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21 U.S.C. § 355a — Pediatric studies of drugs
Federal law — U.S. Code and appendices · legal_authorities
**(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
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Source location: Title 21, Chapter 9, § 355a; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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; or
(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) for a rare disease or condition, the period referred to in [section 360cc(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc/a&num=0&edition=prelim) 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 certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or
(II) a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim),
the period during which an application may not be approved under [section 355(c)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3&num=0&edition=prelim) or [section 355(j)(5)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/B&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under [section 355(c)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3&num=0&edition=prelim) or [section 355(j)(5)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/B&num=0&edition=prelim) shall be extended by a period of six months after the date the patent expires (including 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 expiration 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 relating to the use of an approved drug in the pediatric population may produce health benefits in that population and makes a written request to the holder of an approved 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) for pediatric 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 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, respectiv ely; or
(II) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii) and (iv) of subsection (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) for a rare disease or condition, the period referred to in [section 360cc(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc/a&num=0&edition=prelim) 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 certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or
(II) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim),
the period during which an application may not be approved under [section 355(c)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3&num=0&edition=prelim) or [section 355(j)(5)(B)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/B/ii&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under [section 355(c)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3&num=0&edition=prelim) or [section 355(j)(5)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/B&num=0&edition=prelim) shall be extended by a period of six months after the date the patent expires (including 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 expiration 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 investigational new drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim), the sponsor of an application for a new drug 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 the holder of an approved application for a drug 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), 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 racial minorities. Such request to conduct pediatric 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 studies. 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 approved 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 intention of the applicant or holder to act on the request by—
(I) indicating when the pediatric studies 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 request.
(ii) *Disagree with request* — If, on or after September 27, 2007, the applicant or holder does not agree to the request on the grounds that it is not possible to develop the appropriate pediatric formulation, 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 reports 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 reports.
(3) **Action on submissions** — The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission.
(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 notify 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 respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing.
(5) **Effect of subsection** — Nothing in this subsection alters or amends [section 331(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/j&num=0&edition=prelim) or [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
(6) **Consultation** — With respect to a drug that is a qualified countermeasure (as defined in [section 247d–6a of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6a&num=0&edition=prelim)), a security countermeasure (as defined in [section 247d–6b of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6b&num=0&edition=prelim)), or a qualified pandemic or epidemic product (as defined in [section 247d–6d of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6d&num=0&edition=prelim)), the Secretary shall solicit input from the Assistant Secretary for Preparedness and Response regarding the need for and, from the Director of the Biomedical Advanced Research and Development Authority regarding the conduct of, pediatric studies under this section.
**(e) Notice of determinations on studies requirement**
(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 approvals under subsection (b)(2) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) 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 regarding market exclusivity and shall include a copy of the written request made under subsection (b) or (c).
(2) **Identification of certain drugs** — The Secretary shall publish a notice identifying any drug for which, on or after September 27, 2007, a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population (or specified subpopulation) if the pediatric formulation 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 pediatric studies**
(1) **Internal review** — The Secretary shall utilize the internal review committee established under [section 355d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355d&num=0&edition=prelim) to review all written requests issued on or after September 27, 2007, in accordance with paragraph (2).
(2) **Review of written requests** — The committee referred to in paragraph (1) shall review all written requests issued pursuant 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 Secretary 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 activity 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284m&num=0&edition=prelim);
(B) the specific drugs and drug uses, including 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 involved;
(D) the number of pediatric formulations developed and the number of pediatric formulations 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 conducted under such sections for distribution pursuant to subsection (k)(2); and
(G) information regarding reports submitted on or after September 27, 2007.
(7) **Informing internal review committee** — The Secretary shall provide to the committee referred to in paragraph (1) any response 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 period under subsection (c)(1)(A)(i)(II) for a supplemental application if all other requirements 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 period under subsection (c)(1)(A)(ii).
**(h) Relationship to pediatric research requirements** 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 accordance with subsection (d)(4). Written requests under this section may consist of a study or studies required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim).
**(i) Labeling changes**
(1) **Priority status for pediatric applications and supplements** — Any application or supplement to an application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) proposing a labeling change as a result of any pediatric study conducted pursuant to this section—
(A) shall be considered to be a priority application 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 Commissioner determines that the sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling 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 determines to be appropriate; and
(ii) if the sponsor of the application does not agree within 30 days after the Commissioner’s request to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Committee.
(B) *Action by the Pediatric Advisory Committee* — Not later than 90 days after receiving a referral under subparagraph (A)(ii), the Pediatric Advisory Committee shall—
(i) review the pediatric study reports; and
(ii) make a recommendation to the Commissioner concerning appropriate labeling changes, if any.
(C) *Consideration of recommendations* — The Commissioner shall consider the recommendations of the Pediatric Advisory Committee and, if appropriate, not later than 30 days after receiving the recommendation, make a request to the sponsor 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 subparagraph (C), does not agree to make a labeling change requested by the Commissioner, 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 authority of the United States to bring an enforcement action under this chapter when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory 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 Secretary determines that a pediatric study conducted under this section does or does not demonstrate 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 include information about the results of the study and a statement of the Secretary’s determination.
**(k) Dissemination of pediatric information**
(1) **In general** — Not later than 210 days after the date of submission of a report on a pediatric study under this section, the Secretary shall make available to the public the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under subsection (b) or (c).
(2) **Dissemination of information regarding labeling changes** — Beginning on September 27, 2007, the Secretary shall include as a requirement of a written request that the sponsors of the studies that result in labeling changes that are reflected in the annual summary developed pursuant to subsection (f)(6)(F) distribute, at least annually (or more frequently if the Secretary determines that it would be beneficial to the public health), such information to physicians and other health care providers.
(3) **Effect of subsection** — Nothing in this subsection alters or amends [section 331(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/j&num=0&edition=prelim) or [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
**(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 labeling 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 received) are referred to the Office of Pediatric Therapeutics established under [section 393a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section393a&num=0&edition=prelim). In considering the reports, the Director of such Office shall provide for the review of the reports by the Pediatric Advisory Committee, including obtaining any recommendations 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 appropriate, refer to the Office of Pediatric Therapeutics all pediatric adverse event reports for a drug for which a pediatric study was conducted under this section. In considering such reports, the Director of such Office may provide for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendation of such Committee 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 providing 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 exclusivity under this section and market exclusivity awarded to an applicant for approval of a drug under [section 355(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j&num=0&edition=prelim)** If a 180-day period under [section 355(j)(5)(B)(iv) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/B/iv&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j&num=0&edition=prelim) 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 exclusivity period expires, by the number of days of the overlap if the 180-day period would, but for the application of this subsection, expire during 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355d&num=0&edition=prelim), determines that there is a continuing need for information relating to the use of the drug in the pediatric population (including neonates, as appropriate), the Secretary shall carry out the following:
(A) For a drug for which a listed patent has not expired, 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) has not ended, make a determination regarding whether an assessment shall be required to be submitted under [section 355c(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c/b&num=0&edition=prelim).
(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) apply, the Secretary shall refer the drug for inclusion on the list established under [section 284m of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284m&num=0&edition=prelim) for the conduct of studies.
(C) For a drug that is a qualified countermeasure (as defined in [section 247d–6a of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6a&num=0&edition=prelim)), a security countermeasure (as defined in [section 247d–6b of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6b&num=0&edition=prelim)), or a qualified pandemic or epidemic product (as defined in [section 247d–6d of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6d&num=0&edition=prelim)), in addition to any action with respect to such drug under subparagraph (A) or (B), the Secretary shall notify the Assistant Secretary for Preparedness and Response and the Director of the Biomedical Advanced Research and Development Authority of all pediatric studies in the written request issued by the Commissioner of Food and Drugs.
(2) **Public notice** — The Secretary shall give the public notice of a decision under paragraph (1)(A) not to require an assessment under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim) and the basis for such decision.
(3) **Effect of subsection** — Nothing in this subsection alters or amends [section 331(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/j&num=0&edition=prelim) or [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
**(o) Prompt approval of drugs when pediatric information 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) shall not be considered ineligible for approval under that section or misbranded under [section 352 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352&num=0&edition=prelim) on the basis that the labeling of the drug omits a pediatric indication or any other aspect 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/F&num=0&edition=prelim), clause (iii) or (iv) of [section 355(c)(3)(E) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3/E&num=0&edition=prelim), or [section 360cc(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc/a&num=0&edition=prelim), or by an extension of such exclusivity under this section or [section 355f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355f&num=0&edition=prelim).
(2) **Labeling** — Notwithstanding clauses (iii) and (iv) of [section 355(j)(5)(F) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/F&num=0&edition=prelim), clauses (iii) and (iv) of [section 355(c)(3)(E) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3/E&num=0&edition=prelim), or [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&num=0&edition=prelim), the Secretary may require that the labeling of a drug approved pursuant to an application submitted under subsection (b)(2) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) that omits a pediatric indication or other aspect of labeling as described in paragraph (1) include—
(A) a statement that, because of marketing 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 pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.
(3) **Preservation of pediatric exclusivity and extensions** — This subsection does not affect—
(A) the availability or scope of exclusivity under—
(i) this section;
(ii) [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for pediatric formulations; or
(iii) [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&num=0&edition=prelim);
(B) the availability or scope of an extension to any such exclusivity, including an extension under this section or [section 355f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355f&num=0&edition=prelim);
(C) the question of the eligibility for approval under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) of any application described in subsection (b)(2) or (j) of such section that omits any other aspect of labeling protected by exclusivity under—
(i) clause (iii) or (iv) of [section 355(j)(5)(F) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/F&num=0&edition=prelim);
(ii) clause (iii) or (iv) of [section 355(c)(3)(E) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3/E&num=0&edition=prelim); or
(iii) [section 360cc(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc/a&num=0&edition=prelim); or
(D) except as expressly provided in paragraphs (1) and (2), the operation of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&num=0&edition=prelim).
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(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
**(a) Request by sponsor; preconditions; “rare disease or condition” defined**
(1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—
(A) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim),
the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) 11 See References in Text note below. respecting the designation of the drug.
(2) For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,0
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360bb
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
The Secretary shall establish an internal committee within the Food and Drug Administration to carry out the activities as described in sections 355a(f) and 355c(f) of this title. Such internal committee shall include employees of the Food and Drug Administration, with expertise in pediatrics (including representation from the Office of Pediatric Therapeutics), biopharmacology, statistics, chemistry, legal issues, pediatric ethics, neonatology, and the appropriate expertise pertaining to the pediatric product under review, such as expertise in child and adolescent psychiatry or pediatric rare diseases, and other individuals designated by the Secretary.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355d
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Liability protections**
(1) **In general** — Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.
(2) **Scope of claims for loss**
(A) *Loss* — For purposes of this section, the term “loss” means any type of loss, including—
(i) death;
(ii) physical, mental, or emotional injury, illness, disability, or condition;
(iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
(iv) loss of or damage to property, including business interruption loss.
Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.
(B) *Scope* — The immunity under paragraph (1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.
(3) **Certain conditions** — Subject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—
(A) the countermeasure was administered or used during the effective period of the declaration th
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–6d
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Extension** If the Secretary approves an application pursuant to [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a drug that has been designated as a qualified infectious disease product under subsection (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or the 7-year period described in [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&num=0&edition=prelim), as applicable, shall be extended by 5 years.
**(b) Relation to pediatric exclusivity** Any extension under subsection (a) of a period shall be in addition to any extension of the period under [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim) with respect to the drug.
**(c) Limitations** Subsection (a) does not apply to the approval of—
(1) a supplement to an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for any qualified infectious disease product for which an extension described in subsection (a) is in effect or has expired;
(2) a subsequent application filed with respect to a product approved under [section 355 of this title](https://uscode.house
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355f
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(a)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
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