October 14, 2022 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 117
South Atlantic Fishery Management Council; Public Meeting
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Habitat Protection and Ecosystem-Based Management Advisory Panel (Habitat AP).
International Product Change-Priority Mail Express International, Priority Mail International & First-Class Package International Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a Priority Mail Express International, Priority Mail International & First-Class Package International Service contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments
The Food and Drug Administration (FDA or Agency) is announcing publication of a discussion paper providing information for stakeholders and soliciting public comments on specific areas of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing for drugs, including biological products regulated by CDER and the Center for Biologics Evaluation and Research (CBER). FDA recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The discussion paper includes a series of questions for each technology to stimulate feedback from the public.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Notice of Public Meeting of the Indiana Advisory Committee to the U.S. Commission on Civil Rights
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 that the Indiana Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold planning meetings via Zoom on Tuesday, November 1, 2022, and December 6, 2022 at 1 p.m. (ET) to discuss and select the topic for the Committee's civil rights project; votes may be taken.
Notice of Public Meetings of the Pennsylvania Advisory Committee to the U.S. Commission on Civil Rights
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 that the Pennsylvania Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold series of web-based panel discussions on Friday October 28, 2022 from 12 p.m.-2 p.m. eastern time, and Tuersday November 2, 2022 from 12 p.m.-2 p.m. eastern time. The purpose of these meetings is for the Committee to hear testimony regarding civil rights and fair housing in the state.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Certain Robotic Floor Cleaning Devices and Components Thereof; Notice of Request for Submissions on the Public Interest
Notice is hereby given that on October 7, 2022, the presiding administrative law judge (``ALJ'') issued an Initial Determination on Violation of Section 337. The ALJ also issued a Recommended Determination on remedy and bonding should a violation be found in the above-captioned investigation. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation. This notice is soliciting comments from the public only.
Notice of Public Meetings of the Virginia Advisory Committee to the U.S. Commission on Civil Rights
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, that the Virginia Advisory Committee (Committee) will hold a web meeting via Zoom on Tuesday, November 1, 2022, at 12:00 p.m. Eastern Time. The purpose of the meeting is to discuss identified findings and recommendations from previous panels on police oversight and accountability in Virginia.
Notice of Public Meeting of the Nevada Advisory Committee to the U.S. Commission on Civil Rights
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, that the Nevada Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a virtual business meeting via ZoomGov at 3 p.m. Pacific on Thursday, October 20, 2022. The purpose of the meeting is to narrow down and discuss details of project proposal on civil rights and teacher shortages.
Commission Information Collection Activities (Ferc-539), Comment Request; Extension
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-539 (Gas Pipeline Certificates: Import & Export Related Applications), which will be submitted to the Office of Management and Budget (OMB). The Commission published a 60-day notice in the Federal Register on August 1, 2022 and received no comments on the 60-day notice.
Agency Information Collection Activities; Application for Designation as National Recreation Trail or National Water Trail
In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection with revisions.
Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Consideration of Deferred Action for Childhood Arrivals
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Certain Graphics Systems, Components Thereof, and Digital Televisions Containing the Same; Notice of Commission Decision Not To Review Initial Determinations Terminating the Investigation as to Certain Patent Claims and Granting Complainants' Motion To Amend the Complaint and Notice of Investigation
Notice is hereby given that the U.S. International Trade Commission (``the Commission'') has determined not to review two initial determinations (``IDs'') of the presiding administrative law judge (``ALJ''): (1) Order No. 23 terminating the investigation as to claims 17-21 of U.S. Patent No. 8,468,547 (``the '547 patent'') (collectively, the ``Withdrawn Claims''); and (2) Order No. 24 granting complainants' motion to amend the complaint and notice of investigation (``NOI'') in the above-captioned investigation to correct the names of two respondents.
Abilene Christian University
The U.S. Nuclear Regulatory Commission (NRC) is providing public notice of receipt and availability of an application for a construction permit from Abilene Christian University (ACU). The construction permit application is dated August 12, 2022.
Chesapeake and Ohio Canal National Historical Park Commission Request for Nominations
The National Park Service, U.S. Department of the Interior, is requesting nominations for qualified persons to serve as members of the Chesapeake and Ohio Canal National Historical Park Commission (Commission).
Demurrage and Detention Billing Requirements
The Federal Maritime Commission (Commission) is seeking public comment on a proposed rule that requires common carriers and marine terminal operators to include specific minimum information on demurrage and detention invoices and outlines certain billing practices relevant to appropriate timeframes for issuing invoices, disputing charges with the billing party, and resolving such disputes. The proposed rule addresses considerations identified in the Ocean Shipping Reform Act of 2022. The proposed rule would adopt minimum information that common carriers must include in a demurrage or detention invoice; add to this list additional information that must be included in or with a demurrage or detention invoice; further define prohibited practices by clarifying which parties may be appropriately billed for demurrage or detention charges; and establish billing practices that billing parties must follow when invoicing for demurrage or detention charges.
Certain Semiconductors and Devices and Products Containing the Same, Including Printed Circuit Boards, Automotive Parts, and Automobiles; Institution of Investigation
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 23, 2022, under section 337 of the Tariff Act of 1930, as amended, on behalf of Daedalus Prime LLC of Bronxville, New York. A supplement to the complaint was filed on September 12, 2022. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain semiconductors and devices and products containing the same, including printed circuit boards, automotive parts, and automobiles by reason of the infringement of certain claims of U.S. Patent No. 8,775,833 (``the '833 patent''); U.S. Patent No. 8,898,494 (``the '494 patent''); U.S. Patent No. 9,575,895 (``the '895 patent''); U.S. Patent No. 10,049,080 (``the '080 patent''); U.S. Patent No. 10,394,300 (``the '300 patent''); and U.S. Patent No. 10,705,588 (``the '588 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Certain Artificial Eyelash Extension Systems, Products, and Components Thereof; Notice of the Commission's Final Determination Finding No Violation of Section 337; Termination of the Investigation
Notice is hereby given that the U.S. International Trade Commission (``Commission'') has found no violation of section 337 of the Tariff Act of 1930, as amended, in the above-captioned investigation. The investigation is terminated.
Cross-Media Electronic Reporting: Authorized Program Revision Approval, Maine Department of Environmental Protection
This notice announces the Environmental Protection Agency's (EPA) approval of the Maine Department of Environmental Protection (ME DEP) request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.
Notice of Availability and Virtual Public Meetings for the Draft Environmental Impact Statement for Proposed Land Acquisition at the Washington Navy Yard, Washington, District of Columbia
Pursuant to the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality Regulations, the DoN prepared and filed with the United States Environmental Protection Agency (U.S. EPA), a Draft Environmental Impact Statement (EIS) that evaluates the potential environmental effects associated with the acquisition of land at the Southeast Federal Center (SEFC), at the Washington Navy Yard (WNY), Washington, DC. The Navy proposes to obtain 6 acres of land on the SEFC (the SEFC E Parcels) to improve the overall Antiterrorism (AT) posture of the WNY. By obtaining the SEFC E Parcels, the Navy would: (1) improve the WNY AT posture by reducing the encroachment threat posed by planned, private development on the SEFC E Parcels; (2) protect mission-critical activities conducted at the WNY from visual surveillance, and acoustic and electronic eavesdropping; and (3) enhance the overall safety of personnel, facilities, and infrastructure at the WNY. Should the Navy obtain ownership of the SEFC E Parcels, the Navy is considering three alternative uses for the acquired property: construction and operation of a relocated Navy Museum, construction of administrative facilities, or maintaining the status quo (no new development).
Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR): Reconsideration of Fugitive Emissions Rule
The Environmental Protection Agency (EPA) is proposing to repeal regulatory amendments promulgated through a final rule adopted in 2008 under the Clean Air Act (CAA or Act) that addressed the consideration of ``fugitive'' emissions of air pollutants from stationary sources when determining the applicability of certain permitting requirements under the Act. Those amendments have been stayed as a result of the reconsideration process. To bring closure to the reconsideration proceeding, the EPA is proposing to fully repeal the 2008 rule by removing the stayed provisions of the regulatory amendments adopted in 2008. The EPA is also proposing to remove a related exemption for modifications that would be considered major solely due to the inclusion of fugitive emissions. As a result of the proposed changes, all existing major stationary sources would be required to include fugitive emissions in determining whether a physical or operational change constitutes a ``major modification,'' requiring a permit under the Prevention of Significant Deterioration (PSD) or Nonattainment New Source Review (NNSR) programs.
Data Protection Review Court
As authorized and directed by the Executive order of October 7, 2022, ``Enhancing Safeguards for United States Signals Intelligence Activities,'' this rule amends Department of Justice regulations to establish within the Department a Data Protection Review Court (``DPRC''). The DPRC will review determinations made by the Civil Liberties Protection Officer of the Office of the Director of National Intelligence (``ODNI CLPO'') in response to qualifying complaints that allege certain violations of United States law in the conduct of United States signals intelligence activities. Applications for review by the DPRC must be filed by individuals through the appropriate public authority in a designated foreign country or regional economic integration organization. To facilitate their independent and impartial review, DPRC judges will not be subject to the day-to-day supervision of the Attorney General and will be subject to removal protections. DPRC decisions, including the direction of appropriate remedial measures to be undertaken by United States intelligence agencies, will be final and binding. Individual complainants will not be informed whether they were subject to signals intelligence activities, but instead will receive a standardized notice that states that the DPRC's review has been completed and either did not identify any covered violations or the DPRC issued a determination requiring any appropriate remediation.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Tugs Towing Drill Rig in Cook Inlet, Alaska
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued two incidental harassment authorizations (IHAs) to Hilcorp Alaska LLC to incidentally harass, by Level B harassment only, marine mammals during tugs towing jack-up rig activity in Cook Inlet, Alaska.
Qualification of Drivers; Exemption Applications; Hearing
FMCSA announces its decision to renew exemptions for 40 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Hearing
FMCSA announces receipt of applications from 13 individuals for an exemption from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
Notice of Availability of Draft Study; Extension of Comment Period
The Coast Guard is extending the comment period of the draft Pacific Coast Port Access Route Study (PAC-PARS) in order to provide stakeholders with additional time to provide the Coast Guard with valuable input. This study evaluates safe access routes for the movement of vessel traffic proceeding to or from ports or places along the western seaboard of the United States and determines whether a shipping safety fairway (``fairway'') and/or routing measures should be established, adjusted or modified.
Notice of Inventory Completion Amendment: University of California, Berkeley, Berkeley, CA
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of California, Berkeley, has amended a Notice of Inventory Completion published in the Federal Register on February 2, 2005. This notice amends both the number of associated funerary objects and the cultural affiliation of the human remains and associated funerary objects removed from Sonoma County, CA.
Notice of Inventory Completion: University of Michigan, Ann Arbor, MI
The University of Michigan has completed an inventory of human remains and associated funerary objects in consultation with the appropriate Indian Tribes or Native Hawaiian organizations and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the University of Michigan. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Statement of Work; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the Statement of Work to assess communication between FDA and sponsors through product quality information requests during application review and to identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of FDA and sponsors in communicating through product quality information requests is described in detail in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027.'' As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising as needed and requesting contractor proposals.
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in a New Drug Application, Abbreviated New Drug Application, or Biologics License Application; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.'' This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the supply of a product sooner than if a CP were not used. This final guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products. This document finalizes a revised draft guidance that published on April 20, 2016, entitled ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability ProtocolsProtein Drug Products and Biological ProductsChemistry, Manufacturing, and Controls Information'' that published in September 2003, was withdrawn on May 6, 2015.
Agency Information Collection Activities: Comment Request; Form Title: EIB 12-01 Medium-Term Master Guarantee Agreement Disbursement Approval Request
The Export-Import Bank of the United States (EXIM Bank), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. EXIM Bank has an electronic disbursement approval processing system for guaranteed lenders with transactions documented under Medium-Term Master Guarantee Agreements. After an export transaction has been authorized by EXIM Bank and legal documentation has been completed, the lender will obtain and review the required disbursement documents (e.g., invoices, bills of lading, Exporter's Certificate, etc.) and will disburse the proceeds of the loan for eligible goods and services. In order to obtain approval of the disbursement, the lender will access and complete an electronic questionnaire through EXIM Bank's online application system (EXIM Online). Using the form, the lender will input key data and request EXIM Bank's approval of the disbursement. EXIM Bank's action (approved or denied) is posted on the lender's history page. The information collected in the questionnaire will assist EXIM Bank in determining that each disbursement under a Medium-Term Guarantee meets all the terms and conditions for approval. The information collection tool can be reviewed at: https://exim.gov/sites/default/files/pub/pending/eib12- 01.pdf.
Agency Information Collection Activities: Final Collection; Comment Request; Form Title: EIB 09-01 Payment Default Report OMB 3048-0028
The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. This collection allows insured/guaranteed parties and insurance brokers to report overdue payments from the borrower and/or guarantor. To facilitate completion, the form includes many checkboxes and self-populating fields. Also, customers can submit it electronically through EXIM Online, replacing paper reporting. EXIM provides insurance, loans, and loan guarantees for the financing of exports of goods and services. The form can be viewed at: https:// www.exim.gov/sites/default/files//forms/eib09-01_0.pdf
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Express, Priority Mail, First-Class Package Service, and Parcel Select Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Parcel Select Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
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