Change Requests
What is an ICR?
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.
When are they submitted?
Federal agencies are required to submit an ICR whenever they create, renew, modify 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.
Where to find an ICR?
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 25 of 1250 results
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| 202601-0572-001 | 7 CFR Part 1786, Prepayment of RUS Guaranteed & Insured Loans to Electric & Telephone Borrowers | USDA/RUS | 2026-01-14 | None | None | Received in OIRA | Revision of a currently approved collection
7 CFR Part 1786, Prepayment of RUS Guaranteed & Insured Loans to Electric & Telephone Borrowers
Key Information
Abstract
This information collection contains submissions for 7 CFR part 1786, subpart E, "Discounted Prepayments on RUS Notes in the Event of a Merger of Certain RUS Electric Borrowers", subpart F, "Discounted Prepayments on RUS Electric Loans", and subpart G, "Refinancing and Prepayment of RUS Guaranteed FFB Loans pursuant to Section 306(c) of the RE Act". Subparts E and F allow agency borrowers to prepay RUS loans and subpart G allows refinancing. |
- | 0572-0088 | ||
| 202601-0570-001 | Food Supply Chain Guarantee Loan Program | USDA/RBS | 2026-01-14 | None | None | Received in OIRA | Revision of a currently approved collection
Food Supply Chain Guarantee Loan Program
Key Information
Abstract
Section 1001 of the American Recovery Act of 2021, P.L. 117-2 provided funding for fiscal year 2022 (FY22) to the Secretary of Agriculture to provide assistance to maintain and improve food and agricultural supply chain resiliency. The purpose of the Food Supply Chain (FSC) Guaranteed loan is to make funds available to qualified applicants and projects to facilitate financing for the start-up or expansion of activities in the middle of the food supply chain, particularly the aggregation, processing, manufacturing, storing, transporting, wholesaling, or distribution of food, to increase capacity and help create a more resilient, diverse, and secure U.S. food supply chain. |
- | 0570-0077 | ||
| 202512-0648-006 | Alaska American Fisheries Act Permits | DOC/NOAA | 2026-01-14 | None | None | Received in OIRA | Extension without change of a currently approved collection
Alaska American Fisheries Act Permits
Key Information
Abstract
The National Marine Fisheries Service (NMFS), Alaska Regional Office, requests extension of this currently approved information collection. This information collection contains applications for permits and transfers necessary for NMFS to manage the Bering Sea and Aleutian Islands (BSAI) pollock fishery under the American Fisheries Act. The AFA established sector allocations in the BSAI pollock fishery, determined eligible vessels and processors, allowed the formation of cooperatives, set limits on the participation of AFA vessels in other fisheries, and imposed special catch weighing and monitoring requirements on AFA vessels. No changes have been made to the forms since the 2023 renewal. |
- | 0648-0393 | ||
| 202511-0704-006 | Defense Federal Acquisition Regulation Supplement (DFARS) part 225, Foreign Acquisition, and Defense Contractors Performing Private Security Functions Outside the United States | DOD/DODDEP | 2026-01-14 | None | None | Received in OIRA | Reinstatement without change of a previously approved collection
Defense Federal Acquisition Regulation Supplement (DFARS) part 225, Foreign Acquisition, and Defense Contractors Performing Private Security Functions Outside the United States
Key Information
Abstract
In accordance with section 862 of the National Defense Authorization Act of 2008 (Pub. L. 110-181) contractors performing private security functions are required to establish a process under which contractors are required to report certain security incidents. These contractors must ensure that their personnel performing private security functions comply, reporting incidents in which a weapon is discharged, personnel are attacked or killed, or property is destroyed, or active, lethal countermeasures are employed. |
- | 0704-0549 | ||
| 202509-0704-004 | Defense Federal Acquisition Regulation Supplement (DFARS) Part 228, Bonds and Insurance, and Related Clauses at 252.228 | DOD/DODDEP | 2026-01-14 | None | None | Received in OIRA | Revision of a currently approved collection
Defense Federal Acquisition Regulation Supplement (DFARS) Part 228, Bonds and Insurance, and Related Clauses at 252.228
Key Information
Abstract
DFARS Part 228 and the related clauses at 252.228 require contractors to submit information concerning data required to enable processing and monitoring of accident reports/insurance claims relating to war hazard losses and other accidents involving aircraft, missiles, or space launch vehicles; and written representation that non-Spanish concerns have obtained the required types of insurance under service or contruction contracts to be performed in Spain by other than Spanish concerns. |
- | 0704-0216 | ||
| 202601-2137-001 | Class Location Change Notification Requirements | DOT/PHMSA | 2026-01-14 | None | None | Received in OIRA | New collection (Request for a new OMB Control Number)
Class Location Change Notification Requirements
Key Information
Abstract
The Pipeline Safety: Class Location Change Requirements Final Rule requires natural gas transmission pipeline operators to notify PHMSA if they choose to use an alternative to either an inline-inspection device or when conducting pressure tests on their pipelines. This information collection allows operators who choose to use a different method of pressure testing to demonstrate that the alternative method is sufficient and for the Office of Pipeline Safety to ensure that the technology is suitable for use. Operators will also be required to notify PHMSA if they use Integrity Management protocols to manage pipeline segments that have changed from a Class 1 to a Class 3 location. This prompt notification would provide PHMSA an opportunity to oversee the operator’s implementation of the proposed Class 1 to Class 3 location segment regulations. This information collection promotes the US DOT’s Safety Strategic Goals. The PHMSA delegation of authority is found in 49 CFR 1.97 which allows for PHMSA to exercise the authority vested in the Secretary in under Chapter 601 of title 49, U.S.C. |
- | 2137-0639 | ||
| 202512-0572-001 | 7 CFR Part 1717, Subpart Y, "Settlement of Debt Owed by Electric Borrowers" | USDA/RUS | 2026-01-14 | None | None | Received in OIRA | Revision of a currently approved collection
7 CFR Part 1717, Subpart Y, "Settlement of Debt Owed by Electric Borrowers"
Key Information
Abstract
This collection of information implements RUS policies and procedures for settlement of debt owed by electric borrowers. This collection requires only information essential for determining the need for debt settlement; the amount of relief needed; amount of debt that can be repaid; scheduling of repayment; and, opportunities for enhancing the amount of debt that can be recovered. |
- | 0572-0116 | ||
| 202512-0572-003 | 7 CFR 1792, Subpart C-Seismic Safety of New Building Construction | USDA/RUS | 2026-01-14 | None | None | Received in OIRA | Revision of a currently approved collection
7 CFR 1792, Subpart C-Seismic Safety of New Building Construction
Key Information
Abstract
This regulation provides RUS borrowers, grant recipients, and the public with rules for compliance with seismic safety requirements for new building construction using RUS loan, grant, or guaranteed funds. |
- | 0572-0099 | ||
| 202512-0572-002 | 7 CFR Part 1717, Subpart D, Mergers and Consolidations of Electric Borrowers | USDA/RUS | 2026-01-14 | None | None | Received in OIRA | Revision of a currently approved collection
7 CFR Part 1717, Subpart D, Mergers and Consolidations of Electric Borrowers
Key Information
Abstract
This information addresses the requirements of RUS policies and procedures for mergers and consolidations of RUS electric program borrowers. |
- | 0572-0114 | ||
| 202511-0945-001 | 42 CFR Part 2 HHS Complaint Form | HHS/OCR | 2026-01-13 | None | None | Received in OIRA | New collection (Request for a new OMB Control Number)
42 CFR Part 2 HHS Complaint Form
Key InformationAbstract
This information collection addresses the burden on individuals for filing a complaint of a potential violation of 42 CFR Part 2, Confidentiality of Substance Use Disorder (SUD) Patient Records, with the HHS Secretary through the Office for Civil Rights. |
- | |||
| 202601-0938-004 | Rural Emergency Hospital Quality Reporting (REHQR) (CMS-10870) | HHS/CMS | 2026-01-13 | None | None | Received in OIRA | Revision of a currently approved collection
Rural Emergency Hospital Quality Reporting (REHQR) (CMS-10870)
Key Information
Abstract
The Consolidated Appropriations Act (CAA), 2021, was signed into law in December 2020. In this legislation, Congress established a new Medicare provider type: Rural Emergency Hospitals (REHs). Section 125 of Division CC of the CAA, 2021 added section 1861(kkk) to the Social Security Act (the Act). This section defines an REH as a facility that, in relevant part, was as of December 27, 2020: (1) a Critical Access Hospital (CAH) or a subsection (d) hospital with not more than 50 beds located in a county (or equivalent unit of local government) in a rural area (defined in section 1886(d)(2)(D) of the Act); or (2) was a subsection (d) hospital with not more than 50 beds that was treated as being in a rural area pursuant to section 1886(d)(8)(E) of the Act. Under section 1861(kkk)(7) of the Act, as added by section 125 of Division CC of the CAA, 2021, the Secretary is required to establish quality measurement reporting requirements for REHs, which may include the use of a small number of claims-based measures or patient experience surveys. An REH must submit quality measure data to the Secretary, and the Secretary shall establish procedures to make the data available to the public on a CMS website. |
- | 0938-1454 | ||
| 202512-0920-007 | [NCHHSTP] The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs) | HHS/CDC | 2026-01-13 | None | None | Received in OIRA | Reinstatement without change of a previously approved collection
[NCHHSTP] The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
Key Information
Abstract
The purpose of this information collection is to determine the acceptability and feasibility of NATs that are used at the point-of-care (POC NAT) implementation in clinical and community settings. POC NATs have the potential to help address some of the remaining challenges to ending the HIV epidemic in the United States by assisting with early detection of acute HIV infection and by providing a more efficient viral load monitoring tool for people living with HIV. This study is the first of its kind in the US and is critical to understanding the utility of rapid point-of-care (POC) nucleic acid tests (NAT) and provider and patient perspectives on its use in the US. |
- | 0920-1357 | ||
| 202508-1210-003 | Model Employer Children's Health Insurance Program Notice | DOL/EBSA | 2026-01-13 | None | None | Received in OIRA | Extension without change of a currently approved collection
Model Employer Children's Health Insurance Program Notice
Key Information
Abstract
On February 4, 2009, President Obama signed the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA, Pub. L. 111-3). Under ERISA section 701(f)(3)(B)(i)(I), Public Health Service Act (PHS) section 2701(f)(3)(B)(i)(I), and section 9801(f)(3)(B)(i)(I) of the Internal Revenue Code, as added by Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), an employer that maintains a group health plan in a State that provides medical assistance under a State Medicaid plan under title XIX of the Social Security Act (SSA), or child health assistance under a State child health plan under title XXI of the SSA, in the form of premium assistance for the purchase of coverage under a group health plan, is required to make certain disclosures. Specifically, the employer is required to notify each employee of potential opportunities currently available in the State in which the employee resides for premium assistance under Medicaid and CHIP for health coverage of the employee or the employee's dependents. These notices are referred to as “Employer CHIP Notices.” ERISA section 701(f)(3)(B)(i)(II) requires the Department of Labor to provide employers with model language for the Employer CHIP Notices to enable them to timely comply with this requirement, which is referred to as the “Model Employer CHIP Notice.” The model language is required to include information on how an employee may contact the State in which the employee resides for additional information regarding potential opportunities for premium assistance, including how to apply for such assistance. |
- | 1210-0137 | ||
| 202512-0920-002 | Performance Progress and Monitoring Report | HHS/CDC | 2026-01-13 | None | None | Received in OIRA | Extension without change of a currently approved collection
Performance Progress and Monitoring Report
Key Information
Abstract
The purpose of the Performance Progress and Monitoring Report (PPMR, OMB Control No. 0920-1132) is to help CDC be responsible for the stewardship of these funds while providing excellent, professional services to our partners and stakeholders. This Extension request will not change the forms or Burden Hours for the approved ICR. |
- | 0920-1132 | ||
| 202601-0938-003 | Ambulatory Surgical Center Quality Reporting Program (CMS-10530) | HHS/CMS | 2026-01-13 | None | None | Received in OIRA | Revision of a currently approved collection
Ambulatory Surgical Center Quality Reporting Program (CMS-10530)
Key Information
Abstract
Section 109(a) of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109-432) amended section 1833(t) of the Social Security Act by adding a new subsection (17) that affects the payment rate update applicable to Outpatient Prospective Payment System (OPPS) payments for services furnished by hospitals in outpatient settings on or after January 1, 2009. Section 1833(t)(17)(A) of the Social Security Act, which applies to hospitals as defined under section 1886(d)(1)(B) of the Social Security Act, requires that hospitals that fail to report data required for quality measures selected by the Secretary in the form and manner required by the Secretary under section 1833(t)(17)(B) of the Social Security Act will incur a reduction in their annual payment update (APU) factor to the hospital outpatient department fee schedule by 2.0 percentage points. Hospital OQR Program payment determinations are made based on Hospital OQR Program quality measure data reported and supporting forms submitted by hospitals as specified through rulemaking. To reduce burden, a variety of different data collection mechanisms are employed, with every consideration taken to employ existing data and data collection systems. |
- | 0938-1270 | ||
| 202601-0930-001 | Toolkit Protocol for the Crisis Counseling Assistance and Training Program (CCP) | HHS/SAMHSA | 2026-01-13 | None | None | Received in OIRA | Reinstatement without change of a previously approved collection
Toolkit Protocol for the Crisis Counseling Assistance and Training Program (CCP)
Key Information
Abstract
Data collection about services delivered and users of the services will be collected from the CCPs through standardized information tools which will then be reported to SAMHSA for appropriate processing and analysis. CCPs will be required to use the tools for data collection throughout the life of the program. |
- | 0930-0270 | ||
| 202601-1845-003 | Work Colleges Application and Agreement | ED/FSA | 2026-01-13 | None | None | Received in OIRA | No material or nonsubstantive change to a currently approved collection
Work Colleges Application and Agreement
Key Information
Abstract
The Higher Education Opportunity Act, Pub. L. 110-315, established the allocation of Federal Work Study funds to recognize, encourage, and promote the use of comprehensive work-learning service programs as part of a financial plan which decreases reliance on grants and loans. The Work Colleges Program is one of the three Federal Work-Study Programs. The other two Federal Work-Study Programs are the Federal Work-Study (FWS) Program and the Job Location and Development (JLD) Program. This is request for an extension without change of the current information collection. The participants are required to apply initially and once approved and participating, must reapply annually. The data collected is used by the Department to certify the Work Colleges agreement and collect the request for funding amount and the anticipated number of students for the year. The data is used in conjunction with institutional program reviews to assess the administrative capability and compliance of the applicant. There are no other resources for collecting this data. |
- | 1845-0153 | ||
| 202601-1845-001 | Comprehensive Transition Program (CTP) for Disbursing Title IV Aid to Students with Intellectual Disabilities Expenditure Report | ED/FSA | 2026-01-13 | None | None | Received in OIRA | No material or nonsubstantive change to a currently approved collection
Comprehensive Transition Program (CTP) for Disbursing Title IV Aid to Students with Intellectual Disabilities Expenditure Report
Key Information
Abstract
This is a request for an extension of the current information collection 1845-0113 Financial Assistance for Students with Intellectual Disabilities Expenditure Report. There have been no changes to the regulatory requirements for this collection. The Higher Education Opportunity Act, Pub. L. 110-315, added provisions to the Higher Education Act, as amended (HEA) in sections 760 and 766 that enable eligible students with intellectual disabilities to receive Federal Pell Grant (Pell), Supplemental Educational Opportunity Grant (FSEOG), and Federal Work Study (FWS) funds if they are enrolled in an approved program. This collection provides the method for institutions to report the number of Pell Grant, SEOG and FWS funds used for such a purpose. |
- | 1845-0113 | ||
| 202601-0970-004 | Placement and Transfer of Unaccompanied [Alien] Children into ORR Care Provider Facilities | HHS/ACF | 2026-01-13 | None | None | Received in OIRA | No material or nonsubstantive change to a currently approved collection
Placement and Transfer of Unaccompanied [Alien] Children into ORR Care Provider Facilities
Key Information
Authorizing Statutes
Abstract
The Office of Refugee Resettlement (ORR) Unaccompanied Alien Children (UAC) Bureau provides care and custody for unaccompanied alien children until they can be safely released to a sponsor, repatriated to their home country, or obtain legal status. ORR funds residential care provider facilities that provide temporary housing and other services to children in ORR custody. Generally, care provider facilities are State licensed (with the exception of those located in states unwilling to license them and temporary influx care facilities) and must meet ORR requirements to ensure a high-level quality of care. Services provided at care provider facilities include, but are not limited to, education, recreation, vocational training, acculturation, nutrition, medical, mental health, legal, and case management. ORR uses several forms directly related to the care of unaccompanied alien children. The forms in this information collection allow ORR to place unaccompanied alien children referred to ORR by federal agencies into care provider facilities and to transfer children within the ORR care provider network. On September 26, 2025, the Office of Management and Budget approved revised versions of forms P-4 and P-7 through emergency approval, as authorized under 5 CFR 1320.13. ORR is proposing revisions to one form in this collection, the Authorization for Medical, Dental, and Mental Health Care (Form P-2). The purpose of the Authorization for Medical, Dental and Mental Health Care (Form P-2) is to inform the treating healthcare provider that the care provider program has the authority, on behalf of ORR, to provide consent for certain healthcare services for unaccompanied alien children and to collect the child’s health records for these services. In addition, the form explains the reimbursement procedure for the submission of healthcare claims. The approved version of the Authorization for Medical, Dental and Mental Health Care (Form P-2) is not consistent with ORR’s current consent policies, guidance on required healthcare services, and reimbursement processes. The lack of alignment has caused confusion in the healthcare community and a delay in reimbursement of services.Emergency Justfication:ACF is requesting emergency review and approval by OMB to update two forms approved under the Placement and Transfer of Unaccompanied Children into ORR Care Provider Facilities information collection (OMB #0970-0554), as authorized under 5 CFR 1320.13. ACF is requesting approval as soon as possible due to secure beds becoming available on September 15, 2025 and requests 180 days of approval, during which time a full revision request will be submitted under normal procedures under the Paperwork Reduction Act. The information collection is essential to the mission of the agency, the use of normal clearance procedures is reasonably likely to prevent or disrupt the collection of information, and public harm is reasonably likely to result if normal clearance procedures are followed. For additional information see Attachment A. |
- | 0970-0554 | ||
| 202601-2139-001 | Origin and Destination 40 Percent Collection | DOT/RITA | 2026-01-13 | None | None | Received in OIRA | Extension without change of a currently approved collection
Origin and Destination 40 Percent Collection
Key Information
Abstract
TThe DOT is obligated by statue to collect and disseminate the data collected in the Origin and Destination data collection. The collection is mandatory and is required to obtain benefit of the data. All US certificated air carriers that sell airline passenger tickets are required to report. The data collection being collected is considered reporting. The collection frequency is monthly. The data collected are itineraries of passenger’s air travel. Data reported includes passenger’s origin, destination, year and month traveled, fare paid, total taxes paid, via point(s), dwell time, air carrier that sold the ticket to the passenger, and air carrier that is scheduled to transport the passenger. The users of the data are, including, but not limited to, the DOT, Federal Aviation Administration, Government Accountability Office, Department of Commerce, Bureau of Labor Statistics, Airport Commissions, Aircraft Manufacturers, Air Carriers, and Educational Institutions. The DOT is obligated by statute to collect and disseminate this information. There are many private and public stakeholders that depend on these data to make decisions on aviation business and policy. For example, these data are used by the aviation industry to plan air services, develop commercial aviation infrastructure, measure the economic impact of passenger flows, and create business plans for start-up airlines. The Origin and Destination data are also a primary source of information used to quantify and evaluate the effectiveness of Federal Aviation policy and programs as well as develop and implement new policies and infrastructure initiatives. Data from the O&D data set are used by the Department to fulfill its aviation mission as described in Part A of the Justification. This is not a revision. |
- | 2139-0014 | ||
| 202601-1845-002 | Work Colleges Expenditure Report | ED/FSA | 2026-01-13 | None | None | Received in OIRA | No material or nonsubstantive change to a currently approved collection
Work Colleges Expenditure Report
Key Information
Abstract
The Higher Education Opportunity Act, Pub. L. 110-315, established the allocation of Federal Work Study funds to recognize, encourage, and promote the use of comprehensive work-learning service programs as part of a financial plan which decreases reliance on grants and loans. The Work Colleges Program is one of the three Federal Work-Study Programs. The other two Federal Work-Study Programs are the Federal Work-Study (FWS) Program and the Job Location and Development (JLD) Program. This is a request for an extension without change of the current information collection. The participants are required to report expenditure of funds annually. The data collected is used by the Department to monitor program effectiveness and accountability of fund expenditures. The data is used in conjunction with institutional program reviews to assess the administrative capability and compliance of the applicant. |
- | 1845-0152 | ||
| 202601-0938-005 | Hospital Outpatient Quality Reporting (OQR) Program (CMS-10250) | HHS/CMS | 2026-01-12 | None | None | Received in OIRA | Revision of a currently approved collection
Hospital Outpatient Quality Reporting (OQR) Program (CMS-10250)
Key Information
Abstract
Section 109(a) of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109-432) amended section 1833(t) of the Social Security Act by adding a new subsection (17) that affects the payment rate update applicable to Outpatient Prospective Payment System (OPPS) payments for services furnished by hospitals in outpatient settings on or after January 1, 2009. Section 1833(t)(17)(A) of the Social Security Act, which applies to hospitals as defined under section 1886(d)(1)(B) of the Social Security Act, requires that hospitals that fail to report data required for quality measures selected by the Secretary in the form and manner required by the Secretary under section 1833(t)(17)(B) of the Social Security Act will incur a reduction in their annual payment update (APU) factor to the hospital outpatient department fee schedule by 2.0 percentage points. Hospital OQR Program payment determinations are made based on Hospital OQR Program quality measure data reported and supporting forms submitted by hospitals as specified through rulemaking. To reduce burden, a variety of different data collection mechanisms are employed, with every consideration taken to employ existing data and data collection systems. |
- | 0938-1109 | ||
| 202601-1212-003 | Termination Premium | PBGC | 2026-01-12 | None | None | Received in OIRA | Extension without change of a currently approved collection
Termination Premium
Key Information
Abstract
In certain cases where a PBGC-insured pension plan terminates in a distress or involuntary termination, the plan sponsors and members of their controlled groups must pay the termination premium to PBGC for three years under 29 USC 1307 and 29 CFR Part 4007, which also requires retention and production of records necessary to support premium payments. The information in this collection identifies the plan and sponsor group and lets PBGC verify premium computations. The retained records facilitate audits. |
- | 1212-0064 | ||
| 202508-1210-007 | Notice Requirements of the Health Care Continuation Coverage Provisions | DOL/EBSA | 2026-01-12 | None | None | Received in OIRA | Extension without change of a currently approved collection
Notice Requirements of the Health Care Continuation Coverage Provisions
Key Information
Abstract
The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) provides that under certain circumstances participants and beneficiaries of group health plans that satisfy the definition of “qualified beneficiaries” under COBRA may elect to continue group health coverage temporarily following events known as “qualifying events” that would otherwise result in loss of coverage. Under the regulatory guidelines, plan administrators are required to distribute notices: a general notice to be distributed to all participants in group health plans subject to COBRA; an employer notice that must be completed by the employer upon the occurrence of a qualifying event; a notice and election form to be sent to a participant upon the occurrence of a qualifying event that might cause the participant to lose group health coverage; an employee notice that may be completed by a qualified beneficiary upon the occurrence of certain qualifying events such as divorce or disability; and, two other notices, one of early termination and the other a notice of unavailability. Also included in the ICR are two model notices that the Department believes will help reduce costs for service providers in preparing and delivering notices to comply with the regulations. |
- | 1210-0123 | ||
| 202601-0915-001 | Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations | HHS/HSA | 2026-01-12 | None | None | Received in OIRA | Revision of a currently approved collection
Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations
Key Information
Abstract
Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service (PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS (Secretary) that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program), and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed statutorily defined 340B ceiling prices. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that choose to participate in the 340B Program must comply with the requirements of section 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) of the PHS Act prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the covered entity. |
- | 0915-0327 |