Department of Health and Human Services February 1, 2019 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on February 13-14, 2019, in Atlanta, Georgia.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2019. See list of public meetings below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsAmendments and Requests for Final Approval to Tentatively Approved ANDAs.'' This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest lawful approval date.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the assessment of risk evaluation and mitigation strategies (REMS) entitled ``REMS Assessment: Planning and Reporting; Draft Guidance for Industry.'' The draft guidance is one of several guidance documents being developed to fulfill performance goals under the fifth authorization of the prescription drug user fee program, the Prescription Drug User Fee Act V. This draft guidance describes how to develop a REMS Assessment Plan; specifically, how the REMS program goals, objectives, and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the REMS is meeting its risk mitigation goals. The draft guidance recommends assessing the REMS using both process measures and outcome measures and provides examples of metrics by assessment categories, as well as data sources that may be utilized to evaluate the performance of the REMS. The draft guidance also discusses considerations for assessing the impact of REMS on patient access to the drug or its burden to the healthcare delivery system. Finally, this draft guidance provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.

Findings of research misconduct have been made against Srikanth Santhanam, Ph.D. (Respondent), staff scientist in the Division of Gastroenterology, Department of Internal Medicine, Washington University in St. Louis (WUSTL). Dr. Santhanam engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK109384, R03 DK100737, P30 DK052574, and T32 DK077653; National Institute of Allergy and Infectious Diseases (NIAID), NIH, grants R01 AI126587 and U01 AI1095776; and National Cancer Institute (NCI), NIH, grants R21 CA206039 and P30 CA091842. The administrative actions, including supervision for a period of two (2) years, were implemented beginning on December 14, 2018, and are detailed below.

This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors provides advice on programmatic activities. This meeting complements year-long activities to ensure NTP's scientific direction, expertise, and capabilities are strategically positioned to address public health issues and provide the necessary scientific information to inform decision-making. The agenda includes talks by invited speakers on ``The Changing Toxicology Landscape: Challenges and the Future of Risk Assessment'' followed by time for BSC discussion and input to NTP. The talks were originally scheduled for December 11, 2018; however, the meeting day was cancelled due to inclement weather. This meeting is by webcast only and is open to the public. Registration is requested for oral comment and is required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.