121 STAT. 868
‘‘(I) Information detailing the progress made in conducting pediatric studies. ‘‘(II) If no progress has been made in conducting such studies, evidence and documentation that such studies will be conducted with due diligence and at the earliest possible time. ‘‘(ii) PUBLIC AVAILABILITY.—The information submitted through the annual review under clause (i) shall promptly be made available to the public in an easily accessible manner, including through the Web site of the Food and Drug Administration. ‘‘(4) WAIVERS.— ‘‘(A) FULL WAIVER.—On the initiative of the Secretary or at the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments for a drug or biological product under this subsection if the applicant certifies and the Secretary finds that— ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients is so small or the patients are geographically dispersed); ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in all pediatric age groups; or ‘‘(iii) the drug or biological product— ‘‘(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients; and ‘‘(II) is not likely to be used in a substantial number of pediatric patients. ‘‘(B) PARTIAL WAIVER.—On the initiative of the Secretary or at the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of the requirement to submit assessments for a drug or biological product under this subsection with respect to a specific pediatric age group if the applicant certifies and the Secretary finds that— ‘‘(i) necessary studies are impossible or highly impracticable (because, for example, the number of patients in that age group is so small or patients in that age group are geographically dispersed); ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in that age group; ‘‘(iii) the drug or biological product— ‘‘(I) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and ‘‘(II) is not likely to be used by a substantial number of pediatric patients in that age group; or ‘‘(iv) the applicant can demonstrate that reasonable attempts to produce a pediatric formulation necessary for that age group have failed. ‘‘(C) PEDIATRIC FORMULATION NOT POSSIBLE.—If a waiver is granted on the ground that it is not possible
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