Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
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.
Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals'); Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period for the draft guidance for Industry and Food and Drug Administration Staff entitled ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').'' A notice of the availability of the draft guidance and our request for comments appeared in the Federal Register of December 31, 2015. We initially established February 29, 2016, as the deadline for the submission of requested comments that can help improve the Agency's policy for notifying the public about medical device ``emerging signals.'' The Agency is taking this action due to the unanticipated high-level of interest from external stakeholders and the medical device community and will allow interested persons additional time to submit comments.
HHS-Operated Risk Adjustment Methodology Meeting; March 31, 2016
This notice announces the rescheduling of the March 25, 2016 meeting on the HHS-operated risk adjustment program, which is open to the public. The purpose of this stakeholder meeting is to solicit feedback on the HHS-operated risk adjustment methodology and to discuss potential improvements to the HHS risk adjustment methodology for the 2018 benefit year and beyond. This meeting, the ``HHS-operated Risk Adjustment Methodology Conference,'' will allow issuers, States, and other interested parties to discuss the contents of a White Paper to be published in advance of this meeting. This meeting will also provide an opportunity for participants to ask clarifying questions. The comments and information HHS obtains through this meeting may be used in future policy making for the HHS risk adjustment program.