Florida Senate - 2025 COMMITTEE AMENDMENT
Bill No. CS for SB 1356
Ì909844EÎ909844
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/02/2025 .
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The Committee on Fiscal Policy (Burton) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 1004.4211, Florida Statutes, is created
6 to read:
7 1004.4211 The Florida Institute for Pediatric Rare
8 Diseases; the Sunshine Genetics Pilot Program; the Sunshine
9 Genetics Consortium.—
10 (1) The Florida Institute for Pediatric Rare Diseases is
11 established within the Florida State University College of
12 Medicine as a statewide resource for pediatric rare disease
13 research and clinical care. The purpose of the institute is to
14 improve the quality of life and health outcomes for children and
15 families affected by rare diseases by advancing knowledge,
16 diagnosis, and treatment of pediatric rare diseases through
17 research, clinical care, education, and advocacy.
18 (2) The goals of the institute are to:
19 (a) Conduct research to better understand the causes,
20 mechanisms, and potential treatments for pediatric rare
21 diseases, including leveraging emerging research methods.
22 (b) Develop advanced diagnostic and genetic screening tools
23 and techniques to enable health care providers to identify rare
24 diseases in newborns and children more rapidly, accurately, and
25 economically.
26 (c) Provide comprehensive multidisciplinary clinical
27 services and care for children with rare diseases. Such care may
28 include, but is not limited to, patient, family, and caregiver
29 support and resources to help navigate the challenges associated
30 with these conditions, support groups, and patient advocacy.
31 (d) Educate and train health care professionals, including,
32 but not limited to, genetic counselors, pediatricians,
33 scientists, and other specialists in the field of pediatric rare
34 diseases.
35 (e) Establish collaborations with other research
36 institutions, medical centers, patient and family advocacy
37 organizations, and government agencies whenever deemed
38 appropriate by the institute director to share expertise, raise
39 awareness, and promote a collective effort to tackle pediatric
40 rare diseases.
41 (3)(a) The institute shall establish and administer the
42 Sunshine Genetics Pilot Program to be administered for a period
43 of 5 years. The pilot program shall provide newborn genetic
44 screening, including, but not limited to, whole genome
45 sequencing. Genetic screening shall be performed by the
46 institute and institutional members of the oversight board upon
47 approval of the oversight board.
48 (b) The institute may establish partnerships with Florida
49 universities and colleges and health care service providers to
50 promote and assist in the implementation of the pilot program.
51 (c) The pilot program shall be an opt-in program and a
52 parent of a newborn must provide consent to participate in the
53 pilot program.
54 (d) The institute and institutional members of the
55 oversight board shall release clinical findings of a newborn’s
56 screening to the newborn’s health care practitioner and the
57 newborn’s parent. As used in this paragraph, the term “health
58 care practitioner” means a physician or physician assistant
59 licensed under chapter 458; an osteopathic physician or
60 physician assistant licensed under chapter 459; an advanced
61 practice registered nurse, registered nurse, or licensed
62 practical nurse licensed under part I of chapter 464; a midwife
63 licensed under chapter 467; a speech-language pathologist or
64 audiologist licensed under part I of chapter 468; a dietitian or
65 nutritionist licensed under part X of chapter 468; or a genetic
66 counselor licensed under part III of chapter 483.
67 (e) The institute shall:
68 1. Maintain a secure database to collect and store all
69 pilot program data, including, but not limited to, newborn
70 genomics sequence data and deidentified newborn data.
71 2. Provide deidentified newborn data to members of the
72 consortium pursuant to a data sharing agreement to support
73 ongoing and future research.
74 (f) By December 1, 2030, the institute shall provide a
75 report on the Sunshine Genetics Pilot Program to the Governor,
76 the President of the Senate, and the Speaker of the House of
77 Representatives. The report must include, at a minimum:
78 1. Study population and enrollment metrics.
79 2. Whole genome sequencing metrics.
80 3. Clinical and public health impact.
81 4. Cost effectiveness and economic benefits.
82 (4)(a) The Sunshine Genetics Consortium is established to
83 create a network of clinical and academic research
84 professionals, geneticists, and physicians from state
85 universities and this state’s children’s hospitals to
86 collaborate with leaders in the genetic industry and build and
87 support a culture of collaborative research and the development
88 of cutting-edge genetic and precision medicine in the state. The
89 consortium shall:
90 1. Integrate state-of-the-art genomic sequencing
91 technologies.
92 2. Advance research and the development of cutting-edge
93 genetic and precision medicine.
94 3. Leverage advancements in artificial intelligence
95 utilization in genomics.
96 4. Develop educational opportunities for clinicians on
97 genomic tools.
98 5. Support the growth and education of geneticists to meet
99 demand.
100 6. Solicit and leverage funds from nonprofits, private
101 industry, and others for the purpose of expanding the Sunshine
102 Genetics Pilot Program and to support genetic screenings by
103 institutional members of the oversight board.
104 7. Promote patient care that supports families with
105 children diagnosed with genetic disorders.
106 8. Report on the use of deidentified newborn data by
107 members of the consortium.
108 (b)1. The consortium shall be administered at the institute
109 by an oversight board. The board shall convene at least once
110 every 6 months.
111 2. The oversight board for the consortium shall consist of
112 the director of the institute, who shall serve as chair, and the
113 following voting members, who shall serve 2-year terms:
114 a. One member nominated by the dean of the University of
115 Florida’s College of Medicine and approved by the university’s
116 president.
117 b. One member nominated by the dean of the University of
118 South Florida’s College of Medicine and approved by the
119 university’s president.
120 c. One member nominated by the dean of the University of
121 Miami’s School of Medicine and approved by the university’s
122 president.
123 d. One member nominated by the dean of Florida
124 International University’s School of Medicine and approved by
125 the university’s president.
126 e. One member nominated by Nicklaus Children’s Hospital and
127 approved by the hospital’s president and chief executive
128 officer.
129 f. One member appointed by the Governor.
130 g. One member appointed by the President of the Senate.
131 h. One member appointed by the Speaker of the House of
132 Representatives.
133 3. The board shall be responsible for the promotion and
134 oversight of the consortium, including, but not limited to, the
135 nomination and appointment of members of the consortium.
136 (c) Beginning October 15, 2026, and annually thereafter,
137 the consortium shall provide a report to the Governor, the
138 President of the Senate, and the Speaker of the House of
139 Representatives on research projects, research findings,
140 community outreach initiatives, and future plans for the
141 consortium.
142 (5) The provisions of this section shall be implemented to
143 the extent of available appropriations contained in the annual
144 General Appropriations Act for such purpose.
145 Section 2. This act shall take effect July 1, 2025.
146
147 ================= T I T L E A M E N D M E N T ================
148 And the title is amended as follows:
149 Delete everything before the enacting clause
150 and insert:
151 A bill to be entitled
152 An act relating to the Florida Institute for Pediatric
153 Rare Diseases; creating s. 1004.4211, F.S.;
154 establishing the Florida Institute for Pediatric Rare
155 Diseases within the Florida State University College
156 of Medicine; providing the purpose of the institute;
157 providing the goals of the institute; requiring the
158 institute to establish and administer the Sunshine
159 Genetics Pilot Program for a specified period;
160 providing the purpose of the pilot program; providing
161 institute responsibilities and duties relating to the
162 pilot program; providing requirements for
163 participation in the pilot program and data collection
164 and release in the pilot program; defining the term
165 “health care practitioner”; providing reporting
166 requirements for the pilot program; establishing the
167 Sunshine Genetics Consortium for specified purposes;
168 requiring the consortium to be administered at the
169 institute by an oversight board; providing for the
170 membership and terms of the board; providing reporting
171 requirements for the consortium; specifying that
172 implementation of the act is subject to appropriation;
173 providing an effective date.