Department of Health and Human Services March 8, 2018 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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 the record retention requirement of the soy protein/coronary heart disease health claim.
Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.'' The topic to be discussed is the appropriate design of clinical studies to evaluate devices including digital health technologies intended for the diagnosis, monitoring, or treatment of sleep disordered breathing (SDB) in adults. Study design considerations to be discussed include definitions for SDB conditions, inclusion/exclusion criteria for studies of these conditions, use of SDB assessment technologies, controls, and study endpoints.
Health Information Technology Advisory Committee 2018 Schedule
This notice fulfills obligations under section 3002 of the Public Health Service Act (PHSA), as amended by the 21st Century Cures Act. Section 3002(b) (5) of the PHSA, as amended, mandates that the Health Information Technology Advisory Committee shall develop a schedule for the assessment of policy recommendations and the Secretary shall publish such schedule in the Federal Register.
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