§ 284m. Program for 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. 1944

   Best Pharmaceuticals for Children Act

   Pub. L. 107–109 § 3(3) · 115 Stat. 1408

   Enacted · 42 U.S.C. § 284m

   July 1, 1944, ch. 373, title IV, § 409I, as added Pub. L. 107–109, § 3(3), Jan. 4, 2002, 115 Stat. 1408

   Source evidence

   Code source credit
   July 1, 1944, ch. 373, title IV, § 409I, as added Pub. L. 107–109, § 3(3), Jan. 4, 2002, 115 Stat. 1408

   Enacted provision · exact public law section
   (3) by adding at the end the following: “SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. “(a) List of Drugs for Which Pediatric Studies Are Needed.— “(1) In general.— Not later than one year after the date of enactment of this section, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop, prioritize, and publish an annual list of approved drugs for which— “(A) (i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)); “(ii) there is a submitted application that could be approved under the criteria of section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)); “(iii) there is no patent protection or market exclusivity protection under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or “(iv) there is a referral for inclusion on the list under section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(C)); and “(B) in the case of a drug referred to in clause (i), (ii), or (iii) of subparagraph (A), additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population. “(2) Consideration of available information.— In developing and prioritizing the list under paragraph (1), the Secretary shall consider, for each drug on the list— “(A) the availability of information concerning the safe and effective use of the drug in the pediatric population; “(B) whether additional information is needed; “(C) whether new pediatric studies concerning the drug may produce health benefits in the pediatric population; and “(D) whether reformulation of the drug is necessary. “(b) Contracts for Pediatric Studies.— The Secretary shall award contracts to entities that have the expertise to conduct pediatric clinical trials (including qualified universities, hospitals, laboratories, contract research organizations, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct pediatric studies concerning one or more drugs identified in the list described in subsection (a). “(c) Process for Contracts and Labeling Changes.— “(1) Written request to holders of approved applications for drugs lacking exclusivity.— The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified in the list described in subsection (a)(1)(A) (except clause (iv)) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (a) or (b) of section 505A of the Federal Food, Drug, and Cosmetic Act, including with respect to information provided on the pediatric studies to be conducted pursuant to the request. “(2) Requests for contract proposals.— If the Commissioner Deadline. of Food and Drugs does not receive a response to a written request issued under paragraph (1) within 30 days of the date on which a request was issued, or if a referral described in subsection (a)(1)(A)(iv) is made, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for contract proposals to conduct the pediatric studies described in the written request. “(3) Disqualification.— A holder that receives a first right of refusal shall not be entitled to respond to a request for contract proposals under paragraph (2). “(4) Guidance.— Not later than 270 days after the date Deadline. of enactment of this section, the Commissioner of Food and Drugs shall promulgate guidance to establish the process for the submission of responses to written requests under paragraph (1). “(5) Contracts.— A contract under this section may be awarded only if a proposal for the contract is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. “(6) Reporting of studies.— “(A) In general.— On completion of a pediatric study in accordance with a contract awarded under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study. “(B) Availability of reports.— Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)(4)(D)) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs. “(C) Action by commissioner.— The Commissioner of Food and Drugs shall take appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7). “(7) Requests for labeling change.— During the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall— “(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied; “(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and “(C) (i) place in the public docket file a copy of the report and of any requested labeling changes; and “(ii) publish in the Federal Register a summary of the report and a copy of any requested labeling changes. “(8) Dispute resolution.— “(A) Referral to pediatric advisory subcommittee of the anti-infective drugs advisory committee.— If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request 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 under subparagraph (A), the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee shall— “(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and “(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any. “(9) FDA determination.— Not later than 30 days after Deadline. receiving a recommendation from the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate. “(10) Failure to agree.— If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). “(11) No effect on authority.— Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic 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. “(12) Recommendation for formulation changes.— If a pediatric study completed under public contract indicates that a formulation change is necessary and the Secretary agrees, the Secretary shall send a nonbinding letter of recommendation regarding that change to each holder of an approved application. “(d) Authorization of Appropriations.— “(1) In general.— There are authorized to be appropriated to carry out this section— “(A) $200,000,000 for fiscal year 2002; and “(B) such sums as are necessary for each of the five succeeding fiscal years. “(2) Availability.— Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.”.

2. 2003

   Pediatric Research Equity Act of 2003

   Pub. L. 108–155 § 3(b)(6) · 117 Stat. 1936

   Struck · 42 U.S.C. § 284m(c)(8); 42 U.S.C. § 284m(c)(9); 42 U.S.C. § 284m(c)(11)

   Pub. L. 108–155 struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing

   Source evidence

   Code amendment note
   Subsec. (c)(8), (9), (11). Pub. L. 108–155 struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing.

   Enacted provision · exact public law section
   (6) Paragraphs (8), (9), and (11) of section 409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) are amended by striking “Advisory Subcommittee of the Anti-Infective Drugs” each place it appears.

3. 2007

   National Institutes of Health Reform Act of 2006

   Pub. L. 109–482 title I § 103(b)(14) · 120 Stat. 3675

   Struck · 42 U.S.C. § 284m(d)

   Pub. L. 109–482 struck out subsec. (d) which related to authorization and availability of appropriations

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 109–482 struck out subsec. (d) which related to authorization and availability of appropriations.

   Enacted provision · exact public law section
   (14) by striking subsection (d) of section 42 USC 284m. 409I;

   Effective date note
   Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

4. 2007

   Best Pharmaceuticals for Children Act of 2007

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

   Amended · 42 U.S.C. § 284m

   Pub. L. 110–85 amended section generally. Prior to amendment, section related to development of list of drugs for which pediatric studies are needed, award of contracts for pediatric studies, process for requesting contract proposals to conduct certain pediatric studies, reporting of completed studies, requests for labeling changes and dispute resolution, and recommendation by the Secretary for formulation changes

   Source evidence

   Code amendment note
   Pub. L. 110–85 amended section generally. Prior to amendment, section related to development of list of drugs for which pediatric studies are needed, award of contracts for pediatric studies, process for requesting contract proposals to conduct certain pediatric studies, reporting of completed studies, requests for labeling changes and dispute resolution, and recommendation by the Secretary for formulation changes.

   Enacted provision · exact public law section
   (b) Program for Pediatric Studies of Drugs.— Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended to read as follows: “SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. “(a) List of Priority Issues in Pediatric Therapeutics.— “(1) In general.— Not Deadline. Publication. later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications that require study. The list shall be revised every three years. “(2) Consideration of available information.— In developing and prioritizing the list under paragraph (1), the Secretary shall consider— “(A) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; “(B) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and “(C) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators. “(b) Pediatric Studies and Research.— The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection. “(c) Process for Proposed Pediatric Study Requests and Labeling Changes.— “(1) Submission of proposed pediatric study request.— The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which— “(A) (i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act; or “(ii) there is a submitted application that could be approved under the criteria of such section; and “(B) there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and “(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population. “(2) Written request to holders of approved applications for drugs lacking exclusivity.— The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) of section 505A of such Act, including with respect to information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested. “(3) Requests for proposals.— If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b). “(4) Disqualification.— A holder that receives a first right of refusal shall not be entitled to respond to a request for proposals under paragraph (3). “(5) Contracts, grants, or other funding mechanisms.— A contract, grant, or other funding may be awarded under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. “(6) Reporting of studies.— “(A) In general.— On completion of a pediatric study in accordance with an award under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study, including a written request if issued. “(B) Availability of reports.— Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs. “(C) Action by commissioner.— The Commissioner of Food and Drugs shall take appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7). “(7) Requests for labeling change.— During the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall— “(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied; “(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and “(C) (i) place in the public docket file a copy of the report and of any requested labeling changes; and “(ii) Federal Register, publication. Web site. publish in the Federal Register and through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes. “(8) Dispute resolution.— “(A) Referral to pediatric advisory committee.— If, not later than the Deadline. end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request 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), the Pediatric Advisory Committee shall— “(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and “(ii) Recommenda- tions. make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any. “(9) FDA determination.— Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate. “(10) Failure to agree.— If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act. “(11) No effect on authority.— Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic 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. “(d) Dissemination of Pediatric Information.— Not later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress. “(e) Authorization of Appropriations.— “(1) In general.— There are authorized to be appropriated to carry out this section— “(A) $200,000,000 for fiscal year 2008; and “(B) such sums as are necessary for each of the four succeeding fiscal years. “(2) Availability.— Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.” .

5. 2010

   Biologics Price Competition and Innovation Act of 2009

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

   Inserted · 42 U.S.C. § 284m(a)(1)

   Pub. L. 111–148 inserted “, biological products,” after “including drugs”

   Source evidence

   Code amendment note
   Subsec. (a)(1). Pub. L. 111–148 inserted “, biological products,” after “including drugs”.

   Enacted provision · exact public law section
   (A) Program for pediatric study of drugs.— Subsection (a)(1) of section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended by inserting “, biological products,” after “including drugs”.

6. 2012

   Food and Drug Administration Safety and Innovation Act

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

   Inserted · 42 U.S.C. § 284m(c)(1)

   Pub. L. 112–144, § 509(d)(1)(A), inserted “or section 262(m) of this title,” after “Cosmetic Act,”

   Source evidence

   Code amendment note
   Subsec. (c)(1). Pub. L. 112–144, § 509(d)(1)(A), inserted “or section 262(m) of this title,” after “Cosmetic Act,”.

   Enacted provision · exact public law section
   (A) in the matter preceding subparagraph (A), by inserting “or section 351(m) of this Act,” after “Cosmetic Act,”;

7. 2012

   Food and Drug Administration Safety and Innovation Act

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

   Inserted · 42 U.S.C. § 284m(c)(1)(A)(i)

   Pub. L. 112–144, § 509(d)(1)(B), inserted “or section 262(k) of this title” after “Cosmetic Act”

   Source evidence

   Code amendment note
   Subsec. (c)(1)(A)(i). Pub. L. 112–144, § 509(d)(1)(B), inserted “or section 262(k) of this title” after “Cosmetic Act”.

   Enacted provision · exact public law section
   (B) in subparagraph (A)(i), by inserting “or section 351(k) of this Act” after “Cosmetic Act”; and

8. 2012

   Food and Drug Administration Safety and Innovation Act

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

   Amended · 42 U.S.C. § 284m(c)(1)(B)

   Pub. L. 112–144, § 509(d)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and”

   Source evidence

   Code amendment note
   Subsec. (c)(1)(B). Pub. L. 112–144, § 509(d)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act; and”.

   Enacted provision · exact public law section
   (C) by amending subparagraph (B) to read as follows: “(B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act, or applicable twelve-year period referred to in section 351(k)(7) of this Act, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act has ended for at least one form of the drug; and” ; and

9. 2012

   Food and Drug Administration Safety and Innovation Act

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

   1. Struck · 42 U.S.C. § 284m(c)(2)

      Pub. L. 112–144, § 509(d)(2), struck out “for drugs lacking exclusivity” after “applications” in heading, and in text struck out “under section 505 of the Federal Food, Drug, and Cosmetic Act” after “for the drug”

   2. Substituted · 42 U.S.C. § 284m(c)(2)

      Pub. L. 112–144, § 509(d)(2), substituted “505A of the Federal Food, Drug, and Cosmetic Act or section 262(m) of this title” for “505A of such Act”

   Source evidence

   Code amendment note
   Subsec. (c)(2). Pub. L. 112–144, § 509(d)(2), struck out “for drugs lacking exclusivity” after “applications” in heading, and in text struck out “under section 505 of the Federal Food, Drug, and Cosmetic Act” after “for the drug” and substituted “505A of the Federal Food, Drug, and Cosmetic Act or section 262(m) of this title” for “505A of such Act”.

   Enacted provision · exact public law section
   (2) in paragraph (2)— (A) in the paragraph heading, by striking “for drugs lacking exclusivity”; (B) by striking “under section 505 of the Federal Food, Drug, and Cosmetic Act”; and (C) by striking “505A of such Act” and inserting “505A of the Federal Food, Drug, and Cosmetic Act or section 351(m) of this Act”.

10. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 507(d) · 126 Stat. 993

    Substituted · 42 U.S.C. § 284m(e)(1)

    Pub. L. 112–144, § 507(d), substituted “to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017.” for “to carry out this section—

    Source evidence

    Code amendment note
    Subsec. (e)(1). Pub. L. 112–144, § 507(d), substituted “to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017.” for “to carry out this section—

    “(A) $200,000,000 for fiscal year 2008; and “(B) such sums as are necessary for each of the four succeeding fiscal years.”

    Enacted provision · exact public law section
    (d) Program for Pediatric Study of Drugs in PHSA.— Section 409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is amended by striking “to carry out this section” and all that follows through the end of paragraph (1) and inserting “to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017.”.

11. 2013

    Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

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

    1. Added · 42 U.S.C. § 284m(a)(2)

       Pub. L. 113–5, § 307(b)(1), added par. (2)

    2. Struck · 42 U.S.C. § 284m(a)(2)

       Pub. L. 113–5, § 307(b)(1), struck out former par. (2). Prior to amendment, text read as follows: “In developing and prioritizing the list under paragraph (1), the Secretary shall consider—

    Source evidence

    Code amendment note
    Subsec. (a)(2). Pub. L. 113–5, § 307(b)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: “In developing and prioritizing the list under paragraph (1), the Secretary shall consider—

    “(A) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; “(B) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and “(C) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators.”

    Enacted provision · exact public law section
    (1) by striking subsection (a)(2) and inserting the following: “(2) Consideration of available information.— In developing and prioritizing the list under paragraph (1), the Secretary— “(A) shall consider— “(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; “(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and “(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and “(B) may consider the availability of qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), and qualified pandemic or epidemic products (as defined in section 319F–3) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.” ; and

12. 2013

    Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

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

    Substituted · 42 U.S.C. § 284m(b)

    Pub. L. 113–5, § 307(b)(2), substituted “paragraphs (1) and (2)(A) of subsection (a)” for “subsection (a)”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 113–5, § 307(b)(2), substituted “paragraphs (1) and (2)(A) of subsection (a)” for “subsection (a)”.

    Enacted provision · exact public law section
    (2) in subsection (b), by striking “subsection (a)” and inserting “paragraphs (1) and (2)(A) of subsection (a)”.

13. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(1) · 131 Stat. 1005

    Inserted · 42 U.S.C. § 284m(a)(2)(A)(ii)

    Pub. L. 115–52, § 501(1), inserted “and identification of biomarkers for such diseases, disorders, or conditions,” after “biologics,”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(ii). Pub. L. 115–52, § 501(1), inserted “and identification of biomarkers for such diseases, disorders, or conditions,” after “biologics,”.

    Enacted provision · exact public law section
    (1) in subsection (a)(2)(A)(ii), by inserting “and identification of biomarkers for such diseases, disorders, or conditions,” after “biologics,”;

14. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(2)(A)(i) · 131 Stat. 1005

    Amended · 42 U.S.C. § 284m(c)(6)(B)

    Pub. L. 115–52, § 501(2)(A)(i), amended subpar. (B) generally. Prior to amendment, text read as follows: “Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs.”

    Source evidence

    Code amendment note
    Subsec. (c)(6)(B). Pub. L. 115–52, § 501(2)(A)(i), amended subpar. (B) generally. Prior to amendment, text read as follows: “Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs.”

    Enacted provision · exact public law section
    (i) by amending subparagraph (B) to read as follows: “(B) Availability of reports.— “(i) In general.— Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and not later than 90 days after submission of such report, shall be— “(I) posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of— “(aa) human research participants, including with respect to privacy, security, informed consent, and protected health information; and “(bb) proprietary interests, confidential commercial information, and intellectual property rights; and “(II) assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments. “(ii) Submission of comments.— An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.” ; and

15. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(2)(A)(ii) · 131 Stat. 1005

    Substituted · 42 U.S.C. § 284m(c)(6)(C)

    Pub. L. 115–52, § 501(2)(A)(ii), substituted “action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).” for “appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7).”

    Source evidence

    Code amendment note
    Subsec. (c)(6)(C). Pub. L. 115–52, § 501(2)(A)(ii), substituted “action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).” for “appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7).”

    Enacted provision · exact public law section
    (ii) in subparagraph (C), by striking “appropriate action” and all that follows through the period and inserting “action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).”; and

16. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(2)(B)(i) · 131 Stat. 1005

    Substituted · 42 U.S.C. § 284m(c)(7)

    Pub. L. 115–52, § 501(2)(B)(i), substituted “Within” for “During” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (c)(7). Pub. L. 115–52, § 501(2)(B)(i), substituted “Within” for “During” in introductory provisions.

    Enacted provision · exact public law section
    (i) in the matter preceding subparagraph (A), by striking “During” and inserting “Within”;

17. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(2)(B)(ii) · 131 Stat. 1005

    Substituted · 42 U.S.C. § 284m(c)(7)(C)(i)

    Pub. L. 115–52, § 501(2)(B)(ii), substituted “include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of” for “place in the public docket file a copy of the report and of”

    Source evidence

    Code amendment note
    Subsec. (c)(7)(C)(i). Pub. L. 115–52, § 501(2)(B)(ii), substituted “include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of” for “place in the public docket file a copy of the report and of”.

    Enacted provision · exact public law section
    (ii) in subparagraph (C)(i), by striking “place” and all that follows through “and of” and inserting “include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of”; and

18. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(2)(B)(iii) · 131 Stat. 1005

    Struck · 42 U.S.C. § 284m(c)(7)(C)(ii)

    Pub. L. 115–52, § 501(2)(B)(iii), struck out “in the Federal Register and” after “publish”

    Source evidence

    Code amendment note
    Subsec. (c)(7)(C)(ii). Pub. L. 115–52, § 501(2)(B)(iii), struck out “in the Federal Register and” after “publish”.

    Enacted provision · exact public law section
    (iii) in clause (ii), by striking “in the Federal Register and”;

19. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(3) · 131 Stat. 1005

    1. Redesignated · 42 U.S.C. § 284m(d)

       Pub. L. 115–52, § 501(3), (4), redesignated subsec. (e) as (d)

    2. Struck · 42 U.S.C. § 284m(d)

       Pub. L. 115–52, § 501(3), (4), struck out former subsec. (d). Prior to amendment, text of subsec. (d) read as follows: “Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress.”

    Source evidence

    Code amendment note
    Subsec. (d). Pub. L. 115–52, § 501(3), (4), redesignated subsec. (e) as (d) and struck out former subsec. (d). Prior to amendment, text of subsec. (d) read as follows: “Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress.”

    Enacted provision · exact public law section
    (3) by striking subsection (d);

20. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(5) · 131 Stat. 1005

    Substituted · 42 U.S.C. § 284m(d)(1)

    Pub. L. 115–52, § 501(5), substituted “2018 through 2022” for “2013 through 2017”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 115–52, § 501(5), substituted “2018 through 2022” for “2013 through 2017”.

    Enacted provision · exact public law section
    (5) in paragraph (1) of subsection (d), as so redesignated, by striking “2013 through 2017” and inserting “2018 through 2022”.

21. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 501(4) · 131 Stat. 1005

    Redesignated · 42 U.S.C. § 284m(e)

    Pub. L. 115–52, § 501(4), redesignated subsec. (e) as (d)

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 115–52, § 501(4), redesignated subsec. (e) as (d).

    Enacted provision · exact public law section
    (4) by redesignating subsection (e) as subsection (d); and

22. 2022

    FDA User Fee Reauthorization Act of 2022

    Pub. L. 117–180 div. F title V § 5001 · 136 Stat. 2114

    Substituted · 42 U.S.C. § 284m(d)(1)

    Pub. L. 117–180 substituted “$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022” for “$25,000,000 for each of fiscal years 2018 through 2022”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–180 substituted “$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022” for “$25,000,000 for each of fiscal years 2018 through 2022”.

    Enacted provision · exact public law section
    SEC. 5001. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR CHILDREN PROGRAM.   Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “$25,000,000 for each of fiscal years 2018 through 2022” and inserting “$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022”.

23. 2022

    Further Continuing Appropriations and Extensions Act, 2023

    Pub. L. 117–229 div. C title III § 302 · 136 Stat. 2308

    Substituted · 42 U.S.C. § 284m(d)(1)

    Pub. L. 117–229 substituted “$5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022” for “$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–229 substituted “$5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022” for “$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022”.

    Enacted provision · exact public law section
    SEC. 302. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR CHILDREN PROGRAM.   Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “$5,273,973 for the period beginning on October 1, 2022 and ending on December 16, 2022” and inserting “$5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022”.

24. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 div. FF title III § 3102 · 136 Stat. 4459

    Substituted · 42 U.S.C. § 284m(d)(1)

    Pub. L. 117–328, which directed the substitution of “$25,000,000 for each of fiscal years 2023 through 2027” for “$5,273,973 for the period beginning on October 1, 2022 and ending on December 23, 2022”, could not be executed because “$5,273,973” did not appear after the intervening amendment by Pub. L. 117–229. See below

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 117–328, which directed the substitution of “$25,000,000 for each of fiscal years 2023 through 2027” for “$5,273,973 for the period beginning on October 1, 2022 and ending on December 23, 2022”, could not be executed because “$5,273,973” did not appear after the intervening amendment by Pub. L. 117–229. See below.

    Enacted provision · exact public law section
    SEC. 3102. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR CHILDREN PROGRAM.   Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 284m(d)(1)) is amended by striking “$5,273,973 for the period beginning on October 1, 2022 and ending on December 23, 2022” and inserting “$25,000,000 for each of fiscal years 2023 through 2027”.

25. 2026

    Pub. L. 119–75 div. J title V § 6504 · 140 Stat. 692

    Substituted · 42 U.S.C. § 284m(d)(1)

    Pub. L. 119–75 substituted “section, $25,000,000 for each of fiscal years 2026 through 2028.” for “section, $5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022.”

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 119–75 substituted “section, $25,000,000 for each of fiscal years 2026 through 2028.” for “section, $5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022.”

27 of 28 references resolved to an enrolled provision · 1 unresolved