Department of Health and Human Services March 2022 – 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 award of approximately $3,000,000, for Year 1 funding to the National AIDS and STDs Control Program (NASCP) within the Federal Ministry of Health (FMOH). The award will involve substantial engagement with CDC- supported states with the objective of establishing HIV/AIDS programmatic sustainability including the achievement and maintenance of HIV/AIDS epidemic control at national and sub-national levels and across all sub-populations. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $2,000,000 for Year 1 of funding to the Servicos Provinciais de Sa[uacute]de de Zambezia (SPS Zambezia), Mozambique. The award will strengthen the institutional capacity of SPS Zambezia to plan, coordinate, and supervise HIV-related activities to contribute to accelerated progress towards the 95-95-95 goals (95% of HIV-positive individuals knowing their status, 95% of those receiving ART [Antiretroviral therapy], and 95% of those achieving viral suppression) and ensure sustainable control of the epidemic in Mozambique. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the award of approximately $1,400,000 for Year 1 of, and an average 1 year award amount of $350,000, funding to the Machakos County Government, Makueni County Government, Kitui County Government, and Nairobi County Government (represented by Nairobi Metropolitan Services). The awards will advance current efforts to attain ownership, leadership, and implementation capacity for HIV services by the Nairobi, Machakos, Makueni and Kitui County governments, and to achieve and sustain HIV epidemic control through sustainable high-quality comprehensive HIV prevention and treatment services. Funding amounts for years 2-5 will be set at continuation.

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 Patent Applications listed in the Supplementary Information section of this notice to Macala Bio, Inc. located in 1000 NW Wall Street, Suite 220, Bend, OR 97703.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $450,000 for Year 1 of funding to the Burkina Faso Ministry of Health. to build laboratory and SI capacity to improve the provision of HIV testing, treatment, retention in line with HIV epidemic control and 95-95-95 targets (95% of HIV-positive individuals knowing their status, 95% of those receiving ART [Antiretroviral therapy], and 95% of those achieving viral suppression). Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director (ACD) Health Equity Workgroup (HEW). The HEW will consist of approximately 15 members who are experts in fields associated with health equity; public health science and practice; public health policy development, analysis, and implementation.

This notice announces the application of COLA for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Pathology to include Histopathology, Cytology and Oral Pathology. We have determined that COLA meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant COLA deeming authority for the specialty of Pathology to include Histopathology, Cytology and Oral Pathology for a period of 2 years.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Bio-Rad Laboratories for the BioPlex 2200 SARS-CoV-2 IgG, and Quotient Suisse SA for the MosaiQ COVID-19 Antibody Magazine. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

The National Advisory Committee on Seniors and Disasters (NACSD) and the National Advisory Committee on Individuals With Disabilities and Disasters (NACIDD), or Committees, were established by sections 2811B and 2811C, respectively, of the Public Health Service (PHS) Act, as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) of 2019. The Committees are governed by the provisions of the Federal Advisory Committee Act (FACA) and the General Services Administration FACA Final Rule. The Committees evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS to support and enhance all- hazards public health and medical preparedness, response, and recovery. The NACSD provides focus on the unique needs of older adults, while the NACIDD focuses on helping HHS meet the needs of people with disabilities (PWD). The Secretary of HHS has formally delegated authority to operate the NACSD and the NACIDD to ASPR.

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 Department of Health and Human Services (HHS or Department) is postponing, pending judicial review, the effective date of a final rule entitled ``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET final rule) and published in the Federal Register of January 19, 2021, and a final rule correction published in the Federal Register of March 23, 2021.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

The Food and Drug Administration (FDA or Agency) 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.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Eduardo Navarro from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Navarro was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Mr. Navarro was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of December 24, 2021 (30 days after receipt of the notice), Mr. Navarro had not responded. Mr. Navarro's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.