PACT Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 3773 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 HOUSE OF REPRESENTATIVES JUNE 8, 2021 Mr. JOYCE of Pennsylvania (for himself and Ms. SCHRIER) introduced the following bill; which was referred to the Committee on Energy and Commerce 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Pediatricians Accel- 4 erate Childhood Therapies Act of 2021’’ or the ‘‘PACT 5 Act of 2021’’. 6 VerDate Sep 11 2014 20:21 Jun 27, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3773.IH H3773 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3773 IH SEC. 2. TRANS-NIH AWARDS FOR EARLY-CAREER PEDI- 1 ATRIC RESEARCHERS. 2 Part G of title IV of the Public Health Service Act 3 (42 U.S.C. 288 et seq.) is amended by adding at the end 4 the following new section: 5 ‘‘SEC. 489A. TRANS-NIH AWARDS FOR EARLY-CAREER PEDI- 6 ATRIC RESEARCHERS. 7 ‘‘(a) IN GENERAL.—The Director of the NIH shall 8 make awards to outstanding scientists, including physi- 9 cian-scientists, to support early-career researchers focus- 10 ing on pediatric research, including basic, clinical, 11 translational, or pediatric pharmacological research. 12 ‘‘(b) PRIORITY RESEARCH POPULATIONS.—In car- 13 rying out subsection (a), the Director of NIH may 14 prioritize the issuance of awards to applicants who— 15 ‘‘(1) are individual researchers presenting quali- 16 fying applications and representing populations that 17 have been historically underrepresented in pediatric 18 medical research, including women and underrep- 19 resented racial minorities; or 20 ‘‘(2) are institutions of higher education that 21 are eligible to receive funds under part A or B of 22 title III of the Higher Education Act of 1965, part 23 A or B of title V of such Act, or subpart 4 of part 24 A of title VII of such Act, or research institutions 25 partnering with such institutions of higher education 26 VerDate Sep 11 2014 20:21 Jun 27, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3773.IH H3773 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3773 IH to offer programs to support early-career pediatric 1 researchers. 2 ‘‘(c) PRIORITY RESEARCH TOPIC AREAS.—In car- 3 rying out subsection (a), the Director of NIH, in consulta- 4 tion with the Director of the Eunice Kennedy Shriver Na- 5 tional Institute of Child Health and Human Development 6 and the directors of other national research institutes and 7 national centers that participate within the Trans-NIH 8 Pediatric Research Consortium, shall— 9 ‘‘(1) establish priority research topic areas, in- 10 formed by external stakeholders, including research 11 institutions, research societies, patient organizations, 12 and industry; and 13 ‘‘(2) consider opportunities to align such pri- 14 ority pediatric research topic areas with current and 15 future priorities of the National Institutes of Health, 16 including— 17 ‘‘(A) pediatric and adolescent mental and 18 behavioral health, including addiction medicine; 19 ‘‘(B) childhood cancer; 20 ‘‘(C) precision medicine, genetics, and 21 genomics; 22 ‘‘(D) rare diseases and disorders, such as 23 sickle cell disease, and other diseases and dis- 24 VerDate Sep 11 2014 20:21 Jun 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3773.IH H3773 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3773 IH orders with significant unmet training needs; 1 and 2 ‘‘(E) fetal, placental, and neonatal develop- 3 ment. 4 ‘‘(d) REQUIREMENTS.—The Director of NIH— 5 ‘‘(1) shall require recipients of awards under 6 this section to use such awards to support pediatric 7 research activities, including costs associated with 8 laboratory staff and other costs associated with the 9 conduct of research; and 10 ‘‘(2) may allow recipients of awards under this 11 section to use such awards for costs associated with 12 receiving guidance and training from senior re- 13 searchers and mentors, as necessary to help such re- 14 cipients reach a state of research independence, in- 15 cluding conferences and other meeting participation. 16 ‘‘(e) SUPPLEMENT, NOT SUPPLANT.—Awards made 17 under this section shall be used to supplement, and not 18 supplant, other funding for pediatric research and pedi- 19 atric training.’’. 20 SEC. 3. TRANS-NIH PEDIATRIC CONSORTIUM. 21 Title IV of the Public Health Service is amended by 22 inserting after section 409D (42 U.S.C. 284h) the fol- 23 lowing new section: 24 VerDate Sep 11 2014 20:21 Jun 27, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3773.IH H3773 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3773 IH ‘‘SEC. 409D–1. TRANS-NIH PEDIATRIC CONSORTIUM. 1 ‘‘(a) ESTABLISHMENT.—The Director of NIH shall 2 establish and maintain a consortium to be known as the 3 Trans-NIH Pediatric Research Consortium (in this sec- 4 tions referred to as the ‘Consortium’) to coordinate pedi- 5 atric research programs across the National Institutes of 6 Health. 7 ‘‘(b) MEMBERSHIP.—The members of the Consor- 8 tium shall consist of representatives of multiple national 9 research institutes and national centers. 10 ‘‘(c) CHAIR.—The Chair of the Consortium shall be 11 the Director of the Eunice Kennedy Shriver National In- 12 stitute of Child Health and Human Development (or the 13 Director’s designee). 14 ‘‘(d) DUTIES.—In coordinating pediatric research 15 programs across the National Institutes of Health, the 16 Consortium shall— 17 ‘‘(1) establish pediatric research priorities; 18 ‘‘(2) identify gaps and opportunities for re- 19 search collaborations involving multiple national re- 20 search institutes and national centers; and 21 ‘‘(3) identify opportunities to develop the next 22 generation of pediatric researchers. 23 ‘‘(e) CONSULTATION.—The Consortium shall consult 24 regularly with external experts in the field of pediatric re- 25 VerDate Sep 11 2014 20:21 Jun 27, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3773.IH H3773 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 3773 IH search, including children’s hospitals, children’s research 1 institutions, patient organizations, and other stakeholders. 2 ‘‘(f) REPORTING.—Beginning one year after the date 3 of enactment of the Pediatricians Accelerate Childhood 4 Therapies Act of 2021 and every 2 years thereafter, the 5 Consortium shall submit to Congress, and make publicly 6 available on the website of the National Institutes of 7 Health, a report on— 8 ‘‘(1) any research project involving pediatrics 9 and involving more than one Institute or Center that 10 was supported during the review period; 11 ‘‘(2) any strategic initiatives that include a sig- 12 nificant pediatric component; 13 ‘‘(3) career development awards for early-career 14 researchers focused in pediatrics, including specific 15 numbers of awards and amount of funding, made 16 during the review period; 17 ‘‘(4) details on the composition of awards for 18 early-career researchers, including demographic de- 19 tails indicating the proportion of recipients from 20 populations that have been underrepresented in pedi- 21 atric medical research; and 22 ‘‘(5) such other information as the Director of 23 NIH determines appropriate.’’. 24 Æ VerDate Sep 11 2014 20:21 Jun 27, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H3773.IH H3773 kjohnson on DSK79L0C42PROD with BILLS