Department of Health and Human Services February 14, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Brian Michael Parks for a period of 5 years from importing or offering for import any article of food (including dietary supplements) or drug into the United States. FDA bases this order on a finding that Mr. Parks was convicted of one felony count under Federal law for distribution of an unapproved new drug with the intent to defraud and mislead. The factual basis supporting Mr. Parks' conviction, as described below, is conduct relating to the importation into the United States of any food and of any drug or controlled substance. Mr. Parks was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 17, 2021 (30 days after receipt of the notice), Mr. Parks had not responded. Mr. Parks' failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA or we) is classifying the adjunctive predictive cardiovascular indicator 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 adjunctive predictive cardiovascular indicator'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.

The Office of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), is soliciting public comment regarding national health security threats, challenges, and promising practices to help inform the development of the 2023-2026 National Health Security Strategy (NHSS). Since 2006, Congress has required the Secretary of HHS to develop and submit a 4-year NHSS and implementation plan that describe ``potential emergency health security threats and identify the process to be prepared to identify and respond to such threats.'' The quadrennial NHSS is a key U.S. Government vehicle for advancing public health and medical emergency capabilities, and serves as a tool to address priority threats, measure progress, identify gaps, and focus action to implement national health security capabilities.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NIOSH. The BSC NIOSH consists of 15 experts in fields associated with occupational safety and health, such as occupational medicine, occupational nursing, industrial hygiene, occupational safety, engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, biostatistics, psychology, wellness, research translation, and evaluation.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Monitoring and Reporting for the Overdose Data to Action Co-Operative Agreement. Information collected will provide crucial data for program performance monitoring, budget tracking, and where applicable, program success for programs funded under Overdose Data to Action (CDC-RFA-CE19-1904).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled CDC/ATSDR Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. The information collection activities provide a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the federal government's commitment to improving service delivery.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Population-based Surveillance of Outcomes, Needs, and Well-being of Children and Adolescents with Congenital Heart Defects (CHD). The purpose of this collection is to provide insight into public health questions that remain for CHD and to develop services and allocate resources to improve long-term health and well-being.