Department of Health and Human Services January 11, 2021 – Federal Register Recent Federal Regulation Documents

Under the National Childhood Vaccine Injury Act (NCVIA), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on proposed updated vaccine information statements for vaccines covered by the National Vaccine Injury Compensation Program (VICP).

The Food and Drug Administration (FDA, we, or Agency) is requesting comments on a document entitled ``Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.'' The concept paper outlines a potential framework for how sponsors of new animal drug products containing medically important antimicrobial drugs approved for use in or on animal feed might voluntarily establish appropriately defined durations of therapeutic administration to food-producing animals where none currently exist. Establishing appropriately defined durations of use to mitigate development of antimicrobial resistance would be consistent with previous efforts by FDA to protect public health by promoting the judicious use of these drugs in food-producing animals.