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

Page 240 TITLE 21—FOOD AND DRUGS § 355a (1) prohibiting a license holder from pro- viding an eligible product developer access to a covered product in the absence of an author- ization under this section; or (2) in any way negating the applicability of a REMS with ETASU, as otherwise required under such section 355–1 of this title, with re- spect to such covered product. (Pub. L. 116–94, div. N, title I, § 610, Dec. 20, 2019, 133 Stat. 3130.) Editorial Notes CODIFICATION Section was enacted as part of the Further Consoli- dated Appropriations Act, 2020, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. Section is comprised of section 610 of Pub. L. 116–94. Subsecs. (d) and (f) of section 610 of Pub. L. 116–94 amended section 355–1 of this title. § 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 discre- tion, may include pharmacokinetic studies) in pediatric age groups (including neonates in ap- propriate cases) in which a drug is anticipated to be used, and, at the discretion of the Sec- retary, 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, the Sec- retary determines that information relating to the use of a new drug in the pediatric popu- lation may produce health benefits in that population, the Secretary makes a written re- quest 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 re- quested 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 sub- section (c)(3)(E)(ii) of section 355 of this title, 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 ref- erences 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, re- spectively; or (II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such sec- tion, and in clauses (iii) and (iv) of sub- section (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and (ii) if the drug is designated under section 360bb of this title for a rare disease or condi- tion, the period referred to in section 360cc(a) of this title is deemed to be seven years and six months rather than seven years; and (B)(i) if the drug is the subject of— (I) a listed patent for which a certifi- cation has been submitted under sub- section (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 355 of this title and for which pedi- atric studies were submitted prior to the expiration of the patent (including any patent extensions); or (II) a listed patent for which a certifi- cation has been submitted under sub- sections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 355 of this title, the period during which an application may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (including any patent extensions); or (ii) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the patent infringement litigation re- sulting from the certification the court de- termines that the patent is valid and would be infringed, the period during which an ap- plication may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (in- cluding any patent extensions). (2) Exception The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(4) is made later than 9 months prior to the expira- tion of such period. (c) Market exclusivity for already-marketed drugs (1) In general Except as provided in paragraph (2), if the Secretary determines that information relat- ing to the use of an approved drug in the pedi- atric population may produce health benefits in that population and makes a written re- quest to the holder of an approved application under section 355(b)(1) of this title for pedi- atric studies (which shall include a timeframe for completing such studies), the holder 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 sub- section (c)(3)(E)(ii) of section 355 of this title, 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 ref- erences 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, respectiv ely; or (II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such sec- Page 241 TITLE 21—FOOD AND DRUGS § 355a tion, and in clauses (iii) and (iv) of sub- section (j)(5)(F) of such section, is deemed to be three years and six months rather than three years; and (ii) if the drug is designated under section 360bb of this title for a rare disease or condi- tion, the period referred to in section 360cc(a) of this title is deemed to be seven years and six months rather than seven years; and (B)(i) if the drug is the subject of— (I) a listed patent for which a certifi- cation has been submitted under sub- section (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 355 of this title and for which pedi- atric studies were submitted prior to the expiration of the patent (including any patent extensions); or (II) a listed patent for which a certifi- cation has been submitted under sub- section (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 355 of this title, the period during which an application may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B)(ii) of this title shall be extended by a period of six months after the date the patent expires (in- cluding any patent extensions); or (ii) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the patent infringement litigation re- sulting from the certification the court de- termines that the patent is valid and would be infringed, the period during which an ap- plication may not be approved under section 355(c)(3) of this title or section 355(j)(5)(B) of this title shall be extended by a period of six months after the date the patent expires (in- cluding any patent extensions). (2) Exception The Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(4) is made later than 9 months prior to the expira- tion of such period. (d) Conduct of pediatric studies (1) Request for studies (A) In general The Secretary may, after consultation with the sponsor of an application for an in- vestigational new drug under section 355(i) of this title, the sponsor of an application for a new drug under section 355(b)(1) of this title, or the holder of an approved applica- tion for a drug under section 355(b)(1) of this title, issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and ra- cial minorities. Such request to conduct pe- diatric studies shall be in writing and shall include a timeframe for such studies and a request to the sponsor or holder to propose pediatric labeling resulting from such stud- ies. If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not requesting studies in neonates. (B) Single written request A single written request— (i) may relate to more than one use of a drug; and (ii) may include uses that are both ap- proved and unapproved. (2) Written request for pediatric studies (A) Request and response (i) In general If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (b) or (c), the applicant or holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the in- tention of the applicant or holder to act on the request by— (I) indicating when the pediatric stud- ies will be initiated, if the applicant or holder agrees to the request; or (II) indicating that the applicant or holder does not agree to the request and stating the reasons for declining the re- quest. (ii) Disagree with request If, on or after September 27, 2007, the ap- plicant or holder does not agree to the re- quest on the grounds that it is not possible to develop the appropriate pediatric for- mulation, the applicant or holder shall submit to the Secretary the reasons such pediatric formulation cannot be developed. (B) Adverse event reports An applicant or holder that, on or after September 27, 2007, agrees to the request for such studies shall provide the Secretary, at the same time as the submission of the re- ports of such studies, with all postmarket adverse event reports regarding the drug that is the subject of such studies and are available prior to submission of such re- ports. (3) Action on submissions The Secretary shall review and act upon a submission by a sponsor or holder of a pro- posed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submis- sion. (4) Meeting the studies requirement Not later than 180 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so no- tify the sponsor or holder. The Secretary’s only responsibility in accepting or rejecting the reports shall be to determine, within the 180-day period, whether the studies fairly re- spond to the written request, have been con- ducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the require- ments of the Secretary for filing. Page 242 TITLE 21—FOOD AND DRUGS § 355a (5) Effect of subsection Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18. (6) Consultation With respect to a drug that is a qualified countermeasure (as defined in section 247d–6a of title 42), a security countermeasure (as de- fined in section 247d–6b of title 42), or a quali- fied pandemic or epidemic product (as defined in section 247d–6d of title 42), the Secretary shall solicit input from the Assistant Sec- retary for Preparedness and Response regard- ing the need for and, from the Director of the Biomedical Advanced Research and Develop- ment Authority regarding the conduct of, pe- diatric studies under this section. (e) Notice of determinations on studies require- ment (1) In general The Secretary shall publish a notice of any determination, made on or after September 27, 2007, that the requirements of subsection (d) have been met and that submissions and ap- provals under subsection (b)(2) or (j) of section 355 of this title for a drug will be subject to the provisions of this section. Such notice shall be published not later than 30 days after the date of the Secretary’s determination re- garding market exclusivity and shall include a copy of the written request made under sub- section (b) or (c). (2) Identification of certain drugs The Secretary shall publish a notice identi- fying any drug for which, on or after Sep- tember 27, 2007, a pediatric formulation was developed, studied, and found to be safe and ef- fective in the pediatric population (or speci- fied subpopulation) if the pediatric formula- tion for such drug is not introduced onto the market within one year after the date that the Secretary publishes the notice described in paragraph (1). Such notice identifying such drug shall be published not later than 30 days after the date of the expiration of such one year period. (f) Internal review of written requests and pedi- atric studies (1) Internal review The Secretary shall utilize the internal re- view committee established under section 355d of this title to review all written requests issued on or after September 27, 2007, in ac- cordance with paragraph (2). (2) Review of written requests The committee referred to in paragraph (1) shall review all written requests issued pursu- ant to this section prior to being issued. (3) Review of pediatric studies The committee referred to in paragraph (1) may review studies conducted pursuant to this section to make a recommendation to the Sec- retary whether to accept or reject such reports under subsection (d)(4). (4) Activity by committee The committee referred to in paragraph (1) may operate using appropriate members of such committee and need not convene all members of the committee. (5) Documentation of committee action For each drug, the committee referred to in paragraph (1) shall document, for each activ- ity described in paragraph (2) or (3), which members of the committee participated in such activity. (6) Tracking pediatric studies and labeling changes The Secretary, in consultation with the committee referred to in paragraph (1), shall track and make available to the public, in an easily accessible manner, including through posting on the Web site of the Food and Drug Administration— (A) the number of studies conducted under this section and under section 284m of title 42; (B) the specific drugs and drug uses, in- cluding labeled and off-labeled indications, studied under such sections; (C) the types of studies conducted under such sections, including trial design, the number of pediatric patients studied, and the number of centers and countries in- volved; (D) the number of pediatric formulations developed and the number of pediatric for- mulations not developed and the reasons such formulations were not developed; (E) the labeling changes made as a result of studies conducted under such sections; (F) an annual summary of labeling changes made as a result of studies con- ducted under such sections for distribution pursuant to subsection (k)(2); and (G) information regarding reports sub- mitted on or after September 27, 2007. (7) Informing internal review committee The Secretary shall provide to the com- mittee referred to in paragraph (1) any re- sponse issued to an applicant or holder with respect to a proposed pediatric study request. (g) Limitations Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b) or (c) has already been applied— (1) may receive an additional six-month pe- riod under subsection (c)(1)(A)(i)(II) for a sup- plemental application if all other require- ments under this section are satisfied, except that such drug may not receive any additional such period under subsection (c)(1)(B); and (2) may not receive any additional such pe- riod under subsection (c)(1)(A)(ii). (h) Relationship to pediatric research require- ments Exclusivity under this section shall only be granted for the completion of a study or studies that are the subject of a written request and for which reports are submitted and accepted in ac- cordance with subsection (d)(4). Written re- quests under this section may consist of a study or studies required under section 355c of this title. Page 243 TITLE 21—FOOD AND DRUGS § 355a (i) Labeling changes (1) Priority status for pediatric applications and supplements Any application or supplement to an appli- cation under section 355 of this title proposing a labeling change as a result of any pediatric study conducted pursuant to this section— (A) shall be considered to be a priority ap- plication or supplement; and (B) shall be subject to the performance goals established by the Commissioner for priority drugs. (2) Dispute resolution (A) Request for labeling change and failure to agree If, on or after September 27, 2007, the Com- missioner determines that the sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the la- beling for the drug that is the subject of the application, not later than 180 days after the date of submission of the application— (i) the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner de- termines to be appropriate; and (ii) if the sponsor of the application does not agree within 30 days after the Commis- sioner’s request to make a labeling change requested by the Commissioner, the Com- missioner shall refer the matter to the Pe- diatric Advisory Committee. (B) Action by the Pediatric Advisory Com- mittee Not later than 90 days after receiving a re- ferral under subparagraph (A)(ii), the Pedi- atric Advisory Committee shall— (i) review the pediatric study reports; and (ii) make a recommendation to the Com- missioner concerning appropriate labeling changes, if any. (C) Consideration of recommendations The Commissioner shall consider the rec- ommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the rec- ommendation, make a request to the spon- sor of the application to make any labeling change that the Commissioner determines to be appropriate. (D) Misbranding If the sponsor of the application, within 30 days after receiving a request under sub- paragraph (C), does not agree to make a la- beling change requested by the Commis- sioner, the Commissioner may deem the drug that is the subject of the application to be misbranded. (E) No effect on authority Nothing in this subsection limits the au- thority of the United States to bring an en- forcement action under this chapter when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advi- sory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action. (j) Other labeling changes If, on or after September 27, 2007, the Sec- retary determines that a pediatric study con- ducted under this section does or does not dem- onstrate that the drug that is the subject of the study is safe and effective, including whether such study results are inconclusive, in pediatric populations or subpopulations, the Secretary shall order the labeling of such product to in- clude information about the results of the study and a statement of the Secretary’s determina- tion. (k) Dissemination of pediatric information (1) In general Not later than 210 days after the date of sub- mission of a report on a pediatric study under this section, the Secretary shall make avail- able to the public the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under subsection (b) or (c). (2) Dissemination of information regarding la- beling changes Beginning on September 27, 2007, the Sec- retary shall include as a requirement of a written request that the sponsors of the stud- ies that result in labeling changes that are re- flected in the annual summary developed pur- suant to subsection (f)(6)(F) distribute, at least annually (or more frequently if the Sec- retary determines that it would be beneficial to the public health), such information to phy- sicians and other health care providers. (3) Effect of subsection Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18. (l) Adverse event reporting (1) Reporting in first 18-month period Beginning on September 27, 2007, during the 18-month period beginning on the date a label- ing change is approved pursuant to subsection (i), the Secretary shall ensure that all adverse event reports that have been received for such drug (regardless of when such report was re- ceived) are referred to the Office of Pediatric Therapeutics established under section 393a of this title. In considering the reports, the Di- rector of such Office shall provide for the re- view of the reports by the Pediatric Advisory Committee, including obtaining any rec- ommendations of such Committee regarding whether the Secretary should take action under this chapter in response to such reports. (2) Reporting in subsequent periods Following the 18-month period described in paragraph (1), the Secretary shall, as appro- priate, refer to the Office of Pediatric Thera- peutics all pediatric adverse event reports for a drug for which a pediatric study was con- ducted under this section. In considering such reports, the Director of such Office may pro- vide for the review of such reports by the Pedi- atric Advisory Committee, including obtain- ing any recommendation of such Committee Page 244 TITLE 21—FOOD AND DRUGS § 355a regarding whether the Secretary should take action in response to such reports. (3) Preservation of authority Nothing in this subsection shall prohibit the Office of Pediatric Therapeutics from pro- viding for the review of adverse event reports by the Pediatric Advisory Committee prior to the 18-month period referred to in paragraph (1), if such review is necessary to ensure safe use of a drug in a pediatric population. (4) Effect The requirements of this subsection shall supplement, not supplant, other review of such adverse event reports by the Secretary. (m) Clarification of interaction of market exclu- sivity under this section and market exclu- sivity awarded to an applicant for approval of a drug under section 355(j) of this title If a 180-day period under section 355(j)(5)(B)(iv) of this title overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 355(j) of this title entitled to the 180-day period under that section loses a portion of the 180-day period to which the applicant is entitled for the drug, the 180-day period shall be extended from— (1) the date on which the 180-day period would have expired by the number of days of the overlap, if the 180-day period would, but for the application of this subsection, expire after the 6-month exclusivity period; or (2) the date on which the 6-month exclu- sivity period expires, by the number of days of the overlap if the 180-day period would, but for the application of this subsection, expire dur- ing the six-month exclusivity period. (n) Referral if pediatric studies not submitted (1) In general Beginning on September 27, 2007, if pediatric studies of a drug have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request under subsection (d) and if the Secretary, through the committee established under section 355d of this title, determines that there is a continuing need for informa- tion relating to the use of the drug in the pedi- atric population (including neonates, as appro- priate), the Secretary shall carry out the fol- lowing: (A) For a drug for which a listed patent has not expired, or for which a period of ex- clusivity eligible for extension under sub- section (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 has not ended, make a deter- mination regarding whether an assessment shall be required to be submitted under sec- tion 355c(b) of this title. (B) For a drug that has no unexpired listed patents and for which no unexpired periods of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 apply, the Secretary shall refer the drug for inclusion on the list established under section 284m of title 42 for the conduct of studies. (C) For a drug that is a qualified counter- measure (as defined in section 247d–6a of title 42), a security countermeasure (as de- fined in section 247d–6b of title 42), or a qualified pandemic or epidemic product (as defined in section 247d–6d of title 42), in addi- tion to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Pre- paredness and Response and the Director of the Biomedical Advanced Research and De- velopment Authority of all pediatric studies in the written request issued by the Commis- sioner of Food and Drugs. (2) Public notice The Secretary shall give the public notice of a decision under paragraph (1)(A) not to re- quire an assessment under section 355c of this title and the basis for such decision. (3) Effect of subsection Nothing in this subsection alters or amends section 331(j) of this title or section 552 of title 5 or section 1905 of title 18. (o) Prompt approval of drugs when pediatric in- formation is added to labeling (1) General rule A drug for which an application has been submitted or approved under subsection (b)(2) or (j) of section 355 of this title shall not be considered ineligible for approval under that section or misbranded under section 352 of this title on the basis that the labeling of the drug omits a pediatric indication or any other as- pect of labeling pertaining to pediatric use when the omitted indication or other aspect is protected by patent, or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title, clause (iii) or (iv) of section 355(c)(3)(E) of this title, or section 360cc(a) of this title, or by an extension of such exclusivity under this section or section 355f of this title. (2) Labeling Notwithstanding clauses (iii) and (iv) of sec- tion 355(j)(5)(F) of this title, clauses (iii) and (iv) of section 355(c)(3)(E) of this title, or sec- tion 360cc of this title, the Secretary may re- quire that the labeling of a drug approved pur- suant to an application submitted under sub- section (b)(2) or (j) of section 355 of this title that omits a pediatric indication or other as- pect of labeling as described in paragraph (1) include— (A) a statement that, because of mar- keting exclusivity for a manufacturer— (i) the drug is not labeled for pediatric use; or (ii) in the case of a drug for which there is an additional pediatric use not referred to in paragraph (1), the drug is not labeled for the pediatric use under paragraph (1); and (B) a statement of any appropriate pedi- atric contraindications, warnings, pre- cautions, or other information that the Sec- retary considers necessary to assure safe use. (3) Preservation of pediatric exclusivity and extensions This subsection does not affect— Page 245 TITLE 21—FOOD AND DRUGS § 355a (A) the availability or scope of exclusivity under— (i) this section; (ii) section 355 of this title for pediatric formulations; or (iii) section 360cc of this title; (B) the availability or scope of an exten- sion to any such exclusivity, including an extension under this section or section 355f of this title; (C) the question of the eligibility for ap- proval under section 355 of this title of any application described in subsection (b)(2) or (j) of such section that omits any other as- pect of labeling protected by exclusivity under— (i) clause (iii) or (iv) of section 355(j)(5)(F) of this title; (ii) clause (iii) or (iv) of section 355(c)(3)(E) of this title; or (iii) section 360cc(a) of this title; or (D) except as expressly provided in para- graphs (1) and (2), the operation of section 355 of this title or section 360cc of this title. (June 25, 1938, ch. 675, § 505A, as added Pub. L. 105–115, title I, § 111, Nov. 21, 1997, 111 Stat. 2305; amended Pub. L. 107–109, §§ 2, 4, 5(b)(2), 7–11(a), 18(a), 19, Jan. 4, 2002, 115 Stat. 1408, 1411, 1413–1415, 1423, 1424; Pub. L. 108–155, §§ 2(b)(2), 3(a), (b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108–173, title XI, § 1104, Dec. 8, 2003, 117 Stat. 2461; Pub. L. 110–85, title V, § 502(a)(1), Sept. 27, 2007, 121 Stat. 876; Pub. L. 111–148, title VII, § 7002(g)(2)(B), Mar. 23, 2010, 124 Stat. 820; Pub. L. 112–144, title V, §§ 501(a), 502(a)(1), (b), 509(a), July 9, 2012, 126 Stat. 1039, 1040, 1047; Pub. L. 113–5, title III, § 307(a), Mar. 13, 2013, 127 Stat. 191; Pub. L. 114–255, div. A, title III, § 3102(2), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title V, § 505(a)–(b)(2)(A), title VI, § 608, Aug. 18, 2017, 131 Stat. 1046, 1050; Pub. L. 117–9, § 1(b)(2), Apr. 23, 2021, 135 Stat. 258.) Editorial Notes AMENDMENTS 2021—Subsec. (c)(1)(A)(i)(II). Pub. L. 117–9 substituted ‘‘(c)(3)(E)’’ for ‘‘(c)(3)(D)’’. 2017—Subsecs. (b), (c). Pub. L. 115–52, § 505(b)(2)(A), substituted ‘‘subsection (d)(4)’’ for ‘‘subsection (d)(3)’’ in introductory provisions of par. (1) and in par. (2). Subsec. (d)(3) to (6). Pub. L. 115–52, § 505(b)(1), added par. (3) and redesignated former pars. (3) to (5) as (4) to (6), respectively. Subsec. (f)(3). Pub. L. 115–52, § 505(b)(2)(A), substituted ‘‘subsection (d)(4)’’ for ‘‘subsection (d)(3)’’. Subsec. (f)(7). Pub. L. 115–52, § 505(a), added par. (7). Subsec. (h). Pub. L. 115–52, § 505(b)(2)(A), substituted ‘‘subsection (d)(4)’’ for ‘‘subsection (d)(3)’’. Subsec. (o). Pub. L. 115–52, § 608(1), struck out ‘‘under section 355(j)’’ after ‘‘approval of drugs’’ in heading. Subsec. (o)(1). Pub. L. 115–52, § 608(2), substituted ‘‘under subsection (b)(2) or (j) of section 355 of this title’’ for ‘‘under section 355(j) of this title’’ and ‘‘, or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title, clause (iii) or (iv) of section 355(c)(3)(E) of this title, or section 360cc(a) of this title, or by an extension of such exclusivity under this sec- tion or section 355f of this title’’ for ‘‘or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title’’. Subsec. (o)(2). Pub. L. 115–52, § 608(3), in introductory provisions, inserted ‘‘clauses (iii) and (iv) of section 355(c)(3)(E) of this title, or section 360cc of this title,’’ after ‘‘section 355(j)(5)(F) of this title,’’ and substituted ‘‘drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 355 of this title’’ for ‘‘drug approved under section 355(j) of this title’’. Subsec. (o)(3). Pub. L. 115–52, § 608(4), amended par. (3) generally. Prior to amendment, text read as follows: ‘‘This subsection does not affect— ‘‘(A) the availability or scope of exclusivity under this section; ‘‘(B) the availability or scope of exclusivity under section 355 of this title for pediatric formulations; ‘‘(C) the question of the eligibility for approval of any application under section 355(j) of this title that omits any other conditions of approval entitled to ex- clusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title; or ‘‘(D) except as expressly provided in paragraphs (1) and (2), the operation of section 355 of this title.’’ 2016—Subsec. (p). Pub. L. 114–255 struck out subsec. (p) which related to Institute of Medicine study. 2013—Subsec. (d)(5). Pub. L. 113–5, § 307(a)(1), added par. (5). Subsec. (n)(1)(C). Pub. L. 113–5, § 307(a)(2), added sub- par. (C). 2012—Subsec. (d)(1)(A). Pub. L. 112–144, § 502(b), in- serted at end ‘‘If a request under this subparagraph does not request studies in neonates, such request shall include a statement describing the rationale for not re- questing studies in neonates.’’ Subsec. (h). Pub. L. 112–144, § 502(a)(1), amended sub- sec. (h) generally. Prior to amendment, text read as fol- lows: ‘‘Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclu- sivity pursuant to this section.’’ Subsec. (k)(2). Pub. L. 112–144, § 509(a)(1), substituted ‘‘subsection (f)(6)(F)’’ for ‘‘subsection (f)(3)(F)’’. Subsec. (l)(1). Pub. L. 112–144, § 509(a)(2)(A), sub- stituted ‘‘first 18-month period’’ for ‘‘year one’’ in heading and ‘‘18-month’’ for ‘‘one-year’’ in text. Subsec. (l)(2). Pub. L. 112–144, § 509(a)(2)(B), sub- stituted ‘‘periods’’ for ‘‘years’’ in heading and ‘‘18- month period’’ for ‘‘one-year period’’ in text. Subsec. (l)(3), (4). Pub. L. 112–144, § 509(a)(2)(C), (D), added par. (3) and redesignated former par. (3) as (4). Subsec. (n). Pub. L. 112–144, § 509(a)(3)(A), substituted ‘‘submitted’’ for ‘‘completed’’ in heading. Subsec. (n)(1). Pub. L. 112–144, § 509(a)(3)(B)(i), sub- stituted ‘‘have not been submitted by the date specified in the written request issued or if the applicant or holder does not agree to the request’’ for ‘‘have not been completed’’ in introductory provisions. Subsec. (n)(1)(A). Pub. L. 112–144, § 509(a)(3)(B)(ii), in- serted ‘‘, or for which a period of exclusivity eligible for extension under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 has not ended’’ after ‘‘expired’’ and struck out at end ‘‘Prior to making such a determination, the Secretary may not take more than 30 days to certify whether the Foundation for the National Institutes of Health has sufficient funding at the time of such cer- tification to initiate and fund all of the studies in the written request in their entirety within the timeframes specified within the written request. Only if the Sec- retary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the writ- ten request to the Foundation for the National Insti- tutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certifi- cation has been made at the end of the 30-day period, or if the Secretary certifies that funds are not suffi- cient to initiate and fund all the studies in their en- tirety, the Secretary shall consider whether assess- ments shall be required under section 355c(b) of this title for such drug.’’ Subsec. (n)(1)(B). Pub. L. 112–144, § 509(a)(3)(B)(iii), substituted ‘‘no unexpired listed patents and for which Page 246 TITLE 21—FOOD AND DRUGS § 355a no unexpired periods of exclusivity eligible for exten- sion under subsection (b)(1) or (c)(1) of this section or under subsection (m)(2) or (m)(3) of section 262 of title 42 apply,’’ for ‘‘no listed patents or has 1 or more listed patents that have expired,’’. Subsec. (o)(2)(B). Pub. L. 112–144, § 509(a)(4), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: ‘‘a statement of any appropriate pedi- atric contraindications, warnings, or precautions that the Secretary considers necessary.’’ Subsec. (q). Pub. L. 112–144, § 501(a), struck out subsec. (q). Text read as follows: ‘‘A drug may not receive any 6-month period under subsection (b) or (c) unless— ‘‘(1) on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug; ‘‘(2) on or before October 1, 2012, an application for the drug is accepted for filing under section 355(b) of this title; and ‘‘(3) all requirements of this section are met.’’ 2010—Subsec. (p)(4) to (6). Pub. L. 111–148 added pars. (4) to (6) and struck out former pars. (4) and (5) which read as follows: ‘‘(4) review and assess the pediatric studies of biologi- cal products as required under subsections (a) and (b) of section 355c of this title; and ‘‘(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of bio- logics.’’ 2007—Pub. L. 110–85 amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) re- lating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effec- tive date for certain applications, notice of determina- tions on studies requirement, limitations, research re- quirements, labeling supplements, dissemination of in- formation, prompt approval of drugs, report to Con- gress not later than Jan. 1, 2001, and sunset provisions. 2003—Subsec. (b)(1)(A)(i). Pub. L. 108–173, § 1104(1), sub- stituted ‘‘(j)(5)(F)(ii)’’ for ‘‘(j)(5)(D)(ii)’’ in two places. Subsec. (b)(1)(A)(ii). Pub. L. 108–173, § 1104(2), sub- stituted ‘‘(j)(5)(F)’’ for ‘‘(j)(5)(D)’’. Subsec. (b)(2). Pub. L. 108–155, § 3(a), substituted ‘‘355(j)(5)(B)’’ for ‘‘355(j)(4)(B)’’ in two places. Subsec. (c)(1)(A)(i). Pub. L. 108–173, § 1104(1), sub- stituted ‘‘(j)(5)(F)(ii)’’ for ‘‘(j)(5)(D)(ii)’’ in two places. Subsec. (c)(1)(A)(ii). Pub. L. 108–173, § 1104(2), sub- stituted ‘‘(j)(5)(F)’’ for ‘‘(j)(5)(D)’’. Subsec. (c)(2). Pub. L. 108–155, § 3(a), substituted ‘‘355(j)(5)(B)’’ for ‘‘355(j)(4)(B)’’ in two places. Subsec. (e). Pub. L. 108–173, § 1104(3), substituted ‘‘355(j)(5)(F)’’ for ‘‘355(j)(5)(D)’’. Subsec. (h). Pub. L. 108–155, § 2(b)(2), substituted ‘‘pe- diatric research requirements’’ for ‘‘regulations’’ in heading and ‘‘by a provision of law (including a regula- tion) other than this section’’ for ‘‘pursuant to regula- tions promulgated by the Secretary’’ in text. Subsec. (i)(2). Pub. L. 108–155, § 3(b)(1), struck out ‘‘Advisory Subcommittee of the Anti-Infective Drugs’’ before ‘‘Advisory Committee’’ wherever appearing. Subsec. (l). Pub. L. 108–173, § 1104(3), substituted ‘‘355(j)(5)(F)’’ for ‘‘355(j)(5)(D)’’ wherever appearing. 2002—Subsec. (a). Pub. L. 107–109, § 19(2), (3), redesig- nated subsec. (g) as (a). Former subsec. (a) redesignated (b). Subsec. (a)(1)(A). Pub. L. 107–109, § 19(1)(A), (B), sub- stituted ‘‘(j)(5)(D)(ii)’’ for ‘‘(j)(4)(D)(ii)’’ in two places in cl. (i) and ‘‘(j)(5)(D)’’ for ‘‘(j)(4)(D)’’ in cl. (ii). Subsec. (b). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (a) as (b). Pub. L. 107–109, § 2(1), struck out heading and text of subsec. (b). Text read as follows: ‘‘Not later than 180 days after November 21, 1997, the Secretary, after con- sultation with experts in pediatric research shall de- velop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The Secretary shall annually update the list.’’ Subsec. (c). Pub. L. 107–109, § 2(2), in introductory pro- visions, inserted ‘‘determines that information relating to the use of an approved drug in the pediatric popu- lation may produce health benefits in that population and’’ after ‘‘the Secretary’’ and struck out ‘‘concerning a drug identified in the list described in subsection (b) of this section’’ after ‘‘such studies)’’. Subsec. (c)(1)(A). Pub. L. 107–109, § 19(1)(A), (B), sub- stituted ‘‘(j)(5)(D)(ii)’’ for ‘‘(j)(4)(D)(ii)’’ in two places in cl. (i) and ‘‘(j)(5)(D)’’ for ‘‘(j)(4)(D)’’ in cl. (ii). Subsec. (d)(1). Pub. L. 107–109, § 19(4), substituted ‘‘subsection (b) or (c)’’ for ‘‘subsection (a) or (c)’’ in in- troductory provisions. Subsec. (d)(2). Pub. L. 107–109, §§ 18(a), 19(4), sub- stituted ‘‘subsection (b) or (c)’’ for ‘‘subsection (a) or (c)’’ and inserted ‘‘In reaching an agreement regarding written protocols, the Secretary shall take into ac- count adequate representation of children of ethnic and racial minorities.’’ after first sentence. Subsec. (d)(3). Pub. L. 107–109, § 19(4), substituted ‘‘subsection (b) or (c)’’ for ‘‘subsection (a) or (c)’’. Subsec. (d)(4). Pub. L. 107–109, § 4, added par. (4). Subsec. (e). Pub. L. 107–109, § 19(1)(C), (4), substituted ‘‘section 355(j)(5)(D)’’ for ‘‘section 355(j)(4)(D)’’ and ‘‘subsection (b) or (c)’’ for ‘‘subsection (a) or (c)’’. Subsec. (g). Pub. L. 107–109, § 19(2), (3), (5), redesig- nated subsec. (h) as (g) and substituted ‘‘subsection (b) or (c)’’ for ‘‘subsection (a) or (b)’’ in introductory provi- sions. Former subsec. (g) redesignated (a). Pub. L. 107–109, § 7, inserted ‘‘(including neonates in appropriate cases)’’ after ‘‘pediatric age groups’’. Subsec. (h). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g). Subsec. (i). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (l) as (i). Former subsec. (i) redesignated (h). Subsec. (j). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n). Pub. L. 107–109, § 8, added subsec. (j) and struck out heading and text of former subsec. (j). Text read as fol- lows: ‘‘A drug may not receive any six-month period under subsection (a) or (c) of this section unless the ap- plication for the drug under section 355(b)(1) of this title is submitted on or before January 1, 2002. After January 1, 2002, a drug shall receive a six-month period under subsection (c) of this section if— ‘‘(1) the drug was in commercial distribution as of November 21, 1997; ‘‘(2) the drug was included by the Secretary on the list under subsection (b) of this section as of January 1, 2002; ‘‘(3) the Secretary determines that there is a con- tinuing need for information relating to the use of the drug in the pediatric population and that the drug may provide health benefits in that population; and ‘‘(4) all requirements of this section are met.’’ Subsec. (k). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m). Subsec. (l). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (o) as (l). Former subsec. (l) redesignated (i). Pub. L. 107–109, § 5(b)(2), added subsec. (l). Subsec. (m). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j). Pub. L. 107–109, § 9, added subsec. (m). Subsec. (n). Pub. L. 107–109, § 19(4), which directed substitution of ‘‘subsection (b) or (c)’’ for ‘‘subsection (a) or (c)’’ in subsec. (m), was executed by making the substitution in introductory provisions of subsec. (n), to reflect the probable intent of Congress. Pub. L. 107–109, § 19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k). Pub. L. 107–109, § 10, added subsec. (n). Subsec. (o). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (o) as (l). Pub. L. 107–109, § 11(a), added subsec. (o). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2012 AMENDMENT Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that: Page 247 TITLE 21—FOOD AND DRUGS § 355a ‘‘(1) APPLICATION.—Notwithstanding any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provi- sion applies beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 [Sept. 27, 2007] or the date of the enactment of the Pedi- atric Research Equity Act of 2007 [Sept. 27, 2007], any amendment made by this Act to such a provision ap- plies beginning on the date of the enactment of this Act [July 9, 2012]. ‘‘(2) TRANSITIONAL RULE FOR ADVERSE EVENT REPORT- ING.—With respect to a drug for which a labeling change described under section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or made, respectively, during the one-year period that ends on the day before the date of enactment of this Act [July 9, 2012], the Secretary [of Health and Human Services] shall apply section 505A(l) and section 505B(i), as applicable, to such drug, as such sections were in effect on such day.’’ EFFECTIVE DATE OF 2007 AMENDMENT Pub. L. 110–85, title V, § 502(a)(2), Sept. 27, 2007, 121 Stat. 885, provided that: ‘‘(A) IN GENERAL.—The amendment made by this sub- section [amending this section] shall apply to written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) issued on or after the date of the enactment of this Act [Sept. 27, 2007]. ‘‘(B) CERTAIN WRITTEN REQUESTS.—A written request issued under section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, which has been ac- cepted and for which no determination under sub- section (d)(2) of such section has been made before such date of enactment, shall be subject to such section 505A, except that such written requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A of the Federal Food, Drug, and Cosmetic Act, as in effect on or after the date of the enactment of this Act.’’ EFFECTIVE DATE OF 2003 AMENDMENT Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title. EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107–109, § 11(b), Jan. 4, 2002, 115 Stat. 1416, pro- vided that: ‘‘The amendment made by subsection (a) [amending this section] takes effect on the date of en- actment of this Act [Jan. 4, 2002], including with re- spect to applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that are approved or pending on that date.’’ CONSTRUCTION OF 2007 AMENDMENTS ON PEDIATRIC STUDIES Pub. L. 110–85, title IX, § 901(e), Sept. 27, 2007, 121 Stat. 942, provided that: ‘‘This title [enacting sections 353c, 355–1, 355e, 360a, and 360bbb–6 of this title, amending sections 331, 333, 334, 352, 355, and 381 of this title and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 331, 352, and 355 of this title] and the amendments made by this title may not be construed as affecting the au- thority of the Secretary of Health and Human Services to request pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a] or to require such studies under section 505B of such Act [21 U.S.C. 355c].’’ PLAN FOR EARLIER SUBMISSION OF PEDIATRIC STUDIES Pub. L. 115–52, title V, § 505(c), Aug. 18, 2017, 131 Stat. 1046, provided that: ‘‘The Secretary of Health and Human Services, acting through the internal review committee established under section 505C of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C. 355d) shall, not later than one year after the date of enact- ment of this Act [Aug. 18, 2017], develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or sec- tion 351(m) of the Public Health Service Act (42 U.S.C. 262(m)). Such plan shall include recommendations to achieve— ‘‘(1) earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, discussion of such requests at the meet- ing required under section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a); ‘‘(2) earlier issuance of written requests for a pedi- atric study under such section 505A, including for in- vestigational new drugs prior to the submission of an application under section 505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and ‘‘(3) shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A or such section 351(m).’’ DRAFT GUIDANCE FOR NEONATAL STUDIES Pub. L. 115–52, title V, § 505(d)(2), Aug. 18, 2017, 131 Stat. 1047, provided that: ‘‘Not later than 2 years after the date of enactment of this Act [Aug. 18, 2017], the Secretary shall issue draft guidance on clinical phar- macology considerations for neonatal studies for drugs and biological products.’’ COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE Pub. L. 112–144, title V, § 503, July 9, 2012, 126 Stat. 1040, provided that: ‘‘Not later than 1 year after the date of enactment of this Act [July 9, 2012], the Sec- retary of Health and Human Services (referred to in this title [see Tables for classification] as the ‘Sec- retary’) shall issue internal standard operating proce- dures that provide for the review by the internal review committee established under section 505C of the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c). Such internal standard operating procedures shall be made publicly available on the Internet Web site of the Food and Drug Administration.’’ ACCESS TO DATA Pub. L. 112–144, title V, § 504, July 9, 2012, 126 Stat. 1040, provided that: ‘‘Not later than 3 years after the date of enactment of this Act [July 9, 2012], the Sec- retary [of Health and Human Services] shall make available to the public, including through posting on the Internet Web site of the Food and Drug Administra- tion, the medical, statistical, and clinical pharma- cology reviews of, and corresponding written requests issued to an applicant, sponsor, or holder for, pediatric studies submitted between January 4, 2002, and Sep- tember 27, 2007, under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months of market exclusivity was granted and that resulted in a labeling change. The Secretary shall make public the information described in the preceding sentence in a manner consistent with how the Secretary releases information under section 505A(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).’’ REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM Pub. L. 107–109, § 16, Jan. 4, 2002, 115 Stat. 1421, as amended by Pub. L. 108–155, § 3(b)(4), Dec. 3, 2003, 117 Stat. 1942, required the Comptroller General, not later than Oct. 1, 2006, and in consultation with the Sec- retary of Health and Human Services, to submit to Congress a report on specified issues concerning the ef- fectiveness of the pediatric exclusivity program. Page 248 TITLE 21—FOOD AND DRUGS § 355b 1 So in original. Probably should be preceded by ‘‘section’’. 2 So in original. Probably should be ‘‘Committee’’. STUDY BY GENERAL ACCOUNTING OFFICE Pub. L. 107–109, § 18(b), Jan. 4, 2002, 115 Stat. 1423, re- quired the Comptroller General, not later than Jan. 10, 2003, to conduct a study relating to the representation of children of ethnic and racial minorities in studies under section 355a of this title and to submit a report to Congress describing the findings of the study. § 355b. Adverse-event reporting (a) Toll-free number in labeling Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that the labeling of each drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355] (regard- less of the date on which approved) include the toll-free number maintained by the Secretary for the purpose of receiving reports of adverse events regarding drugs and a statement that such number is to be used for reporting purposes only, not to receive medical advice. With re- spect to the final rule: (1) The rule shall provide for the implemen- tation of such labeling requirement in a man- ner that the Secretary considers to be most likely to reach the broadest consumer audi- ence. (2) In promulgating the rule, the Secretary shall seek to minimize the cost of the rule on the pharmacy profession. (3) The rule shall take effect not later than 60 days after the date on which the rule is pro- mulgated. (b) Drugs with pediatric market exclusivity (1) In general During the one year beginning on the date on which a drug receives a period of market exclusivity under 505A 1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report of an adverse event regarding the drug that the Secretary of Health and Human Serv- ices receives shall be referred to the Office of Pediatric Therapeutics established under sec- tion 393a of this title. In considering the re- port, the Director of such Office shall provide for the review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such subcommittee 2 re- garding whether the Secretary should take ac- tion under the Federal Food, Drug, and Cos- metic Act [21 U.S.C. 301 et seq.] in response to the report. (2) Rule of construction Paragraph (1) may not be construed as re- stricting the authority of the Secretary of Health and Human Services to continue car- rying out the activities described in such para- graph regarding a drug after the one-year pe- riod described in such paragraph regarding the drug has expired. (Pub. L. 107–109, § 17, Jan. 4, 2002, 115 Stat. 1422; Pub. L. 108–155, § 3(b)(5), Dec. 3, 2003, 117 Stat. 1942.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see sec- tion 301 of this title and Tables. CODIFICATION Section was enacted as part of the Best Pharma- ceuticals for Children Act, and not as part of the Fed- eral Food, Drug, and Cosmetic Act which comprises this chapter. AMENDMENTS 2003—Subsec. (b)(1). Pub. L. 108–155 struck out ‘‘Advi- sory Subcommittee of the Anti-Infective Drugs’’ before ‘‘Advisory Committee’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2003 AMENDMENT Amendment by Pub. L. 108–155 effective Dec. 3, 2003, except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of this title. § 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 applica- tion) for a drug— (i) under section 355 of this title 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 for a new active ingredient, new indication, new dos- age form, new dosing regimen, or new route of administration, shall submit with the application the assess- ments described in paragraph (2). (B) Certain molecularly targeted cancer indi- cations A person that submits, on or after the date that is 3 years after August 18, 2017, an origi- nal application for a new active ingredient under section 355 of this title or section 262 of title 42, shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological prod- uct 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 substan- tially relevant to the growth or progres- sion of a pediatric cancer. (2) Assessments (A) In general The assessments referred to in paragraph (1)(A) shall contain data, gathered using ap- propriate formulations for each age group