Department of Health and Human Services December 15, 2021 – Federal Register Recent Federal Regulation Documents

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Julia Fees 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. Fees was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Ms. Fees' conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Fees 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 12, 2021 (30 days after receipt of the notice), Ms. Fees had not responded. Ms. Fees' failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.

The Food and Drug Administration (FDA or we) is classifying the endoscopic transhepatic venous access needle 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 endoscopic transhepatic venous access needle's 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.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) will hold public meetings for the 2022 calendar year (CY). Information about ACICBL, agendas, and materials for these meetings can be found on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-co mmunity- linkages/.

The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule based, in part, on the recommendations of the Orthopaedic and Rehabilitation Devices Panel, regarding the classification of spinal spheres for use in intervertebral fusion procedures.