Amended IN Assembly April 22, 2019 Amended IN Assembly March 21, 2019 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 617Introduced by Assembly Member MullinFebruary 14, 2019 An act to add Chapter 3 (commencing with Section 125360) to Part 5.5 of Division 106 of the Health and Safety Code, relating to public health.LEGISLATIVE COUNSEL'S DIGESTAB 617, as amended, Mullin. Stem Cell Clinic Regulation Advisory Group.Existing law requires the State Department of Public Health to establish and maintain an anonymous registry of embryos that are available for research. Existing law makes it the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells shall be reviewed by a stem cell research oversight committee.Existing federal law creates an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) and to establish current good tissue practice and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Existing federal law requires the federal Food and Drug Administration to register, list, and regulate HCT/Ps for these purposes.This bill would require the department, no later than an unspecified date, February 1, 2020, to convene the Stem Cell Clinic Regulation Advisory Group for purposes of, among other duties, holding a series of stakeholder meetings to review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics, and to make recommendations to the Legislature, on or before an unspecified date, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Chapter 3 (commencing with Section 125360) is added to Part 5.5 of Division 106 of the Health and Safety Code, to read: CHAPTER 3. Stem Cell Clinic Regulation Advisory Group125360. For purposes of this chapter, the following definitions apply:(a) Clinic has the meaning set forth in Section 1200.(b) Department means the State Department of Public Health.(c) FDA means the federal Food and Drug Administration.(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).(e) Stem cell therapy means a therapy involving the use of HCT/Ps.125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.
Amended IN Assembly April 22, 2019 Amended IN Assembly March 21, 2019 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 617Introduced by Assembly Member MullinFebruary 14, 2019 An act to add Chapter 3 (commencing with Section 125360) to Part 5.5 of Division 106 of the Health and Safety Code, relating to public health.LEGISLATIVE COUNSEL'S DIGESTAB 617, as amended, Mullin. Stem Cell Clinic Regulation Advisory Group.Existing law requires the State Department of Public Health to establish and maintain an anonymous registry of embryos that are available for research. Existing law makes it the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells shall be reviewed by a stem cell research oversight committee.Existing federal law creates an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) and to establish current good tissue practice and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Existing federal law requires the federal Food and Drug Administration to register, list, and regulate HCT/Ps for these purposes.This bill would require the department, no later than an unspecified date, February 1, 2020, to convene the Stem Cell Clinic Regulation Advisory Group for purposes of, among other duties, holding a series of stakeholder meetings to review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics, and to make recommendations to the Legislature, on or before an unspecified date, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
Amended IN Assembly April 22, 2019 Amended IN Assembly March 21, 2019
Amended IN Assembly April 22, 2019
Amended IN Assembly March 21, 2019
CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION
Assembly Bill No. 617
Introduced by Assembly Member MullinFebruary 14, 2019
Introduced by Assembly Member Mullin
February 14, 2019
An act to add Chapter 3 (commencing with Section 125360) to Part 5.5 of Division 106 of the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 617, as amended, Mullin. Stem Cell Clinic Regulation Advisory Group.
Existing law requires the State Department of Public Health to establish and maintain an anonymous registry of embryos that are available for research. Existing law makes it the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells shall be reviewed by a stem cell research oversight committee.Existing federal law creates an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) and to establish current good tissue practice and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Existing federal law requires the federal Food and Drug Administration to register, list, and regulate HCT/Ps for these purposes.This bill would require the department, no later than an unspecified date, February 1, 2020, to convene the Stem Cell Clinic Regulation Advisory Group for purposes of, among other duties, holding a series of stakeholder meetings to review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics, and to make recommendations to the Legislature, on or before an unspecified date, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.
Existing law requires the State Department of Public Health to establish and maintain an anonymous registry of embryos that are available for research. Existing law makes it the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells shall be reviewed by a stem cell research oversight committee.
Existing federal law creates an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) and to establish current good tissue practice and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Existing federal law requires the federal Food and Drug Administration to register, list, and regulate HCT/Ps for these purposes.
This bill would require the department, no later than an unspecified date, February 1, 2020, to convene the Stem Cell Clinic Regulation Advisory Group for purposes of, among other duties, holding a series of stakeholder meetings to review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics, and to make recommendations to the Legislature, on or before an unspecified date, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Chapter 3 (commencing with Section 125360) is added to Part 5.5 of Division 106 of the Health and Safety Code, to read: CHAPTER 3. Stem Cell Clinic Regulation Advisory Group125360. For purposes of this chapter, the following definitions apply:(a) Clinic has the meaning set forth in Section 1200.(b) Department means the State Department of Public Health.(c) FDA means the federal Food and Drug Administration.(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).(e) Stem cell therapy means a therapy involving the use of HCT/Ps.125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Chapter 3 (commencing with Section 125360) is added to Part 5.5 of Division 106 of the Health and Safety Code, to read: CHAPTER 3. Stem Cell Clinic Regulation Advisory Group125360. For purposes of this chapter, the following definitions apply:(a) Clinic has the meaning set forth in Section 1200.(b) Department means the State Department of Public Health.(c) FDA means the federal Food and Drug Administration.(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).(e) Stem cell therapy means a therapy involving the use of HCT/Ps.125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.
SECTION 1. Chapter 3 (commencing with Section 125360) is added to Part 5.5 of Division 106 of the Health and Safety Code, to read:
### SECTION 1.
CHAPTER 3. Stem Cell Clinic Regulation Advisory Group125360. For purposes of this chapter, the following definitions apply:(a) Clinic has the meaning set forth in Section 1200.(b) Department means the State Department of Public Health.(c) FDA means the federal Food and Drug Administration.(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).(e) Stem cell therapy means a therapy involving the use of HCT/Ps.125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.
CHAPTER 3. Stem Cell Clinic Regulation Advisory Group125360. For purposes of this chapter, the following definitions apply:(a) Clinic has the meaning set forth in Section 1200.(b) Department means the State Department of Public Health.(c) FDA means the federal Food and Drug Administration.(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).(e) Stem cell therapy means a therapy involving the use of HCT/Ps.125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.
CHAPTER 3. Stem Cell Clinic Regulation Advisory Group
CHAPTER 3. Stem Cell Clinic Regulation Advisory Group
125360. For purposes of this chapter, the following definitions apply:(a) Clinic has the meaning set forth in Section 1200.(b) Department means the State Department of Public Health.(c) FDA means the federal Food and Drug Administration.(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).(e) Stem cell therapy means a therapy involving the use of HCT/Ps.
125360. For purposes of this chapter, the following definitions apply:
(a) Clinic has the meaning set forth in Section 1200.
(b) Department means the State Department of Public Health.
(c) FDA means the federal Food and Drug Administration.
(d) HCT/Ps means human cells, tissues, or cellular or tissue-based products, as defined in Section 1271.3 of Title 21 of the Code of Federal Regulations, as amended August 31, 2016, as published in the Federal Register (81 Fed. Reg. 60223).
(e) Stem cell therapy means a therapy involving the use of HCT/Ps.
125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.
125361. (a) No later than ____, February 1, 2020, the department shall convene the Stem Cell Clinic Regulation Advisory Group for purposes of holding a series of stakeholder meetings. The duties of the advisory group include all of the following:
(1) Review current licensing and certification laws and the departments procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics.
(2) Make recommendations to the Legislature, on or before ____, July 1, 2020, regarding how to improve state oversight of clinics offering or providing stem cell therapies to patients.
(3) Adopt, if appropriate, emergency regulations to protect the public against stem cell therapies that are not in compliance with federal laws and regulations, including regulations adopted by the federal Food and Drug Administration. The department shall consult relevant stakeholders prior to promulgating regulations and shall provide a 90-day notice to stakeholders prior to adopting regulations. The adoption of these regulations is an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.
(b) In carrying out the duties described in subdivision (a), the department shall consult with the medical community, bioethicists, legal scholars, and patient advocacy groups. The department is authorized to consult with the California Institute for Regenerative Medicine.