April 2, 2019 – Federal Register Recent Federal Regulation Documents
Results 101 - 114 of 114
Federal Employees Health Benefits Acquisition Regulations: Self Plus One and Contract Matrix Update
The Office of Personnel Management (OPM) is issuing this proposed rule to update its regulations concerning ``self plus one'' and the contract matrix. OPM is updating the Federal Employees Health Benefits Acquisition Regulations (FEHBAR) to include a recently added enrollment type called ``self plus one'' to the carrier advertising instructions and also provides notice to interested stakeholders that we are updating and clarifying the contract clause matrix.
Revocation of the Test for Mycoplasma
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the biologics regulations by removing the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA is proposing this action because the existing test for Mycoplasma is restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
The Food and Drug Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects those errors.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations.
Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive
This document revises the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program Policy Directives. Specifically, the Small Business Administration combines the two directives into one document, clarifies the data rights and Phase III preference afforded to SBIR and STTR small business awardees, adds definitions relating to data rights, and clarifies the benchmarks for progress towards commercialization.
Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters
We are adopting a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 A-1, MBB-BK 117A-3, MBB-BK 117 A-4, MBB-BK 117 B-1, MBB-BK 117 B-2, MBB-BK 117 C-1, and MBB-BK 117 C-2 helicopters. This AD requires repetitive inspections of the tail rotor (T/R) gearbox housing. This AD was prompted by a report that a crack was found in a T/R gearbox housing. The actions of this AD are intended to correct an unsafe condition on these products.
Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters
We are adopting a new airworthiness directive (AD) for Bell Helicopter Textron Canada Limited (BHTC) Model 429 helicopters. This AD requires inspecting each main rotor pitch link rod end bearing assembly (bearing) for wear and play. This AD was prompted by reports of worn bearings. The actions of this AD are intended to prevent an unsafe condition on these products.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Spiny Lobster Fishery of the Gulf of Mexico and South Atlantic; Amendment 13
The Gulf of Mexico (Gulf) and South Atlantic Fishery Management Councils (Councils) have submitted Amendment 13 to the Fishery Management Plan for Spiny Lobster in the Gulf of Mexico and South Atlantic (FMP), for review, approval, and implementation by NMFS. Amendment 13 would modify the applicable Federal regulations for the harvest of spiny lobster in the exclusive economic zone (EEZ) off Florida to be compatible with Florida regulations, and would re- establish a procedure for an enhanced cooperative management with Florida. The purpose of Amendment 13 is to more effectively manage and enforce the harvest of spiny lobster.
Modernizing Ignitable Liquids Determinations
The Environmental Protection Agency (EPA or the Agency) is proposing to update the regulations for the identification of ignitable hazardous waste under the Resource Conservation and Recovery Act (RCRA) and to modernize the RCRA test methods that currently require the use of mercury thermometers. These proposed revisions would provide greater clarity to hazardous waste identification, provide flexibility in testing requirements, improve environmental compliance, and, thereby, enhance protection of human health and the environment.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.
FAST Act Modernization and Simplification of Regulation S-K
We are adopting amendments to modernize and simplify certain disclosure requirements in Regulation S-K, and related rules and forms, in a manner that reduces the costs and burdens on registrants while continuing to provide all material information to investors. The amendments are also intended to improve the readability and navigability of disclosure documents and discourage repetition and disclosure of immaterial information. To provide for a consistent set of rules to govern incorporating information by reference and hyperlinking, we are also adopting parallel amendments to several rules and forms applicable to investment companies and investment advisers, including amendments that would require certain investment company filings to be submitted in HyperText Markup Language format.
Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of one amendment request. The amendment request is for Oconee Nuclear Station, Units 1, 2, and 3. For the amendment request, the NRC proposes to determine that it involves no significant hazards consideration. Because the amendment request contains sensitive unclassified non-safeguards information (SUNSI) an order imposes procedures to obtain access to SUNSI for contention preparation.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Amendment To Control of Emissions of Volatile Organic Compounds From Consumer Products
The Environmental Protection Agency (EPA) is approving a revision to the State of Maryland's state implementation plan (SIP). The State of Maryland's SIP revision pertains to Code of Maryland Regulations (COMAR) 26.11.32Control of Emissions of Volatile Organic Compounds (VOCs) from Consumer Products. This action is being taken under the Clean Air Act (CAA).
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