Department of Health and Human Services February 12, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XADAGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on a report as required by agency rules that relate to the transmission of passenger, crew, and flight/voyage information for public health purposes. The report can be found at https://www.cdc.gov/quarantine/final-rule-communicable-diseas es.html. Interested members of the public may submit comment regarding this report.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

On January 28, 2019, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) published a notice announcing the next meeting of the Advisory Committee on Immunization Practices on February 27-28, 2019 in Atlanta, GA. The notice did not include the docket number for public comment or instructions for submitting public comment. This notice provides that information for the public.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on safety labeling changes and the implementation of a certain section of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the 2019 Million Hearts[supreg] Hypertension Control Challenge. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2022. In order to prevent one million events, we need to decrease smoking, sodium consumption and physical inactivity by 20%; improve performance on appropriate aspirin use, blood pressure control, cholesterol management, and smoking cessation to 80%; and improve outcomes for priority populations. Over the last five years, we have seen tremendous progress by providers and health care systems that focus on improving their performance in controlling patients' blood pressure. Getting to 80% control would mean that 10 million more Americans with hypertension would have their blood pressure under control, and be at substantially lower risk for strokes, heart attacks and other events. For more information about the initiative, visit https://millionhearts.hhs.gov/ . The challenge is an important way to call attention to the need for improved control, provides a powerful motivation and target for clinicians, and will improve understanding of successful implementation strategies at the health system level. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as 2019 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.