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21 U.S.C. § 355c–1 — Report

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21 U.S.C. § 355c–1 — Report

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Stable record: federal_law:legal_authorities:record_usc_62dc4e9841cd8e0d778f87ef
Source file: Laws/federal/codes/united-states-code/title-21/section-355c1-report--b75086c52e.md
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Source location: Title 21, Chapter 9, § 355c–1; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) In general** Not later than four years after July 9, 2012, and every five years thereafter, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the Internet Web site of the Food and Drug Administration, a report on the implementation of sections 355a and 355c of this title. **(b) Contents** Each report under subsection (a) shall include— (1) an assessment of the effectiveness of sections 355a and 355c of this title in improving information about pediatric uses for approved drugs and biological products, including the number and type of labeling changes made since July 9, 2012, and the importance of such uses in the improvement of the health of children; (2) the number of required studies under such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim) that have not met the initial deadline provided under such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim), including— (A) the number of deferrals and deferral extensions granted and the reasons such extensions were granted; (B) the number of waivers and partial waivers granted; and (C) the number of letters issued under subsection (d) of such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); (3) an assessment of the timeliness and effectiveness of pediatric study planning since July 9, 2012, including the number of initial pediatric study plans not submitted in accordance with the requirements of subsection (e) of such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim) and any resulting rulemaking; (4) the number of written requests issued, accepted, and declined under such [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim) since July 9, 2012, and a listing of any important gaps in pediatric information as a result of such declined requests; (5) a description and current status of referrals made under subsection (n) of such [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim); (6) an assessment of the effectiveness of studying biological products in pediatric populations under such sections 355a and 355c of this title and [section 284m of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284m&num=0&edition=prelim); (7) (A) the efforts made by the Secretary to increase the number of studies conducted in the neonatal population (including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe); and (B) the results of such efforts; (8) (A) the number and importance of drugs and biological products for children with cancer that are being tested as a result of the programs under such sections 355a and 355c of this title and under [section 284m of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284m&num=0&edition=prelim); and (B) any recommendations for modifications to such programs that would lead to new and better therapies for children with cancer, including a detailed rationale for each recommendation; (9) any recommendations for modification to such programs that would improve pediatric drug research and increase pediatric labeling of drugs and biological products; (10) an assessment of the successes of and limitations to studying drugs for rare diseases under such sections 355a and 355c of this title; (11) an assessment of the impact of the amendments to such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim) made by the FDA Reauthorization Act of 2017 on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer; (12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act,11 See References in Text note below. regarding earlier submission of pediatric studies under sections 355a and 355c of this title and [section 262(m) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/m&num=0&edition=prelim), including— (A) the average length of time after the approval of an application under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim) or [section 262(a) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim) before studies conducted pursuant to such [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim), 355c of this title, or [section 262(m) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/m&num=0&edition=prelim) are completed, submitted, and incorporated into labeling; (B) the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request; (C) the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies; (D) the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim) or [section 262(a) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim); and (E) the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests; (13) a list of sponsors of applications or holders of approved applications who received exclusivity under such [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim) or such [section 262(m) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/m&num=0&edition=prelim) after receiving a letter issued under such [section 355c(d)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c/d/1&num=0&edition=prelim) for any drug or biological product before the studies referred to in such letter were completed and submitted; (14) a list of assessments and investigations required under such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); (15) how many requests under such [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim) for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) of such [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim), approved prior to 3 years after August 18, 2017, have been issued by the Food and Drug Administration, and how many such requests have been completed; and (16) the Secretary’s assessment of the overall impact of the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric cancer research and the orphan drug program, as well any subsequent recommendations. **(c) Stakeholder comment** At least 180 days prior to the submission of each report under subsection (a), the Secretary shall consult with representatives of patient groups (including pediatric patient groups), consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report including suggestions for modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355c — Research into pediatric uses for drugs and biological products

**(a) New drugs and biological products** (1) **In general** (A) *General requirements* — Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug— (i) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or (ii) under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, shall submit with the application the assessments described in paragraph (2). (B) *Certain molecularly targeted cancer indications* — A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is— (i) intended for the treatment of an adult cancer; and (ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer. (2) **Assessments** (A) *In general* — The assessments referred to in

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355c

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 284m — Program for pediatric studies of drugs

**(a) List of priority issues in pediatric therapeutics** (1) **In general** — Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or indications that require study. The list shall be revised every three years. (2) **Consideration of available information** — In developing and prioritizing the list under paragraph (1), the Secretary— (A) shall consider— (i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; (ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and (iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and (B) may consider the availability of qualified countermeasures (as defined in [section 247d–6a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6a&num=0&edition=prelim)), security countermeasures (as defined in [section 247d–6b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6b&num=0&edition=prelim)), and qualified pandemic or epidemic products (as defined in [section 247d–6d of this title]

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 284m

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355a — Pediatric studies of drugs

**(a) Definitions** As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. **(b) Market exclusivity for new drugs** (1) **In general** — Except as provided in paragraph (2), if, prior to approval of an application that is submitted under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)— (A) (i) (I) the period referred to in subsection (c)(3)(E)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355a

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