Department of Health and Human Services June 15, 2016 – Federal Register Recent Federal Regulation Documents
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Tobacco Product Manufacturing Facility Visits
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing an invitation for participation in its Tobacco Product Manufacturing Facility Visits. This program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of newly deemed tobacco products and their components and parts, including any related laboratory testing, and to observe the manufacturing operations of the tobacco industry. The purpose of this document is to invite parties interested in participating in Tobacco Product Manufacturing Facility Visits to submit requests to CTP.
Menu Labeling Public Workshops; Public Meetings
The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss menu labeling requirements. We will announce an additional public meeting to be held in Oakland, California, in a separate Federal Register notice later this year. The purpose of the public meetings is to help the regulated industry comply with the requirements of the menu labeling final rule.
Styrene Information and Research Center; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.
Submission for OMB Review; 30-Day Comment Request; Women's Health Initiative (NHLBI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 4, 2016, Pages: 19207-19208. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Freedom of Information Regulations
The Department of Health and Human Services (HHS) is proposing to revise and republish its regulations implementing the Freedom of Information Act (FOIA). The regulations are being revised in order to incorporate changes made to the FOIA by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the Electronic FOIA Act of 1996 (E-FOIA Act). Additionally, the regulations are being updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS's fee schedule, and to make provisions clearer. Because of the numerous changes to the organization and to the headings, the regulations are being republished in their entirety.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 042
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 042'' (Recognition List Number: 042), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Use of Symbols in Labeling
The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as ``stand-alone symbols'') if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement ``Rx only'' or ``[rx] only'' in the labeling for prescription devices.
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