Change Requests

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TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (Proposed Rule)

Key Information

Abstract

EPA is requiring reporting and recordkeeping requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA) as amended by the Fiscal Year 2020 National Defense Authorization Act (NDAA). As mandated by the amendment, EPA will require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report to EPA certain information. This is a one-time reporting event to provide greater transparency on the uses and risks associated with PFAS and is mandated by the NDAA. The total one-time burden and cost of the action are summarized in Table 1. Table 2 annualizes the burden and cost over a three-year ICR approval period (although the reporting is a one-time activity).

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

15 USC 2607	View Law

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Pesticides Data Call In Program (Renewal)

Key Information

Abstract

This ICR covers the information collection (IC) activities associated with the issuance of data-call-ins (DCIs) under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA regulates the use of pesticides under the authority of two federal statutes: FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA) , both as amended by the Food Quality Protection Act (FQPA) of 1996. In general, before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a "registration" or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements. FIFRA also requires EPA to assess whether the continued registration of a pesticide causes unreasonable adverse effects on human health or the environment and to decide whether to pursue appropriate regulatory measures. EPA uses the DCIs issued under this ICR to acquire the data necessary to support registration review. In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with the use of the product. Applicants, or potential registrants, must generate or provide the scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide. The data allow EPA to evaluate whether a pesticide has the potential to cause harmful effects to human health and the environment, including effects to non-target organisms, federally threatened and endangered (listed) species, and to surface water or ground water. Through a rigorous scientific and public process, EPA specifies the kinds of data and information necessary to make regulatory judgments about the risks and benefits of pesticide products under FIFRA section 3, 4 and 5, as well as the data and information needed to determine the safety of pesticide chemical residues under FFDCA section 408. The regulations in 40 CFR part 158 describe the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process (e.g., as used in the registration review program); or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. As described in 40 CFR 158.30, however, FIFRA provides EPA with flexibility to require, or not require, data and information for the purposes of making regulatory judgments for individual pesticide products, thereby allowing for the data required to be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. EPA may, therefore, require the submission of additional data or information beyond that specified in the regulations if such data or information are needed to evaluate a pesticide product as required by FIFRA and FFDCA. This ICR describes how DCIs are issued and presents the Agency’s estimates of the information collection burden and costs associated with issuing DCIs.

Federal Register Notices

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

Authorizing Statutes

21 USC 346a	View Law

7 USC 136 et seq.	View Law

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5-Star Safety Ratings Label Quantitative Concept Testing

Key Information

Abstract

This information collection request (ICR) requests approval for four new information collections that will be used by the National Highway Traffic Safety Administration (NHTSA) to conduct a one-time study to collect information to enhance the usefulness of vehicle safety rating information and guide the potential redesign of the Government 5-Star Safety Ratings section of the Monroney label (vehicle window sticker). The information collections include a screener questionnaire, an information collection to qualitative feedback to improve its quantitative survey instrument, and the quantitative survey. The information collected will allow NHTSA and the New Car Assessment Program (NCAP) to fulfill a congressional mandate to improve highway traffic safety. As NCAP is responsible for providing consumers with important safety information that will assist them in their vehicle purchase decisions, this research will be used to gather data to enhance the usefulness of that safety rating information and guide the potential redesign of the Government 5-Star Safety Ratings section of the Monroney label (vehicle window sticker) accordingly.

SPD-15 Implementation	Yes

Federal Register Notices

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

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Part 1239 Clauses 1252.239-72 and 1252-239-74

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Part 1239 Clause 1252.239-75

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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[Medicaid] Medical Necessity and Contract Amendments Under Mental Health Parity (CMS-10556)

Key Information

Abstract

The final rule amends the Medicaid and CHIP regulations to implement the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). MHPAEA is a federal law that generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder (MH/SUD) benefits from imposing less favorable benefit limitations on those benefits than on medical/surgical benefits. The final rule applies mental health parity requirements to Medicaid Managed Care Organizations (MCOs), Section 1937 Alternative Benefit Plans (ABPs), and the CHIP. The final rule also contains provisions related to the disclosure of information related to the reason for denial of reimbursement or payment for MH/SUD benefits. The text only clarifies the expectations for disclosing information concerning the denial of reimbursement or payment for MH/SUD benefits. It does not impose any new or revised third-party disclosure requirements.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 3 502	View Law

Pub.L. 110 - 343 512(b)	View Law

Pub.L. 111 - 148 2001(c)	View Law

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Part 1239 Clauses 1252.239-76; 1252-239-77; 1252-239-80; 1252-239-83; 1252-239-85; and 1252-239-88.

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage (CMS-10511)

Key Information

Abstract

Section 1862(m) of the Act (established by section 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003)) allows for payment of the routine costs of care furnished to Medicare beneficiaries in a Category A investigational device exemption (IDE) trial and authorizes the Secretary to establish criteria to ensure that Category A IDE trials conform to appropriate scientific and ethical standards. By providing Medicare coverage of routine costs in Category A trials, the Congress removed a financial barrier that may have discouraged beneficiaries from participating in these trials. It also gives Medicare beneficiaries the opportunity to have earlier access to new medical devices. Based on our rulemaking authority in section 1871 of the Act, we are applying the same Medicare coverage requirements and scientific and ethical standards to Medicare coverage related to Category B IDE studies/trials that would be applicable to Category A IDE studies/trials. CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in ?405.212 are met for purposes of coverage of items and services described in paragraphs (a) and (b) of this section: (1) FDA IDE approval letter. (2) IDE study protocol. (3) IRB approval letter. (4) National Clinical Trials (NCT) number. (5) Supporting materials, as needed.

Federal Register Notices

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

Authorizing Statutes

42 USC 1102	View Law

42 USC 1861	View Law

42 USC 205(a)	View Law

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Part 1239 Clauses 1252.239-89 and 1252-239-90

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Study of Warning Devices for Stopped Commercial Motor Vehicles

Key Information

Abstract

FMCSA is seeking Office of Management and Budget (OMB) approval of a new information collection entitled “Study of Warning Devices for Stopped Commercial Motor Vehicles.” Participation in the study is voluntary, so in the event of participation, no small business will have an imposed burden that it is not willing to bear. Information collection activities are planned for an 18-month period. Parked or disabled commercial motor vehicles (PDCMVs) on the road negatively impact traffic operations and safety. FMCSA requires specific warning devices to be carried on all commercial motor vehicles (CMVs) and, except in the case of necessary traffic stops, be deployed near the vehicle whenever it is stopped on the road or shoulder. Advances in automated driving system (ADS) technology have raised critical questions regarding potential barriers to regulatory compliance with warning device safety standards and regulations which reference a “driver.” Alternative types of warning devices developed by industry, including those intended to increase driver safety during device deployment, have resulted in multiple applications for exemption from the corresponding safety regulations. These recent issues related to warning device requirements also call attention to unresolved questions of how and to what extent the use of such devices improves traffic safety. Given the increasing focus on ADS, questions surrounding the safety of CMV drivers when deploying warning devices, and the availability of new technology and alternative devices, there is a need to thoroughly evaluate the use of warning devices under current regulations. FMCSA has established a contract with Virginia Tech Transportation Institute (VTTI) to collect the information associated with this ICR. Under indirect oversight of an FMCSA Contracting Officer’s Representative, experienced VTTI research staff will perform all data collection activities described in this ICR. The findings will contribute to safety by ensuring that FMCSA’s decisions and regulations are data-driven and based on safety. FMCSA’s purpose for collecting this information is to develop an understanding of whether and to what extent the deployment of warning devices near a stopped commercial motor vehicle affects the driving behavior of passing motorists, and those elements of driving behavior which have the potential to influence the likelihood of a crash involving the stopped vehicle.

Federal Register Notices

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

Authorizing Statutes

49 USC 504	View Law

49 USC 31133	View Law

49 USC 31136	View Law

49 USC 31502	View Law

49 USC 31108	View Law

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Payment of Indemnity and Compensation for Highly Pathogenic Avian Influenza

Key Information

Abstract

Interim final rule amending regulations related to conditions for payment of indemnity and compensation for highly pathogenic avian influenza claims. Amendments include new activities related to biosecurity audits and instrument for conducting same, and reconsideration process for audit results.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 107 - 171 10401-18	View Law

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Maritime Administration (MARAD) Mariner Preparedness Exercise (PrepEx) Survey (MARAD Mariner PrepEx Survey)

Key Information

Abstract

This is a survey that will be conducted on a voluntary basis that provides vital information to the Ready Reserve Force Program. This exercise is designed to test MARAD’s internal administrative procedures, as well as the coordination necessary for a complete activation of MARAD's Ready Reserve Force (RRF) and the Military Sealift Command (MSC) Surge Sealift Fleet to meet strategic sealift requirements. Periodic testing is necessary in view of the dynamics that affect the RRF program, which include changes in RRF fleet composition, readiness status, ship location as well as changes to the seafaring manpower base.

Federal Register Notices

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

Authorizing Statutes

49 USC 192	View Law

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Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

Key Information

Abstract

This information collection supports information collection requirements under the Current Good Manufacturing Practice regulations for Positron Emission Tomography (PET) drugs. The regulations establish recordkeeping requirements that include: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints. The regulations also require 3rd Party Disclosure requirements regarding specific notices. Respondents to the collection are manufacturers of PET drugs.

Federal Register Notices

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

Authorizing Statutes

21 USC 301 et. seq.	View Law

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Request Type:

Part 1239 Clause 1252.239-70

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems. DOT provided a 60-day comment period for the public to respond to the proposed rule and submit comments. The public comment period closed on February 7, 2022. DOT received no public comments on the proposed rule and no public comments were received on any of the information collection requirements in the rule. The final rule is estimated to be published in the month of September 2022.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Request Type:

Survey of Airman Satisfaction with Aeromedical Certification Services

Key Information

Abstract

• The survey will be available for completion electronically. • The collection is reported by survey and is voluntary. • Airmen who have sought a medical certification within two years of the survey administration will be invited to participate in the survey. • The survey will take place approximately every two years. • The survey will be administered by the Safe Operations in Aerospace Research (SOAR) Laboratory of the Civil Aerospace Medical Institute with the support of Cherokee Federal. • Demographic information will be collected from respondents, but any information disseminated to the public will be presented in aggregate form. • The information obtained from the survey will be used to brief the Federal Air Surgeon, the Regional Flight Surgeons, and the Director of the Civil Aerospace Medical Institute following the survey closing. • Data will be used by the senior managers of the Office of Aerospace Medicine (OAM) to: (a) evaluate stakeholder satisfaction with aeromedical certification services provided by or on behalf of the FAA; (b) identify areas in which improvements in service delivery can be made; and (c) assess changes in stakeholder satisfaction as a result of those improvements. • All publications would provide data in aggregate (e.g., a technical report or journal article). • The information from the survey will also be briefed in the Federal Air Surgeon’s Medical Bulletin. • It is anticipated that the information collected will be disseminated to the public or used to support publicly disseminated information. As explained in the preceding paragraphs, the information gathered has utility. OAM will retain control over the information and safeguard it from improper access, modification, and destruction, consistent with OAM standards for privacy of information. See response to Question 10 of this Supporting Statement for more information on the OAM guarantee of privacy. Prior to dissemination, the information will be subjected to quality control measures and a pre-dissemination review per Section 515 of Public Law 106-554.

Federal Register Notices

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

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Facilities Transferring Oil or Hazardous Materials in Bulk -- Letter of Intent and Operations Manual

Key Information

Abstract

A Letter of Intent is a notice to the CG Captain of the Port that an operator intends to operate a facility that will transfer bulk oil or hazardous materials to or from vessels. An Operations Manual (OM) is also required. The OM establishes procedures for a facility to follow when conducting transfers and in the event of a spill. The authority for the requirements is 33 U.S.C. 1321.

Federal Register Notices

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

Authorizing Statutes

33 USC 1321	View Law

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Confirmation of Request for Reasonable Accommodation

Key Information

Abstract

The information collection requirement is necessary to obtain and record requests for reasonable accommodation, with the intent to measure and ensure Agency compliance with 29 U.S.C. § 791, Employment of Individuals with Disabilities; E.O. 13164, Requiring Federal Agencies to Establish Procedures to Facilitate the Provision of Reasonable Accommodation; EEO MD-715, EEO Reporting Requirements for Federal Agencies.

Federal Register Notices

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

Authorizing Statutes

29 USC 791	View Law

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Postmarket Surveillance of Medical Devices

Key Information

Abstract

This information collection implements section 522 of the Federal Food, Drug, and Cosmetic Act, which governs the postmarket surveillance of medical devices. Respondents to the information collection are medical device manufacturers who must conduct surveillance in accordance with statutory orders issued by FDA in support of the clearance or approval of certain devices. The information collection is intended to ensure the continued safety of medical devices.

Federal Register Notices

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

Authorizing Statutes

21 USC 360l	View Law

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Nondestructive Testing of Certain Cargo Tanks on Unmanned Barges

Key Information

Abstract

The Coast Guard uses the results of nondestructive testing to evaluate the suitability of older pressure-vessel-type cargo tanks of unmanned barges to remain in service. Once every ten years it subjects such a tank, on an unmanned barge, 30 years old or older to nondestructive testing. The statutory authority is 46 U.S.C. 3703. This authority is delegated by the Secretary to the Coast Guard via the Department of Homeland Security Delegation No. 0170.1, Revision No. 01.2. (II)(92.b.

Federal Register Notices

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

Authorizing Statutes

46 USC 3703	View Law

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Cargo Securing Manuals

Key Information

Abstract

This information is used by the Coast Guard to review cargo securing manuals (CSM) for compliance with safety standards established by international treaty. The authority of 46 U.S.C. 2103 is delegated by the Secretary to the Coast Guard via the Department of Homeland Security Delegation No. 0170.1, Revision No. 01.2. (II)(92.a). The authority of 46 U.S.C. 3306 is delegated by the Secretary to the United States Coast Guard .

Federal Register Notices

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

Authorizing Statutes

46 USC 2103	View Law

46 USC 3306	View Law

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Real ID Applicant Information and Documentation

Key Information

Abstract

This collection of information relates to the States’ collection of information from driver’s license applicants. DHS has a separate collection of information related to DHS interaction with States, e.g., State certification (see OMB Control No. 1601–0005).

Federal Register Notices

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

Authorizing Statutes

49 USC 30301	View Law

Pub.L. 109 - 13 202	View Law

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Alaska Community Quota Entity (CQE) Program

Key Information

Abstract

The National Marine Fisheries Service (NMFS), Alaska Regional Office, requests a revision and extension of this currently approved information collection, which incorporates minor updates for clarity and regulatory accuracy. These changes to the forms include updating the Public Reporting Burden Statement to include the form's specific purpose, and updating website links. Additionally, the “Application for Transfer of Quota Share to or from a Community Quota Entity” form was updated to include the correct the language from "The party to whom a CQE is seeking to transfer the IFQ must hold a Transfer Eligibility Certificate (TEC) unless they are a resident of the Aleutian Islands (Adak) for at least 12 months" to "The party to whom a CQE is seeking to transfer the IFQ must hold a Transfer Eligibility Certificate (TEC) unless they hold an Aleutian Islands (Adak) TEC." This change accurately reflects current regulations and requirements. No other changes were made to the collection other than adjustments to reflect the most current available data. This information collection is for applications, permits, and reports that are necessary for NMFS to manage the Community Quota Entity (CQE) Program. NMFS requires this information for fisheries management and to evaluate the ability of a specific CQE to represent an eligible community. Without this collection, the cost of making decisions based on inadequate information would adversely affect the viability of the CQE fishing industry and impact the economic health of the participating communities.

Federal Register Notices

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

Authorizing Statutes

16 USC 1801 et seq.	View Law

16 USC 773c	View Law

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Substance Use Disorder Treatment and Recovery (STAR) Loan Repayment Program (LRP) and the Pediatric Specialty Loan Repayment Program

Key Information

Abstract

Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the ‘‘SUPPORT for Patients and Communities Act 2020 requires an STAR LRP application. The legislative authority stating the need for the information collected in this application is found in Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the ‘‘SUPPORT for Patients and Communities Act 2020. The Bureau of Health Workforce (BHW) in the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) will administer the STAR LRP. Under the STAR LRP, HHS will enter into contracts with selected primary care health professionals including behavioral health providers and paraprofessionals. In return, HHS will assist the awardees in their repayment of outstanding qualifying educational loans.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 115 - 271 0	View Law

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Foreign Schools Eligibility Criteria Apply to Participate in Title IV HEA Programs

Key Information

Abstract

This request is for an extension of the information collection of the requirements in the policies and procedures related to the eligibility of foreign schools to apply to participate in Title IV, HEA programs that were added by the Higher Education Opportunity Act of 2008 (HEOA). The information in 34 CFR Sections 600.54, 600.55, 600.56, and 600.57 is used by the Department during the initial review for eligibility certification, recertification and annual evaluations. These regulations help to ensure that all foreign institutions participating in the Title IV, HEA programs are meeting the minimum participation standards.

Federal Register Notices

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

Authorizing Statutes

20 USC 1002,1082, 1088,1092	View Law

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Grazing Permits, 25 CFR 166

Key Information

Abstract

This information collection allows BIA to obtain the information necessary to determine whether an applicant is eligible to acquire, modify, or assign a grazing permit on trust or restricted lands and to allow a successful applicant to meet bonding requirements, related to grazing on Tribal land, individually-owned Indian land, or government land.

Federal Register Notices

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

Authorizing Statutes

25 USC 3701, et seq.	View Law

Presidential Action: