Change Requests

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Trust Land Mortgage Lender Checklists

Key Information

Abstract

The Secretary of the Interior is authorized under 25 CFR 152; 70 Stat. 62; and 25 U.S.C. §5135 (Mortgages and deeds of trust by individual Indian owners; removal from trust or restricted status; application to Secretary) to provide individual Indians owning an individual tract of trust land the ability to mortgage their land for the purpose of home acquisition and construction, home improvements, and economic development. The BIA is required to review the trust mortgage application for conformity to statutes, policies, and regulations. Mortgage documents submitted to BIA from the lending institutions will assist BIA staff in their analysis to approve or disapprove a trust land mortgage application request.

Federal Register Notices

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

Authorizing Statutes

25 USC 5135	View Law

70 Stat. 62

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Regulation N (the Mortgage Acts and Practices –- Advertising Rule )

Key Information

Abstract

Regulation N requires covered persons to retain: (1) Copies of materially different commercial communications and related materials, regarding any term of any mortgage credit product, that the person made or disseminated during the relevant time period; (2) documents describing or evidencing all mortgage credit products available to consumers during the relevant time period; and (3) documents describing or evidencing all additional products or services (such as credit insurance or credit disability insurance) that are or may be offered or provided with the mortgage credit products available to consumers during the relevant time period. The FTC and the CFPB share enforcement authority for Regulation N and thus the two agencies split the burden estimates.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 8 626	View Law

Pub.L. 111 - 203 H. R. 4173	View Law

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25 CFR 170, Tribal Transportation Program

Key Information

Abstract

The information submitted by tribes allows them to participate in planning the development of transportation needs in their area; the information provides data for administration, documenting plans, and for oversight of the program by the Department. The revision accounts for updates made to the regulations as a result of passage of MAP-21 and FAST Act legislation.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 114 - 94 1001 et seq.	View Law

23 USC 202(d)	View Law

Pub.L. 112 - 141 1101 et seq.	View Law

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Tribal Education Department Grant Program

Key Information

Abstract

Under 25 U.S.C. §2020, Congress appropriated funding through the Bureau of Indian Education (BIE) for the development and operation of tribal departments or divisions of education for the purpose of planning and coordinating all educational programs of the Tribe. All tribal education departments (TEDs) awarded will provide coordinating services and technical assistance to the school(s) they serve, expected outcome for student success, and how the proposed project will increase student competency. For a Federally recognized tribe to be eligible to receive a grant, the tribe shall submit a grant application proposal. Once the grant has been awarded, each awardee will be responsible for quarterly and annual reports.

Federal Register Notices

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

Authorizing Statutes

25 USC 2020	View Law

25 USC 450h(a)	View Law

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U.S. Fish and Wildlife Service ArcGIS Online (AGOL) Platform

Key Information

Abstract

The U.S. Fish and Wildlife Service (Service) collects and maintains necessary geospatial data to meet our mission in accordance with the Federal Funding Accountability and Transparency Act of 2006, as amended (31 U.S.C. 6101); Geospatial Data Act of 2018 (43 U.S.C. chapter 46, 2801–2811); National Technology Transfer and Advancement Act of 1995 (Public Law 104–113); Open, Public, Electronic, and Necessary (OPEN) Government Data Act; Title II of the Foundations for Evidence-Based Policymaking Act of 2018 (Public Law 115–435); OMB Circular A-16, “Coordination of Geographic Information and Related Spatial Data Activities”; OMB Circular A-119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities”; and OMB Circular A-130, “Managing Information as a Strategic Resource.” Geospatial data identifies and depicts geographic locations, boundaries, and characteristics of features on the surface of the earth. Geospatial data includes geographic coordinates (e.g., latitude and longitude) to identify the location of earth’s features, and data associated to geographic locations (e.g., land survey data and land cover type data). The Service’s organizational ArcGIS online program (AGOL), accessed at http://fws.maps.arcgis.com, is an easy place to share data with the public and partners, as well as internally among Service staff. It can also be used to build and deploy mobile-enabled online maps, applications, and services for geographic information systems (GIS) users and non-GIS users alike. Sensitive data is restricted from public access via an internal-facing intranet version of AGOL. Moreover, because the system contains only controlled unclassified information (CUI) that would be designated as low impact under the Federal Information Security Act (FISMA; 2002), no personally identifiable information (PII) is allowed within the system. The AGOL platform enables the Service to effectively manage geospatial data resources and technology to successfully deliver geospatial services in support of the Service’s mission. Data collected through AGOL enables improved visualization, analysis, interoperability, modeling, sharing, and decision support. The benefits include increased accuracy, increased productivity, and more efficient information management and application support.

Federal Register Notices

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

Authorizing Statutes

43 USC 46	View Law

Pub.L. 104 - 113 1115	View Law

44 USC 3506(b)(6)	View Law

Pub.L. 115 - 435 101-403	View Law

31 USC 6101	View Law

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Claim for Relocation Payments - Residential, DI-381; Claim for Relocation Payments - Nonresidential, DI-382

Key Information

Abstract

The information on the application will be used to determine the amount of money, if any, owed to persons or businesses displaced by Federal acquisition of their real property.

Federal Register Notices

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

Authorizing Statutes

42 USC 4601	View Law

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Payment for Appointed Counsel in Involuntary Indian Child Custody Proceedings in State Courts, 25 CFR 23.13

Key Information

Abstract

The BIA is seeking renewal of the approval for the information collection conducted under 25 CFR 23, implementing the Indian Child Welfare Act (25 U.S.C. 1901). The information collection allows BIA to receive written requests by State courts that appoint counsel for an indigent Indian parent or Indian custodian in an involuntary Indian child custody proceeding when appointment of counsel is not authorized by State law. The applicable BIA Regional Director uses this information to decide whether to certify that the client in the notice is eligible to have his/her counsel compensated by the BIA in accordance with the Indian Child Welfare Act.

Federal Register Notices

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

Authorizing Statutes

25 USC 1901	View Law

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[Medicaid] Medicaid Managed Care and Supporting Regulations (CMS-10855)

Key Information

Abstract

This collection of information request is associated with our September 26, 2024 (89 FR 79020) final rule (CMS-2434-F; RIN 0938-AU28). We intend to fold the following collection of information requirements and burden estimates under CMS-10108 (OMB 0938-0920). However, there are a number of conflicting activities that make this impractical at this time. To address those conflicts, as a stop gap measure we are proposing to submit the collection of information requirements and burden estimates under CMS-10855 (OMB 0938-1445). When ready we will be folding them to their proper place under CMS-10108 (OMB 0938-0920). Most Medicaid beneficiaries receive either all or part of their health care benefits through Medicaid managed care programs, including their prescription drug benefits. Because of the specialized nature of the prescription drug benefit, many of the Medicaid managed care plans (MCOs, PIHPS, or PAHPS) either own, or contract with, PBMs to administer the pharmacy benefit. In § 438.3(s), Medicaid MCOs, PIHPs, and PAHPs that provide coverage of covered outpatient drugs (CODs) would be required to structure any contract that it has with any subcontractor (e.g., PBM) for the delivery or administration of the COD benefit so that the subcontractor is required to report separately the amounts related to the incurred claims described in § 438.8(e)(2) to the managed care plan. The provisions would ensure that medical loss ratios (MLRs) reported by MCOs, PIHPs and PAHPs that use subcontractors in the delivery of COD coverage would be more accurate and transparent. The separate payment requirements would help States and managed care plans better understand whether they are appropriately and efficiently paying for the delivery of CODs, a significant part of which is funded by the Federal Government.

Federal Register Notices

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

Authorizing Statutes

42 USC 1396a	View Law

Presidential Action:

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Plan Asset Transactions Determined by In-House Asset Managers under Prohibited Transaction Class Exemption 96-23

Key Information

Abstract

The Department granted PTE 84-14 (49 FR 9494, as corrected 50 FR 41430), a class exemption that permits various parties in interest (as defined in ERISA section 3(14)) to employee benefit plans to engage in transactions involving plan assets if, among other conditions, the assets are managed by a “qualified professional asset manager” (QPAM), but still did not provide relief for transactions involving the assets of plans managed by an in-house asset manager. The Department granted PTE 96-23 (61 FR 15975), Class Exemption for Plan Asset Transactions Determined by In-House Asset Managers. The class exemption permits various parties in interest to employee benefit plans to engage in transactions involving plan assets if, among other requirements, the assets are managed by an in-house asset manager (INHAM). PTE 96-23 contains requirements for written guidelines between an INHAM and a property manager that an INHAM has retained to act on its behalf. The information collection requirements consist of the requirements that the INHAM develop written policies and procedures designed to assure compliance with the conditions of the exemption and have an independent auditor conduct an annual INHAM exemption audit and issue an audit report to each plan.

Federal Register Notices

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

Authorizing Statutes

29 USC 1108	View Law

Presidential Action:

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Report to U.S. SSA by Person Receiving Benefits for a Child or Adult Unable to Handle Funds/Report to U.S. SSA

Key Information

Abstract

SSA uses Forms SSA-7161-OCR-SM and SSA 7162-OCR-SM to: (1) determine continuing entitlement to Social Security benefits; (2) correct benefit amounts for beneficiaries outside the United States; and (3) monitor the performance of representative payees outside the United States. This collection is mandatory as an annual (or every other year, depending on the country of residence) review for fraud prevention. In addition, the results can affect benefits by increasing or decreasing payment amount or by causing SSA to suspend or terminate benefits. SSA employees collect this information via paper form. The respondents are individuals living outside the United States who are receiving benefits on their own (or on behalf of someone else) under Title II of the Act.

Federal Register Notices

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

Authorizing Statutes

42 USC 403	View Law

42 USC 405	View Law

Presidential Action:

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Brownfields Programs - Accomplishment Reporting in Assessment, Cleanup, and Redevelopment Exchange System (ACRES) (Revision)

Key Information

Abstract

This ICR covers the collection of information from those organizations that receive cooperative agreements, contracts, and Targeted Brownfields Assessment (TBA) funds from EPA under the authority of the section 104(k) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) as amended by the Brownfields Utilization, Investment, and Local Development (BUILD) Act (Pub.L. 115-141). CERCLA 104(k), as amended, authorizes EPA to award grants or cooperative agreements and contract funding to states, tribes, local governments, other eligible entities, and nonprofit organizations to support the assessment and cleanup of brownfields sites. Under section 101(39) of CERCLA, a brownfields site means real property, the expansion, redevelopment, or reuse of which may be complicated by the presence or potential presence of a hazardous substance, pollutant, or contaminant. Cooperative agreement recipients (recipients) have general reporting and record keeping requirements as a condition of their cooperative agreement that result in burden. A portion of this reporting and record keeping burden is authorized under 2 CFR Part 1500 and identified in the EPAs general grants ICR (OMB Control Number 2030-0020). EPA requires Brownfields program recipients to maintain and report additional information to EPA on the uses and accomplishments associated with funded brownfields activities. EPA has expanded programmatic reporting requirements to include TBA contractors and technical assistance contractors. EPA will use several forms to assist recipients and contractors in reporting the information and to ensure consistency of the information collected. EPA uses this information to meet Federal stewardship responsibilities to manage and track how program funds are being spent, to evaluate the performance of the Brownfields Cleanup and Land Revitalization Program, to meet the Agency's reporting requirements under the Government Performance and Results Act, and to report to Congress and other program stakeholders on the status and accomplishments of the program.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 107 - 118 1-232	View Law

Presidential Action:

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Cooperation with States at Commerical Nuclear Power Plants and Other Nuclear Production and Utilization Facilities, Policy Statement

Key Information

Abstract

States and Federally recognized Indian Tribes are involved and interested in monitoring the safety status of nuclear power plants and other nuclear production and utilization facilities. This involvement is, in part, in response to the States' and Tribes' public health and safety responsibilities and, in part, in response to their citizens' desire to become more knowledgeable about the safety of nuclear power plants and other nuclear production and utilization facilities. States and Tribes have identified NRC inspections as one possible source of knowledge for their personnel regarding NRC licensee activities, and the NRC, through the policy statement, “Cooperation with States at Commercial Nuclear Power Plants and Other Nuclear Production or Utilization Facilities” (57 FR 6462; February 25, 1992), has been amenable to accommodating States' and Tribes' needs in this regard. The NRC uses the information collected under this information collection requirement to allow States and Federally recognized Indian Tribes to participate in or observe inspections at NRC-licensed facilities. The types of information collected include written requests identifying specific inspections States and Tribes wish to observe; identification-related information required for site access to NRC-licensed facilities; training and qualifications of State and Tribal personnel participating in inspections; information required to define inspection roles for States and Tribes; and information to coordinate NRC and State and Tribal inspections.

Federal Register Notices

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

Authorizing Statutes

42 USC 2011-2059	View Law

Pub.L. 83 - 703 1-311	View Law

Presidential Action:

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Prohibited Transaction Class Exemption for Certain Transactions Between Investment Companies and Employee Benefit Plans (PTE 1977-4)

Key Information

Abstract

PTE 77-4, which was originally granted on April 8, 1977, exempts from the prohibited transaction restrictions the purchase and sale by an employee benefit plan of shares from a registered, open-end investment company (mutual fund) when a fiduciary of the plan (e.g., an investment manager) is also the investment advisor for the investment company. There are three disclosure requirements incorporated within the class exemption. The first requirement is intended to put the plan on notice of possible fees associated with the redemption of open-end mutual fund shares. It requires disclosure of any redemption fees in the current prospectus of the open-end mutual fund (the prospectus in effect at the time of the plan’s acquisition or disposal of such shares). The class exemption permits a plan to pay a redemption fee on the sale, by redemption, of open-end mutual fund shares only if the fee is paid to the open-end mutual company and the above noted disclosure is made. The second requirement is that, at the time of the purchase or sale of such mutual fund shares, an independent fiduciary receive a copy of the current prospectus issued by the open-end mutual fund and full written disclosure of the investment advisory fees charged to or paid by the plan and the open-end mutual fund to the investment advisor. Pursuant to advisory opinion 2013-04A, the Department interprets the term “prospectus” in PTE 77-4 to include a “summary prospectus” if the summary prospectus meets the requirements of the Securities and Exchange Commission’s revised disclosure provisions for mutual funds including a summary prospectus rule that were published in 2009 Pursuant to the SEC’s revised disclosure provisions, mutual funds also are required to send the full prospectus to the investor upon an investor’s request, and to provide the full prospectus on-line at a specified internet site. The third requirement is that the independent fiduciary be notified of any changes in the fees and approves in writing the plan’s purchase or sale of affected mutual fund shares, or the plan’s continued possession of any such mutual fund shares that it had acquired before the fee changes.

Federal Register Notices

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

Authorizing Statutes

26 USC 4975	View Law

29 USC 1108	View Law

Presidential Action:

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Claim for Damage Injury or Death

Key Information

Abstract

This form is utilized by those persons making a claim against the United States Government under the Federal Tort Claims Act.

Federal Register Notices

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

Authorizing Statutes

28 USC 2672	View Law

Presidential Action:

Reference Number:

Omb Control Number:

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Request Type:

Labor Relations Report

Key Information

Abstract

This package requests information from the Department of Energy Facilities Management Contractors for contract administration, management oversight and cost control. This information is used to ensure that Department contractors recruit and retain a workforce in accordance with the terms of their contract and in compliance with statutory and regulatory requirements as identified by the contract. Collection is made to Department contractors, not the general public.

Federal Register Notices

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

Authorizing Statutes

42 USC 7254	View Law

42 USC 7256(a)	View Law

Presidential Action:

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NASA Safety Reporting System

Key Information

Abstract

The NASA Safety Reporting System (NSRS) was established to provide a fast response hazard identification and reporting system, which aids in the elimination of unsafe conditions and the prevention of accidents. In addition, the NSRS serves as a mechanism for elevating problems to selected upper management when standard channels fail. The NSRS is a voluntary, anonymous, and non-punitive supplement to formal safety reporting procedures and is administered by an independent agent, ARES Corporation of McLean Virginia. The only means of reporting to the NSRS is the NSRS report form, which is available to all NASA and contractor employees. During the first year of operation the NSRS handled safety hazard reports pertaining to the Space Shuttle program. Subsequently, the NSRS has been expanded to handle safety hazard reports pertaining to all NASA programs, projects, and operations. The information provided by these reports has resulted in direct changes to NASA policies, procedures, and operations which has significantly reduced NASA's safety risk. Information collected is maintained in accordance with NASA Records Retention Schedule 1441.1, 2017 Edition. This information collection enables NASA Contractors to voluntarily and confidentially report safety concerns or hazards pertaining to any NASA program, project, or operation which has not been resolved through local safety reporting processes. The report is received and processed by an independent agent. No changes to the collection instrument have been made since the collection's previous PRA approval in 2016.

Federal Register Notices

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

Authorizing Statutes

51 USC 20101-20164	View Law

Presidential Action:

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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.

Federal Register Notices

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

Authorizing Statutes

7 USC 901	View Law

Presidential Action:

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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.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 194 - 265 303(d)	View Law

16 USC 1851	View Law

Presidential Action:

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Request for Approval to Sell Capital Assets

Key Information

Abstract

A borrower's assets provide the security for a Government loan. Selling of assets reduces the security and increases the risk to the Government. RUS Form 369 allows the borrowers to seek agency permission to sell some of its assets.

Federal Register Notices

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

Authorizing Statutes

7 USC 901	View Law

Presidential Action:

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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.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 109 - 432 109(b)	View Law

42 USC 1395	View Law

Presidential Action:

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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.

Federal Register Notices

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

Authorizing Statutes

42 USC 2756b	View Law

Presidential Action:

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Concluded:

Action:

Request Type:

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.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 116 - 260 125	View Law

42 USC 1395x	View Law

Presidential Action:

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Action:

Request Type:

Petition for Finding under the Employee Retirement Income Security Act Section 3(40)

Key Information

Abstract

The term “multiple employer welfare arrangement” (MEWA) is defined in Section 3(40) of the Employee Retirement Income Security Act of 1974 (ERISA) as an employee welfare benefit plan or any other arrangement which is established or maintained for the purpose of offering or providing [welfare plan benefits] to the employees of two or more employers, (including one or more self-employed individuals), or their beneficiaries, except that such term does not include any such plan or other arrangement which is established or maintained under or pursuant to one or more agreements which the Secretary of Labor (the Secretary) finds to be collective bargaining agreements. Under Section 514(b)(6) of ERISA, an employee welfare benefit plan that is a MEWA is generally subject to state insurance law. The Department's regulation at 29 CFR 2510.3-40 sets forth criteria for determining when an employee welfare benefit plan is established or maintained under or pursuant to collective bargaining agreements for purposes of section 3(40) of ERISA. The Department's regulations at 29 CFR part 2570, subpart H set forth procedures for administrative hearings to obtain a determination by the Secretary as to whether a particular entity is an employee welfare benefit plan established or maintained under or pursuant to one or more collective bargaining agreements for purposes of section 3(40) of ERISA. To initiate adjudicatory proceedings, an entity is required to file a petition for a determination under Section 3(40) of ERISA with an Administrative Law Judge (ALJ). The petition must identify the parties, describe the basis on which the petition is being filed and the entity in question, provide evidence that the entity satisfies the criteria to be an employee welfare benefit plan, and include affidavits as to both the competency of the affiant to testify and the facts that allegedly establish the entity as a plan established under or pursuant to agreements that the Secretary finds to be a collective bargaining agreement.

Federal Register Notices

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

Authorizing Statutes

29 USC 1003(40)	View Law

29 USC 1135	View Law

Presidential Action:

Reference Number:

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Received:

Concluded:

Action:

Request Type:

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.

Federal Register Notices

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

Authorizing Statutes

29 USC 1168	View Law

29 USC 1166	View Law

Presidential Action:

Reference Number:

Omb Control Number:

Agency:

Received:

Concluded:

Action:

Request Type:

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.

Federal Register Notices

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

Authorizing Statutes

42 USC 256b	View Law

Pub.L. 102 - 585 601-602	View Law

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