Aidan’s Law

I 116TH CONGRESS 1ST SESSION H. R. 534 To amend the Public Health Service Act, in relation to requiring adrenoleukodystrophy screening of newborns. IN THE HOUSE OF REPRESENTATIVES JANUARY 14, 2019 Ms. CLARKE of New York (for herself and Mr. ZELDIN) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act, in relation to requiring adrenoleukodystrophy screening of newborns. 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 ‘‘Aidan’s Law’’. 4 SEC. 2. FINDINGS. 5 Congress finds the following: 6 (1) Adrenoleukodystrophy is a deadly genetic 7 disease that destroys myelin, the protective sheath 8 that surrounds the brain’s neurons, which are the 9 VerDate Sep 11 2014 22:06 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H534.IH H534 kjohnson on DSK79L0C42 with BILLS 2 •HR 534 IH nerve cells that allow us to think and to control our 1 muscles. 2 (2) Adrenoleukodystrophy affects 1 in 17,000 3 people and most severely affects boys and men. 4 (3) Adrenoleukodystrophy newborn screening 5 tests have been validated with false positive of less 6 than 0.1 percent. 7 (4) Early identification of adrenoleukodystrophy 8 allows those who are affected to be treated and have 9 the best chance at a healthy life. 10 SEC. 3. SCREENING OF ADRENOLEUKODYSTROPHY. 11 (a) IN GENERAL.—Part A of title XI of the Public 12 Health Service Act (42 U.S.C. 300b–1 et seq.) is amended 13 by adding at the end the following: 14 ‘‘SEC. 1118. ADRENOLEUKODYSTROPHY. 15 ‘‘(a) IN GENERAL.—Each hospital, child care center, 16 clinic, or other similar institution caring for infants who 17 are 28 days or less of age (as designated by the Secretary) 18 may administer, or cause to have administered, to every 19 such infant in its care a test for adrenoleukodystrophy in 20 accordance with this section. 21 ‘‘(b) PROCESS.— 22 ‘‘(1) IN GENERAL.—In carrying out this sec- 23 tion, the chief executive officer for health in each 24 State may prescribe standards and procedures for 25 VerDate Sep 11 2014 22:06 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H534.IH H534 kjohnson on DSK79L0C42 with BILLS 3 •HR 534 IH the administration of testing under subsection (a), 1 including recording the results of such tests, track- 2 ing activities, conducting follow-up reviews, and car- 3 rying out educational activities. 4 ‘‘(2) DISSEMINATION OF INFORMATION.—In 5 carrying out this section, the chief executive officer 6 for health in each State may prescribe standards 7 and procedures setting forth the manner in which 8 testing information is disseminated to a parent or 9 guardian of the infant to be tested. 10 ‘‘(3) FAILURE TO PRESCRIBE.—If a State has 11 not prescribed standards and procedures that are 12 approved as provided for in paragraph (4) by the 13 date that is 2 years after the date of enactment of 14 this section, the Discretionary Advisory Committee 15 on Heritable Disorders in Newborns and Children 16 established under section 1111 (referred to in this 17 section as the ‘Advisory Committee’) shall prescribe 18 appropriate standards and procedures which may be 19 implemented by such State. 20 ‘‘(4) REVIEW AND APPROVAL.—The standards 21 and procedures prescribed under this subsection 22 shall be subject to review and approval by the Advi- 23 sory Committee. In reviewing or prescribing stand- 24 ards and procedures as required under this sub- 25 VerDate Sep 11 2014 22:06 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H534.IH H534 kjohnson on DSK79L0C42 with BILLS 4 •HR 534 IH section, the Advisory Committee shall consider 1 standards and procedures adopted in other States 2 with respect to the screening of adrenoleukodystro- 3 phy, the standards and procedures adopted in such 4 State with respect to the screening of infants for 5 other heritable diseases, and any scientific evidence 6 the Advisory Committee considers relevant to pro- 7 vide for the screening of infants for adrenoleukodys- 8 trophy.’’. 9 (b) REAUTHORIZATION OF HERITABLE DISORDERS 10 PROGRAM.—Section 1117 of the Public Health Service 11 Act (42 U.S.C. 300b–16) is amended— 12 (1) in paragraph (1), by striking ‘‘and’’ at the 13 end; 14 (2) by redesignating paragraph (2) as para- 15 graph (3); and 16 (3) by inserting after paragraph (1), the fol- 17 lowing: 18 ‘‘(2) to carry out the Heritable Disorders Pro- 19 gram under section 1109, $15,000,000 for each of 20 fiscal years 2020 through 2023; and’’. 21 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 22 IN NEWBORNS AND CHILDREN. 23 Section 1111(b) of the Public Health Service Act (42 24 U.S.C. 300b–10(b)) is amended— 25 VerDate Sep 11 2014 22:06 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H534.IH H534 kjohnson on DSK79L0C42 with BILLS 5 •HR 534 IH (1) in paragraph (7) by striking ‘‘and’’ after 1 the semicolon; 2 (2) by redesignating paragraph (8) as para- 3 graph (9); and 4 (3) by inserting after paragraph (7) the fol- 5 lowing: 6 ‘‘(8) carry out activities as provided for under 7 section 1118; and’’. 8 Æ VerDate Sep 11 2014 22:06 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H534.IH H534 kjohnson on DSK79L0C42 with BILLS