2020 – Federal Register Recent Federal Regulation Documents

In accordance with the Privacy Act, we are issuing public notice of our intent to modify an existing system of records entitled, Disability Analysis File (DAF) and the National Beneficiary Survey (NBS) Data System (60-0382), last published on December 21, 2018. This notice publishes details of the modified system as set forth below under the caption, SUPPLEMENTARY INFORMATION.

The DoD has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The DoD has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

This document corrects technical and typographical errors that appeared in the final rule published in the September 29, 2020 Federal Register entitled ``Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures,'' which established the Radiation Oncology Model and the End-Stage Renal Disease Treatment Choices Model.

EPA (or the Agency) is finalizing its proposed decisions to not impose financial responsibility requirements under section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) for facilities in three industry sectors: The electric power generation, transmission, and distribution industry, pursuant to EPA's proposal of July 29, 2019; the petroleum and coal products manufacturing industry, pursuant to EPA's proposal of December 23, 2019; and the chemical manufacturing industry, pursuant to EPA's proposal of February 21, 2020. Today's final rulemakings are based on the individual administrative records for each of the three proposed rulemakings, supported by additional analysis conducted in consideration of comments received in the public comment period for each proposed rule. In particular, after examining the existing environmental protections and regulations in place today and analyzing the Superfund program's experience cleaning up sites in each industry, the Agency concluded that facilities in these three industries operating under a modern regulatory framework do not present a level of risk that warrants financial responsibility requirements under CERCLA section 108(b). Today's final rulemakings are based on the record for these rulemakings, and do not affect EPA's authority to take a response or enforcement action under CERCLA with respect to any particular facility or industry, and do not affect the Agency's authorities that may apply to particular facilities under other environmental statutes. This combined final rulemaking comprises the Agency's final actions on each of the three proposed rules.

This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).

This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the Centers for Medicare & Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.

This final rule amends the safe harbors to the Federal anti- kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the Department of Health and Human Services' (HHS's) Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of ``remuneration'' added by the Bipartisan Budget Act of 2018 (Budget Act of 2018).

We, the U.S. Fish and Wildlife Service (Service), propose to list whitebark pine (Pinus albicaulis), a high-elevation tree species found across western North America, as a threatened species under the Endangered Species Act of 1973 (Act), as amended. If we finalize this rule as proposed, it would extend the Act's protections to this species. We also propose a rule issued under section 4(d) of the Act that is necessary and advisable to provide for the conservation of the species. We have determined that designation of critical habitat for the whitebark pine is not prudent at this time.

On September 28, 2020, the Farm Credit Administration (FCA) published a final rule that repealed the regulatory requirement that production credit associations (PCAs) amortize their loans in 15 years or less, while requiring all Farm Credit System (FCS or System) associations to address amortization through their credit underwriting standards and internal controls. In that publication, FCA inadvertently omitted a statement that the Office of Management and Budget's Office of Information and Regulatory Affairs determined that the final rule is not a major rule under the applicable provisions of the Congressional Review Act. This document corrects that error.

In compliance with the Paperwork Reduction Act of 1995, the Office of the Undersecretary of Defense for Acquisition and Sustainment announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

We, the U.S. Fish and Wildlife Service (Service), have received an application from TG High Prairie, LLC (applicant) for an incidental take permit (ITP) under the Endangered Species Act (ESA), for its High Prairie Wind Energy Facility. If approved, the ITP would be for a 6-year period and would authorize the incidental take of covered species, including the endangered Indiana bat, threatened northern long-eared bat, and the little brown bat, currently under discretionary review. While the ITP is for 6 years, the wind energy project is scheduled to be operational for thirty years and intensive monitoring conducted during this permit term will inform the need for future avoidance or a new long-term ITP that will comply with a new NEPA analysis and habitat conservation plan (HCP). The applicant has prepared a HCP that describes the actions and measures that the applicant would implement to avoid, minimize, and mitigate incidental take of the covered species for the first 6 years. We also announce the availability of a draft environmental assessment, which has been prepared in response to the permit application in accordance with the requirements of the National Environmental Policy Act (NEPA). We request public comment on the application, which includes the applicant's proposed HCP, the Service's draft environmental assessment, prepared pursuant to NEPA and associated documents. We provide this notice to seek review and comment from the public and Federal, Tribal, State and local governments.

The DoD has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The U.S. Nuclear Regulatory Commission (NRC) is issuing NUREG- 2224, ``Dry Storage and Transportation of High Burnup Spent Nuclear Fuel.'' The NUREG provides technical background information applicable to high burnup spent nuclear fuel (HBU SNF), provides an engineering assessment of recent NRC-sponsored mechanical testing of HBU SNF, and presents example approaches for licensing and certification of HBU SNF in transportation and dry storage.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 survey previously ran a 60-day FRN in 83 FR 66276 on 12/ 26/2018. As required under the PRA we are providing the public an opportunity to comment on any changes or updates applied to this IC since the 2018 publication. We are requesting an abbreviated public comment period for additional 30-days prior to publication of a 30-day FRN and submittal to OMB. Any changes to the survey from the initial 60-day FRN publication are incorporated into the revised version of the survey. This notice solicits comments on any revisions since the initial publication in 2018. This is a new information collection 0985-New Inventory of Adult Protective Services Practices and Service Innovations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.'' This draft guidance focuses on specific recommendations pertinent to gastric pH- dependent drug-drug interaction (DDI) assessment and describes the FDA's recommendations regarding when clinical DDI studies with acid- reducing agents (ARAs) are needed; design of the clinical studies; interpretation of study results; and communicating findings and options for managing pH-dependent DDIs in product labeling.

Notice is hereby given of a virtual public meeting of the Interagency Marine Debris Coordinating Committee (IMDCC). IMDCC members will discuss federal marine debris activities, with a particular emphasis on the topics identified in the section on Matters to Be Considered.

As a result of the determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on certain frozen fish fillets (fish fillets) from the Socialist Republic of Vietnam (Vietnam) would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of the AD order.