Sec. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES
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## SEC. 505 ENSURING THE COMPLETION OF PEDIATRIC STUDIES ###
(a)Extension of Deadline for Deferred Studies Section 505B (21 U.S.C. 355c) is amended— ####
(1)in subsection (a)(3)— #####
(A)by redesignating subparagraph
(B)as subparagraph (C); #####
(B)by inserting after subparagraph
(A)the following: > > ##### “(B) Deferral extension > > > ###### “(i) In general > > On the initiative of the Secretary or at the request of the applicant, the Secretary may grant an extension of a deferral approved under subparagraph
(A)for submission of some or all assessments required under paragraph
(1)if— > > > ###### “(I) > > the Secretary determines that the conditions described in subclause
(II)or
(III)of subparagraph (A)(i) continue to be met; and > > > ###### “(II) > > the applicant submits a new timeline under subparagraph (A)(ii)(IV) and any significant updates to the information required under subparagraph (A)(ii). > > > ###### “(ii) Timing and information > > If the deferral extension under this subparagraph is requested by the applicant, the applicant shall submit the deferral extension request containing the information described in this subparagraph not less than 90 days prior to the date that the deferral would expire. The Secretary shall respond to such request not later than 45 days after the receipt of such letter. If the Secretary grants such an extension, the specified date shall be the extended date. The sponsor of the required assessment under paragraph
(1)shall not be issued a letter described in subsection
(d)unless the specified or extended date of submission for such required studies has passed or if the request for an extension is pending. For a deferral that has expired prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act or that will expire prior to 270 days after the date of enactment of such Act, a deferral extension shall be requested by an applicant not later than 180 days after the date of enactment of such Act. The Secretary shall respond to any such request as soon as practicable, but not later than 1 year after the date of enactment of such Act. Nothing in this clause shall prevent the Secretary from updating the status of a study or studies publicly if components of such study or studies are late or delayed.” > ; and #####
(C)in subparagraph (C), as so redesignated— ######
(i)in clause (i), by adding at the end the following: > > ###### “(III) > > Projected completion date for pediatric studies. > > > ###### “(IV) > > The reason or reasons why a deferral or deferral extension continues to be necessary.” > ; and ######
(ii)by amending clause
(ii)to read as follows: > > ###### “(ii) Public availability > > Not later than 90 days after the submission to the Secretary of the information submitted through the annual review under clause (i), the Secretary shall make available to the public in an easily accessible manner, including through the Internet Web site of the Food and Drug Administration— > > > ###### “(I) > > such information; > > > ###### “(II) > > the name of the applicant for the product subject to the assessment; > > > ###### “(III) > > the date on which the product was approved; and > > > ###### “(IV) > > the date of each deferral or deferral extension under this paragraph for the product.” > ; and ####
(2)in subsection (f)— #####
(A)in the subsection heading, by inserting “Deferral Extensions,” after “Deferrals,”; #####
(B)in paragraph (1), by inserting “, deferral extension,” after “deferral”; and #####
(C)in paragraph (4)— ######
(i)in the paragraph heading, by inserting “deferral extensions,” after “deferrals,”; and ######
(ii)by inserting “, deferral extensions,” after “deferrals”. ###
(b)Tracking of Extensions; Annual Information Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows: > > ##### “(D) > > aggregated on an annual basis— > > > ###### “(i) > > the total number of deferrals and deferral extensions requested and granted under this section and, if granted, the reasons for each such deferral or deferral extension; > > > ###### “(ii) > > the timeline for completion of the assessments; and > > > ###### “(iii) > > the number of assessments completed and pending;” > . ###
(c)Action on Failure To Complete Studies ####
(1)Issuance of letter Subsection
(d)of section 505B (21 U.S.C. 355c) is amended to read as follows: > > ### “(d) Submission of Assessments > > If a person fails to submit a required assessment described in subsection (a)(2), fails to meet the applicable requirements in subsection (a)(3), or fails to submit a request for approval of a pediatric formulation described in subsection
(a)or (b), in accordance with applicable provisions of subsections
(a)and (b), the following shall apply: > > > #### “(1) > > Beginning 270 days after the date of enactment of the Food and Drug Administration Safety and Innovation Act, the Secretary shall issue a non-compliance letter to such person informing them of such failure to submit or meet the requirements of the applicable subsection. Such letter shall require the person to respond in writing within 45 calendar days of issuance of such letter. Such response may include the person’s request for a deferral extension if applicable. Such letter and the person’s written response to such letter shall be made publicly available on the Internet Web site of the Food and Drug Administration 60 calendar days after issuance, with redactions for any trade secrets and confidential commercial information. If the Secretary determines that the letter was issued in error, the requirements of this paragraph shall not apply. > > > #### “(2) > > The drug or biological product that is the subject of an assessment described in subsection (a)(2), applicable requirements in subsection (a)(3), or request for approval of a pediatric formulation, may be considered misbranded solely because of that failure and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 303), but such failure shall not be the basis for a proceeding— > > > ##### “(A) > > to withdraw approval for a drug under section 505(e); or > > > ##### “(B) > > to revoke the license for a biological product under section 351 of the Public Health Service Act.” > . ####
(2)Tracking of letters issued Subparagraph
(D)of section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by subsection (b), is further amended— #####
(A)in clause (ii), by striking “; and” and inserting a semicolon; #####
(B)in clause (iii), by adding “and” at the end; and #####
(C)by adding at the end the following: > > ###### “(iv) > > the number of postmarket non-compliance letters issued pursuant to subsection (d), and the recipients of such letters;” > .
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Sec. 505
ENSURING THE COMPLETION OF PEDIATRIC STUDIES
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