Department of Health and Human Services October 2023 – Federal Register Recent Federal Regulation Documents

This notice announces the dates and times of the virtual Healthcare Common Procedure Coding System (HCPCS) public meeting to be held November 28, 2023 through November 30, 2023 to discuss our preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and non-biological products, as well as how to register for those meetings.

The U.S. Department of Health and Human Services (HHS) solicits written comments from the public on the current Healthy People 2030 objectives, and written comments from the public proposing additional new core, developmental, or research objectives or topics to be included in Healthy People 2030. Public comment informed the development of Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input. The updated set of Healthy People 2030 objectives and topics will be incorporated on https://health.gov/healthypeople. This updated set will reflect further review and deliberation by Federal Healthy People topic area workgroups, the Federal Interagency Workgroup on Healthy People 2030, and other Federal subject matter experts.

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2024. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2024, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2024 are $343.40 for aged enrollees and $427.20 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2024 is $174.70, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus the $3.00 repayment amount required under current law. (The 2024 premium is 5.9 percent or $9.80 higher than the 2023 standard premium rate of $164.90, which included the $3.00 repayment amount.) The Part B deductible for 2024 is $240.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment amount, that individual will have to pay a total monthly premium of about 35, 50, 65, 80, or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60, or $10.20, respectively. Beginning in 2023, certain Medicare enrollees who are 36 months post kidney transplant, and therefore are no longer eligible for full Medicare coverage, can elect to continue Part B coverage of immunosuppressive drugs by paying a premium. For 2024, the immunosuppressive drug premium is $103.00.

This notice announces the monthly premium for uninsured enrollees under the Medicare Hospital Insurance (Part A) program in calendar year 2024. This premium is paid by enrollees aged 65 and over who are not otherwise eligible for benefits under Part A (hereafter known as the ``uninsured aged'') and by certain individuals with disabilities who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2024 for these individuals will be $505. The premium for certain other individuals as described in this notice will be $278.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.'' This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. During the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), FDA became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol. FDA is concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. This guidance replaces the guidance for industry entitled ``Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)'' published in January 2021.

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2024 under Medicare's Hospital Insurance (Part A) program. The Medicare statute specifies the formulas used to determine these amounts. For CY 2024, the inpatient hospital deductible will be $1,632. The daily coinsurance amounts for CY 2024 will be as follows: $408 for the 61st through 90th day of hospitalization in a benefit period; $816 for lifetime reserve days; and $204 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Aerosols from Harmful Algal Blooms: Exposures and Health Effects in Highly Exposed Populations. The goal of this study is to conduct exploratory analyses of the relationships between HAB-related biomonitoring data, environmental data, and symptom reporting.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting and related Request for Information (RFI). This meeting is open to the public. The public is welcome to obtain the link to attend this meeting by following the instructions posted on the Committee website: https://ncvhs.hhs.gov/meetings/full-committee- meeting-15. To submit comments in response to the RFI, please send by close of business January 12, 2024, to NCVHSmail@cdc.gov, and include on the subject line: Response from [your organization and/or name] regarding ICD-11 RFI. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting.

In support of the HHS Bridge Access Program for COVID-19 Vaccines and Treatments, HRSA provided more than $81 million in one- time funding to all current Health Center Program operational (H80) award recipients and to health center look-alikes that previously received American Rescue Plan funding (L2C awards).

The Substance Abuse and Mental Health Services Administration published a document in the Federal Register of September 7, 2023, announcing a Notice of request for information (RFI). The document contained incorrect date in the DATES section.

The Biomedical Advanced Research and Development Authority (BARDA) annually hosts BARDA Industry Day (BID), a two-day conference with industry and our government partners to share BARDA's goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate collaboration between public and private sectors within the health security space. This year, BARDA plans to discuss implementation efforts for our 2022-2026 Strategic Plan, which focuses on strengthening the health security of the nation, embracing lessons learned from the COVID-19 pandemic, incorporating new avenues of promising research and development, and addressing the imperative for MCMs that are safe, effective, and widely accessible.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry, Inc., proposing that the food additive regulations be amended to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products at a level not to exceed 3 percent.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations for Topical Ophthalmic Drug Products.'' This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs.

The Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting proposed revisions to an approved information collection the Tribal Child Support Enforcement Direct Funding Requests(Office of Management and Budget (OMB) #0970- 0218, expiration March 31, 2026). We are proposing a new requirement for tribes or tribal organizations to provide that charging fees and recovering costs will not be permitted.

The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, 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.

The Department of Health and Human Services (``HHS'' or ``Department'') has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the Federal Register of January 23, 2017.

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, 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 collections of information in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.