Agency Emergency Processing under OMB Review; The Evaluation of Long-Term Antibiotic Drug Therapy for Persons Involved in Anthrax Remediation Activities

Zusammenfassung

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the evaluation of approximately 1,200 people involved in the decontamination/cleanup ("remediation") of various facilities contaminated with anthrax spores during a terrorist event in the fall of 2001. The 1,200 decontamination workers have been on continuous prophylactic antibiotics for greater than 60 days and FDA wants to evaluate these workers for adverse events that may have occurred in light of this prolonged drug exposure.