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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as ‘‘Aidan’s Law’’. 

5 SEC. 2. FINDINGS. 

6 Congress finds the following: 

7 (1) Adrenoleukodystrophy is a deadly genetic 

8 disease that destroys myelin, the protective sheath 

9 that surrounds the brain’s neurons, which are the 


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1 nerve cells that allow us to think and to control our 

2 muscles. 

3 (2) Adrenoleukodystrophy affects 1 in 17,000 

4 people and most severely affects boys and men. 

5 (3) Adrenoleukodystrophy newborn screening 

6 tests have been validated with false positive of less 

7 than 0.1 percent. 

8 (4) Early identification of adrenoleukodystrophy 

9 allows those who are affected to be treated and have 

10 the best chance at a healthy life. 

11 SEC. 3. SCREENING OF ADRENOLEUKODYSTROPHY. 

12 (a) IN GENERAL.—Part A of title XI of the Public 

13 Health Service Act (42 U.S.C. 300b–1 et seq.) is amended 

14 by adding at the end the following: 

15 ‘‘SEC. 1118. ADRENOLEUKODYSTROPHY. 

16 ‘‘(a) IN GENERAL.—Each hospital, child care center, 

17 clinic, or other similar institution caring for infants who 

18 are 28 days or less of age (as designated by the Secretary) 

19 may administer, or cause to have administered, to every 

20 such infant in its care a test for adrenoleukodystrophy in 

21 accordance with this section. 

22 ‘‘(b) PROCESS.— 

23 ‘‘(1) IN GENERAL.—In carrying out this sec24 tion, the chief executive officer for health in each 

25 State may prescribe standards and procedures for 


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1 the administration of testing under subsection (a), 

2 including recording the results of such tests, track3 ing activities, conducting follow-up reviews, and car4 rying out educational activities. 

5 ‘‘(2) DISSEMINATION OF INFORMATION.—In 

6 carrying out this section, the chief executive officer 

7 for health in each State may prescribe standards 

8 and procedures setting forth the manner in which 

9 testing information is disseminated to a parent or 

10 guardian of the infant to be tested. 

11 ‘‘(3) FAILURE TO PRESCRIBE.—If a State has 

12 not prescribed standards and procedures that are 

13 approved as provided for in paragraph (4) by the 

14 date that is 2 years after the date of enactment of 

15 this section, the Discretionary Advisory Committee 

16 on Heritable Disorders in Newborns and Children 

17 established under section 1111 (referred to in this 

18 section as the ‘Advisory Committee’) shall prescribe 

19 appropriate standards and procedures which may be 

20 implemented by such State. 

21 ‘‘(4) REVIEW AND APPROVAL.—The standards 

22 and procedures prescribed under this subsection 

23 shall be subject to review and approval by the Advi24 sory Committee. In reviewing or prescribing stand25 ards and procedures as required under this subVerDate Sep 11 2014 22:06 Jan 28, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H534.IH H534

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1 section, the Advisory Committee shall consider 

2 standards and procedures adopted in other States 

3 with respect to the screening of adrenoleukodystro4 phy, the standards and procedures adopted in such 

5 State with respect to the screening of infants for 

6 other heritable diseases, and any scientific evidence 

7 the Advisory Committee considers relevant to pro8 vide for the screening of infants for adrenoleukodys9 trophy.’’. 

10 (b) REAUTHORIZATION OF HERITABLE DISORDERS

11 PROGRAM.—Section 1117 of the Public Health Service 

12 Act (42 U.S.C. 300b–16) is amended— 

13 (1) in paragraph (1), by striking ‘‘and’’ at the 

14 end; 

15 (2) by redesignating paragraph (2) as para16 graph (3); and 

17 (3) by inserting after paragraph (1), the fol18 lowing: 

19 ‘‘(2) to carry out the Heritable Disorders Pro20 gram under section 1109, $15,000,000 for each of 

21 fiscal years 2020 through 2023; and’’. 

22 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

23 IN NEWBORNS AND CHILDREN. 

24 Section 1111(b) of the Public Health Service Act (42 

25 U.S.C. 300b–10(b)) is amended— 


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1 (1) in paragraph (7) by striking ‘‘and’’ after 

2 the semicolon; 

3 (2) by redesignating paragraph (8) as para4 graph (9); and 

5 (3) by inserting after paragraph (7) the fol6 lowing: 

7 ‘‘(8) carry out activities as provided for under 

8 section 1118; and’’. 

Æ 


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