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

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Notice of Hearing: Reconsideration of Disapproval South Carolina Medicaid State Plan Amendments (SPAs) 16-0012-A, 17-0006-A, and 18-0011-A
Document Number: 2019-22319
Type: Notice
Date: 2019-10-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on November 20, 2019, at the Department of Health and Human Services, Division of Medicaid Field Operations, South, Centers for Medicare & Medicaid Services, Division of Medicaid and Children's Health Operations, 61 Forsyth St., Suite 4T20, Atlanta, Georgia 30303-8909 to reconsider CMS's decision to disapprove South Carolina's Medicaid SPAs 16-0012-A, 17-0006-A, and 18-0011-A.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22275
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
Document Number: 2019-22274
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has 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.
Draft NTP Technical Reports on Toxicology and Carcinogenesis Studies of HMB and PFOA; Availability of Documents; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2019-22273
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces the availability of two draft NTP Technical Reports on toxicology and carcinogenesis studies scheduled for peer review for the following substances: 2-hydroxy-4-methoxybenzophenone and perfluorooctanoic acid. The peer-review meeting will be held by webcast only and available to the public for remote viewing. Registration is required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-22242
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22241
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2019-22240
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2019-22239
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2019-22238
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2019-22237
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meetings
Document Number: 2019-22236
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22235
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-22234
Type: Notice
Date: 2019-10-11
Agency: Department of Health and Human Services, National Institutes of Health
Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-22194
Type: Notice
Date: 2019-10-10
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 ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.
Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-22192
Type: Notice
Date: 2019-10-10
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 ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings- Labeling Considerations.'' This guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in the clinical setting.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2019-22189
Type: Notice
Date: 2019-10-10
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.
Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases With a Focus on Pediatric Patient Perspectives; Public Workshop
Document Number: 2019-22187
Type: Notice
Date: 2019-10-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT 6): Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives.'' The purpose of this workshop is to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Nurse Corps Loan Repayment Program; Information Collection Request Title: Nurse Corps Loan Repayment Program, OMB No. 0915-0140-Revision
Document Number: 2019-22166
Type: Notice
Date: 2019-10-10
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: Proposed Collection: Public Comment Request; Public Comment Request; Hospital Campaign for Organ Donation Scorecard, OMB No. 0915-0373, Revision
Document Number: 2019-22163
Type: Notice
Date: 2019-10-10
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program (RWHAP) Compilation of Best Practice Strategies and Interventions, OMB No. 0906-xxxx-NEW
Document Number: 2019-22162
Type: Notice
Date: 2019-10-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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.
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry; Availability
Document Number: 2019-22117
Type: Notice
Date: 2019-10-10
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 ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.'' This guidance, developed by the Oncology Center of Excellence at FDA, describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements. In the streamlined process, the sponsor submits all information about the oncology trial (including information about the investigational in vitro diagnostic) to the investigational new drug application (IND). As part of IND review, the Center for Biologics Evaluation and Research (CBER) works with the Center for Drug Evaluation and Research (CDER), or CDER or CBER works with the Center for Devices and Radiological Health (CDRH), as appropriate, to determine if the investigational in vitro diagnostic is significant risk, nonsignificant risk, or exempt.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2019-22116
Type: Notice
Date: 2019-10-10
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-22115
Type: Notice
Date: 2019-10-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22114
Type: Notice
Date: 2019-10-10
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-22082
Type: Notice
Date: 2019-10-09
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection titled The National Intimate Partner and Sexual Violence Survey (NISVS). CDC will collect information about individual's experiences of sexual violence, stalking and intimate partner violence and information about the health consequences of these forms of violence. CDC produces national and state level prevalence estimates of these types of violence.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-22081
Type: Notice
Date: 2019-10-09
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Application Form and Related Forms for the Operation of the National Death Index. The National Death Index (NDI) is designed to allow NCHS to collect mortality data, to support epidemiological research and to furnish mortality information.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-22080
Type: Notice
Date: 2019-10-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-22079
Type: Notice
Date: 2019-10-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Plan for Foster Care and Adoption Assistance-Title IV-E (OMB #0970-0433)
Document Number: 2019-22072
Type: Notice
Date: 2019-10-09
Agency: Department of Health and Human Services, Administration for Children and Families
Public Law 115-123 added two new programs to title IV-E of the Social Security Act: The Prevention Services Program and the Kinship Navigator Program. Title IV-E agencies will be required to report information regarding these programs in title IV-E plans. Therefore, the Administration for Children and Families (ACF) is requesting to revise the existing information collection Plan for Foster Care and Adoption Assistance (OMB #0970-0433) to include two new information collections specific to these two new programs.
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Document Number: 2019-21984
Type: Notice
Date: 2019-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that JYNNEOS, (Smallpox and Monkeypox Vaccine, Live, Non-replicating), manufactured by Bavarian Nordic A/S, meets the criteria for a priority review voucher.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2019-21983
Type: Notice
Date: 2019-10-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-21979
Type: Notice
Date: 2019-10-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2019-21977
Type: Notice
Date: 2019-10-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-21976
Type: Notice
Date: 2019-10-09
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2019-21975
Type: Notice
Date: 2019-10-09
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-21965
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Traumatic Brain Injury (TBI) State Partnership Program, OMB approval number 0985-NEW
Document Number: 2019-21906
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to review substantive changes to 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.
Notice of Single Source Award to the Telehealth Focused Rural Health Research Center
Document Number: 2019-21904
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In FY 2019, HRSA provided $788,000 in additional funding to The University of Iowa for the Telehealth Focused Rural Health Research Center and extended the project period for 12 months.
Proposed Changes to the Scholarships for Disadvantaged Students Program
Document Number: 2019-21903
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
On May 22, 2019, HRSA published a 30-day notice in the Federal Register soliciting feedback on a range of issues pertaining to the Scholarships for Disadvantaged Students (SDS) Program to assist the agency in updating certain SDS policies. HRSA requested feedback on adjusting funding allocations to respond to projected workforce shortages, transitioning data collection from 1 year of data to a 3- year average to demonstrate eligibility, and increasing the maximum scholarship award from $30,000 to $40,000. As a result of HRSA's comprehensive review of existing policies, and taking into consideration the comments received, HRSA is issuing this final notice.
Submission for OMB Review; Head Start (HS) Connects: Individualizing and Connecting Families to Family Support Services (New Collection)
Document Number: 2019-21893
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff, parents/ guardians, and community providers at six Head Start programs for case studies that explore case management and coordination of family support services.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Correction
Document Number: 2019-21865
Type: Rule
Date: 2019-10-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the August 16, 2019 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals.''
National Inventory for Poliovirus Containment: Minimizing Risk of Poliovirus Release From Laboratories in the United States; Availability
Document Number: 2019-21864
Type: Notice
Date: 2019-10-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The United States National Authority for Containment of Poliovirus (NAC), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), announces the availability of the National Inventory for Poliovirus Containment survey. This survey is designed to collect relevant laboratory inventory data to ensure facilities throughout the United States are in compliance with requirements established in the World Health Organization (WHO) Global Action Plan (GAPIII), as adapted for the WHO Region of the Americas. Per GAPIII, each country is required to complete a national inventory of poliovirus-containing materials, including poliovirus potentially infectious materials (PIM).
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2019-21853
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2019-21851
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2019-21850
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-21849
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-21845
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
Document Number: 2019-21839
Type: Notice
Date: 2019-10-08
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.
Privacy Act of 1974; System of Records
Document Number: 2019-21768
Type: Notice
Date: 2019-10-08
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services
In accordance with requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is updating an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), system No. 09-70-0550, titled ``Medicare Retiree Drug Subsidy Program'' (RDSP), and renaming it ``Retiree Drug Subsidy (RDS), HHS/CMS/CM.'' This system collects and maintains information about individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees.
Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments
Document Number: 2019-21750
Type: Notice
Date: 2019-10-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2021 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 meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.