2023 – Federal Register Recent Federal Regulation Documents
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30-Day Notice of Proposed Information Collection: I2U2 Project Proposal Submission Template
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Agency Information Collection Activities: Submission for OMB Review; Renewal of Generic Clearance; Comment Request
Consistent with the Paperwork Reduction Act of 1995, the U.S. International Trade Commission (Commission) has submitted a proposal for the collection of information to the Office of Management and Budget (OMB) for approval. The proposed information collection is a three-year extension of the current generic clearance (approved by OMB under Control No. 3117-0222) under which the Commission can issue information collections for the collection of qualitative feedback on agency service delivery. Any comments submitted to OMB on the proposed information collection should be specific, indicating which part of the information collection plan is objectionable, describing the issue in detail, and including specific revisions or language changes. The Commission did not receive any comments in response to the 60-day notice that it published in the Federal Register on October 27, 2023.
Revised Technical Guidance for Assessing Environmental Justice in Regulatory Analysis: Extension of Public Comment Period
The Environmental Protection Agency (EPA) is announcing a 15- day extension of the public comment period on the draft revision of the Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (EJ Technical Guidance). The original Federal Register document announcing the public comment period was published on November 15, 2023. The EPA is extending the deadline of the comment period from January 15, 2024 to January 30, 2024.
Applications for New Awards; Office of Indian Education Formula Grants to Local Educational Agencies
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2024 for Office of Indian Education (OIE) Formula Grants to Local Educational Agencies (Formula Grants), Assistance Listing Number 84.060A. This notice relates to the approved information collection under OMB control number 1810-0021.
Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance entitled ``Potency Assurance for Cellular and Gene Therapy Products.'' FDA is issuing this draft guidance to provide recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we describe how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, we describe requirements for potency assurance, including testing required for lot release.
Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Quality Considerations for Topical Ophthalmic Drug Products.'' This revised draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions) intended for topical delivery in and around the eye. Specifically, this revised draft guidance discusses microbiological considerations; approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/ dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The revised draft guidance applies to marketed products including ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs, drugs compounded by outsourcing facilities, and the drug or biological product constituent part of a combination product. This guidance revises the draft guidance for industry of the same name issued in October 2023.
Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification
The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing the availability of version 2.3 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). The version update is not applicable to CBER- regulated drug products marketed for human use with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs); CBER-regulated therapeutic biological products marketed for human use with approved Biologic License Applications (BLAs); Whole Blood or blood components; and human cells, tissues, and cellular and tissue- based products (HCT/Ps) regulated solely under the Public Health Service Act.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Health Insurance Assistance Program Annual Sub-Recipients Report OMB Control Number 0985-0070
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 the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed extension without change for the information collection requirements related to State Health Insurance Assistance Program Annual Sub-Recipients Report OMB Control Number 0985-0070.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) OMB Control Number 0985-0022
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 the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed revision for the Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT) OMB Control Number 0985-0022.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Title VI Program Performance Report (OMB Control Number 0985-0007)
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 the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Title VI Program Performance Report (OMB Control Number 0985-0007).
Agency Information Collection Activities; USDA Generic Solution for Solicitation for Funding Opportunity Announcement
In compliance with the Paperwork Reduction Act, the U.S. Department of Agriculture (USDA) is requesting comments concerning authorization to revise the approved USDA Generic Solution for Solicitation for Funding Opportunity Announcement information collection request (ICR). This is a revision request. We are revising the ICR to cover the additional use across USDA agencies for grants, agreements, and other Federal financial assistance programs.
Federal Travel Regulation; Updating Glossary of Terms and E-Gov Travel Service Requirements
GSA is proposing to amend the Federal Travel Regulation (FTR) Glossary of Terms to add the term ``Online booking tool (OBT)'' and revise the definition of ``E-Gov Travel Service (ETS)''; remove outdated policies on implementing ETS; renumber ETS regulations in a sequential order as necessary; and make miscellaneous editorial corrections.
Adjustment to Premium Processing Fees
The Department of Homeland Security (DHS) is increasing premium processing fees charged by U.S. Citizenship and Immigration Services (USCIS) to reflect the amount of inflation from June 2021 through June 2023 according to the Consumer Price Index for All Urban Consumers. The adjustment increases premium processing fees from $1,500 to $1,685, $1,750 to $1,965, and $2,500 to $2,805.
National Organic Program (NOP); Organic Livestock and Poultry Standards; Correction
The Agricultural Marketing Service (AMS) is correcting non- substantive errors in the regulatory text of the Organic Livestock and Poultry Standards (OLPS) final rule published on November 2, 2023. The corrections are intended to improve readability and clarity.
Air Plan Approval; Oklahoma; Revisions to Air Pollution Control Rules
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving revisions to the State Implementation Plan (SIP) for Oklahoma, submitted to the EPA by the State of Oklahoma designee (``the State'') on January 30, 2023. The SIP revisions being approved address amendments to subchapters regarding Control of Emission of Volatile Organic Compounds (VOCs) and Emission of Volatile Organic Compounds (VOCs) in Nonattainment Areas and Former Nonattainment Areas.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: White Lightning (Motor); Invitation for Public Comments
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: TACKLE BOX (Motor); Invitation for Public Comments
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: Ra (Motor); Invitation for Public Comments
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: OFF WATCH (Motor); Invitation for Public Comments
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: ODIN (Motor); Invitation for Public Comments
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Coastwise Endorsement Eligibility Determination for a Foreign-Built Vessel: MIKHAYA (Sail); Invitation for Public Comments
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Safety Zone; Marina Del Rey, California
The Coast Guard is adding two events to the table regarding ``Southern California Annual Firework Events for the Los Angeles Long Beach Captain of the Port Zone''. The additions are temporary safety zones, one for the Marina del Rey Annual Boat Parade Fireworks Show and another for the Marina Del Rey New Year's Eve Fireworks Display. Entry into these zones is prohibited during the annual events in order to provide for the safety of the waterway users and to keep them clear of potential harmful debris within the fallout zone.
Safety Zone; Marina del Rey, California
The Coast Guard will enforce a safety zone for a recurring firework event taking place December 31, 2023, in the Los Angeles-Long Beach Captain of the Port Zone. This action is necessary and intended to provide for the safety of life and property on navigable waterways during these events. During the enforcement period, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any official patrol vessels displaying a Coast Guard ensign.
Multilayered Wood Flooring From the People's Republic of China: Preliminary Results and Partial Rescission of Countervailing Duty Administrative Review; 2021
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of multilayered wood flooring (wood flooring) from the People's Republic of China (China). The period of review (POR) is January 1, 2021, through December 31, 2021. Interested parties are invited to comment on these preliminary results of review.
Data Collection Available for Public Comments
The Small Business Administration (SBA) intends to request approval from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Evaluation of A Toolkit To Support Evidence-Based Writing Instruction in Grades 2 Through 4
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).
Establish Anchorage Ground; Port Westward Anchorage, Columbia River, Oregon and Washington
The Coast Guard is considering establishing an anchorage ground near Port Westward, Oregon in the Columbia River. We are considering this action after receiving requests suggesting that this anchorage ground is necessary to provide for the safe anchoring of commercial vessels in the navigable waters of the Lower Columbia River. We invite your comments on this proposed rulemaking.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Safety Zone; Erie Canal, North Tonawanda, NY
The Coast Guard is establishing a temporary safety zone for navigable waters within a 105-foot radius of a pedestrian bridge and the surrounding Erie Canal in North Tonawanda, NY. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Eastern Great Lakes.
Agency Information Collection Activity Under OMB Review: Foreign Medical Program (FMP) Registration Form and Claim Cover Sheet
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, 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.
Drawbridge Operation Regulation; River Rouge, Detroit, MI
The Coast Guard is altering the operations of all movable bridges over the River Rouge, Detroit, MI to improve communications and establish winter hours.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Lead and Copper Rule Revisions (LCRR) (Renewal)
The U.S. Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Lead and Copper Rule Revisions (LCRR)'' (EPA ICR Number 2606.03, OMB Control Number 2040-0297) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the LCRR ICR, which is currently approved through December 31, 2023. Public comments were previously requested via the Federal Register on July 24, 2023, during a 60-day comment period. This notice allows for an additional 30 days for public comments.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water (Renewal)
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water (EPA ICR Number 2563.02, OMB Control Number 2040-0299) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2023. Public comments were previously requested via the Federal Register on July 11, 2023 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Disposal of Coal Combustion Residuals From Electric Utilities (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Disposal of Coal Combustion Residuals from Electric Utilities, EPA ICR Number 2609.03, OMB Control Number 2050-0223 to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2023. Public comments were previously requested via the Federal Register on May 1, 2023 during a 60-day comment period.
Preventing the Improper Use of CHIPS Act Funding; Revised Definition of “Material Expansion”
The Department of Commerce (the Department), through the National Institute of Standards and Technology, is amending the definition of ``material expansion'' in the September 25, 2023 final rule, Preventing the Improper Use of CHIPS Act Funding, to clarify that the construction of new semiconductor manufacturing facilities falls within the scope of the rule.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; of the Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 information collection (IC) extension solicits comments on the information collection requirements relating to the Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042).
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-July Through September 2023
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from July through September 2023. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Notice of Availability of Software and Documentation for Licensing
Pursuant to the provisions of section 801 of Public Law 113-66 (2014 National Defense Authorization Act); the Department of the Air Force announces the availability of WIFI Distinct Native Attribute (DNA) Fingerprinting Demonstration Code, V23, dated 15 Nov 2023, to include source code (MATLAB m-files), experimentally collected WIFI data (MATLAB mat-files), and operation checking (Ops Check) documentation software and related documentation for to illustrate some basic elements of Distinct Native Attribute (DNA) fingerprinting. DNA fingerprints are extracted from radio frequency device emissions and used to discriminate (uniquely identify) specific hardware devices using machine learning (ML) techniques. The demonstrated discriminability is akin to using human fingerprints and/or human DNA to discriminate (identify) individuals. The package includes a series of folders and code for performing end-to-end DNA fingerprinting. The folders are sequentially numbered and include some experimentally collected WiFi signals; some 1D and 2D fingerprint extraction/ generation code, and some machine learning code for performing the discrimination. All of the code includes header information indicating contributing researchers and appropriate references for signals and systems where the DNA fingerprinting has been demonstrated.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040
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 the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed revision for the information collection requirements related to the State Health Insurance Assistance Program (SHIP) Client Contact Forms OMB Control Number 0985-0040.
Information Collection Being Reviewed by the Federal Communications Commission
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. 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.
Digital Low Power Television and Television Translator Stations
In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved the information collection requirements associated with the Commission's rules in a Report and Order which adopts rules to clarify for all stakeholders the status of LPTV FM6 service and codify that these services may be provided by a group of 14 existing FM6 stations, and only by those stations. This document is consistent with the Commission's Report and Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of those rules.
Review of the Commission's Assessment and Collection of Regulatory Fees; Assessment and Collection of Regulatory Fees for Fiscal Year 2023
In this document, the Federal Communications Commission (Commission) amends its rules to simplify and streamline the Commission's procedures for filing waiver, deferral, and reduction requests for regulatory fees and the procedures for filing installment payment requests for all debt owed to the Commission, including regulatory fees, to reduce administrative expenses and ensure more rapid disposition of such requests.
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