Department of Health and Human Services September 22, 2022 – Federal Register Recent Federal Regulation Documents

The Children's Bureau, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for an evaluation of a set of resources that are being developed to support the identification and care of children with prenatal substance or alcohol exposure in the child welfare system.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC and the agenda for this meeting can be found on the CHAC website at https://www.cdc.gov/maso/facm/facmCHACHSPT.html and the meeting website at https://targethiv.org/ta-org/chac.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``How To Obtain a Covered Product Authorization.'' This guidance describes how eligible product developers can obtain a Covered Product Authorization (CPA) from FDA under the law widely known as the CREATES Act. The CREATES Act provides a pathway for eligible product developers to obtain access to the product samples they need to fulfill testing and other regulatory requirements to support their applications. As described in further detail below, to make use of this pathway, an eligible product developer seeking to develop a product subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) must obtain a CPA from the Agency. This guidance replaces the December 2014 draft guidance for industry ``How To Obtain a Letter From FDA Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD,'' which has been withdrawn. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA, Agency, or we) has determined that prescription NIX (permethrin) 1% topical creme rinse was not withdrawn from sale for reasons of safety or effectiveness. However, because NIX (permethrin) 1% topical creme rinse has been approved for nonprescription use, NIX and any generic product referencing prescription NIX would be misbranded under FDA regulations if marketed with the ``Rx only'' symbol. Moreover, FDA will not approve abbreviated new drug applications (ANDAs) referencing prescription NIX (permethrin) 1% topical creme rinse.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) is proposing to collect data to explore how one state's changes to Temporary Assistance for Needy Families (TANF) policies and services in response to the COVID-19 pandemic were experienced by different racial and ethnic groups in that state. The goal is to obtain an in-depth understanding of how TANF participants of different racial and ethnic backgrounds experienced these policy and programmatic changes by comparing those experiences within one state, and to assess whether those changes may have helped to ameliorate challenges around program and benefit access for different populations or potentially created new challenges.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Electronic Submission Template for Medical Device 510(k) Submissions.'' This final guidance is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This guidance document provides further standards for the submission of 510(k)s by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.