federal_register: 2018-25958

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2018-25958 Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments Notice The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled "Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards." FDA is also requesting public comments on the subject. The purpose of the meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards initiatives, the FDA Information Technology (IT) Strategic Plan, and electronic submissions gateway target timeframes. 2018-11-29 2018 11 https://www.federalregister.gov/documents/2018/11/29/2018-25958/prescription-drug-user-fee-act-of-2017-electronic-submissions-and-data-standards-announcement-of https://www.govinfo.gov/content/pkg/FR-2018-11-29/pdf/2018-25958.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled "Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards." FDA is also requesting public comments on the subject. The purpose...  

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