Department of Health and Human Services September 23, 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 Roy Tuccillo, Sr. for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Tuccillo was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Tuccillo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 17, 2022 (30 days after receipt of the notice), Mr. Tuccillo has not responded. Mr. Tuccillo's 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 Agency) is announcing the availability of a final guidance for industry entitled ``Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.'' Combating the opioid overdose epidemic is an urgent public health priority for FDA. Naloxone hydrochloride (``naloxone'') is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs and is aware of concerns that harm reduction programs are having difficulty acquiring naloxone. FDA is issuing this guidance to clarify the scope of the public health emergency exclusion and exemption under the Drug Supply Chain Security Act as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid public health emergency. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Customer Surveys Generic Clearance for the National Center for Health Statistics. The goal of this project is to conduct voluntary customer surveys to assess strengths in agency products and services, and to evaluate how well it addresses the emerging needs of its data users.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Muscular Dystrophy Questionnaire. The purpose of the proposed study is to describe the epidemiology of COVID-19 and flu and the experience with pain, fatigue, pregnancy, and infertility for adults living with muscular dystrophy (MD) who are identified through MD STARnet. Information will be used to develop interventions that improve the lives of people with MD and their families.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 a proposed study entitled ``Perceptions of Prescription Drug Products With Medication Tracking Capabilities.''

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The ACF, ACYF, Children's Bureau, Division of Capacity Building announces the intent to award a single-source cooperative agreement in the amount of up to $10,000,000 to the Center for Adoption Support and Education in Burtonsville, MD. The purpose of this award is to continue to scale the web-based National Training Initiative for Adoption Competent Mental Health Training program to remaining states in the nation, refine and update the curriculum as needed and perform an updated evaluation regarding current use of the curriculum.