Department of Health and Human Services September 28, 2016 – Federal Register Recent Federal Regulation Documents

The National Heart, Lung, and Blood Institute (NHLBI) COPD National Action Plan; Request for Public Comments
Document Number: 2016-23392
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
NHLBI, with input from federal and nonfederal partners, is developing the COPD National Action Plan to help guide stakeholders nationwide in their efforts to reduce the burden of Chronic Obstructive Pulmonary Disease (COPD). The purpose of this notice is to seek public input on the current draft of the COPD National Action Plan.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2016 Performance Review Board (PRB)
Document Number: 2016-23391
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2016 Performance Review Board.
Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry; Availability
Document Number: 2016-23367
Type: Rule
Date: 2016-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use the implied nutrient content claim ``healthy'' to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim ``healthy'' on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ``low fat'', or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments
Document Number: 2016-23365
Type: Proposed Rule
Date: 2016-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term ``healthy'' in the labeling of human food products. This action is consistent with our recently released 2016-2025 Foods and Veterinary Medicine (FVM) Program's strategic plan with specific goals for nutrition and other planned and recent activity including the issuance of final rules updating certain of our nutrition labeling regulations. In addition, we received a citizen petition asking that we update, among other things, our nutrient content claim regulations to be consistent with current federal dietary guidance. In particular, the petitioners request that FDA amend the regulation defining the nutrient content claim ``healthy'' with respect to total fat intake and amend the regulation to emphasize whole foods and dietary patterns rather than specific nutrients. We invite public comment on the term ``healthy'', generally, and as a nutrient content claim in the context of food labeling and on specific questions contained in this document.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-23340
Type: Notice
Date: 2016-09-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; IONSYS
Document Number: 2016-23330
Type: Notice
Date: 2016-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for IONSYS 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 Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-23315
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Document Number: 2016-23314
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2016-23313
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-23312
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23311
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Division of Independent Review Grant Reviewer Recruitment Form
Document Number: 2016-23306
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.