Department of Health and Human Services July 27, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Antimicrobial Animal Drug Sales and Distribution Reporting
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.
Medicare Program; Hospice Wage Index for Fiscal Year 2013
This notice sets forth the hospice wage index for fiscal year (FY) 2013 and will continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction through FY 2013 of 55 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2014 through FY 2016. This notice clarifies that providers should report additional diagnoses on hospice claims. This notice also updates the public on the status of hospice payment reform and the quality reporting program.
Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k) Submissions To Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small- bore Connectors Intended for Enteral Applications.'' The use of common connector designs, such as luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k) submitters regarding the submission expectations regarding design and testing to reduce the risk of unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Application by the American Association of Diabetes Educators (AADE) for Continued Recognition as a National Accreditation Organization for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training
This final notice announces the approval of an application from the American Association of Diabetes Educators for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries.
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