June 17, 2020 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Agriculture, Forest Service, is giving notice of intent to issue an order closing the Beattie Gulch Trailhead and McConnell Fishing Access areas north and west of Gardiner, Montana to the discharge of firearms in advance of the public comment period for the proposed closure. At the end of the notice of intent period, the Forest Service will solicit public comments, as specified in this notice, on the proposed forest order.

NMFS is opening the Summer Herring Savings Area 2 in the Bering Sea subarea of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent the underharvest of the 2020 pollock total allowable catch (TAC) and facilitate pollock harvest by the American Fisheries Act (AFA) inshore sector, AFA mothership sector, and Community Development Quota (CDQ) program in the Bering Sea subarea of the BSAI.

NMFS and the Assessment Oversight Panel will convene the Management Track Assessment Peer Review Meeting for the purpose of reviewing Atlantic Herring, Butterfish, Atlantic Surf Clam, and Longfin Inshore Squid. The Management Track Assessment Peer Review is a formal scientific peer-review process for evaluating and presenting stock assessment results to managers for fish stocks in the offshore U.S. waters of the northwest Atlantic. Assessments are prepared by Stock Assessment Workshop (SAW) working groups and reviewed by an independent panel of stock assessment experts called the Assessment Oversight Panel (AOP). The public is invited to attend the presentations and discussions between the review panel and the scientists who have participated in the stock assessment process.

On June 9, 2020, the Department of Commerce, published a 30- day public comment period notice in the Federal Register with FR Document Number 2020-12413 (Pages 35257-35258), and on March 24, 2020, published a 60-day public comment period notice with FR Document Number 2020-06174 (Page 16612) seeking public comments for an information collection entitled, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' This document referenced incorrect information in the DATA section, and Commerce hereby issues a correction notice as required by the Paperwork Reduction Act of 1995.

Free Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops will be held in July, August, and September of 2020. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2020 and will be announced in a future notice.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 9, 2020. The document announced the withdrawal of approval (as of April 8, 2020) of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following four ANDAs after receiving a withdrawal request from Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202: ANDA 065488, Azithromycin Oral Suspension, Equivalent to (EQ) 100 milligrams (mg) base/5 milliliters (mL); EQ 200 mg base/5 mL; ANDA 078410, Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg; ANDA 090441, Imipramine Hydrochloride Tablets, 10 mg, 25 mg, and 50 mg; and ANDA 200563, Ciprofloxacin Oral Suspension, 250 mg/5 mL and 500 mg/5 mL. Before FDA withdrew the approval of these ANDAs, Lupin Pharmaceuticals, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Lupin Pharmaceuticals, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 065488, 078410, 090441, and 200563 is still in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry.'' The revised guidance provides blood establishments that collect blood and blood components with FDA's recommendations to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk. The guidance announced in this notice supersedes the guidance entitled ``Recommendations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry'' dated August 2013 and updated August 2014.

This notice informs the public that the Assistant Secretary Indian Affairs proclaimed approximately 114 acres, more or less, an addition to the reservation of the Shakopee Mdewakanton Sioux Community of Minnesota on June 3, 2020.

This notice announces that the Model Tribal Gaming Compact between the United Keetoowah Band of Cherokee Indians in Oklahoma and the State of Oklahoma (Compact), and the Extension of State-Tribal Gaming Compact between the State Of Oklahoma and the United Keetoowah Band of Cherokee Indians in Oklahoma (Extension), are taking effect.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Ohio Advisory Committee (Committee) will hold a series of web based hearings to hear testimony regarding COVID-19 and health disparities in the state.

This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the ACVETEO. The ACVETEO will discuss the DOL core programs and services that assist veterans seeking employment and raise employer awareness as to the advantages of hiring veterans. There will be an opportunity for individuals or organizations to address the committee. Any individual or organization that wishes to do so should contact Mr. Gregory Green at 202-693-4734. Additional information regarding the Committee, including its charter, current membership list, annual reports, meeting minutes, and meeting updates may be found at https://www.dol.gov/agencies/vets/about/advisorycommittee. Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistive listening devices, and/or materials in alternative format) should notify the Advisory Committee no later than Monday, July 13, 2020 by contacting Mr. Gregory Green at 202-693-4734. Requests made after this date will be reviewed, but availability of the requested accommodations cannot be guaranteed. The meeting site is accessible to individuals with disabilities. This Notice also describes the functions of the ACVETEO. Notice of this meeting is required under Section 10(a) (2) of the Federal Advisory Committee Act. This document is intended to notify the general public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.'' The guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The guidance finalizes the draft guidance of the same title dated January 2020, and supersedes the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry,'' dated May 2010, and updated January 2016.

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.'' The revised guidance provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to their donor educational materials, donor history questionnaires, and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance also incorporates certain other recommendations related to donor educational materials. The guidance announced in this notice supersedes the guidance of the same title dated December 2015.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.'' This guidance is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on June 13, 2018.

On November 29, 1999, the President signed into law the Patent and Trademark Office Efficiency Act (``1999 Act''), which, among other things, established two Public Advisory Committees to review the policies, goals, performance, budget, and user fees of the United States Patent and Trademark Office (USPTO) with respect to patents, in the case of the Patent Public Advisory Committee, and trademarks, in the case of the Trademark Public Advisory Committee, and to advise the Director on these matters (now codified in the United States Code). The America Invents Act Technical Corrections Act made several amendments to the 1999 Act, including the requirement that the terms of the USPTO Public Advisory Committee members be realigned by 2014 so that December 1 would be used as the start and end date, with terms staggered so that each year, three existing terms expire and three new terms begin on December 1. With this notice, the USPTO is requesting nominations for up to three members of the Patent Public Advisory Committee and for up to three members of the Trademark Public Advisory Committee, for terms of three years beginning on December 1, 2020.

NMFS has received a revised application from Virginia Electric and Power Company, D.B.A. Dominion Virginia Power for an incidental take permit, pursuant to the Endangered Species Act for activities associated with the otherwise lawful continued operation and maintenance of the Dominion Chesterfield Power Station in Chesterfield, VA. We are publishing this notice to inform the public that we are considering issuing a 5-year permit to the applicant that would authorize take of Atlantic sturgeon (Acipenser oxyrinchus oxyrinchus) from the Chesapeake Bay.

EIA reinstates the Residential Energy Consumption Survey (RECS), with changes, under OMB Control Number 1905-0092, as required by the Paperwork Reduction Act of 1995. RECS collects data on energy characteristics, consumption, and expenditures for the residential sector of the United States. This collection is comprised of five forms including: Form EIA 457-A Household Survey, Form EIA 457-D Energy Supplier Survey: Household Propane Usage, Form EIA 457-E Energy Supplier Survey: Household Electricity Usage, Form EIA 457-F Energy Supplier Survey: Household Natural Gas Usage, and Form EIA 457-G Energy Supplier Survey: Household Fuel Oil/Kerosene Usage.

Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

The EAC Office of Grants Management (EAC/OGM) is responsible for distributing, monitoring, and providing technical assistance to states and grantees on the use of Federal funds. EAC/OGM also reports on how the funds are spent, negotiates indirect cost rates with grantees, and resolves audit findings on the use of Help America Vote Act (HAVA) funds. The EAC-PR has been developed for both interim and final progress reports for grants issued under HAVA authority. EAC received emergency clearance of its Coronavirus Aid, Relief and Economic Security (CARES) Act report form due to the public health emergency posed by COVID19. This format builds upon that report for the separate grant awards given by EAC.