LEGISLATIVE FISCAL ESTIMATE
ASSEMBLY, No. 5592
STATE OF NEW JERSEY
221st LEGISLATURE
DATED: JULY 3, 2025
SUMMARY
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Synopsis: |
Establishes licensure requirement for source plasma donation centers. |
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Type of Impact: |
Annual increase in State expenditures and revenues. |
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Agencies Affected: |
Department of Health, Judiciary. |
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Office of Legislative Services Estimate |
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Fiscal Impact |
Annual |
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State Expenditure Increase |
Indeterminate |
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State Revenue Increase |
Indeterminate |
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· The Office of Legislative Services (OLS) concludes that Department of Health costs will increase by an indeterminate amount annually to establish and enforce a separate licensure and regulatory system for source plasma donation centers, which are currently regulated by the department as blood banks.
· Based on an analysis conducted by the California Legislature of AB 725 (2025), the OLS concludes that the department will face indeterminate up-front costs to hire additional staff and develop or purchase an information technology platform for the source plasma donation licensing program. These costs will be incurred prior to the point at which the department will begin collecting applicants’ licensing fees.
· Given that the OLS cannot anticipate either the amount of the initial or renewal licensing fees that the department will charge, or the number of license applicants, the magnitude of the bill’s revenue impact is indeterminate.
· State revenues will further increase, albeit by an indeterminate amount, attributable to penalties paid by licensed source plasma donation centers that are found to be in violation of the bill’s provisions.
BILL DESCRIPTION
The bill requires source plasma donation centers to apply annually for a license from the Department of Health in order to operate within the State, and directs the department to establish the process by which source plasma donation center operators will apply for licensure, as well as the requisite initial and renewal licensure fees. The initial licensure fee for a source plasma donation center that is operating prior to the bill’s effective date will be $25. The income received from the licensure and renewal fees will be appropriated to the department to implement the bill’s requirements.
The department will promulgate rules and regulations governing the donations of source plasma, in accordance with federal regulations and voluntary industry standards. The department is authorized to enter and inspect any source plasma donation center, and to investigate the center’s premises, books, and records.
The department is authorized to enforce violations of the licensure standards established under the bill, and to suspend, revoke, and refuse to grant a license to an applicant. A licensee may request a hearing on a disputed violation, with the department rendering a decision on the violation within 48 hours. If the department rules against the licensee, the licensee may apply for injunctive relief in the Superior Court of New Jersey. Under the bill, first-time violators will be assessed a penalty ranging from $100 to $1,000, while repeat offenders will face a fine ranging between $500 and $5,000.
FISCAL ANALYSIS
EXECUTIVE BRANCH
None received.
OFFICE OF LEGISLATIVE SERVICES
The OLS concludes that Department of Health expenditures will increase by an indeterminate amount annually to establish and enforce a separate licensure and regulatory system for source plasma donation centers, which are currently regulated by the department as blood banks. To the extent that the department’s enforcement of the newly-established source plasma donation center licensing requirements results in an increased number of applications for injunctive relief in the Superior Court of New Jersey, as permitted under the bill, costs to the Judiciary may increase.
The OLS assumes that the department will establish initial and renewal licensure fees at the level necessary to support the department’s costs for personnel and information technology infrastructure necessary to regulate the State’s source plasma donation centers. However, the OLS cannot anticipate either the amount of the licensing fee that the department will establish, or the number of applicants for licensure.
State revenues will further increase, albeit by an indeterminate amount, attributable to penalties paid by licensed source plasma donation centers that are found to be in violation of the bill’s provisions. Given that the bill provides for a range of penalties, which will depend upon the severity and frequency of the violations, the OLS cannot determine the amount by which penalty collections will affect State revenues.
For context, an analysis by the California Assembly Committee on Appropriations of AB 725 (2025), which requires the California Department of Public Health (CDPH) to establish a licensing and enforcement program for source plasma donation centers, projects that the CDPH will incur $3.7 million in additional costs in each of the first two years following the bill’s effective date, and $2.53 million in annual costs thereafter to hire additional staff, promulgate regulations, and establish an information technology platform for the licensing program. Although AB 725 specifies that the licensing application fee will be set at an amount to cover CDPH costs to administer the licensing program, the analysis notes that the CDPH will incur substantive costs before it can begin collecting licensing fees.
The OLS concludes that the department will similarly face indeterminate up-front costs to hire additional staff and develop or purchase an information technology platform for the source plasma donation licensing program. These costs will be incurred prior to the point at which the department will begin collecting applicants’ licensing fees. Since the department’s Office of Clinical Laboratory Improvement Services currently licenses and regulates source plasma donation centers as blood banks, the department could potentially minimize costs for the source plasma donation center licensing program by reassigning certain staff who have blood bank regulatory expertise to the new licensing program. Similarly, to the extent that the department can adapt existing information technology platforms used by the blood bank licensing program to the source plasma donation center licensing program, State costs may be reduced.
Under existing statute and regulations, the department assesses a licensure fee of $100.00 from blood banks that serve as collection centers, plus a variable fee that is based upon the annual number of collections made by the facility. These variable fees range from $250.00 for a facility that performs up to 200 collections annually to $1,900.00 for a facility that makes more than 50,000 collections annually.
A source plasma donation center is a facility, other than a blood bank, which utilizes plasmapheresis to separate the fluid portion of human blood for use as source material for plasma protein therapies. Plasma protein therapies are used to treat a variety of medical conditions, many of which are rare genetic conditions. Source plasma donation centers are regulated by the federal Food and Drug Administration, in addition to the department. Moreover, the International Quality Plasma Program, which is operated by the Plasma Protein Therapeutics Association (PPTA), offers a voluntary certification program for source plasma donation centers. According to a search of a PPTA database, 12 source plasma donation centers currently operate in the State.
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Section: |
Human Services |
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Analyst: |
Senior Fiscal Analyst |
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Approved: |
Thomas Koenig Legislative Budget and Finance Officer |
This legislative fiscal estimate has been produced by the Office of Legislative Services due to the failure of the Executive Branch to respond to our request for a fiscal note.
This fiscal estimate has been prepared pursuant to P.L.1980, c.67 (C.52:13B-6 et seq.).