enforcement activities that are used to— (A) determine whether a substance is misbranded; (B) determine whether an improper manufacturing practice occurred during the manufacturing of a substance; (C) determine whether a substance is unsafe; and (D) determine whether a substance is adulterated or otherwise in violation of the Federal Food, Drug, and Cosmetic Act (other than by making a determination described in subparagraph (A), (B), or (C)). (e) Reports.— (1) Interim report.— (A) In general.— Not later than 6 months after the date of enactment of this Act, the Comptroller General shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate an interim report containing the findings resulting from the study and the recommendations described in subparagraph (B). (B) Recommendations.— Such report shall include the recommendations of the Comptroller General for administrative reform, including recommendations regarding opportunities for encouraging economy and efficiency through the appropriate targeting of problems, managing resources appropriately, and making adequate determinations of risk or safety, in carrying out activities related to such supplements. (2) Final report.— (A) In general.— Not later than 12 months after the date of enactment of this Act, the Comptroller General shall prepare and submit to the Committee on Energy106 STAT. 4504 and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a final report containing the findings resulting from the study and the recommendations described in subparagraph (B). (B) Recommendations.— Such report shall contain the recommendations described in paragraph (1)(B).