federal_register: 2012-18366

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-18366 Antimicrobial Animal Drug Sales and Distribution Reporting Proposed Rule The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance. 2012-07-27 2012 7 https://www.federalregister.gov/documents/2012/07/27/2012-18366/antimicrobial-animal-drug-sales-and-distribution-reporting https://www.govinfo.gov/content/pkg/FR-2012-07-27/pdf/2012-18366.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the...

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