Department of Health and Human Services July 26, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC): Evaluation''. The purpose of this study is to improve sexually transmitted disease care in the United States.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice accompanies a Notice of Proposed Rulemaking and invites comment on the information collection request Airline and Vessel and Traveler Information Collection. This information collection request pertains to CDC's activities with regard to requirements at proposed Sec. 71.4 and Sec. 71.5 that airlines and vessels arriving to the United States from foreign countries send passenger, crew, and conveyance information (aka manifests) to CDC in the event that a communicable disease of public health concern is suspected or confirmed in a person aboard who poses a potential public health risk to other travelers and their communities after arriving in the United States. This information also pertains to current activities with regard to the collection of manifests from domestic flights within the United States, as well as the collection of traveler information using the Passenger Locator Form (PLF) on both international and domestic flights.

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: 044 (Recognition List Number: 044), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' When finalized, this draft document will define the expected content and forms of the unique device identifier (UDI), to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). This draft guidance is not the final version of the guidance nor is it in effect at this time.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.