September 2020 – Federal Register Recent Federal Regulation Documents

The Small Business Administration (SBA) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act and OMB procedures, SBA is publishing this notice to allow all interested member of the public an additional 30 days to provide comments on the proposed collection of information.

In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Advisory Committee of State Regulators. The Advisory Committee will provide advice and recommendations on a broad range of policy issues regarding the regulation of state-chartered financial institutions throughout the United States, including its territories. The meeting is open to the public. Out of an abundance of caution related to current and potential coronavirus developments, the public's means to observe this meeting of the Advisory Committee of State Regulators will be via a Webcast live on the internet. In addition, the meeting will be recorded and subsequently made available on-demand approximately two weeks after the event. To view the live event, visit https://fdic.windrosemedia.com. To view the recording, visit https://fdic.windrosemedia.com/ index.php?category=Advisory+Committee+State+Regulators. If you require a reasonable accommodation to participate, please contact DisabilityProgram@fdic.gov or call 703-562-2096 to make necessary arrangements.

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval new information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on October 7, 2016. The collection involves the development and approval of new and revised training curriculum for certificate holders using part 121 pilot training and qualification programs.

This notice announces that the Environmental Protection Agency issued a final permit decision under Title V of the Clean Air Act (CAA) to MPLX for the operation of MPLX's Uintah County, Utah, Wonsits Valley Compressor Station.

The Federal Transit Administration (FTA) announces the opportunity to apply for approximately $6.22 million of Fiscal Year (FY) 2020 funding under the Pilot Program for Transit-Oriented Development Planning (Catalog of Federal Domestic Assistance #20.500). FTA may award additional funds if they are made available to the program prior to the announcement of project selections. As required by Federal public transportation law and subject to funding availability, funds will be awarded competitively to support comprehensive planning associated with new fixed guideway and core capacity improvement projects.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA SubmissionsAmendments and Requests for Final Approval to Tentatively Approved ANDAs.'' This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections (earliest lawful approval date). This guidance finalizes the draft guidance of the same title issued on February 1, 2019.

The National Marine Fisheries Service (NMFS) is providing notification that the agency will not identify additional fisheries to observe on the 2021 Annual Determination (AD), pursuant to its authority under the Endangered Species Act (ESA or Act). Through the AD, NMFS identifies U.S. fisheries operating in the Atlantic Ocean, Gulf of Mexico, and Pacific Ocean that will be required to take observers upon NMFS' request. The purpose of observing identified fisheries is to learn more about sea turtle bycatch in a given fishery, evaluate measures to prevent or reduce sea turtle bycatch, and implement the prohibition against sea turtle takes. Fisheries identified on the 2018 and 2020 ADs (see Table 1) remain on the AD for a 5-year period and are required to carry observers upon NMFS' request until December 31, 2022, and September 29, 2025 respectively.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic RiskQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk. Since the ICH M7 Guideline was finalized, the worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. To facilitate the implementation of the ICH M7 Guideline, the ICH M7 Implementation Working Group has developed a series of questions and answers (Q&As). The scope of this draft Q&A guidance follows that of the ICH M7 Guideline. The draft Q&A guidance is intended to clarify, promote the convergence of, and improve the harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided when developing drugs, completing marketing authorization applications, and using drug master files.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' Sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Coronavirus Disease 2019 (COVID-19)-related symptoms across subjects when designing clinical trials of drugs to treat or prevent COVID-19 in adult and adolescent outpatient subjects. To assist sponsors, this guidance describes an example with a set of common COVID-19-related symptoms as well as an approach to their measurement for use in clinical trials. Given the public health emergency presented by COVID- 19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Breast Implants Certain Labeling Recommendations to Improve Patient Communication.'' This guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel- filled breast implants. FDA is issuing this guidance to help ensure that a patient receives and understands the benefits and risks of breast implants. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of breast implants that uniquely pertain to individual patients.

The Small Business Administration (SBA) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act and OMB procedures, SBA is publishing this notice to allow all interested member of the public an additional 30 days to provide comments on the proposed collection of information.

The Department of State is publishing an update to its List of Restricted Entities and Subentities Associated with Cuba (Cuba Restricted List) with which direct financial transactions are generally prohibited under the Cuban Assets Control Regulations (CACR). The Department of Commerce's Bureau of Industry and Security (BIS) generally will deny applications to export or reexport items for use by entities or subentities on the Cuba Restricted List.

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.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

The FAA is adopting a new airworthiness directive (AD) for certain model McCauley Propeller Systems (McCauley) governors installed on airplanes. This AD was prompted by reports of an unapproved variant McCauley idler gear bearing, part number (P/N) A-20028, that could be installed in the affected governors. This AD requires replacing the governor with a governor that is eligible for installation. The FAA is issuing this AD to address the unsafe condition on these products.

The United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is proposing a revision to the method of interpretation for determining ``sample grade criteria,'' in the Bean Inspection Handbook, as it pertains to the class ``Blackeye beans,'' in the U.S. Standards for Beans under the United States Agricultural Marketing Act (AMA). Stakeholders in the dry bean processing/handling industry requested that AMS amend the definition of sample grade in the Blackeye bean inspection instructions by revising the unit of measurement for the factor Insect Webbing or Filth and removing clean-cut weevil-bore as a sample grade factor. Clean-cut weevil-bore will be considered a damage factor only. To ensure that the Blackeye bean class standard remains relevant, AMS invites interested parties to comment on whether revising the inspection instructions facilitate the marketing of Blackeye beans. This action does not revise or amend the Grade and Grade Requirements for the class Blackeye Beans in the U.S. Standard for Beans.

The United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is proposing a revision to the method of interpretation for determining ``whole peas,'' in the Pea and Lentil Inspection Handbook, as it pertains to the class ``Split Peas,'' in the U.S. Standards for Split Peas under the United States Agricultural Marketing Act (AMA). Stakeholders in the pea processing/ handling industry requested AMS to amend the interpretation of whole peas in the Split Pea inspection instructions by increasing the percent requirement for the factor whole peas. To ensure that the Split Pea class standard remains relevant, AMS invites interested parties to comment on whether revising the inspection instruction facilitates the marketing of Split Peas. This action does not revise or amend the Grade and Grade Requirements for the class Split Peas in the U.S. Standard for Split Peas.

The United States Environmental Protection Agency (EPA) announces a public meeting of the Environmental Financial Advisory Board (EFAB). The purpose of the meeting will be for the EFAB to provide advice on how the EPA can encourage private investment in Opportunity Zones, receive a briefing on the Agency's response to recent EFAB reports, receive updates on EPA activities relating to environmental finance, and consider possible future advisory topics.