Information Collection Request (ICR) Tracker

Key Information

Federal Register Notices

Authorizing Statutes

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Under 38 U.S.C. 1787, VA is required to furnish hospital care and medical services to the family members of certain veterans who were stationed at Camp Lejeune between 1953 and 1987. In order to furnish such care, VA must collect necessary information from the family members to ensure that they meet the requirements of the law. The specific hospital care and medical services that VA must provide are for a number of illnesses and conditions connected to exposure to contaminated drinking water while at Camp Lejeune. VA will furnish Camp Lejeune family members with hospital care and medical services for 15 illnesses and conditions that are life threatening and require immediate medical intervention. The forms in this collection will be used to determine eligibility and reimbursement for this medical care. Some minor changes to the wording in VA Form 10-10068b have been made to clarify the information being collected from the treating physician. Also, VA Form 10-10068b may now be used up to two times annually per patient, and there is an associated increase in the estimated burden hours.

Key Information

Federal Register Notices

Authorizing Statutes

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CDC in collaboration with state and local health departments in the 50 states, the District of Columbia, and U.S. dependent areas, conducts national surveillance for cases of HIV infection that provides critical data across the spectrum of HIV disease from HIV diagnosis, to AIDS, the end-stage disease caused by infection with HIV, and death. HIV surveillance data are used to monitor the extent and characteristics of the HIV burden in the United States. In addition, this national system provides essential data to estimate HIV incidence and monitor patterns in HIV drug resistance and genetic diversity, detect HIV clusters, and perinatal exposures. This Non-Substantive Change Request is submitted to revise questions in the National HIV Surveillance System (NHSS) OMB No. 0920-0573 to align with EO 14168. Changes are only made to the Gender/Sex questions in this data collection. Modifications of other demographic questions will be done in a future Revision. There are no anticipated changes to the approved burden associated with this data collection in this Change Request.

Key Information

Federal Register Notices

Authorizing Statutes

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The Stem Cell Therapeutic and Research Act of 2005 (Public Law 109-129, December 20, 2005) as amended and codified in Section 379A of the Public Health Service Act (42 U.S.C. 247l), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. The Public Health Service Act requires the Secretary of HHS to contract for the establishment and maintenance of information related to patients who have received stem cell therapeutic products and to do so using an electronic format. HRSA has established the Stem Cell Therapeutic Outcomes Database (SCTOD), a component of the C.W. Bill Young Cell Transplantation Program (Program), which necessitates certain electronic record-keeping and reporting requirements to perform functions related to hematopoietic stem cell transplantation (HCT) under contract to HHS. Data are collected from transplant centers by the Center for International Blood and Marrow Transplant Research. They are used for ongoing analysis of transplant outcomes to improve treatment and survival for patients who may benefit from cellular therapies.

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Federal Register Notices

Authorizing Statutes

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The proposed collection OMB 2133-0506 (Merchant Marine Medals and Awards) is used by MARAD personnel to process and verify requests for service awards. There are no changes to this collection since the last renewal.

Key Information

Federal Register Notices

Authorizing Statutes

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The Food and Drug Administration (FDA) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (Deeming rule), deeming all products that meet the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act’s user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA.

Key Information

Federal Register Notices

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This information collection accounts for burden that may be attendant to recommendations discussed in FDA guidance applicable to pharmacists and veterinarians who compound animal drugs from bulk drug substances.

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Federal Register Notices

Authorizing Statutes

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Plan administrators of plans terminating voluntarily must submit certain information to the PBGC and provide certain information to affected third parties. The PBGC needs the information required to be submitted to ensure that a voluntary termination if 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.

Key Information

Federal Register Notices

Authorizing Statutes

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This regulation (45 CFR 673) implements Antarctic Science, Tourism, and Conservation Act of 1996 requirements for U.S. non-governmental operators organizing expeditions to Antarctica on non-U.S. flagged vessels.

Key Information

Federal Register Notices

Authorizing Statutes

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The information collection supports FDA regulations at 21 CFR 1.101 and pertains to the notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).

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Federal Register Notices

Authorizing Statutes

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The reporting requirements of this regulation implement the Dietary Supplement Health and Education Act. The subject regulation establishes reporting procedures necessary to inform FDA when dietary supplement manufacturers are making statements of nutritional support on their labels or in their labeling. FDA is seeking OMB approval of an electronic submission method for this collection.

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Federal Register Notices

Authorizing Statutes

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The Commission administers Sections 2 and 3 of Public Law 89-777 (46 U.S.C. 44101-44106), which require vessel owners, charterers and operators of passenger vessels with passenger berths or stateroom accommodations for at least 50 passengers, and embarking passengers at United States ports, to establish their financial responsibility to meet liability incurred for death or injury and to indemnify passengers in the event of nonperformance of transportation. 46 CFR Part 540, entitled Passenger Vessel Financial Responsibility, implements Public Law 89-777. The regulation (and its related application Form FMC-131, Application for Certificate of Financial Responsibility) requires owners, operators or charterers of passenger vessels subject to Public Law 89-777 to apply for an initial certificate or to file an amendment to existing certificates. The Commission’s rules require that applications be filed at least 60 days prior to any advertising, promotion or collection of deposits and fares for a Certificate (Performance), and at least 60 days prior to sailing for a Certificate (Casualty). Applicants may apply separately for each certificate or for both certificates on one application. The method of establishing financial responsibility may be different for each certificate. The applicant has the option of using (1) insurance, (2) escrow accounts, (3) guaranties, (4) surety bonds, or (5) self-insurance (for casualty only) to establish financial responsibility to qualify for a Certificate (Casualty) evidencing compliance with Section 2 of Public Law 89-777, or to qualify for a Certificate (Performance) evidencing compliance with Section 3 of Public Law 89-777. Upon receipt, examination, and approval of the application form and evidence of financial responsibility, a Certificate of Financial Responsibility for Indemnification of Passengers for Nonperformance of Transportation and Certificate of Financial Responsibility to Meet Liability Incurred for Death or Injury to Passengers or Other Persons on Voyages are issued to the applicant/certificant. The certificates must be presented to U.S. Customs and Border Protection (CBP) or Coast Guard officials at the time the vessel clears a United States port. The cap on passenger vessel financial responsibility under Section 3 (Performance) of Public Law 89-777, 46 U.S.C. 44101-44106, is adjusted biennially to the nearest $1 million using the Bureau of Labor Statistics’s Consumer Price Index for all Urban Consumers (CPI-U). Smaller passenger vessel operators’ (PVO) financial responsibility requirements may be adjusted by requesting consideration for alternative forms of protection from the Director of the Bureau of Certification and Licensing. The FMC’s PVO Certificates (Performance) are required to be renewed every 5 years. The renewal of the certificates assists U.S. Customs and Border Protection officers in determining the validity of a certificate, and ensures that the FMC periodically confirms PVO information previously submitted.

Key Information

Federal Register Notices

Authorizing Statutes

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Data collection is designed to conduct a comprehensive evaluation of the dissemination, implementation, and outcomes of the CDC Clinical Practice Guideline for Prescribing Opioids for Pain – United States, 2022 (2022 CDC Clinical Practice Guideline). Resulting data will be used for purposes of evaluation and to ensure that Americans have access to safer, effective ways of managing their pain. This change request is submitted to comply with recent executive orders.

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A worksheet through which carriers will submit the information required by, and other information necessary to implement, Executive Order 14256, as amended. The worksheet is where the carrier will declare its duty collection methodology (i.e., ad valorem or specific duty) for the given month, package count, value (if applicable), and total duty amount. The second page will be utilized by the carrier to list the specifics of imported postal items. CBP will use this information to determine the amount of duty that carriers owe pursuant to Executive Order 14256, as amended. CBP can also use the worksheet as a reference when subsequently auditing carriers’ liability for duties.Emergency Justfication:IEEPA authorizes the President “to deal with any unusual and extraordinary threat, which has its source in whole or substantial part outside the United States, to the national security, foreign policy, or economy of the United States.” 50 U.S.C. § 1701(a). Once the President declares a national emergency relating to such a threat, IEEPA empowers the President to “regulate . . . importation . . . with respect to any property, subject to the jurisdiction of the United States.” Proclamation 10886 formally declared a national emergency in order to address and abate the synthetic opioid crisis from the PRC, Canada and Mexico to the United States. This crisis, noted in EO 14195, is “killing approximately two hundred Americans per day, putting a severe strain on our healthcare system, ravaging our communities, and destroying our families,” and synthetic opioid overdose “is the leading cause of death for people aged 18 to 45 in the United States.” Executive Order 14324 states that it is still necessary and appropriate to suspend duty-free de minimis treatment under 19 U.S.C. 1321(a)(2)(C) in the manner and for the articles described below to deal with the unusual and extraordinary threats, which have their source in whole or substantial part outside the United States, to the national security, foreign policy, and economy of the United States. Following normal PRA clearance procedures would prevent CBP from getting PRA authorization for the International Mail Duty Worksheet urgently needed to properly gather all the necessary information, crucial to deal with the unusual and extraordinary threats which have their source in whole or substantial part outside the United States.

Key Information

Federal Register Notices

Authorizing Statutes

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The Uniform Financial Reporting Requirements are used as a basis for preparing and filing semi-annual and annual financial statements with the Maritime Administration. Regulations requiring financial reports to the Maritime Administration are authorized by Section 801 of the Merchant Marine Act, 1936. Financial reports are also required by regulation of purchasers of ships from MARAD on credit, companies chartering ships from MARAD, and of companies having Title XI guarantee obligations.

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Federal Register Notices

Authorizing Statutes

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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.

Key Information

Federal Register Notices

Authorizing Statutes

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The program is to publish four forms. These are to be used to collect key information concerning voting system manufacturers and their systems, as well as information regarding anomalies in voting systems used in federal elections. These forms will collect: - The voting system manufacturer registration form collects information on the ownership, contact details for certain directors and senior staff, and the quality processes for manufacturers who wish to participate in the EAC's Testing and Certification program. -The voting system application collects administrative information on new or modified voting systems that are being submitted for testing by a registered voting system manufacturer. -The voting system anomaly report will collect initial anomaly information as reported by voting system manufacturers and election officials. -The root cause analysis form collects information on voting system anomalies, test results, and findings.

Key Information

Federal Register Notices

Authorizing Statutes

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The Federal Communications Commission (Commission) is requesting that the Office of Management and Budget (OMB) approve a three-year extension of the information collection, titled “47 CFR 43.82, Annual International Circuit Capacity Reports.” Pursuant to 47 CFR § 43.82, cable landing licensees and entities holding capacity on submarine cables file electronically annual circuit capacity reports, in a format set out in a Filing Manual. This non-substantive change justification request is being submitted to the Office of Management (OMB) for review and approval. Please see the non-substantive change justification for the reason behind this change request to OMB.

Key Information

Federal Register Notices

Authorizing Statutes

Abstract

FMCSA registers for-hire motor carriers of regulated commodities and of passengers, surface freight forwarders, property brokers, and certain Mexico-domiciled motor carriers, as mandatory reporting. These motor carriers may conduct transportation services in the United States only if they are registered with FMCSA. FMCSA is still accepting forms OP-1, OP-1(P), OP-1(FF), and OP-1(NNA) for existing registrants wishing to apply for additional authorities. FMCSA requires Form OP-1(MX) for Mexico-domiciled carriers that wish to operate beyond the U.S. municipalities on the U.S.-Mexico border and their commercial zones. Information collected through these forms, as an ICR extension, aids FMCSA in determining the type of operation a company may run, the cargo it may carry, and the resulting level of insurance coverage the applicant will be required to obtain and maintain to continue its operating authority. The OP-1 series requests information on the applicant’s familiarity with relevant safety requirements, the applicant’s willingness to comply with those requirements during its operations, and the applicant’s willingness to meet any specific statutory and regulatory requirements applicable to its proposed operations. FMCSA also uses information from these forms to prepare (for each applicant) a public notice of the registration application, which is published in the “FMCSA Register.” Publication of this notice initiates a 10-day period during which an interested party may file a complaint seeking denial of the registration on a limited number of statutory grounds. Effective December 12, 2015, OP-1 series forms, with the exception of OP-1(MX), can only be used to apply for additional authorities, not for initial registration with FMCSA. These forms request information to identify the applicant, the nature and scope of its proposed operations, a narrative description of the applicant’s safety policies and procedures, and information regarding the drivers and vehicles it plans to use in U.S. operations. There is no requirement for the OP-1, OP-1(P), OP-1(FF), and OP-1(NNA) forms be filed on a periodic basis. The forms are filed on an “as needed” basis. Since the rollout of URS Phase I, the sole purpose of these forms is to allow existing registrants to apply for additional authorities. A new OP-1(MX) application form is currently required only if a Mexico-domiciled carrier wishes to extend the scope of its authority or is applying for new authority.

Key Information

Federal Register Notices

Authorizing Statutes

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The purpose of this request is to renew the currently OMB approved ICR. Form M is required to collect financial, operating, equipment, and employment data from individual motor carriers of property and household goods. All for-hire (common and contract) motor carriers of property with gross annual operating revenue of $3 million or more must file the annual report Form M. Form MP-1 is required to collect financial, operating, equipment, and employment data from individual motor carriers of passengers. All Class I for-hire motor carriers of passengers with gross annual operating revenues of $5 million or more are required to file the annual report Form MP-1. FMCSA has created electronic forms that may be prepared, signed electronically, and submitted to FMCSA via https://ask.fmcsa.dot.gov/app/ask/. However, forms can still be mailed to FMCSA. The data collected is available to users in its original form. The data are not used by the U.S. Department of Transportation, and, based on a comment to a proposed rule finalized on December 17, 2013 (78 FR 76241), the data are no longer used by trucking associations. The agency is also considering how it might remove some of this reporting requirement, consistent with statue, through a separate rulemaking, but the agency needs to renew the Collection of Information now while that process plays out. Insurance companies, consultants, law firms, academia, trade publications and others may use the data to assess industry growth and its impact on the economy, to identify industry changes that may affect national transportation, and to monitor company financial stability. In the past, the Bureau of Economic Analysis (BEA) used the data to inform the national annual input-output and Gross Domestic Product (GDP) estimates, to prepare estimates of industry output, and to provide details on inputs to supplement the information on motor carriers of passengers collected by the U.S. Census Bureau. FMCSA is not aware of anyone currently using this information. FMCSA does not use the information collected through either Form M or Form MP-1, nor does it enforce the filing requirements found in part 369. The Agency was not provided the necessary resources to administer the data collection and the financial reports are of little if any value in fulfilling the Agency’s safety mission. FMCSA estimates that the annual burden hour for this information collection has decreased by approximately 78 hours due to decreased Form M and Form MP-1 submissions received by the Agency between 2018 and 2020.

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SBA Forms 2181, 2182 and 2183 provide SBA with the necessary information to make decisions regarding the approval or denial of an applicant for a small business investment company (SBIC) license. SBA uses this information to assess an applicant's ability to successfully operate an SBIC within the scope of the Small Business Investment Act of 1958, as amended.Emergency Justfication:See document titled, “Request for Emergency Processing of an Information Collection, OMB Control No. 3245-0062” under Supplementary Documents.