2019 – Federal Register Recent Federal Regulation Documents

The Commodity Futures Trading Commission (CFTC or Commission) is requesting nominations for membership on the Subcommittee on Margin Requirements for Non-Cleared Swaps (Subcommittee) under the Global Markets Advisory Committee (GMAC). The GMAC is a discretionary advisory committee established by the Commission in accordance with the Federal Advisory Committee Act.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.

For the period beginning July 1, 2019, and ending on December 31, 2019, the prompt payment interest rate is 2\5/8\ per centum per annum.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Xsto BioSciences, Inc. (Xsto), located in San Carlos, California.

The Coast Guard is proposing a temporary safety zone for all navigable waters of the Ohio River, extending the entire width of the river, from mile marker (MM) 756.4 to MM 757.4 in Owensboro, KY. This safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a fireworks display. Entry into, transiting through or anchoring within this zone would be prohibited unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative. We invite your comments on this proposed rulemaking.

The Department of Education is issuing a notice inviting applications for new authorities for fiscal year (FY) 2020 under the Innovative Assessment Demonstration Authority.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

The Food Safety and Inspection Service (FSIS) is announcing and requesting comment on new pathogen reduction performance standards for Salmonella in raw ground beef and beef manufacturing trimmings. The Agency is also announcing how it plans to assess whether establishments producing raw ground beef and/or beef manufacturing trimmings are effectively addressing Salmonella, using a 52-week moving window of FSIS sampling results and other related verification activities. Approximately one year (52 weeks) after the new standards are made final, the Agency plans to post individual establishment performance as either ``meeting'' or ``not meeting'' the pathogen reduction performance standard on the FSIS website, based on the most recent 48 Salmonella sample results. Finally, FSIS is also announcing that it intends to increase Salmonella sampling to once per week in beef establishments that produce greater than 50,000 pounds of raw ground beef and beef manufacturing trimmings per day, so that a sufficient number of Salmonella samples (i.e., 48) are collected to assess these establishments' performance against the new Salmonella performance standards. Note that FSIS will continue to analyze these beef manufacturing trimmings samples for Escherichia coli O517:H7 and applicable non-O157 Shiga-toxin producing E. coli (STEC); FSIS will continue to analyze these ground beef samples for E. coli O157:H7. Although unlikely with this change, if fewer than 48 samples are collected or analyzed in a 52-week window at an establishment, its status would be reported as ``N/A,'' provided the establishment has two or fewer Salmonella positives in that window. FSIS will consider comments received on this notice before announcing the final performance standards in the Federal Register and assessing whether establishments meet them.

NMFS apportions amounts of the non-specified reserve, to the initial total allowable catch (ITAC) of Bering Sea (BS) Pacific ocean perch, Bering Sea and Aleutian Islands (BSAI) Alaska plaice, and BSAI Kamchatka flounder; and to the to the total allowable catch (TAC) of BSAI arrowtooth flounder, BSAI northern rockfish, BSAI sharks, and Bering Sea and Eastern Aleutian Islands (BS/EAI) blackspotted/rougheye rockfish. This action is necessary to allow the fisheries to continue operating. It is intended to promote the goals and objectives of the fishery management plan for the BSAI management area.

The National Oceanic and Atmospheric Administration (NOAA) is considering a request to amend the boundary of the Elkhorn Slough National Estuarine Research Reserve (Elkhorn Slough NERR or the Reserve) and is soliciting comments from the public on the proposed boundary expansion. The public is also invited to comment on the draft environmental assessment for the proposed boundary expansion. Any person wishing to comment on the proposed boundary expansion or the environmental assessment may submit comments as described under ADDRESSES below.

The Food and Drug Administration (FDA or we) is classifying the self-fitting air-conduction hearing aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the self-fitting air-conduction hearing aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

This notice sets forth the schedule and proposed agenda for a meeting of the Civil Nuclear Trade Advisory Committee (CINTAC).

This notice sets forth the schedule and proposed agenda of a meeting of the Environmental Technologies Trade Advisory Committee (ETTAC).

This Federal Register notice announces meetings of the Maritime Advisory Committee for Occupational Safety and Health (MACOSH) workgroups and full Committee on November 19 and 20, 2019 in Washington, DC.

The Department of Labor (DOL) is submitting the Office of the Assistant Secretary for Policy, Chief Evaluation Office (CEO) sponsored information collection request (ICR) proposal titled, ``Reemployment Services and Eligibility Assessments (RESEA) Implementation Study,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the New Jersey Advisory Committee to the Commission will convene by conference call, on Friday, November 15, 2019 at 11:30 a.m. (EST). The purpose of the meeting is to discuss and vote on the project proposal for the Committee's civil rights project on the collateral consequences of a criminal record on forfeiture of private property and access to professional licenses.

The Mid-Atlantic Fishery Management Council's (MAFMC's) Summer Flounder, Scup, and Black Sea Bass Monitoring Committee and Bluefish Monitoring Committee will hold a public meeting.

The North Pacific Fishery Management Council (Council) Groundfish Plan Teams will meet November 12, 2019 through November 15, 2019.

The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. 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 30 days for public comment.