2020 – Federal Register Recent Federal Regulation Documents
Results 2,801 - 2,850 of 27,998
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.
Johnson Matthey Pharmaceutical Materials Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Proposed Collection; Comment Request for Form 8823
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning Form 8823, Low-Income Housing Credit Agencies Report of Noncompliance or Building Disposition.
Notice of Public Meetings of the Maryland Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that meetings of the Maryland Advisory Committee to the Commission will convene by conference call at 12 p.m. (ET) on the following Tuesdays: December 1, 2020; January 5 and February 2, 2021. The purpose of the meetings is to continue its work on health disparities and COVID-19 in Maryland.
Notice of Public Meeting of the Oregon Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that the Oregon Advisory Committee (Committee) to the Commission will hold a web hearing from 1 p.m. to 3:30 p.m. (PST) on Friday, December 11, 2020. The purpose of the web hearing is to hear testimony regarding pre-trial release and bail practices. This web hearing is titled, ``Community Perspectives.''
Notice of Public Meeting of the Oregon Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that the Oregon Advisory Committee (Committee) to the Commission will hold a web hearing from 1 p.m. to 3:30 p.m. (PST) on Friday, December 4, 2020. The purpose of the web hearing is to hear testimony regarding pre-trial release and bail practices. This web hearing is titled, ``Access to Justice.''
Agenda and Notice of Public Meeting of the Rhode Island Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Rhode Island State Advisory Committee to the Commission will convene by web conference, on Wednesday, December 9, 2020 at 12 p.m. (ET). The purpose of the meeting is to discuss the Committee's project on licensing for formerly incarcerated individuals.
Agenda and Notice of Public Meeting of the New Hampshire Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that the New Hampshire State Advisory Committee to the Commission will convene a briefing on Wednesday, December 9, 2020 at 4 p.m. (ET). The purpose of the meeting is to hear testimony on solitary confinement in New Hampshire.
Competitive Price Adjustment
The Commission is recognizing a recently filed Postal Service document with the Commission concerning changes in rates of general applicability for competitive international products. The changes are scheduled to take effect January 24, 2021. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Agency Information Collection Activities; Proposed Collection; Comment Request; Consultation Procedures: Foods Derived From New Plant Varieties
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 pertaining to FDA consultation procedures for foods derived from new plant varieties, including information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Presidential Declaration Amendment of a Major Disaster for the State of Oregon
This is an amendment of the Presidential declaration of a major disaster for the State of Oregon (FEMA-4562-DR), dated 09/15/ 2020. Incident: Wildfires and Straight-line Winds. Incident Period: 09/07/2020 through 11/03/2020.
Clinical Drug Interaction Studies With Combined Oral Contraceptives; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clinical Drug Interaction Studies With Combined Oral Contraceptives.'' This guidance assists sponsors of investigational new drug applications and new drug applications in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs) during drug development as well as determining how to communicate the results and recommendations from the DDI studies. Specifically, this guidance focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug on a COC, including the need for and design of the clinical studies and the interpretation of the study results.
Agency Information Collection Activities; Submission for OMB Review; Comment Request
In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the OCC, the Board, and the FDIC (the agencies) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. On July 22, 2020, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), requested public comment for 60 days on a proposal to revise and extend the Consolidated Reports of Condition and Income (Call Reports) (FFIEC 031, FFIEC 041, and FFIEC 051) and the Regulatory Capital Reporting for Institutions Subject to the Advanced Capital Adequacy Framework (FFIEC 101), which are currently approved collections of information. In the July 2020 notice, the Board, under the auspices of the FFIEC, also requested public comment for 60 days on a proposal to revise and extend the Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002) and the Report of Assets and Liabilities of a Non-U.S. Branch that is Managed or Controlled by a U.S. Branch or Agency of a Foreign (Non-U.S.) Bank (FFIEC 002S), which also are currently approved collections of information. The Board published this proposal on behalf of the agencies. Finally, on October 4, 2019, the agencies, under the auspices of the FFIEC, requested public comment for 60 days on proposed Call Report and FFIEC 101 revisions to implement the agencies' proposed total loss absorbing capacity (TLAC) investments rule for advanced approaches banking organizations. The comment period for the July 2020 notice ended on September 21, 2020. The comment period for the October 2019 notice ended on December 3, 2019, and the agencies subsequently adopted a TLAC investments final rule. As described in the SUPPLEMENTARY INFORMATION section, after considering the comments received on the two notices, the agencies are proceeding with the proposed revisions to the reporting forms and instructions for the Call Reports, FFIEC 101, and FFIEC 002 with certain modifications. The SUPPLEMENTARY INFORMATION section also discusses certain Call Report instructional clarifications. The agencies hereby give notice of their plan to submit to OMB a request to approve the revision and extension of these information collections, and again invite comment on the renewal.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Oregon
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Oregon (FEMA-4562-DR), dated 10/20/2020. Incident: Wildfires and Straight-line Winds. Incident Period: 09/07/2020 through 11/03/2020.
Presidential Declaration Amendment of a Major Disaster for the State of Oregon
This is an amendment of the Presidential declaration of a major disaster for the State of Oregon (FEMA-4562-DR), dated 09/15/ 2020. Incident: Wildfires and Straight-line Winds. Incident Period: 09/07/2020 and continuing.
Notice of Availability; Proposed Updated Compliance Manual on Religious Discrimination
The Equal Employment Opportunity Commission (EEOC or Commission) is announcing the availability of a draft updated guidance, entitled ``Proposed Updated Compliance Manual on Religious Discrimination.'' The proposed updated guidance explains a variety of issues applicable to religious discrimination claims, discusses typical scenarios in which religious discrimination and requests for religious accommodation may arise, and provides guidance to employers on how to balance the needs of individuals in a diverse religious climate. The proposed guidance, when finalized, will supersede the Commission's Compliance Manual on Religious Discrimination issued on July 22, 2008.
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scallop Committee via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scallop Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Medicare Program; National Expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports
This notice announces the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports to all states, but we are delaying the implementation of the expansion to all additional states due to the COVID-19 Public Health Emergency. The model will continue to operate in the states currently participating in the model under section 1115A of the Social Security Act (the Act), which includes Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. CMS will continue to monitor the Public Health Emergency and will provide public notice before implementing the model in additional states.
Elemental Impurities in Animal Drug Products-Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' This guidance provides recommendations to sponsors regarding the control of elemental impurities in animal drug products, including all dosage forms and routes of administration.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; SABIT Participant Application, Participant Survey, Alumni Survey
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
Notice Pursuant to The National Cooperative Research and Production Act of 1993-Telemanagement Forum
Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and FDA staff.'' The guidance for industry and FDA staff describes how and when FDA intends to collect, compile, and publicize lists of retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the guidance. FDA's goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.
Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota Transfer from NC to CT
NMFS announces that the State of North Carolina is transferring a portion of its 2020 commercial summer flounder quota to the State of Connecticut. This quota adjustment is necessary to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial quotas for North Carolina and Connecticut.
Grain Handling Facilities; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements contained in the standard on Grain Handling Facilities.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2021
This notice announces a $599.00 calendar year (CY) 2021 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2021 and on or before December 31, 2021.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Standardizing Phytosanitary Treatment Regulations: Approval of Cold Treatment and Irradiation Facilities; Cold Treatment Schedules; and Establishment of Fumigation and Cold Treatment Compliance Agreements
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States.
Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes
The FAA is adopting a new airworthiness directive (AD) for certain Pilatus Aircraft Ltd. Model PC-24 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as overheating of the electrical wiring splices close to the right-hand pitot-static connector on frame 10. The FAA is issuing this AD to address the unsafe condition on these products.
Medicare Program; Town Hall Meeting on Merit-Based Incentive Payment System (MIPS) Value Pathway (MVP) Implementation
This notice announces a virtual Town Hall meeting for CMS to share updates on the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) policy considerations and for stakeholders to provide feedback on those MVP considerations for future implementation. Clinicians, professional organizations, third party vendors, stakeholders, and other interested parties are invited to this meeting to present their individual views on MVP design and implementation. The opinions and alternatives provided during this meeting will assist us as we evaluate our policies on essential components of the MVP framework, including, but not limited to, expanding reporting options to allow clinicians to form subgroups and report MVPs, MVP scoring policies, as well as other areas of MVP refinement. The meeting is open to the public, but registration is required, and attendance is limited. We encourage early registration to secure a spot.
Airworthiness Directives; Piper Aircraft, Inc. Airplanes
The FAA is adopting a new airworthiness directive (AD) for certain Piper Aircraft, Inc. (Piper) Models PA-28-140, PA-28-150, PA- 28-160, PA-28-180, PA-28-235, PA-32-260, and PA-32-300 airplanes. This AD was prompted by reports of corrosion found in an area of the main wing spar not easily accessible for inspection. This AD requires inspecting the left and right main wing spars for corrosion, and, if corrosion is found, taking all necessary corrective actions. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Textron Aviation, Inc., (Type Certificate Previously Held by Cessna Aircraft Company) Airplanes
The FAA is superseding Airworthiness Directive (AD) AD 2019- 08-13 for Textron Aviation, Inc., (type certificate previously held by Cessna Aircraft Company) Models 525, 525A, and 525B airplanes with Tamarack Aerospace Group (Tamarack) active load alleviation system (ATLAS) winglets installed in accordance with Supplemental Type Certificate (STC) SA03842NY. AD 2019-08-13 was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as malfunction of the ATLAS. This AD results from the identification of corrective actions that, if implemented, allow operators to reactivate the ATLAS and restore operations to normal procedures. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Criteria: Special Class Airworthiness Criteria for the Percepto Robotics, Ltd. Percepto System 2.4
The FAA announces the availability of and requests comments on proposed airworthiness criteria for the Percepto Robotics, Ltd. Model Percepto System 2.4 unmanned aircraft system (UAS). This document proposes airworthiness criteria the FAA finds to be appropriate and applicable for the UAS design.
Airworthiness Criteria: Special Class Airworthiness Criteria for the Flytrex, Inc. FTX-M600P
The FAA announces the availability of and requests comments on proposed airworthiness criteria for the Flytrex, Inc. Model FTX-M600P unmanned aircraft system (UAS). This document proposes airworthiness criteria the FAA finds to be appropriate and applicable for the UAS design.
Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for certain Pilatus Aircraft Ltd. (Pilatus) Model PC-24 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as improperly manufactured cockpit and cabin evaporator filters installed during production on some PC-24 airplanes. The FAA is proposing this AD to address the unsafe condition on these products.
Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security United States Coast Guard-061 Maritime Analytic Support System (MASS) System of Records
The Department of Homeland Security is giving concurrent notice of a modified and reissued system of records pursuant to the Privacy Act of 1974 for the ``Department of Homeland Security/United States Coast Guard-061 Maritime Analytic Support System (MASS) System of Records'' and this proposed rulemaking. In this proposed rulemaking, the Department and the United States Coast Guard propose to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.
Privacy Act of 1974; System of Records
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to modify and reissue a current DHS system of records titled, ``DHS/United States Coast Guard (USCG)-061 Maritime Awareness Global Network (MAGNET) System of Records.'' The modified system of records is to be reissued and renamed as ``DHS/USCG- 061 Maritime Analytic Support System (MASS) System of Records.'' This system of records allows the DHS/USCG to collect and maintain records in a centralized location that relate to the U.S. Coast Guard's missions that are found within the maritime domain. The information covered by this system of records is relevant to the eleven U.S. Coast Guard statutory missions (Port, Waterways, and Coastal Security (PWCS); Drug Interdiction; Aid to Maritime Navigation; Search and Rescue (SAR) Operations; Protection of Living Marine Resources; Ensuring Marine Safety, Defense Readiness; Migrant Interdiction; Marine Environmental Protection; Ice Operations; and Law Enforcement). DHS/USCG is updating this system of records notice to include and update additional data sources, system security and auditing protocols, routine uses, and user interfaces. Additionally, DHS/USCG is concurrently issuing a Notice of Proposed Rulemaking, and subsequent Final Rule, to exempt this system of records from certain provisions of the Privacy Act due to criminal, civil, and administrative enforcement requirements. Furthermore, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice. This modified system will be included in DHS's inventory of record systems.
List of Approved Spent Fuel Storage Casks: NAC International, Inc. MAGNASTOR® Storage System, Certificate of Compliance No. 1031, Amendment No. 9
The U.S. Nuclear Regulatory Commission (NRC) is confirming the effective date of December 7, 2020, for the direct final rule that was published in the Federal Register on September 22, 2020. The direct final rule amends the NRC's spent fuel storage regulations by revising the NAC International, Inc. MAGNASTOR[supreg] Storage System listing within the ``List of approved spent fuel storage casks'' to include Amendment No. 9 to Certificate of Compliance No. 1031.
Fisheries Off West Coast States; Delay Implementation of West Coast Groundfish Electronic Monitoring Program
This final rule delays implementation of the Electronic Monitoring (EM) Program for the West Coast Groundfish Trawl Rationalization Program to January 1, 2022. NMFS is making this change to provide additional time for industry and prospective service providers to prepare for implementation, to strengthen Pacific Fishery Management Council (Council) and industry support for the EM program, and to increase participation when it is implemented in 2022.
Defense Federal Acquisition Regulation Supplement: Authorities for Minimizing the Use of Materials Containing Hexavalent Chromium (DFARS Case 2020-D031)
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to remove references to revoked Executive Orders related to minimizing the use of materials containing hexavalent chromium.
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