Department of Health and Human Services March 26, 2021 – Federal Register Recent Federal Regulation Documents

Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
Document Number: 2021-06361
Type: Notice
Date: 2021-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. On March 27, 2020, new provisions were added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. FDA refers to the OTC Monograph Drug user fee program as ``OMUFA'' throughout this document. This notice publishes the OMUFA fee rates for FY 2021.
Privacy Act of 1974; Matching Program
Document Number: 2021-06321
Type: Notice
Date: 2021-03-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Peace Corps for ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Peace Corps Health Benefits Plan.''
Privacy Act of 1974; Matching Program
Document Number: 2021-06313
Type: Notice
Date: 2021-03-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Department of Defense, Defense Manpower Data Center for ``The Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Department of Defense Health Benefits Plan.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-06291
Type: Notice
Date: 2021-03-26
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 National Program of Cancer Registries Program Evaluation Instrument (NPCR-PEI). The NPCR Program Evaluation Instrument (PEI) is a web-based survey instrument designed to evaluate NPCR-funded registries' operational attributes and their progress towards meeting program standards. The PEI monitors the integration of surveillance, registry operations and health information systems, the utilization of established data standards, and the electronic exchange of health data. The PEI serves to inform CDC and NPCR Program Consultants where technical assistance is most needed to continue to improve and enhance the NPCR.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-06290
Type: Notice
Date: 2021-03-26
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' The information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Federal government's commitment to improving service delivery.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-06289
Type: Notice
Date: 2021-03-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-06288
Type: Notice
Date: 2021-03-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-06284
Type: Notice
Date: 2021-03-26
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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-06283
Type: Notice
Date: 2021-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-06282
Type: Notice
Date: 2021-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-06281
Type: Notice
Date: 2021-03-26
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: 2021-06266
Type: Notice
Date: 2021-03-26
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.
Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-06265
Type: Notice
Date: 2021-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee
Document Number: 2021-06259
Type: Notice
Date: 2021-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Blood Products Advisory Committee (the Committee) in the Center for Biologics Evaluation and Research. Nominations will be accepted for upcoming vacancies effective with this notice. 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. This notice is not for nominations for non-voting industry representatives.
Ursula Wing: Final Debarment Order
Document Number: 2021-06258
Type: Notice
Date: 2021-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ursula Wing for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Wing was convicted of one felony count under Federal law for conspiracy to defraud the United States. Ms. Wing was given notice of the proposed debarment and an opportunity to request a hearing to show why she should not be debarred within the timeframe prescribed by regulation. Ms. Wing failed to request a hearing. Ms. Wing's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Advisory Committee for Women's Services; Notice of Meeting Cancellation
Document Number: 2021-06256
Type: Notice
Date: 2021-03-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-06228
Type: Notice
Date: 2021-03-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-06227
Type: Notice
Date: 2021-03-26
Agency: Department of Health and Human Services, National Institutes of Health
Thomas J. Whalen: Final Debarment Order
Document Number: 2021-06219
Type: Notice
Date: 2021-03-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Thomas J. Whalen for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Whalen was convicted of multiple offenses; two of these are relevant to this debarment: One count of importation contrary of law-aiding and abetting and one count of healthcare fraud-aiding and abetting. The factual basis supporting Mr. Whalen's conviction is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Whalen was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 13, 2021 (30 days after receipt of the notice), Mr. Whalen had not responded. Mr. Whalen's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
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