June 28, 2023 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 108
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Internal Revenue Service (IRS) Information Collection Requests
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Electronic Monitoring Systems for Atlantic Highly Migratory Species (HMS)
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 Office of Management and Budget (OMB).
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Phase II of the Richmond-San Rafael Bridge Restoration Project
NMFS has received a request from the California Department of Transportation (Caltrans) for authorization to take marine mammals incidental to Phase II of the Richmond-San Rafael Bridge Restoration Project in Richmond, CA. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.
Notice To Announce Tribal Consultation for an All of Us Research Program Update and To Discuss the Program's Policies and Protections Around Data Access and Use Statement for Fiscal Year 2023
The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH) hereby gives notice that the All of Us Research Program will be hosting a virtual Tribal Consultation with American Indian and Alaska Native (AI/AN) Federally Recognized Tribes. The consultation will include an update on our approach to Tribal engagement, discussion about integrating data from self-identified AI/ AN participants in the program's data platform, the All of Us Research Hub at https://www.researchallofus.org, and program planning.
Agency Information Collection Activities; Revision of a Currently Approved Collection: Notice of Appeal or Motion
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Bureau of Fiscal Service Information Collection Requests
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes FDA's interpretation of, and policies concerning, the statutory prohibition on wholesaling for certain compounded drugs. This draft guidance also describes examples of how FDA intends to apply the statutory wholesaling provision.
Safety Zone; Marathon July 4th Fireworks, Marathon, FL
The Coast Guard is establishing a temporary safety zone on the waters surrounding Marathon, Florida, during the Marathon July 4th Fireworks event. The safety zone will encompass a 200-yard radius on Sombrero Beach. The safety zone is necessary to ensure the safety of participant vessels, spectators, and the general public during the event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Key West or a designated representative.
Safety Zone; Key West July 4th Fireworks, Key West, FL
The Coast Guard is establishing a temporary safety zone on the waters surrounding Key West, Florida, during the Key West July 4th Fireworks event. The safety zone will include an 800-foot radius around the White Street Pier in Key West, FL. The safety zone is necessary to ensure the safety of participant vessels, spectators, and the general public during the event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Key West or a designated representative.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys Off New Jersey and New York
NMFS has received a request from Atlantic Shores Offshore Wind Bight, LLC (Atlantic Shores) for authorization to take marine mammals incidental to marine site characterization surveys offshore of New Jersey and New York in the Bureau of Ocean Energy Management (BOEM) Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS) Lease Area OCS-A 0541 and associated export cable route (ECR) area. NMFS is requesting comments on its proposal to issue an incidental harassment authorization to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met, as described in the Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.
30-Day Notice of Proposed Information Collection: State Assistance Management System (SAMS) Domestic Results Monitoring Module
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.
Notice of Availability of a Draft Programmatic Environmental Assessment
The Federal Aviation Administration announces that a Draft Programmatic Environmental Assessment for the Bipartisan Infrastructure Law-funded Airport Traffic Control Tower Replacement Program is available for public review and comment.
Agency Information Collection Activities; Revision of a Currently Approved Collection: Application To Adjust Status From Temporary to Permanent Resident
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico
In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico (GOM), notification is hereby given that a Letter of Authorization (LOA) has been issued to LLOG Exploration Company (LLOG) for the take of marine mammals incidental to geophysical survey activity in the GOM.
Agency Information Collection Activities; Comment Request; Evaluation of the Professional Learning Resources of the REL NW Toolkit for Using Technology To Support Postsecondary Student Learning
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).
Technology Advisory Committee
The Commodity Futures Trading Commission (CFTC) announces that on July 18, 2023, from 12:00 p.m. to 4:30 p.m. Eastern Daylight Time, the Technology Advisory Committee (TAC or Committee) will hold an in- person public meeting at the CFTC's Washington, DC headquarters with options for the public to attend virtually. At this meeting, the TAC will discuss digital assets and blockchain technology, cybersecurity, and emerging and evolving technologies.
Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four Abbreviated New Drug Applications for Oxandrolone Tablets
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, held by Gemini Laboratories, LLC (Gemini). Gemini voluntarily requested withdrawal of this application and waived its opportunity for a hearing. In addition, FDA is withdrawing approval of four abbreviated new drug applications (ANDAs) for oxandrolone tablets from multiple ANDA holders. Upsher-Smith Laboratories, LLC (Upsher- Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz) voluntarily requested withdrawal of their respective applications and waived their opportunity for a hearing.
Qualification of Drivers; Exemption Applications; Hearing
FMCSA announces its decision to renew exemptions for eight 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.
Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Patient-Matched Guides to Orthopedic Implants.'' This draft guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. This draft guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This draft guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review. This draft guidance is not final nor is it for implementation at this time.
Agency Information Collection Request. 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Receipt of Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Audubon's Crested Caracara, Brevard County, FL; Categorical Exclusion
We, the Fish and Wildlife Service (Service), announce receipt of an application from Malabar PO, LLC and Stellar Communities, LLC (applicants) for an incidental take permit (ITP) under the Endangered Species Act. The applicants request the ITP to take the federally listed Audubon's crested caracara (Polyborus plancus audubonii) incidental to the construction, operation, maintenance, vegetative management, and occupancy of a residential development in Brevard County, Florida. We request public comment on the application, which includes the applicants' proposed habitat conservation plan (HCP), and on the Service's preliminary determination that the proposed permitting action may be eligible for a categorical exclusion pursuant to the Council on Environmental Quality's National Environmental Policy Act (NEPA) regulations, the Department of the Interior's (DOI) NEPA regulations, and the DOI Departmental Manual. To make this preliminary determination, we prepared a draft environmental action statement and low-effect screening form, both of which are also available for public review. We invite comment from the public and local, State, Tribal, and Federal agencies.
Receipt of Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Scrub-Jay; Marion County, FL; Categorical Exclusion
We, the Fish and Wildlife Service (Service), announce receipt of an application from Richard McGinley and Marion County, Florida (Florida Crossroads Commerce Park) (applicants) for an incidental take permit (ITP) under the Endangered Species Act. The applicants request the ITP to take the federally listed Florida scrub-jay (Aphelocoma coerulescens) incidental to the construction of a warehouse, loading docks, parking lots, and associated stormwater systems within an existing industrial park, and incidental to Marion County's expansion of SW 49th Avenue in Marion County, Florida. We request public comment on the application, which includes the applicants' proposed habitat conservation plan (HCP), and on the Service's preliminary determination that the proposed permitting action may be eligible for a categorical exclusion pursuant to the Council on Environmental Quality's National Environmental Policy Act (NEPA) regulations, the Department of the Interior's (DOI) NEPA regulations, and the DOI Departmental Manual. To make this preliminary determination, we prepared a draft environmental action statement and low-effect screening form, both of which are also available for public review. We invite comment from the public and local, State, Tribal, and Federal agencies.
Information Collections Being Submitted for Review and Approval to Office of Management and Budget
As part of its continuing effort to reduce paperwork burdens, 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. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it can further reduce the information collection burden for small business concerns with fewer than 25 employees.
Information Collections 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. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid 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 Office of Management and Budget (OMB) control number.
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.'' This guidance provides recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter (OTC) animal drugs (collectively, ``promotional communications''). FDA is issuing this guidance to describe the Agency's recommendations for how manufacturers, distributors, and packers (collectively, ``firms'') that include quantitative efficacy or risk information about their drugs in DTC promotional communications can make the language and presentation more consumer-friendly. This guidance finalizes the draft guidance of the same title issued in October 2018.
Petition for Exemption; Summary of Petition Received; The Boeing Company
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the color additive petition for which we published a notice of filing in the Federal Register on May 3, 2023. In the notice, FDA requested comments on a filed color additive petition submitted by Environmental Defense Fund, et al., proposing that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
The MAFMC will hold a public joint meeting (webinar) of its River Herring and Shad (RH/S) Committee and Advisory Panel to review recent RH/S developments and develop recommendations for the MAFMC, including for the Atlantic mackerel fishery's RH/S cap.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council (Council) will hold a two-day in-person meeting of its Standing, Reef Fish, Socioeconomic, and Ecosystem Scientific and Statistical Committees (SSC).
Fisheries of the U.S. Caribbean; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
The SEDAR 87 assessment process of U.S. Caribbean yellowtail snapper and stoplight parrotfish will consist of a Data Workshop, and a series of assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.
Caribbean Fishery Management Council; Public Meeting
The Caribbean Fishery Management Council's (Council) Puerto Rico District Advisory Panel (PR-DAP) will hold a public hybrid meeting to discuss the items contained in the tentative agenda included in the SUPPLEMENTARY INFORMATION.
Caribbean Fishery Management Council's Outreach and Education Advisory Panel; Public Meeting
The Caribbean Fishery Management Council's (Council) Outreach and Education Advisory Panel (OEAP) will hold a public hybrid meeting to address the items contained in the tentative agenda included in the SUPPLEMENTARY INFORMATION.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries
The Food and Drug Administration (FDA) 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.
Intent To Establish the Tribal Advisory Committee and Solicitation of Nominations for Membership to the Committee
In accordance with section 12303 of the Agriculture Improvement Act of 2018 and the Federal Advisory Committee Act, as amended, the United States Department of Agriculture announces its intent to establish of the Tribal Advisory Committee by the Secretary of Agriculture. The Tribal Advisory Committee will advise the Secretary on matters related to Tribal and Indian affairs. The Tribal Advisory Committee will be governed by the provisions of FACA as applicable. Duration of the Tribal Advisory Committee is required by legislation to be permanent, and the Charter will be renewed biannually by the Secretary of Agriculture. This notice also solicits for nominations for membership on the Tribal Advisory Committee.
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