SB0456sam001 100TH GENERAL ASSEMBLY

Sen. Julie A. Morrison

Filed: 11/6/2017

10000SB0456sam001 LRB100 05000 MJP 30604 a

AMENDMENT TO SENATE BILL 456

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

"Section 5. The Newborn Metabolic Screening Act is amended by adding Section 3.35 as follows:

(410 ILCS 240/3.35 new)

Sec. 3.35. Spinal muscular atrophy. In accordance with the timetable specified in this Section, the Department shall provide all newborns with screening tests for the presence of spinal muscular atrophy, beginning on the earlier of the following:

(1) January 1, 2019; or

(2) within 6 months following the occurrence of all of the following:

(A) the establishment and verification of relevant and appropriate performance specifications as defined under the federal Clinical Laboratory Improvement Amendments and regulations thereunder for federal Food and Drug Administration-cleared or in-house developed methods, performed under an institutional review board approved protocol, if required;

(B) the availability of quality assurance testing and comparative threshold values for spinal muscular atrophy;

(C) the acquisition and installment by the Department of the equipment necessary to implement the initial pilot and statewide volume of screening tests for spinal muscular atrophy;

(D) the establishment of precise threshold values ensuring defined disorder identification for spinal muscular atrophy;

(E) the development and validation of a reliable methodology for screening newborns for spinal muscular atrophy using dried blood spots and quality assurance testing methodology for such test or the approval of a test for spinal muscular atrophy using dried blood spots by the federal Food and Drug Administration;

(F) the authentication of pilot testing achieving each milestone described in subparagraphs (A) through (E) of this paragraph for spinal muscular atrophy; and

(G) the authentication of achieving the potential of high throughput standards for statewide volume of spinal muscular atrophy concomitant with each milestone described in subparagraphs (A) through (E) of this paragraph.

The Department is authorized to implement an additional fee for the screening no sooner than 6 months prior to beginning the testing in order to accumulate the resources for start-up and other costs associated with the implementation of the screening and thereafter to support the costs associated with screening and follow-up programs for spinal muscular atrophy. The Department may adopt emergency rules in accordance with Section 5-45 of the Illinois Administrative Procedure Act to implement this Section.

Section 99. Effective date. This Act takes effect upon becoming law.".