Section 885.5 - Testing Required for Licensing(a) Licensing an OSCA is subject to successful screening through: (1) standardized efficacy tests;(2) standardized toxicity tests;(3) such other tests as deemed necessary by the Administrator in order to determine the efficacy, toxicity or appropriate use of the OSCA.(b) Testing necessary to determine compliance with the efficacy and toxicity criteria shall, as applicable, be conducted consistent with the testing methods or procedures approved by the Administrator, and found in the Guidance Document.(c) All tests shall be performed by the applicant or his/her designee. The Administrator or his/her authorized agent may verify or require verification of the results of any tests. Any verification costs incurred by the Administrator will be paid from the applicant's licensing fee.Cal. Code Regs. Tit. 14, § 885.5
1. New section filed 12-31-96; operative 12-31-96 pursuant to Government Code section 11343.4(d). Submitted to OAL for printing only pursuant to Government Code section 8670.13.2 (Register 97, No. 1).
2. Amendment of section and NOTE filed 7-28-98; operative 8-27-98 (Register 98, No 31). Note: Authority: Section 8670.13.1, Government Code. Reference: Sections 8670.13.1 and 8670.13.2, Government Code.
1. New section filed 12-31-96; operative 12-31-96 pursuant to Government Code section 11343.4(d). Submitted to OAL for printing only pursuant to Government Code section 8670.13.2 (Register 97, No. 1).
2. Amendment of section and Note filed 7-28-98; operative 8-27-98 (Register 98, No 31).