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SB-883 Umbilical Cord Blood Collection Program.(2021-2022)



Current Version: 09/27/22 - Chaptered

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SB883:v96#DOCUMENT

Senate Bill No. 883
CHAPTER 604

An act to amend Sections 1627, 1629.5, and 103625 of, and to repeal and add Section 1630 of, the Health and Safety Code, relating to public health.

[ Approved by Governor  September 27, 2022. Filed with Secretary of State  September 27, 2022. ]

LEGISLATIVE COUNSEL'S DIGEST


SB 883, Roth. Umbilical Cord Blood Collection Program.
Existing law requests the University of California to establish and administer the Umbilical Cord Blood Collection Program, until January 1, 2023, for the purpose of collecting units of umbilical cord blood for public use, as defined, in transplantation and providing nonclinical units for specified research. Existing law requires the University of California, by January 1, 2022, if it elects to administer the program, to provide a report to the Assembly and Senate Committees on Health that addresses specified information relating to the program, including the number of cord blood units collected and registered under the program, disaggregated by race and ethnicity.
This bill would extend the provisions of the program until January 1, 2027. The bill would require the University of California, by January 1, 2026, if it elects to administer the program, to provide a report to the Assembly and Senate Committees on Health that addresses specified information relating to the program.
Existing law requires any funds made available for purposes of the program to be deposited into the Umbilical Cord Blood Collection Program Fund. Under existing law, moneys in the fund are available, upon appropriation by the Legislature, for purposes of the program.
Existing law, until January 1, 2023, requires the collection of an $18 fee for certified copies of birth certificates, except as specified. Under existing law, $2 of the fee is required to be paid to the fund. Existing law, to be operative January 1, 2023, reduces the fee for certified copies of birth certificates to $16 and eliminates the requirement that $2 of the fee be paid to the fund.
This bill would extend both of those dates until January 1, 2027. By extending the collection of the $2 fee to be paid to the fund for 4 additional years, the bill would impose a tax.
Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 1627 of the Health and Safety Code is amended to read:

1627.
 (a) (1) The University of California is requested to develop a plan to establish and administer the Umbilical Cord Blood Collection Program for the purpose of collecting units of umbilical cord blood for public use in transplantation and providing nonclinical units for research pertaining to biology and new clinical utilization of stem cells derived from the blood and tissue of the placenta and umbilical cord. The program shall conclude no later than January 1, 2027.
(2) For purposes of this article, “public use” means both of the following:
(A) The collection of umbilical cord blood units from genetically diverse donors that will be owned by the University of California. This inventory shall be accessible by the National Registry and by qualified California-based and other United States and international registries and transplant centers to increase the likelihood of providing suitably matched donor cord blood units to patients or research participants who are in need of a transplant.
(B) Cord blood units with a lower number of cells than deemed necessary for clinical transplantation and units that meet clinical requirements, but for other reasons are unsuitable, unlikely to be transplanted, or otherwise unnecessary for clinical use, may be made available for research.
(b) (1) In order to implement the collection goals of this program, the University of California may, commensurate with available funds appropriated to the University of California for this program, contract with one or more selected applicant entities that have demonstrated the competence to collect and ship cord blood units in compliance with federal guidelines and regulations.
(2) It is the intent of the Legislature that, if the University of California contracts with another entity pursuant to this subdivision, the following shall apply:
(A) The University of California may use a competitive process to identify the best proposals submitted by applicant entities to administer the collection and research objectives of the program, to the extent that the University of California chooses not to undertake these activities itself.
(B) In order to qualify for selection under this section to receive, process, cryopreserve, or bank cord blood units, the entity shall, at a minimum, have obtained an investigational new drug (IND) exemption from the FDA or a biologic license from the FDA, as appropriate, to manufacture clinical grade cord blood stem cell units for clinical indications.
(C) In order to qualify to receive appropriate cord blood units and placental tissue to advance the research goals of this program, an entity shall, at a minimum, be a laboratory recognized as having performed peer-reviewed research on stem and progenitor cells, including those derived from placental or umbilical cord blood and postnatal tissue.
(3) A medical provider or research facility shall comply with, and shall be subject to, existing penalties for violations of all applicable state and federal laws with respect to the protection of any medical information, as defined in Section 56.05 of the Civil Code, and any personally identifiable information contained in the umbilical cord blood inventory.
(c) The University of California is encouraged to make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage existing resources.
(d) (1) All information collected pursuant to the program shall be confidential, and shall be used solely for the purposes of the program, including research. Access to confidential information shall be limited to authorized persons who are bound by appropriate institutional policies or who otherwise agree, in writing, to maintain the confidentiality of that information.
(2) Any person who, in violation of applicable institutional policies or a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section, may be denied further access to any confidential information maintained by the University of California, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided for in this section shall not be construed to limit or otherwise restrict any remedy, provisional or otherwise, provided by law for the benefit of the University of California or any other person covered by this section.
(3) Notwithstanding the restrictions of this section, an individual to whom the confidential information pertains shall have access to their own personal information.
(e) It is the intent of the Legislature that the plan and implementation of the program provide for both of the following:
(1) Limit fees for access to cord blood units to the reasonable and actual costs of storage, handling, and providing units, as well as for related services such as donor matching and testing of cord blood and other programs and services typically provided by cord blood banks and public use programs.
(2) The submittal of the plan developed pursuant to subdivision (a) to the health and fiscal committees of the Legislature.
(f) It is additionally the intent of the Legislature that the plan and implementation of the program attempt to provide for all of the following:
(1) Development of a strategy to increase voluntary participation by hospitals in the collection and storage of umbilical cord blood and identify funding sources to offset the financial impact on hospitals.
(2) Consideration of a medical contingency response program to prepare for and respond effectively to biological, chemical, or radiological attacks, accidents, and other public health emergencies where victims potentially benefit from treatment.
(3) Exploration of the feasibility of operating the program as a self-funding program, including the potential for charging users a reimbursement fee.

SEC. 2.

 Section 1629.5 of the Health and Safety Code is amended to read:

1629.5.
 (a) On or before January 1, 2026, if it elects to administer the Umbilical Cord Blood Collection Program, the University of California shall provide a report to the Assembly and Senate Committees on Health that addresses, at a minimum, all of the following:
(1) The number of cord blood units collected and registered under the program, disaggregated by race and ethnicity.
(2) The number of registered units transplanted as a result of the program, disaggregated by race and ethnicity.
(3) The number of California residents receiving a transplant as a result of the program.
(4) The number of units made available for research and a summary of key research findings as a result of the program.
(5) Annual budget information on the program, including revenues, spending, and beginning- and end-of-year balances.
(6) Budget information for each participating cord blood bank, including collection and storage costs and available revenues to cover those costs.
(7) Fees charged by participating cord blood banks for collecting, storing, handling, and providing units, and a summary of how these fees were determined.
(8) Nationwide data on cord blood units collected, registered, and transplanted, disaggregated by race and ethnicity.
(9) A summary of available cell sources for a hematopoietic stem cell transplant and research on the ability of underrepresented groups to find a suitable match for a transplant.
(10) Any other outcomes or data regarding the impact of the program.
(b) The requirement for submitting a report imposed under subdivision (a) is inoperative on December 31, 2026, pursuant to Section 10231.5 of the Government Code.

SEC. 3.

 Section 1630 of the Health and Safety Code is repealed.

SEC. 4.

 Section 1630 is added to the Health and Safety Code, to read:

1630.
 This article shall remain in effect only until January 1, 2027, and as of that date is repealed.

SEC. 5.

 Section 103625 of the Health and Safety Code, as amended by Section 8 of Chapter 38 of the Statutes of 2017, is amended to read:

103625.
 (a) A fee of twelve dollars ($12) shall be paid by the applicant for a certified copy of a fetal death or death record.
(b) (1) A fee of twelve dollars ($12) shall be paid by a public agency or licensed private adoption agency applicant for a certified copy of a birth certificate that the agency is required to obtain in the ordinary course of business. A fee of eighteen dollars ($18) shall be paid by any other applicant for a certified copy of a birth certificate. Four dollars ($4) of any eighteen-dollar ($18) fee is exempt from subdivision (e) and shall be paid either to a county children’s trust fund or to the State Children’s Trust Fund, in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code. Two dollars ($2) of any eighteen-dollar ($18) fee is exempt from subdivision (e) and shall be paid to the Umbilical Cord Blood Collection Program Fund in conformity with Section 1628.
(2) The board of supervisors of any county that has established a county children’s trust fund may increase the fee for a certified copy of a birth certificate by up to three dollars ($3) for deposit in the county children’s trust fund in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code.
(c) A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage record, that has been filed with the county recorder or county clerk, that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage record that has been filed with the county recorder or county clerk. Three dollars ($3) of any six-dollar ($6) fee is exempt from subdivision (e) and shall be transmitted monthly by each local registrar, county recorder, and county clerk to the state for deposit into the General Fund as provided by Section 1852 of the Family Code.
(d) A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage dissolution record obtained from the State Registrar that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage dissolution record obtained from the State Registrar.
(e) Each local registrar, county recorder, or county clerk collecting a fee pursuant to subdivisions (a) to (d), inclusive, shall do the following:
(1) Transmit 15 percent of the fee for each certified copy to the State Registrar by the 10th day of the month following the month in which the fee was received.
(2) Retain 85 percent of the fee for each certified copy solely to support the issuing agency for all activities related to the issuance of certified copies of records pursuant to subdivisions (a) to (d), inclusive.
(f) In addition to the fees prescribed pursuant to subdivisions (a) to (d), inclusive, all applicants for certified copies of the records described in those subdivisions shall pay an additional fee of three dollars ($3), that shall be collected by the State Registrar, the local registrar, county recorder, or county clerk, as the case may be.
(g) The local public official charged with the collection of the additional fee established pursuant to subdivision (f) may create a local vital and health statistics trust fund. The fees collected by local public officials pursuant to subdivision (f) shall be distributed as follows:
(1) Forty-five percent of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.
(2) The remainder of the fee collected pursuant to subdivision (f) shall be deposited into the collecting agency’s vital and health statistics trust fund, except that in any jurisdiction in which a local vital and health statistics trust fund has not been established, the entire amount of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.
(3) Moneys transmitted to the State Registrar pursuant to this subdivision shall be deposited in accordance with Section 102247.
(h) Moneys in each local vital and health statistics trust fund shall be available to the local official charged with the collection of fees pursuant to subdivision (f) for the applicable jurisdiction for the purpose of defraying the administrative costs of collecting and reporting with respect to those fees and for other costs as follows:
(1) Modernization of vital record operations, including improvement, automation, and technical support of vital record systems.
(2) Improvement in the collection and analysis of health-related birth and death certificate information, and other community health data collection and analysis, as appropriate.
(i) Funds collected pursuant to subdivision (f) shall not be used to supplant funding in existence on January 1, 2002, that is necessary for the daily operation of vital record systems. It is the intent of the Legislature that funds collected pursuant to subdivision (f) be used to enhance service to the public, to improve analytical capabilities of state and local health authorities in addressing the health needs of newborn children and maternal health problems, and to analyze the health status of the general population.
(j) Each county shall annually submit a report to the State Registrar by March 1 containing information on the amount of revenues collected pursuant to subdivision (f) in the previous calendar year and on how the revenues were expended and for what purpose.
(k) Each local registrar, county recorder, or county clerk collecting the fee pursuant to subdivision (f) shall transmit 45 percent of the fee for each certified copy to which subdivision (f) applies to the State Registrar by the 10th day of the month following the month in which the fee was received.
(l) The nine dollar ($9) increase to the base fee authorized in subdivision (a) for a certified copy of a fetal death record or death record and subdivision (b) for a certified copy of a birth certificate shall be applied incrementally as follows:
(1) A five dollar ($5) increase applied as of January 1, 2012.
(2) An additional two dollar ($2) increase applied as of January 1, 2013.
(3) An additional two dollar ($2) increase applied as of January 1, 2014.
(m) In providing for the expiration of the surcharge on birth certificate fees on June 30, 1999, the Legislature intends that juvenile dependency mediation programs pursue ancillary funding sources after that date.
(n) This section shall remain in effect only until January 1, 2027, and as of that date is repealed.

SEC. 6.

 Section 103625 of the Health and Safety Code, as amended by Section 9 of Chapter 38 of the Statutes of 2017, is amended to read:

103625.
 (a) A fee of twelve dollars ($12) shall be paid by the applicant for a certified copy of a fetal death or death record.
(b) (1) A fee of twelve dollars ($12) shall be paid by a public agency or licensed private adoption agency applicant for a certified copy of a birth certificate that the agency is required to obtain in the ordinary course of business. A fee of sixteen dollars ($16) shall be paid by any other applicant for a certified copy of a birth certificate. Four dollars ($4) of any sixteen-dollar ($16) fee is exempt from subdivision (e) and shall be paid either to a county children’s trust fund or to the State Children’s Trust Fund, in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code.
(2) The board of supervisors of any county that has established a county children’s trust fund may increase the fee for a certified copy of a birth certificate by up to three dollars ($3) for deposit in the county children’s trust fund in conformity with Article 5 (commencing with Section 18965) of Chapter 11 of Part 6 of Division 9 of the Welfare and Institutions Code.
(c) A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage record, that has been filed with the county recorder or county clerk, that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage record that has been filed with the county recorder or county clerk. Three dollars ($3) of any six-dollar ($6) fee is exempt from subdivision (e) and shall be transmitted monthly by each local registrar, county recorder, and county clerk to the state for deposit into the General Fund as provided by Section 1852 of the Family Code.
(d) A fee of three dollars ($3) shall be paid by a public agency applicant for a certified copy of a marriage dissolution record obtained from the State Registrar that the agency is required to obtain in the ordinary course of business. A fee of six dollars ($6) shall be paid by any other applicant for a certified copy of a marriage dissolution record obtained from the State Registrar.
(e) Each local registrar, county recorder, or county clerk collecting a fee pursuant to subdivisions (a) to (d), inclusive, shall do the following:
(1) Transmit 15 percent of the fee for each certified copy to the State Registrar by the 10th day of the month following the month in which the fee was received.
(2) Retain 85 percent of the fee for each certified copy solely to support the issuing agency for all activities related to the issuance of certified copies of records pursuant to subdivisions (a) to (d), inclusive.
(f) In addition to the fees prescribed pursuant to subdivisions (a) to (d), inclusive, all applicants for certified copies of the records described in those subdivisions shall pay an additional fee of three dollars ($3), that shall be collected by the State Registrar, the local registrar, county recorder, or county clerk, as the case may be.
(g) The local public official charged with the collection of the additional fee established pursuant to subdivision (f) may create a local vital and health statistics trust fund. The fees collected by local public officials pursuant to subdivision (f) shall be distributed as follows:
(1) Forty-five percent of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.
(2) The remainder of the fee collected pursuant to subdivision (f) shall be deposited into the collecting agency’s vital and health statistics trust fund, except that in any jurisdiction in which a local vital and health statistics trust fund has not been established, the entire amount of the fee collected pursuant to subdivision (f) shall be transmitted to the State Registrar.
(3) Moneys transmitted to the State Registrar pursuant to this subdivision shall be deposited in accordance with Section 102247.
(h) Moneys in each local vital and health statistics trust fund shall be available to the local official charged with the collection of fees pursuant to subdivision (f) for the applicable jurisdiction for the purpose of defraying the administrative costs of collecting and reporting with respect to those fees and for other costs as follows:
(1) Modernization of vital record operations, including improvement, automation, and technical support of vital record systems.
(2) Improvement in the collection and analysis of health-related birth and death certificate information, and other community health data collection and analysis, as appropriate.
(i) Funds collected pursuant to subdivision (f) shall not be used to supplant funding in existence on January 1, 2002, that is necessary for the daily operation of vital record systems. It is the intent of the Legislature that funds collected pursuant to subdivision (f) be used to enhance service to the public, to improve analytical capabilities of state and local health authorities in addressing the health needs of newborn children and maternal health problems, and to analyze the health status of the general population.
(j) Each county shall annually submit a report to the State Registrar by March 1 containing information on the amount of revenues collected pursuant to subdivision (f) in the previous calendar year and on how the revenues were expended and for what purpose.
(k) Each local registrar, county recorder, or county clerk collecting the fee pursuant to subdivision (f) shall transmit 45 percent of the fee for each certified copy to which subdivision (f) applies to the State Registrar by the 10th day of the month following the month in which the fee was received.
(l) In providing for the expiration of the surcharge on birth certificate fees on June 30, 1999, the Legislature intends that juvenile dependency mediation programs pursue ancillary funding sources after that date.
(m) This section shall become operative on January 1, 2027.