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Rep. Stephanie A. Kifowit
Filed: 3/19/2019
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1 | | AMENDMENT TO HOUSE BILL 595
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2 | | AMENDMENT NO. ______. Amend House Bill 595 by replacing |
3 | | everything after the enacting clause with the following:
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4 | | "Section 5. The Illinois Administrative Procedure Act is |
5 | | amended by changing Section 5-45 as follows: |
6 | | (5 ILCS 100/5-45) (from Ch. 127, par. 1005-45) |
7 | | Sec. 5-45. Emergency rulemaking. |
8 | | (a) "Emergency" means the existence of any situation that |
9 | | any agency
finds reasonably constitutes a threat to the public |
10 | | interest, safety, or
welfare. |
11 | | (b) If any agency finds that an
emergency exists that |
12 | | requires adoption of a rule upon fewer days than
is required by |
13 | | Section 5-40 and states in writing its reasons for that
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14 | | finding, the agency may adopt an emergency rule without prior |
15 | | notice or
hearing upon filing a notice of emergency rulemaking |
16 | | with the Secretary of
State under Section 5-70. The notice |
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1 | | shall include the text of the
emergency rule and shall be |
2 | | published in the Illinois Register. Consent
orders or other |
3 | | court orders adopting settlements negotiated by an agency
may |
4 | | be adopted under this Section. Subject to applicable |
5 | | constitutional or
statutory provisions, an emergency rule |
6 | | becomes effective immediately upon
filing under Section 5-65 or |
7 | | at a stated date less than 10 days
thereafter. The agency's |
8 | | finding and a statement of the specific reasons
for the finding |
9 | | shall be filed with the rule. The agency shall take
reasonable |
10 | | and appropriate measures to make emergency rules known to the
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11 | | persons who may be affected by them. |
12 | | (c) An emergency rule may be effective for a period of not |
13 | | longer than
150 days, but the agency's authority to adopt an |
14 | | identical rule under Section
5-40 is not precluded. No |
15 | | emergency rule may be adopted more
than once in any 24-month |
16 | | period, except that this limitation on the number
of emergency |
17 | | rules that may be adopted in a 24-month period does not apply
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18 | | to (i) emergency rules that make additions to and deletions |
19 | | from the Drug
Manual under Section 5-5.16 of the Illinois |
20 | | Public Aid Code or the
generic drug formulary under Section |
21 | | 3.14 of the Illinois Food, Drug
and Cosmetic Act, (ii) |
22 | | emergency rules adopted by the Pollution Control
Board before |
23 | | July 1, 1997 to implement portions of the Livestock Management
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24 | | Facilities Act, (iii) emergency rules adopted by the Illinois |
25 | | Department of Public Health under subsections (a) through (i) |
26 | | of Section 2 of the Department of Public Health Act when |
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1 | | necessary to protect the public's health, (iv) emergency rules |
2 | | adopted pursuant to subsection (n) of this Section, (v) |
3 | | emergency rules adopted pursuant to subsection (o) of this |
4 | | Section, or (vi) emergency rules adopted pursuant to subsection |
5 | | (c-5) of this Section. Two or more emergency rules having |
6 | | substantially the same
purpose and effect shall be deemed to be |
7 | | a single rule for purposes of this
Section. |
8 | | (c-5) To facilitate the maintenance of the program of group |
9 | | health benefits provided to annuitants, survivors, and retired |
10 | | employees under the State Employees Group Insurance Act of |
11 | | 1971, rules to alter the contributions to be paid by the State, |
12 | | annuitants, survivors, retired employees, or any combination |
13 | | of those entities, for that program of group health benefits, |
14 | | shall be adopted as emergency rules. The adoption of those |
15 | | rules shall be considered an emergency and necessary for the |
16 | | public interest, safety, and welfare. |
17 | | (d) In order to provide for the expeditious and timely |
18 | | implementation
of the State's fiscal year 1999 budget, |
19 | | emergency rules to implement any
provision of Public Act 90-587 |
20 | | or 90-588
or any other budget initiative for fiscal year 1999 |
21 | | may be adopted in
accordance with this Section by the agency |
22 | | charged with administering that
provision or initiative, |
23 | | except that the 24-month limitation on the adoption
of |
24 | | emergency rules and the provisions of Sections 5-115 and 5-125 |
25 | | do not apply
to rules adopted under this subsection (d). The |
26 | | adoption of emergency rules
authorized by this subsection (d) |
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1 | | shall be deemed to be necessary for the
public interest, |
2 | | safety, and welfare. |
3 | | (e) In order to provide for the expeditious and timely |
4 | | implementation
of the State's fiscal year 2000 budget, |
5 | | emergency rules to implement any
provision of Public Act 91-24
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6 | | or any other budget initiative for fiscal year 2000 may be |
7 | | adopted in
accordance with this Section by the agency charged |
8 | | with administering that
provision or initiative, except that |
9 | | the 24-month limitation on the adoption
of emergency rules and |
10 | | the provisions of Sections 5-115 and 5-125 do not apply
to |
11 | | rules adopted under this subsection (e). The adoption of |
12 | | emergency rules
authorized by this subsection (e) shall be |
13 | | deemed to be necessary for the
public interest, safety, and |
14 | | welfare. |
15 | | (f) In order to provide for the expeditious and timely |
16 | | implementation
of the State's fiscal year 2001 budget, |
17 | | emergency rules to implement any
provision of Public Act 91-712
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18 | | or any other budget initiative for fiscal year 2001 may be |
19 | | adopted in
accordance with this Section by the agency charged |
20 | | with administering that
provision or initiative, except that |
21 | | the 24-month limitation on the adoption
of emergency rules and |
22 | | the provisions of Sections 5-115 and 5-125 do not apply
to |
23 | | rules adopted under this subsection (f). The adoption of |
24 | | emergency rules
authorized by this subsection (f) shall be |
25 | | deemed to be necessary for the
public interest, safety, and |
26 | | welfare. |
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1 | | (g) In order to provide for the expeditious and timely |
2 | | implementation
of the State's fiscal year 2002 budget, |
3 | | emergency rules to implement any
provision of Public Act 92-10
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4 | | or any other budget initiative for fiscal year 2002 may be |
5 | | adopted in
accordance with this Section by the agency charged |
6 | | with administering that
provision or initiative, except that |
7 | | the 24-month limitation on the adoption
of emergency rules and |
8 | | the provisions of Sections 5-115 and 5-125 do not apply
to |
9 | | rules adopted under this subsection (g). The adoption of |
10 | | emergency rules
authorized by this subsection (g) shall be |
11 | | deemed to be necessary for the
public interest, safety, and |
12 | | welfare. |
13 | | (h) In order to provide for the expeditious and timely |
14 | | implementation
of the State's fiscal year 2003 budget, |
15 | | emergency rules to implement any
provision of Public Act 92-597
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16 | | or any other budget initiative for fiscal year 2003 may be |
17 | | adopted in
accordance with this Section by the agency charged |
18 | | with administering that
provision or initiative, except that |
19 | | the 24-month limitation on the adoption
of emergency rules and |
20 | | the provisions of Sections 5-115 and 5-125 do not apply
to |
21 | | rules adopted under this subsection (h). The adoption of |
22 | | emergency rules
authorized by this subsection (h) shall be |
23 | | deemed to be necessary for the
public interest, safety, and |
24 | | welfare. |
25 | | (i) In order to provide for the expeditious and timely |
26 | | implementation
of the State's fiscal year 2004 budget, |
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1 | | emergency rules to implement any
provision of Public Act 93-20
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2 | | or any other budget initiative for fiscal year 2004 may be |
3 | | adopted in
accordance with this Section by the agency charged |
4 | | with administering that
provision or initiative, except that |
5 | | the 24-month limitation on the adoption
of emergency rules and |
6 | | the provisions of Sections 5-115 and 5-125 do not apply
to |
7 | | rules adopted under this subsection (i). The adoption of |
8 | | emergency rules
authorized by this subsection (i) shall be |
9 | | deemed to be necessary for the
public interest, safety, and |
10 | | welfare. |
11 | | (j) In order to provide for the expeditious and timely |
12 | | implementation of the provisions of the State's fiscal year |
13 | | 2005 budget as provided under the Fiscal Year 2005 Budget |
14 | | Implementation (Human Services) Act, emergency rules to |
15 | | implement any provision of the Fiscal Year 2005 Budget |
16 | | Implementation (Human Services) Act may be adopted in |
17 | | accordance with this Section by the agency charged with |
18 | | administering that provision, except that the 24-month |
19 | | limitation on the adoption of emergency rules and the |
20 | | provisions of Sections 5-115 and 5-125 do not apply to rules |
21 | | adopted under this subsection (j). The Department of Public Aid |
22 | | may also adopt rules under this subsection (j) necessary to |
23 | | administer the Illinois Public Aid Code and the Children's |
24 | | Health Insurance Program Act. The adoption of emergency rules |
25 | | authorized by this subsection (j) shall be deemed to be |
26 | | necessary for the public interest, safety, and welfare.
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1 | | (k) In order to provide for the expeditious and timely |
2 | | implementation of the provisions of the State's fiscal year |
3 | | 2006 budget, emergency rules to implement any provision of |
4 | | Public Act 94-48 or any other budget initiative for fiscal year |
5 | | 2006 may be adopted in accordance with this Section by the |
6 | | agency charged with administering that provision or |
7 | | initiative, except that the 24-month limitation on the adoption |
8 | | of emergency rules and the provisions of Sections 5-115 and |
9 | | 5-125 do not apply to rules adopted under this subsection (k). |
10 | | The Department of Healthcare and Family Services may also adopt |
11 | | rules under this subsection (k) necessary to administer the |
12 | | Illinois Public Aid Code, the Senior Citizens and Persons with |
13 | | Disabilities Property Tax Relief Act, the Senior Citizens and |
14 | | Disabled Persons Prescription Drug Discount Program Act (now |
15 | | the Illinois Prescription Drug Discount Program Act), and the |
16 | | Children's Health Insurance Program Act. The adoption of |
17 | | emergency rules authorized by this subsection (k) shall be |
18 | | deemed to be necessary for the public interest, safety, and |
19 | | welfare.
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20 | | (l) In order to provide for the expeditious and timely |
21 | | implementation of the provisions of the
State's fiscal year |
22 | | 2007 budget, the Department of Healthcare and Family Services |
23 | | may adopt emergency rules during fiscal year 2007, including |
24 | | rules effective July 1, 2007, in
accordance with this |
25 | | subsection to the extent necessary to administer the |
26 | | Department's responsibilities with respect to amendments to |
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1 | | the State plans and Illinois waivers approved by the federal |
2 | | Centers for Medicare and Medicaid Services necessitated by the |
3 | | requirements of Title XIX and Title XXI of the federal Social |
4 | | Security Act. The adoption of emergency rules
authorized by |
5 | | this subsection (l) shall be deemed to be necessary for the |
6 | | public interest,
safety, and welfare.
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7 | | (m) In order to provide for the expeditious and timely |
8 | | implementation of the provisions of the
State's fiscal year |
9 | | 2008 budget, the Department of Healthcare and Family Services |
10 | | may adopt emergency rules during fiscal year 2008, including |
11 | | rules effective July 1, 2008, in
accordance with this |
12 | | subsection to the extent necessary to administer the |
13 | | Department's responsibilities with respect to amendments to |
14 | | the State plans and Illinois waivers approved by the federal |
15 | | Centers for Medicare and Medicaid Services necessitated by the |
16 | | requirements of Title XIX and Title XXI of the federal Social |
17 | | Security Act. The adoption of emergency rules
authorized by |
18 | | this subsection (m) shall be deemed to be necessary for the |
19 | | public interest,
safety, and welfare.
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20 | | (n) In order to provide for the expeditious and timely |
21 | | implementation of the provisions of the State's fiscal year |
22 | | 2010 budget, emergency rules to implement any provision of |
23 | | Public Act 96-45 or any other budget initiative authorized by |
24 | | the 96th General Assembly for fiscal year 2010 may be adopted |
25 | | in accordance with this Section by the agency charged with |
26 | | administering that provision or initiative. The adoption of |
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1 | | emergency rules authorized by this subsection (n) shall be |
2 | | deemed to be necessary for the public interest, safety, and |
3 | | welfare. The rulemaking authority granted in this subsection |
4 | | (n) shall apply only to rules promulgated during Fiscal Year |
5 | | 2010. |
6 | | (o) In order to provide for the expeditious and timely |
7 | | implementation of the provisions of the State's fiscal year |
8 | | 2011 budget, emergency rules to implement any provision of |
9 | | Public Act 96-958 or any other budget initiative authorized by |
10 | | the 96th General Assembly for fiscal year 2011 may be adopted |
11 | | in accordance with this Section by the agency charged with |
12 | | administering that provision or initiative. The adoption of |
13 | | emergency rules authorized by this subsection (o) is deemed to |
14 | | be necessary for the public interest, safety, and welfare. The |
15 | | rulemaking authority granted in this subsection (o) applies |
16 | | only to rules promulgated on or after July 1, 2010 (the |
17 | | effective date of Public Act 96-958) through June 30, 2011. |
18 | | (p) In order to provide for the expeditious and timely |
19 | | implementation of the provisions of Public Act 97-689, |
20 | | emergency rules to implement any provision of Public Act 97-689 |
21 | | may be adopted in accordance with this subsection (p) by the |
22 | | agency charged with administering that provision or |
23 | | initiative. The 150-day limitation of the effective period of |
24 | | emergency rules does not apply to rules adopted under this |
25 | | subsection (p), and the effective period may continue through |
26 | | June 30, 2013. The 24-month limitation on the adoption of |
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1 | | emergency rules does not apply to rules adopted under this |
2 | | subsection (p). The adoption of emergency rules authorized by |
3 | | this subsection (p) is deemed to be necessary for the public |
4 | | interest, safety, and welfare. |
5 | | (q) In order to provide for the expeditious and timely |
6 | | implementation of the provisions of Articles 7, 8, 9, 11, and |
7 | | 12 of Public Act 98-104, emergency rules to implement any |
8 | | provision of Articles 7, 8, 9, 11, and 12 of Public Act 98-104 |
9 | | may be adopted in accordance with this subsection (q) by the |
10 | | agency charged with administering that provision or |
11 | | initiative. The 24-month limitation on the adoption of |
12 | | emergency rules does not apply to rules adopted under this |
13 | | subsection (q). The adoption of emergency rules authorized by |
14 | | this subsection (q) is deemed to be necessary for the public |
15 | | interest, safety, and welfare. |
16 | | (r) In order to provide for the expeditious and timely |
17 | | implementation of the provisions of Public Act 98-651, |
18 | | emergency rules to implement Public Act 98-651 may be adopted |
19 | | in accordance with this subsection (r) by the Department of |
20 | | Healthcare and Family Services. The 24-month limitation on the |
21 | | adoption of emergency rules does not apply to rules adopted |
22 | | under this subsection (r). The adoption of emergency rules |
23 | | authorized by this subsection (r) is deemed to be necessary for |
24 | | the public interest, safety, and welfare. |
25 | | (s) In order to provide for the expeditious and timely |
26 | | implementation of the provisions of Sections 5-5b.1 and 5A-2 of |
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1 | | the Illinois Public Aid Code, emergency rules to implement any |
2 | | provision of Section 5-5b.1 or Section 5A-2 of the Illinois |
3 | | Public Aid Code may be adopted in accordance with this |
4 | | subsection (s) by the Department of Healthcare and Family |
5 | | Services. The rulemaking authority granted in this subsection |
6 | | (s) shall apply only to those rules adopted prior to July 1, |
7 | | 2015. Notwithstanding any other provision of this Section, any |
8 | | emergency rule adopted under this subsection (s) shall only |
9 | | apply to payments made for State fiscal year 2015. The adoption |
10 | | of emergency rules authorized by this subsection (s) is deemed |
11 | | to be necessary for the public interest, safety, and welfare. |
12 | | (t) In order to provide for the expeditious and timely |
13 | | implementation of the provisions of Article II of Public Act |
14 | | 99-6, emergency rules to implement the changes made by Article |
15 | | II of Public Act 99-6 to the Emergency Telephone System Act may |
16 | | be adopted in accordance with this subsection (t) by the |
17 | | Department of State Police. The rulemaking authority granted in |
18 | | this subsection (t) shall apply only to those rules adopted |
19 | | prior to July 1, 2016. The 24-month limitation on the adoption |
20 | | of emergency rules does not apply to rules adopted under this |
21 | | subsection (t). The adoption of emergency rules authorized by |
22 | | this subsection (t) is deemed to be necessary for the public |
23 | | interest, safety, and welfare. |
24 | | (u) In order to provide for the expeditious and timely |
25 | | implementation of the provisions of the Burn Victims Relief |
26 | | Act, emergency rules to implement any provision of the Act may |
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1 | | be adopted in accordance with this subsection (u) by the |
2 | | Department of Insurance. The rulemaking authority granted in |
3 | | this subsection (u) shall apply only to those rules adopted |
4 | | prior to December 31, 2015. The adoption of emergency rules |
5 | | authorized by this subsection (u) is deemed to be necessary for |
6 | | the public interest, safety, and welfare. |
7 | | (v) In order to provide for the expeditious and timely |
8 | | implementation of the provisions of Public Act 99-516, |
9 | | emergency rules to implement Public Act 99-516 may be adopted |
10 | | in accordance with this subsection (v) by the Department of |
11 | | Healthcare and Family Services. The 24-month limitation on the |
12 | | adoption of emergency rules does not apply to rules adopted |
13 | | under this subsection (v). The adoption of emergency rules |
14 | | authorized by this subsection (v) is deemed to be necessary for |
15 | | the public interest, safety, and welfare. |
16 | | (w) In order to provide for the expeditious and timely |
17 | | implementation of the provisions of Public Act 99-796, |
18 | | emergency rules to implement the changes made by Public Act |
19 | | 99-796 may be adopted in accordance with this subsection (w) by |
20 | | the Adjutant General. The adoption of emergency rules |
21 | | authorized by this subsection (w) is deemed to be necessary for |
22 | | the public interest, safety, and welfare. |
23 | | (x) In order to provide for the expeditious and timely |
24 | | implementation of the provisions of Public Act 99-906, |
25 | | emergency rules to implement subsection (i) of Section 16-115D, |
26 | | subsection (g) of Section 16-128A, and subsection (a) of |
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1 | | Section 16-128B of the Public Utilities Act may be adopted in |
2 | | accordance with this subsection (x) by the Illinois Commerce |
3 | | Commission. The rulemaking authority granted in this |
4 | | subsection (x) shall apply only to those rules adopted within |
5 | | 180 days after June 1, 2017 (the effective date of Public Act |
6 | | 99-906). The adoption of emergency rules authorized by this |
7 | | subsection (x) is deemed to be necessary for the public |
8 | | interest, safety, and welfare. |
9 | | (y) In order to provide for the expeditious and timely |
10 | | implementation of the provisions of Public Act 100-23, |
11 | | emergency rules to implement the changes made by Public Act |
12 | | 100-23 to Section 4.02 of the Illinois Act on the Aging, |
13 | | Sections 5.5.4 and 5-5.4i of the Illinois Public Aid Code, |
14 | | Section 55-30 of the Alcoholism and Other Drug Abuse and |
15 | | Dependency Act, and Sections 74 and 75 of the Mental Health and |
16 | | Developmental Disabilities Administrative Act may be adopted |
17 | | in accordance with this subsection (y) by the respective |
18 | | Department. The adoption of emergency rules authorized by this |
19 | | subsection (y) is deemed to be necessary for the public |
20 | | interest, safety, and welfare. |
21 | | (z) In order to provide for the expeditious and timely |
22 | | implementation of the provisions of Public Act 100-554, |
23 | | emergency rules to implement the changes made by Public Act |
24 | | 100-554 to Section 4.7 of the Lobbyist Registration Act may be |
25 | | adopted in accordance with this subsection (z) by the Secretary |
26 | | of State. The adoption of emergency rules authorized by this |
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1 | | subsection (z) is deemed to be necessary for the public |
2 | | interest, safety, and welfare. |
3 | | (aa) In order to provide for the expeditious and timely |
4 | | initial implementation of the changes made to Articles 5, 5A, |
5 | | 12, and 14 of the Illinois Public Aid Code under the provisions |
6 | | of Public Act 100-581, the Department of Healthcare and Family |
7 | | Services may adopt emergency rules in accordance with this |
8 | | subsection (aa). The 24-month limitation on the adoption of |
9 | | emergency rules does not apply to rules to initially implement |
10 | | the changes made to Articles 5, 5A, 12, and 14 of the Illinois |
11 | | Public Aid Code adopted under this subsection (aa). The |
12 | | adoption of emergency rules authorized by this subsection (aa) |
13 | | is deemed to be necessary for the public interest, safety, and |
14 | | welfare. |
15 | | (bb) In order to provide for the expeditious and timely |
16 | | implementation of the provisions of Public Act 100-587, |
17 | | emergency rules to implement the changes made by Public Act |
18 | | 100-587 to Section 4.02 of the Illinois Act on the Aging, |
19 | | Sections 5.5.4 and 5-5.4i of the Illinois Public Aid Code, |
20 | | subsection (b) of Section 55-30 of the Alcoholism and Other |
21 | | Drug Abuse and Dependency Act, Section 5-104 of the Specialized |
22 | | Mental Health Rehabilitation Act of 2013, and Section 75 and |
23 | | subsection (b) of Section 74 of the Mental Health and |
24 | | Developmental Disabilities Administrative Act may be adopted |
25 | | in accordance with this subsection (bb) by the respective |
26 | | Department. The adoption of emergency rules authorized by this |
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1 | | subsection (bb) is deemed to be necessary for the public |
2 | | interest, safety, and welfare. |
3 | | (cc) In order to provide for the expeditious and timely |
4 | | implementation of the provisions of Public Act 100-587, |
5 | | emergency rules may be adopted in accordance with this |
6 | | subsection (cc) to implement the changes made by Public Act |
7 | | 100-587 to: Sections 14-147.5 and 14-147.6 of the Illinois |
8 | | Pension Code by the Board created under Article 14 of the Code; |
9 | | Sections 15-185.5 and 15-185.6 of the Illinois Pension Code by |
10 | | the Board created under Article 15 of the Code; and Sections |
11 | | 16-190.5 and 16-190.6 of the Illinois Pension Code by the Board |
12 | | created under Article 16 of the Code. The adoption of emergency |
13 | | rules authorized by this subsection (cc) is deemed to be |
14 | | necessary for the public interest, safety, and welfare. |
15 | | (dd) In order to provide for the expeditious and timely |
16 | | implementation of the provisions of Public Act 100-864, |
17 | | emergency rules to implement the changes made by Public Act |
18 | | 100-864 to Section 3.35 of the Newborn Metabolic Screening Act |
19 | | may be adopted in accordance with this subsection (dd) by the |
20 | | Secretary of State. The adoption of emergency rules authorized |
21 | | by this subsection (dd) is deemed to be necessary for the |
22 | | public interest, safety, and welfare. |
23 | | (ee) In order to provide for the expeditious and timely |
24 | | implementation of the provisions of this amendatory Act of the |
25 | | 100th General Assembly, emergency rules implementing the |
26 | | Illinois Underground Natural Gas Storage Safety Act may be |
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1 | | adopted in accordance with this subsection by the Department of |
2 | | Natural Resources. The adoption of emergency rules authorized |
3 | | by this subsection is deemed to be necessary for the public |
4 | | interest, safety, and welfare. |
5 | | (ff) In order to provide for the expeditious and timely |
6 | | implementation of the provisions of this amendatory Act of the |
7 | | 101st General Assembly, emergency rules may be adopted by the |
8 | | Department of Labor in accordance with this subsection (ff) to |
9 | | implement the changes made by this amendatory Act of the 101st |
10 | | General Assembly to the Minimum Wage Law. The adoption of |
11 | | emergency rules authorized by this subsection (ff) is deemed to |
12 | | be necessary for the public interest, safety, and welfare. |
13 | | (gg) In order to provide for the expeditious and timely |
14 | | implementation of the provisions of this amendatory Act of the |
15 | | 101st General Assembly, emergency rules to implement the |
16 | | changes made by this amendatory Act of the 101st General |
17 | | Assembly to the Newborn Metabolic Screening Act may be adopted |
18 | | in accordance with this subsection (gg) by the Department of |
19 | | Public Health. The adoption of emergency rules authorized by |
20 | | this subsection (gg) is deemed to be necessary for the public |
21 | | interest, safety, and welfare. |
22 | | (Source: P.A. 100-23, eff. 7-6-17; 100-554, eff. 11-16-17; |
23 | | 100-581, eff. 3-12-18; 100-587, Article 95, Section 95-5, eff. |
24 | | 6-4-18; 100-587, Article 110, Section 110-5, eff. 6-4-18; |
25 | | 100-864, eff. 8-14-18; 100-1172, eff. 1-4-19; 101-1, eff. |
26 | | 2-19-19.) |
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1 | | Section 10. The Newborn Metabolic Screening Act is amended |
2 | | by adding Section 3.40 as follows: |
3 | | (410 ILCS 240/3.40 new) |
4 | | Sec. 3.40. Guanidinoacetate methyltransferase deficiency. |
5 | | In accordance with the timetable specified in this Section, the |
6 | | Department shall provide all newborns with a screening test for |
7 | | guanidinoacetate methyltransferase deficiency using a method |
8 | | that determines the presence or absence of guanidinoacetate |
9 | | methyltransferase deficiency, beginning on the earlier of the |
10 | | following: |
11 | | (1) July 1, 2021; or |
12 | | (2) within 6 months following the occurrence of all
of |
13 | | the following: |
14 | | (A) the establishment and verification of
relevant |
15 | | and appropriate performance specifications as defined |
16 | | under the federal Clinical Laboratory Improvement |
17 | | Amendments and regulations thereunder for federal Food |
18 | | and Drug Administration-cleared or in-house developed |
19 | | methods, performed under an institutional review board |
20 | | approved protocol, if required; |
21 | | (B) the availability of quality assurance
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22 | | materials and comparative threshold values to |
23 | | determine the presence or absence of guanidinoacetate |
24 | | methyltransferase deficiency; |
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1 | | (C) the procurement and installation by the
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2 | | Department of the equipment necessary to implement the |
3 | | initial pilot and statewide volume of screening tests |
4 | | for guanidinoacetate methyltransferase deficiency; |
5 | | (D) the establishment of precise threshold values
|
6 | | ensuring defined disease identification for |
7 | | guanidinoacetate methyltransferase deficiency; |
8 | | (E) the development and validation of a reliable
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9 | | methodology for screening newborns for |
10 | | guanidinoacetate methyltransferase deficiency using |
11 | | dried blood spots and quality assurance testing |
12 | | methodology for such test or the approval and |
13 | | procurement of a test for guanidinoacetate |
14 | | methyltransferase deficiency using dried blood spots |
15 | | by the federal Food and Drug Administration; |
16 | | (F) the authentication of pilot testing achieving
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17 | | each milestone described in subparagraphs (A) through |
18 | | (E) of this paragraph for guanidinoacetate |
19 | | methyltransferase deficiency; and |
20 | | (G) the authentication of achieving the potential
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21 | | of high throughput standards for statewide volume of |
22 | | guanidinoacetate methyltransferase deficiency |
23 | | concomitant with each milestone described in |
24 | | subparagraphs (A) through (E) of this paragraph. |
25 | | The Department is authorized to implement an additional fee |
26 | | for the screening upon the effective date of this amendatory |
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1 | | Act of the 101st General Assembly in order to accumulate the |
2 | | resources for start-up and other costs associated with the |
3 | | implementation of the screening and thereafter to support the |
4 | | costs associated with screening. If the Department has not |
5 | | implemented statewide screening for guanidinoacetate |
6 | | methyltransferase deficiency under this Section within 36 |
7 | | months after the effective date of this amendatory Act of the |
8 | | 101st General Assembly, then the Department shall cease |
9 | | collecting any additional fees related to the screening. The |
10 | | Department may adopt emergency rules in accordance with Section |
11 | | 5-45 of the Illinois Administrative Procedure Act to implement |
12 | | this Section. ".
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