Department of Health and Human Services February 23, 2016 – Federal Register Recent Federal Regulation Documents
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period
In the Federal Register of November 18, 2015, the Food and Drug Administration (FDA) published a proposed rule entitled ``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' The proposed rule would establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. We are taking this action to reopen the comment period in response to requests to allow interested persons additional time to submit comments.
Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment of a Public Docket
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing a public workshop to gather scientific information on waterpipes and waterpipe tobacco and to identify areas of research that may inform CTP's regulation of these tobacco products. The workshop will include presentations and panel discussions about the current state of the science, and will focus on product use and design, smoke constituents, environmental impacts, and the impact of marketing these products on population health, including on both users and nonusers. FDA is also opening a public docket to receive data, information, and comments on this topic.
Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of filing that appeared in the Federal Register of January 4, 2016. In the notice, FDA requested comments on a filed food additive petition (FAP 5A4810), submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Medicare Program; Public Meetings in Calendar Year 2016 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2016 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. As indicated in this notice, we are reorganizing public meeting content under two main headings: (1) Drugs/Biologics, Radiopharmaceuticals/Radiologic Imaging Agents, and (2) Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other.
Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids.''
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; 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 provided in the notice entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'' that appeared in the Federal Register of January 26, 2016. That notice announced the availability of a draft guidance for industry and FDA staff and requested comments by March 28, 2016. FDA is extending the draft guidance's comment period by 30 days in response to requests for an extension to allow interested persons additional time to submit comments.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2015
This quarterly notice lists of the OMHA Case Processing Manual (OCPM) manual instructions that were published from October through December, 2015. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
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