Notice Designating State Title IV-D Child Support Agencies as “Public Bodies”
This notice designates state IV-D child support agencies as public bodies authorized to perform specific functions of the Central Authority under Article 6(3) of the the Hague Convention of 23 November 2007 on the International Recovery of Child Support and Other Forms of Family Maintenance (Convention).and specifies functions to be performed by the state agencies in relation to applications under the Convention.
Battery Safety Concerns in Electronic Nicotine Delivery Systems; Public Workshop; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is announcing several actions concerning issues related to batteries used in electronic nicotine delivery systems (ENDS), including electronic cigarettes (e-cigarettes). These actions are intended to give CTP staff an opportunity to hear from the public, including tobacco product manufacturers, importers, researchers, and academic investigators, about ENDS battery safety concerns (e.g., overheating, fire, explosion), risk mitigation, and design parameters. Additionally, FDA is interested in information related to communication to consumers and the general public related to ENDS battery safety concerns. FDA is announcing a public workshop on ENDS batteries and safety hazards. The 2-day public workshop will include presentations and panel discussions about ENDS battery safety concerns as well as how potential safety hazards and risks are communicated to consumers and the general public. In conjunction with the public workshop, FDA is establishing a public docket to gather data and information on hazards and risks associated with the use of batteries in ENDS. Regardless of attendance at the public workshop, interested parties are invited to submit comments, including data and research.
In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This draft guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether or not the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling.
Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Technical Electronic Product Radiation Safety Standards Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2018.
Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.''