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

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2024. The calendar year 2024 AIC threshold amounts are $180 for ALJ hearings and $1,840 for judicial review.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 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 a generic clearance to collect information to support communications used by FDA about drug products.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled ``Antimicrobial Susceptibility Test (AST) System DevicesUpdating Breakpoints in Device Labeling.'' This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretative Criteria website (STIC website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.

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 updates to the currently approved information collection project: ``Medical Expenditures Panel SurveyHousehold and Medical Provider Components.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA, the Agency, or we) 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 Centers for Medicare & Medicaid Services (CMS) announce the extension of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) exemption period for the State of Washington. The exemption period is extended for 6 months, that is until April 2, 2024.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Healthcare Industry Waste and Lifecycle Assessment, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

ACF proposes to allow a title IV-E agency to claim Federal financial participation (FFP) for the administrative cost of an attorney providing: legal representation in foster care proceedings of a title IV-E agency or any other public agency or tribe that has an agreement in effect under which the other agency has placement and care responsibility of a title IV-E eligible child; independent legal representation of a child who is either a candidate for title IV-E foster care, or in title IV-E foster care (hereafter, referred to as a child ``who is eligible for title IV-E foster care''), the child's parent(s), and the child's relative caregiver(s) in foster care and other civil legal proceedings when such legal representation is found necessary by the Secretary to carry out the requirements in the title IV-E agency's title IV-E foster care plan; and legal representation of an Indian child's tribe, when the child's tribe intervenes in any state court proceeding for the foster care placement or termination of parental rights of an Indian child who is in title IV-E foster care or an Indian child who is a candidate for title IV-E foster care when such legal representation is found necessary by the Secretary to carry out the requirements in the title IV-E agency's title IV-E foster care plan.

This notice announces a town hall meeting in accordance with the Social Security Act (the Act) to discuss fiscal year (FY) 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this virtual meeting to present their comments, recommendations, and data regarding whether the FY 2025 new medical services and technologies applications meet the substantial clinical improvement criterion.

The purpose of this National Institutes of Health (NIH) Request for Information (RFI) is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research.

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 information collection associated with applications for FDA approval to market a new drug or generic drug.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Association for State Directors of Developmental Disabilities Services (NASDDDS) for the Link Center: Bridging I/DD and Mental Health Systems cooperative agreement. The purpose of this project is to improve the quality of life for people with intellectual and/or developmental disabilities (I/DD) and mental health conditions by supporting state agencies with policy development, service design, and service coordination resources, and sharing resources to individuals, families, direct support professionals, clinicians, and other policymakers. The administrative supplement for FY 2023 will amount to $540,000, bringing the total award for FY 2023 to $1,214,978.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates 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.

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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of two additional draft chapters of a multichapter draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapters are entitled ``Chapter 11Food Allergen Program'' and ``Chapter 16 Acidified Foods.'' This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.'' As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system. This final guidance supersedes the final guidance ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,'' issued October 2, 2014.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients With Renal Impairment.'' The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.

This document sets forth proposed rules related to the fees established by the No Surprises Act for the Federal independent dispute resolution (IDR) process, as established by the Consolidated Appropriations Act, 2021 (CAA). These proposed rules would amend existing regulations to provide that the administrative fee amount charged by the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) to participate in the Federal IDR process, and the ranges for certified IDR entity fees for single and batched determinations will be set by the Departments through notice and comment rulemaking. These proposed rules would also set forth the methodology used to calculate the administrative fee and the considerations used to develop the certified IDR entity fee ranges. This document also proposes the amount of the administrative fee for disputes initiated on or after the later of the effective date of these rules or January 1, 2024. Finally, this document proposes the certified IDR entity fee ranges for disputes initiated on or after the later of the effective date of these rules or January 1, 2024. In accordance with 5 U.S.C. 553(b)(4), a summary of this rule may be found at https://www.regulations.gov/.

The Administration for Children and Families (ACF), Office of Community Service (OCS), Division of Energy Assistance announces a preliminary determination that funds from the Federal fiscal year (FFY) 2022 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal organizations that received FFY 2023 direct LIHEAP grants. The purpose of this award is to redistribute FFY 2022 annual LIHEAP funds that grant recipients were unable to obligate or carry over to FFY 2023. No sub-recipients of these grant recipients or other entities may apply for these funds.

Office of Child Support Services (OCSS) proposes to replace the gender-specific term ``paternity'' with the gender-neutral term ``parentage'' throughout the Child Support Services Program to be inclusive of all family structures served by the child support services program. While title IV-D (Child Support and Establishment of Paternity) requires States and Tribes to have laws permitting the establishment of paternity and requiring genetic testing in contested paternity cases, OCSS also recognizes that title IV-D does not preclude States and Tribes from having parentage establishment laws and procedures for all families. The proposed changes to chapter III of the child support regulations recognize developments in State laws regarding parentage establishment and provide States and Tribes optional flexibility to establish parentage for all children in accordance with their laws, regardless of the gender of their parents or family structure.

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 Social and Economic Barriers to Receiving Optimal Services Along the Cancer Care Continuum. This mixed methods data collection effort will help CDC understand the social and economic barriers that colorectal, breast, and cervical cancer survivors and their caregivers face at each stage of the cancer care continuum, from screening through survivorship, and how these barriers may vary by population.

The Family and Youth Services Bureau (FYSB) within the Administration on Children, Youth and Families (ACYF) is accepting mandatory formula grant applications and State plans from States and Territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Notice of Funding Opportunity (NOFO) sets forth the application requirements for recipients. This request is to extend Office of Management and Budget (OMB) approval of the request for information. No changes are proposed.

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.

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 National Institutes of Health (NIH) is soliciting comments and suggestions from the public on the DRAFT ``Scientific Integrity Policy of the National Institutes of Health'' (DRAFT NIH Scientific Integrity Policy). The DRAFT NIH Scientific Integrity Policy codifies NIH's long-standing expectations to preserve scientific integrity throughout all NIH activities, establishes key roles and responsibilities for those who will lead the agency's scientific integrity program, and, as appropriate, establishes relevant reporting and evaluation mechanisms.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services seeks an update to the existing data collection for the Annual Survey of Refugees. The Annual Survey of Refugees is a yearly sample survey of refugee households entering the U.S. in the previous 5 fiscal years. The requested update is based upon results of a multi-year effort in instrument redesign and field testing. ACF estimates the proposed changes will increase response burden from 48 to 50 minutes per respondent.

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https://www.dhhs.gov/ohrp/sachrp-committee/meetings/ index.html.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.'' This draft guidance provides information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027'' (PDUFA VII commitment letter) and ``Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027'' (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This draft guidance, within the context of approval and licensure decisions by FDA, describes the use of alternative tools to assess manufacturing facilities identified in an NDA, an ANDA, or a BLA to establish that these facilities meet the applicable requirements, including under the Federal Food, Drug, and Cosmetic (FD&C Act) or the Public Health Service Act (PHS Act).

This final rule simplifies processes for eligible individuals to enroll and retain eligibility in the Medicare Savings Programs (MSPs). This final rule better aligns enrollment into the MSPs with requirements and processes for other public programs. Finally, this final rule reduces the complexity of applications and reenrollment for eligible individuals.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is proposing to provide one-year supplemental funding in FY 2023 to three Hawaii grant programs to support Maui residents in the aftermath of the Maui wildfires. The Hawaii State Department of Health, the recipient for Certified Community Behavioral Health Clinics Planning, Development, and Implementation (CCBHC-PDI), Grants for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances Program (CMHI), and Community Mental Health Services Block Grant (MHBG) will be offered a total of $2,765,556 in supplemental funding since they are the only recipient providing or able to provide services to Maui residents.

The invention described below presents an advancement concerning osteoclast fusion; osteoclasts are responsible for human skeletal remodeling and their dysfunction is a key factor for both rare and common bone diseases. The invention covers methods for modulating osteoclast fusion and bone resorption through the Lupus autoantigen (La) protein. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, has conducted conceptual in-vitro studies and is now seeking potential licensees and collaborators for further development and advancement.

The Food and Drug Administration (FDA) Office of Women's Health and Office of Clinical Pharmacology is announcing the following public workshop: ``Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research.'' The purpose of the public workshop is to discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated drugs and biologics used by menopausal women for non-menopause-related indications. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop. Presentations will discuss whether changes in drug absorption, distribution, metabolism, and elimination, if any, could be affected by hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes). The discussion is further intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD. Speakers will highlight areas with the greatest need for further research and exploration.

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 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.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the draft National One Health Framework to Address Zoonotic Diseases and Advance Public Health Preparedness in the United States: A Framework for One Health Coordination and Collaboration across Federal Agencies (NOHF-Zoonoses). As directed by Congress through the House Appropriations Committee report accompanying the 2021 omnibus appropriations bill and the 2023 Consolidated Appropriations Act, CDC has partnered with the U.S. Department of the Interior (DOI), the U.S. Department of Agriculture (USDA), and other departments and agencies to develop this One Health framework to address zoonotic diseases and advance public health preparedness. This framework will facilitate One Health collaboration for zoonotic disease prevention and control across the United States Government for the next five years. It describes a common vision, mission, and goals for key federal partners involved in implementing a One Health approach to address zoonotic diseases and advance public health preparedness in the United States.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements (in scope of the parent award) for the 58 Community Mental Health Services Block Grant (MHBG) recipients funded in FY 2023. The total amount of available funding is $8,292,318. The 58 MHBG recipients are eligible to receive up to $142,971 for a total of $8,292,318. If all eligible MHBG recipients do not apply, remaining funds will be redistributed to applicants. The funding amount per recipient may be adjusted if any MHBG recipients decline the funding. These recipients have a project end date of September 30, 2024. The supplemental funding will be used for providing and/or obtaining training and technical assistance, or workforce development meetings and activities.

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 an information technology (IT) strategic plan entitled the ``FDA Information Technology Strategy'' and a request for comment on this IT Strategy. As part of our User Fee Program commitments and Omnibus Bill requirements, FDA will develop and publish an FDA Data and Technology Strategic Plan by September 29, 2023. This plan will define and shape the future course of FDA's data and technology capabilities, building on the existing FDA Modernization Framework. The plan will also integrate Agency and center strategies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Regulatory Considerations for Prescription Drug Use-Related Software.'' This draft guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug- led, drug-device combination product, which is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center.

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 ``Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs.''