PACT Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1357 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 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-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 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1357 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Pediatricians Accel- 2 erate Childhood Therapies Act of 2021’’ or the ‘‘PACT 3 Act of 2021’’. 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 early-career researchers focus- 14 ing on pediatric research, including basic, clinical, 15 translational, or pediatric pharmacological research. 16 ‘‘(b) PRIORITY RESEARCH POPULATIONS.—In car- 17 rying out subsection (a), the Director of NIH may 18 prioritize the issuance of awards to applicants who— 19 ‘‘(1) are individual researchers presenting quali- 20 fying applications and representing populations that 21 have been historically underrepresented in pediatric 22 medical research, including women and underrep- 23 resented racial minorities; or 24 ‘‘(2) are institutions of higher education that 25 are eligible to receive funds under part A or B of 26 VerDate Sep 11 2014 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1357 IS title III of the Higher Education Act of 1965, part 1 A or B of title V of such Act, or subpart 4 of part 2 A of title VII of such Act, or research institutions 3 partnering with such institutions of higher education 4 to offer programs to support early-career pediatric 5 researchers. 6 ‘‘(c) PRIORITY RESEARCH TOPIC AREAS.—In car- 7 rying out subsection (a), the Director of NIH, in consulta- 8 tion with the Director of the Eunice Kennedy Shriver Na- 9 tional Institute of Child Health and Human Development 10 and the directors of other national research institutes and 11 national centers that participate within the Trans-NIH 12 Pediatric Research Consortium, shall— 13 ‘‘(1) establish priority research topic areas, in- 14 formed by external stakeholders, including research 15 institutions, research societies, patient organizations, 16 and industry; and 17 ‘‘(2) consider opportunities to align such pri- 18 ority pediatric research topic areas with current and 19 future priorities of the National Institutes of Health, 20 including— 21 ‘‘(A) pediatric and adolescent mental and 22 behavioral health, including addiction medicine; 23 ‘‘(B) childhood cancer; 24 VerDate Sep 11 2014 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1357 IS ‘‘(C) precision medicine, genetics, and 1 genomics; 2 ‘‘(D) rare diseases and disorders, such as 3 sickle cell disease, and other diseases and dis- 4 orders with significant unmet training needs; 5 and 6 ‘‘(E) fetal, placental, and neonatal develop- 7 ment. 8 ‘‘(d) REQUIREMENTS.—The Director of NIH— 9 ‘‘(1) shall require recipients of awards under 10 this section to use such awards to support pediatric 11 research activities, including costs associated with 12 laboratory staff and other costs associated with the 13 conduct of research; and 14 ‘‘(2) may allow recipients of awards under this 15 section to use such awards for costs associated with 16 receiving guidance and training from senior re- 17 searchers and mentors, as necessary to help such re- 18 cipients reach a state of research independence, in- 19 cluding conferences and other meeting participation. 20 ‘‘(e) SUPPLEMENT, NOT SUPPLANT.—Awards made 21 under this section shall be used to supplement, and not 22 supplant, other funding for pediatric research and career 23 development awards.’’. 24 VerDate Sep 11 2014 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1357 IS SEC. 3. TRANS-NIH PEDIATRIC CONSORTIUM. 1 Title IV of the Public Health Service is amended by 2 inserting after section 409D (42 U.S.C. 284h) the fol- 3 lowing new section: 4 ‘‘SEC. 409D–1. TRANS-NIH PEDIATRIC CONSORTIUM. 5 ‘‘(a) ESTABLISHMENT.—The Director of NIH shall 6 establish and maintain a consortium to be known as the 7 Trans-NIH Pediatric Research Consortium (in this sec- 8 tions referred to as the ‘Consortium’) to coordinate pedi- 9 atric research programs across the National Institutes of 10 Health. 11 ‘‘(b) MEMBERSHIP.—The members of the Consor- 12 tium shall consist of representatives of multiple national 13 research institutes and national centers. 14 ‘‘(c) CHAIR.—The Chair of the Consortium shall be 15 the Director of the Eunice Kennedy Shriver National In- 16 stitute of Child Health and Human Development (or the 17 Director’s designee). 18 ‘‘(d) DUTIES.—In coordinating pediatric research 19 programs across the National Institutes of Health, the 20 Consortium shall— 21 ‘‘(1) establish pediatric research priorities; 22 ‘‘(2) identify gaps and opportunities for re- 23 search collaborations involving multiple national re- 24 search institutes and national centers; and 25 VerDate Sep 11 2014 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1357 IS ‘‘(3) identify opportunities to develop the next 1 generation of pediatric researchers. 2 ‘‘(e) CONSULTATION.—The Consortium shall consult 3 regularly with external experts in the field of pediatric re- 4 search, including children’s hospitals, children’s research 5 institutions, patient organizations, and other stakeholders. 6 ‘‘(f) REPORTING.—Beginning one year after the date 7 of enactment of the Pediatricians Accelerate Childhood 8 Therapies Act of 2021 and every 2 years thereafter, the 9 Consortium shall submit to Congress, and make publicly 10 available on the website of the National Institutes of 11 Health, a report on— 12 ‘‘(1) any research project involving pediatrics 13 and involving more than one Institute or Center that 14 was supported during the review period; 15 ‘‘(2) any strategic initiatives that include a sig- 16 nificant pediatric component; 17 ‘‘(3) career development awards for early-career 18 researchers focused in pediatrics, including specific 19 numbers of awards and amount of funding, made 20 during the review period; 21 ‘‘(4) details on the composition of awards for 22 early-career researchers, including demographic de- 23 tails indicating the proportion of recipients from 24 VerDate Sep 11 2014 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1357 IS populations that have been underrepresented in pedi- 1 atric medical research; and 2 ‘‘(5) such other information as the Director of 3 NIH determines appropriate.’’. 4 Æ VerDate Sep 11 2014 05:57 May 21, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S1357.IS S1357 kjohnson on DSK79L0C42PROD with BILLS