PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 869
dkrause on GSDDPC44 with PUBLAW
to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. An applicant seeking either a full or partial waiver shall submit to the Secretary documentation detailing why a pediatric formulation cannot be developed and, if the waiver is granted, the applicant’s submission shall promptly be made available to the public in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration. ‘‘(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. ‘‘(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.— ‘‘(1) IN GENERAL.—After providing notice in the form of a letter (that, for a drug approved under section 505, references a declined written request under section 505A for a labeled indication which written request is not referred under section 505A(n)(1)(A) to the Foundation of the National Institutes of Health for the pediatric studies), the Secretary may (by order in the form of a letter) require the sponsor or holder of an approved application for a drug under section 505 or the holder of a license for a biological product under section 351 of the Public Health Service Act to submit by a specified date the assessments described in subsection (a)(2), if the Secretary finds that— ‘‘(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the labeled indications; and ‘‘(ii) adequate pediatric labeling could confer a benefit on pediatric patients; ‘‘(B) there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients for 1 or more of the claimed indications; or ‘‘(C) the absence of adequate pediatric labeling could pose a risk to pediatric patients. ‘‘(2) WAIVERS.— ‘‘(A) FULL WAIVER.—At the request of an applicant, the Secretary shall grant a full waiver, as appropriate, of the requirement to submit assessments 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 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—
VerDate Aug 31 2005
08:41 Jul 13, 2009
Jkt 059194
PO 00001
Frm 00047
Fmt 6580
Sfmt 6581
O:\FROMSTAT\PUBL085.121
Public information. Web site.
APPS10
PsN: PUBL085
�
