Department of Health and Human Services March 28, 2018 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-06221
Type: Notice
Date: 2018-03-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-06184
Type: Notice
Date: 2018-03-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of an Approved Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-06169
Type: Notice
Date: 2018-03-28
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.
Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-06168
Type: Notice
Date: 2018-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Cigarettes, Smokeless Tobacco, and Covered Tobacco Products; Change of Office Name and Address; Technical Amendment
Document Number: 2018-06164
Type: Rule
Date: 2018-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its Cigarettes, Smokeless Tobacco, and Covered Tobacco Products regulations to reflect a change of office name and mailing address for the Center for Tobacco Products' (CTP's) Office of Compliance and Enforcement. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2018-06155
Type: Notice
Date: 2018-03-28
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Document Number: 2018-06154
Type: Notice
Date: 2018-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
Document Number: 2018-06135
Type: Notice
Date: 2018-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 the information collection requirements for a voluntary survey for the U.S. Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the U.S. Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress that is required by April 2019. The proposed survey will be used to determine what food defense activities, if any, State Agencies have completed to date.
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