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		<ns0:Id>20250SB__082997AMD</ns0:Id>
		<ns0:VersionNum>97</ns0:VersionNum>
		<ns0:History>
			<ns0:Action>
				<ns0:ActionText>INTRODUCED</ns0:ActionText>
				<ns0:ActionDate>2025-02-21</ns0:ActionDate>
			</ns0:Action>
			<ns0:Action>
				<ns0:ActionText>AMENDED_SENATE</ns0:ActionText>
				<ns0:ActionDate>2025-03-26</ns0:ActionDate>
			</ns0:Action>
			<ns0:Action>
				<ns0:ActionText>AMENDED_SENATE</ns0:ActionText>
				<ns0:ActionDate>2025-04-24</ns0:ActionDate>
			</ns0:Action>
		</ns0:History>
		<ns0:LegislativeInfo>
			<ns0:SessionYear>2025</ns0:SessionYear>
			<ns0:SessionNum>0</ns0:SessionNum>
			<ns0:MeasureType>SB</ns0:MeasureType>
			<ns0:MeasureNum>829</ns0:MeasureNum>
			<ns0:MeasureState>AMD</ns0:MeasureState>
		</ns0:LegislativeInfo>
		<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Senators Wiener and Weber Pierson</ns0:AuthorText>
		<ns0:AuthorText authorType="COAUTHOR_ORIGINATING">(Coauthors: Senators Becker and McNerney)</ns0:AuthorText>
		<ns0:Authors>
			<ns0:Legislator>
				<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
				<ns0:House>SENATE</ns0:House>
				<ns0:Name>Wiener</ns0:Name>
			</ns0:Legislator>
			<ns0:Legislator>
				<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
				<ns0:House>SENATE</ns0:House>
				<ns0:Name>Weber Pierson</ns0:Name>
			</ns0:Legislator>
			<ns0:Legislator>
				<ns0:Contribution>COAUTHOR</ns0:Contribution>
				<ns0:House>SENATE</ns0:House>
				<ns0:Name>Becker</ns0:Name>
			</ns0:Legislator>
			<ns0:Legislator>
				<ns0:Contribution>COAUTHOR</ns0:Contribution>
				<ns0:House>SENATE</ns0:House>
				<ns0:Name>McNerney</ns0:Name>
			</ns0:Legislator>
		</ns0:Authors>
		<ns0:Title> An act to add Chapter 12 (commencing with Section 11899) to Part 1 of Division 3 of Title 2 of the Government Code, and to add Section 127698 to the Health and Safety Code, relating to research and development.</ns0:Title>
		<ns0:RelatingClause>research and development</ns0:RelatingClause>
		<ns0:GeneralSubject>
			<ns0:Subject>California Institute for Scientific Research: CalRx Initiative: vaccines.</ns0:Subject>
		</ns0:GeneralSubject>
		<ns0:DigestText>
			<html:p>Existing law establishes various grant and loan programs for research, including, among others, the California Institute for Regenerative Medicine, California Firefighter Cancer Prevention and Research Program, and the Public Interest Research, Development, and Demonstration Program.</html:p>
			<html:p>This bill would establish the California Institute for Scientific Research within the Government Operations Agency. The bill would create the California Institute for Scientific Research Fund, upon appropriation by the Legislature, and require the moneys in the fund to be used by the Government Operations Agency to award grants and make loans to public or private research companies, universities, institutes, and organizations for scientific research and development, in specific areas of research, including, but not limited to, biomedical, behavioral, and climate
			 research. </html:p>
			<html:p>This bill would create the California Institute for Scientific Research Council, as specified. The bill would require the council to, among other things, develop the strategic objectives and priorities of the institute and determine the research projects that will be funded by the California Institute for Scientific Research Fund, as specified. The bill would require a majority vote by the appointed members for the council for the approval of funding for any research project or proposal presented for funding. The bill would authorize the council to establish one or more scientific peer review panels consisting of experts in specified fields of research for the purposes of reviewing and prioritizing proposals on the basis of the track record of the investigators, scientific merit of the proposal, and potential benefit to the health and well-being of the population, natural resources, and environment of the state.</html:p>
			<html:p>This bill would require all research and development funded by the California Institute for Scientific Research Fund to be conducted under established standards of open scientific exchange, peer review, and public oversight. The bill would require the funds to be awarded on the basis of the research priorities established for the institute by the council and the scientific merit of the proposed research, as determined by an open, competitive, scientific peer review process that ensures objectivity, consistency, and high quality.</html:p>
			<html:p>Existing law, the California Affordable Drug Manufacturing Act of 2020, requires the California Health and Human Services Agency (CHHSA) or its departments to enter into partnerships to, among other things, address shortages in the market for generic prescription drugs and increase patient access to affordable drugs. The act also requires CHHSA to enter into partnerships resulting in the production,
			 procurement, or distribution of generic prescription drugs, in accordance with specified conditions and procedures. The state has launched the CalRx Initiative, a program that in part serves to implement the act.</html:p>
			<html:p>This bill would require CHHSA, notwithstanding anything to the contrary in the above-described act, to enter into partnerships or contracts resulting in the development, production, procurement, or distribution of vaccines, by any entity that is authorized to do so under federal or state law, with the intent that these drugs be made widely available to public and private purchasers, providers, suppliers, and pharmacies. Under the bill, this requirement would be implemented through the CalRx Initiative and subject to an appropriation.</html:p>
		</ns0:DigestText>
		<ns0:DigestKey>
			<ns0:VoteRequired>MAJORITY</ns0:VoteRequired>
			<ns0:Appropriation>NO</ns0:Appropriation>
			<ns0:FiscalCommittee>YES</ns0:FiscalCommittee>
			<ns0:LocalProgram>NO</ns0:LocalProgram>
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			<ns0:ImmediateEffect>NO</ns0:ImmediateEffect>
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				<ns0:Urgency>NO</ns0:Urgency>
				<ns0:TaxLevy>NO</ns0:TaxLevy>
				<ns0:Election>NO</ns0:Election>
				<ns0:UsualCurrentExpenses>NO</ns0:UsualCurrentExpenses>
				<ns0:BudgetBill>NO</ns0:BudgetBill>
				<ns0:Prop25TrailerBill>NO</ns0:Prop25TrailerBill>
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	</ns0:Description>
	<ns0:Bill id="bill">
		<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
		<ns0:BillSection id="id_BAD3F66A-C054-44D7-BED1-2A804FB075AD">
			<ns0:Num>SECTION 1.</ns0:Num>
			<ns0:Content>
				<html:p>The Legislature finds and declares the following:</html:p>
				<html:p>
					(a)
					<html:span class="EnSpace"/>
					Since World War II, the United States has been a global leader in scientific research and innovation. Through government agencies such as the National Institutes of Health (NIH), the United States Food and Drug Administration (FDA), the federal Centers for Disease Control and Prevention (CDC), and the National Oceanic and Atmospheric Administration (NOAA), the scientific community has been able to create life enhancing biomedical and public health discoveries.
				</html:p>
				<html:p>
					(b)
					<html:span class="EnSpace"/>
					Americans have benefited greatly from this research with improved
				health, cures for diseases, vaccines, and improved air quality and environment.
				</html:p>
				<html:p>
					(c)
					<html:span class="EnSpace"/>
					The United States economy has benefited greatly from this research as well. For every dollar invested in NIH research there is a return of approximately $2.50 in economic activity.
				</html:p>
				<html:p>
					(d)
					<html:span class="EnSpace"/>
					Research funding is a significant part of the University of California’s operations. Federal grants pay for faculty research and graduate student researcher and post-doctoral salaries. Federal research grants totaled $3,850,000,000 to the University of California in the 2023–24 fiscal year.
				</html:p>
				<html:p>
					(e)
					<html:span class="EnSpace"/>
					Public and private university research has led to the founding of thousands of startups, driving economic expansion and technological innovation. Funding reductions
				could limit research opportunities, slowing the state’s competitiveness and economic progress.
				</html:p>
				<html:p>
					(f)
					<html:span class="EnSpace"/>
					The Trump Administration, spearheaded by Elon Musk’s Department of Government Efficiency, has slashed personnel and programs at all federal science agencies, threatening the continued leadership, and perhaps the existence, of these agencies. Impacted agencies include, but are not limited to, NIH, CDC, NOAA, FDA, the National Weather Service, and the National Aeronautics and Space Administration. The Trump Administration is systemically dismantling scientific research in America.
				</html:p>
				<html:p>
					(g)
					<html:span class="EnSpace"/>
					This dismantling will lead to long-lasting, perhaps irreparable damage to everything, including the quality of life for all Americans. Our health care, environment, and economy will feel the
				effects for decades to come.
				</html:p>
				<html:p>
					(h)
					<html:span class="EnSpace"/>
					California must step up and fill the void left by the federal cuts.
				</html:p>
				<html:p>
					(i)
					<html:span class="EnSpace"/>
					In light of the current Secretary of the United States Department of Health and Human Services’ skepticism about vaccines, there is real worry that the federal government will no longer undertake the research needed, adopt the policies necessary, or spearhead the manufacturing of vaccines needed to keep Americans safe from infectious diseases.
				</html:p>
			</ns0:Content>
		</ns0:BillSection>
		<ns0:BillSection id="id_77794ACA-4592-40C4-A92F-83AC18E37745">
			<ns0:Num>SEC. 2.</ns0:Num>
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				Chapter 12 (commencing with Section 11899) is added to Part 1 of Division 3 of Title 2 of the 
				<ns0:DocName>Government Code</ns0:DocName>
				, to read:
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			<ns0:Fragment>
				<ns0:LawHeading id="id_B64D065A-7D61-4119-BA2F-5B850711A495" type="CHAPTER">
					<ns0:Num>12.</ns0:Num>
					<ns0:LawHeadingVersion id="id_11CC9611-2DAD-48CB-81B1-69D435883360">
						<ns0:LawHeadingText>California Institute for Scientific Research</ns0:LawHeadingText>
					</ns0:LawHeadingVersion>
					<ns0:LawSection id="id_19D4C9B6-DD04-4A70-854C-8800B7E10ADD">
						<ns0:Num>11899.</ns0:Num>
						<ns0:LawSectionVersion id="id_4A969575-7B30-4348-8CB8-5006FD0F509D">
							<ns0:Content>
								<html:p>
									(a)
									<html:span class="EnSpace"/>
									The California Institute for Scientific Research is established within the Government Operations Agency.
								</html:p>
								<html:p>
									(b)
									<html:span class="EnSpace"/>
									The institute’s role is to facilitate scientific research by awarding grants and making loans to public or private research companies, universities, institutes, and organizations for scientific research and development, including, but not limited to, research in any of the following fields:
								</html:p>
								<html:p>
									(1)
									<html:span class="EnSpace"/>
									Biomedical.
								</html:p>
								<html:p>
									(2)
									<html:span class="EnSpace"/>
									Behavioral.
								</html:p>
								<html:p>
									(3)
									<html:span class="EnSpace"/>
									Climate,
						  including climate change and its impact on human health.
								</html:p>
								<html:p>
									(4)
									<html:span class="EnSpace"/>
									Weather.
								</html:p>
								<html:p>
									(5)
									<html:span class="EnSpace"/>
									Ocean.
								</html:p>
								<html:p>
									(6)
									<html:span class="EnSpace"/>
									Coastal and marine ecosystems and resources.
								</html:p>
								<html:p>
									(7)
									<html:span class="EnSpace"/>
									Detecting and responding to new and emerging health threats.
								</html:p>
								<html:p>
									(8)
									<html:span class="EnSpace"/>
									Disease prevention.
								</html:p>
								<html:p>
									(9)
									<html:span class="EnSpace"/>
									Promoting healthy and safe behaviors, communities, and environment.
								</html:p>
								<html:p>
									(10)
									<html:span class="EnSpace"/>
									Safety, efficacy, and security of drugs, biological products, medical devices, our nation’s food supply, and cosmetics.
								</html:p>
							</ns0:Content>
						</ns0:LawSectionVersion>
					</ns0:LawSection>
					<ns0:LawSection id="id_72143024-05D5-4F27-82FE-324C2B4A4AE6">
						<ns0:Num>11899.1.</ns0:Num>
						<ns0:LawSectionVersion id="id_6384ED7D-C763-4E66-844C-7B444AA4CE5B">
							<ns0:Content>
								<html:p>
									(a)
									<html:span class="EnSpace"/>
									Upon appropriation by the Legislature, funds shall be deposited in the California Institute for Scientific Research Fund, which is hereby created.
								</html:p>
								<html:p>
									(b)
									<html:span class="EnSpace"/>
									Moneys in the California Institute for Scientific Research Fund shall be used by the Government Operations Agency to award grants and make loans to public or private research companies, universities, institutes, and organizations for scientific research and development, including, but not limited to, research in any of the fields described in subdivision (b) of Section 11899.
								</html:p>
								<html:p>
									(c)
									<html:span class="EnSpace"/>
									(1)
									<html:span class="EnSpace"/>
									All research and development funded by the California Institute
						  for Scientific Research Fund shall be conducted under
						  established standards of open scientific exchange, peer review, and public oversight.
								</html:p>
								<html:p>
									(2)
									<html:span class="EnSpace"/>
									All grants or loans provided under this section shall be awarded or made available to researchers or projects located within this state, except that funding for research collaboratives between California and out-of-state researchers shall be permitted.
								</html:p>
								<html:p>
									(3)
									<html:span class="EnSpace"/>
									All grants or loans provided under this section shall be awarded based on both of the following:
								</html:p>
								<html:p>
									(A)
									<html:span class="EnSpace"/>
									The basis of the research priorities established for the institute by the California Institute for Scientific Research Council as described in subdivision (a) of Section 11899.2.
								</html:p>
								<html:p>
									(B)
									<html:span class="EnSpace"/>
									The scientific merit of
						  the proposed research, as determined by an open, competitive, scientific peer review process that ensures
						  objectivity, consistency, and high quality, as described in subdivision (f) of Section 11899.2.
								</html:p>
								<html:p>
									(4)
									<html:span class="EnSpace"/>
									The institute shall prioritize funding research that replaces funding cuts by the federal government.
								</html:p>
								<html:p>
									(5)
									<html:span class="EnSpace"/>
									To be eligible for funding, all research projects submitted for potential funding shall be reviewed and approved by an institutional review board that meets the requirements of federal law and regulations.
								</html:p>
								<html:p>
									(d)
									<html:span class="EnSpace"/>
									Not more than 5 percent of the moneys in the fund shall be used for administrative costs of the Government Operations Agency.
								</html:p>
								<html:p>
									(e)
									<html:span class="EnSpace"/>
									All intellectual property assets developed using funds authorized for, or made available to, the
						  institute shall be treated pursuant to state and federal law.
								</html:p>
							</ns0:Content>
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					</ns0:LawSection>
					<ns0:LawSection id="id_4F5D7A5F-63E5-46E8-8214-0696D45CBA5F">
						<ns0:Num>11899.2.</ns0:Num>
						<ns0:LawSectionVersion id="id_C41D9C7E-00C9-4B16-A933-F189A7C9CA6D">
							<ns0:Content>
								<html:p>
									(a)
									<html:span class="EnSpace"/>
									There is hereby established the California Institute for Scientific Research Council that shall do all of the following:
								</html:p>
								<html:p>
									(1)
									<html:span class="EnSpace"/>
									Develop the strategic objectives and priorities of the institute.
								</html:p>
								<html:p>
									(2)
									<html:span class="EnSpace"/>
									Actively participate in the overall management of the institute.
								</html:p>
								<html:p>
									(3)
									<html:span class="EnSpace"/>
									Determine which research projects will be funded by the California Institute for Scientific Research Fund based on the research priorities established for the institute pursuant to paragraph (1) and the technical merits of the proposals, as determined by scientific peer review
						  panels created pursuant to subdivision (f).
								</html:p>
								<html:p>
									(b)
									<html:span class="EnSpace"/>
									(1)
									<html:span class="EnSpace"/>
									The council shall consist of 10 to 13 members appointed by the Secretary of the Governmental Operations Agency.
								</html:p>
								<html:p>
									(A)
									<html:span class="EnSpace"/>
									A majority of members of the council shall be scientists with current or past research experience in the fields described in subdivision (b) of Section 11899.
								</html:p>
								<html:p>
									(B)
									<html:span class="EnSpace"/>
									At least two members of the council shall be members of the public.
								</html:p>
								<html:p>
									(2)
									<html:span class="EnSpace"/>
									(A)
									<html:span class="EnSpace"/>
									Individuals and organizations may submit nominations for membership to the Secretary of the Governmental Operations Agency.
								</html:p>
								<html:p>
									(B)
									<html:span class="EnSpace"/>
									The Secretary of the
						  Governmental Operations Agency shall solicit nominations from relevant organizations and individuals.
								</html:p>
								<html:p>
									(c)
									<html:span class="EnSpace"/>
									(1)
									<html:span class="EnSpace"/>
									The council shall contain the proportional representation of appointees described in paragraph (1) of subdivision (b) when the council approves the funding of research grants.
								</html:p>
								<html:p>
									(2)
									<html:span class="EnSpace"/>
									Vacancies affecting the proportional representation shall be filled before grants are approved, and within 45 days after the occurrence of a vacancy.
								</html:p>
								<html:p>
									(d)
									<html:span class="EnSpace"/>
									A vote of a majority of the appointed members of the council shall be required for the approval of funding of any research project or proposal presented for funding.
								</html:p>
								<html:p>
									(e)
									<html:span class="EnSpace"/>
									Council members shall serve
						  without compensation, but may receive reimbursement for travel and necessary expenses actually incurred in the performance of their duties.
								</html:p>
								<html:p>
									(f)
									<html:span class="EnSpace"/>
									(1)
									<html:span class="EnSpace"/>
									The council may establish one or more scientific peer review panels consisting of experts in the fields described in subdivision (b) of Section 11899 for the purposes of reviewing and prioritizing proposals on the basis of the track record of the investigators, scientific merit of the proposal, and potential benefit to the health and well-being of the population, natural resources, and environment of the state.
								</html:p>
								<html:p>
									(2)
									<html:span class="EnSpace"/>
									An expert on a scientific review panel shall not have a collaborative or commercial relationship to any applicant of a proposal for funding that the expert is reviewing and prioritizing pursuant to paragraph
						  (1).
								</html:p>
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		</ns0:BillSection>
		<ns0:BillSection id="id_ABC11548-497F-4BDD-96F7-11F254C38FDF">
			<ns0:Num>SEC. 3.</ns0:Num>
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				Section 127698 is added to the 
				<ns0:DocName>Health and Safety Code</ns0:DocName>
				, to read:
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			<ns0:Fragment>
				<ns0:LawSection id="id_0ECE8597-8717-41BC-A7B2-F5F8BDBE901F">
					<ns0:Num>127698.</ns0:Num>
					<ns0:LawSectionVersion id="id_AD3662A9-0534-4C9C-BCDF-9FE37E077F57">
						<ns0:Content>
							<html:p>
								(a)
								<html:span class="EnSpace"/>
								Notwithstanding anything to the contrary in this chapter, CHHSA shall enter into partnerships or contracts resulting in the development, production, procurement, or distribution of vaccines, by any entity that is authorized to do so under federal or state law, with the intent that these drugs be made widely available to public and private purchasers, providers, suppliers, and pharmacies.
							</html:p>
							<html:p>
								(b)
								<html:span class="EnSpace"/>
								This section shall be implemented, through the CalRx Initiative, subject to an appropriation made by the Legislature for the purpose of this section.
							</html:p>
							<html:p>
								(c)
								<html:span class="EnSpace"/>
								For purposes of this section, the following definitions
						apply:
							</html:p>
							<html:p>
								(1)
								<html:span class="EnSpace"/>
								“Pharmacy” has the same meaning as set forth in Section 4037 of the Business and Professions Code.
							</html:p>
							<html:p>
								(2)
								<html:span class="EnSpace"/>
								“Provider” and “supplier” have the same meanings as set forth in subdivision (b) of Section 1367.50.
							</html:p>
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