I 

114TH CONGRESS 

2D SESSION H. R. 4692 

To amend the Public Health Service Act, in relation to requiring 

adrenoleukodystrophy screening of newborns. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 3, 2016 

Ms. CLARKE of New York 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 the ‘‘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. REQUIRING THE SCREENING OF ADRENOLEUKO12 DYSTROPHY. 

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

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

15 by adding at the end the following: 

16 ‘‘SEC. 1118. ADRENOLEUKODYSTROPHY. 

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

18 clinic, or other similar institution caring for infants who 

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

20 shall administer, or cause to have administered, to every 

21 such infant in its care a test for adrenoleukodystrophy in 

22 accordance with this section. 

23 ‘‘(b) PROCESS.— 

24 ‘‘(1) IN GENERAL.—In carrying out this sec25 tion, the chief executive officer for health in each 


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1 State shall prescribe standards and procedures for 

2 the administration of testing under subsection (a), 

3 including recording the results of such tests, track4 ing activities, conducting follow-up reviews, and car5 rying out educational activities. 

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

7 carrying out this section, the chief executive officer 

8 for health in each State shall prescribe standards 

9 and procedures setting forth the manner in which 

10 testing information is disseminated to a parent or 

11 guardian of the infant to be tested. 

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

13 not prescribed standards and procedures that are 

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

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

16 this section, the Discretionary Advisory Committee 

17 on Heritable Disorders in Newborns and Children 

18 established under section 1111 (referred to in this 

19 section as the ‘Advisory Committee’) shall prescribe 

20 appropriate standards and procedures for such 

21 State. 

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

23 and procedures prescribed under this subsection 

24 shall be subject to review and approval by the Advi25 sory Committee. In reviewing or prescribing standVerDate Sep 11 2014 22:32 Mar 07, 2016 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4692.IH H4692

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1 ards and procedures as required under this sub2 section, the Advisory Committee shall consider 

3 standards and procedures adopted in other States 

4 with respect to the screening of adrenoleukodystro5 phy, the standards and procedures adopted in such 

6 State with respect to the screening of infants for 

7 other heritable diseases, and any scientific evidence 

8 the Advisory Committee considers relevant to pro9 vide for the screening of infants for adrenoleukodys10 trophy.’’. 

11 (b) PENALTY.—A State that fails to prescribe stand12 ards and procedures as required under section 1118 of the 

13 Public Health Service Act shall not be eligible for funds 

14 under the Heritable Disorders Program established under 

15 title XI of the Public Health Service Act (42 U.S.C. 300b– 

16 1 et seq.). 

17 (c) REAUTHORIZATION OF HERITABLE DISORDERS

18 PROGRAM.—Section 1117 of the Public Health Service 

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

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

21 end; 

22 (2) by redesignating paragraph (2) as para23 graph (3); and 

24 (3) by inserting after paragraph (1), the fol25 lowing: 


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1 ‘‘(2) to carry out the Heritable Disorders Pro2 gram under section 1109, $15,000,000 for each of 

3 fiscal years 2016 through 2019; and’’. 

4 SEC. 4. ADVISORY COMMITTEE ON HERITABLE DISORDERS 

5 IN NEWBORNS AND CHILDREN. 

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

7 U.S.C. 300b–10(b)) is amended— 

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

9 the semicolon; 

10 (2) by redesignating paragraph (8) as para11 graph (9); and 

12 (3) by inserting after paragraph (7) the fol13 lowing: 

14 ‘‘(8) carry out activities are provided for under 

15 section 1118; and’’. 

Æ 


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