Department of Health and Human Services October 19, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-25310
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Solicitation for Applications From Individuals Interested in Being Appointed to the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2016-25307
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH), within the Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides advice and recommendations to the Secretary of HHS, through the Assistant Secretary for Health (ASH), on a broad range of issues and topics related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The appointments of two Committee members are scheduled to end during the 2016 calendar year. Nominations of qualified candidates are being sought to fill the positions that are scheduled to be vacated.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
Document Number: 2016-25232
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 requirements for premarket approval of medical devices.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-25231
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, Administration for Children and Families
Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket
Document Number: 2016-25223
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years.
Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY
Document Number: 2016-25222
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for PLEGRIDY 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; REPATHA
Document Number: 2016-25221
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for REPATHA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC
Document Number: 2016-25220
Type: Notice
Date: 2016-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for PRILOSEC OTC 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.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-25215
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-25214
Type: Notice
Date: 2016-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions
Document Number: 2016-25118
Type: Notice
Date: 2016-10-19
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
ONC Health IT Certification Program: Enhanced Oversight and Accountability
Document Number: 2016-24908
Type: Rule
Date: 2016-10-19
Agency: Department of Health and Human Services, Office of the Secretary
This final rule finalizes modifications and new requirements under the ONC Health IT Certification Program (``Program''), including provisions related to the Office of the National Coordinator for Health Information Technology (ONC)'s role in the Program. The final rule creates a regulatory framework for ONC's direct review of health information technology (health IT) certified under the Program, including, when necessary, requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules. The final rule also sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Program. In addition, it includes provisions for expanded public availability of certified health IT surveillance results.