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

Results 351 - 400 of 2,555
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20153
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2021-20152
Type: Notice
Date: 2021-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2021-20151
Type: Notice
Date: 2021-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the webcast lines available. Check the CLIAC website on the day of the meeting for the web conference link www.cdc.gov/cliac.
Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-20150
Type: Notice
Date: 2021-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-20114
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-20113
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-20111
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20110
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-20109
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-20108
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-20107
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 30-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institute of Mental Health (NIMH)
Document Number: 2021-20076
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
National Cancer Institute; Notice of Meeting
Document Number: 2021-20075
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2021-20071
Type: Notice
Date: 2021-09-17
Agency: Department of Health and Human Services, National Institutes of Health
Product-Specific Guidances for Ferric Oxyhydroxide; Revised Draft Guidances for Industry; Availability
Document Number: 2021-20064
Type: Notice
Date: 2021-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of revised draft guidances for industry entitled ``Draft Guidance for Ferric Oxyhydroxide.'' The revised draft guidances, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for ferric oxyhydroxide oral tablets (previously sucroferric oxyhydroxide) and ferric oxyhydroxide intravenous injectable (previously iron sucrose).
Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program
Document Number: 2021-20060
Type: Notice
Date: 2021-09-17
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Agency's Biosimilars User Fee Program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Document Number: 2021-20057
Type: Notice
Date: 2021-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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 Request; 60-Day Public Comment Request
Document Number: 2021-19976
Type: Notice
Date: 2021-09-16
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.
Agency Father Generic Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-19975
Type: Notice
Date: 2021-09-16
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.
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2021-19960
Type: Notice
Date: 2021-09-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2021-19947
Type: Notice
Date: 2021-09-16
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.
Requirements Related to Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement
Document Number: 2021-19797
Type: Proposed Rule
Date: 2021-09-16
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury, Office of Personnel Management
This document sets forth proposed rules implementing certain provisions of Title I (No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021 (CAA). These proposed rules would amend and add provisions to existing rules under the Internal Revenue Code (Code), the Employee Retirement Income Security Act (ERISA), the Public Health Service Act (PHS Act), and the Federal Employees Health Benefits (FEHB) Act. These proposed rules would implement certain provisions of the No Surprises Act that would increase transparency by requiring group health plans and health insurance issuers in the group and individual markets, and FEHB carriers, to submit certain information about air ambulance services to the Secretaries of Health and Human Services (HHS), Labor, and the Treasury, and the Director of the Office of Personnel Management, as applicable, and by requiring providers of air ambulance services to submit certain information to the Secretaries of HHS and Transportation. These proposed rules also include HHS-only proposed rules that would increase transparency by requiring a health insurance issuer offering individual health insurance coverage or short-term, limited-duration insurance to disclose to policyholders and to report to HHS any direct or indirect compensation provided by the issuer to an agent or broker associated with enrolling individuals in such coverage. These proposed rules would also provide the process by which HHS would investigate complaints and potential violations of PHS Act provisions and, if warranted, take enforcement action, including the imposition of civil money penalties, against providers and facilities, including providers of air ambulance services. These proposed rules would amend existing regulations to clarify the process to investigate complaints and potential violations of the PHS Act and impose civil money penalties against plans and issuers. These proposed rules would also establish the process by which HHS would impose civil money penalties if a provider of air ambulance services fails to submit some or all required data to HHS.
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
Document Number: 2021-20016
Type: Proposed Rule
Date: 2021-09-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of ``Reasonable and Necessary'' final rule, which was published on January 14, 2021, and would be effective on December 15, 2021. We are providing a public comment period to allow interested parties to provide comments about the proposed repeal, our intent to conduct future rulemaking to explore an expedited coverage pathway that provides access to innovative beneficial technologies and the reasonable and necessary definition.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19937
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-19936
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-19935
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program
Document Number: 2021-19925
Type: Notice
Date: 2021-09-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the Food Contact Substance Notification Program.
Performance Review Board Members
Document Number: 2021-19907
Type: Notice
Date: 2021-09-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the names of the Performance Review Board Members who are reviewing performance of Senior Executive Service (SES) members, Title 42 (T42) executives, and Senior Level (SL) employees for Fiscal Year 2021.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-19882
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-19874
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-19873
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19872
Type: Notice
Date: 2021-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
Document Number: 2021-19790
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer COVID-19 therapeutics that are covered countermeasures under section VI of this Declaration.
National Biodefense Science Board
Document Number: 2021-19789
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services
The National Biodefense Science Board (NBSB or the Board) is authorized under Section 319M of the Public Health Service (PHS) Act, as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee Act, which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19761
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-19760
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-19759
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-19754
Type: Notice
Date: 2021-09-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-19753
Type: Notice
Date: 2021-09-14
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 Coal Workers' Health Surveillance Program (CWHSP). The CWHSP is a Congressionally mandated medical examination program for monitoring the health of coal miners and was originally established under the Federal Coal Mine Health and Safety Act of 1969 with all subsequent amendments (the Act). HHS proposes to revise the National Institute for Occupational Safety and Health (NIOSH) CWHSP regulations by amending existing regulatory text to allow compensation for pathologists who perform autopsies on coal miners at a market rate, on a discretionary basis as needed for public health purposes.
Proposed Collection; 60-Day Comment Request; Investigational Agent Accountability Record Forms and International Investigator Statement in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute)
Document Number: 2021-19741
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-19708
Type: Notice
Date: 2021-09-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection National Institute of Environmental Health Science (NIEHS)
Document Number: 2021-19693
Type: Notice
Date: 2021-09-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
Document Number: 2021-19690
Type: Notice
Date: 2021-09-13
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.
PolyMedica Industries Inc., et al.; Withdrawal of Approval of Three New Drug Applications
Document Number: 2021-19689
Type: Notice
Date: 2021-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for those NDAs.
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
Document Number: 2021-19688
Type: Rule
Date: 2021-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is October 11, 2022.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2021-19686
Type: Notice
Date: 2021-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. At least one portion of the meeting will be closed to the public.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-19681
Type: Notice
Date: 2021-09-13
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.
Opportunity for Comments on Proposed Updates to the Bright Futures Periodicity Schedule as Part of the HRSA-Supported Preventive Services Guidelines for Infants, Children, and Adolescents
Document Number: 2021-19630
Type: Notice
Date: 2021-09-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice seeks public comment on several proposed updates to The Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (``Bright Futures Periodicity Schedule''), as part of the HRSA-supported preventive service guidelines for infants, children, and adolescents. Please see https:// mchb.hrsa.gov/maternal-child-health-topics/child-health/brigh t- futures.html for additional information. The Periodicity Schedule is maintained in part through a national cooperative agreement, the Bright Futures Pediatric Implementation Program. If accepted by HRSA, a proposed update to the Bright Futures Periodicity Schedule will provide additional clinical guidance to providers and, under the Public Health Service Act, would require certain insurance plans and issuers to provide coverage without cost-sharing of such updated preventive care and screenings.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Allogeneic T Cell and Gene Therapy Vector Chimeric Antigen Receptor (CAR) Therapies Targeting CD22 Alone or in Combination With CARs Targeting CD19 for the Treatment of B-Cell Malignancies
Document Number: 2021-19618
Type: Notice
Date: 2021-09-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Sana Biotechnology Inc. Life Sciences Inc., (``Sana''), located in Seattle, Washington.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2021-19604
Type: Notice
Date: 2021-09-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Athenex, Inc. (``Athenex'') headquartered in Buffalo, NY.