November 10, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 89
Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of July 15, 2020. In that notice, FDA requested comments on draft guidance for industry (GFI) #61 entitled ``Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.'' FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Evaluating the DC Opportunity Scholarship Program After the 2017 Reauthorization; Correction
On November 5, 2020, the U.S. Department of Education published a 60-day comment period notice in the Federal Register with FR DOC# 2020-24608 (Page 70596, First Column, Second Column; Page 70597, First Column) seeking public comment for an information collection entitled, ``Evaluating the DC Opportunity Scholarship Program After the 2017 Reauthorization.'' The docket number is incorrect. The correct docket number is ED-2020-SCC-0173. The PRA Coordinator, Strategic Collections and Clearance, Office of the Chief Data Officer, Office of Planning, Evaluation and Policy Development, hereby issues a correction notice as required by the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send 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.
Proposed Agency Information Collection Activities; Comment Request
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On August 24, 2020, FRA published a notice providing a 60-day period for public comment on the ICR.
Regulatory Considerations for Microneedling Products; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Regulatory Considerations for Microneedling Products.'' This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document also provides information on the regulatory pathway to market for microneedling devices for aesthetic use.
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.
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