November 2020 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is announcing a 90- day public comment period associated with release of the ORD Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments, or IRIS Handbook. The IRIS Handbook provides operating procedures for developing assessments including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values. EPA is releasing this document and the charge questions for public comment in advance of a National Academy of Sciences, Engineering, and Medicine (NASEM) peer review. Comments received will be summarized and provided to the committee conducting the peer review. This document was prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA's Office of Research and Development (ORD).

In accordance with the Environmental Protection Agency (EPA) Administrator's October 16, 2017, Directive Promoting Transparency and Public Participation in Consent Decrees and Settlement Agreements, notice is hereby given of a proposed stipulated order of partial dismissal to address several claims in a lawsuit filed by Northwest Environmental Advocates in the U.S. District Court for the District of Idaho. On September 24, 2013 the Northwest Environmental Advocates and the Idaho Conservation League (collectively ``Plaintiffs'') filed an amended complaint bringing claims against the EPA alleging, among other things, that it failed to perform duties mandated by the Endangered Species Act (ESA) to consult with the Fish & Wildlife Service and the National Marine Fisheries Service (collectively ``the Services'') regarding its actions under the Clean Water Act (CWA) and that EPA failed to complete various mandatory duties under the CWA with respect to various new and revised water quality standards adopted by the Idaho Department of Environmental Quality. EPA seeks public input on the proposed stipulated order of partial dismissal prior to its final decision-making to settle the litigation.

In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM) are proposing to renew an information collection.

The Environmental Protection Agency (EPA) is announcing the availability of and seeking public comment on an updated draft guidance document entitled ``Guidance for Plant Regulator Products and Claims, including Plant Biostimulants,'' which was originally issued for public review and comment in March 2019. Guidance documents are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. EPA updated the original draft guidance document in response to the public comments received on the original draft guidance document. EPA is seeking an additional round of public comment on this updated draft guidance document, which is intended to provide guidance on identifying product claims that are considered to be plant regulator claims by the Agency, thereby subjecting the products to regulation as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Examples are provided of both claims that are considered plant regulator claims and claims that are not considered plant regulator claims. This draft guidance document also contains a narrative discussion regarding current and previously registered plant regulator active ingredients and their modes of action. This draft guidance does not address or attempt to provide a regulatory definition for ``plant biostimulant'' or for ``nutritional chemical'' or to change any existing regulatory definitions. After considering the comments received on this draft updated guidance, EPA intends to issue a final guidance document.

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 that the Maine Advisory Committee (Committee) will hold three meetings. One will be on Friday, December 11, 2020, at 2:30 p.m. (ET) for the purpose of hearing from the public on the challenges to digital access in Maine. The second and third meetings will be on Thursdays, December 17, 2020 and January 21, 2021, both at 12:00 p.m. for the purpose of hearing testimony about digital equity issues in Maine.

This notice announces an open teleconference meeting of the President's Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. The Federal Advisory Committee Act (FACA) requires that public notice of these meetings be announced in the Federal Register.

The Coast Guard announces that the Eighth Coast Guard District's Prevention Division has issued certificates of alternative compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to vessels of special construction or purpose that cannot fully comply with the light, shape, and sound signal provisions of 72 COLREGS without interfering with the vessel's design and construction. We are issuing this notice because its publication is required by statute. This notification of issuance of certificates of alternative compliance promotes the Coast Guard's marine safety mission.

We are advising the public that we have prepared a final environmental assessment and finding of no significant impact relative to the release of Aphalara itadori for the biological control of Japanese, Giant, and Bohemian knotweeds (Fallopia japonica, F. sachalinensis, and F. x bohemica), significant invasive weeds, within the contiguous United States. Based on our finding of no significant impact, we have determined that an environmental impact statement need not be prepared.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

The Department of Homeland Security, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995.

The U.S. Nuclear Regulatory Commission (NRC) is issuing an Order approving the transfer of Provisional Operating License No. DPR-5 for Indian Point Nuclear Generating Station, Unit No. 1 (IP1); Renewed Facility Operating License Nos. DPR-26 and DPR-64 for Indian Point Nuclear Generating Unit Nos. 2 and 3, respectively, (collectively, with IP1, the Indian Point Energy Center (IPEC)); and the general license for the IPEC independent spent fuel storage installation to Holtec International (Holtec) subsidiaries. The Holtec subsidiaries would be known as Holtec Indian Point 2, LLC (Holtec IP2) and Holtec Indian Point 3, LLC (Holtec IP3). The Order also approves the transfer of operating authority from the currently licensed operator, Entergy Nuclear Operations, Inc. (ENOI), to Holtec Decommissioning International, LLC (HDI). The NRC is also issuing conforming amendments for the facility operating licenses for administrative purposes to reflect the transfer of the licenses from ENOI to HDI and the planned name change for Entergy Nuclear Indian Point 2, LLC and Entergy Nuclear Indian Point 3, LLC to Holtec IP2 and Holtec IP3, respectively.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 to Regulatory Guide (RG) 5.76, ``Physical Protection Programs at Nuclear Power Reactors (SGI),'' as a final RG. The NRC has revised RG 5.76 to provide licensees guidance on the implementation of the ``Reasonable Assurance of Protection Time'' concept. This RG (Revision 1) clarifies issues that have been identified through interactions with stakeholders and inspection activities since the original publication of the guide.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a change to a currently approved information collection.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of a currently approved information collection.

This is an amendment of the Presidential declaration of a major disaster for the State of California (FEMA-4569-DR), dated 10/16/ 2020. Incident: Wildfires. Incident Period: 09/04/2020 through 11/17/2020.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring John Kapoor from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that John Kapoor was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. John Kapoor was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. Mr. Kapoor, through counsel, submitted a letter to FDA, which commented on some of the factual circumstances surrounding the case. In the letter, he also stated that he did not intend to request a hearing nor, however, would he acquiesce to debarment. As of August 26, 2020 (30 days after receipt of the notice), Mr. Kapoor has not requested a hearing. His failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

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

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the CLIAC. The CLIAC consists of 20 experts including the Chair who represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Barry J. Cadden from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Cadden was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Cadden was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of July 9, 2020 (30 days after receipt of the notice), Mr. Cadden had not responded. Mr. Cadden's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.