federal_register: 2013-30818

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2013-30818 Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment Notice The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled "PDUFA V Information Technology Plan." This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals. 2013-12-26 2013 12 https://www.federalregister.gov/documents/2013/12/26/2013-30818/draft-prescription-drug-user-fee-act-v-information-technology-plan-availability-for-comment https://www.govinfo.gov/content/pkg/FR-2013-12-26/pdf/2013-30818.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled "PDUFA V Information Technology Plan." This plan is intended to provide FDA's approach for enhancing...

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