2020 – Federal Register Recent Federal Regulation Documents
Results 3,651 - 3,700 of 27,998
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Revised Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017,'' which supersedes the now withdrawn final guidance issued in May 2018 (May 2018 guidance). This revised final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017. In particular, this revised final guidance removes section VI.B. contained in the May 2018 guidance, regarding the ``same product as another product'' prescription drug program fee exception for certain prescription drug products under the Federal Food, Drug, and Cosmetic Act.
Notice of a Federal Advisory Committee Meeting Manufactured Housing Consensus Committee
This notice sets forth the schedule and proposed agenda for the Technical System Subcommittee teleconference meeting of the MHCC. The meeting is open to the public. The agenda for the meeting provides an opportunity for citizens to comment on the business before the MHCC Subcommittee.
Polyethylene Terephthalate Film, Sheet, and Strip From the United Arab Emirates: Preliminary Results of Antidumping Duty Administrative Review; 2018-2019
The Department of Commerce (Commerce) preliminarily finds that Flex Middle East FZE (Flex), the sole producer/exporter subject to this administrative review, has made sales of subject merchandise at less than normal value. Interested parties are invited to comment on these preliminary results.
Holtec Decommissioning International, LLC; Indian Point Nuclear Generating Unit Nos. 1, 2, and 3
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an exemption in response to the February 12, 2020, request from Holtec Decommissioning International, LLC (HDI) related to Indian Point Nuclear Generating Unit Nos. 1, 2, and 3 (referred to individually as IP1, IP2, and IP3, respectively, and collectively as the Indian Point Energy Center or IPEC), located in Westchester County, New York. The exemption would permit HDI to use funds from the IP1, IP2, and IP3 nuclear decommissioning trusts (NDTs) for spent fuel management and site restoration activities for IP1, IP2, and IP3, respectively. The exemption would also allow such withdrawals without prior notification to the NRC. The NRC staff is issuing an Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) associated with the proposed exemption.
Privacy Act of 1974; System of Records
The OSD is modifying the system of records, ``Employer Support of the Guard and Reserve Member Management System (MMS),'' DHRA 17 DoD. The MMS allows the Employer Support of the Guard and Reserve (ESGR) to maintain a roster of and facilitate communication between ESGR members, as well as track individual training and volunteer efforts. Volunteer leadership can securely access training records of members to adjust resources as necessary to ensure adequate training among volunteer team members. This system of records notice (SORN) is being revised to expand the category of individuals covered by the system. Additional administrative changes were made to update the SORN in accordance with the OMB's requirements.
Submission for OMB Review; Preaward Survey Forms (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408)
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve a revision and renewal of a previously approved information collection requirement regarding preaward survey forms.
Submission for OMB Review; Prospective Subcontractor Requests for Bonds
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve a revision and renewal of a previously approved information collection requirement regarding prospective subcontractor requests for bonds.
Privacy Act of 1974; System of Records
FMC-40 The Service Contract Filing System (SERVCON) is the Federal Maritime Commission's (Commission's) automated filing system for service contracts. Shippers or vessel-operating common carriers (VOCCs) are required to file service contracts with the Commission on form FMC-83. This system is not being discontinued, however, SERVCON does not meet the requirements of a Privacy Act System of Records as it does not maintain ``records'' as defined under the Privacy Act (PA), that are ``about'' an individual.
Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States
This rule announces the approval of, and regulations to implement, an action to require commercially permitted vessels in both the New England and Mid-Atlantic Fishery Management Council regions to submit vessel trip reports electronically within 48 hours of the end of a trip. This action will also require for-hire vessels with permits for species managed by the New England Fishery Management Council to submit vessel trip reports electronically within 48 hours of the end of a trip. Document retention requirements will be removed with this action. This action is intended to increase data quality and timeliness of vessel trip reports.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; National Survey of Children's Health
The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the proposed revision of the National Survey of Children's Health, prior to the submission of the information collection request (ICR) to OMB for approval.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Impact Study of Federally-Funded Magnet Schools
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of a currently approved collection.
Marine Mammals; File No. 23554
Notice is hereby given that Colleen Reichmuth, Ph.D., Long Marine Laboratory, Institute of Marine Sciences Address at the University of California at Santa Cruz, 115 McAllister Way, Santa Cruz, CA 95060, has applied in due form for a permit to conduct research on pinnipeds in captivity.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Acquisition and Sustainment announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Monosodium Glutamate From the Republic of Indonesia: Final Results of Antidumping Duty Administrative Review; 2017-2018
The Department of Commerce (Commerce) determines that the sole mandatory respondent, PT. Cheil Jedang Indonesia (CJ Indonesia), did not sell subject merchandise in the United States at prices below normal value during the period of review (POR) November 1, 2017 through October 31, 2018.
Passenger Vehicle and Light Truck Tires From the Socialist Republic of Vietnam: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of passenger vehicle and light truck tires (passenger tires) from the Socialist Republic of Vietnam (Vietnam). The period of investigation is January 1, 2019 through December 31, 2019. Interested parties are invited to comment on this preliminary determination.
Environmental Management Site-Specific Advisory Board, Savannah River Site
This notice announces an online virtual meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act requires that public notice of this online virtual meeting be announced in the Federal Register.
Record of Decision for Final Environmental Impact Statement for Remediation of Area IV and the Northern Buffer Zone of the Santa Susana Field Laboratory, California
The U.S. Department of Energy (DOE) announces its decision to initiate groundwater remediation in Area IV of the Santa Susana Field Laboratory (SSFL). DOE-EM will implement the preferred alternatives for groundwater remediation identified in the SSFL Area IV Final Environmental Impact Statement (EIS), with the exception of Building 4100/Building 56 Landfill Trichloroethylene (TCE) Plume, for which DOE will implement monitored natural attenuation. This alternative is a combination of the Treatment Alternative and the Monitored Natural Attenuation Alternative. This action will be taken in accordance with applicable federal, state, and local laws and regulations, and approvals made by the California Department of Toxic Substances Control (DTSC). This action will also be taken consistent with agreements and decisions resulting from interagency consultations conducted in accordance with applicable federal, state, and local laws and regulations, including the Programmatic Agreement executed with the California State Historic Preservation Officer pursuant to the National Historic Preservation Act and the Biological Opinion issued by the U.S. Fish and Wildlife Service pursuant to the Endangered Species Act.
Petitions for Modification of Application of Existing Mandatory Safety Standards
This notice is a summary of two petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
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.
Meeting of the National Drinking Water Advisory Council
The U.S. Environmental Protection Agency's (EPA) Office of Ground Water and Drinking Water is announcing a virtual meeting of the National Drinking Water Advisory Council (NDWAC or Council) as authorized under the Safe Drinking Water Act (SDWA). The purpose of the meeting is to allow EPA to present an overview of Safe Drinking Water Act programs for fiscal year 2021 and to receive input from Council members. Additional details will be provided in the meeting agenda, which will be posted on EPA's website at https://www.epa.gov/ndwac prior to the meeting.
60-Day Notice of Proposed Information Collection: FLO Professional Development Fellowship (PDF) Application
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
Notice of Correction
The Court Services and Offender Supervision Services for the District of Columbia (CSOSA) is correcting a notice published in the October 30, 2020 issue of the Federal Register (Notice) entitled SES Performance Review Board (PRB). This correction applies to the misspelling of the name of a PRB member.
Performance Review Board Membership
Notice is given of the names of members of a Performance Review Board for the Department of the Army.
Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enhancing the Diversity of Clinical Trial PopulationsEligibility Criteria, Enrollment Practices, and Trial Designs.'' This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials. This guidance is being issued, in part, to satisfy the mandates of the FDA Reauthorization Act of 2017 (FDARA). This guidance finalizes the draft guidance of the same title issued on June 7, 2019.
Public Availability of the Securities and Exchange Commission's FY 2016 and FY 2017 Service Contract Inventory
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), SEC is publishing this notice to advise the public of the availability of the FY2017 Service Contract Inventory (SCI) and the FY2016 SCI Analysis along with the FY2018 Service Contract Inventory (SCI) and the FY2017 SCI Analysis. The SCI provides information on FY2016 and FY2017 actions over $150,000 for service contracts. The inventory organizes the information by function to show how SEC distributes contracted resources throughout the agency. SEC developed the inventory per the guidance issued on January 17, 2017 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/mem oranda/ 2017/service_contract_inventories.pdf. The Service Contract Inventory Analysis for FY2016 provides information based on the FY 2016 Inventory and the Service Contract Inventory Analysis for FY2017 provides information based on the FY 2017 Inventory. Please note that the SEC's FY 2016 and FY 2017 Service Contract Inventory data is now included in government-wide inventory available on www.acquisition.gov. The government-wide inventory can be filtered to display the inventory data for the SEC. The SEC has posted its FY 2017 and FY2018 plans for analyzing data, a link to the FY 2017 and 2018 government-wide Service Contract Inventory, the FY 2016 SCI Analysis, and the FY 2017 SCI Analysis on the SEC's homepage at https:// www.sec.gov/about/secreports.shtml and https://www.sec.gov/open.
Proposed Amendment of Class E Airspace; Kankakee, IL
This action proposes to amend the Class E airspace extending upward from 700 feet above the surface at Greater Kankakee Airport, Kankakee, IL. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Kankakee VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program.
Airworthiness Directives; Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235- 200, CN-235-300 airplanes and Model C-295 airplanes. This proposed AD was prompted by cracks found on certain left- and right-hand stringers in a certain area of the fuselage. This proposed AD would require repetitive inspections for cracking or broken rivets of certain left- and right-hand stringers and surrounding structure, and repair if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Military Reservist Economic Injury Disaster Loans; Interest Rate for First Quarter FY 2021
This is a notice of the Military Reservist Economic Injury Disaster Loans interest rate for loans approved on or after October 30, 2020.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed; Approval of Information Collection: General Aviation and Part 135 Activity Survey
The FAA's primary requirement is for annual hours flown, optimal determination of sample size is based on flight time variation by state and aircraft type, and a sampling fraction is determined for each cell with a no-zero population. Sample units are selected randomly within each stratum. Respondents to this survey are owners of general aviation aircraft. This information is used by FAA, NTSB, and other government agencies, the aviation industry, and others for safety assessment, planning, forecasting, cost/benefit analysis, and to target areas for research.
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