Stem Cell Regulations Governing CIRM Grants

Adopted CIRM Stem Cell Grant Regulations

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Pending Regulations

All documents associated with pending CIRM regulations can be found on the link below.

For help complying with CIRM's stem cell regulations, see our series of guidance documents that summarize the CIRM MES regulations.

CIRM Regulations:
 

Chapter 1. Conflicts of Interest

Chapter 2. Scientific and Medical Accountability Standards
 

Chapter 3. Intellectual Property Requirements for Non-Profit Organizations (applicable to grants made before December 17, 2009)
 

Chapter 4. Intellectual Property and Revenue Sharing Requirements for For-Profit Organizations (applicable to grants made before December 17, 2009)
 

Chapter 5. Grants Administration Policies

Chapter 6. Intellectual Property and Revenue Sharing Requirements for Non-Profit and For-Profit Grantees (applicable to grants made before January 27, 2014)
 

Chapter 6. Intellectual Property and Revenue Sharing Requirements for Non-Profit and For-Profit Grantees  (effective January 27th, 2014)
 

Chapter 7. Facilities Grants Administration Policies
 

Chapter 8. Loan Administration Policy
 

Chapter 9. Repository for Induced Pluripotent Stem Cells and Embryonic Stem Cells
 

Authority to adopt regulations:

Health & Safety Code Section 125290.40, subdivision (j), permits the ICOC to adopt, amend and rescind rules and regulations to carry out the purposes and provisions of Proposition 71 (“Act”) and to govern the procedures of the ICOC.  Properly adopted regulations carry the same force and effect as law.

Types of Regulations:

The Act provides two methods for the ICOC to adopt regulations - either “Interim” regulations or permanent regulations adopted pursuant to the California Administrative Procedures Act (“APA”). 

Prop 71 Interim Regulations.

The ICOC may adopt interim regulations exempted from compliance with the procedures set forth in the APA. The interim regulations are adopted by the ICOC and remain in effect for 270 days unless earlier superseded by regulations adopted pursuant to the APA. (125290.40, subd. (k).)  Not every regulation adopted by the ICOC will be preceded by an “interim” version (see below).

Formal APA Regulations.

The ICOC may also adopt regulations pursuant to procedures described in the APA in the same manner as other state agencies.  Unless otherwise provided in the regulations themselves, these regulations remain in effect indefinitely or until they are repealed or amended by the ICOC in procedures established by the office of Administrative Law, the agency that implements the APA.  (These procedures are described at the OAL website: www.oal.ca.gov.) 

The ICOC will approve a draft policy or regulation(s) for submission to the OAL to begin the regulation adoption process.  Staff will place the policy or draft regulations in proper form and will make a formal submission to the OAL, called the “OAL Notice.”  Links to both documents (when completed) can be found in the chart below.

Except in the case of interim and emergency regulations, the APA establishes a formal rulemaking process which includes a minimum 45 day public-comment period. During that period, comments may be submitted to the CIRM in response to the proposed regulation.

How to submit public comments:

You may submit written statements, arguments, or comments relating to the proposed regulation in writing to the CIRM during the comment period specified for each regulation.

Comments may be submitted electronically to the address indicated, mailed to:

CIRM Proposed Rulemaking [indicate the specific proposed regulation, e.g., Conflict of Interest Code]
210 King Street,
San Francisco, CA,
or sent via FAX to (415) 396-9141.

Consideration of public comment:

The CIRM will consider all relevant material it receives during a Noticed opportunity to comment before adopting, amending, or repealing any regulation, including comments received via FAX and email. (Govt. Code §§11346.8, subd. (a); 11340.8, subd. (a).) Responses to comments received during the public comment period will be provided in the final statement of reasons submitted to the office of Administrative Law along with any modifications made to the proposed regulation responsive to the public comments received.

General Questions?
Please contact the CIRM at info@cirm.ca.gov

 

© 2013 California Institute for Regenerative Medicine