§ 355a. Pediatric studies of drugs

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 title I § 111 · 111 Stat. 2296

   Enacted · 21 U.S.C. § 355a

   June 25, 1938, ch. 675, § 505A, as added Pub. L. 105–115, title I, § 111, Nov. 21, 1997, 111 Stat. 2305

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 505A, as added Pub. L. 105–115, title I, § 111, Nov. 21, 1997, 111 Stat. 2305

   Enacted provision · exact public law section
   SEC. 111. PEDIATRIC STUDIES OF DRUGS. Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following: “SEC. 505A PEDIATRIC STUDIES OF DRUGS. “(a) Market Exclusivity for New Drugs.— If, prior to approval of an application that is submitted under section 505(b)(1), 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), and such studies are completed within any such timeframe and the reports thereof submitted in accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)— “(1) (A) (i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(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)(D) of such section, and in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six months rather than three years; and “(B) if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and “(2) (A) 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 505 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 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or “(B) 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 505, 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 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions). “(b) Secretary To Develop List of Drugs for Which Additional Pediatric Information May Be Beneficial.— Not later than 180 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary, after consultation with experts in pediatric research shall develop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The Secretary snail annually update the list. “(c) Market Exclusivity for Already-Marketed Drugs.— If the Secretary makes a written request to the holder of an approved application under section 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies) concerning a drug identified in the list described in subsection (b), the holder agrees to the request, the studies are completed within any such timeframe, and the reports thereof are submitted in accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)— “(1) (A) (i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(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)(D) of such section, and in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six months rather than three years; and “(B) if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and “(2) (A) 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 505 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 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or “(B) 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 505, 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 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions). “(d) Conduct of Pediatric Studies.— “(1) Agreement for studies.— The Secretary may, pursuant to a written request from the Secretary under subsection (a) or (c), after consultation with— “(A) the sponsor of an application for an investigational new drug under section 505(i); “(B) the sponsor of an application for a new drug under section 505(b)(1); or “(C) the holder of an approved application for a drug under section 505(b)(1), agree with the sponsor or holder for the conduct of pediatric studies for such drug. Such agreement shall be in writing and shall include a timeframe for such studies. “(2) Written protocols to meet the studies requirement.— If the sponsor or holder and the Secretary agree upon written protocols for the studies, the studies requirement of subsection (a) or (c) is satisfied upon the completion of the studies and submission of the reports thereof in accordance with the original written request and the written agreement referred to in paragraph (1). Not later than 60 days after the submission of the report of the studies, the Secretary shall determine if such studies were or were not conducted in accordance with the original written request and the written agreement and reported in accordance with the requirements of the Secretary for filing and so notify the sponsor or holder. “(3) Other methods to meet the studies requirement.— If the sponsor or holder and the Secretary have not agreed in writing on the protocols for the studies, the studies requirement of subsection (a) or (c) is satisfied when such studies have been completed and the reports accepted by the Secretary. Not later than 90 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 90 days, 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. “(e) Delay of Effective Date for Certain Application.— If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or 505(j) for a new drug may occur after submission of reports of pediatric studies under this section, which were submitted prior to the expiration of the patent (including any patent extension) or the applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section 505(j)(4)(D), but before the Secretary has determined whether the requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance or approval under section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable six-month period under subsection (a) or (c) shall be deemed to have been running during the period of delay. “(f) Notice of Determinations on Studies Requirement.— The Secretary shall publish a notice of any determination that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section. “(g) 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 in which a drug is anticipated to be used. “(h) Limitations.— A drug to which the six-month period under subsection (a) or (b) has already been applied— “(1) may receive an additional six-month period under subsection (c)(1)(A)(ii) for a supplemental application if all other requirements under this section are satisfied, except that such a drug may not receive any additional such period under subsection (c)(2); and “(2) may not receive any additional such period under subsection (c)(1)(B). “(i) Relationship to Regulations.— Notwithstanding any other provision of law, if any pediatric study is required pursuant to regulations promulgated by the Secretary and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section. “(j) Sunset.— A drug may not receive any six-month period under subsection (a) or (c) unless the application for the drug under section 505(b)(1) is submitted on or before January 1, 2002. After January 1, 2002, a drug shall receive a six-month period under subsection (c) if— “(1) the drug was in commercial distribution as of the date of enactment of the Food and Drug Administration Modernization Act of 1997; “(2) the drug was included by the Secretary on the list under subsection (b) as of January 1, 2002; “(3) the Secretary determines that there is a continuing 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. “(k) Report.— The Secretary shall conduct a study and report to Congress not later than January 1, 2001, based on the experience under the program established under this section. The study and report shall examine all relevant issues, including— “(1) the effectiveness of the program in improving information about important pediatric uses for approved drugs; “(2) the adequacy of the incentive provided under this section; “(3) the economic impact of the program on taxpayers and consumers, including the impact of the lack of lower cost generic drugs on patients, including on lower income patients; and “(4) any suggestions for modification that the Secretary determines to be appropriate.”.

2. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 19(2) · 115 Stat. 1408

   Redesignated · 21 U.S.C. § 355a(a)

   Pub. L. 107–109, § 19(2), (3), redesignated subsec. (g) as (a). Former subsec. (a) redesignated (b)

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (g) as (a). Former subsec. (a) redesignated (b).

   Enacted provision · exact public law section
   (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

3. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 19(1)(A) · 115 Stat. 1408

   1. Substituted · 21 U.S.C. § 355a(a)(1)(A)

      Pub. L. 107–109, § 19(1)(A), (B), substituted “(j)(5)(D)(ii)” for “(j)(4)(D)(ii)” in cl. (ii)

   2. Substituted · 21 U.S.C. § 355a(a)(1)(A)

      Pub. L. 107–109, § 19(1)(A), (B), substituted “(j)(5)(D)” for “(j)(4)(D)” in cl. (ii)

   Source evidence

   Code amendment note
   Subsec. (a)(1)(A). Pub. L. 107–109, § 19(1)(A), (B), substituted “(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).

   Enacted provision · exact public law section
   (A) by striking “(j)(4)(D)(ii)” each place it appears and inserting “(j)(5)(D)(ii)”;

4. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 19(2) · 115 Stat. 1408

   Redesignated · 21 U.S.C. § 355a(b)

   Pub. L. 107–109, § 19(2), (3), redesignated subsec. (a) as (b)

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (a) as (b).

   Enacted provision · exact public law section
   (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

5. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 2(1) · 115 Stat. 1408

   Struck · 21 U.S.C. § 355a(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 consultation with experts in pediatric research shall develop, 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.”

   Target inherited from the preceding amendment note.

   Source evidence

   Code amendment note
   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 consultation with experts in pediatric research shall develop, 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.”

   Enacted provision · exact public law section
   (1) by striking subsection (b); and

6. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 2(2) · 115 Stat. 1408

   1. Inserted · 21 U.S.C. § 355a(c)

      Pub. L. 107–109, § 2(2), in introductory provisions, inserted “determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and” after “the Secretary”

   2. Struck · 21 U.S.C. § 355a(c)

      Pub. L. 107–109, § 2(2), in introductory provisions, struck out “concerning a drug identified in the list described in subsection (b) of this section” after “such studies)”

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 107–109, § 2(2), in introductory provisions, inserted “determines that information relating to the use of an approved drug in the pediatric population 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)”.

   Enacted provision · exact public law section
   (2) in subsection (c)— (A) by inserting after “the Secretary” the following: “determines that information relating to the use of an approved drug in the pediatric population may produce health benefits in that population and”; and (B) by striking “concerning a drug identified in the list described in subsection (b)”.

7. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 19(1)(A) · 115 Stat. 1408

   1. Substituted · 21 U.S.C. § 355a(c)(1)(A)

      Pub. L. 107–109, § 19(1)(A), (B), substituted “(j)(5)(D)(ii)” for “(j)(4)(D)(ii)” in cl. (ii)

   2. Substituted · 21 U.S.C. § 355a(c)(1)(A)

      Pub. L. 107–109, § 19(1)(A), (B), substituted “(j)(5)(D)” for “(j)(4)(D)” in cl. (ii)

   Source evidence

   Code amendment note
   Subsec. (c)(1)(A). Pub. L. 107–109, § 19(1)(A), (B), substituted “(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).

   Enacted provision · exact public law section
   (A) by striking “(j)(4)(D)(ii)” each place it appears and inserting “(j)(5)(D)(ii)”;

8. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 19(4) · 115 Stat. 1408

   Substituted · 21 U.S.C. § 355a(d)(1)

   Pub. L. 107–109, § 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)” in introductory provisions

   Source evidence

   Code amendment note
   Subsec. (d)(1). Pub. L. 107–109, § 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)” in introductory provisions.

   Enacted provision · exact public law section
   (4) in paragraphs (1), (2), and (3) of subsection (d), subsection (e), and subsection (m) (as redesignated by paragraph (2)), by striking “subsection (a) or (c)” and inserting “subsection (b) or (c)”; and

9. 2002

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 · 115 Stat. 1408

   1. Substituted · 21 U.S.C. § 355a(d)(2)

      Pub. L. 107–109, §§ 18(a), 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)”

   2. Inserted · 21 U.S.C. § 355a(d)(2)

      Pub. L. 107–109, §§ 18(a), 19(4), inserted “In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities.” after first sentence

   Source evidence

   Code amendment note
   Subsec. (d)(2). Pub. L. 107–109, §§ 18(a), 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)” and inserted “In reaching an agreement regarding written protocols, the Secretary shall take into account adequate representation of children of ethnic and racial minorities.” after first sentence.

10. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(4) · 115 Stat. 1408

    Substituted · 21 U.S.C. § 355a(d)(3)

    Pub. L. 107–109, § 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)”

    Source evidence

    Code amendment note
    Subsec. (d)(3). Pub. L. 107–109, § 19(4), substituted “subsection (b) or (c)” for “subsection (a) or (c)”.

    Enacted provision · exact public law section
    (4) in paragraphs (1), (2), and (3) of subsection (d), subsection (e), and subsection (m) (as redesignated by paragraph (2)), by striking “subsection (a) or (c)” and inserting “subsection (b) or (c)”; and

11. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 4 · 115 Stat. 1408

    Added · 21 U.S.C. § 355a(d)(4)

    Pub. L. 107–109, § 4, added par. (4)

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 107–109, § 4, added par. (4).

    Enacted provision · exact public law section
    SEC. 4. WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICATIONS FOR DRUGS THAT HAVE MARKET EXCLUSIVITY. Section 505A(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)) is amended by adding at the end the following: “(4) Written request to holders of approved applications for drugs that have market exclusivity.— “(A) Request and response.— If the Secretary makes a written request for pediatric studies (including neonates, as appropriate) under subsection (c) to the holder of an application approved under section 505(b)(1), the holder, not later than 180 days after receiving the written request, shall respond to the Secretary as to the intention of the holder to act on the request by— “(i) indicating when the pediatric studies will be initiated, if the holder agrees to the request; or “(ii) indicating that the holder does not agree to the request. “(B) No agreement to request.— “(i) Referral.— If the holder does not agree to a written request within the time period specified in subparagraph (A), and if the Secretary 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 refer the drug to the Foundation for the National Institutes of Health established under section 499 of the Public Health Service Act (42 U.S.C. 290b) (referred to in this paragraph as the ‘Foundation’) for the conduct of the pediatric studies described in the written request. “(ii) Public notice.— The Secretary shall give public notice of the name of the drug, the name of the manufacturer, and the indications to be studied made in a referral under clause (i). “(C) Lack of funds.— On referral of a drug under subparagraph (B)(i), the Foundation shall issue a proposal to award a grant to conduct the requested studies unless the Foundation certifies to the Secretary, within a timeframe that the Secretary determines is appropriate through guidance, that the Foundation does not have funds available under section 499(j)(9)(B)(i) to conduct the requested studies. If the Foundation so certifies, the Secretary shall refer the drug for inclusion on the list established under section 4091 of the Public Health Service Act for the conduct of the studies. “(D) Effect of subsection.— Nothing in this subsection (including with respect to referrals from the Secretary to the Foundation) alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. “(E) No requirement to refer.— Nothing in this subsection shall be construed to require that every declined written request shall be referred to the Foundation. “(F) Written requests under subsection (b).— For drugs under subsection (b) for which written requests have not been accepted, if the Secretary 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 issue a written request under subsection (c) after the date of approval of the drug.”.

12. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(1)(C) · 115 Stat. 1408

    1. Substituted · 21 U.S.C. § 355a(e)

       Pub. L. 107–109, § 19(1)(C), (4), substituted “section 355(j)(5)(D)” for “section 355(j)(4)(D)”

    2. Substituted · 21 U.S.C. § 355a(e)

       Pub. L. 107–109, § 19(1)(C), (4), substituted “subsection (b) or (c)” for “subsection (a) or (c)”

    Source evidence

    Code amendment note
    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)”.

    Enacted provision · exact public law section
    (C) by striking “505(j)(4)(D)” each place it appears and inserting “505(j)(5)(D)”;

13. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    1. Redesignated · 21 U.S.C. § 355a(g)

       Pub. L. 107–109, § 19(2), (3), (5), redesignated subsec. (h) as (g)

    2. Redesignated · 21 U.S.C. § 355a(g)

       Pub. L. 107–109, § 19(2), (3), (5), substituted “subsection (b) or (c)” for “subsection (a) or (b)” in introductory provisions. Former subsec. (g) redesignated (a)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 107–109, § 19(2), (3), (5), redesignated subsec. (h) as (g) and substituted “subsection (b) or (c)” for “subsection (a) or (b)” in introductory provisions. Former subsec. (g) redesignated (a).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

14. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 7 · 115 Stat. 1408

    Inserted · 21 U.S.C. § 355a(g)

    Pub. L. 107–109, § 7, inserted “(including neonates in appropriate cases)” after “pediatric age groups”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 7, inserted “(including neonates in appropriate cases)” after “pediatric age groups”.

    Enacted provision · exact public law section
    SEC. 7. NEONATES. Section 505A(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(g)) is amended by inserting “(including neonates in appropriate cases)” after “pediatric age groups”.

15. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(h)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

16. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(i)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (l) as (i). Former subsec. (i) redesignated (h)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (l) as (i). Former subsec. (i) redesignated (h).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

17. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(j)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n)

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (m) as (j). Former subsec. (j) redesignated (n).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

18. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 8 · 115 Stat. 1408

    1. Added · 21 U.S.C. § 355a(j)

       Pub. L. 107–109, § 8, added subsec. (j)

    2. Struck · 21 U.S.C. § 355a(j)

       Pub. L. 107–109, § 8, struck out heading and text of former subsec. (j). Text read as follows: “A drug may not receive any six-month period under subsection (a) or (c) of this section unless the application 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—

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 8, added subsec. (j) and struck out heading and text of former subsec. (j). Text read as follows: “A drug may not receive any six-month period under subsection (a) or (c) of this section unless the application 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 continuing 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.”

    Enacted provision · exact public law section
    SEC. 8. SUNSET. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by striking subsection (j) and inserting the following: “(j) Sunset.— A drug may not receive any 6-month period under subsection (a) or (c) unless— “(1) on or before October 1, 2007, the Secretary makes a written request for pediatric studies of the drug; “(2) on or before October 1, 2007, an application for the drug is accepted for filing under section 505(b); and “(3) all requirements of this section are met.”.

19. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(k)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m)

    Source evidence

    Code amendment note
    Subsec. (k). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (n) as (k). Former subsec. (k) redesignated (m).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

20. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(l)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (o) as (l). Former subsec. (l) redesignated (i)

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (o) as (l). Former subsec. (l) redesignated (i).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

21. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 5(b)(2) · 115 Stat. 1408

    Added · 21 U.S.C. § 355a(l)

    Pub. L. 107–109, § 5(b)(2), added subsec. (l)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 5(b)(2), added subsec. (l).

    Enacted provision · exact public law section
    (2) Treatment as priority supplements.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by adding at the end the following: “(l) Labeling Supplements.— “(1) Priority status for pediatric supplements.— Any supplement to an application under section 505 proposing a labeling change pursuant to a report on a pediatric study under this section— “(A) shall be considered to be a priority 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 the Commissioner determines that an application with respect to which a pediatric study is conducted under this section is approvable and that the only open issue for final action on the application is the reaching of an agreement between the sponsor of the application and the Commissioner 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 to make a labeling change requested by the Commissioner, the Commissioner shall refer the matter to the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee. “(B) Action by the pediatric advisory subcommittee of the anti-infective drugs advisory committee.— Not later than 90 days after receiving a referral Deadline. under subparagraph (A)(ii), the Pediatric Advisory Subcommittee of the Anti-Infective Drugs 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 Subcommittee of the Anti-Infective Drugs 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 Act when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Subcommittee of the Anti-Infective Drugs 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.”.

22. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(m)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j)

    Source evidence

    Code amendment note
    Subsec. (m). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (k) as (m). Former subsec. (m) redesignated (j).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

23. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 9 · 115 Stat. 1408

    Added · 21 U.S.C. § 355a(m)

    Pub. L. 107–109, § 9, added subsec. (m)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 9, added subsec. (m).

    Enacted provision · exact public law section
    SEC. 9. DISSEMINATION OF PEDIATRIC INFORMATION. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) (as amended by section 5(b)(2)) is amended by adding at the end the following: “(m) Dissemination of Pediatric Information.— “(1) In general.— Not later than 180 days after the date Deadline. of submission of a report on a pediatric study under this section, the Commissioner shall make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement, including by publication in the Federal Register. “(2) Effect of subsection.— Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.”.

24. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(4) · 115 Stat. 1408

    Substituted · 21 U.S.C. § 355a(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

    Source evidence

    Code amendment note
    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.

    Enacted provision · exact public law section
    (4) in paragraphs (1), (2), and (3) of subsection (d), subsection (e), and subsection (m) (as redesignated by paragraph (2)), by striking “subsection (a) or (c)” and inserting “subsection (b) or (c)”; and

25. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(n)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (j) as (n). Former subsec. (n) redesignated (k).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

26. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 10 · 115 Stat. 1408

    Added · 21 U.S.C. § 355a(n)

    Pub. L. 107–109, § 10, added subsec. (n)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 10, added subsec. (n).

    Enacted provision · exact public law section
    SEC. 10. CLARIFICATION OF INTERACTION OF PEDIATRIC EXCLUSIVITY UNDER SECTION 505A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND 180-DAY EXCLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j) OF THAT ACT. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) (as amended by section 9) is amended by adding at the end the following: “(n) Clarification of Interaction of Market Exclusivity Under This Section and Market Exclusivity Awarded to an Applicant for Approval of a Drug Under Section 505(j).— If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 505(j) 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.”.

27. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 19(2) · 115 Stat. 1408

    Redesignated · 21 U.S.C. § 355a(o)

    Pub. L. 107–109, § 19(2), (3), redesignated subsec. (o) as (l)

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 107–109, § 19(2), (3), redesignated subsec. (o) as (l).

    Enacted provision · exact public law section
    (2) by redesignating subsections (a), (g), (h), (i), (j), (k), (l), (m), (n), and (o) as subsections (b), (a), (g), (h), (n), (m), (i), (j), (k), and (l) respectively;

28. 2002

    Best Pharmaceuticals for Children Act

    Pub. L. 107–109 § 11(a) · 115 Stat. 1408

    Added · 21 U.S.C. § 355a(o)

    Pub. L. 107–109, § 11(a), added subsec. (o)

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 107–109, § 11(a), added subsec. (o).

    Enacted provision · exact public law section
    (a) In General.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) (as amended by section 10) is amended by adding at the end the following: “(o) Prompt Approval of Drugs Under Section 505(j) When Pediatric Information Is Added to Labeling.— “(1) General rule.— A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 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 505(j)(5)(D). “(2) Labeling.— Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(D), the Secretary may require that the labeling of a drug approved under section 505(j) 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, or precautions that the Secretary considers necessary. “(3) Preservation of pediatric exclusivity and other provisions.— This subsection does not affect— “(A) the availability or scope of exclusivity under this section; “(B) the availability or scope of exclusivity under section 505 for pediatric formulations; “(C) the question of the eligibility for approval of any application under section 505(j) that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(D); or “(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505.”.

29. 2003

    Pediatric Research Equity Act of 2003

    Pub. L. 108–155 § 3(a) · 117 Stat. 1936

    Substituted · 21 U.S.C. § 355a(b)(2)

    Pub. L. 108–155, § 3(a), substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places

    Source evidence

    Code amendment note
    Subsec. (b)(2). Pub. L. 108–155, § 3(a), substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places.

    Enacted provision · exact public law section
    (a) Abbreviated New Drug Application.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended in subparagraphs (A) and (B) of subsection (b)(2) and subparagraphs (A) and (B) of subsection (c)(2) by striking “505(j)(4)(B)” and inserting “505(j)(5)(B)”.

30. 2003

    Pediatric Research Equity Act of 2003

    Pub. L. 108–155 § 3(a) · 117 Stat. 1936

    Substituted · 21 U.S.C. § 355a(c)(2)

    Pub. L. 108–155, § 3(a), substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places

    Source evidence

    Code amendment note
    Subsec. (c)(2). Pub. L. 108–155, § 3(a), substituted “355(j)(5)(B)” for “355(j)(4)(B)” in two places.

    Enacted provision · exact public law section
    (a) Abbreviated New Drug Application.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended in subparagraphs (A) and (B) of subsection (b)(2) and subparagraphs (A) and (B) of subsection (c)(2) by striking “505(j)(4)(B)” and inserting “505(j)(5)(B)”.

31. 2003

    Pediatric Research Equity Act of 2003

    Pub. L. 108–155 § 2(b)(2) · 117 Stat. 1936

    1. Substituted · 21 U.S.C. § 355a(h)

       Pub. L. 108–155, § 2(b)(2), substituted “pediatric research requirements” for “regulations” in text

    2. Substituted · 21 U.S.C. § 355a(h)

       Pub. L. 108–155, § 2(b)(2), substituted “by a provision of law (including a regulation) other than this section” for “pursuant to regulations promulgated by the Secretary” in text

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 108–155, § 2(b)(2), substituted “pediatric research requirements” for “regulations” in heading and “by a provision of law (including a regulation) other than this section” for “pursuant to regulations promulgated by the Secretary” in text.

    Enacted provision · exact public law section
    (2) Section 505A(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(h)) is amended— (A) in the subsection heading, by striking “Regulations” and inserting “Pediatric Research Requirements”; and (B) by striking “pursuant to regulations promulgated by the Secretary” and inserting “by a provision of law (including a regulation) other than this section”.

32. 2003

    Pediatric Research Equity Act of 2003

    Pub. L. 108–155 § 3(b)(1) · 117 Stat. 1936

    Struck · 21 U.S.C. § 355a(i)(2)

    Pub. L. 108–155, § 3(b)(1), struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing

    Source evidence

    Code amendment note
    Subsec. (i)(2). Pub. L. 108–155, § 3(b)(1), struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing.

    Enacted provision · exact public law section
    (1) Section 505A(i)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(i)(2)) is amended by striking “Advisory Subcommittee of the Anti-Infective Drugs” each place it appears.

33. 2003

    Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 1104(1) · 117 Stat. 2066

    Substituted · 21 U.S.C. § 355a(b)(1)(A)(i)

    Pub. L. 108–173, § 1104(1), substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places

    Source evidence

    Code amendment note
    Subsec. (b)(1)(A)(i). Pub. L. 108–173, § 1104(1), substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places.

    Enacted provision · exact public law section
    (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by striking “(j)(5)(D)(ii)” each place it appears and inserting “(j)(5)(F)(ii)”;

34. 2003

    Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 1104(2) · 117 Stat. 2066

    Substituted · 21 U.S.C. § 355a(b)(1)(A)(ii)

    Pub. L. 108–173, § 1104(2), substituted “(j)(5)(F)” for “(j)(5)(D)”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(A)(ii). Pub. L. 108–173, § 1104(2), substituted “(j)(5)(F)” for “(j)(5)(D)”.

    Enacted provision · exact public law section
    (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by striking “(j)(5)(D)” each place it appears and inserting “(j)(5)(F)”; and

35. 2003

    Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 1104(1) · 117 Stat. 2066

    Substituted · 21 U.S.C. § 355a(c)(1)(A)(i)

    Pub. L. 108–173, § 1104(1), substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places

    Source evidence

    Code amendment note
    Subsec. (c)(1)(A)(i). Pub. L. 108–173, § 1104(1), substituted “(j)(5)(F)(ii)” for “(j)(5)(D)(ii)” in two places.

    Enacted provision · exact public law section
    (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by striking “(j)(5)(D)(ii)” each place it appears and inserting “(j)(5)(F)(ii)”;

36. 2003

    Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 1104(2) · 117 Stat. 2066

    Substituted · 21 U.S.C. § 355a(c)(1)(A)(ii)

    Pub. L. 108–173, § 1104(2), substituted “(j)(5)(F)” for “(j)(5)(D)”

    Source evidence

    Code amendment note
    Subsec. (c)(1)(A)(ii). Pub. L. 108–173, § 1104(2), substituted “(j)(5)(F)” for “(j)(5)(D)”.

    Enacted provision · exact public law section
    (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by striking “(j)(5)(D)” each place it appears and inserting “(j)(5)(F)”; and

37. 2003

    Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 1104(3) · 117 Stat. 2066

    Substituted · 21 U.S.C. § 355a(e)

    Pub. L. 108–173, § 1104(3), substituted “355(j)(5)(F)” for “355(j)(5)(D)”

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 108–173, § 1104(3), substituted “355(j)(5)(F)” for “355(j)(5)(D)”.

    Enacted provision · exact public law section
    (3) in subsections (e) and (l), by striking “505(j)(5)(D)” each place it appears and inserting “505(j)(5)(F)”.

38. 2003

    Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 1104(3) · 117 Stat. 2066

    Substituted · 21 U.S.C. § 355a(l)

    Pub. L. 108–173, § 1104(3), substituted “355(j)(5)(F)” for “355(j)(5)(D)” wherever appearing

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 108–173, § 1104(3), substituted “355(j)(5)(F)” for “355(j)(5)(D)” wherever appearing.

    Enacted provision · exact public law section
    (3) in subsections (e) and (l), by striking “505(j)(5)(D)” each place it appears and inserting “505(j)(5)(F)”.

39. 2007

    Best Pharmaceuticals for Children Act of 2007

    Pub. L. 110–85 title V § 502(a)(1) · 121 Stat. 823

    Amended · 21 U.S.C. § 355a

    Pub. L. 110–85 amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) relating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effective date for certain applications, notice of determinations on studies requirement, limitations, research requirements, labeling supplements, dissemination of information, prompt approval of drugs, report to Congress not later than Jan. 1, 2001, and sunset provisions

    Source evidence

    Code amendment note
    Pub. L. 110–85 amended section generally. Prior to amendment, text consisted of subsecs. (a) to (n) relating to pediatric studies of drugs, including market exclusivity, conduct of pediatric studies, delay of effective date for certain applications, notice of determinations on studies requirement, limitations, research requirements, labeling supplements, dissemination of information, prompt approval of drugs, report to Congress not later than Jan. 1, 2001, and sunset provisions.

    Enacted provision · exact public law section
    (1) In general.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read as follows: “SEC. 505A. PEDIATRIC STUDIES OF DRUGS. “(a) Definitions.— As used in this section, the term ‘pediatric studies’ or ‘studies’ means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies. “(b) Market Exclusivity for New Drugs.— “(1) In general.— Except as provided in paragraph (2), if, prior to approval of an application that is submitted under section 505(b)(1), 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)(3)— “(A) (i) (I) the period referred to in subsection (c)(3)(E)(ii) of section 505, 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 526 for a rare disease or condition, the period referred to in section 527(a) 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 505 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 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) 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 505, 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 505(c)(3) or section 505(j)(5)(B) 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)(3) 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 505(b)(1) 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)(3)— “(A) (i) (I) the period referred to in subsection (c)(3)(E)(ii) of section 505, 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)(D) 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 526 for a rare disease or condition, the period referred to in section 527(a) 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 505 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 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B)(ii) 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 505, 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 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions). “(2) Exception.— The Deadline. Secretary shall not extend the period referred to in paragraph (1)(A) or (1)(B) if the determination made under subsection (d)(3) 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 505(i), the sponsor of an application for a new drug under section 505(b)(1), or the holder of an approved application for a drug under section 505(b)(1), issue to the sponsor or holder a written request for the conduct of pediatric studies for such drug. Minorities. In issuing such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such Timeframe. 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. “(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 the date of the enactment of the Best Pharmaceuticals for Children Act of 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 the date of the enactment of the Best Pharmaceuticals for Children Act of 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) 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. “(4) Effect of subsection.— Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. “(e) Notice of Determinations on Studies Requirement.— “(1) In general.— The Secretary shall publish a notice of any determination, made on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section. Such Deadline. Records. 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 the date of the enactment of the Best Pharmaceuticals for Children Act of 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). Deadline. 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 505C to review all written requests issued on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 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)(3). “(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 Public information. Web site. 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 409I of the Public Health Service Act; “(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 the date of the enactment of the Best Pharmaceuticals for Children Act of 2007. “(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.— 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 exclusivity pursuant to this section. “(i) Labeling Changes.— “(1) Priority status for pediatric applications and supplements.— Any application or supplement to an application under section 505 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 the Deadline. date of the enactment of the Best Pharmaceuticals for Children Act of 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) Deadline. 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 Deadline. 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 Deadline. 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 Act 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 the date of the enactment of the Best Pharmaceuticals for Children Act of 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 Deadline. Public information. 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 the date of the enactment of the Best Pharmaceuticals for Children Act of 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)(3)(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 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. “(l) Adverse Event Reporting.— “(1) Reporting in year one.— Beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, during the one-year 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 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). 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 Act in response to such reports. “(2) Reporting in subsequent years.— Following the one-year 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) 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 505(j).— If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 505(j) 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 Completed.— “(1) In general.— Beginning Effective date. on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, if pediatric studies of a drug have not been completed under subsection (d) and if the Secretary, through the committee established under section 505C, 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, make a determination regarding whether an assessment shall be required to be submitted under section 505B(b). Deadline. Certification. 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 certification 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 Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under section 505B(b) for such drug. “(B) For a drug that has no listed patents or has 1 or more listed patents that have expired, the Secretary shall refer the drug for inclusion on the list established under section 409I of the Public Health Service Act for the conduct of studies. “(2) Public notice.— The Secretary shall give the public notice of a decision under paragraph (1)(A) not to require an assessment under section 505B and the basis for such decision. “(3) Effect of subsection.— Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code. “(o) Prompt Approval of Drugs Under Section 505(j) When Pediatric Information Is Added to Labeling.— “(1) General rule.— A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 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 505(j)(5)(F). “(2) Labeling.— Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(F), the Secretary may require that the labeling of a drug approved under section 505(j) 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, or precautions that the Secretary considers necessary. “(3) Preservation of pediatric exclusivity and other provisions.— This subsection does not affect— “(A) the availability or scope of exclusivity under this section; “(B) the availability or scope of exclusivity under section 505 for pediatric formulations; “(C) the question of the eligibility for approval of any application under section 505(j) that omits any other conditions of approval entitled to exclusivity under clause (iii) or (iv) of section 505(j)(5)(F); or “(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505. “(p) Institute of Medicine Study.— Not later than 3 years after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary shall enter into a contract with the Institute of Medicine to conduct a study and report to Congress regarding the written requests made and the studies conducted pursuant to this section. The Institute of Medicine may devise an appropriate mechanism to review a representative sample of requests made and studies conducted pursuant to this section in order to conduct such study. Such study shall— “(1) review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c); “(2) review and assess such representative pediatric studies conducted under subsections (b) and (c) since 1997 and labeling changes made as a result of such studies; “(3) review the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, and ethical issues in pediatric clinical trials; “(4) review and assess the pediatric studies of biological products as required under subsections (a) and (b) of section 505B; and “(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics. “(q) Sunset.— A drug may not receive any 6-month period under subsection (b) or (c) unless— “(1) Deadline. on or before October 1, 2012, the Secretary makes a written request for pediatric studies of the drug; “(2) Deadline. on or before October 1, 2012, an application for the drug is accepted for filing under section 505(b); and “(3) all requirements of this section are met.” .

40. 2010

    Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 title VII § 7002(g)(2)(B) · 124 Stat. 119

    1. Added · 21 U.S.C. § 355a(p)(4)(6)

       Pub. L. 111–148 added pars. (4) to (6)

    2. Struck · 21 U.S.C. § 355a(p)(4)(6)

       Pub. L. 111–148 struck out former pars. (4) and (5) which read as follows:

    Source evidence

    Code amendment note
    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 biological 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 biologics.”

    Enacted provision · exact public law section
    (B) Institute of medicine study.— Section 505A(p) of the Federal Food, Drug, and Cosmetic Act 21 USC 355a. (21 U.S.C. 355b(p)) is amended by striking paragraphs (4) and (5) and inserting the following: “(4) review and assess the number and importance of biological products for children that are being tested as a result of the amendments made by the Biologics Price Competition and Innovation Act of 2009 and the importance for children, health care providers, parents, and others of labeling changes made as a result of such testing; “(5) review and assess the number, importance, and prioritization of any biological products that are not being tested for pediatric use; and “(6) offer recommendations for ensuring pediatric testing of biological products, including consideration of any incentives, such as those provided under this section or section 351(m) of the Public Health Service Act.” .

41. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 502(b) · 126 Stat. 993

    Inserted · 21 U.S.C. § 355a(d)(1)(A)

    Pub. L. 112–144, § 502(b), inserted 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 requesting studies in neonates.”

    Source evidence

    Code amendment note
    Subsec. (d)(1)(A). Pub. L. 112–144, § 502(b), inserted 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 requesting studies in neonates.”

    Enacted provision · exact public law section
    (b) Neonates.— 21 USC 355a. Subparagraph (A) of section 505A(d)(1) is amended by adding at the end the following: “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.”.

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

42. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 502(a)(1) · 126 Stat. 993

    Amended · 21 U.S.C. § 355a(h)

    Pub. L. 112–144, § 502(a)(1), amended subsec. (h) generally. Prior to amendment, text read as follows: “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 exclusivity pursuant to this section.”

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 112–144, § 502(a)(1), amended subsec. (h) generally. Prior to amendment, text read as follows: “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 exclusivity pursuant to this section.”

    Enacted provision · exact public law section
    (1) Federal food, drug, and cosmetic act.— Subsection (h) of section 505A (21 U.S.C. 355a) is amended to read as follows: “(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)(3). Written requests under this section may consist of a study or studies required under section 505B.” .

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

43. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(1) · 126 Stat. 993

    Substituted · 21 U.S.C. § 355a(k)(2)

    Pub. L. 112–144, § 509(a)(1), substituted “subsection (f)(6)(F)” for “subsection (f)(3)(F)”

    Source evidence

    Code amendment note
    Subsec. (k)(2). Pub. L. 112–144, § 509(a)(1), substituted “subsection (f)(6)(F)” for “subsection (f)(3)(F)”.

    Enacted provision · exact public law section
    (1) in subsection (k)(2), by striking “subsection (f)(3)(F)” and inserting “subsection (f)(6)(F)”;

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

44. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(2)(A) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 355a(l)(1)

       Pub. L. 112–144, § 509(a)(2)(A), substituted “first 18-month period” for “year one” in text

    2. Substituted · 21 U.S.C. § 355a(l)(1)

       Pub. L. 112–144, § 509(a)(2)(A), substituted “18-month” for “one-year” in text

    Source evidence

    Code amendment note
    Subsec. (l)(1). Pub. L. 112–144, § 509(a)(2)(A), substituted “first 18-month period” for “year one” in heading and “18-month” for “one-year” in text.

    Enacted provision · exact public law section
    (A) in paragraph (1)— (i) in the paragraph heading, by striking “year one” and inserting “first 18-month period”; and (ii) by striking “one-year” and inserting “18-month”;

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

45. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(2)(B) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 355a(l)(2)

       Pub. L. 112–144, § 509(a)(2)(B), substituted “periods” for “years” in text

    2. Substituted · 21 U.S.C. § 355a(l)(2)

       Pub. L. 112–144, § 509(a)(2)(B), substituted “18-month period” for “one-year period” in text

    Source evidence

    Code amendment note
    Subsec. (l)(2). Pub. L. 112–144, § 509(a)(2)(B), substituted “periods” for “years” in heading and “18-month period” for “one-year period” in text.

    Enacted provision · exact public law section
    (B) in paragraph (2)— (i) in the paragraph heading, by striking “years” and inserting “periods”; and (ii) by striking “one-year period” and inserting “18-month period”;

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

46. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(2)(C) · 126 Stat. 993

    1. Added · 21 U.S.C. § 355a(l)(3); 21 U.S.C. § 355a(l)(4)

       Pub. L. 112–144, § 509(a)(2)(C), (D), added par. (3)

    2. Redesignated · 21 U.S.C. § 355a(l)(3); 21 U.S.C. § 355a(l)(4)

       Pub. L. 112–144, § 509(a)(2)(C), (D), redesignated former par. (3) as (4)

    Source evidence

    Code amendment note
    Subsec. (l)(3), (4). Pub. L. 112–144, § 509(a)(2)(C), (D), added par. (3) and redesignated former par. (3) as (4).

    Enacted provision · exact public law section
    (C) by redesignating paragraph (3) as paragraph (4); and

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

47. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(3)(A) · 126 Stat. 993

    Substituted · 21 U.S.C. § 355a(n)

    Pub. L. 112–144, § 509(a)(3)(A), substituted “submitted” for “completed” in heading

    Source evidence

    Code amendment note
    Subsec. (n). Pub. L. 112–144, § 509(a)(3)(A), substituted “submitted” for “completed” in heading.

    Enacted provision · exact public law section
    (A) in the subsection heading, by striking “completed” and inserting “submitted”; and

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

48. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(3)(B)(i) · 126 Stat. 993

    Substituted · 21 U.S.C. § 355a(n)(1)

    Pub. L. 112–144, § 509(a)(3)(B)(i), substituted “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

    Source evidence

    Code amendment note
    Subsec. (n)(1). Pub. L. 112–144, § 509(a)(3)(B)(i), substituted “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.

    Enacted provision · exact public law section
    (i) in the matter preceding subparagraph (A), by striking “have not been completed” and inserting “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”;

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

49. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(3)(B)(ii) · 126 Stat. 993

    1. Inserted · 21 U.S.C. § 355a(n)(1)(A)

       Pub. L. 112–144, § 509(a)(3)(B)(ii), inserted “, 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”

    2. Struck · 21 U.S.C. § 355a(n)(1)(A)

       Pub. L. 112–144, § 509(a)(3)(B)(ii), 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 certification 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 Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under section 355c(b) of this title for such drug.”

    Source evidence

    Code amendment note
    Subsec. (n)(1)(A). Pub. L. 112–144, § 509(a)(3)(B)(ii), inserted “, 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 certification 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 Secretary makes such certification in the affirmative, the Secretary shall refer all pediatric studies in the written request to the Foundation for the National Institutes of Health for the conduct of such studies, and such Foundation shall fund such studies. If no certification has been made at the end of the 30-day period, or if the Secretary certifies that funds are not sufficient to initiate and fund all the studies in their entirety, the Secretary shall consider whether assessments shall be required under section 355c(b) of this title for such drug.”

    Enacted provision · exact public law section
    (ii) in subparagraph (A)— (I) in the first sentence, by inserting “, 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 351 of the Public Health Service Act has not ended” after “expired”; and (II) by striking “Prior to” and all that follows through the period at the end; and

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

50. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(3)(B)(iii) · 126 Stat. 993

    Substituted · 21 U.S.C. § 355a(n)(1)(B)

    Pub. L. 112–144, § 509(a)(3)(B)(iii), substituted “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,” for “no listed patents or has 1 or more listed patents that have expired,”

    Source evidence

    Code amendment note
    Subsec. (n)(1)(B). Pub. L. 112–144, § 509(a)(3)(B)(iii), substituted “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,” for “no listed patents or has 1 or more listed patents that have expired,”.

    Enacted provision · exact public law section
    (iii) in subparagraph (B), by striking “no listed patents or has 1 or more listed patents that have expired,” and inserting “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 351 of the Public Health Service Act apply,”; and

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

51. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 509(a)(4) · 126 Stat. 993

    Amended · 21 U.S.C. § 355a(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 pediatric contraindications, warnings, or precautions that the Secretary considers necessary.”

    Source evidence

    Code amendment note
    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 pediatric contraindications, warnings, or precautions that the Secretary considers necessary.”

    Enacted provision · exact public law section
    (4) in subsection (o)(2), by amending subparagraph (B) to read as follows: “(B) a statement of any appropriate pediatric contraindications, warnings, precautions, or other information that the Secretary considers necessary to assure safe use.” .

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

52. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 501(a) · 126 Stat. 993

    Struck · 21 U.S.C. § 355a(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—

    Source evidence

    Code amendment note
    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.”

    Enacted provision · exact public law section
    (a) Pediatric Studies of Drugs.— Section 505A (21 U.S.C. 355a) is amended by striking subsection (q) (relating to a sunset).

    Effective date note
    Pub. L. 112–144, title V, § 509(g), July 9, 2012, 126 Stat. 1050, provided that:

53. 2013

    Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

    Pub. L. 113–5 § 307(a)(1) · 127 Stat. 161

    Added · 21 U.S.C. § 355a(d)(5)

    Pub. L. 113–5, § 307(a)(1), added par. (5)

    Source evidence

    Code amendment note
    Subsec. (d)(5). Pub. L. 113–5, § 307(a)(1), added par. (5).

    Enacted provision · exact public law section
    (1) in subsection (d), by adding at the end the following: “(5) Consultation.— With respect to a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act), a security countermeasure (as defined in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–3 of the Public Health Service Act), 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.” ; and

54. 2013

    Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

    Pub. L. 113–5 § 307(a)(2) · 127 Stat. 161

    Added · 21 U.S.C. § 355a(n)(1)(C)

    Pub. L. 113–5, § 307(a)(2), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (n)(1)(C). Pub. L. 113–5, § 307(a)(2), added subpar. (C).

    Enacted provision · exact public law section
    (2) in subsection (n)(1), by adding at the end the following: “(C) For a drug that is a qualified countermeasure (as defined in section 319F–1 of the Public Health Service Act), a security countermeasure (as defined in section 319F–2 of the Public Health Service Act), or a qualified pandemic or epidemic product (as defined in section 319F–3 of such Act), 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.” .

55. 2016

    21st Century Cures Act

    Pub. L. 114–255 div. A title III § 3102(2) · 130 Stat. 1033

    Struck · 21 U.S.C. § 355a(p)

    Pub. L. 114–255 struck out subsec. (p) which related to Institute of Medicine study

    Source evidence

    Code amendment note
    Subsec. (p). Pub. L. 114–255 struck out subsec. (p) which related to Institute of Medicine study.

    Enacted provision · exact public law section
    (2) in section 505A (21 U.S.C. 355a), by striking subsection (p);

56. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 505(b)(2)(A) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 355a(b); 21 U.S.C. § 355a(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)

    Source evidence

    Code amendment note
    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).

    Enacted provision · exact public law section
    (A) Federal food, drug, and cosmetic act.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as amended by paragraph (1), is further amended by striking subsection “(d)(3)” each place it appears and inserting “(d)(4)”.

57. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 505(b)(1) · 131 Stat. 1005

    1. Added · 21 U.S.C. § 355a(d)(3)(6)

       Pub. L. 115–52, § 505(b)(1), added par. (3)

    2. Redesignated · 21 U.S.C. § 355a(d)(3)(6)

       Pub. L. 115–52, § 505(b)(1), redesignated former pars. (3) to (5) as (4) to (6), respectively

    Source evidence

    Code amendment note
    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.

    Enacted provision · exact public law section
    (1) In general.— Section 505A(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)) is amended— (A) by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively; and (B) by inserting after paragraph (2) the following: “(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.” .

58. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 505(b)(2)(A) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 355a(f)(3)

    Pub. L. 115–52, § 505(b)(2)(A), substituted “subsection (d)(4)” for “subsection (d)(3)”

    Source evidence

    Code amendment note
    Subsec. (f)(3). Pub. L. 115–52, § 505(b)(2)(A), substituted “subsection (d)(4)” for “subsection (d)(3)”.

    Enacted provision · exact public law section
    (A) Federal food, drug, and cosmetic act.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as amended by paragraph (1), is further amended by striking subsection “(d)(3)” each place it appears and inserting “(d)(4)”.

59. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 505(a) · 131 Stat. 1005

    Added · 21 U.S.C. § 355a(f)(7)

    Pub. L. 115–52, § 505(a), added par. (7)

    Source evidence

    Code amendment note
    Subsec. (f)(7). Pub. L. 115–52, § 505(a), added par. (7).

    Enacted provision · exact public law section
    (a) Informing Internal Review Committee.— Section 505A(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by adding at the end the following: “(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.” .

60. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 505(b)(2)(A) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 355a(h)

    Pub. L. 115–52, § 505(b)(2)(A), substituted “subsection (d)(4)” for “subsection (d)(3)”

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 115–52, § 505(b)(2)(A), substituted “subsection (d)(4)” for “subsection (d)(3)”.

    Enacted provision · exact public law section
    (A) Federal food, drug, and cosmetic act.— Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as amended by paragraph (1), is further amended by striking subsection “(d)(3)” each place it appears and inserting “(d)(4)”.

61. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 608(1) · 131 Stat. 1005

    Struck · 21 U.S.C. § 355a(o)

    Pub. L. 115–52, § 608(1), struck out “under section 355(j)” after “approval of drugs” in heading

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 115–52, § 608(1), struck out “under section 355(j)” after “approval of drugs” in heading.

    Enacted provision · exact public law section
    (1) in the subsection heading, by striking “under section 505(j)”;

62. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 608(2) · 131 Stat. 1005

    1. Substituted · 21 U.S.C. § 355a(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”

    2. Substituted · 21 U.S.C. § 355a(o)(1)

       Pub. L. 115–52, § 608(2), substituted “, 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” for “or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title”

    Source evidence

    Code amendment note
    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 section or section 355f of this title” for “or by exclusivity under clause (iii) or (iv) of section 355(j)(5)(F) of this title”.

    Enacted provision · exact public law section
    (2) in paragraph (1)— (A) by striking “under section 505(j)” and inserting “under subsection (b)(2) or (j) of section 505”; and (B) by striking “or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F)” and inserting “, or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), clause (iii) or (iv) of section 505(c)(3)(E), or section 527(a), or by an extension of such exclusivity under this section or section 505E”;

63. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 608(3) · 131 Stat. 1005

    1. Inserted · 21 U.S.C. § 355a(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,”

    2. Substituted · 21 U.S.C. § 355a(o)(2)

       Pub. L. 115–52, § 608(3), in introductory provisions, 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”

    Source evidence

    Code amendment note
    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”.

    Enacted provision · exact public law section
    (3) in paragraph (2), in the matter preceding subparagraph (A)— (A) by inserting “clauses (iii) and (iv) of section 505(c)(3)(E), or section 527,” after “section 505(j)(5)(F),”; and (B) by striking “drug approved under section 505(j)” and inserting “drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 505”; and

64. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 608(4) · 131 Stat. 1005

    Amended · 21 U.S.C. § 355a(o)(3)

    Pub. L. 115–52, § 608(4), amended par. (3) generally. Prior to amendment, text read as follows: “This subsection does not affect—

    Source evidence

    Code amendment note
    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 exclusivity 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.”

    Enacted provision · exact public law section
    (4) by amending paragraph (3) to read as follows: “(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 505 for pediatric formulations; or “(iii) section 527; “(B) the availability or scope of an extension to any such exclusivity, including an extension under this section or section 505E; “(C) the question of the eligibility for approval under section 505 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 505(j)(5)(F); “(ii) clause (iii) or (iv) of section 505(c)(3)(E); or “(iii) section 527(a); or “(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505 or section 527.” .

65. 2021

    Pub. L. 117–9 § 1(b)(2) · 135 Stat. 255

    Substituted · 21 U.S.C. § 355a(c)(1)(A)(i)(II)

    Pub. L. 117–9 substituted “(c)(3)(E)” for “(c)(3)(D)”

    Source evidence

    Code amendment note
    Subsec. (c)(1)(A)(i)(II). Pub. L. 117–9 substituted “(c)(3)(E)” for “(c)(3)(D)”.

    Enacted provision · exact public law section
    (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 355a(c)(1)(A)(i)(II)), by striking “(c)(3)(D)” and inserting “(c)(3)(E)”.

79 of 81 references resolved to an enrolled provision · 2 partial