Arizona Administrative Code (Last Updated: November 17, 2016) |
Title 9. HEALTH SERVICES |
Chapter 6. LICENSING OF ENVIRONMENTAL LABORATORIES |
Section R9-14-621. Time-frames
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A. The overall time-frame described in A.R.S. § 41-1072 for each type of approval granted by the Department under this Article is set forth in Table 1.
1. An applicant and the Department may agree in writing to extend the substantive review time-frame and the overall time-frame.
2. An extension of the substantive review time-frame and the overall time-frame may not exceed 25% of the overall time-frame.
B. The administrative completeness review time-frame described in A.R.S. § 41-1072 for each type of approval granted by the Department under this Article is set forth in Table 1 and begins on the date that the Department receives an application or request for approval.
1. The Department shall send a notice of administrative com- pleteness or deficiencies to an applicant within the admin- istrative completeness review time-frame.
a. A notice of deficiencies shall list each deficiency and the information or items needed to complete the application or request for approval.
b. The administrative completeness review time-frame and the overall time-frame are suspended from the
date that a notice of deficiencies is sent until the date that the Department receives all of the missing infor- mation or items from an applicant.
2. If an applicant fails to submit to the Department all of the information and items listed in a notice of deficiencies within 60 days after the date that the Department sent the notice of deficiencies, the Department shall consider the application or request for approval withdrawn and deny the license or other approval requested.
3. If the Department issues a license or other approval to an applicant during the administrative completeness review time-frame, the Department shall not issue a separate written notice of administrative completeness.
C. The substantive review time-frame described in A.R.S. § 41- 1072 is set forth in Table 1 and begins on the date of a notice of administrative completeness.
1. As part of the substantive review for an initial license application, the Department may conduct a laboratory inspection, investigation, or proficiency testing, or a com- bination of the three, as described in R9-14-605.
a. The Department shall commence a laboratory inspection, investigation, or proficiency testing, or combination of the three, no more than 30 days after notice of administrative completeness has been mailed for an in-state laboratory or no more than 60 days after notice of administrative completeness has been mailed for an out-of-state laboratory.
b. The Department and an applicant may mutually agree in writing to schedule a laboratory inspection, proficiency testing, or investigation later than the date required under subsection (C)(1)(a).
2. The Department shall send written notification of approval or denial of a license or other approval to an applicant within the substantive review time-frame.
3. During the substantive review time-frame, the Department may make one comprehensive written request for addi- tional information, unless the Department and applicant have agreed in writing to allow the Department to submit supplemental requests for information.
4. If the Department issues a comprehensive written request or a supplemental request for information, the substantive review time-frame and the overall time-frame are sus- pended from the date that the Department issues the
request until the date that the Department receives all of the information requested.
5. If an applicant fails to submit to the Department all of the information and items listed in a comprehensive written request or a supplemental request for information within 60 days after the date that the Department sent the com- prehensive written request or supplemental request for information, the Department shall deny the license or other approval requested.
6. The Department shall grant a license or other approval unless:
a. An applicant fails to submit requested information or a requested item as described in subsection (B)(2) or (C)(5);
b. For an initial license application or a regular license renewal application where the regular license is not suspended, the Department determines that grounds to deny the license exist under A.R.S. § 36-495.09;
c. For a regular license renewal application where the regular license is suspended, the Department deter- mines that the licensee is not in full compliance with the corrective action plan; A.R.S. Title 36, Chapter 4.3; or this Article;
d. For a request for approval of an alternate method or method alteration, the Department determines that the alternate method or method alteration does not meet the standard for approval under R9-14- 610(C)(4); or
e. For a request for approval of an exemption under R9-14-615(D), the Department determines that the request does not meet the standard for approval under R9-14-615(F).
7. If the Department denies a license or other approval, the Department shall send to the applicant a written notice of denial setting forth the reasons for denial and all other information required by A.R.S. § 41-1076.
Historical Note
New Section adopted by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Section R9-14-621 renumbered from R9-14-620 and amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).