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

Results 601 - 650 of 3,523
Development and Licensure of Vaccines To Prevent COVID-19; Guidance for Industry; Availability
Document Number: 2023-23162
Type: Notice
Date: 2023-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Development and Licensure of Vaccines to Prevent COVID-19.'' This guidance revises the guidance of the same name, which was announced in the Federal Register on August 3, 2020. FDA is issuing this guidance to assist the Agency and sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19. Additionally, this guidance provides an overview of key considerations to satisfy regulatory requirements set forth in the investigational new drug application (IND) regulations and in the licensing regulations for chemistry, manufacturing, and controls (CMC), and nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation of COVID-19 preventive vaccines. FDA is also announcing the withdrawal of an FDA guidance document related to COVID-19.
Benefit-Risk Assessment for New Drug and Biological Products; Guidance for Industry; Availability
Document Number: 2023-23161
Type: Notice
Date: 2023-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Benefit- Risk Assessment for Human Drug and Biological Products.'' FDA has developed this guidance document in accordance with goals associated with the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017 and requirements under the 21st Century Cures Act. The intent of this guidance is to provide drug sponsors and other stakeholders with better clarity on how considerations about a drug's benefits, risks, and risk management options factor into FDA's pre- and postmarket regulatory decisions about new drug applications (NDAs) or biologics license applications (BLAs). This guidance finalizes the draft guidance of the same title issued in September 2021.
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry; Availability
Document Number: 2023-23156
Type: Notice
Date: 2023-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry.'' The guidance document describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics Evaluation and Research (CBER) designed to identify Voluntary Consensus Standards (VCS) that might be used in the preparation and evaluation of submissions for Regenerative Medicine Therapy (RMT) products regulated by CBER when such standards are appropriate. The use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. This program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices where the term ``recognize'' refers to FDA's formal identification of a standard after the determination that the standard is appropriate to meet relevant requirements as defined by law. CBER encourages the use of appropriate standards in the development of CBER- regulated products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2022.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Surveys To Implement Executive Order 14058 in the Health Resources and Services Administration, OMB No. 0915-0212-Revision
Document Number: 2023-23130
Type: Notice
Date: 2023-10-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration
Document Number: 2023-23011
Type: Notice
Date: 2023-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 (PRA).
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision
Document Number: 2023-23031
Type: Notice
Date: 2023-10-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Prospective Grant of Exclusive Patent Commercialization License: Human Monoclonal Antibodies That Broadly Target Coronaviruses
Document Number: 2023-23030
Type: Notice
Date: 2023-10-19
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Leyden Laboratories B.V., located at Emmy Noetherweg 2, 2333 BK Leiden, the Netherlands to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2023-23074
Type: Notice
Date: 2023-10-19
Agency: Department of Health and Human Services
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.
Food and Drug Administration; Center of Drug Evaluation and Research Guidance Documents Related to Coronavirus Disease 2019, Expiration
Document Number: 2023-23071
Type: Notice
Date: 2023-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of guidances for industry entitled ``Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act,'' which posted March 2020 to communicate recommendations for notifying the Agency about the permanent discontinuance or interruption in manufacturing of certain drug products; and ``COVID-19: Potency Assay Consideration for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity'' which posted January 2021 to communicate information on the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. FDA is withdrawing these two guidance documents because new draft guidances are available that reflect comments received on the COVID-19 guidances, and many of the recommendations set forth in the COVID-19 guidances are applicable outside the context of the public health emergency (PHE) and included in the draft guidances.
American Regent, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Document Number: 2023-23064
Type: Notice
Date: 2023-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2023-23110
Type: Notice
Date: 2023-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.'' The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device listed in the guidance that measures or detects common physiological parameters and that is used to support patient monitoring. The guidance is intended to describe the enforcement policy for limited modifications to the indications, functionality, or hardware or software of device types in the scope of the guidance without prior submission of a 510(k) where such submission would be required.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rapid Uptake of Disseminated Interventions Evaluation, OMB No. 0906-xxxx
Document Number: 2023-23108
Type: Notice
Date: 2023-10-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Notice of Closed Meeting
Document Number: 2023-23007
Type: Notice
Date: 2023-10-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2023-23006
Type: Notice
Date: 2023-10-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2023-23002
Type: Notice
Date: 2023-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal
Document Number: 2023-22976
Type: Notice
Date: 2023-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of revised final guidances for industry entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions,'' and ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' Following the issuance of the final rules entitled ``Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports'' (SE) and ``Premarket Tobacco Product Applications and Recordkeeping Requirements'' (PMTA), FDA has made minor updates to these guidances for consistency with the terminology used in those rules. FDA is also announcing the withdrawal of the final guidances entitled ``Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products,'' and ``Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods,'' and a draft guidance entitled ``Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product,'' which are obsolete due to the issuance of the SE final rule or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2023-22972
Type: Notice
Date: 2023-10-18
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Supplemental Evidence and Data Request on Updating the Framework for AHRQ's National Healthcare Quality and Disparities Report (NHQDR)
Document Number: 2023-22915
Type: Notice
Date: 2023-10-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 Updating the Framework for AHRQ's National Healthcare Quality and Disparities Report (NHQDR), 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification
Document Number: 2023-22971
Type: Notice
Date: 2023-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Improving the Quality and Representativeness of the Treatment Center Program Data-Data Modifications to the Current Survey Instrument Format to Minimize Misclassification
Document Number: 2023-22966
Type: Notice
Date: 2023-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection entitled ``Improving the Quality and Representativeness of the Treatment Center Program DataData Modifications to the Current Survey Instrument Format to Minimize Misclassification.''
Determination That NAROPIN (Ropivacaine Hydrochloride) Solution, 50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2023-22960
Type: Notice
Date: 2023-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that Naropin (ropivacaine hydrochloride) solution, 50 milligrams (mg)/10 milliliters (mL) and 75mg/10mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these drug products as long as they meet relevant legal and regulatory requirements.
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability
Document Number: 2023-22957
Type: Rule
Date: 2023-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements.'' The guidance document addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain requirements in FDA's regulations regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. FDA expects that the compliance policy described in the guidance will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components. The guidance announced in this document finalizes the draft guidance of the same title dated May 2022, and supersedes the guidance entitled ``Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry,'' dated April 2020.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; ACL Generic for Administration on Aging Formula Grant Programs OMB Control Number 0985-New
Document Number: 2023-22956
Type: Notice
Date: 2023-10-18
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 new information collection solicits comments on the information collection requirements relating to the ACL Generic for Administration on Aging Formula Grant Programs.
Medicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding-November 28-30, 2023
Document Number: 2023-22953
Type: Notice
Date: 2023-10-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Request for Information (RFI): HHS Initiative To Enhance National All Hazards Hospital Situational Awareness
Document Number: 2023-22931
Type: Notice
Date: 2023-10-18
Agency: Department of Health and Human Services
The Administration for Strategic Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC) are seeking broad public input from entities across the health care readiness community on a national, all-hazards standardized set of essential elements of information (EEIs) and vendor-neutral data collection mechanisms for hospital data that drive action for emergency preparedness and response. This input will inform efforts to provide recommendations for a standardized lens into the readiness of, stress on, and resources available in hospitals before, during, and after emergencies
Notice of Meeting
Document Number: 2023-22797
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for Office of Management and Budget Review; Federal Case Registry (Office of Management and Budget #0970-0421)
Document Number: 2023-22809
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting from the Office of Management and Budget (OMB) to extend approval of the Federal Case Registry (FCR) for an additional three years. The current approval expires November 30, 2023. OCSE is proposing minor changes to punctuation, formatting, grammar, clarity, and spacing to enable easier completion of the form.
Announcement of Solicitation of Written Comments on Healthy People 2030 Objectives
Document Number: 2023-22805
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services
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.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2023-22804
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2024
Document Number: 2023-22823
Type: Notice
Date: 2023-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Rural Health and Economic Development Analysis Program
Document Number: 2023-22814
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA provided additional award funds to the Rural Health and Economic Development Analysis Program recipient to produce a research project that quantifies the relationships between health care and economic factors in rural communities.
Medicare Program; CY 2024 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
Document Number: 2023-22848
Type: Notice
Date: 2023-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2023-22844
Type: Notice
Date: 2023-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined that ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry; Availability
Document Number: 2023-22843
Type: Notice
Date: 2023-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Diabetic Foot Infections: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2023-22842
Type: Notice
Date: 2023-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Diabetic Foot Infections: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint involvement.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2023-22859
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2023-22858
Type: Notice
Date: 2023-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; CY 2024 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
Document Number: 2023-22850
Type: Notice
Date: 2023-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2023-22897
Type: Notice
Date: 2023-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2023-22892
Type: Notice
Date: 2023-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
Document Number: 2023-22575
Type: Notice
Date: 2023-10-16
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-22779
Type: Notice
Date: 2023-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-22778
Type: Notice
Date: 2023-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Rape Prevention and Education (RPE) Program. The RPE Program is designed to assess how recipients are improving prevention infrastructure, implementing, and evaluating prevention strategies to expand efforts to prevent sexual assault, and using data to inform prevention action.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-22777
Type: Notice
Date: 2023-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2023-22770
Type: Notice
Date: 2023-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2023-22791
Type: Notice
Date: 2023-10-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-22780
Type: Notice
Date: 2023-10-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Committee on Vital and Health Statistics
Document Number: 2023-22753
Type: Notice
Date: 2023-10-16
Agency: Department of Health and Human Services
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.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2023-22752
Type: Notice
Date: 2023-10-16
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias (ADRD) on people with the disease and their caregivers. During the meeting on October 30, 2023, the Advisory Council will welcome a new cohort of members and hear updates from federal agencies on key activities over the last quarter. A panel will present information on interventions to reduce the risk of developing dementia.
Notice of Fiscal Year 2023 Health Center Program COVID-19 HHS Bridge Access Program Funding Awards
Document Number: 2023-22751
Type: Notice
Date: 2023-10-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
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).
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