Information Collection Request (ICR) Tracker

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Nonsterile medical devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are normally considered by the Food and Drug Administration (FDA) to be adulterated and misbranded. FDA regulations established a control mechanism by which firms may manufacture and label medical devices as "sterile" at one establishment and ship the devices in interstate commerce for actual sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Manufacturers and sterilizers may sign an agreement containing instructions for maintaining accountability of the number of units in each shipment, acknowledgment that the devices are nonsterile and are being shipped for further processing, and specifications for the product's sterilization processing. This agreement allows the manufacturer to ship adulterated or misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. The agreement must include: (a) Instructions for maintaining accountability of the number of units in each shipment; (b) acknowledgment that the devices are nonsterile, being shipped for further processing; and (c) specifications for sterilization processing. These agreements must be retained for two years, as FDA may review them up to two years after final shipment or delivery of devices.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

This regulation promulgates the policies and procedures for making zero-interest loans and grants to borrowers in accordance with the cushion of credit payments program authorized in section 313 of the Act (7 U.S.C. 940c).

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Little information exists on the prevalence or likelihood of zoonotic SARS-CoV-2 transmission events. Currently, reporting of zoonotic SARS-CoV-2 transmission events is not systematically reported. The information gathered using this surveillance mechanism will provide insight into the role of animals in SARS-CoV-2 transmission and will also provide context for understanding prevalence of linked human and animal infections throughout the nation

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

On March 23, 2018, Congress passed the Consolidated Appropriations Act 2018 (the FY 2018 Appropriations) (Pub.L. 115–141) which established a broadband loan and grant pilot program, the Rural eConnectivity Pilot Program (hereinafter the ReConnect Program). One of the essential goals of the ReConnect Program is to expand broadband service to rural areas without sufficient access to broadband, defined as 10 megabits per second (Mbps) downstream and 1 Mbps upstream. For this purpose, Congress expanded RUS's existing authority to make loans and grants. Loans and grants are limited to the costs of the construction, improvement, and acquisition of facilities and equipment for broadband service in eligible communities. The FY 2018 Appropriations also authorized technical assistance to assist the agency in expanding needed service to the most rural communities. In facilitating the expansion of broadband services and infrastructure, the pilot will fuel long-term rural economic development and opportunities in rural America. One of those opportunities is precision agriculture. The use of this technology requires a robust broadband connection. The awards made under this program will bring high speed broadband to the farms which will allow them to increase productivity.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

This survey form is necessary to ensure ICF/IID provider and client characteristics are available and updated annually for the Federal Government's Automated Survey Processing Environment Suite (ASPEN). The surveyor is required to complete the survey foram at the time of the annual recertification or intial certification survey conducted by the State Survey agency. The team leader for the State Survey team must review and approve the completed form before the completion of the survey. The State Medicaid survey agency is responsible for transferring the 3070H information into ASPEN.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The Paleontological Resources Preservation Act (PRPA) was enacted to preserve paleontological resources for current and future generations because these resources are nonrenewable and are an irreplaceable part of America’s heritage. PRPA requires that implementation be coordinated between the Secretaries of the Interior and Agriculture and that DOI and USDA issue regulations as appropriate to carry out the law. We (DOI) are proposing regulations to implement the PRPA. The proposed rule would preserve, manage, and protect paleontological resources on BLM, NPS, Reclamation, and FWS lands and ensure that these resources are available for current and future generations to enjoy as part of America’s national heritage. The rule would address the management, collection, and curation of paleontological resources from Federal lands using scientific principles and expertise, including collection in accordance with permits, curation in an approved repository, maintenance of confidentiality of specific locality data, and authorization of penalties for illegal collecting, damaging, otherwise altering or defacing, or sale of paleontological resources. Information collected will allow the DOI bureaus to inventory paleontological resources, implement the permitted collection of fossils from the ground, preserve collected fossils in repositories, track and report the location and condition of paleontological resources, implement the civil penalties provisions with due process considerations, and monitor the results of scientific investigations that involve the use of paleontological resources in both the field and in museum collections.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The guidance document provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. A "Pre-Existing" tobacco product is not considered a new tobacco product and thus is not subject to the premarket requirements of the FD&C Act. A Pre-Existing tobacco product may also serve as the predicate tobacco product in a section 905(j) report (intended to be used toward demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the FD&C Act( 21 U.S.C. 387e(j)(1)(A)(i))). FDA interprets the phrase "as of February 15, 2007," as meaning that the tobacco product was commercially marketed in the United States on February 15, 2007. The guidance associated with this collection of information recommends that the manufacturer submit information adequate to demonstrate that the tobacco product was commercially marketed in the United States as of February 15, 2007. Examples of such information may include, but are not limited to, the following: dated copies of advertisements, dated catalog pages, dated promotional material, and dated bills of lading.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

IRC Section 402(e) allows taxpayers to compute a separate tax on a lump sum distribution from a qualified retirement plan. Form 4972 is used to correctly figure that tax. The data is used to verify the correctness of the separate tax. Form 4972 is also used to make the special 20% capital gain election attributable to pre-1974 participation from the lump-sum distribution.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

This non-substantive change request on OMB Control No. 2126-0001 corrects the CFR citations in the two information collections. The Hours of Service (HOS) rules apply to both property and passenger motor carriers. The HOS rules set limits on the on-duty time and driving time of CMV drivers, and mandate the amount and frequency of the time off-duty that such drivers must receive. Two types of information are collected under this IC: (1) drivers’ daily record of duty status (RODS) (electronic records or, in some cases, paper logbooks), and (2) supporting documents, such as fuel and toll receipts, that may be used by motor carriers to verify the accuracy of the RODS and to document expense deductions taken in the determination of taxable income. The information is collected on an annual basis. The purpose of the collection of the RODS and supporting documents of the HOS rules is to provide the Agency with its most effective tool in combating driver fatigue. Enforcement officials at roadside employ the RODS and supporting documents to determine the amount of time a driver has spent off duty prior to the driver’s current duty day. They also determine the amount of time the driver has been on duty that duty day, and the amount of time the driver has been behind the wheel driving during the duty day. Enforcement officials examine the RODS for seven of the immediately preceding days to determine compliance with the HOS rules. The RODS are an invaluable tool used to detect inaccurate and falsified logs that facilitates removing fatigued, unsafe drivers off the road. Enforcement officials employ the RODS and supporting documents retained by the motor carrier when conducting on-site investigative reviews of motor carriers. The safety assessments that result from such reviews are public information, and many shippers routinely examine the assessments, as well as crash and regulatory compliance records, when selecting a motor carrier. The Motor Carrier Safety Assistance Program (MCSAP) requires States, as a condition of receiving grant funding, to adopt and enforce State CMV safety laws and regulations that are compatible with the FMCSRs and these include the HOS rules. States embrace the Federal enforcement scheme for regulating safety in the operation of CMVs, and work closely with Federal investigators in enforcing the HOS rules. Motor carriers also help FMCSA detect fatigued drivers. It is in their interest to be proactive in detecting inaccuracy or falsification of RODS by their CMV drivers to avoid the penalties resulting from such infractions. Replacing paper RODS with electronic RODS enhances the accuracy and minimizes the falsification of RODS. Motor carriers will continue to examine the supporting documents, such as fuel receipts, toll receipts, bills of lading, repair invoices, and compare them to the entries on the RODS. Comparing supporting documents to the RODS helps the motor carrier verify the accuracy of the HOS reported by their CMV drivers. Motor carrier use of the RODS and driver-supplied supporting documents enhances driver adherence to the HOS rules, keeps fatigued drivers off the road, and helps FMCSA protect the public. This ICR supports the Department of Transportation’s Strategic Goal of Safety because the information helps the Agency improve the safety of drivers operating CMVs on our Nation’s highways.

Key Information

Federal Register Notices

Abstract

Federal agencies are required to survey their customers to determine the kind and quality of services customers want and their level of satisfaction with those services. Analysis from the survey is used to measure FEMA's Strategic Plan's objective 3.1 to streamline the disaster survivor experience.

Key Information

Federal Register Notices

Abstract

Collection of information is necessary to fulfill obligations of the regulation at 15 CFR 2011 subpart B to issue specialty sugar certificates, letters to importers signed by the FAS Certifying Authority, and to ensure that U.S. importers comply with requirements. The regulation sets forth the terms and conditions under which the Certifying Authority in FAS issues certificates to importers allowing them to compete to enter specialty sugars under the tariff-rate quota (TRQ) for refined sugar.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The information collection requires renderers, feed manufacturers, and others involved in feed and feed ingredient manufacturing and distribution to maintain written procedures specifying the cleanout procedures or other means and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment. These written procedures are intended to help the firm formalize consistent processes, and then to help inspection personnel confirm that the firm is conducting these processes in compliance with the regulation.

Key Information

Federal Register Notices

Abstract

Under the Railroad Retirement Act, the benefits payable to an annuitant living outside the United States may be subject to withholding under Public Laws 98-21 and 98-76. The form obtains the information needed to determine the amount to be withheld.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Internal Revenue Code (IRC) 6111 requires a sub-set of promoters called “material advisors” to disclose information about the promotion of certain types of transactions called “reportable transactions.” Material advisors to any reportable transaction must disclose certain information about the reportable transaction by filing a Form 8918 with the IRS. Material advisors who file a Form 8918 will receive a reportable transaction number from the IRS. Material advisors must provide the reportable transaction number to all taxpayers and material advisors for whom the material advisor acts as a material advisor.

Key Information

Federal Register Notices

Abstract

The Department of Defense Education Activity (DoDEA) receives requests from researchers to conduct non-DoDEA sponsored research studies in DoDEA schools, districts, and/or areas. To review the proposed research requests, DoDEA is seeking renewal for the DoDEA “Research Study Request” Form 1304.01-F1. The DoDEA “Research Study Request” collects information about the researcher, the research project, audience, timeline, and the statistical analyses that will be conducted during the proposed research study. This information is needed to ensure that the proposed non-DoDEA sponsored research does not unduly interfere with the classroom instructional process or the regular operations of the school, district, and/or areas.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

This regulation promulgates the policies and procedures for making and processing Community Facilities Loans.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Taxpayers will file Form 8910 to claim the credit for certain alternative motor vehicles placed in service during the tax year. The credit attributable to depreciable property (vehicles used for business or investment purposes) is treated as a general business credit. They can report the credit directly on line 1r in Part 111 of form 3800.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

Information is needed to figure and report an installment sale for a casual or incidental sale of personal property, and a sale of real property by someone not in the business of selling real estate. Data is used to determine whether the installment sale has been properly reported and the correct amount of profit is included in income on the taxpayer's return.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The elements of the manufactured food regulatory program standards are intended to ensure that the States have the best practices of a high-quality regulatory program to use for self-assessment and continuous improvement and innovation. The ten standards describe the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the State program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist State programs in determining their level of conformance with the standard. FDA will use the program standards as a tool to improve contracts with State agencies. The program standards will assist both FDA and the States in fulfilling their regulatory obligations.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

The items covered by this information collection package are used for the planning and design of electric distribution, transmission, and generation system and facilities owned by RUS Borrowers.