Source: http://uscode.house.gov/view.xhtml?req=(title:21%20section:355c%20edition:prelim)
Timestamp: 2017-03-24 17:57:43
Document Index: 521737912

Matched Legal Cases: ['§ 355', '§505', '§2', '§402', '§7002', '§501', '§3101', '§3102', '§506', '§402', '§4']

21 USC 355c: Research into pediatric uses for drugs and biological products
TITLE 21 / CHAPTER 9 / SUBCHAPTER V / Part A / § 355c
A person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug-
The assessments referred to in paragraph (1) shall contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate-
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-
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-
(II) the name of the applicant for the product subject to the assessment;
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-
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 age group if the applicant certifies and the Secretary finds that-
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 July 9, 2012, 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 333 of this title), but such failure shall not be the basis for a proceeding-
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
(i) before the date on which the applicant submits the assessments under subsection (a)(2); and
(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.
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.
(June 25, 1938, ch. 675, §505B, as added Pub. L. 108–155, §2(a), Dec. 3, 2003, 117 Stat. 1936
; amended Pub. L. 110–85, title IV, §402(a), Sept. 27, 2007, 121 Stat. 866
; Pub. L. 111–148, title VII, §7002(d)(2), Mar. 23, 2010, 124 Stat. 816
; Pub. L. 112–144, title V, §§501(b), 505–506(b), 509(b), July 9, 2012, 126 Stat. 1040–1044
, 1048; Pub. L. 114–255, div. A, title III, §§3101(a)(2)(D), 3102(3), Dec. 13, 2016, 130 Stat. 1153, 1156.)
Subsec. (l), (m). Pub. L. 114–255, §3102(3), redesignated subsec. (m) as (l) and struck out former subsec. (l) which related to Institute of Medicine study.
Pub. L. 112–144, title V, §506(c), July 9, 2012, 126 Stat. 1045
Pub. L. 110–85, title IV, §402(b), Sept. 27, 2007, 121 Stat. 875
Pub. L. 108–155, §4, Dec. 3, 2003, 117 Stat. 1942