Information Collection Request (ICR) Tracker
ICR Definition
An Information Collection Request (ICR) is a federal agency’s request for approval from the Office of Management and Budget (OMB) to collect information from the public.
Under the Paperwork Reduction Act (PRA), agencies must justify why the information is needed and how it will be used.
Federal agencies are required to submit an ICR whenever they create, renew, modify, or discontinue an information collection. Each ICR includes a description of the collection,
supporting materials and documentation (such as forms, surveys, or scripts), and proof that the agency has met the requirements of the PRA.
The ICR is submitted to the The Office of Information and Regulatory Affairs (OIRA) within OMB for review and approval. OIRA grants approval for a maximum of three years, after
which the collection must be renewed through a new ICR submission.
ICRs are publicly available on RegInfo.gov, and additional guidance can be found in the FAQs.
ICR Explorer
Showing 20 of 610 results
Reference Number | Title | Agency | Expires | Request Type | ||||||||||||||||
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202203-2900-018 | Application for Veterans Pension (VA Form 21P-527EZ) and (VA Form 21P-527) | VA | 2025-08-31 | Revision of a currently approved collection
Application for Veterans Pension (VA Form 21P-527EZ) and (VA Form 21P-527)
Key Information
Federal Register Notices
Authorizing StatutesAbstractVA Form 21P-527EZ, is the prescribed form for claiming Veterans Pension under the Fully Developed Claim program. VA Form 21P-527 is used to gather the necessary information to determine a veteran’s eligibility for Veterans Pension. Without this information, VA will not be able to determine a Veteran’s eligibility to the benefit. A Veteran may also use this form to file a new Veterans Pension claim after VA has discontinued a previous pension award and the Veteran is requesting his or her benefits be reinstated. |
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202203-3064-005 | Market Risk Regulatory Report for Institutions Subject to the Market Risk Capital Rule- FFIEC 102 | FDIC | 2025-08-31 | Extension without change of a currently approved collection
Market Risk Regulatory Report for Institutions Subject to the Market Risk Capital Rule- FFIEC 102
Key Information
Federal Register Notices
Authorizing Statutes12 USC 1817 (View Law) 12 USC 1464 (View Law) AbstractThe Market Risk Regulatory Report for Institutions Subject to the Market Risk Capital Rule (FFIEC 102). is filed quarterly by FDIC-supervised banks and savings associations that are subject to the market risk capital rule. A bank, savings association, bank holding company, savings and loan holding company, or U.S. intermediate holding company must apply the market risk capital rule if the institution has aggregate trading assets and trading liabilities, as reported in the institution’s most recent Consolidated Reports of Condition and Income (Call Report) or Consolidated Financial Statements for Holding Companies (FR Y-9C), as applicable, equal to (a) 10 percent or more of quarter-end total assets or (b) $1 billion or more. The data collected in the Market Risk Regulatory Report is needed to assess the reasonableness and accuracy of a market risk institution’s calculation of its minimum capital requirements under the revised market risk capital rule and to evaluate a market risk institution’s capital in relation to its risks. Each market risk institution is required to file the FFIEC 102. The FFIEC 102 allows the agencies to better track growth in the more credit-risk related, less liquid, and less actively traded products subject to the market risk rule. |
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202204-0910-014 | Substances Generally Recognized as Safe: Notification Procedure | HHS/FDA | 2025-08-31 | Extension without change of a currently approved collection
Substances Generally Recognized as Safe: Notification Procedure
Key Information
Federal Register Notices
Authorizing Statutes21 USC 321 (View Law) 21 USC 348 (View Law) AbstractThis ICR collects information from food manufacturers who wish to obtain a determination from FDA that a food additive is generally recognized as safe (GRAS) and therefore not subject to premarket approval requirements. Respondents submit information as provided in agency regulations regarding GRAS notification, including a description of the substance, intended use, previous communications with the agency, contact information, etc. FDA has developed Form 3667 to facilitate its review of information being submitted so that a GRAS determination can be made. Food additives that are not GRAS must obtain premarket approval. |
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202204-2127-002 | Investigation-Based Crash Data Studies | DOT/NHTSA | 2025-08-31 | Revision of a currently approved collection
Investigation-Based Crash Data Studies
Key Information
Federal Register Notices
Authorizing Statutes23 USC Chapter 4-sec 403 (View Law) 49 USC Chapter 301 - sec 30182 (View Law) Abstracthe information collected serves to identify and develop safety countermeasures that will reduce the severity of injury and property damage caused by motor vehicle crashes. These Investigation-Based Crash Data Studies -- Crash Investigation Sampling System (CISS), Special Crash Investigations (SCI), and Special Studies -- involve voluntary information collections through which NHTSA collects detailed data on real world motor vehicle crashes. Specifically, these systems collect data, on vehicle safety system performance, occupant injury information including their kinematic interaction with interior components and scene geometry, marking and traffic controls. Respondents are police agencies that collection information on police-reported motor vehicle crashes, employees of tow yards where crashed vehicles are stored, people involved in these crashes, and hospitals with medical records for the people injured in the crash. For the standard investigation-based crash data studies acquisition process, once a crash has been selected for investigation, crash technicians or investigators locate, visit, measure, and photograph the crash scene; locate, inspect, and photograph vehicles; conduct a telephone or personal interview with the involved individuals or surrogate (another person who can provide occupant or crash information, such as parents for minor, or a parent or spouse for decreased individual); and obtain and record crash injury information received from various medical data sources. These information collections support NHTSA’s mission to save lives and prevent injuries due to traffic crashes. The data collected from these systems are used to describe and analyze circumstances, mechanisms, and consequences of serious motor vehicle crashes in the United States. Additionally, these data are used by NHTSA to identify the primary factors related to the source of crashes and their injury outcomes, develop and evaluate effective safety countermeasures, the establishment and enforcement of motor vehicle regulations, that reduce the severity of injury and property damage caused by motor vehicle crashes. On November 15, 2021, the Infrastructure Investment and Jobs Act (Pub. L. 117-58), also referred to as the Bipartisan Infrastructure Law (BIL), was signed into law. The Crash Data section (section 24108) of the BIL authorizes the Secretary of Transportation (NHTSA by delegation) to use funds to enhance the collection of data under CISS by, among other things, including additional data collection sites. In the 60-day notice NHTSA published on January 26, 2022 (87 FR 4099), NHTSA estimated that there would be 32 data collection sites in each of the next three years. As a result of the additional funding provided by the BIL, NHTSA now plans to phase in 24 additional data collection sites in CISS over the next 3 years. NHTSA is now accounting for the increases in burden hours for interviewees, Police, Tow Yards and Medical Facilities for an additional 24 data collection sites. The total data collection sites will incrementally increase from 32 to 56 over the next three years. The increase in burden hours and cost for these additional data collection sites are reflected in the Burden to Respondent section of this document. The previous request for CISS (2017) indicated 5,605 burden hours, this request increases the burden to 12,063. The request for the collection of information is revised due to a) Increasing the number of crashes investigated by Crash Technicians for 2021 and future years, b) adding Special Study crashes into this package, and c) adding Special Crash Investigation (SCI) crashes into this package. The combined impact is an increase of 6,458 burden hours to NHTSA’s overall total. |
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202206-0910-003 | Electronic Submission of Medical Device Registration and Listing | HHS/FDA | 2025-08-31 | Extension without change of a currently approved collection
Electronic Submission of Medical Device Registration and Listing
Key Information
Federal Register Notices
Authorizing StatutesAbstractThis information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver. |
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202206-0938-015 | Marketplace Quality Standards (CMS-10520) | HHS/CMS | 2025-08-31 | Revision of a currently approved collection
Marketplace Quality Standards (CMS-10520)
Key Information
Federal Register Notices
Authorizing StatutesPub.L. 111 - 148 1311(h) (View Law) Pub.L. 111 - 148 1311(c)(3)-(4) (View Law) 45 USC 156.1110 (View Law) AbstractSection 1311(c)(3) of the Affordable Care Act directs the Secretary to develop a system to rate QHPs on the basis of quality and price and requires Exchanges to display this quality rating information on their respective websites. Section 1311(c)(4) of the Affordable Care Act requires the Secretary to develop an enrollee satisfaction survey (ESS) system to assess enrollee experience with each QHP (with more than 500 enrollees in the previous year) offered through an Exchange. Section 1311(h) requires QHPs to contract with certain hospitals that meet specific patient safety and health care quality standards beginning January 1, 2015. CMS is requesting approval for information collection associated with these related Marketplace quality standards. |
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202206-1004-002 | Leasing of Solid Minerals Other Than Coal and Oil Shale (43 CFR 3500-3590) | DOI/BLM | 2025-08-31 | Extension without change of a currently approved collection
Leasing of Solid Minerals Other Than Coal and Oil Shale (43 CFR 3500-3590)
Key Information
Federal Register Notices
Authorizing Statutes30 USC Chapter 3A, Subchapter VII (View Law) 30 USC Chapter 3A, Subchapter VIII (View Law) 30 USC Chapter 3A, Subchapter I (View Law) 30 USC Chapter 3A, Subchapter IX (View Law) 30 USC Chapter 7 (View Law) 30 USC Chapter 12 (View Law) 30 USC Chapter 2 (View Law) 5 USC Appendix 30 USC 209 (View Law) 43 USC 1716 (View Law) 43 USC 1719 (View Law) 30 USC Chapter 3A, Subchapter III (View Law) AbstractThe Bureau of Land Management (BLM) seeks to renew the control number (1004-0121) pertaining to the leasing of solid minerals other than coal and oil shale other than coal and oil shale on Federal land, and the development of those lease. Respondents affected by this information collection request are those who desire to obtain lease for Federal minerals other than coal and oil shale, and operators of such leases. The regulations at 43 CFR part 3590 apply to operations for discovery, testing, development, mining, reclamation, and processing. The BLM request that OMB renew this OMB Control Number of an additional three years. |
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202206-2900-015 | RIN 2900-AR11, Fiduciary Bond (38 CFR Part 13) | VA | 2025-08-31 | Existing collection in use without an OMB Control Number
RIN 2900-AR11, Fiduciary Bond (38 CFR Part 13)
Key Information
Federal Register Notices
Authorizing Statutes38 USC Chapter 55 (View Law) 38 USC Chapter 61 (View Law) AbstractDue to Congress authorizing VA to require a prospective fiduciary to obtain a surety bond as a part of the certification process of a prospective fiduciary, VA is requiring fiduciaries to submit proof of adequate bonding with annual accounting to facilitate its oversight responsibility as mandated. RIN 2900-AR11, Fiduciary Bond, does not use a form to collect this information. However, the amended information request is made by VA field fiduciary personnel. They make the request either verbally or by letter that informs the fiduciary to submit the original bond certificate or the contractual agreement between the fiduciary and the bonding company as proof of adequate bonding. This amended collection of information is required to fulfill VA requirements mandated by Congress, for oversight of fiduciaries. The VA Fiduciary Program would not be able to provide adequate oversight of certain fiduciaries appointed to receive VA benefits in excess of $25,000 on behalf of a beneficiary without proof that surety bonds are in place to protect these funds. |
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202207-0938-019 | Agent/Broker Data Collection in Federally-facilitated Health Insurance Exchanges (CMS-10464) | HHS/CMS | 2025-08-31 | Extension without change of a currently approved collection
Agent/Broker Data Collection in Federally-facilitated Health Insurance Exchanges (CMS-10464)
Key Information
Federal Register Notices
Authorizing StatutesPub.L. 111 - 152 1217 (View Law) Pub.L. 111 - 148 1312(e) (View Law) AbstractThe Center for Consumer Information and Insurance Oversight (CCIIO), the agency within Centers for Medicare & Medicaid Services (CMS) charged with helping implement many provisions of the Affordable Care Act including the establishment of Affordable Insurance Exchanges (Exchanges), needs to collect data from individual agent/brokers to register them with the Federally-facilitated Exchange (FFE) and provide the required training in Exchange enrollment policies and procedures. Both section 1312(e) of the Affordable Care Act and 45 CFR ?155.220 permit States to allow agent/brokers to enroll individuals, employers, and employees in Qualified Health Plans (QHPs), including through the Exchanges; and assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions. Agent/brokers will serve as additional access points to the Exchange for individuals or SHOP employers/employees requiring or desiring agent/broker assistance. Agent/brokers must register with the FFE and meet training requirements that enforce their understanding of eligibility and enrollment in Exchanges prior to enrolling individuals or SHOP employer/employees in QHPs through the Exchanges. They must also apply this understanding to the development of any non-Exchange Web site used as a tool for enrollment. Agent/broker designed and administered web sites or tools will improve the flow of information to the FFE, and State-based Exchanges may also find these tools useful toward streamlining data submissions and easing the burden on the Exchange. The collection of information from agent/brokers described in detail below is needed to register and completion training with the FFE. Collected information will be used by CMS/CCIIO to verify the completion of the training requirement, provide the public with a list of registered agent/brokers trained in Exchange enrollment requirements and functions, and perform oversight of agent/brokers operating through the FFE. |
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202207-1557-003 | Country Exposure Report and Country Exposure Information Report (FFIEC 009/FFIEC 009a) | TREAS/OCC | 2025-08-31 | Revision of a currently approved collection
Country Exposure Report and Country Exposure Information Report (FFIEC 009/FFIEC 009a)
Key Information
Federal Register Notices
Authorizing StatutesAbstractThese reports are used by the OCC to monitor overseas exposure of U.S. banks in individual countries. The OCC uses the information to analyze trends in overseas lending by individual U.S. banks and the U.S. banking system as a whole. The data are preliminary indicators of relative levels of risk undertaken by individual banks and serve as a crucial tool in the examination process. |
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202207-3038-006 | Swap Data Recordkeeping and Reporting Requirements: Pre-Enactment and Transition Swaps | CFTC | 2025-08-31 | Revision of a currently approved collection
Swap Data Recordkeeping and Reporting Requirements: Pre-Enactment and Transition Swaps
Key Information
Federal Register Notices
Authorizing StatutesPub.L. 111 - 203 124 Stat. 1376 (2010) (View Law) 7 USC . 2(a), 21(b), and 2(h)(5)(B) (View Law) AbstractThe information is needed to ensure that the Commission and other regulators have access to complete data concerning swaps, as required by the Commodity Exchange Act as amended by the Dodd-Frank Act. The data would be reported to and maintained in swap data repositories, where it would not be disclosed publicly, but would be available to the Commission and other financial regulators for fulfillment of various regulatory mandates. The information is for use by government entities to provide oversight and supervision and to ensure compliance with statutes and regulations relating to swaps. Respondents are entities or persons who trade swaps. The Commission’s regulations in Part 46 require reporting counterparties to report data for pre-enactment swap and transition swaps to SDRs. The SDRs provide this data to the Commission directly. The Commission uses this data in connection with fulfilling its regulatory duties. |
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202207-7100-005 | Market Risk Regulatory Report for Institutions Subject to the Market Risk Capital Rule | FRS | 2025-08-31 | Extension without change of a currently approved collection
Market Risk Regulatory Report for Institutions Subject to the Market Risk Capital Rule
Key Information
Federal Register Notices
Authorizing Statutes12 USC 1844(c) (View Law) 12 USC 1467a(b)(3) (View Law) 12 USC 3106 (View Law) 12 USC 324 (View Law) AbstractThe market risk rule, which requires banking organizations to hold capital to cover their exposure to market risk, is an important component of the regulatory capital rules that have been adopted by the Board, Federal Deposit Insurance Corporation (FDIC), and Office of the Comptroller of the Currency (OCC) (collectively, the agencies). In order to implement the market risk rule, the agencies, acting under the auspices of the FFIEC, implemented the FFIEC 102, which collects key information from respondents on how they measure and calculate market risk under the regulatory capital rules. The Board’s market risk rule applies to state member banks (SMBs), bank holding companies (BHCs), covered savings and loan holding companies (covered SLHCs), and intermediate holding companies (IHCs) with aggregate reported trading assets and trading liabilities equal to or greater than 10 percent of quarter-end total assets or $1 billion (collectively, Board-regulated respondents). Board-regulated respondents must file the FFIEC 102 quarterly with the Board. |
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202208-0704-007 | Department of Defense Standard Tender of Freight Services | DOD/DODDEP | 2025-08-31 | Extension without change of a currently approved collection
Department of Defense Standard Tender of Freight Services
Key Information
Federal Register Notices
Authorizing StatutesAbstractTransportation Service Providers (carriers) furnish information in a uniform format so that the United States Government can determine the cost of transportation, accessorial, and security protective services and select the best value carriers for millions of Bill of Lading shipments annually. |
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202208-0938-006 | National Plan and Provider Enumeration System (NPPES) Supplemental Data Collection (CMS-10749) | HHS/CMS | 2025-08-31 | Existing collection in use without an OMB Control Number
National Plan and Provider Enumeration System (NPPES) Supplemental Data Collection (CMS-10749)
Key Information
Federal Register Notices
Authorizing StatutesPub.L. 114 - 255 4004 (View Law) Pub.L. 112 - 240 3101 (View Law) AbstractThe National Provider Identifier Application and Update Form is used by health care providers to apply for NPIs and furnish updates to the information they supplied on their initial applications. The form is also used to deactivate their NPIs if necessary. The original application form was approved in February 2005 and has been in use since May 23, 2005. The form is available on paper or can be completed via a web-based process. Health care providers can mail a paper application, complete the application via the web-based process via the National Plan and Provider Enumeration System (NPPES), or have a trusted organization submit the application on their behalf via the Electronic File Interchange (EFI) process. The Enumerator uses the NPPES to process the application and generate the NPI. NPPES is the Medicare contractor tasked with issuing NPIs, and maintaining and storing NPI data. The National Provider Identifier (NPI) Application processes over 1 million new provider and/or updates to existing application annually. |
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202208-7100-007 | Country Exposure Report; Country Exposure Information Report | FRS | 2025-08-31 | Revision of a currently approved collection
Country Exposure Report; Country Exposure Information Report
Key Information
Federal Register Notices
Authorizing Statutes12 USC 248(a) (View Law) 12 USC 602 (View Law) 12 USC 625 (View Law) 12 USC 1844(c) (View Law) 12 USC 1467a(b)(2) (View Law) 12 USC 3906 (View Law) 12 USC 5311(a)(1) (View Law) 12 USC 5365 (View Law) 12 USC 324 (View Law) AbstractU.S. commercial banks, savings associations, Edge or agreement corporations, bank holding companies (BHCs), savings and loan holding companies (SLHCs), and U.S. intermediate holding companies of foreign banking organizations (IHCs) (collectively, U.S. banking organizations) that meet certain criteria set forth in the FFIEC 009 instructions must file the quarterly FFIEC 009 with the Board, Federal Deposit Insurance Corporation (FDIC), and Office of the Comptroller of the Currency (OCC) (collectively, the agencies) to report information on international claims. The agencies use this information to monitor the degree of country risk and transfer risk in U.S. banking organizations’ portfolios and the potential impact of adverse international developments on the banking organizations. The FFIEC 009a is a supplement to the FFIEC 009 that must be filed by FFIEC 009 filers that have exposure exceeding certain thresholds set forth in the FFIEC 009a instructions. The FFIEC 009a collects quarterly information on material foreign country exposures of U.S. banking organizations. The agencies collect the FFIEC 009 and FFIEC 009a under the auspices of the FFIEC. The Board is responsible for collecting and compiling the data reported on the FFIEC 009 and FFIEC 009a on behalf of all three agencies. Each of the agencies submits a separate supporting statement to OMB for this collection of information for relevant banking organizations under their supervision. For the Board, these banking organizations are state member banks, Edge or agreement corporations, BHCs, SLHCs, and IHCs. |
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202212-1601-001 | DHS Civil Rights and Civil Liberties Complaint and Privacy Waiver Form | DHS/OS | 2025-08-31 | No material or nonsubstantive change to a currently approved collection
DHS Civil Rights and Civil Liberties Complaint and Privacy Waiver Form
Key Information
Federal Register Notices
Authorizing Statutes6 USC 345 (View Law) 42 USC 2000ee-1 (View Law) AbstractThe U.S. Department of Homeland Security (DHS), Office for Civil Rights and Civil Liberties (CRCL) reviews and investigates civil rights and civil liberties complaints filed by the public regarding U.S. Department of Homeland Security (DHS) policies and activities. Under 6 U.S.C. 345 and 42 U.S.C. 2000ee-1, CRCL reviews and assesses allegations involving a range of alleged civil rights and civil liberties abuses, such as: • Discrimination based on race, ethnicity, national origin, religion, sex, sexual orientation, gender identity, or disability; • Violation of rights while in immigration detention or as subject of immigration enforcement; • Discrimination or inappropriate questioning related to entry into the United States; • Violation of due process rights, such as the right to timely notice of charges or access to lawyer; • Violation of confidentiality provisions of the Violence Against Women Act; • Physical abuse or any other type of abuse; • Denial of meaningful access to DHS or DHS-supported programs, activities, or services due to limited English proficiency and • Any other civil rights, civil liberties, or human rights violation related to a Department program or activity, including allegations of discrimination by an organization or program that receives financial assistance from DHS. |
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202208-3137-002 | Grants to States Program “State Reporting System | IMLS | 2025-09-30 | Revision of a currently approved collection
Grants to States Program “State Reporting System
Key Information
Federal Register Notices
AbstractThe Institute of Museum and Library Services (IMLS) requests an approval of a renewal of the three-year clearance for the agency’s information collection requests for the State Reporting System for the Grants to States (G2S) Program under the Paperwork Reduction Act (PRA). Each State Library Administrative Agency (SLAA) is required, under 20 U.S.C. § 9101 et seq. (in particular 20 U.S.C. § 9134), to submit a plan that details library services goals for a five-year period, along with associated certifications. Pursuant to 20 U.S.C. § 9134 (c), each SLAA that receives an IMLS grant under the Grants to States program is required to evaluate and report on all funded project activities to IMLS, prior to the end of the execution of its five-year plan. Each SLAA receives IMLS funding to support activities for the five-year period through a series of overlapping two-year grant awards. Each SLAA must file interim and final financial reports, and final performance reports for each of these two-year grants through IMLS’s State Program Report (SPR) system. This action is to incorporate a Site Visit Checklist as a stand-alone form in the SPR system, which has an OMB Control Number of 3137-0071, expiring 8/31/2024. |
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202202-0910-004 | Agreement for Shipments of Devices for Sterilization | HHS/FDA | 2025-09-30 | Extension without change of a currently approved collection
Agreement for Shipments of Devices for Sterilization
Key Information
Federal Register Notices
Authorizing Statutes21 Stat. 351 21 Stat. 352 AbstractNonsterile 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. |
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202208-7100-006 | Notice of Proposed Stock Redemption | FRS | 2025-09-30 | Extension without change of a currently approved collection
Notice of Proposed Stock Redemption
Key Information
Federal Register Notices
Authorizing Statutes12 USC 1844(b) (View Law) 12 USC 1844 (c) (View Law) AbstractThe Bank Holding Company Act of 1956 (BHC Act) and Board’s Regulation Y - Bank Holding Companies and Change in Bank Control (12 CFR 225) require a bank holding company (BHC) to seek the prior approval of the Board before purchasing or redeeming its equity securities in certain circumstances. Due to the limited information that a BHC must provide in connection with any such request, there is no required reporting form, and each request for prior approval is generally filed 30 days before the proposed stock purchase or redemption as a notification with the Reserve Bank that has direct supervisory responsibility for the requesting BHC. The Federal Reserve uses the information provided in the redemption notice to supervise BHCs. |
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202202-0910-002 | Medical Device Accessories | HHS/FDA | 2025-09-30 | Extension without change of a currently approved collection
Medical Device Accessories
Key Information
Federal Register Notices
Authorizing Statutes21 USC 321 (View Law) AbstractThe guidance document “Medical Device Accessories--Describing Accessories and Classification Mechanisms for Accessory Types” encourages manufacturers and other parties to utilize the “de novo request” process defined in section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of medical device accessories. This process provides a pathway to class I or class II classification for accessory devices for which general controls, or general and special controls, provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. Under the de novo request process, manufacturers and other parties may submit a de novo requesting that FDA make a classification determination for the accessory device. The de novo must include a description of the device and detailed information and reasons for any recommended classification. |
Why They Are Important
ICRs play a vital role in ensuring transparency and accountability in federal data collection. When federal agencies collect information from 10 or more "persons" (which includes individuals,
businesses, and state, local, and tribal governments), they must submit an ICR to ensure that it fulfills their statutory missions, avoids unnecessary or duplicative requests, and
minimizes burden on the American public. Additionally, Federal Register Notices (FRNs) and the opportunity for public comments provide a formal way for the public to be informed of
proposed ICRs and participate in the process.
ICRs also serve as a key resource for tracking changes to federal data collections. The availability of detailed documentation, such as data collection instruments and methodologies,
allows the general public to identify revisions in a timely manner. These may include revisions prompted by Executive Orders or statistical policies like
OMB's Statistical Policy Directive No. 15 (SPD 15), which are often submitted as "nonsubstantive" or "nonmaterial" changes to a
currently approved collection.[1] Furthermore, ICRs can help determine if a data collection has expired without renewal or has been intentionally
discontinued. By reviewing ICRs, the public can better understand what data is being collected, how it evolves over time, and whether data collections have become inactive–often in response
to shifting priorities and updated standards.
How To Use The Tool
The ICR tracking tool offers a user-friendly view of ICRs that have been recently submitted, reviewed, or are nearing expiration. By aggregating key data from individual ICRs,
the tool allows users to view the current status of each request, including submission, conclusion, and expiration dates, details on whether any changes were made, authorizing statutes,
and more. Users can search for specific information and filter results based on various criteria. If seeking additional information, various text fields are hyperlinked to the full ICR
on RegInfo.gov and associated resources. The tool is updated on a daily basis to reflect the most current information available.
Column descriptions are available below the table.
Column Name
Definition
Categories Include
ICRReferenceNumber
The ICR Reference Number uniquely identifies each ICR review. This number is assigned by the OIRA system when the ICR is created.
ICR Reference Numbers are formatted YYYYMM-NNNN-XXX where YYYYMM is the month of origin, NNNN is the agency/subagency code, and XXX is a 3 digit sequential number assigned per creation per month.
N/A
ICRTitle
The title of the information collection. If the submission is a revision to a currently approved collection, the title is the name of the overall collection rather than the name of the change taking place.
N/A
DateReceived
The date OIRA received the ICR submission from the agency.
N/A
OMBControl
OIRA assigns an OMB Control Number to an Information Collection Request (ICR) upon its first arrival. The same OMB Control Number is used for each review of the ICR.
OMB Control Numbers are formatted NNNN-XXXX, where the NNNN is the agency/subagency code, and the XXXX is a sequential number uniquely identifying the Collection within the agency/subagency’s ICRs.
N/A
DateReceived
The date OIRA received the ICR submission from the agency.
N/A
PreviousICRReferenceNumber
The reference number of the ICR that immediately preceded the current one.
N/A
AgencySubagency
The federal agency and specific subagency, if applicable, that submitted the ICR.
N/A
Abstract
A brief statement describing the need for the collection of information and how it will be used.
N/A
RequestType
Describes the purpose of the agency's submission.
- "Extension without change of a currently approved collection"
- "Existing collection in use without an OMB Control Number"
- "Reinstatement with change of a previously approved collection"
- "New collection (Request for a new OMB Control Number)"
- "No material or nonsubstantive change to a currently approved collection"
- "Revision of a currently approved collection"
- "Reinstatement without change of a previously approved collection"
- "RCF Recertification"
- "RCF No Material or nonsubstantive change to a currently approved collection"
- "RCF New"
TypeOfReviewRequest
Indicates the specific type of action being requested for review.
- "Regular"
- "Emergency"
- "Delegated"
Status
Indicates the current stage of the ICR in OIRA's review process.
- "Received in OIRA" for ICRs currently under review by OIRA
- "Active" for ICRs that are currently approved for use by agencies
- "Historical Active" for previous reviews of ICRs that are currently in the active inventory
- "Historical Inactive" for previous reviews of ICRs that are not currently in the active inventory
- "PreApproved" for ICRs that will become active once the Final Rule of their associated rulemaking has been published
ConcludedDate
The date OIRA completed its review of the ICR.
N/A
ConclusionAction
OIRA's final decision about the ICR.
- “Comment filed on Interim Final Rule”
- “Comment filed on Interim Final Rule and continue”
- “Disapproved”
- “Approved without change”
- “Approved with change”
- “Comment filed on proposed rule”
- “Preapproved”
- “Withdrawn”
- “Withdrawn and continue”
- “Not subject to PRA”
- “Not subject to PRA and continue”
- “Improperly submitted”
- “Improperly submitted and continue”
- “Delegated”
- “Comment filed on proposed rule and continue”
- “Disapproved and continue”
- “Returned - Improperly Submitted”
- “Returned to Agency for Reconsideration”
- “Returned - Outside Generic Clearance”
- “Approved”
CurrentExpirationDate
The date the ICR is set to expire unless it is renewed.
N/A
AuthorizingStatues
Names of federal laws that authorize the agency to collect the information.
N/A
AuthorizingStatuesDetails
Additional details about the legal authority for the information collection, including a URL linking to the full text.
N/A
CitationsForNewStatutoryRequirements
Legal citations that have introduced new or modified statutory requirements since the last ICR submission.
N/A
FederalRegisterNotices
Lists citations of 60-day and 30-day notices published in the Federal Register.
N/A
PublicCommentsReceived
Indicates whether any public comments were received during the Federal Register notice period.
N/A
InformationCollections
Lists the individual information collections associated with the ICR. Each collection includes metadata such as the title, a URL to the collection, the form number (if applicable), and a URL to the form.
N/A
RequestType Filters
1. Select "New collection (Request for an OMB Control Number)" for collections that had not previously been used or sponsored by the agency.
2. Select "Extension without change or a currently approved collection" for collections where the agency wished only to extend the approval of an active collection past its current expiration date without making any material change in the collection instrument, instructions, frequency of collection, or the use to which the information is to be put.
3. Select "Revision of a currently approved collection" for collections where the agency request included a material change to the collection instrument, instructions, its frequency of collection, or the use to which the information is to be put.
4. Select "Reinstatement without change of a previously approved collection" for collections which previously had OMB approval, but the approval had expired or was discontinued before this submission was made, and there is no change to the collection.
5. Select "Reinstatement with change of a previously approved collection" for collections which previously had OMB approval, but the approval has expired or was discontinued before this submission was made, and there is some change to the collection.
6. Select "Existing collection in use without OMB control number" when the collection is currently in use but does not have an OMB control number.
7. Select "No material or nonsubstantive change to a currently approved collection" for collections which introduce minor changes to the ICR, but do not extend the expiration date of the collection.
8. Select "RCF No material or nonsubstantive change to a currently approved collection" for RCF collections that introduce changes to the usage of an active RCF.
9. Select "RCF New" for RCF collections that are the initial usage of the Common Form Host ICR by the using agency.
10. Select "RCF Recertification" for RCF collections that had been recertified due to changes in its related Common Form Host ICR.
[1] "Nonsubstantive" and "nonmaterial" changes introduce minor modifications to the ICR but do not extend the collection's expiration date or require a public comment period.