Department of Health and Human Services November 16, 2021 – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
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 Requirement for Negative Pre- Departure COVID-19 Test Result or Documentation of Recovery from COVID- 19 For All Airline or Other Aircraft Passengers Arriving into the United States from any Foreign Country and Requirement for Proof of COVID-19 Vaccination for Noncitizen, Nonimmigrant Air Passengers Arriving Into The United States From A Foreign Country. This proposed information collection is designed to ensure that CDC complies with Orders published October 25 and October 30, 2021, and to confirm that passengers who are coming into the United States via air travel have tested negative for or recently recovered from COVID-19, and that noncitizen, nonimmigrant passengers are fully vaccinated against COVID- 19.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 the One Health Harmful Algal Bloom System (OHHABS). OHHABS is a surveillance platform which captures data on harmful algal bloom (HAB) events and HAB-associated illnesses.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Per-or-Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs). This Revision information collection request (ICR) will allow ATSDR/NCEH to continue to conduct additional Exposure Assessments (EAs) that may be requested at military or non- military installations.
Determination of Regulatory Review Period for Purposes of Patent Extension; QINLOCK
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QINLOCK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Sanyasi Raju Kalidindi; Grant of Special Termination
The Food and Drug Administration (FDA) has issued an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting special termination of the debarment of Sanyasi Raju Kalidindi. FDA based the order on a finding that Dr. Kalidindi provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction and that terminating Dr. Kalidindi's debarment served the interest of justice and protected the integrity of the drug approval process.
Submission for OMB Review; Head Start Family and Child Experiences Survey (FACES) (OMB #0970-0151)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new wave of the Head Start Family and Child Experiences Survey (FACES) as well as a follow-up to a special data collection fielded in the fall of 2021.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Evidence Based Program Fidelity Surveys [OMB #0985-New]
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the information collection requirements for the Evidence Based Program Fidelity Surveys [OMB #0985-New].
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906-0039-Extension
In compliance with of the Paperwork Reduction Act of 1995, HRSA is submitting 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.
Submission for OMB Review; 30-Day Comment Request; Division of Extramural Research and Training (DERT) Extramural Grantee Data Collection (National Institute of Environmental Health Sciences)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; Intergovernmental Reference Guide (IRG) (OMB No.: 0970-0209)
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is requesting the Office of Management and Budget (OMB) to approve the Intergovernmental Reference Guide (IRG), with content and organizational revisions, for an additional three years. The IRG contains state and tribal child support information that assists state and tribal child support enforcement (CSE) agencies administering their respective programs. The current OMB approval expires on January 31, 2022.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the committee will discuss and vote on a recommendation pertaining to a proposed update to the 2020 Public Health Service (PHS) Guideline for Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection. The following question will be posed to the committee: Does the available data support exempting solid organ transplant candidates who are
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2022 based on our continuing experience with these systems. In this final rule with comment period, we describe the 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 final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, updates Hospital Price Transparency requirements, and updates and refines the design of the Radiation Oncology Model.
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