2021 – Federal Register Recent Federal Regulation Documents
Results 3,701 - 3,750 of 27,092
Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our reporting and recordkeeping requirements for antimicrobial animal drug sales and distribution.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
The Food and Drug Administration (FDA, the Agency, or we) 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.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
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.
Agency Information Collection Activities; Comment Request; International Computer and Information Literacy Study (ICILS 2023) Main Study Sampling, Recruitment, and Data Collection
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement with change of a previously approved collection.
Agency Information Collection Activity Under OMB Review: Election To Waive, Retain, or Re-Elect Due Process Rights if in Receipt of Concurrent Active Duty Service Pay and Disability Compensation Pay
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Schedule for Rating Disabilities: The Cardiovascular System
On September 30, 2021, the Department of Veterans Affairs (VA) published in the Federal Register a final rule that amended the portion of the VA Schedule for Rating Disabilities (``VASRD'' or ``rating schedule'') that addresses the cardiovascular system. This correction addresses the instructions for evaluating peripheral arterial disease in the published final rule and corrects another minor technical error.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
This document corrects the information provided for [Document Identifier: CMS-10790] titled ``Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020.''
Clean Air Act Operating Permit Program; Petitions for Objection to State Operating Permit for Oak Grove Management Company, Oak Grove Steam Electric Station, Robertson County, Texas
The Environmental Protection Agency (EPA) Administrator signed an Order dated October 15, 2021, granting a Petition dated July 25, 2017 from the Environmental Integrity Project and Sierra Club. The Petition requested that the EPA object to a Clean Air Act (CAA) title V operating permit issued by the Texas Commission on Environmental Quality (TCEQ) to Oak Grove Management Company (Oak Grove) for its Oak Grove Steam Electric Station located in Robertson County, Texas.
Export Trade Certificate of Review
The Secretary of Commerce, through the Office of Trade and Economic Analysis (OTEA), issued an amended Export Trade Certificate of Review (Certificate) to CAEA on October 15, 2021.
Export Trade Certificate of Review
The Secretary of Commerce, through the Office of Trade and Economic Analysis (``OTEA''), issued an amended Export Trade Certificate of Review (``Certificate'') to ALCC on October 26, 2021.
Removal of Training Requirements for an Airline Transport Pilot Certificate Issued Concurrently With a Single-Engine Airplane Type Rating
This final rule removes a multiengine training requirement for pilots seeking to obtain an initial airline transport pilot (ATP) certificate concurrently with a single-engine airplane type rating. The final rule also removes a 2014 compliance date because it is no longer necessary.
Agency Information Collection Activity Under OMB Review: Notice of Change in Student Status
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Changes in Flood Hazard Determinations
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The currently effective community number is shown in the table below and must be used for all new policies and renewals.
NextEra Energy Point Beach, LLC; Point Beach Nuclear Plant, Units 1 and 2
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft plant-specific Supplement 23, Second Renewal, to the Generic Environmental Impact Statement (GEIS) for License Renewal of Nuclear Plants, NUREG-1437, regarding the proposed subsequent renewal of Renewed Facility Operating License Nos. DPR-24 and DPR-27 for an additional 20 years of operation for Point Beach Nuclear Plant, Units 1 and 2 (Point Beach). The Point Beach facility is located on the western shore of Lake Michigan (approximately 15 miles NNE of Manitowoc, WI). Possible alternatives to the proposed action (subsequent license renewal) include no action and reasonable replacement power alternatives.
Proposed Flood Hazard Determinations
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Changes in Flood Hazard Determinations
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities.
Supplemental Evidence and Data Request on Partial Breast Irradiation for Breast Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Partial Breast Irradiation for Breast Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Privacy Act of 1974; System of Records
As required by the Privacy Act of 1974, and Office of Management and Budget (OMB) Circular No. A-108, this notice is a new Privacy Act System of Records titled USDA/OSEC-02 Contractor and Visitor Public Health Emergency Records, which include information on contractor employees who work in, as well as visitors to, Department of Agriculture (USDA) facilities during declared public health emergencies. The system contains information provided by the contractor's employees including such information as their applicable vaccination or medical countermeasure status and whether they are experiencing symptoms associated with the public health emergency. Each contractor with employees who will work in USDA facilities (regardless of whether the contract is with USDA or another Federal agency) will be asked to confirm if its employees have been vaccinated or have received appropriate medical countermeasures, in addition, the contractor will be required to ensure that its employees follow the guidelines specified for working in USDA facilities, for example, to mitigate the spread of COVID-19, not fully vaccinated employees are required to wear masks and maintain physical distancing. Visitors to USDA facilities will also be asked to provide information about their vaccination or medical countermeasure status and may be asked to provide proof of their status and information about whether they are experiencing any symptoms associated with the public health emergency.
Notice of Intent To Request a Revision and Extension of a Currently Approved Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection for surveys funded by NASS's many cooperators (Federal agencies, State governments, land grant universities, and other organizations). Results from these surveys are important for the cooperators in carrying out their missions, as well as of general interest to the agricultural community. This generic clearance will allow NASS to conduct surveys in a timely manner for the cooperating institutions providing funding for the surveys.
Proposed Information Collection Activity; ACF-800: Child Care and Development Fund (CCDF) Annual Aggregate Report (OMB #0970-0150)
The Office of Child Care (OCC), Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF- 800: CCDF Annual Aggregate Report (OMB #0970-0150, expiration 2/28/ 2022). There are no changes requested to the form.
Proposed Information Collection Activity; Success Sequence Qualitative Interviews (New Collection)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), proposes interview data collection activities for the Success Sequence Interviews study.
Meeting Announcement; Chief Freedom of Information Act (FOIA) Officers Council
We are announcing a meeting of the Chief Freedom of Information Act (FOIA) Officers Council, co-chaired by the Director of OGIS and the Director of OIP.
Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Generic Clearance for Survey Research Studies. Burden hours and number of contacts will be increased to accommodate the proposed testing for the upcoming three year period.
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.
Proposal To Rescind Implementing Legal Requirements Regarding the Equal Opportunity Clause's Religious Exemption
The Office of Federal Contract Compliance Programs (OFCCP) is proposing to rescind the regulations established in the final rule titled ``Implementing Legal Requirements Regarding the Equal Opportunity Clause's Religious Exemption,'' which took effect on January 8, 2021.
Calcium Bisulfate; Exemption From the Requirement of a Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of calcium bisulfate when used as an inert ingredient (acidifying/buffering agent) in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy- processing equipment, and food-processing equipment and utensils, limited to 2,000 parts per million (ppm). Burdock Group on behalf of SCG Solutions, LLC., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of calcium bisulfate.
Air Plan Approval; AK; Eagle River Second 10-Year PM10
The Environmental Protection Agency (EPA) is approving the Eagle River, Alaska (AK) limited maintenance plan (LMP) submitted on November 10, 2020, by the Alaska Department of Environmental Conservation (ADEC or ``the State''). This plan addresses the second 10-year maintenance period after redesignation for particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers (PM10). The plan relies upon control measures contained in the first 10-year maintenance plan and the determination that the Eagle River area currently monitors PM10 levels well below the PM10 National Ambient Air Quality Standard (NAAQS or ``the standard''). The EPA is approving Alaska's LMP as meeting Clean Air Act (CAA) requirements.
Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Colorado; Control of Emissions From Existing Municipal Solid Waste Landfills
The Environmental Protection Agency (EPA) is approving a Clean Air Act (CAA or the ``Act'') section 111(d) state plan submitted by the Colorado Department of Public Health and Environment (CDPHE or the ``Department'') on March 23, 2021. This state plan was submitted to fulfill the requirements of the CAA and is responsive to the EPA's promulgation of Emission Guidelines and Compliance Times (EG) for existing municipal solid waste (MSW) landfills. The Colorado state plan establishes performance standards and other operating requirements for existing MSW landfills within the State of Colorado and provides for the implementation and enforcement of those standards and requirements by the Department. The EPA is taking this action pursuant to the CAA.
Endangered and Threatened Wildlife and Plants; Threatened Species Status With Section 4(d) Rule for Alligator Snapping Turtle
We, the U.S. Fish and Wildlife Service (Service), announce our 12-month finding on a petition to list the alligator snapping turtle (Macrochelys temminckii), North America's largest freshwater turtle species, as an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). After a review of the best available scientific and commercial information, we find that listing the species is warranted. Accordingly, we propose to list the alligator snapping turtle as a threatened species with a rule issued under section 4(d) of the Act (``4(d) rule''). If we finalize this rule as proposed, it will add the species to the List of Endangered and Threatened Wildlife and extend the Act's protections to the species.
Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities
This final rule updates the home health and home infusion therapy services payment rates for calendar year (CY) 2022 in accordance with existing statutory and regulatory requirements. This rule also finalizes recalibration of the case-mix weights and updates the functional impairment levels, and comorbidity adjustment subgroups while maintaining the current low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rule finalizes a policy to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts and makes conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. It also finalizes proposed changes to the Home Health Quality Reporting Program (QRP) including finalizing proposed measure removals and adoptions, public reporting, and modification of effective dates. It also finalizes proposed modifications to the effective date for the reporting of measures and certain standardized patient assessment data in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH) QRP. In addition, this final rule codifies certain Medicare provider and supplier enrollment policies. It also makes permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE), and updates the home health conditions of participation regarding occupational therapists assessment completion to implement provisions of the Consolidated Appropriations Act, 2021 (CAA 2021). This final rule also finalizes proposals to expand the Home Health Value-Based Purchasing (HHVBP) Model and to end the original HHVBP Model one year early. Lastly, it establishes survey and enforcement requirements for hospice programs as set forth in the CAA 2021; and finalizes revisions to the infection control requirements for long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as ``nursing homes'') that will extend the mandatory COVID-19 reporting requirements beyond the current COVID-19 PHE until December 31, 2024.
Endangered and Threatened Wildlife and Plants; Threatened Species Status With Section 4(d) Rule for Egyptian Tortoise
We, the U.S. Fish and Wildlife Service (Service), propose to list the Egyptian tortoise (Testudo kleinmanni), a terrestrial tortoise from Libya, Egypt, and Israel, as a threatened species under the Endangered Species Act of 1973, as amended (Act). This determination also serves as our 12-month finding on a petition requesting that the Egyptian tortoise be listed as an endangered or threatened species under the Act. After a review of the best scientific and commercial information available, we find that listing the species is warranted. Accordingly, we propose to list the Egyptian tortoise, as a threatened species with a rule issued under section 4(d) of the Act (``4(d) rule''). If we finalize this rule as proposed, it would add this species to the List of Endangered and Threatened Wildlife and extend the Act's protections to the species.
Parts and Accessories Necessary for Safe Operation; Rear Impact Guards and Rear Impact Protection
FMCSA amends the Federal Motor Carrier Safety Regulations (FMCSRs) to include rear impact guards on the list of items that must be examined as part of the required annual inspection for each commercial motor vehicle (CMV). In addition, FMCSA amends the labeling requirements for rear impact guards, and excludes road construction controlled (RCC) horizontal discharge trailers from the rear impact guard requirements, consistent with changes made by the National Highway Traffic Safety Administration (NHTSA) to the corresponding Federal Motor Vehicle Safety Standards (FMVSS). This final rule responds to rulemaking petitions, as well as a recommendation from the Government Accountability Office (GAO).
Sunshine Act Meetings
Roundtable Discussion: E-Poll Book Testing Pilot Program Considerations.
Airworthiness Directives; Airbus SAS Airplanes
The FAA is superseding Airworthiness Directive (AD) 2021-18- 08, which applied to all Airbus SAS Model A319-171N airplanes; Model A320-271N, -272N, and -273N airplanes; and Model A321-271N, -272N, - 271NX, and -272NX airplanes. AD 2021-18-08 required repetitive inspections of the pylon/engine interface rods for damage, and applicable corrective actions, as specified in European Union Aviation Safety Agency (EASA) AD 2021-0177. AD 2021-18-08 also provided for limited installation of affected parts under certain conditions. Since the FAA issued AD 2021-18-08, operators reported that the requirements of EASA AD 2021-0177 were unclear. This AD retains the requirements of AD 2021-18-08, with clarified instructions, as specified in an EASA AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
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