Department of Health and Human Services April 5, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) has determined that CEDAX (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Medical Device Conference (MedCon).'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2022. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and promoting physical activity. For more information about the initiative, visit https://millionhearts.hhs.gov/. To support improved blood pressure control, HHS/CDC is announcing the 2017 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, strategies, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions.