March 1, 2023 – Federal Register Recent Federal Regulation Documents

Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 and Drug Enforcement Administration's (DEA) implementing regulations, after a patient and a practitioner have had an in-person medical evaluation, that practitioner may use telehealth to prescribe that patient any prescription for a controlled medication that the practitioner deems medically necessary. The Ryan Haight Act and DEA's implementing regulations do not apply to other forms of telemedicine, telehealth, or telepsychiatry that are not otherwise addressed in the Controlled Substances Act. This proposed rule applies only in limited circumstances when the prescribing practitioner wishes to prescribe controlled medications via the practice of telemedicine and has not otherwise conducted an in-person medical evaluation prior to the issuance of the prescription.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug Products.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and life-cycle management of CM. The guidance replaces the draft guidance entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug Products'' issued on October 14, 2021. This guidance also replaces the draft guidance entitled ``Quality Considerations for Continuous Manufacturing'' issued on February 27, 2019.

The Coast Guard is establishing a temporary safety zone for certain navigable waters in the Aransas Bay. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a firework display launched from a barge in the Aransas Bay, Corpus Christi, Texas. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Corpus Christi or a designated representative.

New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities.

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committees regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with accrediting nongovernment facilities to perform services related to the export of plants or plant products.

The Assistant SecretaryIndian Affairs made a final agency determination to acquire in trust 269.543 acres, more or less, of land located within the Nation's Reservation, in Madison County and Oneida County, New York, for the Oneida Indian Nation (Nation or OIN) for gaming and other purposes.

In accordance with the Environmental Protection Agency (EPA) Administrator's March 18, 2022, memorandum regarding ``Consent Decrees and Settlement Agreements to resolve Environmental Claims Against the Agency,'' notice is hereby given of a proposed consent decree in Cape Fear River Watch et al., v. United States Environmental Protection Agency, No. 1:22-cv-03809 (D. D.C). On December 23, 2022, Plaintiffs Cape Fear River Watch, Rural Empowerment Association for Community Help, Waterkeepers Chesapeake, Waterkeeper Alliance, Humane Society of the United States, Food & Water Watch, Environment America, Comite Civico del Valle, Center for Biological Diversity, and Animal Legal Defense Fund (collectively, ``Plaintiffs'') filed a complaint against the EPA alleging that the Agency had failed to perform duties mandated by the Clean Water Act (``CWA'') to revise the effluent limitations guidelines (``ELGs'') and promulgate pretreatment standards for the Meat and Poultry Products (``MPP'') industrial category, after EPA had determined that such revised ELGs and standards were appropriate. EPA seeks public input on a proposed consent decree prior to its final decision-making with regard to potential settlement of the litigation.

The U.S. Department of Housing and Urban Development (HUD) is publishing this proposed rule to revise HUD's regulations for branch office registration requirements. To make mortgage industry standards more flexible and modernized, the proposed rule would remove the requirement that lenders and mortgagees register with HUD each branch office where they conduct Federal Housing Administration (FHA) business.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

VBA, Department of Veterans Affairs, is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs (VA), 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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYZULTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

NMFS is prohibiting directed fishing for Pacific cod by vessels using pot gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2023 total allowable catch (TAC) of Pacific cod by vessels using pot gear in the Central Regulatory Area of the GOA.

The Food and Drug Administration (FDA or the Agency) 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.

The Food and Drug Administration (FDA or Agency) is announcing publication of a discussion paper providing information for stakeholders and soliciting public comments on a specific area 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 application of artificial intelligence (AI) to pharmaceutical manufacturing. The discussion paper includes a series of questions to stimulate feedback from the public, including CDER and the Center for Biologics Evaluation and Research (CBER) stakeholders.

The SEDAR 82 assessment of the South Atlantic stock of gray triggerfish will consist of a data workshop, a series of assessment webinars, and a review workshop. A SEDAR 82 Assessment Webinar I is scheduled for March 22, 2023. See SUPPLEMENTARY INFORMATION.

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.

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.

In accordance with the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) is automatically initiating the five-year reviews (Sunset Reviews) of the antidumping and countervailing duty (AD/CVD) order(s) and suspended investigation(s) listed below. The International Trade Commission (the ITC) is publishing concurrently with this notice its notice of Institution of Five-Year Reviews which covers the same order(s) and suspended investigation(s).