Page:United States Statutes at Large Volume 117.djvu/1956

 PUBLIC LAW 108–155—DEC. 3, 2003

117 STAT. 1937

and pediatric patients, the Secretary may conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies. ‘‘(ii) EXTRAPOLATION BETWEEN AGE GROUPS.—A study may not be needed in each pediatric age group if data from one age group can be extrapolated to another age group. ‘‘(3) DEFERRAL.—On the initiative of the Secretary or at the request of the applicant, the Secretary may defer submission of some or all assessments required under paragraph (1) until a specified date after approval of the drug or issuance of the license for a biological product if— ‘‘(A) the Secretary finds that— ‘‘(i) the drug or biological product is ready for approval for use in adults before pediatric studies are complete; ‘‘(ii) pediatric studies should be delayed until additional safety or effectiveness data have been collected; or ‘‘(iii) there is another appropriate reason for deferral; and ‘‘(B) the applicant submits to the Secretary— ‘‘(i) certification of the grounds for deferring the assessments; ‘‘(ii) a description of the planned or ongoing studies; and ‘‘(iii) evidence that the studies are being conducted or will be conducted with due diligence and at the earliest possible time. ‘‘(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

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