§ 284h. Pediatric Research Initiative

Footnotes

1. 1 So in original. The word “and” probably should appear at end of subcl. (III).

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

   Children’s Health Act of 2000

   Pub. L. 106–310 div. A title X § 1001 · 114 Stat. 1101

   Enacted · 42 U.S.C. § 284h

   July 1, 1944, ch. 373, title IV, § 409D, as added Pub. L. 106–310, div. A, title X, § 1001, Oct. 17, 2000, 114 Stat. 1127

   Source evidence

   Code source credit
   July 1, 1944, ch. 373, title IV, § 409D, as added Pub. L. 106–310, div. A, title X, § 1001, Oct. 17, 2000, 114 Stat. 1127

   Enacted provision · exact public law section
   SEC. 1001. ESTABLISHMENT OF PEDIATRIC RESEARCH INITIATIVE. Part B of title IV of the Public Health Service Act, as amended by section 101 of this Act, is amended by adding at the end the following: “Sec. 409D. “pediatric research initiative (a) Establishment.— The Secretary shall establish within the Office of the Director of NIH a Pediatric Research Initiative (referred to in this section as the ‘Initiative’) to conduct and support research that is directly related to diseases, disorders, and other conditions in children. The Initiative shall be headed by the Director of NIH. “(b) Purpose.— The purpose of the Initiative is to provide funds to enable the Director of NIH— “(1) to increase support for pediatric biomedical research within the National Institutes of Health to realize the expanding opportunities for advancement in scientific investigations and care for children; “(2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in the areas that the Director deems most promising; and “(3) in coordination with the Food and Drug Administration, to increase the development of adequate pediatric clinical trials and pediatric use information to promote the safer and more effective use of prescription drugs in the pediatric population. “(c) Duties.— In carrying out subsection (b), the Director of NIH shall— “(1) consult with the Director of the National Institute of Child Health and Human Development and the other national research institutes, in considering their requests for new or expanded pediatric research efforts, and consult with the Administrator of the Health Resources and Services Administration and other advisors as the Director determines to be appropriate; “(2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of grants, and between basic and clinical research so long as the assistance is directly related to the illnesses and conditions of children; and “(3) be responsible for the oversight of any newly appropriated Initiative funds and annually report to Congress and the public on the extent of the total funds obligated to conductor support pediatric research across the National Institutes of Health, including the specific support and research awards allocated through the Initiative. “(d) Authorization.— For the purpose of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 through 2005. “(e) Transfer of Funds.— The Director of NIH may transfer amounts appropriated under this section to any of the Institutes for a fiscal year to carry out the purposes of the Initiative under this section.”.

2. 2007

   National Institutes of Health Reform Act of 2006

   Pub. L. 109–482 title I § 103(b)(10) · 120 Stat. 3675

   1. Redesignated · 42 U.S.C. § 284h(d); 42 U.S.C. § 284h(e)

      Pub. L. 109–482 redesignated subsec. (e) as (d)

   2. Struck · 42 U.S.C. § 284h(d); 42 U.S.C. § 284h(e)

      Pub. L. 109–482 struck out heading and text of former subsec. (d). Text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 through 2005.”

   Source evidence

   Code amendment note
   Subsecs. (d), (e). Pub. L. 109–482 redesignated subsec. (e) as (d) and struck out heading and text of former subsec. (d). Text read as follows: “For the purpose of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 through 2005.”

   Enacted provision · exact public law section
   (10) in section 42 USC 284h. 409D— (A) by striking subsection (d); and (B) by redesignating subsection (e) as subsection (d);

   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.

3. 2007

   Pub. L. 110–154 § 1(b)(4) · 121 Stat. 1826

   Substituted · 42 U.S.C. § 284h(c)(1)

   Pub. L. 110–154 substituted “Eunice Kennedy Shriver National Institute of Child Health and Human Development” for “National Institute of Child Health and Human Development”

   Source evidence

   Code amendment note
   Subsec. (c)(1). Pub. L. 110–154 substituted “Eunice Kennedy Shriver National Institute of Child Health and Human Development” for “National Institute of Child Health and Human Development”.

   Enacted provision · exact public law section
   (4) in section 409D(c)(1) (42 U.S.C. 284h(c)(1)), by striking “National Institute of Child Health and Human Development” and inserting “Eunice Kennedy Shriver National Institute of Child Health and Human Development”;

4. 2013

   National Pediatric Research Network Act of 2013

   Pub. L. 113–55 title II § 202 · 127 Stat. 641

   1. Added · 42 U.S.C. § 284h(d)(f)

      Pub. L. 113–55 added subsecs. (d) and (e)

   2. Redesignated · 42 U.S.C. § 284h(d)(f)

      Pub. L. 113–55 redesignated former subsec. (d) as (f)

   Source evidence

   Code amendment note
   Subsecs. (d) to (f). Pub. L. 113–55 added subsecs. (d) and (e) and redesignated former subsec. (d) as (f).

   Enacted provision · exact public law section
   SEC. 202. NATIONAL PEDIATRIC RESEARCH NETWORK.   Section 409D of the Public Health Service Act (42 U.S.C. 284h; relating to the Pediatric Research Initiative) is amended— (1) by redesignating subsection (d) as subsection (f); and (2) by inserting after subsection (c) the following: “(d) National Pediatric Research Network.— “(1) Network.— In carrying out the Initiative, the Director of NIH, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate— “(A) the pediatric research consortia receiving awards under paragraph (2); or “(B) other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this Act. “(2) Pediatric research consortia.— “(A) In general.— The Director of NIH may award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to— “(i) basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and “(ii) training researchers in pediatric research techniques in order to address unmet pediatric research needs. “(B) Research.— The Director of NIH shall, as appropriate, ensure that— “(i) each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and “(ii) one or more such consortia provide training described in subparagraph (A)(ii). “(C) Organization of consortium.— Each consortium receiving an award under subparagraph (A) shall— “(i) be formed from a collaboration of cooperating institutions; “(ii) be coordinated by a lead institution or institutions; “(iii) agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to— “(I) other consortia; “(II) the National Institutes of Health; “(III) the Food and Drug Administration; “(IV) and other relevant agencies; and “(iv) meet such requirements as may be prescribed by the Director of NIH. “(D) Supplement, not supplant.— Any support received by a consortium under subparagraph (A) shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph. “(E) Duration of support.— Support of a consortium under subparagraph (A) may be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH. “(3) Coordination of consortia activities.— The Director of NIH shall, as appropriate— “(A) provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and “(B) require the periodic preparation and submission to the Director of reports on the activities of each such consortium. “(4) Assistance with registries.— Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention. “(e) Research on Pediatric Rare Diseases or Conditions.— In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to— “(1) consider pediatric rare diseases or conditions, or those related to birth defects; and “(2) conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions.” .

5. 2016

   21st Century Cures Act

   Pub. L. 114–255 § 2071(1) · 130 Stat. 1033

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

   Pub. L. 114–255, § 2071(1), substituted “in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support” for “in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of” in introductory provisions

   Source evidence

   Code amendment note
   Subsec. (d)(1). Pub. L. 114–255, § 2071(1), substituted “in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support” for “in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of” in introductory provisions.

   Enacted provision · exact public law section
   (1) in paragraph (1), by striking “in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of” and inserting “in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support”; and

6. 2016

   21st Century Cures Act

   Pub. L. 114–255 § 2071(2) · 130 Stat. 1033

   Substituted · 42 U.S.C. § 284h(d)(2)(A); 42 U.S.C. § 284h(d)(2)(E)

   Pub. L. 114–255, § 2071(2), substituted “shall” for “may” in introductory provisions of par. (2)(A) and in first sentence of par. (2)(E)

   Source evidence

   Code amendment note
   Subsec. (d)(2)(A), (E). Pub. L. 114–255, § 2071(2), substituted “shall” for “may” in introductory provisions of par. (2)(A) and in first sentence of par. (2)(E).

   Enacted provision · exact public law section
   (2) in paragraph (2)(A) and the first sentence of paragraph (2)(E), by striking “may” each place such term appears and inserting “shall”.

8 of 8 references resolved to an enrolled provision