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

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Data Reporting for Work Participation (formerly titled the Deficit Reduction Act of 2005 TANF Final Rule; OMB #0970-0338). Information collections include the TANF data verification procedures, the TANF Data Report, the Separate State Program (SSP)Maintenance of Effort (MOE) Data Report, the Caseload Reduction Documentation Process, and the Reasonable Cause/Corrective Compliance Documentation Process. We are proposing to continue these information collections without change.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Identifying and Testing Strategies for Management of Opioid Use and Misuse in Older Adults in Primary Care Practices.'' This proposed information collection was previously published in the Federal Register on June 8, 202020 and allowed 60 days for public comment. No comments were received by AHRQ. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELZONRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 biological product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POTELIGEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 biological product.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue use of a coronavirus (COVID- 19) screening form for Unaccompanied Alien Children (UAC) program staff and visitors at ORR-funded programs. The form was originally approved under emergency approval for 6 months. ACF is requesting a 3-year extension of this information collection.

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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Evaluation of Medication- Assisted Treatment (MAT) for Opioid use disorder.'' CDC will use the collection to continue the epidemiologic study to assess the type of MAT (methadone maintenance; buprenorphine; naltrexone; or, counseling, no MAT), and the contextual, provider, and individual factors that influence implementation and improved patient wellbeing.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Connectyx Technologies Holdings Group (``Connectyx'') located in Boca Raton, FL.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management 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 National Clinical Care Commission (the Commission) will conduct a virtual meeting on September 11, 2020. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to diabetes and its complications.

In the August 4, 2020 issue of the Federal Register, we published a final rule entitled ``FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)''. The August 4, 2020 final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital. In addition, we adopted more recent Office of Management and Budget (OMB) statistical area delineations, and applied a 2-year transition for all providers negatively impacted by wage index changes. This correction document corrects the statement of economic significance in the August 4, 2020 final rule.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluating Cancer Drugs in Patients with Central Nervous System Metastases.'' This draft guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The draft guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Institute for Safe Medication Practices (ISMP), PSO number P0009, of its status as a PSO, and has delisted the PSO accordingly.

HRSA is seeking additional nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA Tribal Advisory Council (TAC), which is being established. Specifically, HRSA requests submissions of nominations of qualified tribal officials from the Indian Health Service (IHS) geographic areas of: Alaska; Albuquerque; Billings; Navajo; Phoenix; and Tucson. Nominations for membership must be received on or before September 30, 2020. This will allow tribes and tribal serving organizations from the IHS geographic areas noted above, the additional time needed to identify qualified tribal officials as candidates and submit comprehensive nomination packages.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records to be maintained by the Centers for Disease Control and Prevention, 09-20-0180, ``Electronic Import Permit Program Portal (eIPP Portal).'' The system of records will be used by CDC to monitor the importation of infectious biological agents, infectious substances, and vectors of human disease.

The Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the information collectionCase Plan Requirement, Title IV-E of the Social Security Act, (OMB #0970-0428, expiration 3/31/2021). ACF is reporting a change to the information collectionthe burden estimates in the previously-approved request were based on the children in foster care as the respondent instead of the agency completing the case plan. The burden estimates, therefore, are adjusted accordingly.

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.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Infant Mortality (ACIM or Committee) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.