Sen. Julie A. Morrison

Filed: 11/6/2017





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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
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.".