July 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) has determined that CECLOR CD (cefaclor extended-release tablets) 375 milligrams (mg) and 500 mg were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of secondary bacterial infections of acute bronchitis (SBIAB) that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of any abbreviated new drug application (ANDA) that refers to this drug product and has removed the indication for SBIAB. This determination also will allow FDA to continue to approve ANDAs that refer to these drug products as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for CECLOR CD (cefaclor extended-release tablets) 375 mg and 500 mg that include SBIAB as an indication.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jacobo Geissler for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Geissler was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Geissler was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of April 7, 2021 (30 days after receipt of the notice), Mr. Geissler has not responded. Mr. Geissler's failure to respond and request a hearing constitutes a waiver of Mr. Geissler's right to a hearing concerning this matter.

The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2022 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2022.

This notice announces the extension of the Class III gaming compact between the Pyramid Lake Paiute Tribe of the Pyramid Lake Reservation and the State of Nevada.

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2022 rates for GDUFA II fees.

The Food and Drug Administration (FDA or Agency) has determined that EFUDEX (fluorouracil) topical solution, 5 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug application (ANDA) that refers to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with livestock disease surveillance programs.

The Coast Guard is establishing a temporary safety zone for navigable waters of the St. Clair River in the vicinity of Port Huron, MI. This zone is intended to restrict and control movement of vessels in a portion of the St. Clair River. Though this is an unsanctioned, non-permitted marine event, this zone is necessary to provide for the safety of life on the navigable waters during a float down event near Port Huron, MI.

The Dakota Prairie Grasslands will be implementing a new $10 expanded amenity recreation fee for overnight camping at Coal Creek campground, described in the SUPPLEMENTARY INFORMATION of this notice. The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108- 447) directed the Secretary of Agriculture to publish a six-month advance notice in the Federal Register whenever new recreation fees are established.

NMFS has received a request from the United States Navy for the re-issuance of a previously issued incidental harassment authorization (IHA) with the only change being effective dates. The initial IHA authorized take of one species of marine mammals, by Level B harassment, incidental to construction associated with the Floating Dry Dock Project at Naval Base San Diego in San Diego, California. The project has been delayed and none of the work covered in the initial IHA has been conducted. The initial IHA was effective from September 15, 2020, through September 14, 2021. The Navy has requested re- issuance with new effective dates of September 15, 2021, through September 14, 2022. The scope of the activities and anticipated effects remain the same, authorized take numbers are not changed, and the required mitigation, monitoring, and reporting remains the same as included in the initial IHA. NMFS is, therefore, issuing a second identical IHA to cover the incidental take analyzed and authorized in the initial IHA.

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.

This notification announces receipt of and publishes a petition for waiver and interim waiver from Hussmann Corporation (``Hussmann''), which seeks a waiver for specified Commercial Refrigerator, Freezer, and Refrigerator-Freezer (``CRE'') basic models from the U.S. Department of Energy (``DOE'') test procedure used for determining the energy consumption of CRE. DOE also gives notification of an Interim Waiver Order that requires Hussmann to test and rate the specified CRE basic models in accordance with the alternate test procedure set forth in the Interim Waiver Order. DOE solicits comments, data, and information concerning Hussmann's petition, its suggested alternate test procedure, and the alternate test procedure required under the Interim Waiver Order so as to inform DOE's final decision on Hussmann's waiver request.

On June 23, 2021, the Department of Education (Department) published in the Federal Register a notice inviting applications (NIA) for new awards for fiscal year (FY) 2021 for Rehabilitation Short-Term Training: Client Assistance Program, Assistance Listing Number 84.246K. We are correcting the deadline for intergovernmental review. All other information in the NIA, including the August 9, 2021, deadline for transmittal of applications, remains the same.

The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the subsequent license renewal of Renewed Facility Operating License Nos. DPR-38, DPR-47, and DPR-55, which authorize Duke Energy Carolinas, LLC (Duke Energy or the applicant) to operate Oconee Nuclear Station (ONS), Units 1, 2, and 3. The renewed licenses would authorize the applicant to operate ONS for an additional 20 years beyond the period specified in each of the current renewed licenses. The current renewed operating licenses for ONS expire as follows: Unit 1 on February 6, 2033, Unit 2 on October 6, 2033, and Unit 3 on July 19, 2034.

The Environmental Protection Agency (EPA) is taking final action to approve revisions to the Placer County Air Pollution Control District (PCAPCD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of oxides of nitrogen (NOX) and particulate matter (PM) from open burning. We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).

Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed new collection, and allow 60 days for public comment in response to the notice.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``General Domestic Licenses for Byproduct Material.''

This action amends Class E surface area and Class E airspace extending upward from 700 feet above the surface at Hancock County-Bar Harbor Airport, Bar Harbor, ME. This action would also update the geographic coordinates of the airport to coincide with the FAA's database. In addition, this action also establishes Class E airspace extending upward from 700 feet above the surface for Bar Harbor Heliport, Bar Harbor, ME. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

This is a notice of an Administrative declaration of a disaster for the State of Florida dated 07/22/2021. Incident: Tropical Storm Elsa. Incident Period: 07/08/2021.

OSHA requests information and comment on issues related to the mechanical power presses standard. The standard was issued in 1971 based upon the 1971 American National Standards Institute (ANSI) industry consensus standard for mechanical power presses. This ANSI standard has been updated a number of times since 1971. OSHA is seeking information regarding whether it should update the mechanical power presses standard and, if so, how closely the standard should follow the current ANSI standard for mechanical power presses. It is also seeking information on the types of presses that should be covered, the use and certification of equipment, and other topics such as presence-sensing device initiation (PSDI) systems, and requirements for press modifications, training, and injury reporting. OSHA will use the information received in response to this RFI to determine what action, if any, it may take to reduce regulatory burdens while maintaining worker safety.