Change Requests

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[OS] Centralized Institutional Review for the CDC Expanded Access Investigational New Device (EA-IND) for "Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections.

Key Information

Abstract

This information request is essential to CDC’s response to the Monkeypox outbreak consistent with requirements set forth by the Food and Drug Administration (FDA). CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the expanded access investigational new drug (EA-IND). CDC holds an intermediate-size patient population EA-IND (IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs.

Federal Register Notices

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

Authorizing Statutes

21 USC 312	View Law

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Institutional Dual Use Research of Concern (iDURC) Policy Compliance (Renewal)

Key Information

Abstract

The White House Office of Science and Technology Policy issued the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (iDURC Policy) in September 2014. The purpose of the Policy is to identify Dual Use Research of Concern (DURC) and implement risk mitigation measures where applicable. DURC applies to life science research that provides knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. Institutions subject to the iDURC Policy are those within the United States that (1) receive funding from the U.S. Government to conduct or sponsor life sciences research and (2) conduct or sponsor reserach that involves one or more of the 15 agents or toxins identified in the iDURC Policy, even if the research is not supported by U.S. Government funding. Institutions outside of the United States that receive U.S. Government funding to conduct or sponsor research that involves one or more of the 15 agents or toxins identified in the iDURC Policy are also subject to the Policy. The iDURC Policy requires that institutions subject to the Policy provide education and training on DURC for individuals conducting life sciences research with one or more of the 15 agents or toxins identified in the iDURC Policy. It is also required that they maintain education and training records for the term of the research grant or contract. The policy states that records must be saved for three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation. EPA is submitting an information collection request for the requirement of institutions in maintaining these training records. EPA's Office of Research and Development may choose to collect these records to ensure Policy compliance.

Federal Register Notices

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

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Student Assistance General Provision - Subpart E - Verification Student Aid Application Information

Key Information

Abstract

This request is for an extension of the information collection supporting the policies and reporting requirements contained in Subpart E of Part 668 – Verification and Updating of Student Aid Application Information. Sections 668.53, 668.54, 668.55, 668.56, 668.57, 668.59 and 668.61 contain information collection requirements (OMB control number 1845-0041). This subpart governs the verification and updating of information provided on the Free Application for Federal Student Aid (FAFSA) which is used to calculate an applicant’s Expected Family Contribution (EFC) for purposes of determining an applicant’s need for student financial assistance under Title IV of Higher Education Act of 1965, as amended (HEA). The collection of this documentation helps ensure that students (and parents in the case of PLUS loans) receive the correct amount of Title IV program assistance by providing accurate information to calculate an applicant’s expected family contribution. There has been no change to the regulatory language since the prior information collection filing.

Federal Register Notices

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

Authorizing Statutes

20 USC 1091,1094,1095	View Law

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Cash Management Contract URL Collection

Key Information

Abstract

The Department of Education (the Department) is seeking an extension of OMB control number 1845-0147 for the collection of URLs hosting institutional contracts and contract data relating to campus banking agreements. The regulatory sections for this collection include 34 CFR 668.164(e)(2)(viii) and 34 CFR 668.164(f)(4)(iii)(B), are unchanged. The Department and the public have a strong interest in knowing the terms of marketing contracts of the millions of students receiving millions of dollars in Federal student aid. The Higher Education Act of 1965, as amended (HEA) strongly supports providing important consumer information to students and the public, as evidenced in several parts of the law. The increased transparency will help ensure accountability and encourage institutional practices that are in the interest of students.

Federal Register Notices

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

Authorizing Statutes

20 USC 164(e)(f)	View Law

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Teacher Cancellation Low Income Directory

Key Information

Abstract

The Higher Education Act of 1965, as amended, (HEA) allows for up to a one hundred percent cancellation of a Federal Perkins Loan and loan forgiveness of a Federal Family Education Loan and Direct Loan program loan if the graduate teaches full-time in an elementary or secondary school serving low-income students. The Higher Education Act of 1965, as amended, (HEA) allows for up to a one hundred percent cancellation of a Federal Perkins Loan and loan forgiveness of a Federal Family Education Loan and Direct Loan program loan if the graduate teaches full-time in an elementary or secondary school serving low-income students. The data collected for the development of the Teacher Cancellation Low Income Directory provides web-based access to a list of all elementary and secondary schools, and educational service agencies that serve a total enrollment of more than 30 percent low income students (as defined under Title I, Part A of the Elementary and Secondary Education Act of 1965, as amended). The Directory allows post-secondary institutions to determine whether or not a teacher, who received a Federal Perkins Loan, Direct Loan, or Federal Family Education Loan at their school, is eligible to receive loan cancellation or forgiveness or that a teacher who received a Teacher Education Assistance for College and Higher Education (TEACH) Grant is meeting the service obligation. This revision request updates the collection with an optional school type data element.

Federal Register Notices

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

Authorizing Statutes

20 USC 1078-10	View Law

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National Flood Insurance Program Claims Forms

Key Information

Abstract

After a flood loss, claims forms are used by NFIP Direct policyholders to provide information needed to investigate, document, evaluate, and adjudicate claims against FEMA policies for flood damage to insured property or determine eligibility and settlement for benefits under Coverage D, Increased Cost of Compliance coverage. After a federally-declared disaster, FEMA inspectors use household inspection instruments to verify applicant information and document damage to determine award eligibility.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 108 - 264 205	View Law

Pub.L. 93 - 288 101-606	View Law

42 USC 4001-4131	View Law

42 USC 5174	View Law

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Bank Enterprise Award Program Application

Key Information

Abstract

The purpose of the Bank Enterprise Award Program (BEA Program) is to provide an incentive to Federal Deposit Insurance Corporation-insured (FDIC-insured) depository institutions to increase their lending, investment, and financial services to residents and businesses located in economically distressed communities, and provide assistance to Community Development Financial Institutions (CDFIs) through grants, stock purchases, loans, deposits, and other forms of financial and technical assistance. The CDFI Fund will make awards through the BEA Program to FDIC-insured depository institutions, based upon such institutions' demonstrated increase of qualified activities, as reported in the Application. The Application will solicit information concerning: Applicants' eligibility to participate in the BEA Program; the increase in total dollar value of applicants' qualified activities; impact of qualified activities; and appropriate supporting documentation. The questions that the Application contains, and the information generated thereby, will enable the CDFI Fund to evaluate applicants' activities and determine the extent of applicants' eligibility for BEA Program awards.

Federal Register Notices

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

Authorizing Statutes

12 USC 1834a	View Law

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Forest Activities Schedule

Key Information

Abstract

Taxpayers use Form T to provide information on timber accounts when a sale or deemed sale under Internal Revenue Code (IRC) sections 631(a), 631(b), or other exchange has occurred during the tax year. The IRS uses this information to determine if the taxpayer reported the correct amount of income and deductions.

Federal Register Notices

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

Authorizing Statutes

26 USC 194	View Law

26 USC 611	View Law

26 USC 631	View Law

26 USC 1231	View Law

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Creditability of Foreign Taxes

Key Information

Abstract

Internal Revenue Code (IRC) section 901 allows a taxpayer a tax credit for the amount of any income, war profits, or excess profits taxes it has paid or accrued during the taxable year. Treasury Regulations section 1.901-2A(e) allows a dual capacity taxpayer to apply the safe harbor formula to qualifying levies when determining the credit. Section 1.901-2A(d) requires the taxpayer to provide a statement electing to use the safe harbor formula.

Federal Register Notices

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

Authorizing Statutes

26 USC 901	View Law

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Generation-Skipping Transfer Tax Return for Distributions

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Form 706-GS(D) is used by distributees to compute and report the Federal Generation Skipping Transfer tax imposed by IRC section 2601. IRS uses the information to enforce this tax and to verify that the tax has been properly computed. The distributee will file a single Form 706 GS(D) annually and will report on it all taxable distributions from any trust received during the year. An individual will not file Form 706 GS(D) for any year in which he/she received no taxable distributions.

Federal Register Notices

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

Authorizing Statutes

26 USC 2601	View Law

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Summary of Benefits and Coverage and Uniform Glossary (CMS-10407)

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The Patient Protection and Affordable Care Act, Pub. L. 111-148, was signed into law on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, was signed into law on March 30, 2010 (these are collectively known as the "Affordable Care Act"). The Affordable Care Act amends the Public Health Service Act (PHS Act) by adding section 2715 "Development and Utilization of Uniform Explanation of Coverage Documents and Standardized Definitions." Section 2715 directs the Secretary, in consultation with the National Association of Insurance Commissioners and a working group comprised of stakeholders, to develop standards for use by a group health plan and a health insurance issuer in compiling and providing to applicants, enrollees, and policyholders and certificate holders a summary of benefits and coverage (SBC) that accurately describes the benefits and coverage under the applicable plan or coverage. Section 2715 also directs the Secretary to provide for the development of standards for the defintions of terms used in health insuance. Finally, section 2715 requires 60-days advance notice of any material modification in any of the terms of the plan or coverage that is not reflected in the most recently provided SBC. To implement these disclosure requirements, the final rule would require a collection of information by health insurance issuers in the group and individual markets and third-party administrators. Collection of information requirements relate to the provision of the following: 1. Summary of benefits and coverage (SBC) 2. Coverage examples (as a component of each SBC) 3. A uniform glossary of health coverage and medical terms (uniform glossary) 4. Notice of modifications

Federal Register Notices

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

Authorizing Statutes

42 USC Sec 300gg-21	View Law

Pub.L. 111 - 148 Title 1, Subtitle A, Sec. 1001	View Law

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Application to Determine Returning Resident Status

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Form DS-117 is used by consular officers to determine the eligibility of an alien applicant for special immigrant status as an returning resident because he or she remained out of the United States for more than one year because of circumstances outside of his or her control.

Federal Register Notices

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

Authorizing Statutes

8 USC 1101	View Law

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COLAs Online Access Request

Key Information

Abstract

To provide consumers with adequate information as to the identity of alcohol beverages and prohibit consumer deception, the Federal Alcohol Administration Act (FAA Act) at 26 U.S.C. 205, and the related Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations in 27 CFR chapter I require alcohol beverage bottlers and importers to apply for Certificates of Label Approval (COLAs) for such products introduced into interstate commerce or released from customs custody. Additionally, those regulations require domestic bottlers of distilled spirits and wines to apply for COLA exemptions for certain products sold only in intra-State commerce and require domestic bottlers and importers of distilled spirits to apply for approval of distinctive bottles. The vast majority of bottlers and importers complete and submit such applications electronically using TTB’s web-based COLAs Online system. Specific to this information collection, to protect TTB computer systems from cyber threats and misuse, persons desiring to use COLAs Online must first submit and receive TTB approval of a COLAs Online Access Request. The collected information identifies the COLAs Online access applicant and confirms their authority to act on behalf of a specific alcohol beverage industry member. Applicants submit COLAs Online access requests electronically using the COLAs Online User Registration function or its paper equivalent, TTB F 5013.2, COLAs Online Access Request.

Federal Register Notices

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

Authorizing Statutes

27 USC 205(e)	View Law

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Letterhead Applications and Notices Relating to Denatured Spirits (TTB REC 5150/2)

Key Information

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Under the Internal Revenue Code (IRC) at 26 U.S.C. 5214, denatured spirits (alcohol to which denaturants have been added to render it unfit for beverage purposes) may be withdrawn from distilled spirits plants free of tax for nonbeverage industrial purposes in the manufacture of certain personal and household products. Since it is possible to recover potable alcohol from denatured spirits and articles made with denatured spirits, the IRC at 26 U.S.C. 5271–5275 sets forth provisions regarding such spirits and articles. Under those IRC authorities, the TTB regulations in 27 CFR Part 20, Distribution and Use of Denatured Alcohol and Rum, require specially denatured spirits (SDS) dealers and nonbeverage product manufacturers that use or recover SDS to apply for and obtain a permit. Those part 20 regulations also require such permit holders, and non-permit holders that traffic in large quantities of completely denatured spirits (CDS), to submit letterhead applications or notices to TTB regarding certain changes to their permit information, use of alternate methods and emergency variations, adoption or use of certain formulas, losses in transit, and other specified matters. The collected information is necessary to implement the IRC's statutory provisions regarding denatured spirits and protect the revenue.

Federal Register Notices

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

Authorizing Statutes

26 USC 5271 - 5275	View Law

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Distilled Spirits Plants - Transaction and Supporting Records (TTB REC 5110/05)

Key Information

Abstract

In general, the Internal Revenue Code (IRC) at 26 U.S.C. 5001 imposes Federal alcohol excise tax on distilled spirits produced or imported into the United States. To protect that revenue, the IRC at 26 U.S.C. 5207 requires distilled spirits plant (DSP) proprietors to maintain records and provide reports related to their production, storage, denaturing, and processing activities as the Secretary prescribes by regulation. Under those IRC authorities, the Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations in 27 CFR parts 19, 26, 27, and 28 require DSP proprietors to keep certain usual and customary transaction and supporting records that are common to their distilled spirits production, storage, denaturing, and processing activities. Proprietors use the common transaction and supporting records required under this information collection approval, along with records that are unique to each DSP activity, which are required under other information collection approvals, to document the data provided on their monthly DSP production, storage, denaturing, and processing operations reports. TTB personnel may examine the DSP transaction and supporting records required under this collection to verify the data provided by DSP proprietors in those operations reports and to determine the Federal excise tax liabilities of those proprietors. As such, this information collection is necessary to protect the revenue.

Federal Register Notices

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

Authorizing Statutes

26 USC 5207	View Law

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Reporting and Recordkeeping Requirements Associated with Regulation L

Key Information

Abstract

The Depository Institution Management Interlocks Act (DIMIA) generally prohibits management officials from serving simultaneously with two unaffiliated depository organizations (i.e., depository institutions and depository institution holding companies), but allows for exemptions from the prohibition in certain circumstances. The FR L information collection accounts for the reporting and recordkeeping requirements associated with implementation of DIMIA. Respondents include state member banks (SMBs), bank holding companies (BHCs), and savings and loan holding companies (SLHCs) that qualify for certain exemptions.

Federal Register Notices

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

Authorizing Statutes

12 USC 3205	View Law

12 USC 3207	View Law

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Sections 2.1033 and 15.121, Scanning Receiver Compliance Exhibits

Key Information

Abstract

The Commission's equipment authorization program certifies scanning receivers to determine compliance with Congressionally mandated regulations of applications requesting authorization to market scanning receivers and frequency converters. The regulations prohibit the marketing of radio scanners capable of intercepting or being modified to intercept cellular telephone conversations.

Federal Register Notices

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

Authorizing Statutes

47 USC 303(g), 303(r), 304, 307	View Law

47 USC 301, 302, 303(e), 303(f)	View Law

47 USC 154(i)	View Law

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ACF’s Generic Clearance for Reviewer Recruitment Forms

Key Information

Abstract

This request by the Administration for Children and Families (ACF) is to extend approval of the generic clearance for Reviewer Recruitment Forms with no changes (note that burden estimates have been updated to reflect ongoing collections and estimated future burden, but the purpose and use of this generic have not changed). ACF may recruit reviewers for a variety of different activities and each program office within ACF has a slightly different needs for information about reviewer applicants for different activities. This overarching generic clearance allows ACF to request slightly different information from potential reviewers, yet the individual forms serve the same general function. The abbreviated clearance process of the generic clearance allows program offices to gather a suitable pool of candidates within the varied time periods available for reviewer recruitment. The forms submitted under this umbrella generic are and will be voluntary, low-burden and uncontroversial. Information will be collected electronically unless specified otherwise in an individual generic information collection (GenIC) request. These updates are in response to recent Presidential Actions related to diversity, equity, and inclusion (DEI), such as those covered under the EO Initial Recissions of Harmful Executive Orders and Actions.

Federal Register Notices

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

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Work Opportunity Tax Credit

Key Information

Abstract

The Work Opportunity Tax Credit (WOTC) is a Federal tax credit available to employers for hiring individuals from certain target groups who have consistently faced significant barrier to employment. This submission includes seven WOTC program forms as follows: • ETA Form 9175, Revised November 2016 – Self-Attestation Form (SAF) for the Long-Term Unemployment Recipient • ETA Form 9058 - Report 1, Revised November 2016 - Certification Workload and Characteristics of Certified Individuals • ETA Form 9061, Revised November 2016 - Individual Characteristics Form • ETA Form 9062, Revised April 2016 - Conditional Certification • ETA Form 9063, Revised April 2016 - Employer Certification • ETA Form 9065, Revised April 2016 - Agency Declaration of Verification Results Worksheet

Federal Register Notices

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

Authorizing Statutes

Pub.L. 104 - 188 1201	View Law

26 USC 51	View Law

26 USC 3111	View Law

Pub.L. 116 - 260 113	View Law

Pub.L. 101 - 508 11405(c)	View Law

Pub.L. 97 - 34 261(f)(2)	View Law

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Thriving Communities Initiative

Key Information

Abstract

This is a request for Office of Management and Budget (OMB) renewal for an information collection request (ICR) to enable the Department of Transportation’s (DOT) Office of the Secretary (OST) to implement the Thriving Communities Initiative (TCI) and Build America Bureau programs which includes the Thriving Communities program (TCP), the Rural and Tribal Assistance Pilot Program, and the Asset Concession and Innovative Finance Assistance Program. The TCI was authorized in the Consolidated Appropriations Act, 2022 (H.R. 2471), enacted on March 15, 2022. The Thriving Communities Initiative is a key component in DOT’s Equity Action Plan that will provide direct, coordinated and place-based technical assistance and capacity building support that enables all communities, particularly those that are under-served and historically disadvantaged, to be able to access funding and programs established in the Infrastructure Investment and Jobs Act (IIJA also known as the Bipartisan Infrastructure Law).

Federal Register Notices

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

Authorizing Statutes

Pub.L. 117 - 103 6702 (d) (3)	View Law

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Premarket Approval of Medical Devices

Key Information

Abstract

This information collection supports implementation of statutory requirements that govern premarket approval of medical devices. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Respondents to the information collection are PMA applicants, or persons who own the rights, or otherwise have authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity.

Federal Register Notices

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

Authorizing Statutes

21 USC 360e, 360e-1	View Law

21 USC 351(f)	View Law

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TD 8649, Netting Rule for Certain Conversion Transactions

Key Information

Abstract

Internal Revenue Code (IRC) section 1258 recharacterizes capital gains from conversion transactions as ordinary income to the extent of the time value element. Treasury Regulations section 1.1258-1 provides that certain gains and losses may be netted for purposes of determining the amount of gain recharacterized. To be eligible for netting relief, the taxpayer must identify on its books and records all the positions that are part of the conversion transaction before the close of the day on which the positions become part of the conversion transaction.

Federal Register Notices

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

Authorizing Statutes

26 USC 1258	View Law

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Bonneville Power Administration (BPA) Security

Key Information

Abstract

The information collected in these documents is used to determine access to BPA facilities and report incidents of damage or loss. This information is used to manage and oversee personnel and physical security programs (access control, personal identification for background checks, incident response).

Federal Register Notices

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

Authorizing Statutes

16 USC 832	View Law

42 USC 2165	View Law

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Rev. Proc. 2022-26 - Superfund; Imported Substances; Procedures for Filing a Petition

Key Information

Abstract

Section 4672(a)(2) of the Code allows importers and exporters to petition the Secretary of the Treasury to modify the list of chemical substances subject to the section 4671 excise tax. The collection of information in this revenue procedure is necessary so that the Secretary of the Treasury has sufficient information to process these determination requests. Petitioners are importers or exporters of chemical substances, and interested parties.

Federal Register Notices

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

Authorizing Statutes

26 USC 4672(a)(2)-(3)	View Law

Pub.L. 117 - 58 135	View Law

26 USC 4661, 4671	View Law

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Employment Tax Adjustments and Rules Relating to Additional Medicare Tax

Key Information

Abstract

This information is required to verify compliance with return requirements under section 6011, employment tax adjustments under section 6205 and 6413, and claims for refund of overpayments of employment taxes under section 6402 and 6414.

Federal Register Notices

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

Authorizing Statutes

26 USC 6205(a)	View Law

26 USC 6413(a)	View Law

Presidential Action: