January 2023 – Federal Register Recent Federal Regulation Documents

Veterans Health Administration (VHA), 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 extension of a currently approved collection, and allow 60 days for public comment in response to the notice.

In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the National Veterans Sports Programs and Special Events (NVSPSE), Veterans Health Administration (VHA), 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.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Mark Godding for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Godding was convicted of one felony count under Federal law for Introducing or Delivering for Introduction a Misbranded Drug in Interstate Commerce. The factual basis supporting Mr. Godding's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Godding was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of September 29, 2022 (30 days after receipt of the notice), Mr. Godding had not responded. Mr. Godding's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Securities and Exchange Commission (``Commission'' or ``SEC'') is proposing to amend existing requirements under the Securities Exchange Act of 1934 (``Exchange Act'') to update the disclosure required for order executions in national market system (``NMS'') stocks. First, the Commission is proposing to expand the scope of reporting entities subject to the rule that requires market centers to make available to the public monthly execution quality reports to encompass broker-dealers with a larger number of customers. Next, the Commission is proposing to modify the definition of ``covered order'' to include certain orders submitted outside of regular trading hours and certain orders submitted with stop prices. In addition, the Commission is proposing modifications to the information required to be reported under the rule, including changing how orders are categorized by order size as well as how they are categorized by order type. As part of the changes to these categories, the Commission is proposing to capture execution quality information for fractional share orders, odd- lot orders, and larger-sized orders. Additionally, the Commission is proposing to modify reporting requirements for non-marketable limit orders (``NMLOs'') in order to capture more relevant execution quality information for these orders by requiring statistics to be reported from the time such orders become executable. The Commission is also proposing to eliminate time-to-execution categories in favor of average time to execution, median time to execution, and 99th percentile time to execution, each as measured in increments of a millisecond or finer and calculated on a share-weighted basis. In order to better reflect the speed of the marketplace, the Commission is proposing that the time of order receipt and time of order execution be measured in increments of a millisecond or finer, and that realized spread be calculated at both 15 seconds and one minute. Finally, the Commission is proposing to enhance the accessibility of the required reports by requiring all reporting entities to make a summary report available.

The Food and Drug Administration (FDA, Agency, or we) is classifying the intense pulsed light device for managing dry eye 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 intense pulsed light device for managing dry eye'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.

Navinta LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA will seek approval of the Information Collection Request (ICR) abstracted below. Before submitting this ICR to the Office of Management and Budget (OMB) for approval, FRA is soliciting public comment on specific aspects of the activities identified in the ICR.

The Assistant Secretary of the Army for Civil Works (ASA (CW)) is seeking public comment on any provisions in the Water Resources Development Act (WRDA) of 2022. The Office of the ASA(CW) will consider all comments received during the 60-day public comment period in the preparation of any guidance.

The Department of Energy (DOE) invites public comment on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.

The National Wetland Plant List (NWPL) provides plant species indicator status ratings, which are used in determining whether the hydrophytic vegetation factor is met when conducting wetland delineations under the Clean Water Act and wetland determinations under the Wetland Conservation Provisions of the Food Security Act. Other applications of the NWPL include wetland restoration, establishment, and enhancement projects. To update the NWPL, the U.S. Army Corps of Engineers (USACE), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS), and the U.S. Department of Agriculture Natural Resources Conservation Service (NRCS), is announcing the availability of the proposed changes to the 2022 NWPL and its web address to solicit public comments. The public will now have the opportunity to comment on the proposed changes to wetland indicator status ratings for two plant species in the Arid West (AW) region. In addition, we are accepting comments on the proposal to move from a two-year update cycle to a three-year update cycle for the NWPL. Finally, USACE is seeking comments on the overall NWPL update process.

The Federal Election Commission is announcing the date, time, and place of a public hearing on its audit procedures for political committees that do not receive public funds.

The National Cancer Institute (NCI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Yissum Research and Development (``Yissum''), the technology transfer company of the Hebrew University of Jerusalem, a non-profit research institution located in Jerusalem, Israel for NCI's rights to the patent applications listed in the Supplementary Information section of this notice.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for an additional 30 days of public comment.

In compliance with the Paperwork Reduction Act of 1995 (``PRA''), this notice announces that the Information Collection Request (``ICR'') abstracted below has been forwarded to the Office of Management and Budget (``OMB'') for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

Kinetochem LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Siegfried USA, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Washington (FEMA- 4682-DR), dated 01/12/2023. Incident: Severe Winter Storm, Straight-Line Winds, Flooding, Landslides, and Mudslides. Incident Period: 11/03/2022 through 11/08/2022.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Linda Godding for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Godding was convicted of one felony count under Federal law for introducing or delivering for introduction a misbranded drug in interstate commerce. The factual basis supporting Ms. Godding's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Godding was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of September 29, 2022 (30 days after receipt of the notice), Ms. Godding had not responded. Ms. Godding's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.