Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4605 - COMMUNICABLE DISEASES
REPORTING REQUIREMENTS
Part 4605.7041 - CLINICAL MATERIALS SUBMISSION MODIFICATION

Universal Citation: MN Rules 4605.7041

Current through Register Vol. 49, No. 13, September 23, 2024

The commissioner may modify clinical materials submission requirements under part 4605.7040 if the commissioner determines that one of the following circumstances exists and the modification does not risk the publics health. The circumstances are:

A. laboratory testing methods or capabilities are not sufficient or adequate to determine the presence of the pathogen of concern:

B. surveillance needs have changed: or

C. evolving pathogen knowledge indicates that either the pathogen is no longer a concern or advances in diagnostic testing provide the necessary information to public health.

The commissioner must issue an order that notifies submitters that the commissioner is altering normal submission requirements under part 4605.7040. The commissioners order must identify the circumstance in subpart 1 that warrants the suspensioa the need for different submission requirements, and the situation-specific directions for clinical submission necessary to correct the situation. The directions must identify the following:

A. the submissions of clinical materials that are suspended entirely, if any: or

B. the reduced number of clinical materials that must be submitted: and

C. other specific changes in required procedures that correspond to the altered requirements.

The commissioner must issue an order rescinding the modified procedures when the criteria for the circumstances no longer apply.

Disclaimer: These regulations may not be the most recent version. Minnesota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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