October 6, 2021 – Federal Register Recent Federal Regulation Documents
Results 101 - 114 of 114
Use of Real-World Data and Real-World Evidence To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #266 entitled ``Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.'' The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #265 entitled ``Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.'' The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act.
Airworthiness Directives; General Electric Company Turbofan Engines
The FAA proposes to supersede Airworthiness Directive (AD) 2020-20-13, which applies to certain General Electric Company (GE) CF6- 80A and CF6-80C model turbofan engines. AD 2020-20-13 requires ultrasonic inspection (UI) of high-pressure turbine (HPT) stage 1 and stage 2 disks and replacement of any HPT stage 1 or stage 2 disk that fails the inspection. Since the FAA issued AD 2020-20-13, the manufacturer determined that the requirement to perform UI of affected HPT stage 1 and stage 2 disks should be expanded to include an additional population of affected HPT stage 1 and stage 2 disks. This proposed AD would retain the required UI while expanding the population of affected HPT stage 1 and stage 2 disks. The FAA is proposing this AD to address the unsafe condition on these products.
Amendment of Class D and Class E Airspace; Portsmouth, NH
This action amends Class D airspace and Class E airspace for Portsmouth International Airport at Pease, Portsmouth, NH, due to the decommissioning of the PEASE Very High Frequency Omnidirectional Range Collocated with Distance Measuring Equipment (VOR/DME) and cancellation of the standard instrument associated approach procedures (SIAPs). This action also updates the airport's name and geographic coordinates. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.
Air Plan Approval; MS; BART SIP and Regional Haze Progress Report
The Environmental Protection Agency (EPA) is approving two Mississippi State Implementation Plan (SIP) revisions from the Mississippi Department of Environmental Quality (MDEQ) dated October 4, 2018, and August 13, 2020. The October 4, 2018, SIP revision contains the State's first periodic report describing progress towards reasonable progress goals (RPGs) established for regional haze and contains the associated determination that the State's regional haze SIP is adequate to meet these RPGs for the first implementation period (Progress Report). The August 13, 2020, SIP revision addresses best available retrofit technology (BART) determinations for 14 electric generating units (EGUs) (BART SIP). These EGUs were initially addressed in EPA's prior limited approval and limited disapproval actions on Mississippi's regional haze SIP because of deficiencies arising from the State's reliance on the Clean Air Interstate Rule (CAIR) to satisfy certain regional haze requirements. EPA is approving the BART SIP and finds that it corrects the deficiencies that led to the limited approval and limited disapproval of the State's regional haze SIP. EPA is therefore withdrawing the limited disapproval of Mississippi's regional haze SIP and replacing the prior limited approval with a full approval of the regional haze SIP as meeting all regional haze requirements of the Clean Air Act (CAA or Act) for the first implementation period. EPA is also approving the Progress Report and associated adequacy determination.
Updates on the Export of Deuterium
The U.S. Nuclear Regulatory Commission (NRC) is revising its regulations to remove the NRC's licensing authority for exports of deuterium for non-nuclear end use. The responsibility for the licensing of exports of deuterium for non-nuclear end use is being transferred to the Department of Commerce's Bureau of Industry and Security. The Bureau of Industry and Security is publishing a final rule in this edition of the Federal Register to include such exports under its export licensing jurisdiction. Exports of deuterium for nuclear end use will remain under the NRC's export licensing jurisdiction.
Control of Deuterium That Is Intended for Use Other Than in a Nuclear Reactor Under the Export Administration Regulations (EAR)
The Department of Commerce is publishing this final rule in conjunction with a U.S. Nuclear Regulatory Commission (NRC) final rule to revise its regulations to remove the NRC's licensing authority for exports of deuterium for non-nuclear end use. The responsibility for the licensing of exports of deuterium for non-nuclear end use is being transferred to the Department of Commerce's Bureau of Industry and Security (BIS). BIS is publishing this final rule to include deuterium under its export licensing jurisdiction under the Export Administration Regulations (EAR). This Commerce final rule describes the changes made to the EAR to control the deuterium moved from the export control authority of the NRC to the export control authority of BIS under the EAR. Exports of deuterium for nuclear end use will remain under the NRC's export licensing jurisdiction.
International Trademark Classification Changes
The United States Patent and Trademark Office (USPTO) issues this final rule to incorporate classification changes adopted by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks (Nice Agreement). These changes are listed in the International Classification of Goods and Services for the Purposes of the Registration of Marks (Nice Classification), which is published by the World Intellectual Property Organization (WIPO), and will become effective on January 1, 2022.
Privacy Act of 1974
The Department of Homeland Security (DHS or Department) is proposing to amend its regulations under the Privacy Act of 1974. DHS is proposing to update and streamline the language of several provisions. DHS invites comment on all aspects of this proposal.
Social Security Number Fraud Prevention Act of 2017 Implementation
The Department of Veterans Affairs proposes to amend its regulations implementing the Privacy Act. These revisions would clarify and update the language of procedural requirements pertaining to the inclusion of Social Security account numbers (SSN) on documents that the Department sends by mail. These revisions are also required by the Social Security Number Fraud Prevention Act of 2017, which restricts the inclusion of SSNs on documents sent by mail by the Federal Government.
Privacy Act of 1974: Implementation of Exemptions; Department of Homeland Security U.S. Customs and Border Protection-018 Customs Trade Partnership Against Terrorism System of Records
The U.S. Department of Homeland Security (DHS) is issuing a final rule to amend its regulations to exempt portions of a newly updated and reissued system of records titled, ``DHS/U.S. Customs and Border Protection-018 Customs Trade Partnership Against Terrorism (CTPAT) System of Records'' from certain provisions of the Privacy Act. Specifically, the Department exempts portions of this system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program; Supplemental Proposal
Pursuant to the U.S. Environmental Protection Agency's Significant New Alternatives Policy program, the Agency is proposing, as an additional option, to list for a limited period of time certain substances in the foamblowing sector, extruded polystyrene: Boardstock and billet end-use, as acceptable, subject to narrowed use limits. This proposal supplements the Agency's June 12, 2020, proposal with respect to the proposed listings in the foam-blowing sector, taking into consideration public comments and information received since issuance of the initial proposal. In the June 12, 2020, proposal, EPA proposed to list three foam blowing agent blends as acceptable. In this supplemental proposal, EPA is proposing an additional approach to list these blends as acceptable, subject to narrowed use limits, in the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, from the effective date of a final rule based on this supplemental proposal until January 1, 2023. The Agency is providing an opportunity for public comment on this additional approach for the listings in the foam blowing sector, as well as reopening the public comment period for the proposed listings in the foam blowing sector in the June 12, 2020, proposal. The Agency is not reopening for comment those other portions of the June 12, 2020, proposal which are addressed in a separate final rule issued May 6, 2021.
General Services Administration Acquisition Regulation (GSAR); Clause and Provision Designation Corrections
GSA is issuing a final rule to amend the General Services Administration Acquisition Regulation (GSAR) to correct clause and provision designation and prescription errors, correct deviations and alternate identification issues, and to make other updates to the GSAR related to identification and incorporation of GSAR provisions and clauses.
Flexibility for Head Start Designation Renewals in Certain Emergencies
This rule adopts as final the provision to the Head Start Program Performance Standards (HSPPS) to establish parameters by which ACF may make designation renewal determinations during a federally declared major disaster, emergency, or public health emergency (PHE) and in the absence of all normally required data.
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