Department of Health and Human Services 2021 – Federal Register Recent Federal Regulation Documents

Results 1 - 50 of 3,097
National Committee on Vital and Health Statistics
Document Number: 2021-28341
Type: Notice
Date: 2021-12-30
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. This meeting is open to the public. The public is welcome to obtain the link to attend this meeting by following the instructions that will be posted on the website prior to the meeting at: https://ncvhs.hhs.gov/. Name: National Committee on Vital and Health Statistics (NCVHS), Meeting of the full Committee.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-28358
Type: Notice
Date: 2021-12-30
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 Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-28362
Type: Notice
Date: 2021-12-30
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.
Notice of Meeting; National Advisory Committee on the Sex Trafficking of Children and Youth in the United States
Document Number: 2021-28360
Type: Notice
Date: 2021-12-30
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on January 6, 2022. The purpose of the meeting is for the Committee to finalize the distribution plan for the Committee's January 2022 report. The members of the Committee request comment from the public to inform their ongoing work. Please submit your comments to NAC@nhttac.org with the subject ``NAC Comments,'' as soon as possible and before January 3, 2022.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
Document Number: 2021-28305
Type: Notice
Date: 2021-12-29
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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-28277
Type: Notice
Date: 2021-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-28276
Type: Notice
Date: 2021-12-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: 2021-28275
Type: Notice
Date: 2021-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-28299
Type: Notice
Date: 2021-12-29
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request SHIP COVID-19 Testing and Mitigation Program Data Collection
Document Number: 2021-28268
Type: Notice
Date: 2021-12-29
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.
Most Favored Nation (MFN) Model
Document Number: 2021-28225
Type: Rule
Date: 2021-12-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Transcutaneous Electrical Continence Device
Document Number: 2021-28163
Type: Rule
Date: 2021-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the transcutaneous electrical continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the transcutaneous electrical continence device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Lallemand Inc.; Filing of Food Additive Petition
Document Number: 2021-28162
Type: Proposed Rule
Date: 2021-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Lallemand Inc., proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 heat-killed (``inactive'') baker's yeast as a source of vitamin D2 in specific food categories.
Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter
Document Number: 2021-28160
Type: Rule
Date: 2021-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the diagnostic neurosurgical microscope filter into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the diagnostic neurosurgical microscope filter's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
Document Number: 2021-28159
Type: Rule
Date: 2021-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of October 5, 2021, for the final rule that appeared in the Federal Register of September 2, 2021, and that amended the color additive regulations to provide for the safe use of butterfly pea flower extract in various food categories at levels consistent with good manufacturing practice.
Listing of Color Additives Exempt From Certification; Silver Nitrate; Confirmation of Effective Date
Document Number: 2021-28158
Type: Rule
Date: 2021-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of November 8, 2021, for the final rule that appeared in the Federal Register of October 6, 2021, and that amended the color additive regulations to provide for the safe use of silver nitrate as a color additive in professional-use only cosmetics to color eyebrows and eyelashes.
Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System
Document Number: 2021-28157
Type: Rule
Date: 2021-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the cerebrospinal fluid shunt system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cerebrospinal fluid shunt system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-28217
Type: Notice
Date: 2021-12-28
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: 2021-28216
Type: Notice
Date: 2021-12-28
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.
Medical Devices; Anesthesiology Devices; Classification of the Retrograde Intubation Device
Document Number: 2021-28166
Type: Rule
Date: 2021-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the retrograde intubation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the retrograde intubation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Canned Tuna Deviating From the Standard of Identity; Amendment of Temporary Marketing Permits
Document Number: 2021-28164
Type: Notice
Date: 2021-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the temporary permits issued to Bumble Bee Foods, LLC, and StarKist Seafood Co. to market test canned tuna. The Bumble Bee Foods, LLC's temporary permit is amended to add one additional manufacturing location. The StarKist Seafood Co.'s temporary permit is amended to increase the amount of test product and to add one additional manufacturing location. These amendments will allow the applicants to continue to test market the test product and collect data on consumer acceptance.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-28151
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2021-28150
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; Matching Program
Document Number: 2021-28211
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE) is providing notice of a re-established matching program between HHS/ACF/OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP). The matching program compares state SNAP agency records with new hire, quarterly wage, and unemployment insurance information maintained in the National Directory of New Hires (NDNH). The outcomes of the comparisons help state agencies with establishing or verifying eligibility for applicants and recipients of SNAP benefits, reducing SNAP benefit errors, and maintaining program integrity.
Prospective Grant of Exclusive Patent License: “Griffithsin Compositions for Treatment and Prevention of Anti-Viral Infections”
Document Number: 2021-28196
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to University of Louisville Research Foundation, (``ULRF'') in its rights to the inventions and patents listed in the Supplementary Information section of this notice. ULRF is a Kentucky 501(c)3 non-profit corporation that is the agent of the University of Louisville (``UofL'') for licensing intellectual property owned and controlled by ULRF on behalf of UofL.
Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
Document Number: 2021-27763
Type: Rule
Date: 2021-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule establishes methodologies for adjusting the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule amounts using information from the Medicare DMEPOS competitive bidding program (CBP) for items furnished on or after the effective date specified in the DATES section of this final rule, or the date immediately following the duration of the emergency period described in the Social Security Act (the Act), whichever is later. This final rule also establishes procedures for making benefit category and payment determinations for new items and services that are durable medical equipment (DME), prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations under Medicare Part B. In addition, this rule classifies continuous glucose monitors (CGMs) as DME under Medicare Part B. Lastly, this final rule finalizes certain DME fee schedule-related provisions that were included in two interim final rules with comment period (IFC) that CMS issued on May 11, 2018, and May 8, 2020.
Proposed Information Collection Activity; State Access and Visitation Grant Application (OMB #0970-0482)
Document Number: 2021-28060
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
The federal Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is requesting a 3-year extension of the State Access and Visitation Grant Application (OMB #0970-0482, expiration 5/31/2022). There are changes requested to the form.
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2021-28096
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2021-28093
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-28091
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-28088
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-28087
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: 2021-28103
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2021-28101
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-28100
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-28099
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-28098
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2021-28097
Type: Notice
Date: 2021-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; National Directory of New Hires (OMB No. 0970-0166)
Document Number: 2021-28065
Type: Notice
Date: 2021-12-27
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 the federal Office of Management and Budget (OMB) to approve the National Directory of New Hires (NDNH), with minor changes to the Multistate Employer Registration form, for an additional three years. The current OMB approval expires July 31, 2022.
Proposed Information Collection Activity; Annual Report on Households Assisted by the Low Income Home Energy Assistance Program (LIHEAP) (OMB #0970-0060)
Document Number: 2021-28125
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Community Services (OCS), Division of Energy Assistance, is requesting a 3-year extension of the Household Report Form (OMB #0970-0060, expiration February 28, 2022). Submission of the completed report is one requirement for LIHEAP grant recipients applying for federal LIHEAP block grant funds. OCS proposes minor changes related to reporting of supplemental funding and to update reporting dates and number of respondents.
Proposed Information Collection Activity; Children's Bureau National Youth in Transition Database (NYTD) (OMB #0970-0340)
Document Number: 2021-28058
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the National Youth in Transition Database (NYTD) Youth Services Report and Youth Outcomes Survey Data Collection (OMB #0970-0340, expiration date 03/31/2022). There are no changes requested to the form.
Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-Forming Fish and Fishery Products-Decomposition and Histamine; Availability
Document Number: 2021-28053
Type: Notice
Date: 2021-12-27
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 draft Compliance Policy Guide entitled ``Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products Decomposition and Histamine.'' The draft guidance, when finalized, will replace existing guidance for FDA staff on adulteration associated with decomposition and histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation.
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry; Availability
Document Number: 2021-28051
Type: Notice
Date: 2021-12-27
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 ``Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.'' This guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)-compliant toxicology studies. This guidance finalizes the draft guidance ``Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers'' issued on September 30, 2019. This revision includes editorial changes to improve the clarity of the document.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; Changes to Medicare Graduate Medical Education Payments for Teaching Hospitals; Changes to Organ Acquisition Payment Policies
Document Number: 2021-27523
Type: Rule
Date: 2021-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period finalizes certain provisions of the fiscal year 2022 IPPS/LTCH PPS proposed rule. These provisions implement policies based on legislative changes relative to Medicare graduate medical education (GME) for teaching hospitals provided by sections 126, 127, and 131 of the Consolidated Appropriations Act (CAA), 2021; and changes, clarifications, and codifications for Medicare organ acquisition payment policies relative to organ procurement organizations (OPOs), transplant hospitals, and donor community hospitals. In addition, this final rule with comment period solicits comments on certain GME issues to inform potential future rulemaking
Fogarty International Center; Notice of Meeting
Document Number: 2021-28006
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-28004
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-28003
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2021-28002
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-28001
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes And Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2021-28000
Type: Notice
Date: 2021-12-27
Agency: Department of Health and Human Services, National Institutes of Health