Section 10036 - Approval of Protocol Amendments and Changes(a) If a program submits an Application for Protocol Amendment form DHCS 5135 (04/16) pursuant to Section 10035(a), the Department shall notify the program, in writing, within 30 days of receipt of the form, whether the documentation is: (1) Complete and accepted for review; or(2) Incomplete, and the Department shall specify the missing or incomplete information or documentation. The program shall have 30 days from the date of the notification to provide the missing information or documentation. The Department shall terminate review of the protocol amendment if the program does not provide all required information or documentation within 30 days. Upon termination of review, the incomplete protocol amendment shall be returned to the program. The program may reapply by submitting a new Application for Protocol Amendment form DHCS 5135 (04/16) to the Department. Termination of review of the protocol amendment shall not constitute a licensing action.(b) The Department shall either approve or deny, in writing, the complete protocol amendment within 30 days after the amendment is accepted for review.Cal. Code Regs. Tit. 9, § 10036
1. New section filed 5-7-2020; operative 7-1-2020 (Register 2020, No. 19). Note: Authority cited: Sections 11750, 11755, 11835 and 11839.3, Health and Safety Code. Reference: Sections 11839.3 and 11839.22, Health and Safety Code.
1. New section filed 5-7-2020; operative 7/1/2020 (Register 2020, No. 19).