August 11, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to Atlantic Shores Offshore Wind Bight, LLC (Atlantic Shores) to incidentally harass, by Level B harassment only, marine mammals during marine site characterization survey activities offshore of New Jersey and New York.

The Coast Guard is establishing a temporary safety zone for all waters of the Alameda Estuary, from surface to bottom, within 250 feet of the pier along the southwest side of Coast Guard Island in support of a munitions transfer on August 13, 2023. The safety zone is necessary to protect personnel, vessels, and the marine environment from the dangers associated with live munitions. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port San Francisco.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.'' The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically under- represented patient populations in clinical trials.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Skate 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.

The Coast Guard is canceling the temporary deviation concerning the Florida East Coast (FEC) Railroad Bridge, mile 7.41, and the NW Dixie Highway Bridge, mile 7.5, across the Okeechobee Waterway (OWW), at Stuart, Florida. The cancellation will allow the Coast Guard to review and adjudicate the comments posted to determine whether this temporary deviation would meet the safe and reasonable needs of navigation while taking into consideration competing modes of transportation.

This notice announces that the Secretary of Homeland Security (Secretary) has authorized updates to modernize Haitian Family Reunification Parole (HFRP). HFRP provides a lawful, safe, and orderly pathway for certain Haitians to seek parole into the United States, allowing them to reunite with family as they wait for their immigrant visas to become available so they may apply to adjust status to lawful permanent resident (LPR). The Secretary has authorized these updates to HFRP in light of technological advancements and process efficiencies created since the HFRP's inception in 2014. Every step of the updated process will be completed online with the exception of a medical exam by a panel physician and the parole determination made upon arrival at an interior U.S. port of entry (POE).

The Food and Drug Administration (FDA or Agency) has determined that ANJESO (meloxicam) solution, 30 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for meloxicam solution, 30 mg/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biosimilar products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This draft guidance for industry revises and replaces the draft guidance of the same name issued in June 2018.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VERCISE GENUS DEEP BRAIN STIMULATION SYSTEM (VERCISE GENUS DBS SYSTEM) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Cancer Institute, both institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to EnZeta Immunotherapies, Inc. of the State of Delaware.

The National Merchant Marine Personnel Advisory Committee (Committee) will conduct a series of meetings over two days in Bronx, NY to discuss issues relating to personnel in the United States Merchant Marine including the training, qualifications, certification, documentation, and fitness of mariners.

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission seeks comments concerning gathering insights from customers and stakeholders about their perceptions, experiences, and expectations that can improve the marketing and outreach of the Agency's services and programs.

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.

The Department of the Treasury is hosting its fiscal year 2023 quarter 4 meeting of the Treasury Advisory Committee on Racial Equity (``TACRE'' or ``Committee''). The Committee is composed of 25 members who will provide information, advice, and recommendations to the Department of the Treasury on matters relating to the advancement of racial equity. This notification provides the date, time, and location of the meeting and the process for participating and providing comments.

The U.S. Copyright Office is issuing a final rule establishing procedures governing ex parte communications with the Office. This final rule adopts regulatory language set forth in the Office's February 2023 notice of proposed rulemaking with some modifications in response to public comments. The rule defines ex parte communications, provides instructions on how to request an ex parte meeting, sets forth the parties' responsibilities after an ex parte meeting, and explains how non-compliant communications will be treated.

We are proposing to update and amend the user fee regulations associated with the agricultural quarantine and inspection (AQI) program. Specifically, we propose to adjust the fees for certain AQI services that are provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States; adjust the caps on prepaid fees associated with commercial trucks and commercial railroad cars; remove certain fee exemptions that are no longer justifiable based upon pathway analyses of risk; and restructure the treatment monitoring fee. We would also revise requirements pertaining to remittances and statements. Specifically, we would require monthly rather than quarterly remittances for the commercial aircraft fee, international air passenger fee, and international cruise passenger fee to make our revenue stream more stable, clarify our requirements, and provide for electronic payments and statements. We would also include in the regulations information on agents responsible for ensuring compliance with paying the user fees and the requirement for entities to notify APHIS in the event they have a change in personnel responsible for fee payments. These proposed changes are necessary to recover the costs of the current level of AQI activity, to account for actual and projected increases in the cost of doing business, to increase fee payer accountability, and to more accurately align fees with the costs associated with each fee service.

The Environmental Protection Agency (EPA) is proposing to approve a portion of a State Implementation Plan (SIP) revision submitted by the Florida Department of Environmental Protection (FDEP) on April 1, 2022, for the purpose of removing several rules from the Florida SIP. EPA is proposing to remove the State's Clean Air Interstate Rule (CAIR) rules from the Florida SIP as well as several Reasonably Available Control Technology (RACT) rules for particulate matter (PM) because these rules have become obsolete. The State has provided a non-interference demonstration to support the removal of these rules from the Florida SIP pursuant to the Clean Air Act (CAA or Act).

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

We, the U.S. Fish and Wildlife Service (Service or USFWS), propose to remove the Apache trout (Oncorhynchus apache), a fish native to Arizona, from the Federal List of Endangered and Threatened Wildlife due to recovery. Our review of the best available scientific and commercial data indicates that the threats to the species have been eliminated or reduced to the point that the species no longer meets the definition of a threatened species or an endangered species under the Endangered Species Act of 1973, as amended (Act). If we finalize this rule as proposed, the prohibitions and conservation measures provided by the Act, particularly through section 7 and our regulations would no longer apply to the Apache trout. We request information and comments from the public regarding this proposed rule for the Apache trout.