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.

Note: Presidential Action influences are notated for ICRs received between January 20, 2025 and July 19, 2025.

Showing 20 of 14013 results

Reference Number
Title
Agency
Received
Status
Request Type
Presidential Action
202411-1024-002 NPS Bear Sighting and Encounter Reports DOI/NPS 2025-09-15 Received in OIRA
Revision of a currently approved collection
NPS Bear Sighting and Encounter Reports

Key Information

Received

2025-09-15
OMB Control #
1024-0281
Previous ICR

202210-1024-001

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

54 USC 100101 (View Law)

Abstract

Bear sighting data provides the park with important data used to determine bear movements, habitat use, and species distribution. This information can be used in backcountry management and planning, field research planning, and educational outreach for visitors. Obtaining immediate information on bear-human conflicts allows managers to respond promptly to mitigate further conflicts. The National Park service will continue using NPS Forms 10-405 and 10-406 to collect information related to observations and interactions of visitors of bears in the Alaskan back country. NPS Form 10-407 will collect information in parks in the lower 48 states.

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202505-2502-002 Section 811 Project Rental Assistance (PRA) for persons with Disabilities HUD/OH 2025-09-15 Received in OIRA
Reinstatement without change of a previously approved collection
Section 811 Project Rental Assistance (PRA) for persons with Disabilities

Key Information

Received

2025-09-15
OMB Control #
2502-0608
Previous ICR

202210-2502-002

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

Pub.L. 111 - 374 811 (View Law)

Abstract

To apply for project rental assistance for extremely low-income persons with disabilities, prospective state housing agencies or other appropriate agencies with partnerships with State Health and Human Services Agency and Medicaid agencies submit completed Project Rental Assistance applications.

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202508-2126-007 Hours of Service (HOS) of Drivers Regulations DOT/FMCSA 2025-09-15 Received in OIRA
Extension without change of a currently approved collection
Hours of Service (HOS) of Drivers Regulations

Key Information

Received

2025-09-15
OMB Control #
2126-0001
Previous ICR

202507-2126-005

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

49 USC 31502 (View Law)

49 USC 31136 (View Law)

49 USC 522 (View Law)

49 USC 521 (View Law)

49 USC 526 (View Law)

Abstract

This request is for renewal of a currently approved ICR, OMB Control No. 2126-0001. The total average burden hour estimate for this ICR increased from the currently approved 50.37 million to 53.40 million hours, an increase of approximately 3.03 million burden hours. This increase is due to the increase in driver population as well as projected industry growth for drivers from 2023 through 2033. 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.

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202508-0704-006 Post Government Employment Advice Opinion Request DOD/DODDEP 2025-09-12 Received in OIRA
Reinstatement without change of a previously approved collection
Post Government Employment Advice Opinion Request

Key Information

Received

2025-09-12
OMB Control #
0704-0467
Previous ICR

202203-0704-017

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

Pub.L. 110 - 181 847 (View Law)

Abstract

The information collection is necessary to obtain minimal information on which to base an opinion about post Government employment of select former and departing Department of Defense (DoD) employees seeking to work for Defense Contractors within two years after leaving DoD. The departing or former DoD employee uses the opinion request form to organize and provide employment-related information to an ethics official who will use the information to render an advisory opinion to the employee requesting the opinion. The National Defense Authorization Act of 2008, Public Law 110-181, section 847, requires that select DoD officials and former DoD officials who, within two years after leaving DoD, expect to receive compensation from a DoD contractor, shall, before accepting such compensation, request a written opinion regarding the applicability of post-employment restrictions to activities that the official or former official may undertake on behalf of a contractor.

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202509-0930-003 988 Cooperative Agreements Monitoring Program HHS/SAMHSA 2025-09-12 Received in OIRA
No material or nonsubstantive change to a currently approved collection
988 Cooperative Agreements Monitoring Program

Key Information

Received

2025-09-12
OMB Control #
0930-0394
Previous ICR

202312-0930-001

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Abstract

The collection of this information is critical to successfully oversee operational response and quality of service through the 988 Suicide and Crisis Lifeline to ensure connections to care for individuals in suicidal crisis or emotional distress contacting in for 988 phone, chat and text support for connecting local, state/territory and national outcomes and monitoring contractual obligations for current and future 988 grant programs. Much of this information is already embedded in the current 988 Suicide and Crisis Lifeline network administrator grants, the 988 state and territory grant program, or the 988 Tribal Response grant program.

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202509-3041-002 Safety Standard for Automatic Residential Garage Door Operators 16 CFR Part 1211 CPSC 2025-09-12 Received in OIRA
Revision of a currently approved collection
Safety Standard for Automatic Residential Garage Door Operators 16 CFR Part 1211

Key Information

Received

2025-09-12
OMB Control #
3041-0125
Previous ICR

202208-3041-003

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

15 USC 2051 et seq. (View Law)

Pub.L. 101 - 608 203 (View Law)

Abstract

Recordkeeping requirements of the Safety Standard for Automatic Residential Garage Door Operators need to be reinstated to preven prevent injuries and deaths associated with garage door operator entrapment. According to the requirement (16 CR, 1211.31), written certification records must be maintained for a period of at least three years from the date of certification of each residential garage door operator subject to the standard. These certificates are based on a test or on a "reasonable" test program and must be made available upon request to CPSC in accordance with section 16(b) of the CPSA.

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202504-3235-020 Schedule 14D-9F - Canadian Securities SEC 2025-09-12 Received in OIRA
Extension without change of a currently approved collection
Schedule 14D-9F - Canadian Securities

Key Information

Received

2025-09-12
OMB Control #
3235-0382
Previous ICR

202208-3235-023

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

15 USC 78l, 78m, 78n, 78o (View Law)

15 USC 77g (View Law)

Abstract

Sections 14(d) and 14(e) of the Securities Exchange Act of 1934 (“Exchange Act”) (15 U.S.C. 78n(d) and (e)) govern certain tender offers. Under Exchange Act Rule 14d-1(b) (17 CFR 240.14d-1), the requirements of certain Commission tender offer rules are deemed satisfied in connection with any tender offer (including an exchange offer) for securities of certain Canadian foreign private issuers (where less than 40 percent of the subject class of securities is held by U.S holders) if the tender offer is subject to and complies with certain Canadian law and the disclosures required under Canadian law are filed with the Commission on Schedule 14D-1F (17 CFR 240.14d-102), among other requirements. Under Exchange Act Rule 14e-2(c) (17 CFR 240.14e-2)—in lieu of requirements under certain Commission rules that require companies subject to tender offers to make a recommendation regarding the offer—certain Canadian foreign private issuers that are the subject of a tender offer filed on Schedule 14D-1F shall file on Schedule 14D-9F (17 CFR. 240.14d–103) disclosure required under certain Canadian law. Schedule 14D-9F must also be filed by directors or officers of such companies that are the subject of the tender offer where required by Canadian law. In addition to the Canadian disclosure that is required on Schedule 14D-9F, Schedule 14-9F must include: a legend concerning the nature of the tender offer; exhibits consisting of reports required under Canadian law to be made publicly available and documents incorporated by reference into the Canadian disclosure; and an undertaking to provide requested information to the Commission. Commission rules and related schedules (including Schedule 14D-9F) that require a recommendation regarding a tender offer by the company that is the subject of the tender offer (and by its directors or officers under certain circumstances) provide important information to securityholders in making their investment decision. Schedule 14D-9F is part of the Commission’s multijurisdictional disclosure system, which reduces expense and increases efficiency in connection with filings with the Commission for certain transactions and may encourage Canadian issuers to extend certain transactions to U.S. securityholders, including tender offers. Schedule 14D-9F provides investors in the securities of Canadian foreign private issuers with the filer’s recommended response to a tender offer. This information is important to securityholders in making investment decisions. Disclosure required under Canadian law is a key aspect of the information required on Schedule 14D-9F, which reduces expense and increases efficiency in connection with tender offer filings with the Commission.

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202506-3235-008 Form G-FIN, Form G-FINW, Form G-FIN-4, and Form G-FIN-5 SEC 2025-09-12 Received in OIRA
New collection (Request for a new OMB Control Number)
Form G-FIN, Form G-FINW, Form G-FIN-4, and Form G-FIN-5

Key Information

Received

2025-09-12

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

15 USC 78o-5 (View Law)

Abstract

Certain financial institutions that are government securities brokers or government securities dealers submit information regarding their government securities activities to their appropriate regulatory authority (ARA) on the forms in this collection. The information on the forms is used by ARAs to ensure compliance with Section 15C(a)(1)(B) of the Securities Exchange Act of 1934 and with the rules of the Department of the Treasury. The SEC is an ARA, but it has not had any of these forms filed with it in the past and does not expect any to be filed with it in the future. An OMB number is being requested, with a single estimated respondent for each form, in the event circumstances changes.

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202504-3220-009 Employee Representative's Status and Compensation Reports RRB 2025-09-12 Received in OIRA
Revision of a currently approved collection
Employee Representative's Status and Compensation Reports

Key Information

Received

2025-09-12
OMB Control #
3220-0014
Previous ICR

202206-3220-001

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

45 USC 231(f) et.seq. (View Law)

Abstract

Benefits are provided under the Railroad Retirement Act (RRA) for individuals who are employee representatives as defined in section 1 of the RRA. The collection obtains information regarding the status of such individuals and their compensation.

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202507-2060-003 NSPS for Other Solid Waste Incineration (OSWI) Units (40 CFR Part 60, Subpart EEEE) (Final Rule) EPA/OAR 2025-09-12 Received in OIRA
Revision of a currently approved collection
NSPS for Other Solid Waste Incineration (OSWI) Units (40 CFR Part 60, Subpart EEEE) (Final Rule)

Key Information

Received

2025-09-12
OMB Control #
2060-0563
Previous ICR

202209-2060-002

Federal Register Notices

60-Day FRN View Notice

Authorizing Statutes

42 USC 7401 (View Law)

Abstract

The New Source Performance Standards (NSPS) for Other Solid Waste Incineration (OSWI) Units (40 CFR Part 60, Subpart EEEE) were proposed on December 9, 2004 (69 FR 71472), promulgated on December 16, 2005 (70 FR 74870), and revised on November 24, 2006 (71 FR 67802). These regulations apply to very small municipal waste combustion units (VSMWC) and institutional waste incineration (IWI) units. A new VSMWC or IWI unit is subject to this subpart if it meets either of two criteria: 1) it commenced construction after August 31, 2020; or 2) it commenced reconstruction or modification on or after 180 days after date of final rule in the Federal Regsiter. On August 31, 2020, the EPA published a proposed rule in the Federal Register for the OSWI NSPS and EG rules that addressed the requisite CAA section 129(a)(5) periodic review (85 FR 54178), as well as other proposed changes to the standards. The EPA is finalizing its CAA section 129(a)(5) review, including our determination that there are no developments in practices, processes, or control technologies that warrant revisions to the OSWI standards and requirements. The EPA is finalizing certain other revisions, including the addition of a subcategory of new VSMWC or IWI units that have a capacity to combust less than 10 TPD of waste that are constructed on or after August 30, 2020, changes to applicability-related and definitional changes; changes to the startup, shutdown, and malfunction (SSM) provisions; changes to testing, monitoring, recordkeeping, and reporting requirements; and other miscellaneous technical and editorial changes. The EPA is also finalizing electronic reporting requirements for submittal of certain reports and performance test results. This ICR includes the burden associated with the existing rule requirements and the incremental burden associated with the final rule. This information is being collected to assure compliance with 40 CFR Part 60, Subpart EEEE.

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202504-3235-019 Form F-8 - Registration Statement SEC 2025-09-12 Received in OIRA
Extension without change of a currently approved collection
Form F-8 - Registration Statement

Key Information

Received

2025-09-12
OMB Control #
3235-0378
Previous ICR

202208-3235-022

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

15 USC 77e, 77f, 77g, 77j, 77s (View Law)

Abstract

Form F-8 (17 CFR 239.38) is one of several forms for registration under the Securities Act of 1933 (“Securities Act”) available to Canadian foreign private issuers under the multijurisdictional disclosure system. Form F-8 is used for Securities Act registration of two types of transactions: (1) exchange offers and (2) business combinations requiring the vote of shareholders of the participating companies. Canadian issuers using Form F-8 file Canadian disclosure documents under cover of the form and provide indemnification disclosure and certain legends and exhibits. The simplified nature of Form F-8 disclosure promotes capital formation with less expense and greater efficiency and encourages Canadian issuers to extend exchange offers and business combinations to U.S. securityholders. The purpose of the Form F-8 information collection is to provide investors with information important to investment decisions while also promoting capital formation by reducing the cost and increasing the efficiency of Securities Act registration in connection with certain exchange offers and business combination transactions, which may encourage Canadian issuers to extend exchange offers and business combinations to U.S. securityholders. In addition, this information is used by broker-dealers, investment banking firms, professional securities analysts, and others in evaluating securities and advising on investment decision making.

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202509-0938-012 Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116) HHS/CMS 2025-09-12 Received in OIRA
Revision of a currently approved collection
Clinical Laboratory Improvement Amendments Application Form 42 CFR 493.1-.2001 (CMS-116)

Key Information

Received

2025-09-12
OMB Control #
0938-0581
Previous ICR

202309-0938-015

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

42 USC 493 (View Law)

Pub.L. 100 - 578 353 (View Law)

Abstract

Clincal Laboratory Certification - The application must be completed by entities performing laboratory's testing specimens for diagnostic or treatment purposes. This information is vital to the certification process.

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202509-0930-002 Evaluation of the Projects for Assistance in Transition from Homelessness (PATH) Program HHS/SAMHSA 2025-09-12 Received in OIRA
No material or nonsubstantive change to a currently approved collection
Evaluation of the Projects for Assistance in Transition from Homelessness (PATH) Program

Key Information

Received

2025-09-12
OMB Control #
0930-0381
Previous ICR

202303-0930-003

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

42 USC 528 (View Law)

Abstract

The primary users of the data to be collected and reported for the PATH evaluation are staff in SAMHSA/CMHS’ Homeless Programs Branch. The information to be collected will be used for two primary purposes: 1) To meet the mandates of Section 528 of the PHS Act which requires the SAMHSA Administrator to evaluate the expenditures of PATH grantees at least once every three years to ensure they are consistent with legislative requirements and to recommend changes to the program design or operations; and 2) To collect information that helps explain and better understand variations among providers on key program measures that are important for program management and policy development.

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202507-2060-008 Renewable Fuel Standard (RFS) Program: Standards for 2026 and 2027, Partial Waiver of 2025 Cellulosic Biofuel Volume Requirement, and Other Changes (Proposed Rule) EPA/OAR 2025-09-12 Received in OIRA
New collection (Request for a new OMB Control Number)
Renewable Fuel Standard (RFS) Program: Standards for 2026 and 2027, Partial Waiver of 2025 Cellulosic Biofuel Volume Requirement, and Other Changes (Proposed Rule)

Key Information

Received

2025-09-12

Federal Register Notices

60-Day FRN View Notice

Authorizing Statutes

42 USC 7401 (View Law)

Abstract

The proposed volume standards and associated percentage standards for 2026 and 2027 do not add to the burdens already estimated under existing, approved ICRs for the RFS program. This proposed rule proposes recordkeeping and reporting for domestic renewable fuel producers to implement the proposed RIN reduction for import-based renewable fuel. We anticipate the increase in burden related to identifying feedstock as foreign or domestic will be very small because the parties already are required to keep underlying records and provide reports for the RFS program, generally. General recordkeeping and reporting for the RFS program is contained in the Renewable Fuel Standard program ICR, OMB Control Number 2060-0725 (expires November 30, 2025).

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202509-3235-003 Rule 204-3, Delivery of brochures and brochure supplements SEC 2025-09-12 Active
No material or nonsubstantive change to a currently approved collection
Rule 204-3, Delivery of brochures and brochure supplements

Key Information

Received

2025-09-12
Concluded

2025-09-12
Expires

2028-08-31
Action

Approved without change
OMB Control #
3235-0047
Previous ICR

202504-3235-005

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

15 USC 80b (View Law)

Abstract

Rule 204-3 under the Investment Advisers Act of 1940 (17 CFR 275.204-3) requires SEC-registered investment advisers to deliver written disclosure statements ("brochures and brochure supplements") to clients and prospective clients containing specified information about the adviser's background, business practices, services, fees, and key supervised personnel. The SEC needs this information collection to ensure investors receive information necessary to make informed decisions about retaining or continuing to employ investment advisers, while the SEC uses the disclosed information in its enforcement, regulatory, and examination programs to monitor adviser compliance and protect investors. Respondents are SEC-registered investment advisers who must deliver current brochures before or when entering into advisory contracts, provide annual updates when there are material changes, deliver brochure supplements for key supervised personnel, and promptly notify clients of disciplinary information changes. This collection fulfills a disclosure requirement where investment advisers provide the brochures and supplements directly to their clients and prospective clients. The brochure is filed with the SEC electronically on IARD, but the brochure supplements are not. The SEC reviews these disclosure documents during examinations to assess compliance with investor protection requirements.

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202509-3041-001 Requirements Pertaining to Third Party Conformity Assessment Bodies CPSC 2025-09-12 Received in OIRA
Revision of a currently approved collection
Requirements Pertaining to Third Party Conformity Assessment Bodies

Key Information

Received

2025-09-12
OMB Control #
3041-0156
Previous ICR

202208-3041-004

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

15 USC 2063(a)(2) (View Law)

Abstract

Section 14(a)(2) of the Consumer Product Safety Act (CPSA), 15 U.S.C.2063(a)(2)requires manufacturers and private labelers of any children's product that is subject to a children's product safety rule to submit samples of the product, or samples that are identical in all material to the product to a third party conformity assessment body accredited by the CPSC to be tested for compliance with such children's product safety rule.

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202505-1240-003 Notice of Termination, Suspension, Reduction, or Increase in Benefit Payments DOL/OWCP 2025-09-12 Received in OIRA
Extension without change of a currently approved collection
Notice of Termination, Suspension, Reduction, or Increase in Benefit Payments

Key Information

Received

2025-09-12
OMB Control #
1240-0030
Previous ICR

202401-1240-002

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

30 USC 901 (View Law)

Abstract

Coal mine operators who pay monthly benefits must notify the Department's Division of Coal Mine Workers' Compensation (DCMWC) of any change in payments and the reason for that change. DCMWC uses this notification to monitor payments and ensure that beneficiaries receive the correct benefit rate.

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202504-3220-001 Nonresident Questionnaire RRB 2025-09-12 Received in OIRA
Revision of a currently approved collection
Nonresident Questionnaire

Key Information

Received

2025-09-12
OMB Control #
3220-0145
Previous ICR

202206-3220-003

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

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.

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202503-0910-004 Export of Medical Devices ; Foreign Letters of Approval HHS/FDA 2025-09-11 Received in OIRA
Extension without change of a currently approved collection
Export of Medical Devices ; Foreign Letters of Approval

Key Information

Received

2025-09-11
OMB Control #
0910-0264
Previous ICR

202208-0910-016

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

21 USC 381 and 382 (View Law)

Abstract

This information collection supports requests for foreign letters of approval to facilitate the export of FDA-regulated devices.

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202502-0910-003 Medical Device Accessories HHS/FDA 2025-09-11 Received in OIRA
Extension without change of a currently approved collection
Medical Device Accessories

Key Information

Received

2025-09-11
OMB Control #
0910-0823
Previous ICR

202202-0910-002

Federal Register Notices

60-Day FRN View Notice
30-Day FRN View Notice

Authorizing Statutes

21 USC 321 (View Law)

Abstract

The 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.

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