Department of Health and Human Services November 10, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
Document Number: 2016-27199
Type: Notice
Date: 2016-11-10
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 reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products.
Health IT Policy Committee Advisory Meeting; Notice of Meeting
Document Number: 2016-27174
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services
Health IT Standards Committee Advisory Meeting; Notice of Meeting
Document Number: 2016-27172
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-27143
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2016-27142
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-27140
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2016-27139
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2016-27138
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-27137
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-27136
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27135
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27134
Type: Notice
Date: 2016-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Amendment to Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability
Document Number: 2016-27107
Type: Notice
Date: 2016-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry.'' The draft guidance document, when finalized, is intended to amend the document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) by expanding the scope of the guidance to include the collection of blood and blood components for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device; removing the recommendation to ask donors about a history of Chagas disease; and providing a recommendation for a reentry algorithm for donors deferred on the basis of screening test results for antibodies to Trypanosoma cruzi (T. cruzi) or on the basis of answering ``yes'' to the Chagas screening question. Further, the guidance is intended to notify blood establishments that collect blood and blood components that FDA has licensed a supplemental test for antibodies to T. cruzi and further testing of donations found repeatedly reactive to a screening test for T. cruzi is therefore required. The draft guidance does not apply to the collection of Source Plasma.
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-27106
Type: Notice
Date: 2016-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroid. This draft guidance is not final nor is it in effect at this time.