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

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.

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.

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.

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.

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.

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.

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.

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.''

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.

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.

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.

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.

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.

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.

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.