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health-and-human-services-department

(31 articles)

Open for Comment: Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots

Health and Human Services Department — 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 2027 based on our continuing experience with these systems. We also describe the 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 systems. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines. (55 days remaining)

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Open for Comment: Recission of the National Cancer Institute Clinical Cancer Education Program Regulation

Health and Human Services Department — The Department of Health and Human Services (HHS), in consultation with the National Institutes of Health (NIH), is proposing to rescind the existing regulation concerning grants under the National Cancer Institute (NCI) Clinical Cancer Education Program because the regulation is obsolete and no longer necessary. (63 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies

Health and Human Services Department — This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule discusses the behavior adjustment and proposes a temporary behavior adjustment and proposes to recalibrate the case-mix weights and update the functional impairment levels; comorbidity subgroups; and low- utilization payment adjustment (LUPA) thresholds for CY 2027. Additionally, this proposed rule discusses the provision of home health palliative care services and includes a request for information (RFI) on a home health specific wage index. This rule would also propose changes to the Home Health Quality Reporting Program (HH QRP) and summarizes potential initiatives to improve alignment between the HH QRP and expanded Home Health Value Based Purchasing (HHVBP) Model. Lastly, the rule would--clarify the application of the DMEPOS face-to- face encounter requirements for the replacement of DMEPOS items; make changes to the provider and supplier enrollment requirements; make changes regarding DME benefit expansion for infusion pumps and drugs; and discuss collection of information requirement changes regarding the DMEPOS Competitive Bidding Program (CBP) country of origin. (56 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program

Health and Human Services Department — This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update the requirements for the ESRD Quality Incentive Program. (58 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Unaccompanied Children Program Foundational Rule; Sponsor Assessment Update To Include Proof of Identity, Background Check, Placement, and Income Verification Standards

Health and Human Services Department — This notice of proposed rulemaking (NPRM, or proposed rule) would establish certain additional requirements for sponsor suitability assessments related to proof of identity, proof of income, and other information required for background checks to promote the safe placement of unaccompanied alien children (UAC). This NPRM proposes acceptable documentation for proof of identity and would require proof of income from potential sponsors of UAC in ORR custody by reason of their immigration status, as described in the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). This NPRM also proposes amendments to background check requirements for sponsor suitability assessments and the conduct of examinations of UAC related to considerations of UAC dangerousness to self or others that align with the One Big Beautiful Bill Act. Finally, this NPRM proposes certain administrative updates to align numbering and terminology between proposals and existing regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM. (59 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP

Health and Human Services Department — This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the "Beneficiary Inducements CMP") for remuneration provided to individuals in connection with their participation in clinical trials. (61 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden for Child Support Enforcement Programs

Health and Human Services Department — The Administration for Children and Families proposes to amend the Child Support regulations to eliminate unnecessary and obsolete regulations in the following sections: State Plan Approval and Grant Procedures, State Plan Requirements, Standards for Program Operations, Federal Financial Participation, Program Performance Measures, Standards, Financial Incentives, and Penalties, Computerized Support Enforcement Systems, Annual State Self-Assessment Review and Report, Tribal Child Support Enforcement (IV-D) Program, and Computerized Tribal IV-D Systems and Office Automation. A plain language summary of this proposed rule is available at https://www.regulations.gov. (32 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection

Health and Human Services Department — This request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements. (32 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

Health and Human Services Department — This proposed rule would codify the Medicare Drug Price Negotiation Program ("Negotiation Program") and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would also propose a modification to the fixed combination drug policy. (62 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Request for Information; Comprehensive Review of the Essential Health Benefits Framework and Typical Employer Plan Standard

Health and Human Services Department — This request for information (RFI) seeks public input to support CMS' comprehensive review of the Essential Health Benefits (EHB) framework and the requirement under the Patient Protection and Affordable Care Act (Affordable Care Act) that the scope of EHB be equal to the scope of benefits provided under a typical employer plan. CMS seeks comment on current interpretations of EHB, State approaches to selecting and updating EHB-benchmark plans, and methodologies used to determine the scope of benefits included as EHB, as well as how these approaches relate to access and market stability under the Affordable Care Act. CMS also seeks comment on variation across States in the scope of benefits included as EHB, cost pressures affecting EHB, processes for updating State EHB-benchmark plans, limitations in available data used to evaluate EHB, and potential impacts of possible future policy changes. The information gathered will inform CMS' evaluation of whether revisions or additions to the current EHB regulations through future notice and comment rulemaking may be appropriate. (30 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Employment and Training Services for Noncustodial Parents in the Child Support Program; Rescission

Health and Human Services Department — The Office of Child Support Enforcement proposes to rescind the Employment and Training Services for Noncustodial Parents in the Child Support Program final rule, published in the Federal Register on December 13, 2024. The final rule allowed child support agencies to utilize Federal Financial Participation under title IV-D of the Social Security Act for providing specific, optional, and non-duplicative employment and training services to eligible noncustodial parents. (62 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Color Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period

Health and Human Services Department — The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a color additive petition proposing that the color additive regulations be amended to remove three specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years. (31 days remaining)

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Open for Comment: Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period

Health and Human Services Department — The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a food additive petition proposing that the food additive regulations be amended to remove four specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years. (31 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden for Family Assistance Programs

Health and Human Services Department — The Administration for Children and Families proposes to amend the Grants to States for Public Assistance Programs regulations, the General Administration--State Plans and Grant Appeals regulations, the General Administration--Public Assistance Programs regulations, the Training and Use of Subprofessionals and Volunteers regulations, the Coverage and Conditions of Eligibility in Financial Assistance Programs regulations, the Financial Assistance to Individuals regulations, the Administration of Financial Assistance Programs regulations, the Fiscal Administration of Financial Assistance Programs regulations, the General Temporary Assistance for Needy Families (TANF) Provisions regulations, the Ensuring That Recipients Work regulations, the Accountability Provisions--General regulations, the Expenditures of State and Federal TANF Funds regulations, the Other Accountability Provisions regulations, the Data Collection and Reporting Requirements regulations, the High Performance Bonus Awards regulations, the Implementation of Section 403(a)(2) of the Social Security Act Bonus to Reward Decrease in Illegitimacy Ratio regulations, the Methodology for Determining Whether an Increase in a State or Territory's Child Poverty Rate Is the Result of the TANF Program regulations, the Tribal TANF Provisions regulations, and The Native Employment Works (NEW) Program regulations to eliminate unnecessary or obsolete regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM. (30 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicaid Program; Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments

Health and Human Services Department — This proposed rule describes alternatives to modify the limit on the total payment rate and other requirements for State directed payments in Medicaid managed care. We propose these changes based on our authority to interpret and implement section 1902(a)(4) of the Social Security Act (the Act) with respect to prepaid inpatient health plans and prepaid ambulatory health plans, and section 1903(m)(2)(A)(iii) of the Act, which require that contracts between States and managed care organizations to provide payments under a risk- based contract for services and associated administrative costs that are actuarially sound. This rule also proposes to set a limit for certain targeted Medicaid payments in Medicaid fee-for-service. We propose this change based on our authority to interpret and implement section 1902(a)(30)(A) of the Act with respect to certain targeted Medicaid payments which require that payments be consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area. (60 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Restoring Flexibility To Support Head Start Program Access

Health and Human Services Department — In this notice of proposed rulemaking (NPRM), the Administration for Children and Families (ACF) proposes to remove requirements from the Head Start Program Performance Standards (Performance Standards) to restore local flexibility to Head Start programs and improve access to quality services. Specifically, this NPRM proposes to remove requirements related to wages and benefits that the Administration believes are not in line with the plain language of the Head Start Act and are costly and overly prescriptive for Head Start programs and staff. ACF estimates these proposed changes, if finalized, will result in over $2 billion in future cost savings for Head Start programs. The proposed rescissions in this NPRM, if finalized, would impact the costliest parts of the final rule published by the Office of Head Start (OHS) in 2024, Supporting the Head Start Workforce and Consistent Quality Programming.\1\ --------------------------------------------------------------------------- (29 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges

Health and Human Services Department — These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as "small group market QHP issuers on the FF-SHOPs") (collectively "impacted payers"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as "HIPAA") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional "referral certification and authorization" transactions and "eligibility for a health plan" transactions associated with prior authorization. We are proposing to add a definition for "failure to report," which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure. (61 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden for Community Services Programs

Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to amend the Block Grants regulations, the Individual Development Account Reserve Funds Established Pursuant to Grants for Assets for Independence regulations, and the Emergency Community Services Homeless Grant Program regulations to eliminate unnecessary or obsolete regulations. The docket on https:/ /www.regulations.gov will include a plain language summary of the NPRM as required. (30 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027

Health and Human Services Department — This rule proposes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year 2027. This proposed rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program. (54 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

Health and Human Services Department — This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes refinement of the IPF PPS outlier policy. These changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2026, through September 30, 2027. We are also proposing the implementation of a standardized IPF patient assessment instrument, and the removal of two measures used in the Inpatient Psychiatric Facilities Quality Reporting Program. (55 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Work Participation Rate Calculation Changes: Recalibration of the Caseload Reduction Credit and Prohibition of Small Checks in Work Participation Rate Calculation

Health and Human Services Department — ACF proposes to make changes to the Temporary Assistance for Needy Families (TANF) program regulations to reset the base year of the caseload reduction credit from fiscal year (FY) 2005 to the new year established by Congress, which is currently FY 2015, and to exclude from the TANF work participation rate calculations certain cases that receive assistance payments benefits of less than $35 for a month. These changes are required by the Fiscal Responsibility Act (FRA) of 2023. The docket on https://www.regulations.gov will include a plain language summary of the NPRM as required by 5 U.S.C. 553(b)(4). (28 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements

Health and Human Services Department — This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2027. This proposed rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index (SSVI), and proposes to require that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this rule proposes conforming regulation text changes to discharge from hospice care regulations; regulation text changes to the face-to-face encounter regulations; and includes requests for information on community palliative care services; the construction of a hospice specific wage index; and the overlap between hospice and medical aid in dying (MAID). Finally, this rule proposes changes to the Hospice Quality Reporting Program. (55 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program

Health and Human Services Department — This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this proposed 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 2027. It also continues the third year of the 3-year phaseout of the rural adjustment, which began in FY 2025. This proposed rule includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; proposes to require all therapy treatments or therapy evaluations to begin within 36-hours from midnight on the day of admission; proposes to require a patient's current functional status be documented on the preadmission screening; proposes requirements for the initial Interdisciplinary Team meeting; and includes a request for information on potential future IRF PPS payment reform. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program. Furthermore, the proposed rule includes changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program. (55 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden in Family Violence and Prevention Services

Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families, proposes to remove duplicative or unnecessary Sections from the Family Violence Prevention and Services program regulations (45 CFR part 1370). These amendments will streamline the Family Violence Prevention and Services regulations and make them more accessible to the public. The docket on https:// www.regulations.gov will include a plain language summary of the NPRM. (30 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden for Children, Youth, and Family Programs

Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to remove duplicative or unnecessary sections from the Runaway and Homeless Youth Program regulations (45 CFR part 1351). These amendments will streamline the Runaway and Homeless Youth Program regulations to make them more accessible to the public. The docket on https://www.regulations.gov will include a plain language summary of the NPRM. (30 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride

Health and Human Services Department — The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM or petitioner), proposing that we amend the color additive regulations to no longer provide for the use of three specified solvents (methylene chloride, trichloroethylene, and ethylene dichloride) for preparing certain color additives because these uses have been permanently abandoned. (59 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests

Health and Human Services Department — The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. (60 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden for Native American Programs

Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to amend the Native American Programs Act regulations (45 CFR part 1336) to eliminate unnecessary or obsolete regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM as required by 5 U.S.C. 553(b)(4). (27 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Reducing Bureaucracy and Burden for Human Services and Emergency Response Programs-Repatriation Program

Health and Human Services Department — The Department of Health and Human Services, Administration for Children and Families proposes to amend the Care and Treatment of Mentally Ill Nationals of the United States, Returned from Foreign Countries regulations and the Assistance for United States Citizens Returned from Foreign Countries regulations to eliminate unnecessary or obsolete regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM. (30 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis

Health and Human Services Department — The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) for blood irradiators intended to irradiate intraoperatively salvaged blood for cancer patients undergoing surgery to assist in prevention of metastasis, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from use of the devices. (59 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department

Open for Comment: Medical Devices; Radiology Devices; Classification of Blood Irradiators

Health and Human Services Department — The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis. (60 days remaining)

comment-periodcomment-periodregulationhealth-and-human-services-department