Department of Health and Human Services August 12, 2020 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Health Workforce Connector, OMB No. 0906-0031-Extension
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Findings of Research Misconduct
Findings of research misconduct have been made against Zhiwei Wang, M.D. (Respondent), former postdoctoral fellow, Department of Pathology, Karmanos Cancer Institute, Wayne State University (WSU). Dr. Wang engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P20 CA101936, P30 CA022453, R01 CA075059, R01 CA083695, R01 CA101870, R01 CA109389, R01CA131151, R01 CA132794, and U19 CA113317. The administrative actions, including debarment for a period of ten (10) years, were implemented beginning on July 21, 2020, and are detailed below.
Submission for OMB Review; Center for States Evaluation Ancillary Data Collection (0970-0501)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the collection of information under the Center for States Evaluation Ancillary Data Collection (OMB #0970- 0501, expiration date 08/31/2020) without changes.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2020
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2020, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Male Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Male Breast Cancer: Developing Drugs for Treatment.'' This guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients. The guidance announced in this notice finalizes the draft guidance of the same title issued on August 27, 2019.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public via webcast and by teleconference. Time will be available for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; and Physician-Owned Hospitals
This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2021 based on our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this proposed rule would establish and update the Overall Hospital Quality Star Rating beginning with the CY 2021; remove certain restrictions on the expansion of physician-owned hospitals that qualify as ``high Medicaid facilities,'' and clarify that certain beds are counted toward a hospital's baseline number of operating rooms, procedure rooms, and beds; and add two new service categories to the OPD Prior Authorization Process.
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate.
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