Correction Orders and Administrative Reconsideration

(A) Whenever the Commissioner or a designated inspection agent finds that a research institution licensed pursuant to 105 CMR 910.000 is not in compliancewithanyregulationin105 CMR 910.000, the Commissioner may order the licensee to correct suchdeficiency. The correction order shall include a statement of the deficiencies found, the provisions of the regulations relied upon, and the period prescribed for correction, which shall be reasonable, depending on the type of deficiencies cited and the time required for correction, which shall not exceed 60 days. (B) The licensee may, within ten days of receipt, file a written request with the Commissioner for administrative reconsideration. The request shall clearly identify the licensee, state the date and nature of the order, the reason why the order should be rescinded or modified, and the approximate time required by the licensee to take corrective measures. (C) If the Commissioner does not grant, deny, or otherwise act upon a request for reconsideration by a research institution within ten days after its receipt by the Commissioner, such request for reconsideration shall be deemed denied andthe CorrectionOrder shall remain in effect. Except in case ofemergency, as determined by the Commissioner, the running of the time specified inthe Correction Order for correction of cited deficiencies shall be tolled upon the filing of a request for administrative reconsideration bya researchinstitution, and shall commence running upon action by the Commissioner or, without such action, upon expiration of the ten day reconsideration period. (D) Upon expiration of the time prescribed in a correction order for the correction of deficiencies, the Commissioner or a designated inspection agent will reinspect the research institution in order to determine compliance by such institution with the correction order. If, upon reinspection, the Commissioner makes a determination of substantial non-compliance with the correction order, the Commissionermayextend the time for compliance or issue an Agency Notice of Action to the research institution in accordance with the procedures set forth in 105 CMR 910.041(B).