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

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 Information Collections to Advance State, Tribal, Local, and Territorial (STLT) Governmental Agency and System Performance, Capacity, and Program Delivery. This collection is used to assess situational awareness of current public health emergencies, make decisions that affect planning, response and recovery activities of subsequent emergencies, and fill CDC and HHS gaps in knowledge of programs and/or STLT governments that will strengthen surveillance, epidemiology, and laboratory science, as well as improve CDC's support and technical assistance to states and communities.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Income Withholding for Support Order (IWO), with minor changes, for an additional 3 years. The current OMB approval expires September 30, 2023.

The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Mark 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 Mr. 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 Mr. Godding's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Godding 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 September 29, 2022 (30 days after receipt of the notice), Mr. Godding had not responded. Mr. Godding'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, Agency, or we) is classifying the intense pulsed light device for managing dry eye 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 intense pulsed light device for managing dry eye'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 National Cancer Institute (NCI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Yissum Research and Development (``Yissum''), the technology transfer company of the Hebrew University of Jerusalem, a non-profit research institution located in Jerusalem, Israel for NCI's rights to the patent applications listed in the Supplementary Information section of this notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Mpox: Development of Drugs and Biological Products.'' FDA is issuing this guidance to support sponsors in their development of drugs and biological products for mpox.

The Food and Drug Administration (FDA, Agency, or we) is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.

The Food and Drug Administration (FDA, Agency, or we) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Accreditation Scheme for Conformity Assessment (ASCA) Program.

The Food and Drug Administration (FDA, Agency, or we) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with the Adverse Event Program for Medical Devices (Medical Program Safety Network (MedSun)).

The Centers for Medicare & Medicaid Services is cancelling the virtual public meeting of the Ground Ambulance and Patient Billing, which was scheduled for January 17 and 18, 2023.