Change Requests

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Payment Collections Operations Contingency Plan (CMS-10515)

Key Information

Abstract

Under sections 1401, 1411, and 1412 of the Affordable Care Act and 45 CFR part 155 subpart D, an Exchange makes an advance determination of tax credit eligibility for individuals who enroll in QHP coverage through the Exchange and seek financial assistance. Using information available at the time of enrollment, the Exchange determines whether the individual meets the income and other requirements for advance payments and the amount of the advance payments that can be used to pay premiums. Advance payments are made periodically under section 1412 of the Affordable Care Act to the issuer of the QHP in which the individual enrolls. Section 1402 of the Affordable Care Act provides for the reduction of cost sharing for certain individuals enrolled in a QHP through an Exchange, and section 1412 of the Affordable Care Act provides for the advance payment of these reductions to issuers. The statute directs issuers to reduce cost sharing for essential health benefits for individuals with household incomes between 100 and 400 percent of the Federal poverty level (FPL) who are enrolled in a silver level QHP through an individual market Exchange and are eligible for advance payments of the premium tax credit. Health insurance issuers will manually enter enrollment and payment data into a Microsoft Excel-based spreadsheet, and submit the information to HHS. The data collection will be used by HHS to make payments or collect charges from issuers under the following programs: advance payments of the premium tax credit, advanced cost-sharing reductions, and Marketplace user fees. HHS will use the information collected to make payments and collect charges in January 2014 and for a number of months thereafter, as may be required based on HHS's operational progress.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 1402	View Law

Pub.L. 111 - 148 1401	View Law

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Citizenship and Immigration Services Ombudsman Request for Case Assistance Form (DHS Form 7001)

Key Information

Abstract

This information collection will be used by the Citizenship and Immigration (CIS) Ombudsman to identify problem areas, propose changes, and assist individuals experiencing problems during the processing of an immigration benefit with U.S. Citizenship and Immigration Services (USCIS)

Federal Register Notices

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

Authorizing Statutes

Pub.L. 107 - 296 452	View Law

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Peace Corps Health History Form

Key Information

Abstract

All Peace Corps Volunteer applicants must undergo a physical examination prior to service during the application process to ensure good health and be able to serve without undue disruption due to health problems.

Federal Register Notices

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

Authorizing Statutes

22 USC 2504(e)	View Law

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Application and Reports for Paleontological Permits, 43 CFR 49

Key Information

Abstract

The Paleontological Resources Preservation Act (PRPA) was enacted to preserve paleontological resources for current and future generations because these resources are nonrenewable and are an irreplaceable part of America’s heritage. PRPA requires that implementation be coordinated between the Secretaries of the Interior and Agriculture and that DOI and USDA issue regulations as appropriate to carry out the law. We (DOI) are proposing regulations to implement the PRPA. The proposed rule would preserve, manage, and protect paleontological resources on BLM, NPS, Reclamation, and FWS lands and ensure that these resources are available for current and future generations to enjoy as part of America’s national heritage. The rule would address the management, collection, and curation of paleontological resources from Federal lands using scientific principles and expertise, including collection in accordance with permits, curation in an approved repository, maintenance of confidentiality of specific locality data, and authorization of penalties for illegal collecting, damaging, otherwise altering or defacing, or sale of paleontological resources. Information collected will allow the DOI bureaus to inventory paleontological resources, implement the permitted collection of fossils from the ground, preserve collected fossils in repositories, track and report the location and condition of paleontological resources, implement the civil penalties provisions with due process considerations, and monitor the results of scientific investigations that involve the use of paleontological resources in both the field and in museum collections.

Federal Register Notices

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

Authorizing Statutes

16 USC 470aaa – aaa-11	View Law

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Energy Efficiency and Conservation Block Grant

Key Information

Abstract

EECBG is a program, authorized by the Energy Independence and Security Act which provides Federal financial assistance and technical support to state and local governments and tribal nations to carry out activities designed to save energy, create and retain jobs, increase energy efficiency, and decrease harmful emissions. Many of the grant recipients are unfamiliar with the provisions surrounding the expenditure of Federal funds and the vast majority has not had a pre-existing professional relationship with DOE. The size and pace of EECBG Program execution create an urgent need for DOE to collect certain information on a quarterly basis in order to adequately monitor, report, and ensure transparency and accountability.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 110 - 140 all	View Law

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Risk Management Program Requirements and Petitions to Modify the List of Regulated Substances under Section 112(r) of the Clean Air Act (Renewal)

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Abstract

This information collection is authorized by the following Clean Air Act (CAA) sections: for on-site documentation of Risk Management Plans (RMPs), section 112(r)(7)(B)(i) and (ii); for submitting an RMP, section 112(r)(7)(B)(iii); and, for on-site documentation and submittal of RMPs, section 114(a)(1). State and local authorities use the information in RMPs to modify and enhance their community response plans. The agencies implementing the Risk Management Program use RMPs to evaluate compliance with the Chemical Accident Prevention Provisions in 40 CFR part 68 and to identify sources for inspection that may pose significant risks to the community. Citizens may use the information to assess and address chemical hazards in their communities and to respond appropriately in the event of a release of a regulated substance.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 91 - 604 112(r)	View Law

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Conditions of Participation for Community Mental Health Centers and Supporting Regulations (CMS-10506)

Key Information

Abstract

The information collection requirements contained in this information collection request are among other requirements classified as (or known as) the CoPs which are based on criteria prescribed in law and are standards designed to ensure that each facility has properly trained staff to provide the appropriate safe physical environment for patients. These particular standards reflect comparable standards developed by industry organizations such as the Joint Commission. The primary users of this information will be State agency surveyors, CMS and community mental health centers (CMHCs )for the purpose of ensuring compliance with Medicare CoPs as well as ensuring the quality of care provided by CMHCs to patients.

Federal Register Notices

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

Authorizing Statutes

42 USC 1395k	View Law

42 USC 1395x(ff)(3)	View Law

Pub.L. 101 - 508 4162	View Law

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NESHAP for Gasoline Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities and Gasoline Dispensing Facilities (40 CFR part 63, subparts BBBBBB and CCCCCC) (Final Rule)

Key Information

Abstract

The NESHAP for Source Categories: Gasoline Distribution Bulk Terminals, Bulk Plants, Pipeline Facilities, and Gasoline Dispensing Facilities applies to owners or operators of any existing or new gasoline distribution facilities that are an area source of hazardous air pollutants (HAP) emissions. In addition to the initial notification and notification of compliance status required by the General Provisions (40 CFR Part 63, Subpart A), respondents are required to submit one-time reports of start of construction, anticipated and actual startup dates, and physical or operational changes to existing facilities. Reports of initial performance tests on control devices at gasoline distribution storage tanks, loading racks, and vapor balance systems are also required and are necessary to show that the installed control devices are meeting the emission limitations required by the NESHAP. Annual reports of storage tank inspections at all affected facilities are required. In addition, respondents must submit semiannual compliance and continuous monitoring system performance reports, and semiannual reports of equipment leaks not repaired within 15 days or loadings of cargo tanks for which vapor tightness documentation is not available.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

42 USC 7401 et seq	View Law

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Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007

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Abstract

The guidance document provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. A "Pre-Existing" tobacco product is not considered a new tobacco product and thus is not subject to the premarket requirements of the FD&C Act. A Pre-Existing tobacco product may also serve as the predicate tobacco product in a section 905(j) report (intended to be used toward demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the FD&C Act( 21 U.S.C. 387e(j)(1)(A)(i))). FDA interprets the phrase "as of February 15, 2007," as meaning that the tobacco product was commercially marketed in the United States on February 15, 2007. The guidance associated with this collection of information recommends that the manufacturer submit information adequate to demonstrate that the tobacco product was commercially marketed in the United States as of February 15, 2007. Examples of such information may include, but are not limited to, the following: dated copies of advertisements, dated catalog pages, dated promotional material, and dated bills of lading.

Federal Register Notices

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

Authorizing Statutes

21 USC 387	View Law

Pub.L. 111 - 111 31	View Law

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Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

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Abstract

This collection requires each tobacco product manufacturer or importer, or an agent, to report to FDA "all constituents, including smoke constituents, identified by [FDA] as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product." These entities must also provide similar information at least 90 days prior to introducing the product into interstate commerce.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 111 31	View Law

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Semi-annual and Annual Performance Reporting Data Catalog for Formula and Discretionary Grant Programs

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Abstract

Currently, OVW uses up to 19 individual OMB-approved PDF forms to collect performance and monitoring data from grantees. These forms each collect slightly different data points and may use different questions to collect information about the same activities. OVW is submitting this new information collection request to consolidate existing and previously OMB-approved OVW information collections under a single collection with a new consolidated OMB number. This new collection would simply aggregate and streamline the performance reporting process covered by the 19 approved collections. This request leverages technology to streamline, modernize, and reduce paperwork.

Federal Register Notices

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

Authorizing Statutes

34 USC 10238	View Law

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Domestic and International Clients Export Services and Customized Forms

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Abstract

The International Trade Administration’s (ITA) is mandated by Congress to broaden and deepen the U.S. exporter base and to attract inward foreign direct investment. ITA accomplishes this by providing counseling, programs and services to help U.S. organizations export and conduct business in overseas markets. This information collection package enables ITA to provide appropriate export services to U.S. businesses and international buyers. The proposed categories of questions include: contact information, organization information, organization type, objectives, products and services, export data, marketing, events and activities, advocacy, education, and more. ITA asks only those questions that provide the required information to assist in fulfilling a client's objective for a requested service and/or event/activity.

Federal Register Notices

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

Authorizing Statutes

15 USC 4724	View Law

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Earthquake Hazards Program Research and Monitoring

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Abstract

Research and monitoring findings are essential to fulfilling USGS's responsibility under the Earthquake Hazards Reduction Act to develop earthquake hazard assessments and recording and reporting earthquake activity nationwide. Residents, emergency responders, and engineers rely on the USGS for this accurate and scientifically sound information. Respondents to Program Announcements submit proposals to support research and monitoring related to earthquake hazard assessments, earthquake causes and effects, and earthquake monitoring. This information is used as the basis for selection and award of projects meeting the USGS's Earthquake Hazards Program objectives. Final reports of research and monitoring findings are required for each funded proposal; annual progress reports are required for awards of a two- to five-year duration. Final reports are made available to the public at the website http://earthquake.usgs.gov/research/external/.

Federal Register Notices

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

Authorizing Statutes

42 USC 7701	View Law

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Medicare Registration Application (CMS-855O)

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Abstract

The publication of the Patient Protection and Affordable Care Act (PPACA), section 6405 - "Physicians Who Order Items or Services Required to be Medicare Enrolled Physicians or Eligible Professionals" (regulation CMS 6010-F), contains a requirement for certain physicians and non-physician practitioners to enroll in the Medicare program for the sole purpose of ordering or referring items or services for Medicare beneficiaries. The PPACA has an effective date applicable to written orders and certifications made on or after July 1, 2010. The CMS 855O allows a physician to receive a Medicare identification number (without being approved for billing privileges) for the sole purpose of ordering and referring Medicare beneficiaries to Medicare approved providers and suppliers. This new Medicare application form allows physicians who do not provide services to Medicare beneficiaries to be given a Medicare identification number without having to supply all the data required for the submission of Medicare claims. It also allows the Medicare program to identify ordering and referring physicians without having to validate the amount of data necessary to determine claims payment eligibility (such as banking information), while continuing to identify the physician's credentials as valid for ordering and referring purposes.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 6405	View Law

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Agreement for Shipments of Devices for Sterilization

Key Information

Abstract

Nonsterile medical devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are normally considered by the Food and Drug Administration (FDA) to be adulterated and misbranded. FDA regulations established a control mechanism by which firms may manufacture and label medical devices as "sterile" at one establishment and ship the devices in interstate commerce for actual sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Manufacturers and sterilizers may sign an agreement containing instructions for maintaining accountability of the number of units in each shipment, acknowledgment that the devices are nonsterile and are being shipped for further processing, and specifications for the product's sterilization processing. This agreement allows the manufacturer to ship adulterated or misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. The agreement must include: (a) Instructions for maintaining accountability of the number of units in each shipment; (b) acknowledgment that the devices are nonsterile, being shipped for further processing; and (c) specifications for sterilization processing. These agreements must be retained for two years, as FDA may review them up to two years after final shipment or delivery of devices.

Federal Register Notices

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

Authorizing Statutes

21 Stat. 352

21 Stat. 351

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Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies (HHA) (CMS-10539)

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Abstract

Home health agencies are required to maintain certain documentation within their own agency records that demonstrates compliance with specific Conditions of Participation for the Medicare program. This documentation is maintained on-site for use in the home health agency survey process.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 101 - 239 6005(b)	View Law

42 USC 1395X	View Law

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Indian Affairs Public Health Needs Assessment

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Abstract

Enhancing the public health and safety capacity throughout Indian Affairs is a force multiplier in achieving the goals of our agency and in meeting the Occupational Safety and Health Act of 1970, Section 5 directive to create a place of employment free from recognized hazards. The purpose of this survey is to identify and prioritize public health issues and needs and enhance the public health and safety capacity throughout Indian country. The Office of Facilities, Property and Safety Management (OFPSM) Public Health and Safety (PHS) Team will use survey results to develop and coordinate action plans.

Federal Register Notices

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

Authorizing Statutes

29 USC 654	View Law

Pub.L. 91 - 596 5	View Law

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Tribal Enrollment Count

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Abstract

Enrollment data is an important source of information which allows the Indian Affairs and other Federal agencies to equitably distribute resources because it is a quantifiable representation of a Tribe’s population. Different population sizes generally require different levels of services and resources. BIA must collect this information to ensure effective, accurate, and timely distribution of assistance to respond to funds specifically appropriated for Indian Country, where applicable. This data will assist Federal agencies in developing distribution formulas for funds under annual appropriations, Inflation Reduction Act of 2022 (P. L. 117-169), or Infrastructure Investment and Jobs Act (P.L. 117-58).

Federal Register Notices

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

Authorizing Statutes

25 USC 2	View Law

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Owner's Certification with HUD Tenant Eligibility and Rent Procedures

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Abstract

Collection of tenant data to ensure owners comply with Federal statutes and regulations that (1) establish policies on who may be admitted to subsidized housing; (2) prohibit discrimination in conjunction with selection of tenants and units; (3) specify how tenants’ incomes and rents must be compiled.

Federal Register Notices

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

Authorizing Statutes

12 USC 1701s	View Law

42 USC 1437	View Law

12 USC 1715z-1	View Law

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Tobacco Products, Exemptions From Substantial Equivalence Requirements

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Abstract

FDA has established in its regulations a pathway for manufacturers to request exemptions from the substantial equivalence requirements of the FD&C Act. An exemption request must be submitted with supporting documentation, the manufacturer's contact information, and a detailed explanation of the modification and its purpose. This information is submitted to FDA so FDA can determine whether an exemption from substantial equivalence to the predicate product is appropriate for the protection of the public health. FDA determines whether to grant or deny the request for an exemption based on whether the criteria in the statute have been satisfied. If FDA determines that the information is insufficient, FDA may request additional information from the manufacturer. If the manufacturer fails to respond within the timeframe requested, FDA will consider the exemption request withdrawn. FDA may rescind an exemption where necessary to protect the public health. FDA may exempt tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, from the requirement of demonstrating substantial equivalence if the Agency determines that (1) the modification would be a minor modification of a tobacco product, (2) a report demonstrating substantial equivalence is not necessary for the protection of public health, and (3) an exemption is otherwise appropriate.

Federal Register Notices

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

Authorizing Statutes

21 USC 387e	View Law

Pub.L. 111 - 111 31	View Law

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National Roadside Survey of Alcohol and Drug Prevalence of Road Users: 2025

Key Information

Abstract

National Roadside Surveys (NRSs) are a central tool in understanding alcohol- and drug-involved driving. Starting in 1973, roadside surveys of drivers on the road have estimated the population-level prevalence of drinking and driving in the United States. The core methodology has continued across decades, but NHTSA has initiated improvements. The number of sites has increased, drugs of interest have been modified to reflect use across the country, and advances in technology have impacted how data can be collected and specimens analyzed. Conducting an NRS on a periodic basis (e.g., about every 10 years) allows NHTSA to examine the prevalence of alcohol and drug use among drivers, and trends across survey years. Given States are legalizing medicinal and/or recreational use of cannabis, and other issues such as the apparent increase in opioid use in the U.S., more information is needed on the level of alcohol- and drug-involved driving to better inform NHTSA’s countermeasure development. Roadside surveys provide objective measures of alcohol and drugs in drivers’ systems when they are actually driving. These measures are based on results from breath tests and oral fluid samples collected using established protocols. Analyses of these specimens allow for the quantitative determination of alcohol and drug levels. Learning more about alcohol and other drug prevalence among road users other than drivers is new to this NRS. These other road users (ORUs) include pedestrians, bicyclists, scooterists, and those using mobility aids. NHTSA will conduct two studies. Study 1 will focus on drivers but include convenience sampling of ORUs passing by the data collection locations. Study 2 is a pilot test assessing the feasibility of a NRS specific to ORUs. Both will collect breath and oral fluid specimens, demographic information, and self-report questionnaire data on roads across the country. Participation will be voluntary and anonymous. Study protocols will be reviewed by a U.S. Department of Health and Human Services-approved IRB. The only personal identifiable information (PII) collected is oral fluid. No DNA analyses will be conducted on the oral fluid specimens. These will only be analyzed for the presence of alcohol and other drugs, and specimens will be destroyed after the study is complete. The results will be reported in aggregate form in research reports. NHTSA anticipates obtaining a Certificate of Confidentiality from the National Institutes of Health (NIH). Study 1 / National Roadside Survey. This request is a voluntary, one-time survey. This survey follows the prior NRS methodology but additionally includes recruiting ORUs who are passing by data collection locations. Data collection will occur in 60 primary sampling units (PSUs) using 5 locations at each PSU (300 locations total). There will be a single data collection event at each location. The biological samples will be sent to a toxicology lab for testing of the presence of alcohol and other drugs. Participants’ responses to survey questions on the use of drugs and traffic safety-related behaviors and attitudes will also be analyzed. Study 2 / Pilot Test for Other Road Users. Study 2 examines the viability of a stand-alone roadside survey focused solely on ORUs. This effort uses 20 new data collection locations, inclusive of 4 PSUs with 5 locations each. This effort is to inform NHTSA on the feasibility of such a targeted roadside survey and to determine the level of effort to execute a nationwide study of ORUs. The same procedures as Study 1 will be used. NHTSA will use the information from both studies to produce technical reports presenting the findings. The technical reports will provide only aggregate (summary) statistics and tables; no PII will be retained or reported. The Study 1 technical report is for audiences interested in traffic safety. The information from Study 2 will also be used by NHTSA in consideration of research on ORUs.

Federal Register Notices

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

Authorizing Statutes

23 USC 403	View Law

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Law Enforcement Officers Killed or Assaulted (LEOKA)

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Abstract

Under Title 28, U.S.C., Sect. 534, this collection requests LEOKA data from local, state, tribal, and federal law enforcement agencies in order for the FBI UCR Program to serve as the national clearing house for collection and dissemination of data.

Federal Register Notices

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

Authorizing Statutes

28 USC 534	View Law

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West Coast Groundfish Logbooks

Key Information

Abstract

This request is for a revision and extension of a currently approved collection. The revision to this collection is to merge the federally mandated logbook requirement for non-trawl groundfish fisheries that occur in the exclusive economic zone off the coasts of Washington, Oregon, and California (0648-0804) into this control number. Once cleared by OMB, control number 0648-0804 will be discontinued. The success of fisheries management programs depends significantly on the availability of fishery data. Currently, the states of Washington and Oregon administer a trawl logbook on behalf of the Pacific Fishery Management Council (Council) and NOAA’s National Marine Fisheries Service (NMFS). The state of California repealed their requirement, effective April 1, 2019, therefore, NMFS created a federal requirement in order to maintain logbook coverage from trawl vessels in California. The log used is a standard format developed by the Council to collect information necessary to effectively manage the fishery on a coast-wide basis. The trawl logbook collects haul-level effort data including tow time, tow location, depth of catch, net type, target strategy, and estimated pounds of fish retained per tow. Each trawl log represents a single fishing trip. Trawl logbook data is used in stock assessments, to evaluate spatial bycatch issues, and is used for fishery monitoring and enforcement. A federal non-trawl logbook was developed and implemented in 2023. Data collected in the non-trawl logbook contributes to stock assessments, informs managers about location-specific catch and discards on non-observed trips and vessels, supports economic analysis, and provides effort information to quantify groundfish fishery effort to allow more precise estimation of bycatch of with Endangered Species Act (ESA) listed species, such as seabirds and humpback whales. NMFS contracts with the Pacific States Marine Fisheries Commission (PSMFC) to distribute and collect the logbook. These data are used regularly by NMFS, the Pacific Fishery Management Council, the West Coast Groundfish Observer Program, NMFS Office of Law Enforcement, and the Coast Guard for fisheries management and enforcement.

Federal Register Notices

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

Authorizing Statutes

16 USC 1801, et seq.	View Law

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Choice Neighborhoods

Key Information

Abstract

The information is required to allow HUD to conduct competitions to award and obligate Choice Neighborhood grant funds in accordance with the appropriations act and to manage/report on the grants that are awarded.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 117 24	View Law

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National Science Foundation (NSF) Breakthrough Innovation Initiative Application

Key Information

Abstract

The U.S. National Science Foundation (NSF) Directorate for Technology, Innovation and Partnerships (TIP) is launching an effort to enable researchers, innovators, and entrepreneurs to apply unconventional approaches to create game-changing technologies and translate discoveries into tangible applications and products.

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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