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Form Approved: OMB No. 0910 0297 Expiration Date: Xxxxxxxxxx xx, 2016. See instructions for OMB Statement, below. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATIONPRESCRIPTION DRUG

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Individuals who are required to submit certain information or documents to the Office of Management and Budget (OMB) may need to refer to the see instructions for omb. This could include government agencies, organizations, or individuals who are involved in processes or activities that require compliance with OMB regulations, reporting requirements, or requesting approvals.

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