March 16, 2023 – Federal Register Recent Federal Regulation Documents

The National Endowment for the Humanities (NEH) will hold twenty-one meetings, by videoconference, of the Humanities Panel, a federal advisory committee, during April 2023. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and the Humanities Act of 1965.

This document provides the public with notice that, on March 7, 2023, Florida East Coast Railway (FECR) submitted a request for amendment (RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP). As this RFA may involve a request for FRA's approval of proposed material modifications to an FRA-certified positive train control (PTC) system, FRA is publishing this notice and inviting public comment on the railroad's RFA to its PTCSP.

The FAA hereby provides notice of intent to release 0.69 acres at the Lakeland Linder Regional Airport, Lakeland, FL from the conditions, reservations, and restrictions as contained in a Quitclaim Deed agreement between the FAA and the City of Lakeland, dated September 26, 1947. The release of property will allow the City of Lakeland to use the property for other than aeronautical purposes. The property is located off of Air Park Drive at the Lakeland Linder Regional Airport in Polk County. The parcel is currently designated as surplus property. The property will be released of its federal obligations for the purpose of selling the property at fair market value for construction of commercial/industrial development. The fair market value lease of this parcel has been determined to be $120,000. Documents reflecting the Sponsor's request are available, by appointment only, for inspection at the Lakeland Linder Regional Airport and the FAA Airports District Office.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.'' The draft guidance provides information for sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs under FDA regulations. This draft guidance revises the draft guidance for industry issued in June 2017 entitled ``Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR part 11 Questions and Answers'' and, when finalized, will supersede the guidance for industry entitled ``Computerized Systems Used in Clinical Investigations'' (May 2007).

The Food and Drug Administration (FDA or Agency) is withdrawing approval of six 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 or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee (BPAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the BPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared the Record of Decision (ROD) for the Whitewater River Groundwater Replenishment Facility located in the Palm Springs-South Coast Field Office. The ROD constitutes the decision of the BLM.

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).

The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections.

The Inter-American Foundation (IAF), as part of its continuing efforts to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps ensure that requested data is provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents is properly assessed. Currently, the IAF is soliciting comments concerning the information collection of the grant application concept note. The purpose of this form is to reduce the time needed to submit and review a proposal for IAF grant funds. Proponents spend a lot of time completing a proposal for grant funds, and IAF Foundation Representatives spend a lot of time reviewing proposals. Internal staff members are not able to read through all the proposals received each year as a result of the volume of submissions and the length of the materials. Given the high proportion of proposals that do not progress to the ``pre-selected'' phase of the review process, there is an opportunity to streamline the initial application requirements to only require the key information a Foundation Representative needs to decide whether or not a project is viable for IAF to fund.

The U.S. Coast Guard is establishing a safety zone over the waters near Naval Base Ventura County, Point Mugu, CA, in support of the Point Mugu Airshow. This action is necessary to provide for the safety of life on these navigable waters in the area near the air demonstrations and to provide an emergency landing area for the event. This regulation prohibits vessels from entering into, transiting through, or remaining within the designated area unless specifically authorized by the Captain of the Port, Sector Los Angeles-Long Beach (COTP), or a designated representative.

The U.S. Department of Commerce (Commerce) determines that Hyosung Heavy Industries Corporation (Hyosung) made sales of large power transformers from the Republic of Korea (Korea) at less than normal value during the period of review (POR) August 1, 2020, through July 31, 2021.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``Pacita Abad'' at the Walker Art Center, Minneapolis, Minnesota; the San Francisco Museum of Modern Art, San Francisco, California; MoMA PS1, New York, New York; and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.