Change Requests

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Investigational Device Exemptions

Key Information

Abstract

This information collection supports Food and Drug Administration (FDA, the agency, us or we) investigational device exemption (IDE) program. Respondents include private sector domestic and foreign medical device sponsors or applicants, including medical device manufacturers, investigators, hospitals, and other healthcare organizations.

Federal Register Notices

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

Authorizing Statutes

21 USC 360j(g))	View Law

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Examination of Records by Comptroller General and Contract Audit: FAR Section(s) Affected: 52.212–5(d), 52.214–26, 52.215–2

Key Information

Abstract

FAR 52.212–5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services. Paragraph (d) of this clause requires contractors to make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction by the Comptroller General of the United States, or an authorized representative. As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. FAR 52.214–26, Audit and Records - Sealed Bidding. This clause requires contractors required to submit certified cost or pricing data in connection with the pricing of a modification under a contract to make all records available to the contracting officer, or its authorized representative, including computations and projections related to the proposal for the modification; the discussions conducted on the proposal(s), including those related to negotiating; pricing of the modification; or performance of the modification. This clause requires contractors to make all records available to the Comptroller General of the United States, or an authorized representative, in the case of pricing a modification. This clause allows the Comptroller General to interview any current employee regarding such transactions. FAR 52.215–2, Audit and Records - Negotiation. This clause requires contractors to maintain records for cost-reimbursement, incentive, time-and-materials, labor-hour, or price redeterminable contracts, or any combination of these, for contracting officers, or an authorized representative, to examine and audit all records and other evidence sufficient to reflect properly all costs claimed to have been incurred or anticipated to be incurred directly or indirectly in performance of a contract. The right of examination includes inspection at all reasonable times of contractor's plants, or parts of them, engaged in performing the pertinent contract. Contractors required to submit certified cost or pricing data in connection with a pricing action under a contract must make all records available to the contracting officer, or its authorized representative, including computations and projections related to the proposal for the contract, subcontract, or modification; the discussions conducted on the proposal(s), including those related to negotiating; pricing of the contract, subcontract, or modification; or performance of the contract, subcontract or modification. Also, this clause requires contractors to make all records available to the Comptroller General of the United States, or an authorized representative, to examine any of the contractor's directly pertinent records involving transactions under the pertinent contract or subcontract. This clause allows the Comptroller General to interview any current employee regarding such transactions.

Federal Register Notices

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

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Ombudsman Inquiry/Request Instrument

Key Information

Abstract

The Office of the Procurement Ombudsman (OPO) is currently tracking and processing vendor inquiries and complaints using a composite of methods including email, Google Sheets, and MS Word Docs which makes it difficult to share, collaborate, centrally store data, effectively track information, as well as producing the necessary analytics (i.e. trend analysis) required for reporting to GSA senior leadership. As a result, the OPO finds it more difficult to help deconflict issues between GSA vendors and the acquisition workforce, as well as producing the necessary analytics required to improve acquisition processes. The Inquiry/Request web site will standardize and automate the collection of the data thereby reducing issues associated with manual receipt and processing of email and telephone calls.

Federal Register Notices

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

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Record of Emergency Data

Key Information

Abstract

Title 10 United States Code §§ 655, 1475-1478, 1482, designate beneficiaries for certain benefits in the event of the Service member’s death, a guide for disposition of a member’s pay and allowances if captured, missing or interned and to expedite the notification process in the event of an emergency and/or the death of the member.

Federal Register Notices

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

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Regulations for Making Excess or Surplus Federal Property Available to the U.S. Merchant Marine Academy, State Maritime Academies and Non-Profit Maritime Training Facilities

Key Information

Abstract

OMB 2133-0504 (Regulations for Making Excess or Surplus Federal Property Available to the U.S. Merchant Marine Academy, State Maritime Academies and Non-Profit Maritime Training Facilities) is used to determine compliance with applicable statutory requirements regarding surplus government property.

Federal Register Notices

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

Authorizing Statutes

46 USC 51103	View Law

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Requirements for Establishing U.S. Citizenship -- 46 CFR 355 and 366

Key Information

Abstract

In accordance with 46 CFR Part 355, shipowners, charterers, equity owners, ship managers, etc., seeking benefits provided by statute are required to provide on an annual basis, an Affidavit of U.S. Citizenship to the Maritime Administration (MARAD) for analysis. The Affidavits of U.S. Citizenship filed with MARAD will be reviewed to determine if the Applicants are eligible to participate in the programs offered by the agency.

Federal Register Notices

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

Authorizing Statutes

46 USC Chapters 531, 535 and 537	View Law

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U.S. Withholding Tax Return for Certain Dispositions by Foreign Persons, Statement of Withholding on Certain Dispositions by Foreign Persons, Statement of Withhold

Key Information

Abstract

Form 8288 is used to report and transmit amounts withheld on certain dispositions and distributions that are subject to sections 1445 and 1446(f)(1). It is also used to report and transmit amounts withheld under section 1446(f)(4) or to claim a credit or refund for amounts withheld under section 1446(f)(4) for transfers occurring on or after January 1, 2023. Form 8288-A is used by the IRS to validate the withholding, and a copy is returned to the transferor for his or her use in filing a tax return. The information provided in § 1.1446(f)–3(d) by the partnership to the IRS will be used by the partnership to report and pay any tax under section 1446(f)(4) and § 1.1446(f)–3 and will be provided on Form 8288–C.

Federal Register Notices

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

Authorizing Statutes

26 USC 1445	View Law

26 USC 1446	View Law

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Timely Mailing Treated As Timely Filing

Key Information

Abstract

This information collection contains regulations that provide guidance as to the only ways to establish prima facie evidence of delivery of documents that have a filing deadline prescribed by the internal revenue laws, absent direct proof of actual delivery. The regulations are necessary to provide greater certainty regarding this issue and to provide specific guidance. The regulations affect taxpayers who mail Federal tax documents to the Internal Revenue Service or the United States Tax Court. Revenue Procedure 97-19 provides the criteria that will be used by the IRS to determine whether a private delivery service qualifies as a designated Private Delivery Service under section 7502 of the Internal Revenue Code.

Federal Register Notices

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

Authorizing Statutes

26 USC 7502	View Law

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Financial Report Form ETA-9130

Key Information

Abstract

ETA utilizes the e-Grants Federal Reporting System, an online 9130 reporting system for recipients to enter and certify quarterly financial data. The data collected is used to assess the effectiveness of ETA programs and to monitor and analyze the financial activity of its recipients. This data collection format permits ETA to evaluate program effectiveness, monitor compliance with statutory limitations, and analyze financial activity, while complying with OMB efforts to streamline Federal financial reporting.

Federal Register Notices

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

Authorizing Statutes

29 USC 3245	View Law

Pub.L. 106 - 107 8	View Law

29 USC 3244(c) and (d)	View Law

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Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools

Key Information

Abstract

This information collection helps implement industry and Food and Drug Administration (FDA) agreed-upon goals that provide for the establishment of systems and procedures intended to improve FDA’s medical device review process under the Medical Device User Fee Act (MDUFA). Consistent with MDUFA performance goal documents developed in collaboration with interested stakeholders, we continue to improve and enhance our processes for providing feedback to sponsors of medical device submissions.

Federal Register Notices

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

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Passenger Ferry Grant Program, Electric or Low-Emitting Ferry Pilot Program, and Ferry Service for Rural Communities Program

Key Information

Abstract

The Passenger Ferry Grant Program provides funding for passenger ferries through a competitive process for capital projects that support passenger ferry systems in urbanized areas, such as ferry vessels, terminals, and related infrastructure. The Electric or Low-Emitting Ferry Pilot Program makes federal funds available for projects that support the purchase of electric or low-emitting ferry vessels. The Ferry Service for Rural Communities Program makes federal funds available to states to ensure basic essential ferry service is provided to rural areas. This information collection (IC) request is for an extension without change of a currently approved collection, which is due to expire on February 28, 2026. This is a voluntary program where applicants submit initial information at the application stage, and if funding is awarded, additional information is submitted during the project management stage. Eligible recipients include direct recipients of Section 5307 Urbanized Area Formula Program funding, designated recipients of Section 5307 funding, public entities engaged in providing public transportation passenger ferry service in urban areas that are eligible to be direct recipients, states, territories, and tribal governments. Information is collected online via FTA's Transit Award Management System (TrAMS).

Federal Register Notices

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

Authorizing Statutes

Pub.L. 117 - 58 71102-71103	View Law

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NESHAP for Source Categories: Generic Maximum Achievable Control Technology Standards (40 CFR part 63, subpart YY) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for Generic Maximum Achievable Control Technology Standards for Acetal Resin; Acrylic and Modacrylic Fiber; Hydrogen Fluoride and Polycarbonate Production were proposed on October 14, 2998; and promulgated on June 29, 1999; and amended on: November 22, 1999; November 2, 2001; June 7, 2002; July 12, 2002; and October 8, 2014. These regulations apply to new and existing facilities of the following four categories: Polycarbonates (PC) Production, Acrylic and Modacrylic Fibers (AMF) Production, Acetal Resins (AR) Production, and Hydrogen Fluoride (HF) Production. New facilities include those that commenced construction or reconstruction after the date of proposal. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. This information is being collected to assure compliance with 40 CFR Part 63, Subpart YY.

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et. seq.	View Law

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Annual Financial and Actuarial Information Reporting (29 CFR Part 4010)

Key Information

Abstract

ERISA section 4010 requires the annual reporting of actuarial and financial information by controlled groups that sponsor pension plans that have significant underfunding. PBGC uses this information to detect and monitor financial problems with the controlled groups and to respond quickly when it learns that a controlled group intends to engage in a transaction that may reduce the assets available to pay plan liabilities.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

29 USC 1310	View Law

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Termination of Single Employer Plans

Key Information

Abstract

Plan administrators of plans terminating voluntarily must submit certain information to PBGC and provide certain information to affected third parties. PBGC needs the information required to be submitted to ensure that a voluntary termination is completed in accordance with statutory and regulatory requirements and to facilitate the payment of benefits to missing participants. Participants need the information required to be disclosed so that they will be informed about the status of the proposed termination of their plan and about their benefits upon termination.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

29 USC 1350	View Law

29 USC 1341	View Law

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Data Request and Attestation for PDP Sponsors (CMS-10691)

Key Information

Abstract

42 CFR 423.513(g)(1)(i) states that beginning in plan year 2020, a PDP sponsor may submit a request to CMS for the data described in paragraph (g)(2) about enrollees in its prescription drug plans. In addition, paragraph (g)(5) provides that as a condition of receiving the requested data, the PDP sponsor must attest that it will adhere to the permitted uses and limitations on the use of the Medicare claims data listed in paragraphs (g)(3) and (4).

Federal Register Notices

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

Authorizing Statutes

Pub.L. 115 - 123 50354	View Law

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[NCEZID] Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats

Key Information

Abstract

Antibiotic resistance has the potential to impact all Americans at every stage of life and CDC is working to drive aggressive action and empower the nation to comprehensively respond to these threats. The goal of this study is to establish a network of public health laboratories to improve detection and characterization of urgent antibiotic resistant threats in healthcare-associated infections, carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Pseudomonas aeruginosa (CRPA), carbapenem-resistant Acinetobacter baumannii (CRAB), and Candida species, including C. auris. The proposed changes are for: 1) wording changes to enhance clarity of two existing data collection forms related to antimicrobial testing, including a monthly report form and a form used to signal alerts; and 2) removal of questions that are no longer relevant. This Change Request results in a net decrease of the overall burden.

Federal Register Notices

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

Authorizing Statutes

42 USC 241	View Law

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Sexual Violence Support & Experience Study (SVSES)

Key Information

Abstract

In March 2019, Acting Secretary of Defense Patrick Shanahan requested the Department of Defense (DoD) to form a team of experts to “take a fresh look” at issues involving the sexual assault investigative and accountability process. The DoD established the Sexual Assault Accountability and Investigation Task Force (SAAITF) to identify, evaluate, and make recommendations to improve the investigation and accountability process. As part of this effort, the 2019 SAAITF report called for a “standardized survey of victim experiences, attitudes, and satisfaction.” The Sexual Violence Support and Experiences Study (SVSES) meets this requirement and will allow the DoD Sexual Assault Prevention and Response Office (SAPRO), other DoD policy offices, and the military Services to use the input of military members to inform improvements to the response system and to address challenges military members face during the military investigation and accountability process.

Federal Register Notices

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

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Appraisals for Higher-Priced Mortgage Loans

Key Information

Abstract

Section 1471 of the Dodd-Frank Act established a new Truth in Lending (TILA) section 129H, which contains appraisal requirements applicable to higher-risk mortgages and prohibits a creditor from extending credit in the form of a higher-risk mortgage loan to any consumer without meeting those requirements. A Higher-risk mortgage is defined as a residential mortgage loan secured by a principal dwelling with an annual percentage rate (APR) that exceeds the average prime offer rate (APOR) for a comparable transaction as of the date the interest rate is set by certain enumerated percentage point spreads. The rule requires that, within three days of application, a creditor provide a disclosure that informs consumers regarding the purpose of the appraisal, that the creditor will provide the consumer a copy of any appraisal, and that the consumer may choose to have a separate appraisal conducted at the expense of the consumer. If a loan meets the definition of a higher-risk mortgage loan, then the creditor would be required to obtain a written appraisal prepared by a certified or licensed appraiser who conducts a physical visit of the interior of the property that will secure the transaction, and send a copy of the written appraisal to the consumer. To qualify for the safe harbor provided under the rule, a creditor is required to review the written appraisal as specified in the text of the rule and appendix A. If a loan is classified as a higher-risk mortgage loan that will finance the acquisition of the property to be mortgaged, and the property was acquired within the previous 180 days by the seller at a price that was lower than the current sale price, then the creditor is required to obtain an additional appraisal.

Federal Register Notices

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

Authorizing Statutes

15 USC 1639h(b)(4)(A)	View Law

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Practice by Former Members and Employees of the Commission

Key Information

Abstract

The Information collected pursuant to 17 C.F.R § 140.735-6 concerning the practice by former members and employees of the Commodity Futures Trading Commission before the Commission is required to keep the Commission aware of any conflicts of interest that may exist, and to ensure compliance with the requirements of 18 U.S.C. § 207 concerning restrictions in this regard placed upon certain former federal members and employees. In order for the Commission to regulate the practice before it by its former members and employees, 17 C.F.R § 140.735-6(e) generally requires former members and employees who are employed or retained to represent any person before the Commission within two years of the termination of their CFTC employment to file a brief written statement with the Commission’s Office of General Counsel regarding that representation.

Federal Register Notices

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

Authorizing Statutes

7 USC 12a(5)	View Law

18 USC 207	View Law

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Registration of Mortgage Loan Originators (Regulation G)

Key Information

Abstract

Regulation G implements the Secure and Fair Enforcement for Mortgage Licensing Act (the S.A.F.E. Act, 12 USC 5101 et sq.) , federal registration requirement with respect to any covered financial institutions, and their employees who act as residential mortgage loan originators (MLOs), to register with the Nationwide Mortgage Licensing System and Registry, obtain a unique identifier, maintain this registration, and disclose to consumers the unique identifier. The rule also requires the covered financial institutions employing these MLOs to adopt and follow written policies and procedures to ensure their employees comply with these requirements and to disclose the unique identifiers of their MLOs.

Federal Register Notices

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

Authorizing Statutes

12 USC 5101	View Law

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Bus Testing Program

Key Information

Abstract

This information collection (IC) request seeks a three-year extension without change for the currently approved collection under OMB Control Number 2132‑0550, “Bus Testing Program.” There have been no changes to the respondent universe, burden hours, or program requirements since OMB last approved this collection in 2023. The response to this collection remains required to obtain or retain a benefit, as federal funds may not be obligated or expended for the acquisition of a new transit bus unless the vehicle satisfies all requirements of FTA’s Bus Testing Program. Respondents to this collection are transit bus manufacturers who submit testing requests to FTA when introducing a new bus model or when major modifications are made to a model previously tested. All information is submitted through FTA’s online bus testing portal. Required information includes bus model and manufacturer details, vehicle specifications, documentation demonstrating compliance with Federal Motor Vehicle Safety Standards, and descriptions of major design changes, if applicable. While the program itself has not changed, this updated IC reflects increased cost estimates for both respondents and the federal government due solely to updated labor rates.

Federal Register Notices

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

Authorizing Statutes

49 USC 5318	View Law

49 USC 5323(c)	View Law

Pub.L. 112 - 141 5318(e)	View Law

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NESHAP for Hazardous Waste Combustors (40 CFR Part 63, Subpart EEE) (Proposed Rule)

Key Information

Abstract

This proposal presents the results of the U.S. Environmental Protection Agencys (EPA) residual risk and technology review for the National Emission Standards for Hazardous Air Pollutants (NESHAP) from Hazardous Waste Combustors (HWC) as required under the Clean Air Act (CAA). In this action, the EPA is proposing to establish emission limits and work practice standards for hydrogen fluoride and hydrogen cyanide emissions from HWC incinerators, cement kilns, solid fuel boilers, and liquid fuel boilers; eliminate the startup, shutdown, and malfunction (SSM) exemption; add a work practice standard for periods of SSM; add electronic reporting procedures and requirements; allow states to choose to exempt area sources from certain permitting requirements; and other clarifications and corrections. In response to comments received on certain aspects of the July 24, 2024, proposed revisions for periods of malfunction, the EPA is withdrawing that proposed rule and instead proposing different provisions to address periods of SSM.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

42 USC 7401 et seq	View Law

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Supporting Statement for Agent/Broker Consent Information Collection (CMS-10840)

Key Information

Abstract

The Patient Protection and Affordable Care Act, Public Law 111-148, enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 (collectively, “Affordable Care Act”), expanded access to health insurance for individuals and employees of small businesses through the establishment of new Affordable Insurance Exchanges (Exchanges), also called Marketplaces. The Exchanges, which became operational on January 1, 2014, enhance competition in the health insurance market, expand access to affordable health insurance for millions of Americans, and provide consumers with a place to easily compare and shop for health insurance coverage. Section 1312(e) of the Affordable Care Act directs the Secretary of the Department of Health and Human Services (HHS) to establish procedures under which a state may permit agents and brokers to enroll qualified individuals and employers into qualified health plans (QHPs) offered through an Exchange and to enable these agents and brokers to assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions. Authority for collection of this information comes from 45 C.F.R. §155.220(c)(5), which states that “HHS or its designee may periodically monitor and audit an agent, broker, or web-broker under this subpart to assess its compliance with the applicable requirements of this section.” This information collection specifically details what information will be required to be collected and maintained by agents, brokers, and web-brokers were they to receive a request from HHS for consent records. Currently, HHS only plans to collect information from a small percentage of agents, brokers, or web-brokers in conjunction with active investigations of potential fraud. Utilizing §155.220(c)(5) and the information to be collected under newly proposed §§ 155.220(j)(2)(ii)(A)(1-2) and 155.220(j)(2)(iii)(A-C), HHS will be able to verify whether or not an agent, broker, or web-broker has obtained consent from a consumer they are assisting in enrolling in coverage in the individual market, and whether the consumer has reviewed their eligibility information and confirmed its accuracy.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

45 USC 155.220	View Law

Pub.L. 111 - 148 1312	View Law

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Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Key Information

Abstract

This collection of information is necessary to enable the Agency to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the Agency's programs.

Federal Register Notices

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

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Collection of Diagnostic Data in the Abbreviated RAPS Format from Medicare Advantage Organizations for Risk Adjusted Payments (CMS-10062)

Key Information

Abstract

Section 1853 of the Social Security Act, hereafter referred to as “the Act,” requires CMS to make advance monthly payments to a Medicare Advantage (MA) organization for each beneficiary enrolled in an MA plan offered by the organization for coverage of Medicare Part A and Part B benefits. Section 1853(a)(1)(C) of the Act requires CMS to adjust the monthly payment amount for each enrollee to take into account the health status of MA plan enrollees. CMS used RAPS data, in combination with encounter data and Fee-For-Service (FFS) data, to develop the diagnosis-based portion of the risk scores for risk adjusted payment to MA organizations, PACE organizations, and MMPs. Risk adjustment allows CMS to pay plans for the health risk of the beneficiaries they enroll, instead of paying an identical average amount for each enrollee. By risk adjusting plan payments, CMS is able to make appropriate and accurate payments for enrollees with differences in expected costs. Risk adjustment is used to adjust bidding and payment based on the health status and demographic characteristics of an enrollee. Risk scores measure individual beneficiaries’ relative risk and the risk scores are used to adjust payments for each beneficiary’s expected expenditures. By risk adjusting plan bids, CMS is able to also use standardized bids as base payments to plans.

Federal Register Notices

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

Authorizing Statutes

42 USC 1395w-23	View Law

42 USC 1395 w-23	View Law

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