II 117th CONGRESS 1st Session S. 1357 IN THE SENATE OF THE UNITED STATES April 22, 2021 Ms. Ernst (for herself, Mr. Coons , Mr. Casey , Mrs. Hyde-Smith , Mr. Wicker , and Mr. Bennet ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to authorize the Director of the National Institutes of Health to make awards to outstanding scientists, including physician-scientists, to support researchers focusing on pediatric research, including basic, clinical, translational, or pediatric pharmacological research, and for other purposes.

1. Short title This Act may be cited as the Pediatricians Accelerate Childhood Therapies Act of 2021 or the PACT Act of 2021 . 2. Trans-NIH Awards for Early-Career Pediatric Researchers Part G of title IV of the Public Health Service Act ( 42 U.S.C. 288 et seq.) is amended by adding at the end the following new section: 489A. Trans-NIH Awards for Early-Career Pediatric Researchers (a) In general The Director of the NIH shall make awards to outstanding scientists, including physician-scientists, to support early-career researchers focusing on pediatric research, including basic, clinical, translational, or pediatric pharmacological research. (b) Priority research populations In carrying out subsection (a), the Director of NIH may prioritize the issuance of awards to applicants who— (1) are individual researchers presenting qualifying applications and representing populations that have been historically underrepresented in pediatric medical research, including women and underrepresented racial minorities; or (2) are institutions of higher education that are eligible to receive funds under part A or B of title III of the Higher Education Act of 1965, part A or B of title V of such Act, or subpart 4 of part A of title VII of such Act, or research institutions partnering with such institutions of higher education to offer programs to support early-career pediatric researchers. (c) Priority research topic areas In carrying out subsection (a), the Director of NIH, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the directors of other national research institutes and national centers that participate within the Trans-NIH Pediatric Research Consortium, shall— (1) establish priority research topic areas, informed by external stakeholders, including research institutions, research societies, patient organizations, and industry; and (2) consider opportunities to align such priority pediatric research topic areas with current and future priorities of the National Institutes of Health, including— (A) pediatric and adolescent mental and behavioral health, including addiction medicine; (B) childhood cancer; (C) precision medicine, genetics, and genomics; (D) rare diseases and disorders, such as sickle cell disease, and other diseases and disorders with significant unmet training needs; and (E) fetal, placental, and neonatal development. (d) Requirements The Director of NIH— (1) shall require recipients of awards under this section to use such awards to support pediatric research activities, including costs associated with laboratory staff and other costs associated with the conduct of research; and (2) may allow recipients of awards under this section to use such awards for costs associated with receiving guidance and training from senior researchers and mentors, as necessary to help such recipients reach a state of research independence, including conferences and other meeting participation. (e) Supplement, not supplant Awards made under this section shall be used to supplement, and not supplant, other funding for pediatric research and career development awards. . 3. Trans-NIH Pediatric Consortium Title IV of the Public Health Service is amended by inserting after section 409D ( 42 U.S.C. 284h ) the following new section: 409D–1. Trans-NIH Pediatric Consortium (a) Establishment The Director of NIH shall establish and maintain a consortium to be known as the Trans-NIH Pediatric Research Consortium (in this sections referred to as the Consortium ) to coordinate pediatric research programs across the National Institutes of Health. (b) Membership The members of the Consortium shall consist of representatives of multiple national research institutes and national centers. (c) Chair The Chair of the Consortium shall be the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (or the Director’s designee). (d) Duties In coordinating pediatric research programs across the National Institutes of Health, the Consortium shall— (1) establish pediatric research priorities; (2) identify gaps and opportunities for research collaborations involving multiple national research institutes and national centers; and (3) identify opportunities to develop the next generation of pediatric researchers. (e) Consultation The Consortium shall consult regularly with external experts in the field of pediatric research, including children’s hospitals, children’s research institutions, patient organizations, and other stakeholders. (f) Reporting Beginning one year after the date of enactment of the Pediatricians Accelerate Childhood Therapies Act of 2021 and every 2 years thereafter, the Consortium shall submit to Congress, and make publicly available on the website of the National Institutes of Health, a report on— (1) any research project involving pediatrics and involving more than one Institute or Center that was supported during the review period; (2) any strategic initiatives that include a significant pediatric component; (3) career development awards for early-career researchers focused in pediatrics, including specific numbers of awards and amount of funding, made during the review period; (4) details on the composition of awards for early-career researchers, including demographic details indicating the proportion of recipients from populations that have been underrepresented in pediatric medical research; and (5) such other information as the Director of NIH determines appropriate. .