CA Health & Safety Code Section 121325

There is hereby created the AIDS Vaccine Clinical Trial Grant Award for the Prevention of Maternal Transmission of HIV Infection. Moneys within the AIDS Clinical Trials Testing Fund, established in accordance with Section 121260, shall, upon appropriation by the Legislature, be available to the department for the purposes of this chapter, that shall include a one-time amount of sixty thousand dollars ($60,000) for the department to develop and process the request for proposal as specified in subdivision (a). Grant awards shall be made available to not more than three manufacturers of an AIDS vaccine approved by the FDA for clinical trials in HIV-positive pregnant women. The purpose is to expedite the completion of an AIDS vaccine to prevent maternal transmission of HIV. The funds are to be used for FDA approved clinical trials.

(a)

The department shall issue a request for proposal (RFP) for the clinical trials of an AIDS vaccine to prevent maternal transmission of HIV infection.

(1)

The RFP shall be based on the criteria provided in subdivision (d).

(2)

Upon issuing the RFP, the department shall publish this fact along with the deadline for grant proposals in the newspapers with the greatest circulation in the major cities of the state, as determined by the department. Additionally, upon issuing the RFP, the same information shall be transmitted to the Secretary of the Senate and the Chief Clerk of the Assembly for publishing in the respective journals of each house of the Legislature.

(b)

Any manufacturer may submit a proposal for the grant award in the response to the RFP issued by the department.

(c)

The department, taking into consideration the committee’s recommendations, shall, for purposes of this chapter, award grants to no more than three California manufacturers after receiving the committee’s recommendations.

(d)

The department, making use of an RFP, shall include a clear description of the criteria to be used to select the projects that will receive funding pursuant to this chapter. The committee shall make recommendations to the department regarding the content of the RFP. The criteria shall include, but not be limited to, the following:

(1)

The potential of the grant recipient to develop a vaccine for the prevention of maternal transmission of HIV infection.

(2)

The financial, technical, and managerial commitment of the grant recipient to the development of the vaccine.

(3)

The commitment of the grant recipient to agree to provide medical treatment, either directly or through reasonable health insurance coverage, to the participant for any injury caused by the AIDS vaccine in the clinical trial. This agreement shall also be included as part of the participant’s informed consent pursuant to Section 121305.

(e)

Grant awards may be made without limitation on the amount of funding from the AIDS Clinical Trials Testing Fund that may be allocated to a single manufacturer, provided that the committee has determined that the grant award is in the public interest.