October 28, 2019 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces a public meeting and two public teleconferences of the SAB Computable General Equilibrium (CGE) Model Review Panel to discuss its review of a CGE model from the EPA's National Center for Environmental Economics.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the opening of a public docket to obtain public comment on proposed new recommendations for hepatitis C virus (HCV) infection screening for adults, including pregnant women. The new recommendations are intended for U.S. healthcare providers and will include supporting scientific evidence of the effectiveness and economic value of screening to diagnose current HCV infection among adults and pregnant women in the United States.

This final rule rescinds the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. This final rule also removes the definitions for the ``Controlling health plan'' (CHP) and ``Subhealth plan'' (SHP).

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.

The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. 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 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 Office of Management and Budget (OMB) control number.

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.