Department of Health and Human Services August 2020 – Federal Register Recent Federal Regulation Documents

The Office of Clinical and Preventive Services (OCPS) announces the award of a single-source cooperative agreement in response to an unsolicited proposal from Johns Hopkins University, Baltimore, Maryland. The proposal submitted was not solicited either formally or informally by any federal government official. OCPS performed an objective review of the unsolicited proposal from Johns Hopkins University (JHU) to develop information on proper actions to mitigate the spread of COVID-19, in a culturally sensitive way. The Johns Hopkins Bloomberg School of Public Health (JHSPH) Center for American Indian Health (CAIH) mission is to work in partnerships with AI/AN communities to raise their health status, self-sufficiency, and health leadership to the highest possible level. This mission is accomplished through research, training and education, and service. The CAIH has more than nine facilities and approximately 100 staff in the Southwestern tribal communities to assist the Indian Health Service (IHS) in containing and mitigating COVID-19, while building a response model and set of communication materials for all IHS regions nationwide. The CAIH can draw on broad expertise from JHU for additional guidance and recommendations on best practices as the situation evolves. The materials will be developed from the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) guidance. Based on an internal review of the proposal and the immediate response of the IHS to address the COVID-19 public health emergency, OCPS determined that the proposal has merit. The long history between the federal government and Native American Tribes and people has often been less than ideal. There are still barriers to the Native American community accepting instruction or direction from the federal government. There is great value in having a third party that has a good history with the community to gather, package and deliver recommendations, in a culturally sensitive way, on staying safe from this disease, when those recommendations may run contrary to cultural norms. This delivery avenue will be more acceptable to the community, and will be more readily recognized for implementation within AI/AN communities. This award is being made noncompetitively because there is no current, pending, or planned funding opportunity announcement under which this proposal could be competed. OCPS has identified two additional key reasons to support rationale for awarding this unsolicited proposal: 1. The JHU CAIH is well known in the AI/AN communities for robust communication/messaging networks, research, training, and subject matter expertise. The dissemination of critical COVID-19 information for tribal communities builds trust, credibility, and integrity of promoting a culturally sensitive public health approach around the information. 2. The JHU CAIH is uniquely positioned to provide culturally specific subject matter expertise drawn from a direct care services or ``boots on the ground'' approach. The CAIH has nearly 40 years of collaboration with Native American tribes and supports public health interventions in more than 140 tribal communities in over 21 states. The breadth of knowledge and existing partnerships will enhance dissemination of information nationally. Legislative Authority: The Snyder Act, 25 U.S.C. Section 13; the Indian Health Care Improvement Act, 25 U.S.C. Section 1621b; and Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136.

Findings of research misconduct have been made against Zhiwei Wang, M.D. (Respondent), former postdoctoral fellow, Department of Pathology, Karmanos Cancer Institute, Wayne State University (WSU). Dr. Wang engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P20 CA101936, P30 CA022453, R01 CA075059, R01 CA083695, R01 CA101870, R01 CA109389, R01CA131151, R01 CA132794, and U19 CA113317. The administrative actions, including debarment for a period of ten (10) years, were implemented beginning on July 21, 2020, and are detailed below.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2020, relating to the Medicare and Medicaid programs and other programs administered by CMS.

In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public via webcast and by teleconference. Time will be available for public comment.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2021 based on our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this proposed rule would establish and update the Overall Hospital Quality Star Rating beginning with the CY 2021; remove certain restrictions on the expansion of physician-owned hospitals that qualify as ``high Medicaid facilities,'' and clarify that certain beds are counted toward a hospital's baseline number of operating rooms, procedure rooms, and beds; and add two new service categories to the OPD Prior Authorization Process.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs 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) 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.'' This guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with their submission of required marketing status notifications. This guidance finalizes the draft guidance of the same title issued on January 31, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.'' The purpose of this guidance is to provide a systematic, risk-based approach to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug- drug interaction (DDI) studies for a therapeutic protein (TP).

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2021. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2021. This final rule adopts more recent Office of Management and Budget statistical area delineations and applies a 5 percent cap on any wage index decreases compared to FY 2020 in a budget neutral manner. This final rule also amends the IRF coverage requirements to remove the post-admission physician evaluation requirement and codifies existing documentation instructions and guidance. In addition, this final rule amends the IRF coverage requirements to allow, beginning with the second week of admission to the IRF, a non-physician practitioner who is determined by the IRF to have specialized training and experience in inpatient rehabilitation to conduct 1 of the 3 required face-to-face visits with the patient per week, provided that such duties are within the non-physician practitioner's scope of practice under applicable state law.

The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), seeks approval for a one-time study to examine child welfare agency family contact activities. The primary objective of this study is to describe how public child welfare agencies are in contact with or receive information about the well-being of children and youth who have exited the foster care system through adoption or guardianship, particularly the experiences of these children with instability. A secondary objective is to understand what types of information child welfare agencies systematically track about these children.

The Agency for Healthcare Research and Quality (AHRQ) announces a Special Emphasis Panel (SEP) meeting on ``HEALTHCARE INFORMATION TECHNOLOGY RESEARCH (HITR) 2020/10-ZHS1 HSR-F (01).'' This SEP meeting will be closed to the public.

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 reporting requirements associated with extralabel drug use in animals.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) 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 Food and Drug Administration (FDA) 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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Limited Population Pathway for Antibacterial and Antifungal Drugs.'' This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This guidance finalizes the draft guidance of the same name issued on June 13, 2018.

Notice is hereby given of the meeting on August 27, 2020 of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and can be accessed remotely. The meeting will include consideration of the minutes from the February 20, 2020, SAMHSA, CMHS NAC meeting; updates from the CMHS Director; a presentation from the SAMHSA Statistics and Data Demonstration, and a discussion from the Assistant Secretary for Mental Health and Substance Use on SAMHSA's response to COVID-19.