BILL NUMBER: AB 2381 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 23, 2008
AMENDED IN ASSEMBLY APRIL 3, 2008
AMENDED IN ASSEMBLY MARCH 10, 2008
INTRODUCED BY Assembly Member Mullin
FEBRUARY 21, 2008
An act to amend Section 125292.10 of the Health and Safety Code,
relating to stem cell research.
LEGISLATIVE COUNSEL'S DIGEST
AB 2381, as amended, Mullin. Stem cell research.
Existing law, the California Stem Cell Research and Cures Act,
establishes the Independent Citizen's Oversight Committee (ICOC) and
the California Institute for Regenerative Medicine, the purpose of
which is, among other things, to make grants and loans for stem cell
research, for research facilities, and for other vital research
opportunities to realize therapies, protocols, and medical procedures
that will result in the cure for, or substantial mitigation of,
diseases and injuries. Existing law authorizes the issuance of bonds,
not to exceed $3,000,000,000, for the purpose of funding this
research. Existing law requires the ICOC to establish standards that
ensure grantees purchase goods and services from California suppliers
to the extent possible.
This bill would define "California supplier" for purposes of this
act.
The California Stem Cell Research and Cures Act, an initiative
measure, provides that the Legislature may amend the non-bond
statutory provisions of that act, to enhance the ability of the
California Institute for Regenerative Medicine to further the
purposes of the grant and loan programs created by that act, with a
70% vote of each house and compliance with specified procedural
requirements.
This bill, which would declare that it enhances the ability of the
institute to further the purposes of the grant and loan programs
created by that act, would therefore require for passage a 70% vote.
Vote: 70%. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 125292.10 of the Health and Safety Code is
amended to read:
125292.10. As used in this chapter and in Article XXXV of the
California Constitution, the following terms have the following
meanings:
(a) "Act" means the California Stem Cell Research and Cures Bond
Act constituting Chapter 3 (commencing with Section 125290.10) of
Part 5 of Division 106 of the Health and Safety Code.
(b) "Adult stem cell" means an undifferentiated cell found in a
differentiated tissue in an adult organism that can renew itself and
may, with certain limitations, differentiate to yield all the
specialized cell types of the tissue from which it originated.
(c) (1) "California supplier" means
a any sole proprietorship, partnership, joint
venture, corporation, or other business entity the
that meets any of the following criteria:
(A) The owners or policymaking
officers of which are domiciled in California and
whose the permanent, principal office
or place of business from which the supplier's trade is directed or
managed is located in California.
(B) A business or corporation, including those owned by, or under
common control of, a corporation, that meets all of the following
criteria:
(i) Has owned and operated a manufacturing facility or research
facility located in California that researches, develops, builds, or
manufactures products for life sciences research, continuously during
the five years prior to submitting a bid or proposal to provide
supplies to a California Institute of Regenerative Medicine (CIRM)
grantee.
(ii) Has been licensed by the state on a continuous basis to
conduct business within the state during the five years prior to
submitting a bid or proposal to provide supplies to a CIRM grantee.
(iii) Has continuously employed California residents for work
within the state during the five years prior to submitting a bid or
proposal to provide supplies to a CIRM grantee.
(C) The entity produces, builds, or manufactures a product or
products in California and for the specific product or products that
are used by CIRM grantees.
(2) For purposes of qualifying as a California supplier, a
distribution or sales management office or facility does not qualify
as a manufacturing or research facility.
(d) "Capitalized interest" means interest funded by bond proceeds.
(e) "Committee" means the California Stem Cell Research and Cures
Finance Committee created pursuant to subdivision (a) of Section
125291.40.
(f) "Constitutional officers" means the Governor, Lieutenant
Governor, Treasurer, and Controller of California.
(g) "Facilities" means buildings, building leases, or capital
equipment.
(h) "Floating-rate bonds" means bonds which do not bear a fixed
rate of interest until their final maturity date, including
commercial paper notes.
(i) "Fund" means the California Stem Cell Research and Disease
Cures Fund created pursuant to Section 125291.25.
(j) "Grant" means a grant, loan, or guarantee.
(k) "Grantee" means a recipient of a grant from the institute. All
University of California grantee institutions shall be considered as
separate and individual grantee institutions.
() "Human reproductive cloning" means the practice of creating or
attempting to create a human being by transferring the nucleus from a
human cell into an egg cell from which the nucleus has been removed
for the purpose of implanting the resulting product in a uterus to
initiate a pregnancy.
(m) "Indirect costs" mean the recipient's costs in the
administration, accounting, general overhead, and general support
costs for implementing a grant or loan of the institute. NIH
definitions of indirect costs will be utilized as one of the bases by
the Scientific and Medical Research Standards Working Group to
create a guideline for recipients on this definition, with
modifications to reflect guidance by the ICOC and this act.
(n) "Institute" means the California Institute for Regenerative
Medicine.
(o) "Interim standards" means temporary standards that perform the
same function as "emergency regulations" under the Administrative
Procedure Act (Government Code, Title 2, Division 3, Part 1, Chapter
4.5, Sections 11371 et seq.) except that in order to provide greater
opportunity for public comment on the permanent regulations, remain
in force for 270 days rather than 180 days.
(p) "Life science commercial entity" means a firm or organization,
headquartered in California, whose business model includes
biomedical or biotechnology product development and
commercialization.
(q) "Medical ethicist" means an individual with advanced training
in ethics who holds a Ph.D., MA, or equivalent training and who
spends or has spent substantial time (1) researching and writing on
ethical issues related to medicine, and (2) administering ethical
safeguards during the clinical trial process, particularly through
service on institutional review boards.
(r) "Pluripotent cells" means cells that are capable of
self-renewal, and have broad potential to differentiate into multiple
adult cell types. Pluripotent stem cells may be derived from somatic
cell nuclear transfer or from surplus products of in vitro
fertilization treatments when such products are donated under
appropriate informed consent procedures. These excess cells from in
vitro fertilization treatments would otherwise be intended to be
discarded if not utilized for medical research.
(s) "Progenitor cells" means multipotent or precursor cells that
are partially differentiated but retain the ability to divide and
give rise to differentiated cells.
(t) "Quorum" means at least 65 percent of the members who are
eligible to vote.
(u) "Research donor" means a human who donates biological
materials for research purposes after full disclosure and consent.
(v) "Research funding" includes interdisciplinary scientific and
medical funding for basic research, therapy development, and the
development of pharmacologies and treatments through clinical trials.
When a facility's grant or loan has not been provided to house all
elements of the research, therapy development, and/or clinical
trials, research funding shall include an allowance for a market
lease rate of reimbursement for the facility. In all cases, operating
costs of the facility, including, but not limited to, library and
communication services, utilities, maintenance, janitorial, and
security, shall be included as direct research funding costs. Legal
costs of the institute incurred in order to negotiate standards with
federal and state governments and research institutions; to implement
standards or regulations; to resolve disputes; and/or to carry out
all other actions necessary to defend and/or advance the institute's
mission shall be considered direct research funding costs.
(w) "Research participant" means a human enrolled with full
disclosure and consent, and participating in clinical trials.
(x) "Revenue positive" means all state tax revenues generated
directly and indirectly by the research and facilities of the
institute are greater than the debt service on the state bonds
actually paid by the General Fund in the same year.
(y) "Stem cells" mean nonspecialized cells that have the capacity
to divide in culture and to differentiate into more mature cells with
specialized functions.
(z) "Vital research opportunity" means scientific and medical
research and technologies and/or any stem cell research not actually
funded by the institute under subparagraph (C) of paragraph (1) of
subdivision (c) of Section 125290.60 which provides a substantially
superior research opportunity vital to advance medical science as
determined by at least a two-thirds vote of a quorum of the members
of the Scientific and Medical Research Funding Working Group and
recommended as such by that working group to the ICOC. Human
reproductive cloning shall not be a vital research opportunity.