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The current standard for drug-sensitive TB (DS-TB) is a 6-month regimen comprising isoniazid (INH), rifampin (also known as rifampicin) (RIF), pyrazinamide (PZA), and ethambutol (EMB), starting with a 2-month intensive phase of all four drugs, followed by 4 months of INH and RIF (Drug-Resistant Tuberculosis, 2024)

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The proposed rule would require applicants submitting an SE report and receiving an SE order to maintain all records supporting the SE report for at least four years