Change Requests

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[NCHHSTP] National HIV Surveillance System (NHSS)

Key Information

Abstract

CDC in collaboration with state and local health departments in the 50 states, the District of Columbia, and U.S. dependent areas, conducts national surveillance for cases of HIV infection that provides critical data across the spectrum of HIV disease from HIV diagnosis, to AIDS, the end-stage disease caused by infection with HIV, and death. HIV surveillance data are used to monitor the extent and characteristics of the HIV burden in the United States. In addition, this national system provides essential data to estimate HIV incidence and monitor patterns in HIV drug resistance and genetic diversity, detect HIV clusters, and perinatal exposures. This Non-Substantive Change Request is submitted to revise questions in the National HIV Surveillance System (NHSS) OMB No. 0920-0573 to align with EO 14168. Changes are only made to the Gender/Sex questions in this data collection. Modifications of other demographic questions will be done in a future Revision. There are no anticipated changes to the approved burden associated with this data collection in this Change Request. Extension of current collection set to expire 02/2026.

Federal Register Notices

60-Day FRN	View Notice
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Authorizing Statutes

42 USC 242b	View Law

42 USC 247b	View Law

42 USC 247c	View Law

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Disability Report - Child

Key Information

Abstract

Sections 223(d)(5)(A) and 1631(e)(1) of the Act require Supplemental Security Income (SSI) claimants to furnish medical and other evidence to prove they are disabled. SSA uses Form SSA-3820-BK to collect information regarding a child applying for SSI disability payments. The information we collect on the SSA-3820-BK then provides the State Disability Determination Services (DDS) adjudicators a detailed explanation of a child’s medical history that is essential to the disability determination. SSA uses Form SSA-3820-BK to collect contact and biographic information about a child. It also includes details pertaining to the child’s condition including medical treating sources, medications being taken, medical tests, educational background, and work history if relevant. The State (DDS) evaluators use the information from Form SSA-3820-BK, including its electronic versions, to request and develop medical and school evidence, and to assess the alleged disability. The information collected on the form, together with medical evidence and other sources of non-medical evidence, provides the evidentiary basis upon which SSA makes its initial disability evaluation. The respondents are the responsible adult(s) applying on behalf of the child, such as the parents, guardians, and other caretakers who petition SSI childhood disability for initial and reconsideration decisions.

Federal Register Notices

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

Authorizing Statutes

42 USC 423	View Law

42 USC 1383	View Law

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Identification of Explosive Materials

Key Information

Abstract

To protect the public from misuse of explosives, implementing regulations at 27 CFR 555.109 require licensees/permittees to mark certain explosives they manufacture or import, as well as mark immediate containers and outside packaging. The markings must include certain information and be clear and permanent, though they can be done via sticky label, marker, etc. Some types of explosives are too small or too fluid, in a form that cannot be marked, and are excepted.

Federal Register Notices

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

Authorizing Statutes

18 USC 923	View Law

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Application/Permit to Import Firearms, Ammunition, and Defense Articles (ATF Form 5330.3A ("Form 6, part I"))

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Abstract

The Gun Control,Act and other statutes prohibit persons from importing firearms, ammunition, and defense articles into the US unless the articles meet certain criteria, the importer is not a prohibited person, and the Attorney General (delegated to Director, ATF) approves that person to import those items. ATF uses this form to collect the information necessary to determine the above facts and approve a person to import the articles; the form then serves as their permit to do so.

Federal Register Notices

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

Authorizing Statutes

18 USC 925	View Law

22 USC 2778	View Law

26 USC 5844	View Law

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Medicare EDI Enrollment Form and EDI Registration (CMS-10164 A/B)

Key Information

Abstract

Federal law requires that CMS minimize the security risk to federal information systems. CMS is requiring that trading partners who wish to conduct the Electronic Data Interchange (EDI) transactions provide certain assurance as a condition of receiving access to the Medicare system for the purpose of conducting EDI exchanges. Health care providers, clearinghouses, and health plans that wish access to the Medicare system are required to complete this form. The information will be used to assure that those entities that access the Medicare system are aware of applicable provisions and penalties.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 104 - 191 262	View Law

Pub.L. 104 - 191 261	View Law

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Essential Community Provider Data Collection to Support QHP Certification (CMS-10561)

Key Information

Abstract

For plan years beginning on or after January 1, 2017, Health and Human Services (HHS) intends to collect more complete provider data for inclusion on the HHS Essential Community Provider (ECP) list to ensure a more accurate reflection of the universe of qualified available ECPs in a given service area that can be counted toward an issuer's satisfaction of the ECP standard. The HHS will collect data on qualified and available ECPs from providers. Providers will submit an ECP petition to be added to the HHS ECP list or provide required missing data fields to remain on the list. The degree of provider participation in this data collection effort through the ECP provider petition will help inform HHS's future proposals for counting issuers' ECP write-ins toward satisfaction of the ECP standard.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 155 1311(c)(1)(C)	View Law

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National Implementation of the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey (CMS-10500)

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Abstract

The information collected in the national implementation of OAS CAHPS will be used for the following purposes: -To provide a source of information from which selected measures can be publicly reported to beneficiaries to help them make informed decisions for outpatient surgery facility selection; -To aid facilities with their internal quality improvement efforts and external benchmarking with other facilities; and -To provide CMS with information for monitoring and public reporting purposes. For the mode experiment, CMS plans to use information from this mode experiment to determine whether additional mode of administration (i.e. Web data collection) should be included in the current national implementation of OAS CAHPS protocols.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 931	View Law

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NESHAP for Coke Oven Pushing, Quenching, and Battery Stacks (40 CFR Part 63, Subpart CCCCC) (Final Rule)

Key Information

Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Coke Oven Pushing, Quenching, and Battery Stacks (40 CFR Part 63, Subpart CCCCC) were proposed on July 3, 2001 (66 FR 35325), promulgated on April 14, 2003 (68 FR 18007), and most-recently amended on August 2, 2005 (70 FR 44285). These regulations apply to pushing, soaking, quenching, and battery stacks on both existing and new coke oven batteries (coke plants) that are major sources of hazardous air pollutant (HAP) emissions. New facilities include those that commenced construction or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR Part 63, Subpart CCCCC. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. Any owner/operator subject to the provisions of this part shall maintain a file containing these documents and retain the file for at least five years following the generation date of such maintenance reports and records. All reports are sent to the delegated state or local authority. If there is no such delegated authority, the reports are sent directly to the U.S. Environmental Protection Agency (EPA) regional office. The final RTR amendments to the rule eliminate the startup, shutdown, and malfunction (SSM) exemption; remove the SSM plan requirement; add electronic submittal of notifications, semiannual reports, and performance test reports; add requirements for the control of mercury (Hg), total acid gases (hydrogen fluoride plus hydrogen chloride) (AG), hydrogen cyanide (HCN), and total polycyclic aromatic hydrocarbons (PAH) from pushing sources; Hg, particulate matter (PM), total AG, and HCN from battery stacks; Hg, PM, AG, total PAH from HRSG main stacks; and Hg PM, total AG, total PAH, and formaldehyde from HRSG bypass/waste heat stacks; and make technical and editorial changes. The remaining portions of the NESHAP remain unchanged.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

44 USC 3501 et seq	View Law

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QHP Issuers Data Collection for Notices for Plan or Display Errors Special Enrollment Periods (CMS-10595)

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Abstract

In the final rule, the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 (CMS-9937-F), we finalized 45 CFR 156.1256, which requires QHP issuers, in the case of a material plan or benefit display error included in 45 CFR 155.420(d)(12), to notify their enrollees of the error and the enrollees’ eligibility for a special enrollment period within 30 calendar days after the issuer is informed by an Federally- facilitated Exchange (FFE) that the error is corrected, if directed to do so by the FFE. This requirement provides notification to QHP enrollees of errors that may have impacted their QHP selection and enrollment and any associated monthly or annual costs, as well as the availability of a special enrollment period under §155.420(d)(12) for the enrollee to select a different QHP, if desired.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 156 1311	View Law

Pub.L. 111 - 148 402	View Law

Pub.L. 111 - 156 1312	View Law

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Elimination of Cost-Sharing for full benefit dual-eligible Individuals Receiving Home and Community-Based Services (CMS-10344)

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This provision is mandated by the Affordable Care Act, section 3309. To implement this provision, CMS needs data from the States, identifying full benefit dual-eligible individuals who are receiving home and community-based services. The States will provide these data as a new data value on their monthly MMA Phase Down report. These data are not available from any other source. CMS will use these new data to set the affected beneficiaries' Medicare Part D copayment to zero.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 3309	View Law

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Strategic Prevention Framework for Prescription Drugs (SPF Rx)

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Abstract

The SPF-Rx program is designed to address nonmedical use of prescription drugs as well as opioid overdoses by raising awareness about the dangers of sharing medications and by working with pharmaceutical and medical communities. The SPF-Rx program aims to promote collaboration between states/tribes and pharmaceutical and medical communities to understand the risks of overprescribing to youth age 12–17 and adults 18 years of age and older and enhance capacity for and access to Prescription Drug Monitoring Program (PDMP) data for prevention purposes.

Federal Register Notices

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

Authorizing Statutes

42 USC 516	View Law

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DC School Choice Incentive Program

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Abstract

The DC Opportunity Scholarship Program (OSP) is currently authorized under the Scholarships for Opportunity and Results Act (SOAR). Under the SOAR Act, the US Department of Education awards a grant to a non-profit to administer scholarships to students who reside in the District of Columbia and come from households whose incomes do not exceed 185% of the poverty line (300% of the poverty line for returning students). The current administrator of the OSP is Serving Our Children (SOC). Under the law, priority is given to siblings of students in the program, and students who are currently attending low-performing schools, as defined by Title I. To assist in the student selection and assignment process, the information collected is used to determine the eligibility of those students who are interested in the available scholarships.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 108 - 199 3	View Law

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Medicare Advantage and Prescription Drug Program: Final Marketing Provisions CFR 422.111(a)(3) and 423.128(a)(3) (CMS-10260)

Key Information

Abstract

This final rule implements provisions of the Social Security Act (the Act) establishing and regulating the Medicare Advantage (MA) program. The MA program was enacted in Title II of The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) on December 8, 2003. The MA program replaces the Medicare+Choice (M+C) program established under Part C of the title XVIII of the Act, while retaining most key features of the M+C program. The MA program attempts to broadly reform and expand the availability of private health plan options to Medicare beneficiaries. Medicare Advantage (MA) organizations and Prescription Drug Plan Sponsors use the information to comply with the eligibility requirements and the MA and Part D contract requirements. CMS will use this information to ensure that correct information is disclosed to Medicare beneficiaries, both potential enrollees and enrollees.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 108 - 117 201	View Law

Pub.L. 110 - 275 103	View Law

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Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338)

Key Information

Abstract

These interim final regulations set forth rules implementing revisions to the Public Health Service (PHS) Act section 2719 for internal claims and appeals and external review processes to implement Section 110 of the No Surprises Act (NSA), which protects participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from receiving surprise medical bills when they receive emergency services, non-emergency services from non-participating providers at participating facilities, and air ambulance services, under certain circumstances. Specifically Section 110 of the NSA amends section 2719 of the PHS Act to require the external review process to apply to participants, beneficiaries, and enrollees of such plans with respect to any adverse determination by a plan or issuer under section 2799A-1 or 2799A-2 of the PHS Act. These protections also extend to grandfathered plans.

Federal Register Notices

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

Authorizing Statutes

45 USC 147.136	View Law

Pub.L. 110 - 110 No Surprises Act	View Law

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Provider Network Coverage Data Collection (CMS-10594)

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Abstract

Proposed §156.230(e)(1) would require that QHP issuers make a good faith effort to provide written notice of discontinuation of a provider 30 days prior to the effective date of the change or otherwise as soon as practicable, to enrollees who are patients seen on a regular basis by the provider or who receive primary care from the provider whose contract is discontinuing. This is a third-party disclosure requirement. CMS is not proposing to collect this notice from QHP issuers in FFMs, therefore we are not specifying ways in which we will use the data. The purpose of this notice is to provide consumers information on when their providers will no longer be available in-network in their QHP. In proposed 156.230(f)(2), we require QHP issuers to provide a notice to enrollees of the possibility of out-of-network charges from an out-of-network provider in an in-network setting at least 10 calendar days prior to the service being provided to avoid counting the out-of-network costs against to the annual limitation on cost sharing.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 156 1311	View Law

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JADE Act Questionnaire

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Abstract

The Immigration and Nationality Act (“INA”), 8 U.S.C. § 1101, sets out application and eligibility requirements for aliens seeking to obtain nonimmigrant and immigrant visas. Grounds for the ineligibility of certain individuals to receive a visa or to be admitted to the United States are detailed in INA section 212(a), 8 U.S.C. § 1182(a) and other statutes.

Federal Register Notices

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

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[NCEZID] National Healthcare Safety Network (NHSN) Respiratory Data

Key Information

Abstract

The goal of this information collection is to 1) capture the daily, aggregate impact of COVID-19 on healthcare facilities, and 2) monitor medical capacity to respond at local, state, and national levels. This information will be used to inform the overall real-time COVID-19 response efforts and possible resource allocation, and enable state and local health departments to gain immediate access to the COVID-19 data for healthcare facilities within their jurisdiction. This Revision is submitted to, make minor changes to wording used on several forms, make adjustments to the burden estimate (increase), and to modify the title of the data collection to: National Healthcare Safety Network (NHSN) Respiratory Data.

Federal Register Notices

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

Authorizing Statutes

42 USC 242b, k, m	View Law

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Indian Self-Determination and Education Assistance Act Programs, 25 CFR 900

Key Information

Abstract

The Indian Self-Determination and Education Assistance Act (ISDEAA), as authorized by 25 USC 450 et. seq., authorizes and directs the Bureau of Indian Affairs (BIA) to contract or compact with, and fund Indian Tribes and Tribal organizations that choose to take over the operation of programs, services, functions and activities (PSFAs) that would otherwise be operated by the BIA. These PSFAs include programs such as law enforcement, social services, and tribal priority allocation programs. Congressional appropriations are divided among BIA and Tribes and Tribal organizations to pay for both the BIA’s direct operation of programs and for the operation of programs by Tribes and Tribal organizations through Self-Determination contracts and compacts. The regulations implementing ISDEAA are at 25 CFR 900. An Indian Tribe or Tribal organization is required to submit this information each time that it proposes to contract with BIA under the ISDEAA. The information collected is used by the BIA to determine applicant eligibility, evaluate applicant capabilities, protect the service population, safeguard Federal funds and resources, and permit the BIA to administer and evaluate Tribal ISDEAA contract programs.

Federal Register Notices

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

Authorizing Statutes

25 USC 450 et seq	View Law

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Invoice Submissions by Contractors for NRC Contracts/Orders

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Abstract

In administering its contracts, the NRC Acquisition Management Division provides billing instructions for its contractors to follow in preparing invoices. These instructions stipulate the level of detail in which supporting data must be submitted for NRC review. The review of this information ensures that all payments made by NRC for valid and reasonable costs are in accordance with the contract terms and conditions.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 83 - 703 1-311	View Law

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Restraint and Seclusion Standards for Psychiatric Residential Treatment Facilities (CMS-R-306)

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Abstract

Psychiatric residential treatment facilities are required to report deaths, serious injuries and attempted suicides to State Medicaid Agency and Protection and Advocacy Organization. Also required to provide residents restraint and seclusion policy in writing, and to document resident record of all activities involving use of restraint and seclusion.

Federal Register Notices

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

Authorizing Statutes

42 USC 483.350	View Law

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(CMS-10578) Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers

Key Information

Abstract

In response to past terrorist attacks, natural disasters, and the subsequent national need to refine the nation’s strategy to handle emergency situations, there continues to be a coordinated effort across Federal agencies to establish a foundation for development and expansion of emergency preparedness systems. This information collection captures the burden necessary to support the development and implementation of emergency preparedness requirements that will be consistent and enforceable across 17 affected Medicare and Medicaid providers and suppliers. We obtained the data used in this discussion on the number of the various Medicare and Medicaid providers and suppliers from Medicare’s Certification and Survey Provider Enhanced Reporting (CASPER) as of , 2015.June 1, 2016. We have not included data for health care facilities that are not Medicare and/or Medicaid certified. This information collection consists primarily of the review, revision, and/or development of emergency plans, policies and procedures, and training and testing materials to ensure on-going compliance with the requirements contained in the regulation, discussed above.

Federal Register Notices

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

Authorizing Statutes

42 USC 1396r	View Law

42 USC 1395i	View Law

42 USC 1395x	View Law

42 USC 1396d	View Law

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State Medicaid Eligibility Quality Control Sample Selection Lists and Supporting Regulations

Key Information

Abstract

The Medicaid Eligibility Quality Control (MEQC) program provides states and the District of Columbia (hereinafter, “states”) a unique opportunity to improve the quality and accuracy of their Medicaid and Children’s Health Insurance Program (CHIP) eligibility determinations. The MEQC program is intended to complement the Payment Error Rate Measurement (PERM) program by ensuring state operations make accurate and timely eligibility determinations so that Medicaid and CHIP services are appropriately provided to eligible individuals.

Federal Register Notices

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

Authorizing Statutes

42 USC 1396b	View Law

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Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-10653)

Key Information

Abstract

Each organization seeking to be treated as an eligible organization that wishes to use the optional accommodation process offered under these final rules must either use the EBSA Form 700 method of self-certification or provide notice to HHS of its religious objection to coverage of all or a subset of contraceptive services.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 1001	View Law

Pub.L. 111 - 148 1563	View Law

42 USC 300gg-13	View Law

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Information Collection Requirements for Non-Exchange Entities (CMS-10666)

Key Information

Abstract

This Information Collection Request (ICR) serves as the formal request for a new data collection clearance associated with the HHS Notice of Benefit and Payment Parameters for 2023 Proposed Rule (2023 Proposed Payment Notice) regarding the authority to allow HHS to collect the necessary information to enable web-brokers and issuers using the Classic DE and EDE pathways to submit a request to deviate from the manner in which standardized options are differentially displayed on HealthCare.gov, if they so choose.

Federal Register Notices

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

Authorizing Statutes

Pub.L. 111 - 148 1400(b)	View Law

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Worker Profiling and Reemployment Services Activity and Worker Profiling and Reemployment Services Outcomes

Key Information

Abstract

The Secretary has interpreted applicable sections of Federal law to require States to identify claimants who are most likely to exhaust their Unemployment Insurance benefits and to provide reemployment services to expedite their return to suitable work. The ETA 9048 report provides information on the basic quarterly activities of the WPRS program, reemployment activities for UI claimants who are likely to exhaust their benefits. The report tracks WPRS claimants from the time they are profiled through the delivery of services. The ETA 9049 report provides information about reemployment outcomes for participants in the WPRS program.

Federal Register Notices

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

Authorizing Statutes

42 USC 503(a) and (j)	View Law

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