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To establish processes and requirements related to the new data elements we are finalizing in this final rule with comment period, we now estimate that it will take a Business Operations Specialist (BLS 13-1000), on average, 8 hours (at a cost of $87.52 per hour) to develop and update the necessary processes and procedures and develop the requirements to implement the proposed data elements, a General and Operations Managers (BLS 11-1021), on average, 2 hours (at a cost of $128.00 per hour) to review the updates, and a Chief Executive (BLS 11-1011) 2 hours (at a cost of $252.82) to review and attest to the accuracy and completeness of the data in the MRF

acetaldehyde concentration in the blood), as opposed to purely subjective markers such as how a study participant felt

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[59] [60] Injection side effects include skin rash, itching, chills, fever, hot flushes, nausea and dizziness