Department of Health and Human Services May 26, 2020 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Request; 30-Day Public Comment Request
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.
Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Announcement of the Re-Approval of AABB (Formerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 4 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.
Medicare and Medicaid Programs; Application From The Joint Commission (TJC) for Continued CMS-Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program
This proposed notice acknowledges the receipt of an application from The Joint Commission for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Amendment and Extension of Order Under Sections 362 and 365 of the Public Health Service Act; Order Suspending Introduction of Certain Persons From Countries Where a Communicable Disease Exists
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the amendment of an Order issued on March 20, 2020 and extended on April 20, 2020 under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, that temporarily suspends the introduction of certain aliens based on the Director's determination that introduction of aliens, regardless of their country of origin, migrating through Canada and Mexico into the United States creates a serious danger of the introduction of COVID-19 into the United States, and the danger is so increased by the introduction of such aliens that a temporary suspension is necessary to protect the public health. This amendment and extension was issued on May 20, 2020 and shall remain in effect until the CDC Director determines that the danger of further introduction of COVID-19 into the United States from covered aliens has ceased to be a serious danger to the public health, and the Order is no longer necessary to protect the public health. CDC shall review the latest information regarding the status of the COVID-19 pandemic and associated public health risks every thirty days to ensure that the Order remains necessary to protect the public health.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Findings of Research Misconduct
Findings of research misconduct have been made against Mr. Logan Fulford (Respondent), who was a graduate research assistant, Cincinnati Children's Hospital Medical Center (CCHMC), and former graduate student, University of Cincinnati (UC). Mr. Fulford engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA142724 and National Heart, Lung, and Blood Institute (NHLBI), NIH, grant R01 HL084151. The administrative actions, including supervision for a period of two (2) years, were implemented beginning on May 8, 2020, and are detailed below.
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