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The Food and Drug Administration (FDA) has released new guidelines for companies submitting information electronically related to drug and biologic license applications. This guidance helps ensure that data is submitted in a standardized format, which the FDA uses to plan and conduct inspections of research sites, known as Bioresearch Monitoring (BIMO) inspections. The guidance also clarifies which trials need to include certain information, aiming to enhance the FDA's inspection process for safety and efficacy claims in drug applications. Additionally, the guidance addresses previous technical issues and provides updated instructions for submissions under specific FDA regulations.

The Railroad Retirement Board (RRB) is seeking feedback on their Information Collection Request (ICR) related to unemployment benefits under the Railroad Unemployment Insurance Act. The ICR describes how they determine if a claimant is available for work, which affects eligibility for unemployment benefits. The RRB invites public comments on whether their forms and processes are effective and if any improvements can be made. Comments should be submitted within 30 days of the notice's publication date.

The Railroad Retirement Board (RRB) is seeking public feedback on an Information Collection Request (ICR) related to the Railroad Unemployment Insurance Act. This request involves collecting data to determine if railroad employees qualify for sickness benefits when they're unable to work due to illness, injury, or pregnancy. The forms required for this process include several specific documents like the Application for Sickness Benefits, and there's no proposed change to them. The RRB is inviting comments to ensure the process is efficient and not burdensome, and comments should be submitted within 30 days of the notice's publication.

The Railroad Retirement Board (RRB) is seeking public comments on a new Information Collection Request (ICR) submitted to the Office of Management and Budget's Office of Information and Regulatory Affairs. The ICR involves collecting information to determine a child's eligibility for annuities under the Railroad Retirement Act, based on dependency on a railway employee. Changes have been proposed to improve Form G-139, which is used to gather financial details necessary to assess this dependency. Comments can be submitted online or via email to the listed contact, Brian Foster, within 30 days of the notice's publication.

In a notice from the Transportation Department, a correction has been issued for an earlier document, identified as 2020-27994, published in the December 21, 2020 issue. The correction changes the date listed in the DATES section from “January 20, 2021” to “January 21, 2021.” This adjustment ensures that readers have the correct timeline regarding the details of the notice.

The Department of Education is inviting applications for the 2021 fiscal year for the Assistance for Arts Education (AAE) Program. The program aims to enhance arts education for students, especially those who are disadvantaged or have disabilities, by providing professional development for educators, developing arts-based educational resources, and fostering arts partnerships in communities. Eligible applicants include local education agencies, higher education institutions, and nonprofit organizations among others. The Department has set aside an estimated $16.5 million for this program, with awards ranging from $375,000 to $2 million.

The General Services Administration (GSA) is revising an existing process for submitting notarized documents related to the System for Award Management (SAM) registration. This change is meant to enhance the security and accuracy of the information in SAM, which is crucial for government acquisitions and assistance programs. GSA is proposing a more efficient method that only requires notarized letters when appointing a new administrator to an existing entity, ensuring minimal disruption to businesses. Public comments on this revision are invited until February 26, 2025.

The Rural Utilities Service (RUS), part of the USDA, has extended and reopened the application period for the Guarantees for Bonds and Notes Issued for Utility Infrastructure Purposes Program, also known as the 313A Program. This program is now accepting applications until January 31, 2025. The program supports loans used for utility infrastructure projects and refinancing, aimed at borrowers who have received or are eligible for loans under the Rural Electrification Act of 1936. Applicants must submit their completed applications electronically to RUS.

The Food and Drug Administration (FDA) has released a draft guidance document titled "M15 General Principles for Model-Informed Drug Development." This document was created under the International Council for Harmonisation (ICH) and provides recommendations on planning, evaluating, and documenting evidence in drug development using models. It aims to help harmonize regulations globally, enhancing drug development and improving manufacturing standards. Public comments on the draft can be submitted until February 28, 2025.

The Food and Drug Administration (FDA) has released final guidance on limiting lead in processed foods for babies and young children under 2 years old. The guidance sets specific action levels for lead: 10 parts per billion (ppb) for most foods, and 20 ppb for certain root vegetables and dry infant cereals. These levels help ensure food safety and reduce lead exposure in the food supply. Interested parties can comment on the guidance, and it becomes available on several FDA websites.