Sen. Julie A. Morrison
Filed: 11/6/2017
 
 

 

 

 
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1
AMENDMENT TO SENATE BILL 456 




2    AMENDMENT NO. ______. Amend Senate Bill 456 by replacing 
3everything after the enacting clause with the following:


 
 
4    "Section 5. The Newborn Metabolic Screening Act is amended  
5by adding Section 3.35 as follows:
 
6    (410 ILCS 240/3.35 new)
7    Sec. 3.35. Spinal muscular atrophy. In accordance with the 
8timetable specified in this Section, the Department shall 
9provide all newborns with screening tests for the presence of 
10spinal muscular atrophy, beginning on the earlier of the 
11following:
12        (1) January 1, 2019; or
13        (2)  within 6 months following the occurrence of all of 
14    the following:
15            (A) the establishment and verification of relevant 
16        and appropriate performance specifications as defined 
 
 
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1        under the federal Clinical Laboratory Improvement 
2        Amendments and regulations thereunder for federal Food 
3        and Drug Administration-cleared or in-house developed 
4        methods, performed under an institutional review board 
5        approved protocol, if required;
6            (B) the availability of quality assurance testing 
7        and comparative threshold values for spinal muscular 
8        atrophy;
9            (C) the acquisition and installment by the 
10        Department of the equipment necessary to implement the 
11        initial pilot and statewide volume of screening tests 
12        for spinal muscular atrophy;
13            (D) the establishment of precise threshold values 
14        ensuring defined disorder identification for spinal 
15        muscular atrophy;
16            (E) the development and validation of a reliable 
17        methodology for screening newborns for spinal muscular 
18        atrophy using dried blood spots and quality assurance 
19        testing methodology for such test or the approval of a 
20        test for spinal muscular atrophy using dried blood 
21        spots by the federal Food and Drug Administration; 
22            (F) the authentication of pilot testing achieving 
23        each milestone described in subparagraphs (A) through 
24        (E) of this paragraph for spinal muscular atrophy; and
25            (G) the authentication of achieving the potential 
26        of high throughput standards for statewide volume of 
 
 
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1        spinal muscular atrophy concomitant with each 
2        milestone described in subparagraphs (A) through (E) 
3        of this paragraph.
4    The Department is authorized to implement an additional fee 
5for the screening no sooner than 6 months prior to beginning 
6the testing in order to accumulate the resources for start-up 
7and other costs associated with the implementation of the 
8screening and thereafter to support the costs associated with 
9screening and follow-up programs for spinal muscular atrophy. 
10The Department may adopt emergency rules in accordance with 
11Section 5-45 of the Illinois Administrative Procedure Act to 
12implement this Section.
  
 
13    Section 99. Effective date. This Act takes effect upon 
14becoming law.".