September 9, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORILISSA 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 patents which claim that human drug product.

The U.S. Department of Commerce (Commerce) preliminarily finds that Hangzhou Ailong Metal Products Co., Ltd. (Ailong) made sales of subject merchandise at prices below normal value (NV). The period of review (POR) is August 1, 2020, through July 31, 2021. Interested parties are invited to comment on these preliminary results.

The U.S. Department of Commerce (Commerce) determines that carbon and alloy steel threaded rod (steel threaded rod) from India is not being sold in the United States at below normal value. The period of review (POR) is September 25, 2019, through March 31, 2021.

The Trinity County Resource Advisory Committee (RAC) will hold two virtual meetings by phone and/or video conference. The committee is authorized under the Secure Rural Schools and Community Self- Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act, as well as make recommendations on recreation fee proposals for sites on the Shasta-Trinity National Forest within Trinity County, consistent with the Federal Lands Recreation Enhancement Act. RAC information and virtual meeting information can be found at the following website: https://www.fs.usda.gov/main/stnf/ workingtogether/advisorycommittees.

The Coconino Resource Advisory Committee (RAC) will hold a public meeting according to the details shown below. The committee is authorized under the Secure Rural Schools and Community Self- Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act (FACA). The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act, as well as make recommendations on recreation fee proposals for sites on the Coconino National Forest, consistent with the Federal Lands Recreation Enhancement Act. General information and meeting details can be found at the following website: https://tinyurl.com/mth7duwz.

Baby Trend, Inc., (BT), has determined that certain BT Hybrid 3-in-1 Combination Booster Seat child restraint systems (CRSs) do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 213, Child Restraint Systems. BT filed an original noncompliance report dated July 6, 2022. BT subsequently petitioned NHTSA on August 1, 2022, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety. This document announces receipt of BT's petition.

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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections related to general drug product labeling and to over-the-counter (OTC) Monograph Drug User Fee (OMUFA) submissions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Statement of Identity and StrengthContent and Format of Labeling for Human Nonprescription Drug Products.'' This draft guidance provides recommendations for the content and format of the required statement of identity on the labeling of human nonprescription drug products. This draft guidance also provides recommendations on the inclusion of the drug product's strength on the labeling. The recommendations in this draft guidance are intended to help manufacturers, packers, distributors, applicants, relabelers, and sponsors ensure consistent content and format of the statement of identity and strength for all human nonprescription drug products. Consistent content and format of the statement of identity and strength may aid consumers in comparing nonprescription drug products and assist consumers in appropriate self-selection.

In this document, the Federal Communications Commission (FCC or Commission) hereby announces that the charter of the Disability Advisory Committee (hereinafter Committee) will be renewed for a two- year period pursuant to the Federal Advisory Committee Act (FACA) and following consultation with the Committee Management Secretariat, General Services Administration.

In accordance with the Privacy Act of 1974, as amended (``Privacy Act''), this document announces a new computer matching program the Federal Communications Commission (``FCC'' or ``Commission'' or ``Agency'') and the Universal Service Administrative Company (USAC) will conduct with the Colorado Governor's Office of Information Technology. The purpose of this matching program is to verify the eligibility of applicants to and subscribers of Lifeline, and the Affordable Connectivity Program (ACP), both of which are administered by USAC under the direction of the FCC. More information about these programs is provided in the SUPPLEMENTARY INFORMATION section below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products.'' To facilitate FDA's internal tracking of submissions to the Agency that include real-world data (RWD) and real- world evidence (RWE), this guidance encourages sponsors and applicants to identify in their submission cover letters certain uses of RWD/RWE. This guidance does not address FDA's substantive review of the RWD/RWE submitted as part of the Agency's standard review process. This guidance finalizes the draft guidance entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics'' issued on May 9, 2019.

On August 29, 2022, the U.S. Court of International Trade (the Court or CIT) issued its final judgment in SeAH Steel Corporation v. United States, Consol. Court No. 20-00150, Slip Op. 22-101, sustaining the U.S. Department of Commerce's (Commerce) remand results pertaining to the administrative review of the antidumping duty (AD) order on certain oil country tubular goods (OCTG) from the Republic of Korea (Korea) covering the period September 1, 2017, through August 31, 2018. Commerce is notifying the public that the CIT's final judgment is not in harmony with Commerce's Final Results of the administrative review, and that Commerce is amending the Final Results with respect to the dumping margin assigned to SeAH Steel Corporation (SeAH).

The FAA is publishing this notice to solicit nominations for membership on the ODA for Transport Airplanes Expert Review Panel (``Review Panel'').

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) proposes a new information collection.

The Agricultural Marketing Service (AMS) is providing additional time for the public to submit comments and information that will inform policy development and future rulemaking proposals regarding the use of poultry grower ranking systems commonly known as tournaments in contract poultry production. AMS seeks this input in response to numerous complaints from poultry growers about the use of tournament systems. Comments in response to this request would help AMS tailor further rulemaking in addition to that already planned and under way to address specific industry practices in relation to tournament systems.

The Environmental Protection Agency has submitted an information collection request (ICR), Gathering Data on Results of Annual and Triennial Testing to Evaluate the Impacts of EPA's 2015 Federal Underground Storage Tank Regulation (EPA ICR Number 2650.02, OMB Control Number 2050-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the Federal Register on June 2, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

This action adds service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``The First Homosexuals: Global Depictions of a New Identity, 1869-1930'' by Alphawood Foundation, through its subsidiary Alphawood Exhibitions LLC, at the Wrightwood 659 Gallery, Chicago, Illinois, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``A Splendid Land: Paintings from Royal Udaipur'' at the Arthur M. Sackler Gallery, Smithsonian Institution, Washington, District of Columbia; at the Cleveland Museum of Art, Cleveland, Ohio; and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

NMFS announces a public meeting of the Permanent Advisory Committee (PAC) to advise the U.S. Commissioners to the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC) on October 27-28, 2022. Meeting topics are provided under the SUPPLEMENTARY INFORMATION section of this notice.

In accordance with the Federal Advisory Committee Act, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel (ASAP).