Page:United States Statutes at Large Volume 115 Part 2.djvu/438

 115 STAT. 1422 PUBLIC LAW 107-109—JAN. 4, 2002 21 USC 355b. Deadline. Regulations. (C) costs to consumers and private insurers as a result of any delay in the availability of lower cost generic equivalents of drugs tested and granted exclusivity under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and loss of revenue by the generic drug industry and retail pharmacies as a result of any such delay; and (D) the benefits to the government, to private insurers, and to consumers resulting from decreased health care costs, including— (i) decreased hospitalizations and fewer medical errors, due to more appropriate and more effective use of medications in children as a result of testing and re-labeling because of the amendments made by this Act; (ii) direct and indirect benefits associated with fewer physician visits not related to hospitalization; (iii) benefits to children from missing less time at school and being less affected by chronic illnesses, thereby allowing a better quality of life; (iv) benefits to consumers from lower health insurance premiums due to lower treatment costs and hospitalization rates; and (v) benefits to employers from reduced need for employees to care for family members. (3) The nature and type of studies in children for each drug granted exclusivity under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including— (A) a description of the complexity of the studies; (B) the number of study sites necessary to obtain appropriate data; (C) the number of children involved in any clinical studies; and (D) the estimated cost of each of the studies. (4) Any recommendations for modifications to the programs established under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) and section 4091 of the Public Health Service Act (as added by section 3) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation. (5) The increased private and Government-funded pediatric research capability associated with this Act and the amendments made by this Act. (6) The number of written requests and additional letters of recommendation that the Secretary issues. (7) The prioritized list of off-patent drugs for which the Secretary issues written requests. (8)(A) The efforts made by the Secretary to increase the number of studies conducted in the neonate population; and (B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of studies ethical and safe. SEC. 17. ADVERSE-EVENT REPORTING. (a) TOLL-FREE NUMBER IN LABELING. —Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate a final rule requiring that

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