(1) General.

(a) A person proposing an undertaking subject to review shall submit a certificate of need application in such form and manner and containing such information as the department has prescribed and published as necessary to such a certificate of need application.

(i) The information, which the department prescribes and publishes as required for a certificate of need application, shall be limited to the information necessary for the department to perform a certificate of need review and shall vary in accordance with and be appropriate to the category of review or the type of proposed project: Provided however, That the required information shall include what is necessary to determine whether the proposed project meets applicable criteria and standards.

(ii) Information regarding a certificate of need application submitted by an applicant after the department has given "notification of the beginning of review" in the manner prescribed by WAC 246-310-170 shall be submitted in writing to the department.

(iii) Except as provided in WAC 246-310-190, no information regarding a certificate of need application submitted by an applicant after the conclusion of the public comment period shall be considered by the department in reviewing and taking action on a certificate of need application. An exception to this rule shall be made when, during its final review period, the department finds an unresolved pivotal issue requires submission of further information by an applicant and the applicant agrees to an extension of the review period in order to resolve this issue as provided for in WAC 246-310-160 (2)(b), 246-310-150 (2)(c), and 246-310-140(4). The department shall give public notice of such request for additional information through the same newspaper in which the "notification of beginning of review" for the project was published. The notice shall identify the project, the nature of the unresolved issue and the information requested of the applicant, and shall state the period of time allowed for receipt of written comments from interested persons.

(b) A person submitting a certificate of need application shall submit one original and one copy of the application to the certificate of need program of the department.

(c) On or before the last day of the applicable screening period for a certificate of need application, as prescribed in subsections (2) and (3) of this section, the department shall send a written notice to the person submitting the application stating whether or not the application has been declared complete. If an application has been found to be incomplete, the notice from the department shall specifically identify the portions of the application where the information provided has been found to be insufficient or indefinite and request supplemental information needed to complete the application.

(d) The department shall not request any supplemental information of a type not prescribed and published as being necessary to a certificate of need application for the type of project being proposed. The department may request clarification of information provided in the application.

(e) A response to the department's request for information to supplement an incomplete application shall be written.

(2) Screening and prereview activities.

(a) The department shall, within a fifteen working-day period for emergency, expedited, and regular reviews, screen the application to determine whether the information provided in the application is complete and as explicit as is necessary for a certificate of need review. This screening period shall begin on the first day after the department has received the application. In the event that the application is lacking significant information relating to the review criteria, the department may, upon notification, reserve the right to screen the application again upon receipt of the applicant's original response unless the applicant exercises option (c)(iii) of this subsection.

(b) The department shall return an incomplete certificate of need application to the person submitting the application if the department has not received a response to a request for the supplemental information sent in accordance with subsection (1)(c) of this section within forty-five days for emergency, expedited, and regular reviews unless extended by mutual agreement, and within one month for concurrent review after such request was sent.

(c) For emergency, expedited, and regular reviews, a person submitting a response to the department's request for supplemental information to complete a certificate of need application within forty-five days after the request was sent by the department, in accordance with subsection (1)(c) of this section, shall have the right to exercise one of the following options:

(i) Submission of written supplemental information and a written request that the information be screened and the applicant be given opportunity to submit further supplemental information if the department determines that the application is still incomplete;

(ii) Submission of written supplemental information with a written request that review of the certificate of need application begin without the department notifying the applicant as to whether the supplemental information is adequate to complete the application; or

(iii) Submission of a written request that the application be reviewed without supplemental information.

(d) The department shall not accept responses to the department's screening letters later than ten days after the department has given "notification of beginning of review."

(e) For concurrent review a person submitting a response to the department's request for supplemental information to complete a certificate of need application within one month after the request was sent by the department, in accordance with subsection (1)(c) of this section, shall submit written supplemental information or a written request that the incomplete application be reviewed. The review shall begin in accordance with the published schedule.

(f) After receipt of a request for review of a certificate of need application, submitted in accordance with subsection (2)(c)(ii) or (iii) of this section, the department shall give notification of the beginning of review in the manner prescribed for a complete application in WAC 246-310-170.

(g) If a person requests the screening of supplemental information in accordance with subsection (2)(c)(i) of this section, such screening shall be carried out in the same number of days and in the same manner as required for an application in accordance with the provisions of subsection (1)(c) and (2)(a) of this section. The process of submitting and screening supplemental information may be repeated until the department declares the certificate of need application complete, the applicant requests that review of the incomplete application begin, or the one hundred twentieth day after the beginning of the first screening period for the application, whichever occurs first. The department shall return an application to the applicant if it is still incomplete on the one hundred twentieth day after the beginning of the first screening period and the applicant has not requested review of such incomplete application.

(3) Withdrawal of applications.

A certificate of need application shall be withdrawn from the certificate of need process if the department receives a written request for withdrawal of the application from the person submitting the application at any time before final action on such application has been taken by the secretary's designee.

(4) Resubmission of applications withdrawn or returned as incomplete.

A submission of a new certificate of need application shall be required for a certificate of need review of any undertaking for which the department has returned an incomplete application in accordance with subsection (2)(b) of this section, or for which a certificate of need application has been withdrawn in accordance with subsection (3) of this section. The content of the application should be updated as necessary before resubmission.