May 12, 2021 – Federal Register Recent Federal Regulation Documents

This notice invites all interested parties to submit nominations to fill vacancies on the Advisory Panel on Outreach and Education (APOE). This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance clarifies, updates, and extends the guidance for industry ``E9 Statistical Principles for Clinical Trials'' issued in September 1998 in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The guidance is intended to better align the choice of statistical methods with questions of regulatory importance and so to improve the reliability of decisions about and representations of the effects of medical products. The guidance replaces the draft guidance issued on October 31, 2017.

We, the U.S. Fish and Wildlife Service, announce the availability of the draft recovery plan for rufa red knot, a bird subspecies listed as threatened under the Endangered Species Act. We request review and comment on this draft recovery plan from local, State, and Federal agencies, and the public.

The Commission has before it a petition for rulemaking filed by KTVL Licensee, LLC (Petitioner), the licensee of KTVL (CBS), channel 10, Medford, Oregon. The Petitioner requests the substitution of channel 16 for channel 10 at Medford, Oregon in the DTV Table of Allotments.

Notice is being given that the FAA is considering a request from the City of Keene to dispose of 10.3 acres of land at Dillant- Hopkins Airport, Swanzey, NH, under the provisions of 49 U.S.C. 47107(h)(2). The land is no longer needed for aviation purposes and may be disposed of by the airport. Ninety percent of the proceeds will be returned to the Federal Aviation Administration and used for a future airport grant. The remaining ten percent will be remitted to the City of Keene and placed in the airport's operation and maintenance fund. An avigation easement will be placed over the property to ensure compatibility with airport operations and airspace protection.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates 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), announce the availability of a draft habitat conservation plan (HCP) and draft categorical exclusion (CatEx) for activities described in an application for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended. The ITP would authorize take of the Santa Barbara County distinct population segment of the California tiger salamander incidental to activities associated with oil production facilities and a solar photovoltaic system near the city of Orcutt in Santa Barbara County, California. The applicant developed the draft HCP as part of their application for an ITP. The Service prepared a draft CatEx in accordance with the National Environmental Policy Act to evaluate the potential effects to the natural and human environment resulting from issuing an ITP to the applicant. We invite public comment on these documents.

The Environmental Protection Agency (EPA) is proposing to approve Michigan Department of Environment, Great Lakes, and Energy (EGLE) promulgated revisions to its Part 18 Prevention of Significant Deterioration of Air Quality rule and the Part 19 New Source Review for Major Sources Impacting Nonattainment Areas rule. The revisions made to Parts 18 and 19 were adopted to ensure consistency with Federal rule language and other parts of the Michigan air quality rules. The proposed rule changes are administrative and are intended to provide clarity to the already approved rule language.

The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the Commonwealth of Pennsylvania, on March 10, 2020. This revision pertains to the Pennsylvania Department of Environmental Protection's (PADEP) amendments to 25 Pa. Code Chapters 121 (General Provisions) and 127 (Construction, Modification, Reactivation and Operation of Sources) to implement Federal nonattainment new source review (NNSR) provisions for the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS). EPA is approving these revisions to the Pennsylvania SIP in accordance with the requirements of the Clean Air Act (CAA).

The Under Secretary for Economic Affairs requests nominations of individuals to the Federal Economic Statistics Advisory Committee. The Under Secretary for Economic Affairs in coordination with the Directors of the Department's statistical agencies, the Bureau of Economic Analysis and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics will consider nominations received in response to this notice, as well as from other sources. The SUPPLEMENTARY INFORMATION section of this notice provides Committee and membership criteria.

The Department of Commerce (Commerce) is rescinding the 2019- 2020 antidumping duty (AD) administrative review of lightweight thermal paper (LWTP) from the People's Republic of China (China) based on a timely request for withdrawal. The period of review (POR) is November 1, 2019, through October 31, 2020.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), 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.

The Susquehanna River Basin Commission will conduct its regular business meeting on June 17, 2021, from Harrisburg, Pennsylvania. Details concerning the matters to be addressed at the business meeting are contained in the Supplementary Information section of this notice. Also the Commission published a document in the Federal Register on April 13, 2021, concerning its public hearing on May 6, 2021, in Harrisburg, Pennsylvania.

NMFS is proposing to set Atlantic bluefin tuna (BFT) General category restricted-fishing days (RFDs) for the 2021 fishing year; clarify the regulations regarding applicability of RFDs to highly migratory species (HMS) Charter/Headboat permitted vessels; and correct references to the Atlantic Tunas General category permit in a section of the Atlantic HMS regulations. This proposed rule would establish RFDs for specific days during the months of July through November 2021. On an RFD, Atlantic Tunas General category permitted vessels may not fish for (including catch-and-release or tag-and-release fishing), possess, retain, land, or sell BFT. On an RFD, HMS Charter/Headboat permitted vessels with a commercial sale endorsement also are subject to these restrictions to preclude commercially for BFT under the General category restrictions and retention limits but may still fish for, possess, retain, or land BFT when fishing recreationally under applicable HMS Angling category rules.

In accordance with the Federal Advisory Committee Act, the purpose of this notice is to announce that the Election Assistance Commission (EAC) has renewed the charters for the Board of Advisors, the Standards Board, and the Technical Guidelines Development Committee for a two-year period through April 13, 2023. The Board of Advisors, the Standards Board, and the Technical Guidelines Development Committee are federal advisory committees under the Federal Advisory Committee Act and created by the Help America Vote Act of 2002.

This proposed rule would implement a recommendation from the Prune Marketing Committee (Committee) to increase the assessment rate established for the 2020-21 and subsequent crop years. The proposed assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Q3D(R2) Guideline for Elemental Impurities.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration and relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. In addition, error corrections to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route) are provided. The draft guidance is intended to recommend acceptable amounts for the listed elemental impurities in pharmaceuticals for the safety of the patient and provide recommendations for conducting a risk assessment for pharmaceutical products.