Change Requests

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Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including API), and AMT Designation

Key Information

Abstract

This information collection supports statutory and regulatory requirements that govern the manufacture, processing, packing, or holding of finished pharmaceuticals, including active pharmaceutical ingredients (APIs). Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 351(a)(2)(B)), a drug is adulterated if the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP regulations. FDA is responsible for enforcing the FD&C Act as well as related statutes, including the Public Health Service Act. Congress enacted these laws to ensure that covered products meet applicable requirements regarding the safety, identity and strength, and the quality and purity characteristics they purport or are represented to possess and are labeled with adequate warnings and instructions for use.

Federal Register Notices

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

Authorizing Statutes

21 USC 331; 374	View Law

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Margin and Capital Requirements for Covered Swap Entities

Key Information

Abstract

Sections 731 and 764 of the Dodd-Frank Wall Street Reform and Consumer Protection Act required the OCC to implement rules for swap entities under its jurisdiction imposing capital requirements and initial and variation margin requirements on all non-cleared swaps. This ICR is being submitted to revise the associated information collection to remove certain provisions determined to be obsolete or not constituting collections of information under the Paperwork Reduction Act.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 203 731, 764	View Law

129 Stat. 3

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Sections 90.1207(e) - (f), Amendment of Part 90 of the Commission's Rules

Key Information

Abstract

Sections 90.1207(e) and (f) of the Commission’s rules require incumbent public safety licensees and public safety applicants in the 4940-4990 MHz (4.9 GHz) band to submit granular technical data into the Commission’s Universal Licensing System (ULS).

Federal Register Notices

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

Authorizing Statutes

47 USC 332(c)(7), 1401-1473	View Law

47 USC 154(i), 161, 303(g), 303(r)	View Law

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Qualification Information for Candidates to Advisory Committees and Subcommittees

Key Information

Abstract

The collection of information is necessary to support the CFTC Advisory Committee Program which includes committees, most of which are governed by the FACA, and subcommittees that report directly to the CFTC FACA committees. Pursuant to the FACA, an agency must ensure that a committee is balanced with respect to the viewpoints represented and the functions to be performed by that committee. Consistent with this, in order to select individuals for potential membership on an advisory committee, the CFTC must determine that potential members are qualified to serve on an advisory committee and that the viewpoints are properly balanced on the committee. The CFTC is also required to ensure that committee members are properly designated as special government employees or representatives. While CFTC subcommittees are not subject to the FACA, the selection process for subcommittee members who are not already serving on the parent committee is similar to that of new committee members. Additionally, the agency follows similar member selection procedures for the agency’s non-FACA committee. CFTC staff would use the information collected to determine the experience and expertise of potential advisory committee and subcommittee members, ensure that the membership on a committee or subcommittee is balanced, and ensure that committee and subcommittee members are properly designated as representatives or special government employees. Respondents would consist of current and potential advisory committee and subcommittee members.

Federal Register Notices

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

Authorizing Statutes

7 USC § 1 et seq.	View Law

5 USC § 1001 et seq.	View Law

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Certification of Training Hours, Wages, and Progress (VA Form 28-1905c)

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Abstract

VA Form 28-1905c, Certification of Training Hours, Wages, and Progress is used to gather the necessary information to determine the claimant’s monthly progression and attendance as outlined in the claimant’s vocational rehabilitation plan. This information is essential to track the type and hours of training as well as the rating of the claimant’s performance toward the completion of his or her training program under 38 U.S.C. Chapter 31 and 38 U.S.C. Chapter 35. Without the information gathered on this form, benefits could be delayed under 38 U.S.C. 501(a).

Federal Register Notices

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

Authorizing Statutes

38 USC Section 3677	View Law

38 USC Section 501(a)	View Law

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Grantee Reporting Requirements for Industry/University Cooperative Research Center (I/UCRC)

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The Industry/University Cooperative Research Centers (I/UCRC) Program was initiated in 1973 to develop long-term partnerships among industry, academe and government. The National Science Foundation invests in these partnerships to promote research programs of mutual interest, contribute to the Nation's research infrastructure base and enhance the intellectual capacity of the engineering or science workforce through the integration of research and education. As appropriate, NSF encourages international collaborations that advance these goals within the global context. This request for reinstatement stems from the following: desire to obtain the best data available from the centers, increased transparency and accountability of the program, and changes in personnel in the program. The program's reporting requirements are outlined to prospective awardees in the solicitation. The extent and complexity of the questions go beyond the standard request for reporting, and a separate clearance would allow flexibility within the program to consider changes as needed.

Federal Register Notices

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

Authorizing Statutes

42 USC 1861 et. seq.	View Law

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Government-Sponsored Enterprise (GSE) Industry Appraisal Report

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This information collection package seeks approval of Department of Veterans Affairs (VA) requirement that appraisers utilize certain industry-standard reports in completing an appraisal. 38 U.S.C. Title 3731 authorizes the VA Secretary to establish a panel of appraisers, prescribe qualifications for such appraisers, and determine reasonable value of a property, construction, repairs or alterations based on an appraisal report provided by a panel appraiser for the purpose of guaranteeing a loan.

Federal Register Notices

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

Authorizing Statutes

38 USC 3731	View Law

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Required Warnings for Cigarette Packages and Advertisements

Key Information

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This ICR collects information from manufacturers, distributors, and certain retailers of cigarettes who will be required to submit plans to FDA relating to the random and equal display and distribution of required warning statements on cigarette packaging and quarterly rotation of required warning statements in alternating sequence in cigarette product advertising ("plan" or "plans"). A record of the FDA-approved plan must also be established and maintained.

Federal Register Notices

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

Authorizing Statutes

21 USC 387e(g)	View Law

21 USC 387c	View Law

21 USC 387i	View Law

Pub.L. 111 - 31 123	View Law

21 USC 371	View Law

21 USC 374	View Law

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National Scenic Byway Program (NSBP)

Key Information

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This information collection request would require State Departments of Transportation and Federally Recognized Indian Tribe(s) on an annual basis to develop applications in order to apply for funding under the National Scenic Byway Program (NSBP) Notice of Funding Opportunity (NOFO) re-published on grants.gov. This grant opportunity will result in the distribution of up to $26.956 million of Fiscal Year (FY) 2023 and 2024 funding for the NSBP competitive grants. FHWA will be publishing an Amendment No. 1 to this NOFO. Applicants that fulfilled the requirements of submitting an application prior to December 16, 2024 NOFO closing date, will be notified of this Amendment No. 1 and will be provided 21 calendar days, from the date of Amendment No. 1 to indicate they are retaining their existing application, submit an amended application, or request withdrawal of their application from consideration for NSBP grant funding. As they were required of applicants in their original application submittal, the information collection still requires the applicants include the mandatory standard forms (SF) 424 (Application for Federal Assistance), SF 424C (Budget Information for Construction), or SF 424A (Budget Information for Non-Construction Programs), SF-424D (Assurances for Construction Programs), or SF424B (Assurances for Non-Construction Programs), SF-LLL (Disclosure of Lobbying Activities), and Grants.gov Lobbying Form. For the response to Amendment No. 1, FHWA is requiring compliant applicants to email an amended project narrative to FHWA. If the amended application also changes content within a standard form, they are also required to attach the amended standard form to the email. If nothing changed within the standard form or another document, there is no need to resubmit that material. If submitting an amended application, the applicant should highlight changes from the original application to assist reviewers. Note: Tribal applicants are not required to submit a Standard Form LLL. The NOFO provides additional details on the information being collected. The purpose of the collection is to determine if the applicants’ eligibility requirements have been met to further evaluate the application for award. Per 23 U.S.C. 162, funds made available for the NSBP grant program are to be awarded on a competitive basis to implement eligible projects on highways designated as National Scenic Byways or All-American Roads (collectively America's Byways®), State scenic byways, or Indian Tribe scenic byways; and plan, design, and develop a State or Indian Tribe scenic byway program per Title 23, United States Code (U.S.C.), Section 162(b). The NOFO describes the application requirements, selection and evaluation criteria, applicable program and Federal requirements, and available technical assistance during the grant solicitation period.

Federal Register Notices

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

Authorizing Statutes

23 USC 162	View Law

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FERC-725X, (RD25-10) Mandatory Reliability Standards: Voltage and Reactive (VAR) Standards

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Abstract

NERC established the Voltage and Reactive (“VAR”) group of Reliability Standards, which consists of two continent-wide Reliability Standards, VAR-001-5 and VAR-002-4.1. These two standards were designed to maintain voltage stability on the Bulk-Power System, protect transmission, generation, distribution, and customer equipment, and support the reliable operation of the Bulk-Power System. Voltage stability is the ability of a power system to maintain acceptable voltage levels throughout the system under normal operating conditions and following a disturbance. Failure to maintain acceptable voltage levels (i.e., voltage levels become too high or too low) may cause violations of System Operating Limits (“SOLs”) and Interconnection Reliability Operating Limits (“IROLs”), resulting in damage to Bulk-Power System equipment, and thereby threaten the reliable operation of the Bulk-Power System.

Federal Register Notices

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

Authorizing Statutes

16 USC 824o	View Law

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Information collections contained in Reforming and Modernizing the NRC’s Radiation Protection Framework proposed rule, 10 CFR Parts 20, 34, 35, 50, 53, and 72

Key Information

Abstract

The NRC is proposing to amend its regulations that govern its standards for protection against radiation. The revisions reflect the agency’s reconsideration of its use of the LNT model for assessing health effects from radiation exposure and its application of the ALARA principle that is predicated on the LNT model. The proposed rule would reflect the NRC’s experience and other developments in the field of radiation protection since the NRC’s last major revisions to these standards in 1991. The proposed rule covers diverse topics, which result in recordkeeping and reporting requirements related to instruction to workers, radiation protection requirements, industrial radiography, medical use of byproduct material, source material licensing, and storage and transportation of radioactive material. In addition to the new information collections in the proposed regulations, this proposed rule would result in amended requirements for NRC Forms 540/540A, 541/541A, and 542/542A. These forms are used on a nationwide basis to reflect the minimum safety-related information for a low-level radioactive waste shipment as required by Federal and State reporting requirements for the safe transportation and disposal of low-level radioactive waste. The rulemaking would not make any changes to the forms themselves. The rulemaking would make the use of the forms optional as long as respondents provide the same information as required in the forms using a different format.

Authorizing Statutes

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Entity List and Unverified List Requests

Key Information

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This collection is needed to provide a procedure for persons or organizations listed on the Entity List and Unverified List to request removal or modification of the entry that affects them.

Federal Register Notices

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

Authorizing Statutes

50 USC 4811-4826	View Law

Pub.L. 95 - 223 203	View Law

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Office of Hearings and Appeals Procedural Regulations (43 CFR Part 4)

Key Information

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OHA exercises the delegated authority of the Secretary of the Interior to conduct hearings and decide appeals from decisions of the bureaus and offices of the Department of the Interior (Department, DOI, Interior). OHA’s hearings and appeals provide administrative process to outside litigants by providing an impartial forum and independent review of bureau and office decisions. OHA review ensures that the Department has an opportunity to correct its own administrative errors, final agency decisions are consistent with law, and, if Department decisions are challenged in federal court, those courts receive fully developed administrative records on which to base judicial review of agency actions.

Federal Register Notices

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

Authorizing Statutes

5 USC 554	View Law

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Foreign Availability Procedures

Key Information

Abstract

The information voluntarily submitted is necessary to prove foreign availability of a controlled product.

Federal Register Notices

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

Authorizing Statutes

50 USC 1702	View Law

Pub.L. 96 - 72 5	View Law

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Reporting of Violations of the Export Administration Regulations

Key Information

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This collection of information is needed to detect violations of the Export Administration Regulations (EAR) and determine if an investigation or prosecution is necessary and to reach a settlement with violators. Reporting violations or imminent violations, whether through voluntary self-disclosures or based on information provided by those who have direct knowledge of possible violations of the EAR, strengthens BIS’s enforcement efforts. The disclosure activities and burden associated with this collection allows BIS to begin and conduct investigations faster and with more accurate information than would be the case if BIS had to detect the violations without such information or disclosures. BIS is revising the title of this collection of information to better reflect enforcement and protective measures associated with the full scope of disclosures that are covered in Part 764 of the EAR.

Federal Register Notices

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

Authorizing Statutes

50 USC §§ 4812(b)(7) and 48	View Law

50 USC 1702	View Law

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Rule 17a-2, 17 CFR 240.17a-2 (Recordkeeping Requirements Relating to Stabilizing Activities)

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The syndicate manager in an offering of securities must collect and retain information regarding stabilizing transactions, syndicate covering transactions, and penalty bids. The Commission does not receive such information and uses it only upon request pursuant to an investigation.

Federal Register Notices

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

Authorizing Statutes

15 USC 78o, 78q, and 78w	View Law

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Native American Library Services Basic Grants Performance Report Form

Key Information

Abstract

The Institute of Museum and Library Services (IMLS) requests a three-year renewal clearance for the Native American Basic Grant Performance Report Form under the Paperwork Reduction Act. The agency uses a standardized performance report form for federally recognized Native American Tribes that receive funding through IMLS’s non-competitive discretionary grant program.

Federal Register Notices

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

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2026-2028 Grant Performance Report Forms

Key Information

Abstract

The Institute of Museum and Library Services (IMLS) requests a three-year renewal clearance for the IMLS Grant Performance Report Forms under the Paperwork Reduction Act. The agency uses standardized performance report forms for libraries, museums, and other organizations that receive funding through its competitive discretionary grant programs. The forms submitted for public review in this Notice are the Interim and Final Performance Report Forms.

Federal Register Notices

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

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FERC-725G, (RD25-10) Mandatory Reliability Standards for the Bulk-Power System: PRC Rel Stds.

Key Information

Abstract

This submission is for a renewal and update of RD25-10. Which updates to PREC-012-2 and PRC-017-1. The purpose of PRC-012-2 is to ensure that remedial action schemes (RAS) do not introduce unintentional or unacceptable reliability risks to the BES. The stated purpose of Reliability Standard PRC-017-1 is to ensure that all RAS are properly designed, meet performance requirements, and are coordinated with other protection systems and to ensure that maintenance and testing programs are developed and misoperations are analyzed and corrected

Federal Register Notices

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

Authorizing Statutes

16 USC 824o	View Law

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Update the National Review of Quick Clearance Laws

Key Information

Abstract

This information collection request is for states to voluntarily provide any move over/quick clearance laws update. The eligible respondents to this voluntary survey include 50 State DOTs, District of Columbia, Commonwealth of Puerto Rico, United States. The collection is via email survey, with data collected as needed. Prior information collection was via a website literature review that resulted in the 2008 Traffic Incident Management Quick Clearance Laws publication. The objective of this outreach effort is to develop a Quick Clearance Laws State of the Practice Report. The intent is to provide awareness and knowledge of current State Quick Clearance Laws through outreach and encourage states to establish them. Federal Highway Administration (FHWA) Traffic Incident Management (TIM) programs aim to reduce the duration and impact of incidents on congestion and improve safety for motorists, crash victims, and incident responders through safe quick clearance practices. Additionally, TIM prioritizes effective mitigation practices to return roadways back to normal flow of traffic. Once published the information would be available to the state DOTs, public and other interested parties via the FHWA website.

Federal Register Notices

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

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Leadership Assesment Surveys

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Abstract

The Office of Personnel Management (OPM) leads Federal agencies in shaping human resources management (HRM) systems to effectively recruit, develop, manage and retain a high quality workforce. We need to solicit input from our customers to measure our performance in providing services that are results-oriented and market-based. Performance surveys are valuable tools to gather information about our customers' view of our performance so we can design and implement new ways to improve our service to meet their needs. Our customers include the general public, Federal benefit recipients, Federal agencies and Federal employees. This meets all requirements for Executive Order 12862 and OMB Memorandum 93-14.

Federal Register Notices

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

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Program Services Evaluation Surveys

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Abstract

The Office of Personnel Management (OPM) leads Federal agencies in shaping human resources management (HRM) systems to effectively recruit, develop, manage and retain a high quality and diverse workforce. We need to solicit input from our customers to evaluate our program services that are citizen-centered, results-oriented and market-based. Program Services Evaluation Surveys are valuable tools to gather information about our program services so we can design and implement new ways to improve our customers satisfaction. Our customers include the general public, Federal benefit recipients, Federal agencies and Federal employees. This meets all requirements for Executive Order 12862 and OMB Memorandum 93-14.

Federal Register Notices

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

Authorizing Statutes

5 USC 1101	View Law

5 USC 1128	View Law

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Requirements for Approved Construction and Non-Construction Investments

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Abstract

In order to effectively administer and monitor its economic development assistance programs, EDA collects certain information from applications for, and recipients of, EDA investment assistance. EDA may award assistance for construction and non-construction projects under the agency’s Public Works and Economic Adjustment Assistance (EAA) Programs (see 13 CFR parts 305 and 307). Public Works Program investments help support the construction or rehabilitation of essential public infrastructure and facilities necessary to generate or retain private sector jobs and investments, attract private sector capital, and promote vibrant economic ecosystems, regional competitiveness and innovation. The EAA Program provides a wide range of technical, planning and infrastructure assistance in regions experiencing adverse economic changes that may occur suddenly or over time.

Federal Register Notices

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

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Administration for Children and Families Generic for Information Collections related to Gatherings

Key Information

Abstract

This request is to establish a new umbrella generic clearance for the Administration for Children and Families (ACF) to request information from potential participants at ACF gatherings, such as meetings or conferences. This may include large scale conferences, meetings for grantees or contractors, workshops, trainings, poster sessions, and other in-person and virtual gatherings for individuals with interest in ACF programs (clients, researchers, policymakers, etc.), among others. To ensure ACF has adequate information to plan these activities, the Agency must often collect information from potential participants such as basic contact information, preferences for attendance (mode, special requests, etc.), organizational affiliation, feedback about meeting content, etc. Additionally, some activities require ACF to have additional information to have the means to select the most appropriate participants for attendance according to the type or purpose of a given activity, or to group participants into the most appropriate category or activity during an event. This may include information about poster presentations, speaking panels, training courses, professional perspectives or experiences, etc. In addition, attendees may be asked to submit an application or abstract for prescreening to be selected for attendance. The planning for meetings is most often on a quick timeline and the standard timeline to comply with a full request under the Paperwork Reduction Act would inhibit the ability to collect information to inform these activities. Therefore, an umbrella generic is necessary to allow for quick turnaround requests for similar information collections related to these activities. As part of this generic, ACF requests OMB provide a response on individual generic information collections within 5 business days. If no response is received and the request meets the purposes, uses and scope outlined in this document, ACF may move forward with the proposed information collection.

Federal Register Notices

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

Authorizing Statutes

42 USC 1310	View Law

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Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

Key Information

Abstract

This information collection supports regulations in 21 CFR part 60 pertaining to patent term restoration and the submission of requests for revision of the regulatory review period under 21 CFR 60.24; due diligence petitions under 21 CFR 60.30; and requests for hearings under 21 CFR 60.40.

Federal Register Notices

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

Authorizing Statutes

35 USC 156	View Law

21 USC 355(j)	View Law

Pub.L. 100 - 670 201	View Law

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