Department of Health and Human Services August 4, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling: Nutrition Facts and Supplement Facts Label and Reference Amounts Customarily Consumed per Eating Occasion
Document Number: 2016-18509
Type: Notice
Date: 2016-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling: Nutrition Facts and Supplement Facts Label and Reference Amounts Customarily Consumed Per Eating Occasion'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2016-18508
Type: Notice
Date: 2016-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Announcement of the Intent to Award a Supplemental Grant to the National Safe Place Network in Louisville, KY
Document Number: 2016-18502
Type: Notice
Date: 2016-08-04
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) announces its intent to award a non-competitive supplemental grant in the amount of up to $310,000 to the National Safe Place Network in Louisville, KY, to support and expand the grantee's activities under their award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
Document Number: 2016-18463
Type: Notice
Date: 2016-08-04
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Certification of Identity for Freedom of Information Act and Privacy Act Requests.''
Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability
Document Number: 2016-18461
Type: Notice
Date: 2016-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Insanitary Conditions at Compounding Facilities.'' Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events in patients, including death. FDA is issuing this draft guidance to assist compounding facilities in identifying insanitary conditions so that they can implement appropriate corrective actions, and to assist State regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions.
Announcement of Requirements and Registration for the “MRC Serves” Video Challenge
Document Number: 2016-18427
Type: Notice
Date: 2016-08-04
Agency: Department of Health and Human Services
The Medical Reserve Corps (MRC) Program housed under the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), announces the launch of the ``MRC Serves'' Video Challenge. The MRC is a national network of volunteers, organized locally to improve the health and safety of their communities. MRC volunteers have medical, public health, other backgrounds and have responded to natural disasters, public health and other emergencies, while also supporting community health activities. The MRC Program is looking for innovative and cost effective ways to promote these activities and demonstrate how MRC units and their volunteers make their communities healthier, prepared, and more resilient. Today there are nearly 200,000 volunteers, in almost 1,000 MRC units nationwide, who give their skills and time year around to support their communities and serve as ambassadors for the MRC to their friends, families, neighbors, and co- workers. The MRC Program would like to engage MRC volunteers to also be national ambassadors by creating short promotional videos that will be used by the MRC Program to highlight how serving as MRC volunteers makes communities healthier, more prepared, and more resilient.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Direct-to-Consumer Advertising Survey
Document Number: 2016-18425
Type: Notice
Date: 2016-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
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