FDA CVM GFI #108 Registering with CVM’s Electronic Submission System

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Registering with CVM’s Electronic Submission System Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides general standards which should be used to register with the Center for Veterinary Medicine’s (CVM or the Center) Electronic Submission System (CVM ESS). CVM’s ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of FDA’s Electronic Records; Electronic Signatures regulation (21 CFR part 11). The CVM ESS registration form and guidance is published in the Electronic Submissions Docket No. FDA-1992-S-0039 (https://www.regulations.gov/). FDA’s regulation at 21 CFR part 11 requires that the Agency identify in the Electronic Submission Docket the types of documents or parts of documents acceptable for official electronic submission. This guidance implements provisions of the Government Paperwork Elimination Act of 1998 (Pub. L. No. 105-277, 112 Stat. 2681), which requires that executive agencies, by October 21, 2003, provide: (1) for the option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitute for paper; and (2) for the use and acceptance of electronic signatures when practicable. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. II. COMMUNICATION BETWEEN CVM AND STAKEHOLDERS Successful electronic submission of information to the CVM ESS for review and evaluation must occur through the FDA Electronic Submissions Gateway (FDA ESG). The FDA ESG is separate and distinct from the CVM ESS. The purpose of the FDA ESG is to provide a centralized, Agency-

wide communications point for securely receiving electronic regulatory submissions. The FDA ESG is a conduit or portal through which electronic submissions to the CVM ESS must first pass. Stakeholders seeking to make electronic submissions to the CVM ESS must register separately both

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