Change Requests

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510(k) Third-Party Review Program

Key Information

Abstract

This ICR collects information from persons who wish to be accredited by the Agency to review certain premarket notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's premarket notification for selected medical devices. After reviewing a submission, the reviewer will forward a copy of the submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers also maintain records of their reviews and a copy of the submission. The purpose of the program is: (1) to provide manufacturers of eligible devices with an alternative review process that could yield more rapid marketing clearance decisions and (2) enable FDA to target its scientific review resources at higher-risk devices while maintaining confidence in the review by third parties of low-to-moderate risk devices.

Federal Register Notices

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

Authorizing Statutes

21 USC 523	View Law

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Entry Summary

Key Information

Abstract

CBP Form 7501, Entry Summary, is used to identify merchandise entering the commerce of the United States, and to document the amount of duty and/or tax paid. CBP Form 7501 is submitted by the importer, or the importer’s agent, for each import transaction. The data on this form is used by CBP as a record of the import transaction; to collect the proper duty, taxes, certifications and enforcement information; and to provide data to the U.S. Census Bureau for statistical purposes. CBP Form 7501 must be filed within 10 working days from the time of entry of merchandise into the United States. Collection of the data on this form is authorized by 19 U.S.C. 1484 and provided for by 19 CFR 142.11 and CFR 141.61. CBP Form 7501 and accompanying instructions can be found at https://www.cbp.gov/newsroom/publications/forms?title=7501&=Apply

Federal Register Notices

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

Authorizing Statutes

19 USC 1484	View Law

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NFA Responsible Person Questionnaire

Key Information

Abstract

ATF Form 5320.23 is required for any responsible person (as defined in 27 CFR 479.11) who is part of a trust or legal entity that is applying on ATF Form 1, Application to Make and Register a Firearm, as the maker or is identified as the transferee on ATF Form 4, Application for Tax Paid Transfer and Registration of Firearm, or ATF Form 5, Application for Tax Exempt Transfer of Firearm. Forms 1, 4 and 5 are required under the National Firearms Act (NFA).

SPD-15 Implementation	Yes

Federal Register Notices

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

Authorizing Statutes

26 USC 5812	View Law

26 USC 5822	View Law

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Application and Permit to Import Firearms, Ammunition, and Defense Articles (ATF 5330.3B (“Form 6, part II”))

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Abstract

Military members use the Form 5330.3B to request approval to import articles described on the application back to the U.S. ATF uses the information to determine if the article(s) described on the application qualify to be imported by the person requesting approval and the form then serves as the authorization for the person to import the items.

Federal Register Notices

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

Authorizing Statutes

18 USC 925 Chapter 44 Firearms	View Law

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Certification of Qualifying State Relief from Disabilities Program (ATF Form 3210.12)

Key Information

Abstract

NICS Improvement Act sought to address gap in information from states about mental health adjudications/commitments prohibiting purchase of firearms. It authorizes grants for states to improve quality and completeness of records available to NICS, but to qualify for a grant, a state official must certify to ATF that the state has implemented a qualifying program permitting persons adjudicated as a mental defective, or committed to an institution to apply for relief from that firearms disability.

Federal Register Notices

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

Authorizing Statutes

18 USC 922	View Law

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Application for Foreign Trade Zone Admission and Status Designation

Key Information

Abstract

This collection is used by business firms which bring merchandise into a foreign trade zone, to register the admission of such merchandise to zones and to apply for the appropriate zone status. Foreign trade zones (FTZs) are geographical enclaves located within the geographical limits of the United States but for tariff purposes are considered to be outside the United States. Imported merchandise may be brought into FTZs for storage, manipulation, manufacture, or other processing and subsequent removal for exportation, consumption in the United States, or destruction. A company bringing goods into an FTZ has a choice of zone status (privileged/non-privileged foreign, domestic, or zone-restricted), which affects the way such goods are treated by Customs and Border Protection (CBP) and treated for tariff purposes upon entry into the customs territory of the United States.

Federal Register Notices

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

Authorizing Statutes

19 USC 81	View Law

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The Student and Exchange Visitor Information System (SEVIS)

Key Information

Abstract

The Student and Exchange Visitor Information System (SEVIS) is a web-based system used to collect and maintain information on F and M nonimmigrant students during their stay in the United States. The system also facilitates the Student and Exchange Visitor Program’s (SEVP) certification of educational institutions to enroll F and M nonimmigrants.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 104 - 208 641	View Law

Pub.L. 107 - 56 -	View Law

8 USC 1372	View Law

Pub.L. 107 - 173 -	View Law

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Solicitation for Applications for Medicare Prescription Drug Plan 2027 Contracts (CMS-10137)

Key Information

Abstract

The Applications for Part D sponsors to offer qualified prescription drug coverage are completed by entities seeking approval to offer Part D benefits under the Medicare Prescription Drug Benefit program established by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and is codified in section 1860D of the Social Security Act (the Act).

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 3314	View Law

Pub.L. 111 - 148 3310	View Law

Pub.L. 111 - 148 6005	View Law

18 Stat. 1860

Pub.L. 108 - 173 1860D	View Law

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Immigration Bond

Key Information

Abstract

ICE collects this information to provide for the posting, maintenance, cancellation, and breach of an immigration surety bond, and for associated financial management activities, including collection of unpaid monies, reimbursement of the bond principal, and the calculation, payment, and reporting of interest. The proposed revisions to the bond form are to clarify the phone number as home or cell and to add an email address field.

Federal Register Notices

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

Authorizing Statutes

8 USC 1183	View Law

8 USC 1363	View Law

26 USC 6109	View Law

31 USC 7701(c)(1)	View Law

8 USC 1226	View Law

8 USC 1231	View Law

8 USC 1103	View Law

8 USC 1360	View Law

8 USC 1229c(b)(3)	View Law

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Naval Academy Information Program Blue and Gold Officer Application

Key Information

Abstract

This information collection is necessary to determine the eligibility and leadership potential of respondents applying to represent the United States Naval Academy as volunteer Blue and Gold Officers. Respondents accepted as Blue and Gold Officers work directly for the Candidate Guidance Officer at the USNA Office of Admissions guiding current and future U.S. Naval Academy candidates through the admissions process Prior military service, current and past military performance, and prior affiliation with the Naval Academy has been found to be an excellent predictor of success as a Blue and Gold Officer. Without this information, the ability for the United States Naval Academy to recruit qualified Blue and Gold Officers would be impacted and would negatively affect the Naval Academy’s ability to recruit qualified candidates.

Federal Register Notices

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

Authorizing Statutes

10 USC 8013	View Law

10 USC 8041	View Law

10 USC 8458	View Law

10 USC 10141	View Law

10 USC 10212	View Law

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Notice to Student or Exchange Visitor

Key Information

Abstract

CBP initiates the Form I-515A receipt or notice to allow an academic nonimmigrant student (F-1), vocational nonimmigrant student (M-1), exchange visitor (J-1), or dependent (F-2, M-2 or J-2) who is without proper documentation to enter the United States temporarily for a 30-day period. To extend the authorized duration of the visit, the F, J or M nonimmigrant must obtain the required documents and, along with the Form I-515A, submit them to the SEVP office within 30-days of entry. This change removes references to “original documents” and “sign in BLUE ink”; replaces mailing address with email address to submit documents electronically; and adds the full titles of Form I-20 and Form DS-2019 for accuracy. The Form I-515A serves as a receipt to an F, M or J nonimmigrant who has been granted 30-day admission to the United States until they submit requested documents to prove eligibility for “duration of status” admission. The revised form clarifies that electronically signed Forms I-20 and DS-2019 are acceptable following the Dec. 12. 2022, Department of Homeland Security’s Interim Final Rule (IFR), “Removal of Obsolete Procedures and Requirements Related to F, J, and M Nonimmigrants,” and Department of State’s March 28, 2023, IFR, “Exchange Visitor Program—Interim Provisions.”

Federal Register Notices

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

Authorizing Statutes

8 USC 1184	View Law

8 USC 1372	View Law

8 USC 1101	View Law

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Application for Withdrawal of Bonded Stores for Fishing Vessels and Certification of Use

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Abstract

The CBP Form 5125 is used for the withdrawal and lading of bonded merchandise (especially alcoholic beverages) for use on board fishing vessels and foreign or domestic vessels involved in international trade. The form also certifies the use: total consumption or partial consumption with secure storage for use on next voyage.

Federal Register Notices

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

Authorizing Statutes

19 USC 1317	View Law

19 USC 1309	View Law

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Consolidation of Certain Reporting and Recordkeeping under Section 8 of the Toxic Substances Control Act (TSCA) (Renewal)

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Abstract

This consolidated ICR involves reporting and recordkeeping activities established under TSCA section 8 for chemical substances. Although imposed for a specific chemical substance, the activities are already established and only vary based on the specific authority under TSCA section 8 and the need for the information for that chemical. EPA is consolidating these ICRs to streamline the presentation of the paperwork burden estimates for these various activities, which will in turn facilitate and reduce the administrative burden for both the public reviewers and the Agency in terms of reviewing and updating the ICR every three (3) years as required by the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., as well as allow for a better assessment of the paperwork burden and costs associated with reporting and recordkeeping activities established under TSCA section 8 for specific chemical substances. This information collection request (ICR) covers reporting and recordkeeping requirements imposed under the authorities in section 8 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607, for persons who manufacture (the term manufacture includes import under TSCA)(Attachment 1) or process chemical substances, mixtures, or categories, or distribute them in commerce. The purpose of the information collection activities is to collect data that will help the Agency evaluate the potential for human health and environmental risks that may be caused by the manufacture, processing, and distribution in commerce of chemical substances, mixtures, or categories. This ICR addresses the following four (4) types of information collections (ICs) required by TSCA section 8 and identifies the persons required to keep records and report such information. The ICs are numbered to facilitate the presentation in the ICR and link to supporting information; and the numbering is not otherwise intended to convey any sequencing or prioritization.

Federal Register Notices

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

Authorizing Statutes

15 USC 2607	View Law

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EPA's ENERGY STAR Product Labeling (Renewal)

Key Information

Abstract

ENERGY STAR is a voluntary program developed in collaboration with industry to create a self-sustaining market for energy efficient products. The ENERGY STAR label is a registered certification label that helps consumers identify products that meet ENERGY STAR energy performance criteria. To protect the integrity of the label, EPA works to ensure that products carrying the label meet appropriate program requirements. EPA sets criteria for ENERGY STAR products and facilitates the sale of certified products by providing consumers with information about the products. To set criteria for efficient products, EPA analyzes data on the performance of products and works with stakeholders to set criteria based on established processes. EPA partners with retailers, energy efficiency program sponsors (EEPS), service providers and product brand owners who wish to use the ENERGY STAR label to differentiate products as more energy efficient. Partners sign Partnership Agreements that require adherence to logo-use guidelines and program requirements, as well as promotion of ENERGY STAR certified products through product offerings. To have products third-party certified as ENERGY STAR, product brand owner partners are required to have eligible products tested in an EPA-recognized laboratory and certified by an EPA-recognized third-party certification body (CB). EPA maintains an XML-based automated data exchange for CBs to share information with EPA on certified products. To monitor the ongoing performance of products and maintain program integrity, EPA also requires CBs to conduct post-market verification testing of a sampling of ENERGY STAR certified products and share information with EPA on products verified twice a year. For thermostats, there are additional reporting requirements to verify product performance. To monitor progress and support the best allocation of resources, EPA requires partners to submit data on annual shipments of and installations and incentives for ENERGY STAR certified products. Finally, for any ENERGY STAR recognition, EPA may ask Partners to submit applications if they wish to participate.

Federal Register Notices

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

Authorizing Statutes

42 USC 6294a.	View Law

42 USC 7403g.	View Law

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Renewable Fuel Standard (RFS) Program (Renewal)

Key Information

Abstract

This ICR is for general registration, recordkeeping, and reporting under the Renewable Fuel Standard (RFS) program, required by Clean Air Act and implementing regulations in 40 CFR parts 80 and 1090. The RFS program relies upon marketable credits (RINs) to function, which necessitates recordkeeping and reporting to establish type and number of RINs generated, sold, retired, etc. EPA provides the secure systems that respondents use to register, submit compliance reports, and transact RINs, which removes a burden from industry. EPA uses the information to monitor compliance with RFS and to ensure the integrity of the RIN market and to ensure the integrity of the RIN market.

Federal Register Notices

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

Authorizing Statutes

42 USC 7414,7542,7545	View Law

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Distribution of Offsite Consequence Analysis Information under Section 112(r)(7)(H) of the Clean Air Act (CAA), As Amended (Renewal)

Key Information

Abstract

The Clean Air Act Section 112(r)(7) requires EPA to promulgate reasonable regulations and appropriate guidance to provide for the prevention and detection of accidental releases and for responses to such releases. The regulations include requirements for submitting a risk management plan (RMP) to EPA. The RMP includes information on off-site consequence analysis (OCA) as well as other elements of the Risk Management Program. On August 5, 1999, the President signed the Chemical Safety Information, Site Security, and Fuels Regulatory Relief Act (CSISSFRRA), which required the President to promulgate regulations on the distribution of OCA information (CAA section 112(r)(7)(H)(ii)) to the public. The President delegated to EPA and the Department of Justice (DOJ) the responsibility to promulgate regulations to govern public dissemination of OCA information. The final rule was published on August 8, 2000 (65 FR 48108) and imposed minimal information collection and record keeping requirements. The Federal government established 55 reading rooms at Federal facilities geographically distributed across the United States and its territories. At a reading room the public can read, but not mechanically copy or remove, paper copies of OCA information for up to 10 stationary sources per calendar month. The public also has access to OCA information that the Local Emergency Planning Committee (LEPC) in the requestor’s local area (where the individual lives or works), is authorized to provide. State agencies are permitted to provide the same public access to paper copies of OCA information that a person would receive at their local agency. EPA also established a Vulnerable Zone Indicator System (VZIS) which indicates whether an address in any state is within the vulnerable zone of one or more stationary sources, according to the data reported in RMPs. The VZIS is available on the internet, which is the method used by all requestors of the data.

Federal Register Notices

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

Authorizing Statutes

42 USC 7412(r)	View Law

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Inclusions to the Section 232 National Security Adjustments to Imports

Key Information

Abstract

Section 232 of the Trade Expansion Act of 1962 (19 U.S.C. 1862) authorizes the Secretary of Commerce (Secretary) to conduct comprehensive investigations to determine the effects of imports of an article on the national security of the United States. Such investigations can be initiated by an application by an interested party, a request from the head of any department or agency, or self-initiated by the Secretary. Once an investigation is initiated, the Secretary submits a report to the President on whether the importation of the article in question is occurring in such quantities or under such circumstances as to threaten to impair the national security of the United States. The President then determines whether it is necessary to take action to adjust the imports of an article and its derivatives under Section 232 of the Trade Expansion Act. Several Proclamations have directed the Secretary to create a process for including additional derivative articles within the scope of the new and existing ad valorem tariffs established under Section 232.. These Proclamations broadly authorize the Secretary to include additional derivative articles within the scope of the tariffs unilaterally, or at the request of a producer (or an industry association representing one or more such producers) of such articles or derivative articles within the United States after establishing that imports of said derivative article have increased in a manner that threatens to impair the national security of the United States or otherwise undermine the objectives set forth in the investigations under Section 232 or their associated Presidential Proclamations.

Federal Register Notices

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

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Recognition of Pass-Through Payment for Additional (New) Categories of Devices Under the Outpatient Prospective Payment System and Supporting Regulations (CMS-10052)

Key Information

Abstract

Information is necessary to determine eligibility of medical devices for establishment of additional device categories for payment under transitional pass-through payment provisions as required by section 1833(t)(6) of the Social Security Act.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 106 - 554 402	View Law

Pub.L. 106 - 113 201(b)	View Law

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HSQ-110 Acquisition, Protection, and Disclosure of Quality Improvement Organization (QIO) Information and Supporting Regulations (CMS-R-70)

Key Information

Abstract

The Peer Review Improvement Act of 1982 authorizes quality improvement organizations (QIOs), formerly known as PROs, to acquire information necessary to fulfill their duties and functions and places limits on disclosure of the information. These requirements are on the QIOs to provide notices to the affected parties when disclosing information about them. These reqirements serve to protect the rights of the affected parties.

Federal Register Notices

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

Authorizing Statutes

45 USC 1301-1320	View Law

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Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization

Key Information

Abstract

This information collection helps support implementation of statutory provisions applicable to laboratories that conduct testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These requirements are codified in 42 U.S.C. 263a and implementing regulations are found in 42 CFR 493.

Federal Register Notices

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

Authorizing Statutes

42 USC 263a (353)	View Law

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Information Collection to provide for the amount of AqueousFilm Forming Foam (AFFF) located at Part 139 airports

Key Information

Abstract

In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for an information collection. The collection involves S.4319 - A bill to provide for progress reports on the national transition plan related to a fluorine-free firefighting foam that requires that the FAA provide progress reports on the status of Part 139 airports transition to fluorine-free firefighting foam no later than 180 days after the date of enactment of this Act, and every 180 days thereafter until the progress report termination date. Within this report, a comprehensive list of the amount of AFFF at each part 139 airport has as of the date of the submission of the progress report, including the amount of such firefighting foam held in firefighting equipment and the number of gallons regularly kept in reserve at each such airport. These progress reports on the development and implementation of a national transition plan related to a fluorine-free firefighting foam that meets the performance standards referenced in Chapter 3 – Agent Compatibility, Substitutions, and Performance Requirements of Advisory Circular 150/5210.6E – Aircraft Fire Extinguishing Agents for Airports (AC 150/5210.62) issued on November 27, 2023 shall be submitted to the appropriate committees of Congress.

Federal Register Notices

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

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No Surprises Act: IDR Process

Key Information

Abstract

The CAA added provisions applicable to group health plans and health insurance issuers in the group and individual markets in a new Part D of title XXVII of the Public Health Service Act (PHS Act) and also added new provisions to part 7 of the Employee Retirement Income Security Act (ERISA), and Subchapter B of chapter 100 of the Internal Revenue Code (Code). Section 102 of the No Surprises Act added Code section 9816, ERISA section 716, and PHS Act section 2799A-1, which contain limitations on cost sharing and requirements for initial payments for emergency services. Section 103 of the No Surprises Act amended Code section 9816, ERISA section 716, and PHS Act section 2799A-1 to establish a Federal independent dispute resolution (Federal IDR) process that nonparticipating providers or facilities and group health plans and health insurance issuers in the group and individual market may use following the end of an unsuccessful open negotiation period to determine the out-of-network rate for certain services. More specifically, the Federal IDR provisions may be used to determine the out-of-network rate for certain emergency services, nonemergency items and services furnished by nonparticipating providers at participating health care facilities, where an All-Payer Model Agreement or specified state law does not apply. Section 105 of the No Surprises Act created Code section 9817, ERISA section 717, and PHS Act section 2799A-2 which contain limitations on cost sharing and requirements for initial payments for air ambulance services, and allow plans and issuers and providers of air ambulance services to access the Federal IDR process. CAA provisions that apply to health care providers and facilities, and providers of air ambulance services, such as requirements around cost sharing, prohibitions on balance billing for certain items and services, and requirements related to disclosures about balance billing protections, were added to title XXVII of the PHS Act in a new part E.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 116 - 260 103 and 105	View Law

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Semi-Annual Progress Report for the SASP-Culturally Specific Grant Program

Key Information

Abstract

The Sexual Assault Services Program Grants to Culturally Specific Programs (SASP-CSP), part of the Sexual Assault Services Program was created by the Violence Against Women and Department of Justice Reauthorization Act of 2005 (VAWA 2005) and is the first Federal funding stream solely dedicated to the provision of direct intervention and related assistance for victims of sexual assault. SASP-CSP targets nonprofit organizations that focus primarily on culturally specific communities and have experience in the area of sexual assault or who partner with an organization having such expertise. OVW will aggregate data from all SASP-CSP grantees’ progress reports to assess the performance of SASP-CSP as a whole and to respond to Congressional, Department of Justice, and other inquiries about how SASP-CSP funds are being used.

Federal Register Notices

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

Authorizing Statutes

34 USC 12511(c)	View Law

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Information Collection Requirements in 42 CFR Sections 478.18, 478.34, 478.36, and 478.42 QIO Reconsiderations and Appeals (CMS-R-72)

Key Information

Abstract

These regulations contain procedures for QIOs (formerly known as PROs) to use in reconsideration of initial determinations. The information requirements contained in these regulations are on QIOs to provide information to parties requesting a reconsideration. These parties will use the information as guidelines for appeal rights in instances where issues are still in dispute.

Federal Register Notices

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

Authorizing Statutes

42 USC 241	View Law

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DHS Traveler Redress Inquiry Program (DHS TRIP)

Key Information

Abstract

The Traveler Inquiry Form (TIF) is the form used to support the Traveler Redress Inquiry Program (TRIP), which will serve as a centralized intake office for traveler redress requests. After receipt, TRIP then passes the information to the relevant DHS component to process the request as appropriate (e.g., TRIP passes the form to TSA to initiate the Watch List Clearance Procedure). Individuals who feel that they have been unnecessarily subjected to additional screening, or denied or delayed boarding, or entry into or departure from the U.S. may complete the form. This form will be used by DHS to determine if there is an error in their record. This collection also serves to help DHS distinguish individuals from an actual individual on a watch list used by DHS, and it helps streamline and expedite future check-in or border crossing experiences.

Federal Register Notices

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

Authorizing Statutes

49 USC 44926	View Law

49 USC 44903	View Law

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