June 21, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, Federal Reserve Clearance for Board Public website Usability Surveys (FR 3076, OMB No. 7100-0366).

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 2, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Glycosyn LLC. An amended complaint was filed on May 16, 2018. An additional supplement to the complaint was also filed on May 25, 2018. The complaint, as amended and supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain human milk oligosaccharides by reason of infringement of U.S. Patent No. 9,453,230 (``the '230 patent'') and U.S. Patent No. 9,970,018 (``the '018 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

This is a Notice of the Presidential declaration of a major disaster for the State of HAWAII (FEMA-4366-DR), dated 06/14/2018. Incident: Kilauea Volcanic Eruption and Earthquakes. Incident Period: 05/03/2018 and continuing.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to Deepwater Wind New England, LLC (DWW), for authorization to take marine mammals incidental to marine site characterization surveys off the coast of Rhode Island and Massachusetts in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0486) and along potential submarine cable routes to a landfall location in Rhode Island, Massachusetts or New York.

This action corrects the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION sections of a notice published on June 6, 2018, which contained some incorrect information that could leave the public misinformed. This notice extends the end date of the comment period, changes the location of a scoping hearing, and adds a sentence to clarify which scoping hearings will be joint Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission hearings.

We are adopting a new airworthiness directive (AD) for certain Honeywell International Inc. (Honeywell) TPE331 turboprop and TSE331 turboshaft engines. This AD was prompted by recent reports of failures of the direct drive fuel control gears and bearings in the hydraulic torque sensor gear assembly, part number (P/N) 3101726-3. This AD requires initial and repetitive engine oil filter sampling and analysis of the affected engines and inspections of certain hydraulic torque sensor gear assemblies. We are issuing this AD to address the unsafe condition on these products.

This document contains a final regulation under Title I of the Employee Retirement Income Security Act (ERISA) that establishes additional criteria under ERISA section 3(5) for determining when employers may join together in a group or association of employers that will be treated as the ``employer'' sponsor of a single multiple- employer ``employee welfare benefit plan'' and ``group health plan,'' as those terms are defined in Title I of ERISA. By establishing a more flexible ``commonality of interest'' test for the employer members than the Department of Labor (DOL or Department) had adopted in sub- regulatory interpretive rulings under ERISA section 3(5), and otherwise removing undue restrictions on the establishment and maintenance of Association Health Plans (AHPs) under ERISA, the regulation facilitates the adoption and administration of AHPs and expands access to affordable health coverage, especially for employees of small employers and certain self-employed individuals. At the same time, the regulation continues to distinguish employment-based plans, the focal point of Title I of ERISA, from commercial insurance programs and other service provider arrangements. The final rule also sets out the criteria that would permit, solely for purposes of Title I of ERISA, certain working owners of an incorporated or unincorporated trade or business, including partners in a partnership, without any common law employees, to qualify as employers for purposes of participating in a bona fide group or association of employers sponsoring an AHP and also to be treated as employees with respect to a trade, business or partnership for purposes of being covered by the AHP. The regulation would affect AHPs, bona fide groups or associations of employers sponsoring such plans, participants and beneficiaries with health coverage under an AHP, health insurance issuers, and purchasers of health insurance not purchased through AHPs.