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

This notice is a notice of intent to award supplemental funding to the nine Minority Fellowship recipients funded in FY 2018 under Notice of Funding Opportunity (NOFO) SM-18-002 and TI-18-013 and in FY 2020 under NOFO SM-20-013. This is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting one-year administrative supplements, which are consistent with the initial award, up to $209,996 each for eight Minority Fellowship Program (MFP) recipients funded under NOFO SM-18-002 and SM- 20-013, and up to $119,053 for the MFP recipient funded under NOFO TI- 18-013, for a total of $1,799,019.

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 the collection of information entitled, ``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.''

This notice announces the issuance of the August 26, 2022 single source funding opportunity titled ``Comprehensive Patient Reported Survey for Mental and Behavioral Health'' available solely to Virginia Commonwealth University (as host institution to The Larry A. Green Center) to support research and development of a patient- provider-payer survey tool that will assist in facilitating the integration of patient care delivery and enable CMS in improving the patient experience, decrease patient and provider burden and improve healthcare operational and administrative efficiencies.

In accordance with the Privacy Act of 1974, the U.S. Department of Health and Human Services (HHS) is modifying an existing system of records, system number 09-80-0361, titled ``OPRE Research and Evaluation Project Records,'' that is maintained by the Administration for Children and Families (ACF), Office of Planning, Research & Evaluation (OPRE). The system of records covers any individually identifiable records about individuals that are retrieved by a personal identifier to conduct OPRE research, evaluation, and data projects that study how to improve the economic and social well-being of children and families and/or increase the effectiveness and efficiency of programs inside and outside ACF working towards that goal. Subject individuals include individuals considered for inclusion or included in an OPRE Project; individuals who provide information about those considered or selected for an OPRE Project; and individuals whose information is in a pre-existing dataset evaluated or analyzed as part of an OPRE Project.

The Agency for Healthcare Research and Quality (AHRQ) seeks public comment about comprehensive, longitudinal, person-centered care planning for people with Multiple Chronic Conditions (MCC). Specifically, the RFI seeks comment on the current state of comprehensive, longitudinal, person-centered care planning for people at risk for or living with MCC across settings of care (e.g., health systems, primary care, home, and other ambulatory practices), including existing models of person-centered care planning, their current scale, and barriers and facilitators to implementation. In addition, the RFI seeks comments about innovative models of care, approaches, promising strategies and solutions in order for clinicians and practices to routinely engage in comprehensive, longitudinal, person-centered care planning to improve the care of people at risk for or living with MCC. This request for information will inform AHRQ's work in improving care for people at risk for or living with MCC.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public via webcast. For this meeting, the TBDWG will review and vote upon the third and final Report to Congress and the HHS Secretary. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.

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 Evaluation of the CDC/NIOSH Health Worker Mental Health Campaign. This project will collect data through the administration of online surveys to health workers and their employers prior to campaign launch and 12 months afterward to assess changes in relevant knowledge, attitudes, and beliefs to help inform recommendations.

This document corrects errors that appeared in the notice published in the August 5, 2022, Federal Register entitled ``Findings of Research Misconduct.'' Applicability Date: The correction notice is applicable for the Findings of Research Misconduct notice published on August 5, 2022.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of its most recent periodic reassessment of the definition of ``small number of animals'' for minor use in major species (contained in our existing regulation for new animal drugs for minor use and minor species). We also are announcing that the small number of animals upper limit thresholds (small numbers) for horses and the food-producing major species (cattle, pigs, turkeys, and chickens) will remain the same. We are separately issuing a direct final rule and a companion proposed rule to revise (i.e., increase) the small numbers for dogs and cats.

HRSA is inviting public comment on the Draft Health Center Program Scope of Project and Telehealth Policy Information Notice (Telehealth PIN). The purpose of the Telehealth PIN is to establish policy for health centers that provide services via telehealth within the HRSA-approved scope of project. The Telehealth PIN also describes considerations and criteria health centers must meet for providing services via telehealth within the Health Center Program scope of project. The Health Center Program is authorized by section 330 of the Public Health Service Act, 42 U.S.C. 254b. HRSA provides federal award funding to health centers to deliver required primary care and additional health services to medically underserved areas and populations. HRSA also certifies entities that it has determined to meet section 330 requirements as Health Center Program look-alikes. Health centers provide required primary care and additional health services to residents of the area served by the health center. Each health center is responsible for maintaining its operations, including developing and implementing its own operating procedures for providing health services through telehealth, in compliance with all Health Center Program requirements and all other applicable federal, state, and local laws and regulations.\1\

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q3D(R2) Guideline for Elemental Impurities.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance revises the guidance for industry ``Q3D(R1) Elemental Impurities'' issued in March 2020 to provide Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration. It also provides relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. The guidance is intended to provide recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products and for conducting risk assessments.