PACT Act of 2019

II 116TH CONGRESS 1ST SESSION S. 3023 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 pharma- cological research, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 11, 2019 Ms. ERNST (for herself, Mr. COONS, Mrs. HYDE-SMITH, Mr. CASEY, Mr. WICKER, Mr. BENNET, and Mr. BROWN) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, 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-sci- entists, to support researchers focusing on pediatric re- search, including basic, clinical, translational, or pediatric pharmacological research, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 02:38 Dec 14, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3023.IS S3023 kjohnson on DSK79L0C42 with BILLS 2 •S 3023 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Pediatricians Accel- 2 erate Childhood Therapies Act of 2019’’ or the ‘‘PACT 3 Act of 2019’’. 4 SEC. 2. TRANS-NIH AWARDS FOR EARLY-CAREER PEDI- 5 ATRIC RESEARCHERS. 6 Part G of title IV of the Public Health Service Act 7 (42 U.S.C. 288 et seq.) is amended by adding at the end 8 the following new section: 9 ‘‘SEC. 489A. TRANS-NIH AWARDS FOR EARLY-CAREER PEDI- 10 ATRIC RESEARCHERS. 11 ‘‘(a) IN GENERAL.—The Director of the NIH shall 12 make awards to outstanding scientists, including physi- 13 cian-scientists, to support researchers focusing on pedi- 14 atric research, including basic, clinical, translational, or 15 pediatric pharmacological research. 16 ‘‘(b) PRIORITY RESEARCH TOPIC AREAS.—In car- 17 rying out subsection (a), the Director of NIH, in consulta- 18 tion with the Director of the Eunice Kennedy Shriver Na- 19 tional Institute of Child Health and Human Development 20 and the directors of other national research institutes and 21 national centers that participate within the Trans-NIH 22 Pediatric Research Consortium, shall— 23 ‘‘(1) establish priority research topic areas, in- 24 formed by external stakeholders, including research 25 VerDate Sep 11 2014 02:38 Dec 14, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3023.IS S3023 kjohnson on DSK79L0C42 with BILLS 3 •S 3023 IS institutions, research societies, patient organizations, 1 and industry; and 2 ‘‘(2) consider opportunities to align such pri- 3 ority pediatric research topic areas with current and 4 future priorities of the National Institutes of Health, 5 including— 6 ‘‘(A) childhood cancer; 7 ‘‘(B) precision medicine, genetics, and 8 genomics; 9 ‘‘(C) rare diseases and disorders, such as 10 sickle cell disease, and other diseases and dis- 11 orders with significant unmet training needs; 12 ‘‘(D) fetal, placental, and neonatal develop- 13 ment; and 14 ‘‘(E) child and adolescent mental health. 15 ‘‘(c) PRIORITY AWARDS.—In making awards under 16 this section, the Director of NIH shall— 17 ‘‘(1) give priority to researchers, including phy- 18 sician-scientists, who have a demonstrated pro- 19 ficiency in conducting pediatric research, but have 20 not yet achieved research independence at the time 21 of their application; and 22 ‘‘(2) give special consideration to researchers 23 from populations that are historically underrep- 24 resented in pediatric medical research. 25 VerDate Sep 11 2014 02:38 Dec 14, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3023.IS S3023 kjohnson on DSK79L0C42 with BILLS 4 •S 3023 IS ‘‘(d) REQUIREMENTS.—The Director of NIH— 1 ‘‘(1) shall require recipients of awards under 2 this section to use such awards to support pediatric 3 research activities, including costs associated with 4 laboratory staff and other costs associated with the 5 conduct of research; and 6 ‘‘(2) may allow recipients of awards under this 7 section to use such awards for costs associated with 8 receiving guidance and training from senior re- 9 searchers as necessary to help such recipients reach 10 a state of research independence, including con- 11 ferences and other meeting participation. 12 ‘‘(e) SUPPLEMENT, NOT SUPPLANT.—Awards made 13 under this section shall be used to supplement, and not 14 supplant, other funding for research career development 15 awards.’’. 16 SEC. 3. TRANS-NIH PEDIATRIC CONSORTIUM. 17 Title IV of the Public Health Service is amended by 18 inserting after section 409D (42 U.S.C. 284h) the fol- 19 lowing new section: 20 ‘‘SEC. 409D–1. TRANS-NIH PEDIATRIC CONSORTIUM. 21 ‘‘(a) ESTABLISHMENT.—The Director of NIH shall 22 establish and maintain a consortium to be known as the 23 Trans-NIH Pediatric Research Consortium (in this sec- 24 tions referred to as the ‘Consortium’) to coordinate pedi- 25 VerDate Sep 11 2014 02:38 Dec 14, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3023.IS S3023 kjohnson on DSK79L0C42 with BILLS 5 •S 3023 IS atric research programs across the National Institutes of 1 Health. 2 ‘‘(b) MEMBERSHIP.—The members of the Consor- 3 tium shall consist of representatives of multiple national 4 research institutes and national centers. 5 ‘‘(c) CHAIR.—The Chair of the Consortium shall be 6 the Director of the Eunice Kennedy Shriver National In- 7 stitute of Child Health and Human Development (or the 8 Director’s designee). 9 ‘‘(d) DUTIES.—In coordinating pediatric research 10 programs across the National Institutes of Health, the 11 Consortium shall— 12 ‘‘(1) establish pediatric research priorities; 13 ‘‘(2) identify gaps and opportunities for re- 14 search collaborations involving multiple national re- 15 search institutes and national centers; and 16 ‘‘(3) identify opportunities to develop the next 17 generation of pediatric researchers. 18 ‘‘(e) CONSULTATION.—The Consortium shall consult 19 regularly with external experts in the field of pediatric re- 20 search, including children’s hospitals, children’s research 21 institutions, patient organizations, and other stake- 22 holders.’’. 23 Æ VerDate Sep 11 2014 02:38 Dec 14, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S3023.IS S3023 kjohnson on DSK79L0C42 with BILLS