HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/HB 1441 Department of Health
SPONSOR(S): Health & Human Services Committee, Health Care Appropriations Subcommittee, Anderson
TIED BILLS: IDEN./SIM. BILLS: SB 1582
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY
CHIEF
1) Healthcare Regulation Subcommittee 19 Y, 0 N Osborne McElroy
2) Health Care Appropriations Subcommittee 14 Y, 0 N, As Aderibigbe Clark
CS
3) Health & Human Services Committee 19 Y, 0 N, As Osborne Calamas
CS
SUMMARY ANALYSIS
In the United States, a rare disease is any condition that nationally affects fewer than 200,000 people. There
may be as many as 7,000 rare diseases impacting the lives of 25-30 million Americans and their families. 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 genetic rare diseases, genetic testing is
often the only way to make a definitive diagnosis. 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 health care settings where their
condition may have never been seen before.
In 2023, the Legislature allocated $500,000 in General Revenue funds in the General Appropriations Act for
pediatric rare disease research grants.
CS/CS/HB 1441 establishes the Andrew John Anderson Pediatric Rare Disease Grant Program (Program)
within DOH with the purpose of advancing the progress of research and cures for rare pediatric diseases. The
Program establishes grants for scientific and clinical research to further the search for new diagnostics,
treatments, and cures for pediatric rare diseases.
Any university or established research institute located in this state may apply for a grant under the Program.
The bill establishes a preference for grant proposals which foster collaboration among institutions, researchers,
and community practitioners.
The bill requires DOH to award Program grants through a competitive, peer-reviewed process. The bill requires
DOH to appoint peer review panels of independent, scientifically qualified individuals to review the scientific
merit of each proposal and establish its priority score. DOH must provide the priority score to the RDAC which
must consider the priority score in its recommendations for funding. DOH, after consultation with the RDAC,
will award grants to selected applicants.
The bill has a significant, negative fiscal impact on state government. See Fiscal Comments. The bill has no
fiscal impact on local governments.
The bill provides an effective date of July 1, 2024.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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 FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
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 7,000 rare diseases impacting the lives of 25-30 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 genetic rare diseases, genetic
testing is often the only way to make a definitive diagnosis. 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
health care settings where their condition may have never been seen before. 2
In 2023, the Legislature allocated $500,000 in General Revenue funds in the General Appropriations
Act for pediatric rare disease research grants.3
Rare Disease Advisory Council
The Legislature established the Rare Disease Advisory Council (RDAC) in 2021 to assist the
Department of Health (DOH) in providing recommendations to improve health outcomes for individuals
with rare diseases residing in the state.4
The establishment of RDACs across the country is an initiative spearheaded by the National
Organization for Rare Disorders (NORD),5 a national nonprofit group advocating for individuals and
families affected by rare diseases.6 Florida was the 19th state to establish a RDAC through legislation.7
Florida’s RDAC is directed to:8
 Consult with experts on rare diseases and solicit public comment to assist in developing
recommendations on improving the treatment of rare diseases in Florida;
 Develop recommended strategies for academic research institutions in Florida to facilitate
continued research on rare diseases;
1 National Organization for Rare Diseases, Rare Disease Day: Frequently Asked Questions. Available at https://rarediseases.org/wp-
content/uploads/2019/01/RDD-FAQ-2019.pdf (last visited January 19, 2024).
2
Department of Health, Rare Disease Advisory Council: Legislative Report, Fiscal Year 2022-2023 (2023). Available at
https://www.floridahealth.gov/provider-and-partner-resources/rdac/_documents/RDACLegislativeReport2023Final_Draft.pdf (last visited
January 20, 2024).
3 Ch. 2023-239, L.O.F., line item 539A; See also, Department of Health, Agency Analysis of HB 1441 (2024). On file with the
Healthcare Regulation Subcommittee.
4 S. 381.99, F.S.
5 National Organization for Rare Disorders (NORD). Project RDAC Year One (2021). Available at https://rarediseases.org/wp-
content/uploads/2021/11/NRD-2200-RDAC-Year1-Highlights_FNL.pdf (last visited January 20, 2024).
6 National Organization for Rare Disorders (NORD). Ab out Us. Available at https://rarediseases.org/about-us/ (last visited January 20,
2024).
7 Supra, note 2.
8 S. 381.99(4), F.S.; See also, the Rare Disease Advisory Council’s 2 nd Legislative Report at: https://www.floridahealth.gov/provider-
and-partner-resources/rdac/_documents/RDACLegislativeReport2023Final_Draft.pdf
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  Develop recommended strategies for health care providers to be informed on how to more
efficiently recognize and diagnose rare diseases in order to effectively treat patients; and
 Provide input and feedback in writing to DOH, the Medicaid program, and other state agencies
on matters that affect people who have been diagnosed with rare diseases.
Effect of Proposed Changes
CS/CS/HB 1441 establishes the Andrew John Anderson Pediatric Rare Disease Grant Program
(Program) within DOH with the purpose of advancing the progress of research and cures for rare
pediatric diseases. The Program establishes grants for scientific and clinical research to further the
search for new diagnostics, treatments, and cures for pediatric rare diseases.
Any university or established research institute located in this state may apply for a grant under the
Program. The bill establishes a preference for grant proposals which foster collaboration among
institutions, researchers, and community practitioners.
The bill requires DOH to award Program grants through a competitive, peer-reviewed process. The bill
requires DOH to appoint peer review panels of independent, scientifically qualified individuals to review
the scientific merit of each proposal and establish its priority score. DOH must provide the priority score
to the RDAC which must consider the priority score in its recommendations for funding. DOH, after
consultation with the RDAC, will award grants to selected applicants.
The Program is subject to an appropriation. The bill grants that the balance of any appropriation from
the General Revenue Fund for the program which has not been disbursed, but which is obligated
under a contract or committed to be expended June 30th of the Fiscal Year, may be carried forward
for up to five years after the effective date of the original appropriation.
The bill provides an effective date of July 1, 2024.
B. SECTION DIRECTORY:
Section 1: Creates s. 381.991, F.S., relating to the Andrew John Anderson Pediatric Rare Disease
Grant Program.
Section 2: Provides an effective date of July 1, 2024.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
None.
2. Expenditures:
The Andrew John Anderson Pediatric Rare Disease Grant Program is subject to appropriation.
See Fiscal Comments.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
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 None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Private research institutions who are eligible for the Andrew John Anderson Pediatric Rare Disease
Grant Program may experience a positive fiscal impact from access to this additional funding.
D. FISCAL COMMENTS:
Andrew John Anderson Pediatric Rare Disease Grant Program
According to DOH, the $500,000 that was allocated in the 2023 General Appropriations Act to fund
research grants for pediatric rare diseases is intended fund the inaugural year of the Andrew John
Anderson Pediatric Rare Disease Grant Program.9
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
Not applicable. The bill does not appear to affect county or municipal governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
The bill provides sufficient rulemaking authority to implement the provisions of the bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
On January 29, 2024, the Health Care Appropriations Subcommittee adopted an amendment and reported the
bill favorably as a committee substitute. The amendment removed language related to the Telehealth Minority
Maternity Care Pilot Program.
On February 22, 2024, the Health and Human Services Committee adopted an amendment and reported the
bill favorable. The amendment made technical changes to the Andrew John Anderson Pediatric Rare Disease
Grant Program and removed all other provisions of the bill.
This analysis is drafted to the committee substitute as passed by the Health and Human Services Committee.
9Id.
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Statutes affected:
H 1441 Filed: 383.147, 383.2163, 383.318, 395.1053, 456.0496
H 1441 c1: 383.147, 383.318, 395.1053, 456.0496