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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NURTEC ODT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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 ``Endorser Status and Actual Use in Direct-to-Consumer Television Ads.''

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a 3-year extension of the Tribal Child Support Enforcement Direct Funding Requests (Office of Management and Budget (OMB) #0970-0218, expiration March 31, 2023) with revisions. We are proposing to provide an optional Table of Contents and Cover Sheet for plan pages.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``How To Obtain a Covered Product Authorization.''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.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting an administrative supplement (in scope of the parent award) up to $20,833 (total costs) for one-year to the Improving Access to Overdose Treatment grant recipients for a total of up to $104,165 (total funding). These recipients were funded in FY 2018 with a project end date of September 30, 2023. The supplemental funding will be utilized specifically to increase the number of health care providers and pharmacists who receive training and technical assistance on the prescribing of drugs or devices approved or cleared under the FDA for emergency treatment of known or suspected opioid overdose.

This supplemental notice invites the public to nominate individuals from populations underrepresented in medicine to serve as members to the AHRQ Initial Review Group (IRG), which is responsible for the scientific peer review of AHRQ grant applications. The AHRQ IRG conducts scientific and technical review for health services research and training grant applications and is comprised of five subcommittees or study sections, each with a particular research focus. AHRQ is seeking nominations from the public, including minority-serving institutions, academic health centers, community-based organizations, professional societies, or other state and federal agencies.

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.