Change Requests

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Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers (Form 855S)

Key Information

Abstract

The primary function of the CMS 855S Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) supplier enrollment application is to gather information from a supplier that tells us who it is, whether it meets certain qualifications to be a health care supplier, where it renders its services or supplies, the identity of the owners of the enrolling entity, and information necessary to establish correct claims payment. The goal of this revision of the CMS 855S is to simplify and clarify the current data collection and to remove obsolete and/or redundant questions. Grammar and spelling errors were corrected. Limited informational text has been added within the application form and instructions in conjunction with links to websites when greater detail is needed by the supplier. To clarify current data collection differentiations and to be in sync with accreditation coding, Section 3D (“Products and Services Furnished by This Supplier”) has been updated. This revision does not offer any new material data collection.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 104 - 134 31001(I)	View Law

42 USC 1395l	View Law

42 USC 424.58	View Law

Pub.L. 111 - 148 6201(3)	View Law

42 USC 3004(b)(1)	View Law

42 USC 1395f	View Law

42 USC 1395g	View Law

42 USC 1395m	View Law

Pub.L. 105 - 33 4313	View Law

Pub.L. 109 - 220 508	View Law

42 USC 424.57	View Law

42 USC 455.460	View Law

42 USC 1395cc	View Law

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Guaranty Agency Financial Report

Key Information

Abstract

The Department of Education (ED) is requesting renewal by extension of the information collection 1845-0026 for the Guaranty Agency Financial Report. There has been no change to the underlying statute or regulations. The Guaranty Agency Financial Report is used by a guaranty agency to request payments of reinsurance for defaulted student loans; make payments for amounts due to ED, for collections on default and lender of last resort loan (default) claims on which reinsurance has been paid and for refunding amounts previously paid for reinsurance claims. The form is also used to determine required reserve levels for agencies; and to collect debt information as required for the “Report on Accounts and Loans Receivable Due from the Public,” SF 220-9 (Schedule 9 Report) as required by the U.S. Department of Treasury.

Federal Register Notices

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

Authorizing Statutes

20 USC 1078	View Law

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Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks Claimed

Key Information

Abstract

This data collection is necessary for the determination of the beginning, continuance, or termination of an Extended Benefit (EB) period in any State, which determine the EB trigger rate. Also, data on initial and continued claims are used to help determine economic indicators. This information collection request is associated with the Final Rule amending 20 CFR 615, Extended Benefits, by implementing the Total Unemployment Rate (TUR) indicator, an optional calculation methodology for triggering on Extended Benefits, in regulations. The Final Rule deletes paragraphs (c) and (d) under the regulatory requirements at § 615.15, pertaining to records and reports State agencies must submit. The reporting instructions for the proper and timely submission of data are provided in ET Handbook No. 401, which governs Unemployment Compensation required reporting.

Federal Register Notices

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

Authorizing Statutes

42 USC 303(a)(6)	View Law

Pub.L. 91 - 373 203	View Law

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Marine Corps Officer Candidate Program Suitability Forms

Key Information

Abstract

Information collection is necessary for the United States Marine Corps to verify a potential officer candidate’s suitability for service. This information collection request consists of two forms used in this process: NAVMC Form 10469, “Academic Certification for Marine Corps Officer Candidate Program,” and NAVMC Form 10064, “Personal Information Questionnaire.” The NAVMC Form 10469 collects information about the candidate’s educational background and standardized test scores, while the NAVMC Form 10064 is used to evaluate the candidate’s moral character via references.

Federal Register Notices

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

Authorizing Statutes

10 USC 8042	View Law

10 USC 12209	View Law

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Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

Key Information

Abstract

This information collection was established as a special control for the class II device type, Novel Influenza A Reagents. This classification results from the review of a request from a device sponsor (CDC) for a diagnostic test intended to diagnose influenza subtype H5 (Asian lineage), commonly known as avian flu. This classification permits the legal distribution of this device, and the information collection addressed here plays a significant role in providing a reasonable assurance of the safety and effectiveness of this device and of similar future devices. Specifically, the information collection asks sponsors to obtain and analyze data postmarket to ensure the continued reliability of the device, given the propensity of influenza viruses to mutate and the potential for changes in disease prevalence. This involves collecting data on the clinical performance of the device under new prevalence conditions if there is a change in prevalence of influenza caused by the specific novel virus that the device is intended to detect, as compared to the prevalence of this virus when the clinical studies described in the 510(k) were conducted. The information collection described above is a measure that FDA determined to be necessary to provide reasonable assurance of safety and effectiveness of Novel Influenza A Reagents.

Federal Register Notices

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

Authorizing Statutes

21 USC 360c	View Law

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Application to Transfer and Register NFA Firearm (Tax-Exempt) (ATF Form 5320.5 (“Form 5”))

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Abstract

Persons who wish to apply to transfer and register a National Firearms Act (NFA) firearm under an exemption from statutory taxes must use ATF Form 5320.5 ("Form 5"). ATF uses the information to determine legality of the firearm transfer under federal, state, and local law, and applicability of the tax exemption. Applicants also use the form to provide the information necessary to support their claim.

SPD-15 Implementation	Yes

Federal Register Notices

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

Authorizing Statutes

26 USC 5812	View Law

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Medicare Self-Referral Disclosure Protocol (CMS-10328)

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Abstract

The Affordable Care Act (ACA) was enacted on March 23, 2010. Section 6409 of the ACA requires the Secretary of the Department of Health and Human Services (the "Secretary"), in cooperation with the Office of Inspector General of the Department of Health and Human Services (the "Inspector General"), to establish a Medicare self-referral disclosure protocol ("SRDP") that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute, section 1877 of the Social Security Act (the Act). In accordance with the ACA, the SRDP was established on September 23, 2010, six months after the date of enactment, and information concerning how to disclose an actual or potential violation of section 1877 of the Act was posted on the CMS website.

Federal Register Notices

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

Authorizing Statutes

42 USC 1395nn	View Law

Pub.L. 111 - 148 6409	View Law

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Limousine Crashworthiness Safety Research

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Abstract

In an effort to understand the limousine market and the characteristics of limousine vehicles with respect to crashworthiness and occupant safety, and to comply with a Congressional mandate, the National Highway Traffic Safety Administration (NHTSA) is seeking approval for a new information collection request (ICR). Many federal safety regulations (e.g., FMVSS No. 208, 209, 210 pertaining to overall occupant protection and seat belts) do not currently apply to limousines and, as a result, the extent of limousine crash safety features and performance is not well known. Furthermore, limousine manufacturers fall into one of three categories (Vehicle Original Equipment Manufacturer (OEM), OEM program participant, OEM program nonparticipants) and the respective differences of these manufacturer’s approach to fabrication and vehicle safety requires targeted research. The proposed NHTSA research will consist of a one-time voluntary interview to manufacturers that fall into one of the three groups related to the limousine market: a) Vehicle Original Equipment Manufacturer (OEM), b) OEM program participant, and c) OEM program nonparticipants. The research will involve a maximum of 160 contacts for a request for an interview with a goal of 41 total completed responses. Recruitment will end when the 41 respondents with completed interviews are attained. Each interview will include approximately 10 – 15 open-ended questions about limousine fabrication intended for reporting on safety characteristics related to evacuation, crashworthiness, occupant seating, and restraints. Three versions of an interview guide will be used, one for each category of manufacturer, and the guides are intended as a framework for discussion rather than a strict script. It is possible that the respondents will not need to be asked each question separately if information is provided through responses to previous questions. The interviewers will not ask questions that are not presented on the interview guide. This information collection serves as a reporting collection. Interview results will be collected and summarized in a final report, which will include an executive summary, introduction, methodology, results, discussion, and conclusions of important market findings relating to the relevant crashworthiness safety topics. The report data will help provide NHTSA with information necessary for cost-benefit analyses and will be made available to the public. This is a new information collection and is not required to go through an Institutional Review Board. This new ICR is a one-time collection that is anticipated to be completed within three years. The Annualized Burden Hours is estimated to be 53 hours and annual labor costs are estimated to be $6,137. There are no additional costs beyond the cost of any hour burden (labor costs).

Federal Register Notices

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30-Day FRN	View Notice

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Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Survey

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Abstract

OPM uses the CAHPS results as part of the FEHB Plan Performance Assessment (PPA). The PPA enables a consistent, objective evaluation of carrier performance and also provides more transparency for enrollees. This assessment uses a discrete set of quantifiable measures to examine key aspects of performance in the areas of clinical quality, customer service and resource use. Eight CAHPS measures are part of this discrete set of quantifiable measures. Taken together with more traditional assessments of contract administration, these measures help ensure that enrollees receive high quality affordable healthcare and a positive customer experience. The PPA is linked to carrier profit and premium adjustment factors. FEHB contracts include language to incorporate the PPA as a determinant of the Service Charge or Performance Adjustment.

Federal Register Notices

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

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Current Population Survey (CPS) Basic Demographics

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Abstract

The CPS demographic data include age, marital status, sex, Armed Forces status, education, race, Hispanic origin, and country of birth. The data are used for subject specific (labor-force and supplement) analytic research, for internal analytic research, for evaluating other surveys, and for selecting other survey samples. The Census Bureau, in conjunction with the Bureau of Labor Statistics (BLS), is proposing an experimental collection in the Current Population Survey (CPS) of Race and Ethnicity information using the new SPD15 standard. The main goal of the study is to assess the effect of the new race and ethnicity standard (2024 SPD15) on estimates obtained from the CPS. The study will also aid in the implementation of the new standard for interviewer-administered data collections (both in-person and by phone). The study will examine the impact of differences in reporting using the new 2024 standard and the 1997 standard (which CPS currently is using) on race distributions, labor force estimates, weighting, and missing data.

Federal Register Notices

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

Authorizing Statutes

29 USC 2	View Law

13 USC 8b, 141, 182	View Law

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Focus Groups As Used By EPA For Economics Projects (Renewal)

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Abstract

The Environmental Protection Agency (EPA) is seeking approval for a generic information collection request (ICR) for the conduct of focus groups and one-on-one interviews related to economics projects primarily for survey development. Focus groups are groups of individuals brought together for moderated discussions on a specific topic or issue. These groups are typically formed to gain insight and understanding of attitudes and perceptions held by the public surrounding an issue. One-on-one interviews, as the term implies, are individual interviews in which a respondent is generally asked to review materials and provide feedback on their content and design as well as the thought processes that the materials invoke. Focus groups and one-on-one interviews (hereafter referred to collectively as focus groups) used as a qualitative research tool have three major purposes: To better understand respondents attitudes, perceptions and emotions in response to specific topics and concepts; To obtain respondent information useful for better defining variables and measures in later quantitative studies; And to further explore findings obtained from quantitative studies. Through these focus groups, the Agency will be able to gain a more in-depth understanding of the publics attitudes, beliefs, motivations and feelings regarding specific issues and will provide invaluable information regarding the quality of draft survey instruments. Focus group discussions are necessary and important steps in the design of a quality survey. Focus groups and one-on-one interviews (hereafter referred to collectively as focus groups) used as a qualitative research tool have three major purposes: To better understand respondents attitudes, perceptions and emotions in response to specific topics and concepts; To obtain respondent information useful for better defining variables and measures in later quantitative studies; and To further explore findings obtained from quantitative studies. Through these focus groups, the Agency will be able to gain a more in-depth understanding of the publics attitudes, beliefs, motivations and feelings regarding specific issues and will provide invaluable information regarding the quality of draft survey instruments. Focus group discussions are necessary and important steps in the design of a quality survey.

Federal Register Notices

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

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Renewable Fuel Standard (RFS) Program: RFS Annual Rules (Renewal)

Key Information

Abstract

Sections 114 and 208 of the Clean Air Act (CAA), 42 U.S.C. 7414 and 7542, authorize EPA to require recordkeeping and reporting regarding enforcement of the provisions of Title II of the CAA. The recordkeeping and reporting requirements of this regulation will allow EPA to monitor compliance under the Renewable Fuel Standard (RFS) program. The relevant regulations are in 40 CFR parts 80 and 1090.

Federal Register Notices

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

Authorizing Statutes

42 USC 7414	View Law

42 USC 7542	View Law

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Air Emissions Reporting Requirements (AERR) (Renewal)

Key Information

Abstract

Under the AERR ICR, 55 State and territorial air quality agencies, including the District of Columbia (DC), and an estimated 14 local and tribal air quality agencies, must annually submit emissions data of oxides of nitrogen (NOx), carbon monoxide (CO), sulfur dioxide (SO2), volatile organic compounds (VOC), particulate matter less than or equal to 10 micrometers in diameter (PM10), particulate matter less than or equal to 2.5 micrometers in diameter (PM2.5), and ammonia (NH3). The current AERR rule, which can be found at 40 CFR Part 51 Subpart A, defines which emissions sources that State, local, and Tribal (SLT) agencies must submit individually as “point sources.” The point source definitions are different depending on the year, and SLTs report more point sources every third year for the “triennial inventory.” For triennial inventory years, States must also submit point source emissions for Lead (Pb), emissions for stationary nonpoint and some nonroad mobile sources, and they must submit model input data for onroad mobile and nonroad mobile equipment. For mobile sources, California has different requirements because it uses different models, and California must submit emissions (rather than model inputs) for these data categories of the same pollutants listed above. The annual emissions data collected through the AERR are used by the EPA Office of Air Quality Planning and Standards (OAQPS) to support development of the National Emissions Inventory (NEI). The NEI is more comprehensive for triennial inventory years because they include updates to all data categories. The EPA uses the NEI in developing national ambient air quality standards (NAAQS), performing regional and national modeling, providing air quality management support (e.g., State implementation plan (SIP) development) to State agencies and multi-jurisdictional organizations (MJOs), and preparing national trends assessments and other special analyses and reports. Currently, the same reporting mechanisms used for the criteria air pollutants and precursors (CAPs) listed above are also used for voluntary reporting of hazardous air pollutants (HAP) and other pollutants. These data are collected by the air agencies for their own purposes, and EPA encourages air agencies to voluntarily provide such data to EPA when it is available.

Federal Register Notices

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

Authorizing Statutes

42 USC 7401 et seq	View Law

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Hydrofluorocarbon Allowance Allocation and Trading Program (Final Rule)

Key Information

Abstract

This information collection is authorized under the AIM Act (Section 103 in Division S, Innovation for the Environment, of the Consolidated Appropriations Act, 2021 (Pub. L. 116- 260)). Consistent with the AIM Act’s mandate that on a periodic basis, to be determined by the Administrator, but not less frequently than annually, each person who, within the applicable reporting period, produces, imports, exports, destroys, transforms, uses as a process agent, receives application-specific allowances, repackages, recycles for fire suppression, or reclaims a regulated substance shall submit to the Administrator reports and maintain records. The reports describe, as applicable, the quantity of the regulated substance that the person—produced, imported, and exported; destroyed by a technology approved by the Administrator; used and entirely consumed (except for trace quantities) in the manufacture of another chemical; used as a process agent; or recycled and reclaimed. Further, anyone who receives application-specific allowances (via allocation, transfer, or conferral) must report on the conferral or transfer of allowances, their use of allowances, and request application-specific allowances annually, if needed and eligible. Additional records must be maintained, as are additional reports to document compliance.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 116 - 260 103	View Law

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

Key Information

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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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)

Key Information

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

Key Information

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

Key Information

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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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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