Page:United States Statutes at Large Volume 117.djvu/1958

 PUBLIC LAW 108–155—DEC. 3, 2003

117 STAT. 1939

patients in that age group is so small or patients in that age group are geographically dispersed); or ‘‘(ii) there is evidence strongly suggesting that the drug or biological product would be ineffective or unsafe in all pediatric age groups. ‘‘(B) PARTIAL WAIVER.—At the request of an applicant, the Secretary shall grant a partial waiver, as appropriate, of the requirement to submit assessments 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)(I) the drug or biological product— ‘‘(aa) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in that age group; and ‘‘(bb) is not likely to be used in a substantial number of pediatric patients in that age group; and ‘‘(II) the absence of adequate labeling could not pose significant risks to pediatric patients; 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 to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. ‘‘(D) LABELING REQUIREMENT.—If the Secretary grants a full or partial waiver because there is evidence that a drug or biological product would be ineffective or unsafe in pediatric populations, the information shall be included in the labeling for the drug or biological product. ‘‘(3) RELATIONSHIP TO OTHER PEDIATRIC PROVISIONS.— ‘‘(A) NO ASSESSMENT WITHOUT WRITTEN REQUEST.—No assessment may be required under paragraph (1) for a drug subject to an approved application under section 505 unless— ‘‘(i) the Secretary has issued a written request for a related pediatric study under section 505A(c) of this Act or section 409I of the Public Health Service Act (42 U.S.C. 284m); ‘‘(ii)(I) if the request was made under section 505A(c)— ‘‘(aa) the recipient of the written request does not agree to the request; or ‘‘(bb) the Secretary does not receive a response as specified under section 505A(d)(4)(A); or ‘‘(II) if the request was made under section 409I of the Public Health Service Act (42 U.S.C. 284m)— ‘‘(aa) the recipient of the written request does not agree to the request; or

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