Sec. 506. PEDIATRIC STUDY PLANS
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## SEC. 506 PEDIATRIC STUDY PLANS ###
(a)In General Subsection
(e)of section 505B (21 U.S.C. 355c) is amended to read as follows: > > ### “(e) Pediatric Study Plans > > > #### “(1) In general > > An applicant subject to subsection
(a)shall submit to the Secretary an initial pediatric study plan prior to the submission of the assessments described under subsection (a)(2). > > > #### “(2) Timing; content; meeting > > > ##### “(A) Timing > > An applicant shall submit the initial pediatric plan under paragraph (1)— > > > ###### “(i) > > before the date on which the applicant submits the assessments under subsection (a)(2); and > > > ###### “(ii) > > not later than— > > > ###### “(I) > > 60 calendar days after the date of the end-of-Phase 2 meeting (as such term is used in section 312.47 of title 21, Code of Federal Regulations, or successor regulations); or > > > ###### “(II) > > such other time as may be agreed upon between the Secretary and the applicant. > > Nothing in this section shall preclude the Secretary from accepting the submission of an initial pediatric plan earlier than the date otherwise applicable under this subparagraph. > > > ##### “(B) Content of initial plan > > The initial pediatric study plan shall include— > > > ###### “(i) > > an outline of the pediatric study or studies that the applicant plans to conduct (including, to the extent practicable study objectives and design, age groups, relevant endpoints, and statistical approach); > > > ###### “(ii) > > any request for a deferral, partial waiver, or waiver under this section, if applicable, along with any supporting information; and > > > ###### “(iii) > > other information specified in the regulations promulgated under paragraph (7). > > > ##### “(C) Meeting > > The Secretary— > > > ###### “(i) > > shall meet with the applicant to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); > > > ###### “(ii) > > may determine that a written response to the initial pediatric study plan is sufficient to communicate comments on the initial pediatric study plan, and that no meeting is necessary; and > > > ###### “(iii) > > if the Secretary determines that no meeting is necessary, shall so notify the applicant and provide written comments of the Secretary as soon as practicable, but not later than 90 calendar days after the receipt of the initial pediatric study plan. > > > #### “(3) Agreed initial pediatric study plan > > Not later than 90 calendar days following the meeting under paragraph (2)(C)(i) or the receipt of a written response from the Secretary under paragraph (2)(C)(iii), the applicant shall document agreement on the initial pediatric study plan in a submission to the Secretary marked ‘Agreed Initial Pediatric Study Plan’, and the Secretary shall confirm such agreement to the applicant in writing not later than 30 calendar days of receipt of such agreed initial pediatric study plan. > > > #### “(4) Deferral and waiver > > If the agreed initial pediatric study plan contains a request from the applicant for a deferral, partial waiver, or waiver under this section, the written confirmation under paragraph
(3)shall include a recommendation from the Secretary as to whether such request meets the standards under paragraphs
(3)or
(4)of subsection (a). > > > #### “(5) Amendments to the plan > > At the initiative of the Secretary or the applicant, the agreed initial pediatric study plan may be amended at any time. The requirements of paragraph (2)(C) shall apply to any such proposed amendment in the same manner and to the same extent as such requirements apply to an initial pediatric study plan under paragraph (1). The requirements of paragraphs
(3)and
(4)shall apply to any agreement resulting from such proposed amendment in the same manner and to the same extent as such requirements apply to an agreed initial pediatric study plan. > > > #### “(6) Internal committee > > The Secretary shall consult the internal committee under section 505C on the review of the initial pediatric study plan, agreed initial pediatric plan, and any significant amendments to such plans. > > > #### “(7) Required rulemaking > > Not later than 1 year after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall promulgate proposed regulations and issue guidance to implement the provisions of this subsection.” > . ###
(b)Conforming Amendments Section 505B (21 U.S.C. 355c) is amended— ####
(1)by amending subclause
(II)of subsection (a)(3)(A)(ii) to read as follows: > > ###### “(II) > > a pediatric study plan as described in subsection (e);” > ; and ####
(2)in subsection (f)— #####
(A)in the subsection heading, by striking “pediatric Plans,” and inserting “pediatric Study Plans,”; #####
(B)in paragraph (1), by striking “all pediatric plans” and inserting “initial pediatric study plans, agreed initial pediatric study plans,”; and #####
(C)in paragraph (4)— ######
(i)in the paragraph heading, by striking “pediatric Plans,” and inserting “pediatric Study Plans,”; and ######
(ii)by striking “pediatric plans” and inserting “initial pediatric study plans, agreed initial pediatric study plans,”. ###
(c)Effective Date **[**[21 U.S.C. 355c note](/us/usc/t21/s355c)**]** ####
(1)In general Subject to paragraph (2), the amendments made by this section shall take effect 180 calendar days after the date of enactment of this Act, irrespective of whether the Secretary has promulgated final regulations to carry out such amendments. ####
(2)Rule of construction Paragraph
(1)shall not be construed to affect the deadline for promulgation of proposed regulations under section 505B(e)(7) of the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a)of this section.
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Sec. 506
PEDIATRIC STUDY PLANS
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