Department of Health and Human Services February 9, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ODOMZO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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) located within the Department of Health and Human Services (HHS) announces the launch of the 2018 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 provider and health care systems that focus on improving their performance in controlling blood pressure. Getting to 80% control would mean that 10 million more Americans would have their blood pressure under control, and be at substantially lower risk for strokes, heart attacks and other cardiovascular events. For more information about the initiative, visit https://millionhearts. hhs.gov/. The Million Hearts Hypertension Control challenge is an important way to call attention to the need for improved blood pressure control, provides a powerful motivation and target for clinicians, and will improve understanding of successful implementation strategies at the health system level. The Million Hearts Hypertension Control Challenge will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as 2018 Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document and further disseminate the systems, strategies, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENTRESTO 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 Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ONIVYDE 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 Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for STRENSIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 biological product.

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