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 12413 results

Reference Number Title Agency Status Request Type
202410-2126-001 Financial Responsibility, Trucking and Freight Forwarding DOT/FMCSA Received in OIRA
Revision of a currently approved collection
Financial Responsibility, Trucking and Freight Forwarding

Key Information

Received 2025-05-05
OMB Control # 2126-0017
Previous ICR 202208-2126-003

Federal Register Notices

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

Authorizing Statutes

49 USC 13904 (View Law)

49 USC 13903 (View Law)

49 USC 13906 (View Law)

49 USC 13902 (View Law)

49 USC 13901 (View Law)

Abstract

FMCSA is seeking approval of revision of the ICR. This ICR has two collection periods. The first period covers the six months prior to the implementation of the Broker and Freight Forward Financial Responsibility Final Rule. There are no changes to the respondents, responses, burden hours or annual burden costs for this period. The second collection period covers the 2.5 years following the implementation of the Broker and Freight Forward Financial Responsibility Final Rule. This collection period has 200,147 respondents, 290,345 responses, 49,722 annual burden hours and a total annual burden cost of $1,725,372. This program change increase, to the existing ICR of 283 hours is due to updates made to three forms, BMC-36, BMC-84, and BMC-85 due to the implementation of the Broker and Freight Forwarder Financial Responsibility Final Rule. This ICR consists of 11 forms/ICs: IC-1, form BMC-91, IC-2: BMC-91X, IC-3: BMC-34, IC-4: BMC-82, IC-5: BMC-83, IC-6: BMC-84, IC-7: BMC-85, IC-8: BMC-35, IC-9: BMC-36, IC-10: BMC-IC-11: BMC-32. These mandatory forms are used annually for reporting purposes, by for-hire motor carriers, freight forwarders and brokers to meet the statutory requirement to submit evidence of financial responsibility prior to their registration by the FMCSA as condition for continuation of their registration. The ICR allows the FMCSA to ensure the public is protected and will be compensated for claims involving bodily injury and property damage, or loss or damage to household goods, respectively, within the limits prescribed by FMCSA. The ICR enforces the filing of surety bonds or trust fund agreements to help ensure that motor carriers and shippers are protected against non-performance of the broker’s or freight forwarder’s legal obligations. Insurance companies can be held liable for any damages that may occur to the public (up to the limits of the policy), and to supersede any exclusions or limitations which may be contained in the insured motor carrier’s or freight forwarder’s policy. Additionally, FMCSA can make a determination regarding whether an entity qualifies for the grant of self-insurance authority.

202411-1219-004 Records of Preshift and Onshift Inspections of Slope and Shaft Areas of Slope and Shaft Areas of Slope and Shaft Sinking Operations at Coal Mines DOL/MSHA Active
Extension without change of a currently approved collection
Records of Preshift and Onshift Inspections of Slope and Shaft Areas of Slope and Shaft Areas of Slope and Shaft Sinking Operations at Coal Mines

Key Information

Received 2025-05-05
Concluded 2025-06-11
Expires 2028-06-30
Action Approved without change
OMB Control # 1219-0082
Previous ICR 202201-1219-002

Federal Register Notices

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

Authorizing Statutes

30 USC 813(h) (View Law)

30 USC 811(a) (View Law)

Abstract

Coal mine operators are required to conduct inspections of slope and shaft areas of hazardous conditions, including tests for methane and oxygen deficiency, before and during each shift and before and after blasting. Records of the results of the inspections are required to be kept.

202504-0910-009 Produce Regulatory Program Standards HHS/FDA Received in OIRA
New collection (Request for a new OMB Control Number)
Produce Regulatory Program Standards

Key Information

Received 2025-05-05

Federal Register Notices

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

Abstract

This information collection helps establish and implement FDA's “Produce Regulatory Program Standards.” Section 1012 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399c) authorizes FDA to administer training and education programs for employees of State, local, Territorial, and Tribal food safety authorities relating to regulatory programs. Also, under section 205 of the FDA Safety Modernization Act (codified in 21 U.S.C. 2224), FDA, together with the Centers for Disease Control and Prevention is directed to enhance foodborne illness surveillance to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses. As part of this effort, we have initiated programs that include developing and instituting regulatory standards intended to reduce the risk of foodborne illness through coordinated efforts with our strategic partners. Regulatory program standards establish a uniform foundation for the design and management of State, local, Tribal, and Territorial programs that have the responsibility for regulating human and animal food. Partnering with other regulatory officials also helps maximize limited resources in administering FDA regulations pertaining to the manufacturing/processing, packing, or holding of food for consumption in the United States.

202504-0910-010 Generic Clearance for Quantitative Testing for the Development of FDA Communications (HFP) HHS/FDA Received in OIRA
Reinstatement without change of a previously approved collection
Generic Clearance for Quantitative Testing for the Development of FDA Communications (HFP)

Key Information

Received 2025-05-05
OMB Control # 0910-0865
Previous ICR 202201-0910-003

Federal Register Notices

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

Authorizing Statutes

21 USC 393(d)(2)(D) (View Law)

Abstract

This Generic Clearance supports the submission and approval of individual information collections designed to test messages relating to products regulated by the Human Foods Program (HFP), including foods and cosmetic products, dietary supplements, and animal food and feed, as they are being developed. We use the information to help improve the effectiveness of FDA communications and educational programs through surveys and experimental studies.

202504-0910-011 Financial Disclosure by Clinical Investigators HHS/FDA Received in OIRA
Extension without change of a currently approved collection
Financial Disclosure by Clinical Investigators

Key Information

Received 2025-05-05
OMB Control # 0910-0396
Previous ICR 202110-0910-010

Federal Register Notices

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

Authorizing Statutes

21 USC 54 (View Law)

Abstract

The collection require sponsors of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.

202505-3145-001 National Science Foundation Education and Training Application Pilot NSF Received in OIRA
Revision of a currently approved collection
National Science Foundation Education and Training Application Pilot

Key Information

Received 2025-05-05
OMB Control # 3145-0248
Previous ICR 202107-3145-002

Federal Register Notices

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

Authorizing Statutes

42 USC 1861 et seq. (View Law)

Abstract

This request is for the renewal of OMB approval for the U.S. National Science Foundation’s “Education and Training Application.” This data collection is critical for monitoring, research, and evaluating NSF’s investments in STEM education and workforce development, and essential to continue fulfilling statutory responsibilities under the Foundations for Evidence-Based Policymaking Act of 2018 (Public Law 115-435).

202504-0920-008 [NCBDDD] The Study to Explore Early Development (SEED) Follow-up Study HHS/CDC Active
No material or nonsubstantive change to a currently approved collection
[NCBDDD] The Study to Explore Early Development (SEED) Follow-up Study

Key Information

Received 2025-05-05
Concluded 2025-05-09
Expires 2026-04-30
Action Approved without change
OMB Control # 0920-1392
Previous ICR 202306-0920-008

Federal Register Notices

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

Authorizing Statutes

42 USC 247b-4 (View Law)

42 USC 241(a) (View Law)

Pub.L. 106 - 310 101 (View Law)

Pub.L. 109 - 416 409C (View Law)

Pub.L. 113 - 157 1 (View Law)

Pub.L. 116 - 60 1-2 (View Law)

Abstract

This project will be utilized to gain knowledge about the expression of autism spectrum disorder (ASD) from childhood through early adulthood that can inform efforts to improve the health and functioning of individuals with ASD as they mature. The SEED Follow-up Study will collect information from families through surveys on the health and functioning of individuals during childhood, adolescence, and young adulthood, and in-person assessments of cognitive abilities. Data obtained through this information collection may improve our understanding of which co-occurring conditions are most prevalent; increase our understanding of the needs of individuals with ASD; how the needs change with age and can be best met at different points in development; and inform research and public health policies on eligibility for services and public health outreach efforts, that could provide opportunities for education, employment, and social connection to improve the health, functioning, and quality of life among persons with ASD and their families. This CR adds Spanish versions for several of the instruments.

202504-7100-013 Senior Credit Officer Opinion Survey on Dealer Financing Terms FRS Active
No material or nonsubstantive change to a currently approved collection
Senior Credit Officer Opinion Survey on Dealer Financing Terms

Key Information

Received 2025-05-05
Concluded 2025-05-05
Expires 2025-07-31
Action Approved without change
OMB Control # 7100-0325
Previous ICR 202409-7100-001

Federal Register Notices

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

Authorizing Statutes

12 USC 225a (View Law)

12 USC 263 (View Law)

Abstract

This partially ad hoc survey collects qualitative and limited quantitative information from senior credit officers at responding financial institutions on (1) stringency of credit terms, (2) credit availability and demand across the entire range of securities financing and over-the-counter derivatives transactions, and (3) the evolution of market conditions and conventions applicable to such activities. The FR 2034 survey will be conducted quarterly, along with the Senior Loan Officer Opinion Survey on Bank Lending Practices (FR 2018; OMB No. 7100-0058). The survey contains 79 core questions divided into three broad sections, as well as additional questions on topics of timely interest.

202505-3060-007 Rules and Regulations Implementing the Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003 (CAN-SPAM ACT); CG Docket No. 04-53 FCC Received in OIRA
Extension without change of a currently approved collection
Rules and Regulations Implementing the Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003 (CAN-SPAM ACT); CG Docket No. 04-53

Key Information

Received 2025-05-02
OMB Control # 3060-1078
Previous ICR 202205-3060-001

Federal Register Notices

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

Authorizing Statutes

15 USC 7701-7713 (View Law)

Abstract

The Commission released a Report and Order on August 12, 2004 (FCC 04-52) adopting rules to prohibit the sending of commercial messages to any address referencing an Internet domain name associated with wireless subscribers' messaging services, unless the individual addressee has given the sender express prior authorization. To assist the senders of such messages in identifying those subscribers, the Commission requires that Commercial Mobile Radio Service (CMRS) providers submit those domain names to the Commission, for inclusion in a list that will be made publicly available on the FCC’s website. No individual subscriber’s electronic mail addresses will be collected or included on this list. CMRS providers will be required to supply the Commission with names of all Internet domains on which they offer mobile messaging service. The rules prohibit sending any commercial messages to addresses that contain domain names that have been included on the official list for at least 30 days or at any time prior to 30 days if the sender otherwise knows that the message is addressed to a wireless device.

202505-3060-009 FM Booster Program Origination Notification; Form 2100, Schedule 336; 47 CFR 74.1206 FCC Received in OIRA
New collection (Request for a new OMB Control Number)
FM Booster Program Origination Notification; Form 2100, Schedule 336; 47 CFR 74.1206

Key Information

Received 2025-05-02

Federal Register Notices

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

Authorizing Statutes

47 USC 154(i), 303, 310, 553 (View Law)

Abstract

On November 21, 2024, the Commission adopted the Second Report and Order and Order on Reconsideration (Second Report and Order), FCC 24-121, which allows FM and low power FM (LPFM) broadcasters to use FM booster stations to originate program content, for up to three minutes of each hour. This option allows FM and LPFM broadcasters to air programming on booster stations different from their primary station to better meet the needs and interests of local listeners. FM boosters are low power, secondary stations that operate in the FM broadcast band. They must be licensed to the same broadcaster and on the same frequency as the primary station, and rebroadcast that primary station’s signal within its protected contour. Until this proceeding, FM boosters were traditionally used only as a means to enhance weak signals of a primary FM station and could not originate programming. With advances in technology it is now possible for FM broadcasters to customize the content delivered to different parts of their service areas by using boosters to air programming different from their primary FM station. Since the April 2024 adoption of the First Report and Order in this proceeding, the Commission has allowed the use of program originating FM boosters on a temporary, experimental basis. The Second Report and Order now establishes specific processing, licensing, and service rules and permanently authorizes broadcasters to originate programming on FM boosters without the need for an experimental authorization.

202505-0694-001 Inclusions to the Section 232 National Security Adjustments to Imports DOC/BIS Active
New collection (Request for a new OMB Control Number)
Inclusions to the Section 232 National Security Adjustments to Imports

Key Information

Received 2025-05-02
Concluded 2025-05-02
Expires 2025-11-30
Action Approved without change
OMB Control # 0694-0146
Previous ICR 202504-0694-002

Federal Register Notices

60-Day FRN View Notice

Abstract

On February 10, 2025, the President issued Proclamation 10895 “Adjusting Imports of Aluminum into the United States”, and Proclamation 10896 “Adjusting Imports of Steel into the United States” which imposed a 25 percent ad valorem tariff on imports of aluminum and steel articles and certain derivative steel and aluminum articles, respectively. These Inclusions Proclamations terminated the aluminum and steel exclusions process as authorized in the clause 3 of Proclamation 9705, clause 1 of Proclamation 9777, and clause 2 of Proclamation 9980, as well as a number of country exemptions and alternative arrangements to the steel and aluminum duties implemented in subsequent Presidential Proclamations. The Inclusions Proclamations also required the Secretary of Commerce (the Secretary) to establish within 90 days a process for including additional derivative aluminum and steel articles within the scope of the ad valorem duties proclaimed in Exclusion Proclamations, Presidential Proclamation 9704, Proclamation 9705, Proclamation 9980, clause 4 of the Proclamation 10896, and clause 5 of Proclamation 10895, respectively. Presidential Proclamations 10895 and 10896 set several requirements for the Department of Commerce to include certain derivative articles of steel and aluminum under the Section 232 Steel and Aluminum Duties established by the Exclusions Proclamations. It authorizes the Secretary to include additional derivative steel or aluminum articles within the scope of the tariffs unilaterally, or at the request of a producer of steel or aluminum articles or derivative articles within the United States, or an industry association representing one or more such producers. Applications for the inclusion of derivative articles must establish that imports of a derivative article have increased in a manner that threatens to impair the national security of the United States or otherwise undermine the objectives set forth in the 2018 Section 232 investigations or any Proclamations issued pursuant thereto. The Inclusions Proclamations direct that the Secretary of Commerce shall issue a determination on any such request within 60 days of its receipt by the Department.

202503-0920-016 [PHIC] Fellowship Management System HHS/CDC Active
No material or nonsubstantive change to a currently approved collection
[PHIC] Fellowship Management System

Key Information

Received 2025-05-02
Concluded 2025-05-09
Expires 2026-03-31
Action Approved without change
OMB Control # 0920-0765
Previous ICR 202412-0920-013

Federal Register Notices

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

Authorizing Statutes

42 USC 301 (View Law)

Abstract

The Centers for Disease Control and Prevention (CDC) uses Fellowship Management System (FMS) to collect, process, and manage data from nonfederal applicants seeking training or public health support services through CDC fellowships. FMS is used to electronically submit fellowship applications, submit fellowship host site proposals, track fellows’ activities during their fellowships, and maintain fellowship alumni directories online. FMS is a key tool in CDC’s efforts to maintain and develop a robust public health workforce. This Change Request aims to follow recent executive orders.

202501-1205-002 Statement of Expenditures and Financial Adjustments of Federal Funds for Unemployment Compensation for Federal Employees and Ex-Service Members DOL/ETA Received in OIRA
Extension without change of a currently approved collection
Statement of Expenditures and Financial Adjustments of Federal Funds for Unemployment Compensation for Federal Employees and Ex-Service Members

Key Information

Received 2025-05-02
OMB Control # 1205-0162
Previous ICR 202204-1205-003

Federal Register Notices

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

Authorizing Statutes

42 USC 503(a)(6) (View Law)

Abstract

Federal civilian and military agencies must reimburse the Federal Employees Compensation Account for the amount expended for benefits to former Federal (civilian) employees and ex-servicemembers. The report informs ETA of the amount to bill such agencies.

202504-0935-001 Medical Office Survey on Patient Safety Culture Comparative Database HHS/AHRQ Received in OIRA
Reinstatement without change of a previously approved collection
Medical Office Survey on Patient Safety Culture Comparative Database

Key Information

Received 2025-05-02
OMB Control # 0935-0196
Previous ICR 202409-0935-001

Federal Register Notices

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

Authorizing Statutes

42 USC 299 (View Law)

Abstract

In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Medical Office Survey on Patient Safety Culture with OMB approval (OMB NO.0935-0131; Approved July 5, 2007). The survey is designed to enable medical offices to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 38 items that measure 10 composites of patient safety culture. In addition to the composite items, 14 items measure staff perceptions how often medical offices have problems exchanging information with other settings as well as other patient safety and quality issues. AHRQ made the survey publicly available along with a Survey User’s Guide and other toolkit materials in January 2009 on the AHRQ website. The AHRQ Medical Office SOPS Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture and may include reportable, non-required supplemental items . Medical offices in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Medical Office SOPS Database (OMB NO. 0935-0196, last approved on September 10, 2018) was developed by AHRQ in 2011 in response to requests from medical offices interested in tracking their own survey results. Those organizations submitting data receive a feedback report, as well as a report of the aggregated, de-identified findings of the other medical offices submitting data. These reports are used to assist medical office staff in their efforts to improve patient safety culture in their organizations. Rationale for the information collection. The Medical Office SOPS and the Medical Office SOPS Database support AHRQ’s goals of promoting improvements in the quality and safety of health care in medical office settings. The survey, toolkit materials, and database results are all made publicly available on AHRQ’s website. Technical assistance is provided by AHRQ through its contractor at no charge to medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.

202504-0910-012 Microbiological Testing and Corrective Measures for Bottled Water HHS/FDA Active
Reinstatement without change of a previously approved collection
Microbiological Testing and Corrective Measures for Bottled Water

Key Information

Received 2025-05-02
Concluded 2025-06-06
Expires 2028-06-30
Action Approved without change
OMB Control # 0910-0658
Previous ICR 202202-0910-003

Federal Register Notices

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

Authorizing Statutes

21 USC 349 (View Law)

Abstract

This collection requires recordkeeping by respondents who process or sell bottled water in the United States to demonstrate that their products comply with applicable testing requirements. The regulations are intended to ensure the safety of bottled water made available for human consumption.

202501-0920-010 National Coal Workers' Health Surveillance Program (CWHSP) HHS/CDC Active
Reinstatement with change of a previously approved collection
National Coal Workers' Health Surveillance Program (CWHSP)

Key Information

Received 2025-05-02
Concluded 2025-06-11
Expires 2028-06-30
Action Approved without change
OMB Control # 0920-0020
Previous ICR 202111-0920-021

Federal Register Notices

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

Authorizing Statutes

Pub.L. 91 - 173 203 (View Law)

Pub.L. 91 - 596 20 (View Law)

42 USC 37 (View Law)

Abstract

The Coal Workers' Health Surveillance Program (CWHSP) is a congressionally-mandated medical examination surveillance program for monitoring the health of coal miners. This program, which operates in accordance with 42 CFR Part 37, is useful in providing information to protect the health of coal miners and to document trends and patterns in the prevalence of coal workers' pneumoconiosis (`black lung' disease) among miners employed in U.S. coal mines.

202505-3060-008 Rules and Regulations Implementing Minimum Customer Account Record Obligations on All Local and Interexchange Carriers (CARE), CG Docket No. 02-386 FCC Active
Extension without change of a currently approved collection
Rules and Regulations Implementing Minimum Customer Account Record Obligations on All Local and Interexchange Carriers (CARE), CG Docket No. 02-386

Key Information

Received 2025-05-02
Concluded 2025-06-05
Expires 2028-06-30
Action Approved without change
OMB Control # 3060-1084
Previous ICR 202203-3060-019

Federal Register Notices

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

Authorizing Statutes

47 USC 201, 202, 222, 258 and 303 (View Law)

47 USC 151-154 (View Law)

Abstract

The Commission adopted final rules governing the exchange of customer account information between local exchange carriers and interexchange carriers. The Commission concluded that mandatory minimum standards are needed in light of record evidence demonstrating that information needed by carriers to execute customer requests and properly bill customers is not being consistently provided by all local exchange carriers and by all interexchange carriers. In December 2007, the Commission declined to adopt mandatory LEC-to-LEC data exchange requirements.

202501-1205-001 Short-Time Compensation Grants DOL/ETA Received in OIRA
Extension without change of a currently approved collection
Short-Time Compensation Grants

Key Information

Received 2025-05-02
OMB Control # 1205-0499
Previous ICR 202204-1205-002

Federal Register Notices

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

Authorizing Statutes

Pub.L. 112 - 96 2164 (View Law)

Pub.L. 116 - 136 2110 (View Law)

Abstract

The enactment of the MCTRJC contains Subtitle D, Short-Time Compensation (STC) Program, also known as the ‘‘Layoff Prevention Act of 2012.’’ The MCTRJC offers grants to implement or enhance an STC program and/or to promote and enroll employers in the program. ETA cannot monitor the STC grants without obtaining from the SWAs the quarterly status of completing the STC grant activities.

202505-1894-001 GEPA Section 427 Guidance for All Grant Applications ED/OS Active
No material or nonsubstantive change to a currently approved collection
GEPA Section 427 Guidance for All Grant Applications

Key Information

Received 2025-05-02
Concluded 2025-05-13
Expires 2026-02-28
Action Approved without change
OMB Control # 1894-0005
Previous ICR 202207-1894-001

Federal Register Notices

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

Authorizing Statutes

Pub.L. 103 - 302 427 (View Law)

Abstract

On October 20, 1994, the Improving America's Schools Act, Public Law 103-382(The Act), became law. The Act added a provision to the General Education Provisions Act (GEPA). Section 427 of GEPA requires an applicant for assistance under Department programs to develop and describe in the grant application the steps it proposes to take to ensure equitable access to, and equitable participation in, its proposed project for students, teachers, and other program beneficiaries. Applicants have responded to the GEPA 427 requirements for approximately the last 27 years, and the current form expires in June 2023. In response to the Agency's Equity Plan resulting from the President's Executive Order 13985, we now propose to update that form by expanding the number of questions from one to four. These four questions are intended to help applicants for Department grant funds to be more intentional and specific as to identifying barriers to equitable access and how they will address those barriers consistent with the requirements of section 427 of GEPA. As with the existing form, applicants retain the flexibility to determine and define for themselves the barriers to “equitable access” and “equitable participation” based on the design of their proposed grant projects and the participants and community the project proposes to serve.

202407-0910-009 Pharmaceutical Distribution Supply Chain HHS/FDA Received in OIRA
Reinstatement with change of a previously approved collection
Pharmaceutical Distribution Supply Chain

Key Information

Received 2025-05-02
OMB Control # 0910-0806
Previous ICR 202107-0910-010

Federal Register Notices

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

Authorizing Statutes

21 USC 360eee (View Law)

Abstract

This information collection implements the Drug Supply Chain Security Act. Manufacturers, repackagers, wholesale distributors, and dispensers must: (1) Notify FDA when they have determined that a product in their possession or control is illegitimate or if a manufacturer when they determine that a product has a high risk of illegitimacy; (2) terminate such notifications after consultation with FDA; (3) notify certain immediate trading partners about an illegitimate product or if a manufacturer about a product with a high risk of illegitimacy; and (4) notify immediate trading partners when such notifications are terminated.

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.