Department of Health and Human Services January 20, 2023 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA, Agency, or we) is classifying the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of November 30, 2022. In that notice, FDA requested comments on draft guidance for industry (GFI) #276 entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Linda Godding for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Godding was convicted of one felony count under Federal law for introducing or delivering for introduction a misbranded drug in interstate commerce. The factual basis supporting Ms. Godding's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Godding was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of September 29, 2022 (30 days after receipt of the notice), Ms. Godding had not responded. Ms. Godding's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.