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

Temporary Halt in Residential Evictions To Prevent the Further Spread of COVID-19
Document Number: 2021-06718
Type: Notice
Date: 2021-03-31
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 extension of an Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions to prevent the further spread of COVID-19.
Notice of Re-Establishment of the Advisory Committee to the Director
Document Number: 2021-06644
Type: Notice
Date: 2021-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-06642
Type: Notice
Date: 2021-03-31
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.
Proposed Information Collection Activity; Head Start Program Performance Standards (0970-0148)
Document Number: 2021-06639
Type: Notice
Date: 2021-03-31
Agency: Department of Health and Human Services, Administration for Children and Families
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the information collection requirements under the Head Start Program Performance Standards (OMB #0970-0148). There are no changes to the information collection.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-06563
Type: Notice
Date: 2021-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Regulatory Agenda
Document Number: 2021-04943
Type: Proposed Rule
Date: 2021-03-31
Agency: Department of Health and Human Services, Office of the Secretary
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York
Document Number: 2021-06499
Type: Notice
Date: 2021-03-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that laboratories located in and licensed by the State of New York that possess a valid permit under the New York State Public Health Law are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-06476
Type: Notice
Date: 2021-03-30
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. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of an Exclusive Patent License: The Development of Natural Killer (NK) Cell Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) T Cell Receptor (TCR) Therapy for the Treatment of KK-LC-1 Expressing Human Cancers
Document Number: 2021-06475
Type: Notice
Date: 2021-03-30
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 Zelluna Immunotherapy (Zelluna), located in Oslo, Norway.
Prospective Grant of Exclusive Patent License: Chimeric Antigen Receptors Targeting CD56
Document Number: 2021-06474
Type: Notice
Date: 2021-03-30
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 Memorial Sloan Kettering Cancer Center, (``MSKCC''), a non-profit research center located in New York, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-06470
Type: Notice
Date: 2021-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Request for Assistance for Child Victims of Human Trafficking
Document Number: 2021-06450
Type: Notice
Date: 2021-03-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP) is requesting a three-year extension of the form: Request for Assistance (RFA) for Child Victims of Human Trafficking (OMB #0970-0362, expiration 07/31/2021). Minor revisions have been made to the form, including the addition of a few fields that will enable the OTIP Child Protection Specialist team to better understand the child's specific needs, connect the child to appropriate services, and help ensure the safety of the child.
CLIA Program; Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2021-06439
Type: Notice
Date: 2021-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the application of the College of American Pathologists (CAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the CAP meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant CAP deeming authority for a period of 6 years.
Medicare and Medicaid Programs; Application From the Joint Commission for Continued Approval of Its Hospice Accreditation Program
Document Number: 2021-06413
Type: Notice
Date: 2021-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Joint Commission for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-06375
Type: Notice
Date: 2021-03-29
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 2021-06373
Type: Notice
Date: 2021-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2021-06372
Type: Notice
Date: 2021-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2021-06371
Type: Notice
Date: 2021-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2021-06370
Type: Notice
Date: 2021-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2021-06369
Type: Notice
Date: 2021-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP); Correction
Document Number: 2021-06368
Type: Notice
Date: 2021-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Neurological Disorders and Stroke Amended; Notice of Meeting
Document Number: 2021-06367
Type: Notice
Date: 2021-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Interdisciplinary, Community-Based Linkages
Document Number: 2021-06341
Type: Notice
Date: 2021-03-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL or Committee). The ACICBL provides advice and recommendations to the Secretary of the Department of Health and Human Services (Secretary) concerning policy and program development, and other significant matters related to activities under Part D, Title VII of the Public Health Service (PHS) Act. Per authorizing legislation, the ACICBL currently focuses on the following program areas and/or disciplines: Area Health Education Centers; Geriatrics; Allied Health; Chiropractic; Podiatric Medicine; Mental and Behavioral Health, including Social Work and Graduate Psychology; and Rural Health. Authority: The ACICBL is required by section 757 (42 U.S.C. 294f) of the PHS Act. Except where otherwise indicated, the Committee is governed by provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C. Appendix 2), as amended, which sets forth standards for the formation and use of advisory committees.
Submission for OMB Review; Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Program for Successful Transition to Adulthood-Extension (OMB #0970-0489)
Document Number: 2021-06340
Type: Notice
Date: 2021-03-29
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) requests an extension to continue data collection for the Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Program for Successful Transition to Adulthood (OMB #0970-0489; Previously titled: Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Independence Program). Information collection activities requested include interviews, focus group discussions and administrative data collection. There are no changes proposed to the currently approved materials.
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BAROSTIM NEO
Document Number: 2021-06210
Type: Notice
Date: 2021-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BAROSTIM NEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-06209
Type: Notice
Date: 2021-03-25
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.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2021-06206
Type: Notice
Date: 2021-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2021-06202
Type: Notice
Date: 2021-03-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Radiation Exposure Screening and Education Program, OMB No. 0906-0012-EXTENSION
Document Number: 2021-06141
Type: Notice
Date: 2021-03-25
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. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
Agency Information Collection Request (ICR); 60-Day Public Comment Request
Document Number: 2021-06138
Type: Notice
Date: 2021-03-25
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 (HHS), is publishing the following summary of a proposed collection for public comment.
Recharter for the Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2021-06114
Type: Notice
Date: 2021-03-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has been rechartered. The effective date of the recharter is March 24, 2021.