Okla. Admin. Code § 310:2-11-4

Current through Vol. 42, No. 4, November 1, 2024

Section 310:2-11-4 - Application processing and review

(a)Filing of applications. Unless otherwise provided in this Subchapter, upon the receipt of an application and the proper fee, each Division will:

(1) file-stamp the application with the date of receipt, the Division name and the application number; and

(2) assign each application to a named person who will do the review. This information will be timely logged.

(b)Administrative completeness review. Unless otherwise provided in this Subchapter, the reviewer has 30 calendar days to initially determine if the filed application is administratively complete.

(1)Not complete. Upon determining that the application is not administratively complete, the reviewer will immediately notify the applicant and indicate with reasonable specificity the inadequacies and measures necessary to complete the application. Such notification does not require or preclude further review of the application and further requests for specific information. If the reviewer fails to notify the applicant as specified in this Paragraph, the period for regulatory review will begin at the close of the administrative completeness review period.

(2)Complete. Upon a determination that the application is administratively complete, the regulatory review period begins.

(c)Regulatory review. Each Division involved will have 30 days from the date an application is determined to be administratively complete to review each application for compliance with the relevant regulations and reach a final determination.

(d)When times are tolled. The time period for regulatory review is tolled (the clock stops) during litigation, during public review (public meetings or hearings, administrative hearings, public comment periods, and review by other federal or State agencies) or when the Division has asked for supplemental information and advised the applicant that the time period is tolled pending receipt.

(e)Supplements. To make up for time lost in reviewing inadequate materials, a request for supplemental information may specify that up to 30 additional calendar days may be added to the deadline for regulatory review, unless the request for supplemental information is a second or later request that identifies new deficiencies not previously identified.

(f)Failure to provide supplemental information. An application is considered withdrawn, if an applicant fails to provide supplemental information within 180 days from the date of request. The 180 day time period may be extended by agreement for good cause.

(g)Extensions. Extensions may be allowed as provided by law or at Consumer Health Service's discretion.

Okla. Admin. Code § 310:2-11-4

Added at 10 Ok Reg 95, eff 10-13-92 (emergency); Added at 10 Ok Reg 1721, eff 7-1-93; Amended at 16 Ok Reg 901, eff 1-5-99 (emergency); Amended at 16 Ok Reg 1389, eff 5-27-99

Amended by Oklahoma Register, Volume 39, Issue 24, September 1, 2022, eff. 9/11/2022