The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Education Postsecondary
BILL: SB 1356
INTRODUCER: Senator Burton
SUBJECT: Florida Institute for Pediatric Rare Diseases
DATE: March 14, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Jahnke Bouck HE Pre-meeting
2. AHS
3. FP
I. Summary:
SB 1356 codifies the Florida Institute for Pediatric Rare Diseases (Institute) within the Florida
State University College of Medicine as a statewide resource dedicated to research and clinical
care related to pediatric rare diseases. The Institute will conduct research, develop diagnostic and
genetic screening tools, provide multidisciplinary clinical services and care, educate and train
healthcare professionals, and collaborate with other institutions and organizations.
The bill requires the Institute to establish and administer the Sunshine Genetics Pilot Program for
3 years. This opt-in pilot program provides genetic screening to newborns, including whole
genome sequencing, contingent upon parental consent. Clinical findings from the screening must
be released to the parent’s healthcare practitioner. The institute is required to maintain a secure
database of pilot program data and provide deidentified data to support research.
Additionally, the bill establishes the Sunshine Genetics Consortium (Consortium) to facilitate
collaboration among researchers, geneticists, and physicians from Florida’s state universities and
children's hospitals. The Consortium’s responsibilities include integrating genomic sequencing
technologies, advancing genetic and precision medicine research, educating healthcare
professionals, leveraging artificial intelligence in genomics, and securing external funding to
expand genetic screening efforts. An oversight board appointed from state universities and
government officials will administer the Consortium and meet periodically.
The bill appropriates $5 million in recurring funds from the General Revenue Fund for Fiscal
Year 2025-2026 to support the Institute, with an additional appropriation of $20 million in
nonrecurring funds specifically designated for launching whole genome sequencing at birthing
centers.
The bill takes effect July 1, 2025.
REVISED:
BILL: SB 1356 Page 2
II. Present Situation:
Rare Diseases
In the United States, a rare disease is any condition that nationally affects fewer than 200,000
people. There may be as many as 10,000 rare diseases impacting the lives of 30 million
Americans and their families.
1
So, while the individual diseases may be rare, the total number of
people impacted by a rare disease is large. Rare diseases include genetic disorders, infectious
diseases, cancers, and various other pediatric and adult conditions. A rare disease can affect
anyone at any point in their life and can be acute or chronic. It is estimated that 80 percent or
more of rare diseases are genetic. For rare genetic diseases, genetic testing is often the only way
to make a definitive diagnosis.
2
Rare diseases present a fundamentally different array of challenges compared to those of more
common diseases; often, patients are set on a “diagnostic odyssey” in order to determine the
cause of their symptoms as they seek treatment in healthcare settings where their condition may
have never been seen before.
3
The Andrew John Anderson Pediatric Rare Disease Grant Program
In 2024, the Florida Legislature established the Andrew John Anderson Pediatric Rare Disease
Grant Program (Grant Program) within the Department of Health (DOH) to support research on
pediatric rare diseases. The Grant Program awards grants through a competitive, peer-reviewed
process to advance new diagnostics, treatments, and cures.
4
The DOH, in consultation with the Rare Diseases Advisory Council,
5
awards grants to
universities and established research institutes in Florida for scientific and clinical research.
Preference may be given to proposals that foster collaborations among institutions, researchers,
and community practitioners.
6
In both 2023 and 2024, the Legislature appropriated $500,000 for the Grant Program.
7
1
National Organization for Rare Diseases (NORD), NORD Rare Disease Database, https://rarediseases.org/rare-diseases/
(last visited Mar. 10, 2025).
2
Department of Health, Rare Disease Advisory Council: Legislative Report, Fiscal Year 2023-2024 (2024), at 6-7, available
at https://www.floridahealth.gov/provider-and-partner-resources/rdac/_documents/2024-rdac-annual-report.pdf.
3
Id.
4
Section 381.991(1)(a), F.S.; See also ch. 224-246, Laws of Fla.
5
See Section 381.99, F.S. The Rare Disease Advisory Council is created adjunct to the DOH for the purpose of providing
recommendations on ways to improve health outcomes for individuals residing in this state who have a rare disease.
6
Section 381.991(1)(b) – (2)(a), F.S. See also, Florida Health, Rare Pediatric Diseases Research Grant Program,
https://www.floridahealth.gov/provider-and-partner-resources/research/research-
programs1/RarePediatricDiseasesResearchGrantProgram.html (last visited Mar. 10, 2025).
7
Specific Appropriation 539A, s. 3, ch. 2023-239, Laws of Fla., and Specific Appropriation 546A, s. 3, ch. 2024-231, Laws
of Fla. BILL: SB 1356 Page 3
Florida State University Institute for Pediatric Rare Diseases
In 2024, Florida State University (FSU) established the Institute for Pediatric Rare Diseases
(Institute) at the FSU College of Medicine. It is the mission of the Institute to transform the lives
of children affected by rare diseases through research, education, diagnosis, and clinical care.
8
The goals include:
9
• Harnessing interdisciplinary collaboration by bringing together scientists, clinicians, and
educators to address the challenges of pediatric rare diseases.
• Leveraging advancements in gene therapy and immune response research to improve
treatment outcomes.
• Enhancing the quality of life for the 15 million children across the United States affected by
pediatric rare diseases.
In 2023, the Legislature allocated $1,000,000 to the Institute,
10
and another $5,000,000 in 2024.
11
Newborn Screening Program
The Legislature created the Florida Newborn Screening Program (NSP) within the DOH, to
promote the screening of all newborns for metabolic, hereditary, and congenital disorders known
to result in significant impairment of health or intellect.
12
The NSP also promotes the
identification and screening of all newborns in the state and their families for environmental risk
factors such as low income, poor education, maternal and family stress, emotional instability,
substance abuse, and other high-risk conditions associated with increased risk of infant mortality
and morbidity to provide early intervention, remediation, and prevention services.
13
The NSP attempts to screen all newborns for hearing impairment and to identify, diagnose, and
manage newborns at risk for select disorders that, without detection and treatment, can lead to
permanent developmental and physical damage or death.
14
The NSP is intended to screen all
prenatal women and newborns, however, parents and guardians may choose to decline the
screening.
15
8
Florida State University, Florida State University News, FSU launches groundbreaking Institute for Pediatric Rare
Diseases, https://news.fsu.edu/news/health-medicine/2024/02/01/fsu-launches-groundbreaking-institute-for-pediatric-rare-
diseases/; See also, Florida State University, Institute for Pediatric Rare Diseases, https://med.fsu.edu/iprd/home (last visited
Mar. 10, 2025).
9
Id.
10
Specific Appropriation 143, s. 2, ch. 2023-239, L.O.F.
11
Specific Appropriation 147, s. 2, ch. 2024-231, L.O.F.
12
Section 383.14(1), F.S.
13
Section 383.148(1), F.S
14
Florida Department of Health, Florida Newborn Screening 2022 Guidelines, available at
https://floridanewbornscreening.com/wp-content/uploads/NBS-Protocols-2022-FINAL.pdf. See also, Florida Newborn
Screening, https://floridanewbornscreening.com/ (last visited Mar. 10, 2025)
15
Section 383.14(4), F.S.; Rule 64C-7.008, F.A.C.; The hospital provider shall request any parent or guardian who objects to
infant (postnatal) risk screening of their child or ward, after the purpose of the screening has been fully explained, to indicate
the objection in writing on the electronic birth record risk screening instrument. BILL: SB 1356 Page 4
Newborn screenings are completed after the baby is 24 hours of age and before discharge from
the hospital. For births outside a hospital setting, the birth provider either completes the
screening or arranges for testing within 1- 2 days after birth.
16
The Florida Genetics and Newborn Screening Advisory Council advises the DOH on disorders
to be included in the NSP panel of screened disorders and the procedures for collecting and
transmitting specimens.
17
Florida’s NSP currently screens for 58 conditions, 55 of which are
screened through the collection of blood spots.
18
Healthcare providers collect drops of blood
from the newborn’s heel on a standardized specimen collection card which is then sent to the
state laboratory for testing.
19
If necessary, healthcare providers refer patients to the appropriate health, education, and social
services.
20
Screening results are released to the newborn’s healthcare provider; in the event of an
abnormal result, the baby’s healthcare provider or a nurse or specialist from NSP’s Follow-up
Program provides follow-up services and referrals for the child and his or her family.
21
III. Effect of Proposed Changes:
SB 1356 creates s. 1004.4210, F.S., to codify the Florida Institute for Pediatric Rare Diseases
(Institute) within the Florida State University College of Medicine as a statewide resource for
pediatric rare disease research and clinical care. The Institute's purpose is to enhance the quality
of life and health outcomes for children and families affected by rare diseases by advancing
knowledge, diagnosis, and treatment of pediatric rare diseases through research, clinical care,
education, and advocacy. The bill specifies the goals of the institute, which are:
• Conducting research to better understand the causes, mechanisms, and potential treatments
for pediatric rare diseases.
• Developing advanced diagnostic and genetic screening tools and techniques.
• Providing comprehensive, multidisciplinary clinical services and care for affected children
and their families.
• Educating and training healthcare professionals, including genetic counselors, pediatricians,
and other specialists.
• Establishing collaborations with other research institutions, advocacy organizations, and
government agencies.
The bill requires the Institute to establish and administer the Sunshine Genetics Pilot Program for
three years, offering genetic testing to newborns in addition to the state’s existing newborn
screening program. The Institute must partner with qualified state universities, colleges, and
healthcare service providers to implement the pilot program and deliver and analyze genetic
16
Florida Newborn Screening, What is Newborn Screening?, https://floridanewbornscreening.com/parents/what-is-newborn-
screening/ (last visited Mar. 10, 2025).
17
Section 383.14(6)(a), F.S.
18
Department of Health, 2024 Agency Analysis of HB 1441 (Feb. 5, 2024).
19
Florida Newborn Screening Program, What is Newborn Screening? available at
https://floridanewbornscreening.com/parents/what-is-newborn-screening/ (last visited March 10, 2025). See also, Florida
Newborn Screening, Specimen Collection Card, http://floridanewbornscreening.com/wp-content/uploads/Order-Form.png
(last visited March 10, 2025).
20
Id.
21
Department of Health, 2024 Agency Analysis of HB 1441 (Feb. 5, 2024). BILL: SB 1356 Page 5
testing results for the pilot program. Parental consent is required for participation and all testing
data and reports will be delivered to the parent’s healthcare provider.
The bill requires the Institute to:
• Conduct the pilot program in compliance with s. 760.40, F.S., which governs genetic testing.
• Maintain a secure database to store all pilot program data, including newborn testing data.
• Deidentify all patient data.
• Enter into an agreement with the Consortium to share deidentified patient data upon the
approval of the board of the Sunshine Genetics Consortium.
• Provide a report to the Governor, the President of the Senate, and the Speaker of the House
of Representatives upon the completion of the pilot program.
The bill also establishes the Sunshine Genetics Consortium (Consortium) to create a network of
clinical and academic research professionals, geneticists, and physicians from state universities
and the state’s children’s hospitals to collaborate with leaders in the genetic industry, build, and
support a culture of collaborative research and the development of cutting-edge genetic and
precision medicine in the state.
The Consortium will:
• Integrate state-of-the-art genomic sequencing technologies.
• Create a biorepository network and database for ongoing and future research.
• Leverage artificial intelligence in genomics.
• Develop clinician education on genomic tools.
• Support education and growth of geneticists to meet demand.
• Solicit external funding to expand the pilot program.
• Promote patient care to support families with children diagnosed with genetic disorders.
• Annually report to the Governor, the President of the Senate, and the Speaker of the House of
Representatives.
The bill requires the Consortium to be administrated at the Institute by an oversight board and
meet periodically. The oversight board is required to serve two-year terms and consist of the
following voting members:
• One member from the Florida State University to be appointed by the Dean of the College of
Medicine.
• One member from the University of Florida to be appointed by the Dean of the College of
Medicine.
• One member from the University of South Florida to be appointed by the Dean of the
College of Medicine.
• One member from the University of Miami to be appointed by the Dean of the College of
Medicine.
• One member appointed by the Governor.
• One member appointed by the President of the Senate.
• One member appointed by the Speaker of the House of Representatives.
The oversight board is responsible for the technical performance and financial management of
the Consortium. BILL: SB 1356 Page 6
The bill appropriates $5 million in recurring funds from the General Revenue Fund for Fiscal
Year 2025-2026 to support the Institute, with an additional appropriation of $20 million in
nonrecurring funds specifically designated for launching whole genome sequencing at birthing
centers.
The bill takes effect July 1, 2025.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None.
C. Government Sector Impact:
The bill appropriates $5 million in recurring funds from the General Revenue Fund for
Fiscal Year 2025-2026 to support the Institute, with an additional appropriation of $20
million in nonrecurring funds specifically designated for launching whole genome
sequencing at birthing centers.
. BILL: SB 1356 Page 7
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill creates section 1004.4210 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.