The purpose of the meeting is to:

1. Approve meeting minutes;

2. Provide information about the status of the comprehensive plan for the Pacific Northwest National Scenic Trail;

3. Discuss and identify future PNT advisory council activity; and

4. Schedule the next meeting.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 14 days after the meeting date listed under DATES .

Please contact the person listed under FOR FURTHER INFORMATION CONTACT , by or before the deadline, for all questions related to the meeting. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received upon request.

Meeting Accommodations: The meeting location is compliant with the Americans with Disabilities Act, and the USDA provides reasonable accommodation to individuals with disabilities where appropriate. If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpretation, assistive listening devices, or other reasonable accommodation to the person listed under the FOR FURTHER INFORMATION CONTACT section, or contact USDA's TARGET Center at (202) 720-2600 (voice and TTY) or USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Council. To ensure that the recommendations of the Council have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and persons with disabilities. USDA is an equal opportunity provider, employer, and lender.

The purpose of the meeting is to:

1. Discuss the current purpose of the Committee;

2. Discuss questions Federal forestry researchers are attempting to address and how they are addressing them; and

3. Identify topics for future meetings.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 14 days after the meeting date listed under DATES .

Please contact the person listed under FOR FURTHER INFORMATION CONTACT , by or before the deadline, for all questions related to the meeting. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received upon request.

Meeting Accommodations: The meeting location is compliant with the Americans with Disabilities Act, and the USDA provides reasonable accommodation to individuals with disabilities where appropriate. If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpretation, assistive listening devices, or other reasonable accommodation to the person listed under the FOR FURTHER INFORMATION CONTACT section, or contact USDA's TARGET Center at (202) 720-2600 (voice and TTY) or USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by USDA, membership shall include to the extent possible individuals with demonstrated ability to represent minorities, women, and persons with disabilities. USDA is an equal opportunity provider, employer, and lender.

The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see, 5 CFR 1320.8(d)). This notice identifies the following information collection that RUS is submitting to OMB as extension to an existing collection with Agency adjustment.

Title: Electric System Emergency Restoration Plan.

OMB Control Number: 0572-0140.

Expiration Date of Approval: March 31, 2024.

Type of Request: Extension of a currently approved information collection.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average .5 hour per response.

Respondents: Not-for-profit institutions.

Estimated Number of Respondents: 41.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 20.5 hours.

Abstract: USDA Rural Development administers rural utilities programs through the Rural Utilities Service (Agency). The Agency manages loan programs in accordance with the Rural Electrification Act (RE Act) of 1936, 7 U.S.C. 901 et seq., as amended. One of the Agency's main objectives is to safeguard loan security. An important part of safeguarding loan security is to make sure Agency financed facilities are utilized responsibly, adequately operated, and maintained. Accordingly, RUS borrowers have a duty to RUS to maintain their respective systems. In performing this duty, borrowers further the purposes of the RE Act while also preserving the value of electric systems to serve as collateral for repayment of RUS assistance.

A substantial portion of the electric infrastructure of the United States resides in rural America and is maintained by rural Americans. RUS is uniquely coupled with the electric infrastructure of rural America and its electric borrowers serving rural America. To ensure that the electric infrastructure in rural America is adequately protected, electric borrowers conduct a Vulnerability and Risk Assessment (VRA) of their respective systems and utilize the results of this assessment to enhance an existing Emergency Restoration Plan (ERP) or to create an ERP. The VRA is utilized to identify specific assets and infrastructure owned or served by the electric utility, to determine the criticality and the risk level associated with the assets and infrastructure including a risk versus cost analysis, to identify threats and vulnerabilities, if present, to review existing mitigation procedures and to assist in the development of new and additional mitigating procedures, if necessary. The ERP provides written procedures detailing response and restoration efforts in the event of a major system outage resulting from a natural or man-made disaster. The annual exercise of the ERP ensures operability and employee competency and serves to identify and correct deficiencies in the existing ERP. The exercise may be implemented individually by a single borrower, or by an individual borrower as a participant in a multi-party (to include utilities, government agencies and other participants or combination thereof) tabletop execution or actual implementation of the ERP.

Electric borrowers maintain ERPs as part of prudent utilities practices. These ERPs are essential to continuous operation of the electric systems. Each electric applicant provides RUS with a written self-certification letter form that an ERP exists for the system and that an initial VRA has been performed as part of the application process.

Comments are invited on:

(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used;

(c) ways to enhance the quality, utility and clarity of the information to be collected; and

(d) ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

Copies of this information collection can be obtained from Crystal Pemberton, Rural Development Innovation Center—Regulations Management Division, at (202) 260-8621. Email: Crystal.Pemberton@usda.gov.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The Census Bureau is committed to conducting research in a cost-efficient manner. The U.S. Census Bureau plans to request an extension of the current OMB approval to conduct a series of medium-scale internet-based tests, as a cost-efficient method of testing questions and contact strategies over the internet through different types of samples. Using internet panel pretesting, we can answer some research questions more thoroughly than in the small-scale testing, but less expensively than in the large-scale field test.

This research program will be used by the Census Bureau and survey sponsors to test alternative contact methods, including emails and text messages, improve online questionnaires and procedures, reduce respondent burden, and ultimately increase the quality of data collected in the censuses and surveys. We will use the clearance to conduct experimental pretesting of decennial and demographic census and survey questionnaires prior to fielding them as well as communications and/or marketing strategies and data dissemination tools for the Census Bureau. The primary method of identifying measurement problems with the questionnaire or survey procedure is split panel tests. This will encompass both methodological and subject matter research questions that can be tested on a medium-scale internet panel.

This research program will also be used by the Census Bureau for remote usability testing of electronic interfaces and to perform other qualitative analyses such as respondent debriefings. An advantage of using remote, medium-scale testing is that participants can test products at their convenience using their own equipment, as opposed to using Census Bureau-supplied computers. A diverse participant pool (geographically, demographically, or economically) is another advantage. Remote usability testing would use click through rates and other paradata, accuracy and satisfaction scores, and written qualitative comments to determine optimal interface designs and to obtain feedback from respondents.

The public is currently offered an opportunity to participate in this research remotely, by signing up for an online research panel. If a person opts in, the Census Bureau will occasionally email (or text, if applicable) the person an invitation to complete a survey for one of our research projects. Invited respondents will be told the topic of the survey, and how long it will take to complete it. Under this clearance, we will also conduct similar-scale and similarly designed research using other email lists to validate preliminary findings and expand the research.

Split sample experiments. This involves testing alternative versions of questionnaires, invitations to questionnaires ( e.g., emails or text messages), or websites, at least some of which have been designed to address problems identified in draft versions or versions from previous waves. The use of multiple questionnaires, invitations, or websites, randomly assigned to permit statistical comparisons, is the critical component here; data collection will be via the internet. Comparison of revised questionnaires (or invitations) against a control version, preferably, or against each other facilitates statistical evaluation of the performance of alternative versions of the questionnaire (or invitation or website).

The number of versions tested and the number of cases per version will depend on the objectives of the test. We cannot specify with certainty a minimum panel size, although we would expect that no questionnaire versions would be administered to less than fifty respondents.

Split sample tests that incorporate methodological questionnaire design experiments will have a larger maximum sample size (up to several hundred cases per panel) than other pretest methods. This will enable the detection of statistically significant differences and facilitate methodological experiments that can extend questionnaire design knowledge more generally for use in a variety of Census Bureau data collection instruments.

Usability Interviews: This method involves getting respondent input to aid in the development of automated questionnaires and websites and associated materials. The objective is to identify problems that keep respondents from completing automated questionnaires accurately and efficiently with minimal burden, or that prevent respondents from successfully navigating websites and finding the information they seek. Remote usability testing may be conducted under this clearance, whereby a user would receive an invitation to use a website or survey, then answer targeted questions about that experience.

Qualitative Interviews: This method involves one-on-one (or sometimes group) interviews in which the respondent is typically asked questions about survey content areas, survey questions or the survey process. A number of different techniques may be involved, including cognitive interviews and focus groups. The objective is to identify problems of ambiguity or misunderstanding, or other difficulties respondents may have answering survey questions in order to improve the information ultimately collected in large scale surveys and censuses.

Data collection for this project is authorized under the authorizing legislation for the questionnaire being tested. This may be Title 13, Sections 131, 141, 161, 181, 182, 193, and 301 for Census Bureau-sponsored surveys, and Title 13, Section 8(b), and Title 15 for surveys sponsored by other Federal agencies. We do not now know what other titles will be referenced, since we do not know what survey questionnaires will be pretested during the course of the clearance.

Literature on and considerations about the use of internet samples for this type of work have been thoroughly covered by a Task Force commissioned by the American Association for Public Opinion Research and are well documented there (Baker, et al., 2013).

The information collected in this program of developing and testing questionnaires will be used by staff from the Census Bureau and sponsoring agencies to evaluate and improve the quality of the data in the surveys and censuses that are ultimately conducted. Because the questionnaires being tested under this clearance are still in the process of development, the data that result from these collections are not considered official statistics of the Census Bureau or other Federal agencies. Data will be included in research reports prepared for sponsors inside and outside of the Census Bureau. The results may also be prepared for presentations related to survey methodology at professional meetings or publications in professional journals.

OMB Control Number: 0607-0978.

Form Number(s): TBD.

Type of Review: Regular submission, Request for an Extension, without Change, of a Currently Approved Collection.

Affected Public: Individuals or households.

Estimated Number of Respondents: 67,600.

Estimated Time per Response: 15 minutes.

Estimated Total Annual Burden Hours: 16,900.

Estimated Total Annual Cost to Public: $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.)

Respondent's Obligation: Voluntary.

Legal Authority: Data collection for this project is authorized under the authorizing legislation for the questionnaire being tested. This may be Title 13, Sections 131, 141, 161, 181, 182, 193, and 301 for Census Bureau-sponsored surveys, and Title 13 and 15 for surveys sponsored by other Federal agencies. We do not now know what other titles will be referenced, since we do not know what survey questionnaires will be pretested during the course of the clearance.

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include, or summarize, each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The agenda will include: (a) an overview on Climate ecosystems and fisheries initiative; (b) overview on IRA funding; (c) overview of Alaska Climate Integrated Modeling and Alaska Dashboard Adaptation Planning Tools; (d) summary of CCTF member survey feedback on climate scenario planning workshop plans; (e) recommended approach for Climate Scenario Planning Workshop; (f) research priorities; (g) future plans; and (h) and other business. The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/3016 prior to the meeting, along with meeting materials.

You can attend the meeting online using a computer, tablet, or smart phone; or by phone only. Connection information will be posted online at: https://meetings.npfmc.org/Meeting/Details/3016.

Public comment letters will be accepted and should be submitted electronically to https://meetings.npfmc.org/Meeting/Details/3016.

Authority: 16 U.S.C. 1801 et seq.

35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period (RRP) is reasonably expected to extend beyond the expiration date of the patent.

On August 28, 2023, Medac Gesellschaft fuer Klinische Spezialpraparate mbH, the owner of record of the ‘162 patent, timely filed an application under 35 U.S.C. 156(d)(5) for a third interim extension of the term of the ‘162 patent. The ‘162 patent claims a method of using the human drug product known by the tradename GRAFAPEX TM (treosulfan). The application for interim patent term extension indicates that a RRP as described in 35 U.S.C. 156(g)(1)(B)(ii) began for GRAFAPEX TM (treosulfan) and is ongoing before the Food and Drug Administration for permission to market and use the product commercially.

Review of the interim patent term extension application indicated that, except for permission to market or use the product commercially, the ‘162 patent would be eligible for an extension of the patent term under 35 U.S.C. 156. Because it was apparent that the RRP would continue beyond the twice-extended expiration date of the ‘162 patent, i.e., October 12, 2023, a third interim extension of the patent term under 35 U.S.C. 156(d)(5) was appropriate.

A third interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,199,162 was granted on October 10, 2023, for a period of one year from the twice-extended expiration date of the ‘162 patent.

As part of its emphasis on fair competition, the Consumer Financial Protection Bureau (CFPB) has launched an initiative, consistent with its legal authority, to scrutinize junk fees charged by banks and financial companies. Junk fees are typically not subjected to the normal forces of competition, leading to excessive costs for services that a consumer may not even want. For example, certain banks and financial companies might hide these unavoidable or surprise charges or disclose them only at a later stage in the consumer's purchasing process, if at all.

The CFPB has observed that supervised institutions have started to compete more when it comes to fees. In recent years, multiple banks have announced they were eliminating overdraft fees or otherwise updating their policies to be more consumer friendly. 1 And many have announced that they are eliminating non-sufficient fund (NSF) fees on consumer deposit accounts. 2

Supervision continues to focus significant resources on identifying and eliminating junk fees charged by supervised institutions. Significantly, financial institutions are refunding over $120 million to consumers for unanticipated overdraft fees and unfair NSF fees. This special edition of Supervisory Highlights updates the public on supervisory work completed since the CFPB published the March 2023 Supervisory Highlights Junk Fees Special Edition. In total, for the topics covered in this edition, Supervision's work has resulted in institutions refunding over $140 million to consumers.

The findings included in this report cover examinations in the areas of deposits, auto servicing, and remittances that generally were completed between February 2023 and August 2023. 3 The report also describes risks identified in connection with payment platforms that parents, guardians, and students use to pay for school lunches. Additionally, consistent with the statutory requirement for Supervision to identify and consider “risks to consumers” throughout its supervisory program, Supervision has obtained data about certain deposit account fee practices and is sharing key data points that shed light on risks to consumers. To maintain the anonymity of the supervised institutions discussed in Supervisory Highlights, references to institutions generally are in the plural and related findings may pertain to one or more institutions.

We invite readers with questions or comments about Supervisory Highlights to contact us at CFPB_Supervision@cfpb.gov.

In recent examinations of depository institutions and service providers, Supervision has reviewed certain fees related to deposit accounts to assess whether supervised entities have engaged in any unfair, deceptive, or abusive acts or practices (UDAAPs) prohibited by the Consumer Financial Protection Act of 2010 (CFPA). 4 Examiners have focused on NSF and overdraft fees in particular and have reviewed statement fees and surprise depositor fees as well. Examiners also have engaged in follow-up work regarding pandemic relief benefits.

Supervision continued examinations of institutions to review for UDAAPs in connection with charging consumers NSF fees, especially with respect to “re-presentments.”  5 A re-presentment occurs when, after declining a transaction because of insufficient funds and assessing an NSF fee for the transaction, the consumer's account-holding institution returns the transaction to the merchant's depository institution, and the merchant presents the same transaction to the consumer's account-holding institution for payment again. In some instances, when the consumer's account remains insufficient to pay for the transaction upon re-presentment, the consumer's account-holding institution again returns the transaction to the merchant and assesses another NSF fee for the transaction, without providing consumers a reasonable opportunity to prevent another fee after the first failed presentment attempt. Absent restrictions on the assessment of NSF fees by the consumer's account-holding institution, this cycle can occur multiple times, and consumers may be charged multiple fees for a single transaction.

Core processors provide critical deposit, payment, and data processing services to many supervised institutions, and the system functionality that these entities develop drives many fee practices, including NSF fee practices. Supervision has examined core processors in their capacity as service providers to covered persons providing deposit services.

Examiners concluded that, in the offering and providing of core service platforms, core processors engaged in an unfair act or practice by contributing to the assessment of unfair NSF fees on re-presented items. An act or practice is unfair when: (1) it causes or is likely to cause substantial injury to consumers; (2) the injury is not reasonably avoidable by consumers; and (3) the injury is not outweighed by countervailing benefits to consumers or to competition. 6 Consumers incurred substantial injury in the form of the relevant re-presentment NSF fees. Consumers were also at increased risk of incurring additional fees on subsequent transactions caused by the re-presentment NSF fees, which lowered consumers' account balances. Injurious fees were foreseeable in light of the system limitations, as the core processor platforms did not allow financial institutions to refrain from charging more than one NSF fee per item without discontinuing NSF fees altogether or manually waiving individual fees. These fees were not reasonably avoidable by consumers, where consumers did not have a meaningful opportunity to prevent another fee after the first failed representment attempt. The consumer injury at issue was not outweighed by countervailing benefits to consumers or competition.

To address these findings, the core processors enhanced the systems they provide to financial institutions to facilitate their implementation of policies to eliminate NSF re-presentment fees. Additionally, Supervision intends to review the practices of financial institutions seeking payment from the consumer's financial institution, often called Originating Depository Financial Institutions, to ensure that represented transactions are coded properly to enable systems to identify the relevant transactions efficiently as well as refrain from charging NSF fees on those transactions.

In other examinations, Supervision found that financial institutions engaged in unfair acts or practices by charging consumers re-presentment NSF fees without affording the consumer a meaningful opportunity to prevent another fee after the first failed representment attempt. 7 The assessment of re-presentment NSF fees caused substantial monetary injury to consumers, totaling tens of millions of dollars that will be refunded to consumers because of examinations during this time period. These injuries were not reasonably avoidable by consumers, regardless of disclosures in account-opening documents, because consumers did not have a reasonable opportunity to prevent another fee after the first failed presentment attempt. And the injuries were not outweighed by countervailing benefits to consumers or competition.

Consistent with the CFPB's longtime position regarding responsible business conduct, institutions proactively developed plans to remediate consumers for assessed re-presentment NSF fees. 8 However, some financial institutions used incomplete reports that only captured certain re-presentment NSF fees charged to consumers. Examiners found that these reports captured consumer accounts that were charged NSF fees on checks only, or on both checks and ACH transactions. Yet they omitted consumer accounts that were assessed NSF fees solely on ACH transactions. After examiners identified this issue, institutions reviewed their remediation methodologies to ensure coverage of both ACH and check re-presentments.

In total, institutions are refunding over $22 million to consumers in response to Supervision directives since CFPB initiated this set of work in 2022. Additionally, the vast majority of institutions reported plans to stop charging NSF fees altogether.

Supervision continued to cite unfair acts or practices at institutions that charged consumers for unfair unanticipated overdraft fees, such as Authorize-Positive Settle-Negative (APSN) overdraft fees, during this time period. APSN overdraft fees occur when financial institutions assess overdraft fees for debit card or ATM transactions where the consumer had a sufficient available balance at the time the consumer authorized the transaction, but given the delay between authorization and settlement the consumer's account balance is insufficient at the time of settlement. This change in balance can occur for many reasons, such as intervening authorizations resulting in holds, settlement of other transactions, timing of presentment of the transaction for settlement, and other complex practices relating to transaction processing order. Supervision's recent matters have built on work described in Winter 2023 Supervisory Highlights, and the CFPB previously discussed this practice in Consumer Financial Protection Circular 2022-06, Unanticipated Overdraft Fee Assessment Practices. 9

Across its examinations, Supervision has identified tens of millions of dollars in injury to thousands of consumers that occurred whether supervised institutions used the consumer's available or ledger balance for fee decisioning. Consumers could not reasonably avoid the substantial injury, irrespective of account opening disclosures. The consumer injury was not outweighed by countervailing benefits to consumers or competition. To remedy the violation, these institutions ceased charging APSN overdraft fees, and will conduct a lookback and issue remediation to injured consumers.

In total, financial institutions are refunding over $98 million to consumers since this work began in 2022. In recent examinations, and consistent with Supervision's earlier work, supervised institutions that had reported to examiners that they engaged in APSN overdraft fee practices now report that they will stop doing so.

As part of the CFPB's ongoing supervisory monitoring related to overdraft practices, Supervision obtained data from several institutions related to fees assessed over the course of 2022, including per item overdraft and NSF fees, sustained overdraft fees, and transfer fees (collectively, “overdraft-related fees”). 10 Supervision also obtained account-level and transaction-level data from several institutions regarding overdraft fees assessed over a one-month period on non-recurring debit card and ATM transactions. 11 Some of the key observations gleaned from the data are discussed below. Please note that the discussion below does not present all of the CFPB's observations or data obtained and that the CFPB's analysis of data provided by institutions is ongoing.

During the time periods reviewed, the relevant institutions charged per-item overdraft fees that ranged from $15 per item to $36 per item. The amount of overdraft coverage provided for consumer transactions on which these fees were charged often was disproportionately small. For example, in these data sets, the median amount of overdraft coverage extended on one-time debit card and ATM transactions ranged from $14 to $30. In fact, the percentage of transactions for which the amount of overdraft coverage provided was less than the relevant per-item overdraft fee ranged from 32% to 74% across institutions.

Supervision obtained institution-level data segmented by certain account characteristics, including: opt-in status, 12 i.e. accounts opted-in to overdraft services for one-time debit card and ATM transactions (“opted-in accounts”) versus accounts not opted-in to such overdraft services (“not opted-in accounts”), and average account balance, i.e. accounts with an average balance at or less than $500 (“lower balance accounts”) versus accounts with an average balance greater than $500 (“higher balance accounts”). Across all institutions monitored, most accountholders do not incur overdraft-related fees. This data set also showed that overdraft-related fees constituted the majority of the total deposit account fees that consumers incurred and an even greater proportion of the total fees assessed to lower balance accounts and opted-in accounts.

In 2022, in this data set, overdraft and NSF fees comprised 53% of all fees that the institutions charged to consumer checking accounts and nearly three-quarters of all fees charged to lower balance accounts and opted-in accounts. Not surprisingly then, while accountholders overall each paid approximately $65 per year in overdraft and NSF fees on average, opted-in accounts and lower balance accountholders paid over $165 and $220 in overdraft and NSF fees on average per year, respectively. A relatively small fraction of bank customers had a lower average balance but paid the majority of overdraft and NSF fees which is consistent with findings in prior research conducted by the CFPB. Indeed, across all institutions in aggregate, one-fifth of accounts were lower-balance accounts, but these accounts paid 68% of per-item overdraft fees assessed and 77% of the per-item NSF fees assessed. In fact, for at least one institution, over half of per-item overdraft fees assessed and over one-third of per-item NSF fees assessed were charged to lower balance, opted-in accounts even though only five percent of the institution's accounts fell into this category.

Data on the frequency of overdraft transactions and fees showed that the number of overdraft transactions and fees varies substantially with opt-in status. Accounts that overdraft most frequently (12 or more overdraft fees per year) were nearly five times as prevalent among opted-in accounts compared to not opted-in accounts.

Supervision also obtained data on account closure attributable to unpaid negative balances and overdraft transactions and the amount of charged-off negative balances attributable to overdraft transactions (excluding fees). With respect to account closure, Supervision found that, across all institutions, most accounts were closed involuntarily and half of such accounts were closed due to an unpaid negative balance attributable to overdraft transactions and overdraft-related fees.

In aggregate, losses to institutions in the form of charge-offs were evenly split between opted in accounts and not opted in accounts. Although overdraft transactions initiated by lower balance accounts were more likely to be charged-off, the average amount charged-off per lower balance account was roughly equal to the amount charged-off per higher balance account and was actually lower at some institutions. Notably, overdraft-related fees themselves generally constituted one-third of the total amount of negative balances charged-off. In fact, overdraft-related fees constituted as much as two-thirds of the total amount of all overdraft charge-offs by at least one institution.

When supervised institutions send account statements to customers that provide information about their deposit accounts during the month, they generally deliver these statements to consumers in paper form, through the U.S. mail, unless consumers elect to receive the statements in verified and secure electronic form, whether by email or through the institution's website or its mobile application.

In recent examinations, Supervision observed that institutions charged fees for the printing and delivery of paper statements, including additional fees when they mailed a statement that was returned undelivered. Supervision found that, in certain instances, institutions did not print or attempt to deliver paper statements but continued to assess paper statement fees and returned mail fees each month.

Supervision found that institutions engaged in an unfair act or practice by assessing paper statement fees and returned mail fees for paper statements they did not attempt to print and deliver. Assessing such delivery-related statement fees for undelivered statements caused substantial injury to consumers. Indeed, in one instance, a senior citizen discovered that her account was almost entirely depleted because an account statement had been returned undelivered five years prior and the institution had been assessing statement fees each month since. Consumers could not reasonably avoid this injury because they had no reason to anticipate that such fees would be assessed. The injury was also not outweighed by countervailing benefits to consumers or competition because assessing delivery-related fees for undelivered statements provides no benefit to consumers and does not actually compensate institutions for any costs incurred.

In response to these findings, the institutions stopped assessing paper statements and returned mail fees for paper statements they did not attempt to deliver and will refund the millions of dollars in such fees that were charged to hundreds of thousands of consumers.

Surprise depositor fees, also known as returned deposit item fees, are fees assessed to consumers when an institution returns as unprocessed a check that the consumer attempted to deposit into his or her checking account. An institution might return a check for several reasons, including insufficient funds in the originator's account, a stop payment order, or problems with the information on the check.

In October 2022, the CFPB issued a compliance bulletin stating that it is likely an unfair act or practice for an institution to have a blanket policy of charging return deposit item fees anytime that a check is returned unpaid, irrespective of the circumstances or patterns of behavior on the account. 13 The CFPB stated that these fees cause substantial monetary injury for each returned item, which consumers likely cannot reasonably avoid because they lack information about and control over whether a check will clear. 14 And it may be difficult to show that this injury from blanket return deposit item policies is outweighed by countervailing benefits to consumers or to competition. 15

In recent examinations, Supervision has evaluated the returned deposit item fee practices at a number of institutions. Most of the examined institutions have advised the CFPB that they have eliminated returned deposit item fees entirely. Others have stated that they are in the process of doing so. As previewed in the October 2022 bulletin, Supervision has not sought to obtain monetary relief for return deposit item fees assessed prior to November 1, 2023. But Supervision will continue to monitor the relevant practices for compliance with the law and may direct remediation from institutions that continue charging unfair returned deposit item fees. 16

As described in past editions of Supervisory Highlights, Supervision conducted examination work to evaluate how financial institutions handled pandemic relief benefits deposited into consumer accounts. 17 Specifically, the CFPB performed a broad assessment centered on whether consumers may have lost access to pandemic relief benefits, namely Economic Impact Payments and unemployment insurance benefits, as a result of financial institutions' garnishment or setoff practices. 18 Further follow-up reviews identified many supervised institutions that risked committing an unfair act or practice in violation of the CFPA in connection with their treatment of pandemic relief benefits which resulted in consumers being charged improper fees. 19

In response to these findings, the institutions (1) refunded protected Economic Impact Payments improperly taken from consumers to set off fees or amounts owed to the institution; (2) refunded garnishment-related fees assessed to consumers for improper garnishment of Economic Impact Payments; and (3) reviewed, updated, and implemented policies and procedures to ensure the institution complies with applicable State and territorial protections regarding its setoff and garnishment practices.

To date, Supervision has identified over $1 million in consumer injury in response to these examination findings, with institutions providing redress to over 6,000 consumers. Thus far, supervised institutions have provided redress of approximately $685,000 to consumers for improper setoff of Economic Impact Payments and approximately $315,000 for improper garnishment-related fees. Most supervised institutions have reported making substantial changes to their policies and procedures to prevent this type of consumer injury in the future.

Examiners also reviewed fee practices in connection with auto loans. Through this work, Supervision continues to identify unfair acts or practices related to auto servicers' handling of refunds of add-on products after loans terminate early. Specifically, some servicers failed to ensure consumers received refunds, while others did so but miscalculated the refund amounts.

When consumers purchase an automobile, auto dealers and finance companies offer optional, add-on products that consumers can purchase. Auto dealers and finance companies often charge consumers for the entire cost of any add-on products at origination, adding the cost of the add-on product as a lump sum to the total amount financed. As a result, consumers typically make payments on these products throughout the loan term, even if the product expires earlier.

Examiners have continued to review servicer practices related to add-on product charges where loans terminated early through payoff or repossession. 20 When loans terminate early, certain products no longer offer any possible benefit to consumers; whether a product offers a benefit depends on the type of product and reason for early termination. For example, many vehicle service contracts continue to provide possible benefits to consumers after early payoff but not after repossession, while a credit product (such as Guaranteed Asset Protection (GAP) or credit-life insurance) will not offer any possible benefits after either early payoff or repossession.

Examiners found auto servicers engaged in unfair acts or practices because consumers suffered substantial injury when servicers failed to ensure they received refunds for add-on products following early loan termination; consumers were essentially required to pay for services they could no longer use, as the relevant products (including vehicle service contracts, GAP, or credit-life insurance) terminated either when the loan contract was terminated or provided no possible benefits after the consumer lost use of the vehicle. Consumers could not reasonably avoid the injury because they had no control over the servicers' refund processing actions. When servicers present consumers with payoff amounts, deficiency balances, or refunds, consumers may have no reason to know that the amounts include unearned add-on product costs. And reasonable consumers might not apply for refunds themselves because they may be unaware that the contract provided that they could do so. Examiners concluded that the injury was not outweighed by any countervailing benefits to consumers or competition.

In response to these findings, servicers are remediating impacted consumers more than $20 million and implementing processes to ensure consumers receive refunds for add-on products that no longer offer any possible benefit to consumers.

Examiners also have continued to identify problems with the calculation of unearned fee amounts after loan termination. 21 Examiners found that servicers engaged in unfair acts or practices when they used miscalculated add-on product refund amounts after loans terminated early. These servicers had a policy to obtain add-on product refunds and relied on service providers to calculate the refund amounts. The service providers miscalculated the refunds due, either because they used the wrong amount for the price of the add-on product or because they deducted fees (such as cancellation fees) that were not authorized under the add-on product contract; the servicers then used these miscalculated refund amounts.

Examiners found that servicers engaged in an unfair act or practice when they used miscalculated add-on product refund amounts after loans terminated early. Using miscalculated refund amounts caused, or was likely to cause, substantial injury because servicers either communicated inaccurately higher deficiency balances or provided smaller refunds than warranted after early loan termination. Consumers could not reasonably avoid the injury because they were not involved in the servicers' calculation process, and it is reasonable for consumers to assume that the calculations are accurate. And the injury was not outweighed by countervailing benefits to consumers or competition.

In response to these findings, servicers are remediating impacted consumers and improving monitoring of service providers.

Examiners also review activities of remittance transfer providers to ensure that fees are disclosed and charged consistent with subpart B of Regulation E (the Remittance Rule). These examinations found that certain providers have violated regulations by failing to appropriately disclose fees or failing to refund fees, in certain circumstances, because of an error.

The Remittance Rule requires that remittance transfer providers disclose any transfer fees imposed by the provider. 22 Recent examinations have found that remittance providers have failed to disclose fees imposed by their agents at the time of the transfer, in violation of 12 CFR 1005.31(b)(1)(ii). This reduced the total wire amount the recipients received as compared to the amount that had been disclosed. Additionally, in the case of an error for failure to make funds available to a designated recipient by the date of availability, the Remittance Rule states that if a remittance transfer provider determines an error occurred, the provider shall refund to the sender any fees imposed, and to the extent not prohibited by law, taxes collected on the remittance transfer. 23 Examiners found that certain providers failed to correct errors by refunding to the sender fees imposed on the remittance transfer, within the specified time frame, where the recipients did not receive the transfers by the promised date, in violation of 12 CFR 1005.33(c)(2)(ii)(B). In response to these findings, supervised institutions implemented corrective action to prevent future violations and provided remediation to consumers charged fees in violation of regulatory requirements.

Some kindergarten through 12th grade school systems contract with companies that run online platforms that allow parents or guardians to manage their students' meal accounts. In most cases, families using these online platforms pay a per-transaction fee to add funds to their meal accounts. Any school district that participates in Federal school meal programs and contracts with fee-based online platforms must also provide free options for adding money to student meal accounts. As a result, families can avoid the transaction fee by adding funds using one of these alternative methods, such as making payments directly to the school or district.

The CFPB learned of covered persons that maintained these online payment platforms where consumers may have paid fees that they would not have paid if they had known of the existence of free options for adding meal funds to the student's account. Because consumers did not know their options, they incurred transaction fees that they could have avoided. As the fees were assessed on a per-transaction basis, the fees likely disproportionately affected lower-income families that must add smaller amounts more often, thereby incurring more transaction fees than higher-income users that can deposit larger amounts less frequently.

The CFPB notified the covered persons that these practices may not comply with consumer financial protection laws.

Set forth below is a recap of the most salient supervision program developments that implicate junk fees. More information including circulars, bulletins, and advisory opinions about the CFPB's junk fee initiative can be found at: https://www.consumerfinance.gov/rules-policy/junk-fees/.

On October 26, 2022, the CFPB issued guidance indicating that overdraft fees may constitute an unfair act or practice under the CFPA, even if the entity complies with the Truth in Lending Act (TILA) and Regulation Z, and the Electronic Fund Transfer Act (EFTA) and Regulation E. 24 As detailed in the circular, when supervised institutions charge surprise overdraft fees, sometimes as much as $36, they may be breaking the law. The circular provides some examples of potentially unlawful surprise overdraft fees, including charging fees on purchases made with a positive balance. These overdraft fees occur when an institution displays that a customer has sufficient available funds to complete a debit card purchase at the time of the transaction, but the consumer is later charged an overdraft fee. Often, the institution relies on complex back-office practices to justify charging the fee. For instance, after the institution allows one debit card transaction when there is sufficient money in the account, it nonetheless charges a fee on that transaction later because of intervening transactions.

Under the Civil Service Reform Act of 1978, Public Law 95-454 (5 U.S.C. 4314(c)(4)), the Department must publish in the Federal Register a list of persons named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members of the Department. The following persons are named to serve on the Performance Review Board:

Alternate:

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

On October 12, 2023, the Department published a RFI on S2S, a potential new program. (88 FR 70652). We are correcting the docket identification number.

Accessible Format: On request to the contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

In FR Doc. No. 2023-22482, appearing on pages 70652-70654 of the Federal Register of October 12, 2023, we make the following correction:

On page 70652, in the heading, remove “[Docket ID ED-2023-IES-0011]” and add, in its place, “[Docket ID ED-2023-IES-0182]”.

This action is directed to the public in general and may be of interest to a wide range of stakeholders, including environmental, human health, and agricultural advocates, the chemical industry, pesticide users, agricultural producers, food manufacturers, pesticide manufacturers, and members of the public interested in the sale, distribution, or use of pesticides. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.

EPA requests public comment during the next 30 days on a pesticide petition (available in docket number EPA-HQ-OPP-2023-0323 at https://www.regulations.gov ). The petitioner requests that EPA revoke all remaining tolerances of the pesticide dicofol currently listed under 40 CFR 180.163. The petition is filed pursuant to section 408 of the FFDCA.

The petitioner indicates that while he is aware that multiple pesticides are allowed for use on tea, he wishes to ensure that the tea he consumes is free of dicofol residues. The petitioner provides a timeline of the registration and use of dicofol as a pesticide in the United States. The timeline describes an Agency decision on May 9, 2012 (77 FR 27164) in which all dicofol tolerances were revoked except for tolerances on “tea, dried' and `tea, plucked leaves.” The 2012 decision indicated that the Agency would address the tea tolerances and public comments received on them in a future document to be published in the Federal Register . The Tea Association of the U.S.A., Inc. previously provided public comments that dicofol is used in tea production in countries such as India, China, and Argentina, and requested that EPA not revoke the dicofol tolerances on tea but maintain them for importation purposes. The petitioner comments that the Agency did not address the remaining tea tolerances and public comments, as previously indicated in the 2012 decision.

Dicofol is an organochlorine miticide that was registered in the United States to control mites on a variety of noncrop areas and on food crops from 1957 to October 31, 2013. All use of dicofol in the United States has been cancelled, and all dicofol tolerances expired on October 31, 2016, except for tolerances on “tea, dried' and `tea, plucked leaves.”

Background materials related to the Agency's registration of dicofol and the phase out of its use are available online in public docket EPA-HQ-OPP-2005-0220 at https://www.regulations.gov. Information related to the Agency's dicofol tolerance actions are available online in public docket EPA-HQ-OPP-2012-0171 at https://www.regulations.gov.

EPA received the EIP Petition and the GASP Petition, each dated March 6, 2023, requesting that the EPA object to the issuance of operating permit no. 0052-OP22, issued by ACHD to U.S. Steel, Clairton in Allegheny County, Pennsylvania. On September 18, 2023, the EPA Administrator issued an order granting in part and denying in part the EIP petition and granting in full the GASP petition. The order itself explains the basis for the EPA's decision.

Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner may request judicial review of those portions of an order that deny issues in a petition. Any petition for review shall be filed in the United States Court of Appeals for the appropriate circuit no later than December 18, 2023.

Board Meeting Agenda Open Session 1. Approval of the September 26, 2023, Board Meeting Minutes 2. Monthly Reports (a) Participant Report (b) Legislative Report 3. Quarterly Reports (c) Investment Review (d) Audit Status (e) Budget Review Closed Session 4. Information covered under 5 U.S.C. 552b(c)(6) and (c)(10).

Authority: 5 U.S.C. 552b(e)(1).

Section 1813 of the Social Security Act (the Act) provides for an inpatient hospital deductible to be subtracted from the amount payable by Medicare for inpatient hospital services furnished to a beneficiary. It also provides for certain coinsurance amounts to be subtracted from the amounts payable by Medicare for inpatient hospital and extended care services. Section 1813(b)(2) of the Act requires the Secretary of the Department of Health and Human Services (the Secretary) to determine and publish each year the amount of the inpatient hospital deductible and the hospital and extended care services coinsurance amounts applicable for services furnished in the following calendar year (CY).

Section 1813(b) of the Act prescribes the method for computing the amount of the inpatient hospital deductible. The inpatient hospital deductible is an amount equal to the inpatient hospital deductible for the preceding CY, adjusted by our best estimate of the payment-weighted average of the applicable percentage increases (as defined in section 1886(b)(3)(B) of the Act) used for updating the payment rates to hospitals for discharges in the fiscal year (FY) that begins on October 1 of the same preceding CY, and adjusted to reflect changes in real case-mix. The adjustment to reflect real case-mix is determined on the basis of the most recent case-mix data available. The amount determined under this formula is rounded to the nearest multiple of $4 (or, if midway between two multiples of $4, to the next higher multiple of $4).

Under section 1886(b)(3)(B)(i)(XX) of the Act, the percentage increase used to update the payment rates for FY 2024 for hospitals paid under the inpatient prospective payment system (IPPS) is the inpatient hospital operating market basket percentage increase, otherwise known as the IPPS market basket update, reduced by an adjustment based on changes in economy-wide productivity (the productivity adjustment) (see section 1886(b)(3)(B)(xi)(II) of the Act). Under section 1886(b)(3)(B)(viii) of the Act, for FY 2024, the applicable percentage increase for hospitals that do not submit quality data as specified by the Secretary is reduced by one quarter of the market basket update. We are estimating that after accounting for those hospitals receiving the lower market basket update in the payment-weighted average update, the calculated deductible will not be affected, since most hospitals submit quality data and receive the full market basket update. Section 1886(b)(3)(B)(ix) of the Act requires that any hospital that is not a meaningful electronic health record (EHR) user (as defined in section 1886(n)(3) of the Act) will have three-quarters of the market basket update reduced by 100 percent for FY 2017 and each subsequent FY. We are estimating that after accounting for these hospitals receiving the lower market basket update, the calculated deductible will not be affected, since most hospitals are meaningful EHR users and are expected to receive the full market basket update.

Under section 1886 of the Act, the percentage increase used to update the payment rates (or target amounts, as applicable) for FY 2024 for hospitals excluded from the inpatient prospective payment system is as follows:

• The percentage increase for long-term care hospitals is the LTCH market basket percentage increase reduced by the productivity adjustment (see section 1886(m)(3)(A) of the Act). In addition, these hospitals may also be impacted by the quality reporting adjustments and the site-neutral payment rates (see sections 1886(m)(5) and 1886(m)(6) of the Act).

• The percentage increase for inpatient rehabilitation facilities is the IRF market basket percentage increase reduced by the productivity adjustment in accordance with section 1886(j)(3)(C)(ii)(I) of the Act. In addition, these hospitals may also be impacted by the quality reporting adjustments (see section 1886(j)(7) of the Act).

• The percentage increase for inpatient psychiatric facilities is the IPF market basket percentage increase reduced by the productivity adjustment (see section 1886(s)(2)(A)(i) of the Act). In addition, these hospitals may also be impacted by the quality reporting adjustments (see section 1886(s)(4) of the Act).

• The percentage increase used to update the target amounts for other types of hospitals that are excluded from the inpatient prospective payment system and that are paid on a reasonable cost basis, subject to a rate-of-increase ceiling, is the IPPS operating market basket percentage increase, which is described at section 1886(b)(3)(B)(ii)(VIII) of the Act and 42 CFR 413.40(c)(3). These other types of hospitals include cancer hospitals, children's hospitals, extended neoplastic disease care hospitals, religious nonmedical health care institutions, and hospitals located outside the 50 states, the District of Columbia, and Puerto Rico.

The IPPS operating market basket percentage increase for FY 2024 is 3.3 percent and the productivity adjustment is 0.2 percentage point, as announced in the final rule that appeared in the Federal Register on August 28, 2023, entitled “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction” (88 FR 59035). Therefore, the percentage increase for hospitals paid under the inpatient prospective payment system that submit quality data and are meaningful EHR users is 3.1 percent (that is, the FY 2024 market basket update of 3.3 percent less the productivity adjustment of 0.2 percentage point). The average payment percentage increase for hospitals excluded from the inpatient prospective payment system is 3.35 percent. This average includes long-term care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, and other hospitals excluded from the inpatient prospective payment system. Weighting these percentages in accordance with payment volume, our best estimate of the payment-weighted average of the increases in the payment rates for FY 2024 is 3.13 percent.

To develop the adjustment to reflect changes in real case-mix, we first calculated an average case-mix for each hospital that reflects the relative costliness of that hospital's mix of cases compared with those of other hospitals. We then computed the change in average case-mix for hospitals paid under the Medicare inpatient prospective payment system in FY 2023 compared with FY 2022. (We excluded from this calculation hospitals whose payments are not based on the inpatient prospective payment system because their payments are based on alternate prospective payment systems or reasonable costs.) We used Medicare bills from prospective payment hospitals that we received as of July 2023. These bills represent a total of about 6.0 million Medicare discharges for FY 2023 and provide the most recent case-mix data available at this time. Based on these bills, the change in average case-mix in FY 2023 is −1.0 percent. Based on these bills and past experience, we expect the overall FY 2023 case mix change to be −1.0 percent as the year progresses and more FY 2023 data become available.

Section 1813 of the Act requires that the inpatient hospital deductible be adjusted only by that portion of the case mix change that is determined to be real. Real case-mix is that portion of case-mix that is due to changes in the mix of cases in the hospital and not due to coding optimization. COVID-19 has complicated the determination of real case-mix changes. COVID-19 cases typically have higher-weighted MS DRGs, which would cause a real increase in case-mix, while hospitals have experienced a reduction in the number of lower-weighted cases, which would also cause a real increase in case-mix. The lower number of COVID-19 cases in 2023 compared with the last several years would therefore mean a decrease in real case mix. Because of the uncertainty, we are assuming that all of the recently observed care is not due to coding optimization and that all of the −1.0 percent is real.

Thus, the estimate of the payment-weighted average of the applicable percentage increases used for updating the payment rates is 3.13 percent, and the real case-mix adjustment factor for the deductible is −1.0 percent. Accordingly, using the statutory formula as stated in section 1813(b) of the Act, we calculate the inpatient hospital deductible for services furnished in CY 2024 to be $1,632. This deductible amount is determined by multiplying $1,600 (the inpatient hospital deductible for CY 2023 (86 FR 64217)) by the payment-weighted average increase in the payment rates of 1.0313 multiplied by the decrease in real case-mix of 0.99, which equals $1,633.58 and is rounded to $1,632. (based on rounding to the nearest multiple of 4).

The coinsurance amounts provided for in section 1813 of the Act are defined as fixed percentages of the inpatient hospital deductible for services furnished in the same CY. The increase in the deductible generates increases in the coinsurance amounts. For inpatient hospital and extended care services furnished in CY 2024, in accordance with the fixed percentages defined in the law, the daily coinsurance for the 61st through 90th day of hospitalization in a benefit period will be $408 (one-fourth of the inpatient hospital deductible as stated in section 1813(a)(1)(A) of the Act); the daily coinsurance for lifetime reserve days will be $816 (one-half of the inpatient hospital deductible as stated in section 1813(a)(1)(B) of the Act); and the daily coinsurance for the 21st through 100th day of extended care services in a skilled nursing facility (SNF) in a benefit period will be $204 (one-eighth of the inpatient hospital deductible as stated in section 1813(a)(3) of the Act).

Table 1 summarizes the deductible and coinsurance amounts for CYs 2023 and 2024, as well as the number of each that is estimated to be paid.

The estimated total decrease in costs to beneficiaries is about $240 million (rounded to the nearest $10 million) because of (1) the increase in the deductible and coinsurance amounts and (2) the decrease in the number of deductibles and daily coinsurance amounts paid. We determine the decrease in cost to beneficiaries by calculating the difference between the CY 2023 and CY 2024 deductible and coinsurance amounts multiplied by the estimated decrease in the number of deductible and coinsurance amounts paid.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment prior to a rule taking effect in accordance with section 1871 of the Act and section 553(b) of the Administrative Procedure Act (APA). Section 1871(a)(2) of the Act provides that no rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under Medicare shall take effect unless it is promulgated through notice and comment rulemaking. Unless there is a statutory exception, section 1871(b)(1) of the Act generally requires the Secretary to provide for notice of a proposed rule in the Federal Register and provide a period of not less than 60 days for public comment before establishing or changing a substantive legal standard regarding the matters enumerated by the statute. Similarly, under 5 U.S.C. 553(b) of the APA, the agency is required to publish a notice of proposed rulemaking in the Federal Register before a substantive rule takes effect. Section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the advance notice and comment requirement and the delay in effective date requirements. Sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act also provide exceptions from the notice and 60-day comment period and the 30-day delay in effective date. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act expressly authorize an agency to dispense with notice and comment rulemaking for good cause if the agency makes a finding that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest.

The annual inpatient hospital deductible and the hospital and extended care services coinsurance amounts announcement set forth in this notice does not establish or change a substantive legal standard regarding the matters enumerated by the statute or constitute a substantive rule, which would be subject to the notice requirements in section 553(b) of the APA. However, to the extent that an opportunity for public notice and comment could be construed as required for this notice, we find good cause to waive this requirement.

Section 1813(b)(2) of the Act requires publication of the inpatient hospital deductible and the hospital and extended care services coinsurance amounts between September 1 and September 15 of the year preceding the year to which they will apply. Further, the statute requires that the agency determine and publish the inpatient hospital deductible and hospital and extended care services coinsurance amounts for each CY in accordance with the statutory formulas, and we are simply notifying the public of the changes to the deductible and coinsurance amounts for CY 2024. We have calculated the inpatient hospital deductible and hospital and extended care services coinsurance amounts as directed by the statute; the statute establishes both when the deductible and coinsurance amounts must be published and what information must be considered by the Secretary in establishing the deductible and coinsurance amounts, and therefore we do not have any discretion in that regard. We find notice and comment procedures to be unnecessary for this notice and we find good cause to waive such procedures under section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act, if such procedures may be construed to be required at all. Through this notice, we are simply notifying the public of the updates to the inpatient hospital deductible and the hospital and extended care services coinsurance amounts, in accordance with the statute, for CY 2024. As such, we note that even if notice and comment procedures were required for this notice, for the reasons stated above, we would find good cause to waive the delay in effective date of the notice, as additional delay would be contrary to the public interest under section 1871(e)(1)(B)(ii) of the Act. Publication of this notice is consistent with section 1813(b)(2) of the Act, and we believe that any potential delay in the effective date of the notice, if such delay were required at all, could cause unnecessary confusion both for the agency and Medicare beneficiaries.

This document does not impose information collection requirements—that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Although this notice does not constitute a substantive rule, we nevertheless prepared this Regulatory Impact Analysis section in the interest of ensuring that the impacts of this notice are fully understood.

This notice announces the Medicare Part A inpatient hospital deductible and associated coinsurance amounts for hospital and extended care services applicable for care provided in CY 2024, as required by section 1813 of the Act. It also responds to section 1813(b)(2) of the Act, which requires the Secretary to provide for publication of these amounts in the Federal Register between September 1 and September 15 of the year preceding the year to which they will apply. As this statutory provision prescribes a detailed methodology for calculating these amounts, we do not have the discretion to adopt an alternative approach on these issues.

We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094 entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The Executive Order 14094 entitled “Modernizing Regulatory Review” (hereinafter, the Modernizing E.O.) amends section 3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule (1) having an annual effect on the economy of $200 million or more in any 1 year (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product) or adversely affecting in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues, for which a centralized review would meaningfully further the President's priorities, or the principles set forth in this Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.

A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or significant effects as per section 3(f)(1) of Executive Order 12866 ($200 million or more in any 1 year). Based on our estimates OMB's Office of Information and Regulatory Affairs has determined that this rulemaking is significant per section 3(f)(1) as measured by the $200 million or more in any 1 year, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act).

As stated in section IV of this notice, we estimate that the total decrease in costs to beneficiaries associated with this notice is about $240 million because of (1) the increase in the deductible and coinsurance amounts and (2) the decrease in the number of deductibles and daily coinsurance amounts paid.

As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf ), in Table 2, we have prepared an accounting statement showing the estimated total decrease in costs to beneficiaries of about $240 million, which is due to the increase in the deductible and coinsurance amounts and the decrease in the number of deductibles and daily coinsurance amounts paid. As stated in section IV of this notice, we determined the decrease in cost to beneficiaries by calculating the difference between the CY 2023 and CY 2024 deductible and coinsurance amounts multiplied by the estimated decrease in the number of deductible and coinsurance amounts paid.

The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by being nonprofit organizations or by meeting the Small Business Administration's definition of a small business (having revenues of less than $9.0 million to $47 million in any 1 year). Individuals and states are not included in the definition of a small entity. This annual notice announces the Medicare Part A deductible and coinsurance amounts for CY 2024 and will have an impact on certain Medicare beneficiaries. As a result, we are not preparing an analysis for the RFA because the Secretary has certified that this notice will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This annual notice announces the Medicare Part A deductible and coinsurance amounts for CY 2024 and will have an impact on certain Medicare beneficiaries. As a result, we are not preparing an analysis for section 1102(b) of the Act because the Secretary has certified that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2023, that threshold is approximately $177 million. This notice will not impose a mandate that will result in the expenditure by state, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $177 million in any 1 year.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This notice will not have a substantial direct effect on state or local governments, preempt state law, or otherwise have Federalism implications.

This notice is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ) and has been transmitted to the Congress and the Comptroller General for review.

Part B is the voluntary portion of the Medicare program that pays all or part of the costs for physicians' services; outpatient hospital services; certain home health services; services furnished by rural health clinics, ambulatory surgical centers, and comprehensive outpatient rehabilitation facilities; and certain other medical and health services not covered by Medicare Part A, Hospital Insurance. Medicare Part B is available to individuals who are entitled to Medicare Part A, as well as to U.S. residents who have attained age 65 and are citizens and to non-citizens who were lawfully admitted for permanent residence and have resided in the United States for 5 consecutive years. Part B requires enrollment and payment of monthly premiums, as described in 42 CFR part 407, subpart B, and part 408, respectively. The premiums paid by (or on behalf of) all enrollees fund approximately one-fourth of the total incurred costs, and transfers from the general fund of the Treasury pay approximately three-fourths of these costs.

The Secretary of Health and Human Services (the Secretary) is required by section 1839 of the Social Security Act (the Act) to announce the Part B monthly actuarial rates for aged and disabled beneficiaries as well as the monthly Part B premium. The Part B annual deductible, income-related monthly adjustment amounts, and the immunosuppressive drug premium are included because their determinations are directly linked to the aged actuarial rate.

The monthly actuarial rates for aged and disabled enrollees are used to determine the correct amount of general revenue financing per beneficiary each month. These amounts, according to actuarial estimates, will equal, respectively, one-half of the expected average monthly cost of Part B for each aged enrollee (age 65 or over) and one-half of the expected average monthly cost of Part B for each disabled enrollee (under age 65).

The Part B deductible to be paid by enrollees is also announced. Prior to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), the Part B deductible was set in statute. After setting the 2005 deductible amount at $110.00, section 629 of the MMA (amending section 1833(b) of the Act) required that the Part B deductible be indexed beginning in 2006. The inflation factor to be used each year is the annual percentage increase in the Part B actuarial rate for enrollees age 65 and over. Specifically, the 2024 Part B deductible is calculated by multiplying the 2023 deductible by the ratio of the 2024 aged actuarial rate to the 2023 aged actuarial rate. The amount determined under this formula is then rounded to the nearest $1.00.

The monthly Part B premium rate to be paid by aged and disabled enrollees is also announced. (Although the costs to the program per disabled enrollee are different than for the aged, the statute provides that the two groups pay the same premium amount.) Beginning with the passage of section 203 of the Social Security Amendments of 1972 (Pub. L. 92-603), the premium rate, which was determined on a fiscal-year basis, was limited to the lesser of the actuarial rate for aged enrollees, or the current monthly premium rate increased by the same percentage as the most recent general increase in monthly Title II Social Security benefits.

However, the passage of section 124 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) suspended this premium determination process. Section 124 of TEFRA changed the premium basis to 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees). Section 606 of the Social Security Amendments of 1983 (Pub. L. 98-21), section 2302 of the Deficit Reduction Act of 1984 (DEFRA 84) (Pub. L. 98-369), section 93130 of the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA 85) (Pub. L. 99-272), section 4080 of the Omnibus Budget Reconciliation Act of 1987 (OBRA 87) (Pub. L. 100-203), and section 6301 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) (Pub. L. 101-239) extended the provision that the premium be based on 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees). This extension expired at the end of 1990.

The premium rate for 1991 through 1995 was legislated by section 1839(e)(1)(B) of the Act, as added by section 4301 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101-508). In January 1996, the premium determination basis would have reverted to the method established by the 1972 Social Security Act Amendments. However, section 13571 of the Omnibus Budget Reconciliation Act of 1993 (OBRA 93) (Pub. L. 103-66) changed the premium basis to 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees) for 1996 through 1998.

Section 4571 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) permanently extended the provision that the premium be based on 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees).

The BBA included a further provision affecting the calculation of the Part B actuarial rates and premiums for 1998 through 2003. Section 4611 of the BBA modified the home health benefit payable under Part A for individuals enrolled in Part B. Under this section, beginning in 1998, expenditures for home health services not considered “post-institutional” are payable under Part B rather than Part A. However, section 4611(e)(1) of the BBA required that there be a transition from 1998 through 2002 for the aggregate amount of the expenditures transferred from Part A to Part B. Section 4611(e)(2) of the BBA also provided a specific yearly proportion for the transferred funds. The proportions were one-sixth for 1998, one-third for 1999, one-half for 2000, two-thirds for 2001, and five-sixths for 2002. For the purpose of determining the correct amount of financing from general revenues of the Federal Government, it was necessary to include only these transitional amounts in the monthly actuarial rates for both aged and disabled enrollees, rather than the total cost of the home health services being transferred.

Section 4611(e)(3) of the BBA also specified, for the purpose of determining the premium, that the monthly actuarial rate for enrollees age 65 and over be computed as though the transition would occur for 1998 through 2003 and that one-seventh of the cost be transferred in 1998, two-sevenths in 1999, three-sevenths in 2000, four-sevenths in 2001, five-sevenths in 2002, and six-sevenths in 2003. Therefore, the transition period for incorporating this home health transfer into the premium was 7 years while the transition period for including these services in the actuarial rate was 6 years.

Section 811 of the MMA, which amended section 1839 of the Act, requires that, starting on January 1, 2007, the Part B premium a beneficiary pays each month be based on that individual's annual income. (The MMA specified that there be a 5-year transition period to reach full implementation of this provision. However, section 5111 of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) modified the transition to a 3-year period, which ended in 2009.) Specifically, if a beneficiary's modified adjusted gross income is greater than the legislated threshold amounts (for 2024, $103,000 for a beneficiary filing an individual income tax return and $206,000 for a beneficiary filing a joint tax return), the beneficiary is responsible for a larger portion of the estimated total cost of Part B benefit coverage. In addition to the standard 25-percent premium, these beneficiaries now have to pay an income-related monthly adjustment amount. The MMA made no change to the actuarial rate calculation, and the standard premium, which will continue to be paid by beneficiaries whose modified adjusted gross income is below the applicable thresholds, still represents 25 percent of the estimated total cost to the program of Part B coverage for an aged enrollee. However, depending on income and tax filing status, a beneficiary can now be responsible for 35, 50, 65, 80, or 85 percent of the estimated total cost of Part B coverage, rather than 25 percent. Section 402 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) modified the income thresholds beginning in 2018, and section 53114 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123) further modified the income thresholds beginning in 2019. For years beginning in 2019, the BBA of 2018 established a new income threshold. If a beneficiary's modified adjusted gross income is greater than or equal to $500,000 for a beneficiary filing an individual income tax return and $750,000 for a beneficiary filing a joint tax return, the beneficiary is responsible for 85 percent of the estimated total cost of Part B coverage. The BBA of 2018 specified that these new income threshold levels be inflation-adjusted beginning in 2028. The end result of the higher premium is that the Part B premium subsidy is reduced, and less general revenue financing is required, for beneficiaries with higher income because they are paying a larger share of the total cost with their premium. That is, the premium subsidy continues to be approximately 75 percent for beneficiaries with income below the applicable income thresholds, but it will be reduced for beneficiaries with income above these thresholds.

The Consolidated Appropriations Act, 2021 (Pub. L. 116-260) established a new basis for Medicare Part B eligibility for post-kidney-transplant immunosuppressive drug coverage only. Medicare eligibility due solely to end-stage renal disease generally ends 36 months after a successful kidney transplant. Beginning in 2023, post-kidney-transplant individuals without certain types of insurance coverage can elect to enroll in Part B and receive coverage of immunosuppressive drugs only. The premium for this continuation of coverage is 15 percent of a different aged actuarial rate, which is equal to 100 percent of costs for aged enrollees (rather than the standard aged actuarial rate, which is equal to one-half of the costs for aged enrollees). Enrollees paying the immunosuppressive premium are not subject to the late enrollment penalty and the $3.00 repayment amounts, but they are subject to the hold-harmless provision (described later) and the income-related monthly adjustment amounts. The law requires transfers equal to the reduction in aggregate premiums payable that results from enrollees with coverage only for immunosuppressive drugs paying the immunosuppressive drug Part B premium rather than the standard Part B premium. These transfers are to be treated as premiums payable for general revenue matching purposes.

Section 4732(c) of the BBA added section 1933(c) of the Act, which required the Secretary to allocate money from the Part B trust fund to the State Medicaid programs for the purpose of providing Medicare Part B premium assistance from 1998 through 2002 for the low-income Medicaid beneficiaries who qualify under section 1933 of the Act. This allocation, while not a benefit expenditure, was an expenditure of the trust fund and was included in calculating the Part B actuarial rates through 2002. For 2003 through 2015, the expenditure was made from the trust fund because the allocation was temporarily extended. However, because the extension occurred after the financing was determined, the allocation was not included in the calculation of the financing rates for these years. Section 211 of MACRA permanently extended this expenditure, which is included in the calculation of the Part B actuarial rates for 2016 and subsequent years.

Another provision affecting the calculation of the Part B premium is section 1839(f) of the Act, as amended by section 211 of the Medicare Catastrophic Coverage Act of 1988 (MCCA 88) (Pub. L. 100-360). (The Medicare Catastrophic Coverage Repeal Act of 1989 (Pub. L. 101-234) did not repeal the revisions to section 1839(f) of the Act made by MCCA 88.) Section 1839(f) of the Act, referred to as the hold-harmless provision, provides that, if an individual is entitled to benefits under section 202 or 223 of the Act (the Old-Age and Survivors Insurance Benefit and the Disability Insurance Benefit, respectively) and has the Part B premium deducted from these benefit payments, the premium increase will be reduced, if necessary, to avoid causing a decrease in the individual's net monthly payment. This decrease in payment occurs if the increase in the individual's Social Security benefit due to the cost-of-living adjustment under section 215(i) of the Act is less than the increase in the premium. Specifically, the reduction in the premium amount applies if the individual is entitled to benefits under section 202 or 223 of the Act for November and December of a particular year and the individual's Part B premiums for December and the following January are deducted from the respective month's section 202 or 223 benefits. The hold-harmless provision does not apply to beneficiaries who are required to pay an income-related monthly adjustment amount.

A check for benefits under section 202 or 223 of the Act is received in the month following the month for which the benefits are due. The Part B premium that is deducted from a particular check is the Part B payment for the month in which the check is received. Therefore, a benefit check for November is not received until December, but December's Part B premium has been deducted from it.

Generally, if a beneficiary qualifies for hold-harmless protection, the reduced premium for the individual for that January and for each of the succeeding 11 months is the greater of either—

• The monthly premium for January reduced as necessary to make the December monthly benefits, after the deduction of the Part B premium for January, at least equal to the preceding November's monthly benefits, after the deduction of the Part B premium for December; or

• The monthly premium for that individual for that December.

In determining the premium limitations under section 1839(f) of the Act, the monthly benefits to which an individual is entitled under section 202 or 223 of the Act do not include retroactive adjustments or payments and deductions on account of work. Also, once the monthly premium amount is established under section 1839(f) of the Act, it will not be changed during the year even if there are retroactive adjustments or payments and deductions on account of work that apply to the individual's monthly benefits.

Individuals who have enrolled in Part B late or who have re-enrolled after the termination of a coverage period are subject to an increased premium under section 1839(b) of the Act. The increase is a percentage of the premium and is based on the new premium rate before any reductions under section 1839(f) of the Act are made.

Section 1839 of the Act, as amended by section 601(a) of the Bipartisan Budget Act of 2015 (Pub. L. 114-74), specified that the 2016 actuarial rate for enrollees age 65 and older be determined as if the hold-harmless provision did not apply. The premium revenue that was lost by using the resulting lower premium (excluding the forgone income-related premium revenue) was replaced by a transfer of general revenue from the Treasury, which will be repaid over time to the general fund.

Similarly, section 1839 of the Act, as amended by section 2401 of the Continuing Appropriations Act, 2021 and Other Extensions Act (Pub. L. 116-159), specified that the 2021 actuarial rate for enrollees age 65 and older be determined as the sum of the 2020 actuarial rate for enrollees age 65 and older and one-fourth of the difference between the 2020 actuarial rate and the preliminary 2021 actuarial rate (as determined by the Secretary) for such enrollees. The premium revenue lost by using the resulting lower premium (excluding the forgone income-related premium revenue) was replaced by a transfer of general revenue from the Treasury, which will be repaid over time.

Starting in 2016, in order to repay the balance due (which includes the transfer amounts and the forgone income-related premium revenue from the Bipartisan Budget Act of 2015 and the Continuing Appropriations Act, 2021 and Other Extensions Act), the Part B premium otherwise determined will be increased by $3.00. These repayment amounts will be added to the Part B premium otherwise determined each year and will be paid back to the general fund of the Treasury, and they will continue until the balance due is paid back.

High-income enrollees pay the $3.00 repayment amount plus an additional $1.20, $3.00, $4.80, $6.60, or $7.20 in repayment as part of the income-related monthly adjustment amount (IRMAA) premium dollars, which reduce (dollar for dollar) the amount of general revenue received by Part B from the general fund of the Treasury. Because of this general revenue offset, the repayment IRMAA premium dollars are not included in the direct repayments made to the general fund of the Treasury from Part B in order to avoid a double repayment. (Only the $3.00 monthly repayment amounts are included in the direct repayments.)

These repayment amounts will continue until the balance due is zero. (In the final year of the repayment, the additional amounts may be modified to avoid an overpayment.) The repayment amounts (excluding those for high-income enrollees) are subject to the hold-harmless provision. The original balance due was $9,066,409,000, consisting of $1,625,761,000 in forgone income-related premium revenue plus a transfer amount of $7,440,648,000 from the provisions of the Bipartisan Budget Act of 2015. The increase in the balance due in 2021 was $8,799,829,000, consisting of $946,046,000 in forgone income-related premium income plus a transfer amount of $7,853,783,000 from the provisions of the Continuing Appropriations Act, 2021 and Other Extensions Act. An estimated $14,624,044,000 will have been repaid to the general fund by the end of 2023, with an estimated $3,242,194,000 remaining to be repaid.

The Medicare Part B monthly actuarial rates applicable for 2024 are $343.40 for enrollees age 65 and over and $427.20 for disabled enrollees under age 65. In section II.B. of this notice, we present the actuarial assumptions and bases from which these rates are derived. The Part B standard monthly premium rate for all enrollees for 2024 is $174.70. The Part B immunosuppressive drug premium is $103.00.

The following are the 2024 Part B monthly premium rates to be paid by (or on behalf of) beneficiaries with full Part B coverage who file either individual tax returns (and are single individuals, heads of households, qualifying widows or widowers with dependent children, or married individuals filing separately who lived apart from their spouses for the entire taxable year) or joint tax returns.

For beneficiaries with immunosuppressive drug only Part B coverage, who file either individual tax returns (and are single individuals, heads of households, qualifying widows or widowers with dependent children, or married individuals filing separately who lived apart from their spouses for the entire taxable year) or joint tax returns, the 2024 Part B monthly premium rates are shown below.

In addition, the monthly premium rates to be paid by (or on behalf of) beneficiaries with full Part B coverage who are married and lived with their spouses at any time during the taxable year, but who file separate tax returns from their spouses, are as follows:

The monthly premium rates to be paid by (or on behalf of) beneficiaries with immunosuppressive drug only Part B coverage who are married and lived with their spouses at any time during the taxable year, but who file separate tax returns from their spouses, are as follows:

The Part B annual deductible for 2024 is $240.00 for all beneficiaries.

Except where noted, the actuarial assumptions and bases used to determine the monthly actuarial rates and the monthly premium rates for Part B are established by the Centers for Medicare & Medicaid Services' Office of the Actuary. The estimates underlying these determinations are prepared by actuaries meeting the qualification standards and following the actuarial standards of practice established by the Actuarial Standards Board.

Under section 1839 of the Act, the starting point for determining the standard monthly premium is the amount that would be necessary to finance Part B on an incurred basis. This is the amount of income that would be sufficient to pay for services furnished during that year (including associated administrative costs) even though payment for some of these services will not be made until after the close of the year. The portion of income required to cover benefits not paid until after the close of the year is added to the trust fund and used when needed.

Because the premium rates are established prospectively, they are subject to projection error. Additionally, legislation enacted after the financing was established, but effective for the period in which the financing is set, may affect program costs. As a result, the income to the program may not equal incurred costs. Trust fund assets must therefore be maintained at a level that is adequate to cover an appropriate degree of variation between actual and projected costs, and the amount of incurred, but unpaid, expenses. Numerous factors determine what level of assets is appropriate to cover variation between actual and projected costs. For 2024, the four most important of these factors are (1) the impact of expected additional payments from the Part B account to 340B providers in response to a judicial remand order; (2) the difference from prior years between the actual performance of the program and estimates made at the time financing was established; (3) the likelihood and potential magnitude of expenditure changes resulting from enactment of legislation affecting Part B costs in a year subsequent to the establishment of financing for that year; and (4) the expected relationship between incurred and cash expenditures. The projected costs have a somewhat higher degree of uncertainty for 2024 due to the impact of the judicial remand order resulting in additional 340B drug payments. The other three factors are analyzed on an ongoing basis, as the trends can vary over time.

Table 1 summarizes the estimated actuarial status of the trust fund as of the end of the financing period for 2022 and 2023.

The monthly actuarial rate for enrollees age 65 and older is one-half of the sum of monthly amounts for (1) the projected cost of benefits and (2) administrative expenses for each enrollee age 65 and older, after adjustments to this sum to allow for interest earnings on assets in the trust fund and an adequate contingency margin. The contingency margin is an amount appropriate to provide for possible variation between actual and projected costs and to amortize any surplus assets or unfunded liabilities.

The monthly actuarial rate for enrollees age 65 and older for 2024 is determined by first establishing per enrollee costs by type of service from program data through 2021 and then projecting these costs for subsequent years. The projection factors used for financing periods from January 1, 2021 through December 31, 2024 are shown in Table 2.

As indicated in Table 3, the projected per enrollee amount required to pay for one-half of the total of benefits and administrative costs for enrollees age 65 and over for 2024 is $349.10. Based on current estimates, the assets at the end of 2023 are sufficient to cover the amount of incurred, but unpaid, expenses, to provide for substantial variation between actual and projected costs. Thus, a negative contingency margin can be included to decrease assets to a more appropriate level. The monthly actuarial rate of $343.40 provides an adjustment of −$3.30 for a contingency margin and −$2.40 for interest earnings.

The contingency margin for 2024 is affected by several factors. Additional payments to 340B drug providers from Part B are expected as a result of a judicial remand order. In the unique context of a pending rulemaking on remand from a court, we anticipate that additional 340B payments will reduce the surplus in 2024, resulting in a higher contingency margin. We also anticipate that, should we finalize proposed payment decreases in future years to providers, that would result in correspondingly lower Part B financing rates in those years. Another factor affecting Part B costs is the broader coverage for certain newly-approved drugs that treat Alzheimer's disease starting in July 2023. The broader coverage of these drugs results in a somewhat higher contingency margin. The Part B projected program costs were developed based on these assumptions and were included in the margin development.

In addition, starting in 2011, manufacturers and importers of brand-name prescription drugs pay a fee that is allocated to the Part B account of the SMI trust fund. For 2024, the total of these brand-name drug fees is estimated to be $2.8 billion. The contingency margin for 2024 has been reduced to account for this additional revenue.

The traditional goal for the Part B reserve has been that assets minus liabilities at the end of a year should represent between 15 and 20 percent of the following year's total incurred expenditures. To accomplish this goal, a 17-percent reserve ratio, which is a fully adequate contingency reserve level, has been the normal target used to calculate the Part B premium. At the end of 2023, the reserve ratio is expected to be 25.3 percent. When the reserve ratio is considerably higher than 20 percent, the typical approach in the premium determination is to target a gradual reduction in the reserve ratio to 20 percent over a number of years. The Secretary, who determines the Part B premium each year under section 1839 of the Act, directed the Office of the Actuary to use a 2024 premium increase of 5.9 percent, which targets a reserve ratio for the Part B premium determination of 22.6 percent by the end of 2024.

The actuarial rate of $343.40 per month for aged beneficiaries, as announced in this notice for 2024, reflects the combined effect of the factors and legislation previously described and the projected assumptions listed in Table 2.

Disabled enrollees are those persons under age 65 who are enrolled in Part B because of entitlement to Social Security disability benefits for more than 24 months or because of entitlement to Medicare under the end-stage renal disease (ESRD) program. Projected monthly costs for disabled enrollees (other than those with ESRD) are prepared in a manner parallel to the projection for the aged using appropriate actuarial assumptions (see Table 2). Costs for the ESRD program are projected differently because of the different nature of services offered by the program.

As shown in Table 4, the projected per enrollee amount required to pay for one-half of the total of benefits and administrative costs for disabled enrollees for 2024 is $436.36. The monthly actuarial rate of $427.20 also provides an adjustment of −$2.39 for interest earnings and −$6.77 for a contingency margin, reflecting the same factors and legislation described previously for the aged actuarial rate at magnitudes applicable to the disabled rate determination. Based on current estimates, the assets associated with the disabled Medicare beneficiaries at the end of 2023 are sufficient to cover the amount of incurred, but unpaid, expenses and to provide for a significant degree of variation between actual and projected costs.

The actuarial rate of $427.20 per month for disabled beneficiaries, as announced in this notice for 2024, reflects the combined net effect of the factors and legislation described previously for aged beneficiaries and the projection assumptions listed in Table 2.

Several factors contribute to uncertainty about future trends in medical care costs. It is appropriate to test the adequacy of the rates using alternative cost growth rate assumptions, the results of which are shown in Table 5. One set represents increases that are higher and, therefore, more pessimistic than the current estimate, and the other set represents increases that are lower and, therefore, more optimistic than the current estimate. The values for the alternative assumptions were determined from a statistical analysis of the historical variation in the respective increase factors.

As indicated in Table 5, the monthly actuarial rates would result in an excess of assets over liabilities of $128,583 million by the end of December 2024 under the cost growth rate assumptions shown in Table 2 and under the assumption that the provisions of current law are fully implemented. This result amounts to 21.9 percent of the estimated total incurred expenditures for the following year.

Assumptions that are somewhat more pessimistic (and that therefore test the adequacy of the assets to accommodate projection errors) produce a surplus of $64,240 million by the end of December 2024 under current law, which amounts to 9.7 percent of the estimated total incurred expenditures for the following year. Under fairly optimistic assumptions, the monthly actuarial rates would result in a surplus of $212,701 million by the end of December 2024, or 41.0 percent of the estimated total incurred expenditures for the following year.

The sensitivity analysis indicates that, in a typical year, the premium and general revenue financing established for 2024, together with existing Part B account assets, would be adequate to cover estimated Part B costs for 2024 under current law, should actual costs prove to be somewhat greater than expected.

As determined in accordance with section 1839 of the Act, the following are the 2024 Part B monthly premium rates to be paid by (or on behalf of) beneficiaries with full Part B coverage who file either individual tax returns (and are single individuals, heads of households, qualifying widows or widowers with dependent children, or married individuals filing separately who lived apart from their spouses for the entire taxable year) or joint tax returns.

For beneficiaries with immunosuppressive drug only Part B coverage who file either individual tax returns (and are single individuals, heads of households, qualifying widows or widowers with dependent children, or married individuals filing separately who lived apart from their spouses for the entire taxable year) or joint tax returns, the 2024 Part B monthly premium rates are shown below.

In addition, the monthly premium rates to be paid by (or on behalf of) beneficiaries with full Part B coverage who are married and lived with their spouses at any time during the taxable year, but who file separate tax returns from their spouses, are as follows:

The monthly premium rates to be paid by (or on behalf of) beneficiaries with immunosuppressive drug only Part B coverage who are married and lived with their spouses at any time during the taxable year, but who file separate tax returns from their spouses, are as follows:

The Part B annual deductible for 2024 is $240.00 for all beneficiaries.

This document does not impose information collection requirements—that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

This notice announces the monthly actuarial rates and premium rates, as required by section 1839(a) of the Act, and the annual deductible, as required by section 1833(b) of the Act, for beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2024. It also responds to section 1839(a)(1) of the Act, which requires the Secretary to provide for publication of these amounts in the Federal Register during the September that precedes the start of each calendar year. As section 1839 prescribes a detailed methodology for calculating these amounts, we do not have the discretion to adopt an alternative approach on these issues.

We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094 entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The Executive Order 14094 entitled “Modernizing Regulatory Review” (hereinafter, the Modernizing E.O.) amends section 3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a notice/rule: (1) having an annual effect on the economy of $200 million or more in any one year (adjusted every 3 years by the Administrator of OIRA for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities, or the principles set forth in the Executive Order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.

A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or with significant effects as per section 3(f)(1) ($200 million or more in any one year). Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is significant per section 3(f)(1) as measured by the $200 million threshold or more in any one year, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act). The 2024 standard Part B premium of $174.70 is $9.80 higher than the 2023 premium of $164.90. We estimate that the total premium increase, for the approximately 62 million Part B enrollees in 2024, will be $7.3 billion, which is an annual effect on the economy of $200 million or more. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking. Therefore, OMB has reviewed these proposed regulations, and the Departments have provided the following assessment of their impact.

As discussed earlier, this notice announces that the monthly actuarial rates applicable for 2024 are $343.40 for enrollees age 65 and over and $427.20 for disabled enrollees under age 65. It also announces the 2024 monthly Part B premium rates to be paid by (or on behalf of) beneficiaries with full Part B coverage who file either individual tax returns (and are single individuals, heads of households, qualifying widows or widowers with dependent children, or married individuals filing separately who lived apart from their spouses for the entire taxable year) or joint tax returns.

For beneficiaries with immunosuppressive drug only Part B coverage, who file either individual tax returns (and are single individuals, heads of households, qualifying widows or widowers with dependent children, or married individuals filing separately who lived apart from their spouses for the entire taxable year) or joint tax returns, the 2024 Part B monthly premium rates are announced and shown below.

In addition, the monthly premium rates to be paid by (or on behalf of) beneficiaries with full Part B coverage who are married and lived with their spouses at any time during the taxable year, but who file separate tax returns from their spouses, are also announced and listed in the following table:

The monthly premium rates to be paid by (or on behalf of) beneficiaries with immunosuppressive drug only Part B coverage who are married and lived with their spouses at any time during the taxable year, but who file separate tax returns from their spouses, are announced and listed in the following table:

As required by OMB Circular A-4 (available at www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf ), in Table 6 we have prepared an accounting statement showing the estimated aggregate Part B premium increase for all enrollees in 2024.

The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule or other regulatory document has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Individuals and States are not included in the definition of a small entity. This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under 65) beneficiaries enrolled in Part B of the Medicare SMI program beginning January 1, 2024. Also, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. As a result, we are not preparing an analysis for the RFA because the Secretary has determined that this notice will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule or other regulatory document may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. As we discussed previously, we are not preparing an analysis for section 1102(b) of the Act because the Secretary has determined that this notice will not have a significant effect on a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. In 2023, that threshold is approximately $177 million. Part B enrollees who are also enrolled in Medicaid have their monthly Part B premiums paid by Medicaid. The cost to each State Medicaid program from the 2024 premium increase is estimated to be more than the threshold. This notice does not impose mandates that will have a consequential effect of the threshold amount or more on State, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it publishes a proposed rule or other regulatory document (and subsequent final rule or other regulatory document) that imposes substantial direct compliance costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have determined that this notice does not significantly affect the rights, roles, and responsibilities of States. Accordingly, the requirements of Executive Order 13132 do not apply to this notice.

In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment prior to a rule taking effect in accordance with section 1871 of the Act and section 553(b) of the Administrative Procedure Act (APA). Section 1871(a)(2) of the Act provides that no rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under Medicare shall take effect unless it is promulgated through notice and comment rulemaking. Unless there is a statutory exception, section 1871(b)(1) of the Act generally requires the Secretary of the Department of Health and Human Services (the Secretary) to provide for notice of a proposed rule in the Federal Register and provide a period of not less than 60 days for public comment before establishing or changing a substantive legal standard regarding the matters enumerated by the statute. Similarly, under 5 U.S.C. 553(b) of the APA, the agency is required to publish a notice of proposed rulemaking in the Federal Register before a substantive rule takes effect. Section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the advance notice and comment requirement and the delay in effective date requirements. Sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act also provide exceptions from the notice and 60-day comment period and the 30-day delay in effective date. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act expressly authorize an agency to dispense with notice and comment rulemaking for good cause if the agency makes a finding that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest.

The annual updated amounts for the Part B monthly actuarial rates for aged and disabled beneficiaries, the Part B premium, and the Part B deductible set forth in this notice do not establish or change a substantive legal standard regarding the matters enumerated by the statute or constitute a substantive rule that would be subject to the notice requirements in section 553(b) of the APA. However, to the extent that an opportunity for public notice and comment could be construed as required for this notice, we find good cause to waive this requirement.

Section 1839 of the Act requires the Secretary to determine the monthly actuarial rates for aged and disabled beneficiaries, as well as the monthly Part B premium (including the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts), for each calendar year in accordance with the statutory formulae, in September preceding the year to which they will apply. Further, the statute requires that the agency promulgate the Part B premium amount, in September preceding the year to which it will apply, and include a public statement setting forth the actuarial assumptions and bases employed by the Secretary in arriving at the amount of an adequate actuarial rate for enrollees age 65 and older. We include the Part B annual deductible, which is established in accordance with a specific formula described in section 1833(b) of the Act, because the determination of the amount is directly linked to the rate of increase in actuarial rate under section 1839(a)(1) of the Act. We have calculated the monthly actuarial rates for aged and disabled beneficiaries, the Part B deductible, and the monthly Part B premium as directed by the statute; since the statute establishes both when the monthly actuarial rates for aged and disabled beneficiaries and the monthly Part B premium must be published and the information that the Secretary must factor into those amounts, we do not have any discretion in that regard. We find notice and comment procedures to be unnecessary for this notice, and we find good cause to waive such procedures under section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act, if such procedures may be construed to be required at all. Through this notice, we are simply notifying the public of the updates to the monthly actuarial rates for aged and disabled beneficiaries and the Part B deductible, as well as the monthly Part B premium amounts and the income-related monthly adjustment amounts to be paid by certain beneficiaries, in accordance with the statute, for CY 2024. As such, we also note that even if notice and comment procedures were required for this notice, we would find good cause, for the previously stated reason, to waive the delay in effective date of the notice, as additional delay would be contrary to the public interest under section 1871(e)(1)(B)(ii) of the Act. Publication of this notice is consistent with section 1839 of the Act, and we believe that any potential delay in the effective date of the notice, if such delay were required at all, could cause unnecessary confusion for both the agency and Medicare beneficiaries.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on October 11, 2023.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Organ Procurement Organization (OPO) Request for Designation as an OPO, Health Insurance Benefits Agreement, and Supporting Regulations; Use: We are seeking reinstatement of a revised version of the CMS-576 form. We are also seeking reinstatement for the CMS-576A form. The CMS-576 and CMS-576A forms have been updated to a fillable .pdf format. In addition, multiple changes were made to the CMS-576 and CMS-576A forms.

Organizations seeking designation from CMS as a qualified and approved Organ Procurement Organization (OPO), as per §§ 371(a) and 1138 of the Social Security Act (“the Act”) must complete and submit the CMS-576 form. After designation as an OPO, the organization must sign CMS-576A form in order to be reimbursed by Medicare for their services. The CMS-576A form requires the OPO “to maintain compliance with the requirements of titles XVIII and XIX of the Act, § 1138 of the Act, applicable regulations including the conditions set forth in Part 486, subpart G, title 42 of the Code of Federal Regulations, those conditions of the Organ Procurement and Transplantation Network established under § 372 of the Public Health Service Act that have been approved by the Secretary, and to report promptly to CMS. Form Number: CMS-576 and 576A (OMB Control Number: 0938-0512); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 16; Total Annual Responses: 16; Total Annual Hours: 32. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.)

Section 1818 of the Social Security Act (the Act) provides for voluntary enrollment in the Medicare Hospital Insurance (Part A) program, subject to payment of a monthly premium, of certain persons aged 65 and older who are uninsured under the Old-Age, Survivors, and Disability Insurance (OASDI) program or the Railroad Retirement Act and do not otherwise meet the requirements for entitlement to Part A. These “uninsured aged” individuals are uninsured under the OASDI program or the Railroad Retirement Act because they do not have 40 quarters of coverage under Title II of the Act (or are/were not married to someone who did). (Persons insured under the OASDI program or the Railroad Retirement Act and certain others do not have to pay premiums for Part A.)

Section 1818A of the Act provides for voluntary enrollment in Medicare Part A, subject to payment of a monthly premium, for certain individuals with disabilities who have exhausted other entitlement. These are individuals who were entitled to coverage due to a disabling impairment under section 226(b) of the Act but who are no longer entitled to disability benefits and premium-free Part A coverage because they have gone back to work and their earnings exceed the statutorily defined “substantial gainful activity” amount (section 223(d)(4) of the Act).

Section 1818A(d)(2) of the Act specifies that the provisions relating to premiums for the aged, under section 1818(d) through section 1818(f), will also apply to certain individuals with disabilities, as described above.

Section 1818(d)(1) of the Act requires us to estimate, on an average per capita basis, the amount to be paid from the Federal Hospital Insurance Trust Fund for services incurred in the upcoming calendar year (CY) (including the associated administrative costs) on behalf of individuals aged 65 and over who will be entitled to benefits under Part A. We must then determine the monthly actuarial rate for the following year (the per capita amount estimated above divided by 12) and publish the dollar amount for the monthly premium in the succeeding CY. If the premium is not a multiple of $1, it is rounded to the nearest multiple of $1 (or, if it is a multiple of 50 cents but not of $1, it is rounded to the next highest $1).

Section 13508 of the Omnibus Budget Reconciliation Act of 1993 (Pub. L. 103-66) amended section 1818(d) of the Act to provide for a reduction in the premium amount for certain voluntary enrollees (sections 1818 and 1818A). The reduction applies to an individual who is eligible to buy into the Part A program and who, as of the last day of the previous month:

• Had at least 30 quarters of coverage under Title II of the Act;

• Was married, and had been married for the previous 1-year period, to a person who had at least 30 quarters of coverage;

• Had been married to a person for at least 1 year at the time of the person's death if, at the time of death, the person had at least 30 quarters of coverage; or

• Is divorced from a person who at the time of divorce had at least 30 quarters of coverage if the marriage lasted at least 10 years.

Section 1818(d)(4)(A) of the Act specifies that the premium that these individuals will pay for CY 2024 will be equal to the premium for uninsured aged enrollees reduced by 45 percent.

Section 1818(g) of the Act requires the Secretary of Health and Human Services (the Secretary), at the request of a state, to enter into a Medicare Part A buy-in agreement with the state to pay Part A premiums for Qualified Medicare Beneficiaries (QMBs). 1 Under the QMB eligibility group, state Medicaid agencies must pay the Part A premium for those not eligible for premium-free Part A, if those individuals meet all of the eligibility requirements for the QMB eligibility group under the state's Medicaid state plan. (Entering into a Part A buy-in agreement would permit states to avoid any Part A late enrollment penalties that individuals may owe and would allow states to enroll persons in Part A at any time of the year, without regard to Medicare enrollment periods.) Other individuals may be eligible for the Qualified Disabled and Working Individuals (QDWIs) eligibility group, through which state Medicaid programs provide coverage for the Part A premiums for individuals who are eligible to enroll in Part A by virtue of section 1818A of the Act and meet certain financial eligibility criteria.

The monthly premium for the uninsured aged and certain individuals with disabilities who have exhausted other entitlement, for the 12 months beginning January 1, 2024, is $505. The monthly premium for the individuals who are eligible under section 1818(d)(4)(B) of the Act, and who are therefore subject to the 45-percent reduction in the monthly premium, is $278.

As discussed in section I of this notice, the monthly Medicare Part A premium is equal to the estimated monthly actuarial rate for CY 2024 rounded to the nearest multiple of $1 and equals one-twelfth of the average per capita amount, which is determined by projecting the number of Part A enrollees aged 65 years and over, as well as the benefits and administrative costs that will be incurred on their behalf.

The steps involved in projecting these future costs to the Federal Hospital Insurance Trust Fund are as follows:

• Establishing the present cost of services furnished to beneficiaries, by type of service, to serve as a projection base;

• Projecting increases in payment amounts for each of the service types; and

• Projecting increases in administrative costs.

We base our projections for CY 2024 on (1) current historical data and (2) projection assumptions derived from current law and the President's Fiscal Year 2024 Budget.

For CY 2024, we estimate that 59,121,430 people aged 65 years and over will be entitled to (enrolled in) benefits (without premium payment) and that they will incur about $358,251 billion in benefits and related administrative costs. Thus, the estimated monthly average per capita amount is $504.97, and the monthly premium is $505. Subsequently, the full monthly premium reduced by 45 percent is $278.

The CY 2024 premium of $505 is approximately 0.2 percent lower than the CY 2023 premium of $506. We estimate that approximately 729,000 enrollees will voluntarily enroll in Medicare Part A by paying the full premium and that over 90 percent of these individuals will have their Part A premium paid for by states, since they are entitled to Part A and enrolled in the QMB program eligibility group. Furthermore, the CY 2024 reduced premium is the same as for CY 2023, at $278, and we estimate that an additional 94,000 enrollees will pay this premium. Therefore, for enrollees paying these premiums in CY 2024, we estimate that the total aggregate savings, compared with the amount that they paid in CY 2023, will be about $9 million.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment prior to a rule taking effect in accordance with section 1871 of the Act and section 553(b) of the Administrative Procedure Act (APA). Section 1871(a)(2) of the Act provides that no rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under Medicare shall take effect unless it is promulgated through notice and comment rulemaking. Unless there is a statutory exception, section 1871(b)(1) of the Act generally requires the Secretary to provide for notice of a proposed rule in the Federal Register and provide a period of not less than 60 days for public comment before establishing or changing a substantive legal standard regarding the matters enumerated by the statute. Similarly, under 5 U.S.C. 553(b) of the APA, the agency is required to publish a notice of proposed rulemaking in the Federal Register before a substantive rule takes effect. Section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the advance notice and comment requirement and the delay in effective date requirements. Sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act also provide exceptions from the notice and 60-day comment period and the 30-day delay in effective date. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act expressly authorize an agency to dispense with notice and comment rulemaking for good cause if the agency makes a finding that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest.

The annual Medicare Part A premium announcement set forth in this notice does not establish or change a substantive legal standard regarding the matters enumerated by the statute or constitute a substantive rule that would be subject to the notice requirements in section 553(b) of the APA. However, to the extent that an opportunity for public notice and comment could be construed as required for this notice, we find good cause to waive this requirement.

Section 1818(d) of the Act requires the Secretary, during September of each year, to determine and publish the amount to be paid, on an average per capita basis, from the Federal Hospital Insurance Trust Fund for services incurred in the impending CY (including the associated administrative costs) on behalf of individuals aged 65 and over who will be entitled to benefits under Part A. Further, the statute requires that the agency determine the applicable premium amount for each CY in accordance with the statutory formula. In this notice, we are simply notifying the public of the changes to the Part A premiums for CY 2024. We have calculated the Part A premiums as directed by the statute, which establishes both when the premium amounts must be published and what information must be factored by the Secretary into these amounts; we do not have any discretion in that regard. We find notice and comment procedures to be unnecessary for this notice, and we find good cause to waive such procedures under section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act, if such procedures may be construed to be required at all. Through this notice, we are simply notifying the public of the updates to the Part A premiums, in accordance with the statute, for CY 2024. As such, we also note that even if notice and comment procedures were required for this notice, for the reasons stated above we would find good cause to waive the delay in effective date of the notice, as additional delay would be contrary to the public interest under section 1871(e)(1)(B)(ii) of the Act. Publication of this notice is consistent with section 1818(d) of the Act, and we believe that any potential delay in the effective date of the notice, if such delay were required at all, could cause unnecessary confusion for both the agency and Medicare beneficiaries.

This document does not impose information collection requirements—that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Although this notice does not constitute a substantive rule, we nevertheless prepared this Regulatory Impact Analysis section in the interest of ensuring that the impacts of this notice are fully understood.

This notice announces the CY 2024 Medicare Part A premiums for the uninsured aged and for certain disabled individuals who have exhausted other entitlement, as required by sections 1818 and 1818A of the Act. It also responds to section 1818(d) of the Act, which requires the Secretary to provide for publication of these amounts in the Federal Register during the September that precedes the start of each CY. As this statutory provision prescribes a detailed methodology for calculating these amounts, we do not have the discretion to adopt an alternative approach on these issues.

We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993); Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011); Executive Order 14094 entitled “Modernizing Regulatory Review” (April 6, 2023); the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354); section 1102(b) of the Social Security Act; section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4); Executive Order 13132 on Federalism (August 4, 1999); and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 14094, “Modernizing Regulatory Review,” amends section 3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule (1) having an annual effect on the economy of $200 million or more in any 1 year (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product) or adversely affecting in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues, for which centralized review would meaningfully further the President's priorities or the principles set forth in this Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.

A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory action/s and/or with significant effects as per section 3(f)(1) of Executive Order 12866 ($200 million or more in any 1 year). Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined that this rulemaking is not significant and not major under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act).

As stated in section IV of this notice, we estimate that the overall effect of the changes in the Medicare Part A premium will be a savings to voluntary enrollees (sections 1818 and 1818A of the Act) of about $9 million.

As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf ), in the Table below we have prepared an accounting statement showing the total aggregate savings to enrollees paying premiums in CY 2024, compared with the amount that they paid in CY 2023. The amount of savings will be about $9 million. As stated in section IV of this notice, the CY 2024 premium of $505 is approximately 0.2 percent lower than the CY 2023 premium of $506. We estimate that approximately 729,000 enrollees will voluntarily enroll in Medicare Part A by paying the full premium and that over 90 percent of these individuals will have their Part A premium paid for by states, since they are enrolled in the QMB eligibility group. Furthermore, the CY 2024 reduced premium of $278 is the same as for CY 2023.

The Regulatory Flexibility Act (RFA) requires agencies to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by being nonprofit organizations or by meeting the Small Business Administration's definition of a small business (having revenues of less than $9.0 million to $47 million in any 1 year). Individuals and states are not included in the definition of a small entity. This annual notice announces the Medicare Part A premiums for CY 2024 and will have an impact on certain Medicare beneficiaries. As a result, we are not preparing an analysis for the RFA because the Secretary has certified that this notice will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare a RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This annual notice announces the Medicare Part A premiums for CY 2024 and will have an impact on certain Medicare beneficiaries. As a result, we are not preparing an analysis for section 1102(b) of the Act because the Secretary has certified that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2023, that threshold is approximately $177 million. This notice would not impose a mandate that will result in expenditures by state, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $177 million in any 1 year.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. This notice will not have a substantial direct effect on state or local governments, preempt state law, or otherwise have Federalism implications.

This final regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ) and has been transmitted to the Congress and the Comptroller General for review.

Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on October 11, 2023.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Extension of a currently approved Information Collection; Title of Information Collection: Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey for Merit-based Incentive Payment Systems (MIPS); Use: The CAHPS for MIPS survey is used in the Quality Payment Program (QPP) to collect data on fee-for-service Medicare beneficiaries' experiences of care with eligible clinicians participating in MIPS and is designed to gather only the necessary data that CMS needs for assessing physician quality performance, and related public reporting on physician performance, and should complement other data collection efforts. The survey consists of the core Agency for Healthcare Research and Quality (AHRQ) CAHPS Clinician & Group Survey, version 3.0, plus additional survey questions to meet CMS's information and program needs. The survey information is used for quality reporting, the compare tool on the Medicare.gov website, and annual statistical experience reports describing MIPS data for all MIPS eligible clinicians.

This 2024 information collection request addresses the requirements related to the statutorily required quality measurement. The CAHPS for MIPS survey results in burden to three different types of entities: groups, virtual groups, and subgroups; vendors; and beneficiaries associated with administering the survey. Virtual groups are subject to the same requirements as groups and subgroups; therefore, we will refer only to “groups” as an inclusive term for all entities unless otherwise noted. Form Number: CMS-10450 (OMB control number: 0938-1222); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profit institutions and Individuals and Households; Number of Respondents: 25,536; Total Annual Responses: 25,536; Total Annual Hours: 5,867 (For policy questions regarding this collection contact Renee Oneill at 410-786-8821.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Review and Approval Process for Waivers for State Innovation; Use: The information required under this collection is necessary to ensure that states comply with statutory and regulatory requirements related to the development and implementation of section 1332 waivers. States seeking waiver authority under section 1332 of the ACA are required to meet certain requirements for applications, public notice, and reporting. The authority for these requirements is found in section 1332 of the ACA. This information collection reflects the requirements provided in the final rules published in February 2012 (77 FR 11700) and September 2021 (86 FR 3412).

On October 24, 2018, the Departments published guidance (86 FR 53575) that provided supplementary information about the requirements that must be met for the approval of a section 1332 waiver, the Secretaries' application review procedures, the calculation of pass-through funding, certain analytical requirements, and operational considerations. However, the September 2021 final rule superseded and rescinded policies and interpretations outlined in the 2018 guidance and repealed the previous codification of the interpretations of the statutory guardrails in part 1 of the 2022 Payment Notice final rule (86 FR 6138). The September 2021 final rule (86 FR 53412) finalized modifications to section 1332 waiver implementing regulations, including changes to many of the policies and interpretations of the statutory guardrails codified in regulation. In addition, the September 2021 final rule modified regulations to provide flexibilities in the public notice requirements and post-award public participation requirements for section 1332 waivers under certain future emergent situations. The final rule also provided new information regarding the processes and procedures for amendments and extensions for approved waiver plans. Form Number: CMS-10383 (OMB Control Number 0938-1389; Frequency: Occasionally; Affected Public: State Governments; Number of Respondents: 19; Total Annual Responses: 399; Total Annual Hours: 5,549. (For policy questions regarding this collection contact Lina Rashid at 301-492-4193.)

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Use: The data collection and reporting requirements in “Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions” (78 FR 39494 (July 1, 2013)), address federal requirements that states must meet with regard to the Exchange minimum function of performing eligibility determinations and issuing certificates of exemption from the shared responsibility payment. In the final regulation, CMS addresses standards related to eligibility, including the verification and eligibility determination process, eligibility redeterminations, options for states to rely on HHS to make eligibility determinations for certificates of exemption, and reporting. CMS developed four appendices of application materials to illustrate the process applicants use to apply for exemptions from the shared responsibility payment. This information collection requests seeks approval for the requirements associated with the collection of information associated with these four appendices. Form Number: CMS-10466 (OMB Control Number 0938-1190; Frequency: Annually; Affected Public: Individuals and Households—State, Local, or Tribal Governments; Number of Respondents: 849; Total Annual Responses: 849; Total Annual Hours: 1,962. (For policy questions regarding this collection contact John Kenna at 301-492-4452.)

Description: The FCR is a national database of information pertaining to child support cases processed by state child support agencies, referred to as “IV-D” cases, and non-IV-D support orders privately established or modified by courts or tribunals on or after October 1, 1998. FCR information is comprised of child support orders and case information from each State Case Registry (SCR). The FCR automatically compares new SCR submissions to existing FCR information and to wage and employment information in the National Directory of New Hires. The Federal Parent Locator Service notifies state agencies if a IV-D case participant in the state matches a participant in a IV-D or non-IV-D case in another state and supplies any matched wage and employment information. Matches enable state agencies to locate parties that live in different states to establish, modify, or enforce child support obligations; to establish paternity; to enforce state law regarding parental kidnapping; and to establish or enforce child custody or visitation determinations.

The FCR instrument, Appendix G: Input Record Layout, contains minor changes in punctuation, formatting, grammar, clarity, and spacing to enable easier completion of the form.

Respondents: State child support enforcement agencies.

Estimated Total Annual Burden Hours: 730.

Authority: 42 U.S.C. 653(h); 42 U.S.C. 654a(e); 42 U.S.C. 654a(f)(1).

FDA is announcing the availability of a final guidance for industry entitled “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol (collectively “pharmaceutical alcohol”) contaminated with or substituted with methanol. During the COVID-19 PHE, FDA became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol. FDA is concerned that other drug products containing pharmaceutical alcohol, which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination.

This guidance outlines a policy intended to help pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in compounding avoid the use of pharmaceutical alcohol that is contaminated with or substituted with methanol in drug products. The policy outlined in the guidance includes, but is not limited to: (1) performing a specific identity test that includes a limit test for methanol on each container within each shipment of each lot of pharmaceutical alcohol before the component is used in the manufacture or preparation of drug products; (2) knowing the entities in pharmaceutical manufacturers' supply chain for pharmaceutical alcohol ( i.e., knowing the identities and appropriately qualifying the manufacturer of the pharmaceutical alcohol and any subsequent distributor(s)); (3) ensuring that all personnel in pharmaceutical manufacturing facilities (especially personnel directly responsible for receipt, testing, and release of pharmaceutical alcohol) are made aware of the importance of proper testing and the potential hazards if the testing is not done; and (4) establishing finished-product test methods to ensure that when testing for ethanol or isopropyl alcohol content (assay), the method also distinguishes between the active ingredient and methanol. The policy outlined in this guidance applies to pharmaceutical alcohols used as an active or inactive ingredient in a drug.

This guidance replaces the guidance entitled “Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)” posted in January 2021 and announced in the Federal Register on February 23, 2021 (86 FR 10977) (hereafter “2021 COVID-19 Methanol Guidance”). FDA issued the guidance to communicate its policy for the duration of the COVID-19 PHE declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). As stated in the 2021 guidance, at such time when the PHE was over, as declared by the HHS Secretary, FDA intended to reassess the guidance. Furthermore, in the Federal Register of March 13, 2023 (88 FR 15417), FDA listed the guidance documents that will no longer be effective with the expiration of the PHE declaration, guidances that FDA was revising to continue in effect for 180 days after the expiration of the PHE declaration to provide a period for stakeholder transition and then would no longer be in effect, and guidances that FDA was revising to continue in effect for 180 days after the expiration of the PHE declaration during which time FDA planned to further revise the guidances. The 2021 COVID-19 Methanol Guidance is included in the latter category. Although the COVID-19 PHE ended May 11, 2023, FDA has determined that the recommendations set forth in the 2021 COVID-19 Methanol Guidance are applicable outside the context of the COVID-19 PHE. FDA is, therefore, issuing this revised final guidance, which will supersede the current guidance. In preparing this guidance, FDA considered comments received regarding the 2021 guidance, as well as the Agency's experience with this matter during the PHE. Updates to this guidance include removal of certain language regarding the COVID-19 PHE, as well as removal of language related to the three hand sanitizer guidance documents that have since been withdrawn.

This guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115 (21 CFR 10.115)) without initially seeking prior comment because the Agency has determined that prior public participation is not feasible or appropriate (see § 10.115(g)(2) and section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))). Specifically, we are not seeking prior comment because, although the COVID-19 PHE has ended, the use of hand sanitizers and other drug products containing pharmaceutical alcohol remains widespread. Given the serious risks to public health, including blindness and death, that can result from methanol contamination, it is thus important to public health to continue to apply the policy described in the guidance, which encourages stringent and continued oversight of such products for the possible presence of methanol.

The guidance represents the current thinking of FDA on “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR parts 210 and 211 have been approved under OMB control number 0910-0139.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs , https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics , https://www.fda.gov/regulatory-information/search-fda-guidance-documents , or https://www.regulations.gov .

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, are the subject of NDA 020781, held by Sandoz Inc., and initially approved on January 27, 1999. ZOFRAN ODT is indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 ; initial and repeat courses of moderately emetogenic cancer chemotherapy; and radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ZOFRAN ODT is also indicated for the prevention of postoperative nausea and/or vomiting.

ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, are currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Sun Pharmaceutical Industries Limited submitted a citizen petition dated August 24, 2023 (Docket No. FDA-2023-P-3682), under 21 CFR 10.30, requesting that the Agency determine whether ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, were withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

FDA is announcing the availability of a draft guidance for industry entitled “Diabetic Foot Infections: Developing Drugs for Treatment.”

The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of DFI without concomitant bone and joint involvement. Specifically, this guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drugs to support an indication for treatment of DFI.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Diabetic Foot Infections: Developing Drugs for Treatment.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014. The collections of information in 21 CFR 201.56 and 201.57 relating to prescription product labeling requirements have been approved under OMB control number 0910-0572.

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents , or https://www.regulations.gov .

Intended Recipient of the Award: The University of Kentucky.

Amount of Non-Competitive Award: One award for $250,000.

Project Period: September 1, 2023, to August 31, 2024.

CFDA Number: 93.155.

Award Instrument: Supplement.

Authority: Social Security Act section 711(b) (42 U.S.C. 912(b)).

Justification: This funding will provide a one-time supplement to the University of Kentucky via the Rural Health and Economic Development Analysis Program with a budget period of September 2023 through August 2024. This supplement will allow the University of Kentucky to build on past and ongoing projects supported by HRSA to improve health care in rural areas by advancing the knowledge base regarding the economic impacts of local health care sectors on rural economies.

Since 1980, Healthy People has provided a comprehensive set of national health promotion and disease prevention objectives with 10-year targets aimed at improving the health of all. Healthy People 2030 objectives present a picture of the nation's health at the beginning of the decade, establish national goals and targets to be achieved by the year 2030, and monitor progress over time. The U.S. Department of Health and Human Services (HHS) is soliciting the submission of written comments regarding the current Healthy People 2030 objectives. The public is also invited to submit proposals for additional new core, developmental, or research objectives that meet the criteria outlined below.

Healthy People 2030 is the product of an extensive collaborative process that relies on input from a diverse array of individuals and organizations, both within and outside the Federal Government, with a common interest in improving the nation's health. Public comments were a cornerstone of Healthy People 2030's development. During the first phase of planning for Healthy People 2030, HHS asked for the public's comments on the initiative's vision, mission, and overarching goals. Those comments helped set the framework for Healthy People 2030. The public was also invited to submit comments on proposed Healthy People 2030 objectives, which helped shape the current set of Healthy People 2030 objectives. HHS most recently solicited comments on one new objective during the 2022 public comment period from October 24, 2022, through December 2, 2022, and three new proposed objectives during the 2021 public comment period from December 3, 2021, through January 10, 2022. These new objectives, which were developed by Healthy People 2030 subject matter experts, meet specific criteria, and reflect public input, are now accessible on https://health.gov/healthypeople.

While there are no new objectives being proposed at this time, the public is invited to provide comment on the current Healthy People 2030 objectives and propose additional core, developmental, or research objectives for consideration that address critical public health issues. Proposed new objectives must meet all the objective selection criteria (see below). The public is also invited to propose new topics to be considered for inclusion in Healthy People 2030.

Core objectives must meet the following five criteria to be included in Healthy People 2030. Core objectives should (1) have a reliable, nationally representative data source with baseline data no older than 2015; (2) have at least two additional data points beyond the baseline during the decade; (3) be of national importance; (4) have effective, evidence-based interventions available to achieve the objective; and (5) have data to help address disparities and achieve health equity.

Developmental objectives will have the following characteristics: (1) represent high priority issues; (2) do not have reliable baseline data yet; and (3) have evidence-based interventions available.

Research objectives will have the following characteristics: (1) represent key opportunities to make progress in areas with limited prior research, a high health or economic burden, or significant disparities between population groups; (2) may or may not have reliable baseline data; and (3) do not have evidence-based interventions available.

Written comments and evidence-based information should be submitted by email to HP2030Comment@hhs.gov by 11:59 p.m. ET on November 20, 2023. Comments received in response to this notice will be reviewed and considered by the Healthy People topic area workgroups, Federal Interagency Workgroup on Healthy People 2030, and other Federal subject matter experts.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Crew Member's Declaration.

OMB Number: 1651-0021.

Form Number: 5129.

Current Actions: Extension without change to the collection.

Type of Review: Extension (without change).

Affected Public: Individuals.

Abstract: CBP Form 5129, Crew Member's Declaration, is a declaration made by crew members listing all goods acquired abroad which are in their possession at the time of arrival in the United States. The data collected on CBP Form 5129 is used for compliance with currency reporting requirements, supplemental immigration documentation, agricultural quarantine matters, and the importation of merchandise by crew members who complete the individual declaration. This form is authorized by 19 U.S.C. 1431 and provided for by 19 CFR 4.7, 4.7a, 4.81, 122.83, 122.84, and 148.61-148.67. CBP Form 5129 is accessible at https://www.cbp.gov/document/forms/form-5129-crew-members-declaration-and-instructions.

Type of Information Collection: Crew Member's Declaration (Form 5129).

Estimated Number of Respondents: 6,000,000.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 6,000,000.

Estimated Time per Response: 10 minutes (0.166 hours).

Estimated Total Annual Burden Hours: 996,000.

The Community Rating System (CRS), codified by the National Flood Insurance Act of 1968, as amended (42 U.S.C. 4022), was designed by the Federal Emergency Management Agency (FEMA) to encourage communities to undertake activities that will mitigate flooding and flood damage beyond the minimum standards for NFIP participation. This ratings system is a voluntary program for communities, and it would provide a method by which flood mitigation activities engaged in by these communities could be measured. The effect of this mitigation activity would reduce the exposure of the communities to damage resulting from flooding and in turn reduce the losses incurred as a result of this flooding. To encourage participation, discounts on flood insurance are offered within communities that successfully complete qualified mitigation actions, and the community ratings system provides the ability to measure these actions and to recertify the communities in successive years.

This proposed information collection previously published in the Federal Register on May 31, 2023, at 88 FR 34873 with a 60-day public comment period. Two public comments were received with one comment providing edits that FEMA has incorporated and one comment that is not germane to this collection. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

Title: Community Rating System (CRS) Program—Application Letter and CRS Quick Check, Community Annual Recertification, Environmental and Historic Preservation Certifications, and NFIP Repetitive Loss Update Form.

Type of Information Collection: Renewal of a currently approved information collection.

OMB Number: 1660-0022.

FEMA Forms: FEMA Form FF-206-FY-23-100 (formerly 086-0-35), Community Rating System Application Letter and Quick Check; FEMA Form FF-206-FY-23-101 (formerly 086-0-35A), Community Annual Recertifications, FEMA Form FF-206-FY-23-102 (formerly 086-0-35B), Environmental and Historic Preservation Certifications, and FEMA Form FF-206-FY-23-103 (formerly 086-0-35C), NFIP Repetitive Loss Update Form.

Abstract: The Community Rating System (CRS) Application Letter & Quick Check, the CRS certification forms, and accompanying guidance are used by communities that participate in the National Flood Insurance Program's (NFIP) CRS program. The CRS is a voluntary program where flood insurance costs are reduced in communities that implement practices, such as building codes and public awareness activities, that are considered to reduce the risks of flooding and promote the purchase of flood insurance.

Affected Public: State, local, or Tribal government.

Estimated Number of Respondents: 2,170.

Estimated Number of Responses: 4,170.

Estimated Total Annual Burden Hours: 52,292.

Estimated Total Annual Respondent Cost: $4,173,947.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $12,992,290.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the Agency, including whether the information shall have practical utility; evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The information collection notice was previously published in the Federal Register on June 21, 2023, at 88 FR 40281, allowing for a 60-day public comment period. USCIS did receive two comment(s) in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0019 in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(1) Type of Information Collection: Revision of a currently approved collection.

(2) Title of the Form/Collection: Application for Citizenship and Issuance of Certificate Under Section 322.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: N-600K; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Form N-600K is used by children who regularly reside in a foreign country to claim U.S. citizenship based on eligibility criteria met by their U.S. citizen parent(s) or grandparent(s). The form may be used by both biological and adopted children under age 18. USCIS uses information collected on this form to determine that the child has met all of the eligibility requirements for naturalization under section 322 of the Immigration and Nationality Act (INA). If determined eligible, USCIS will naturalize and issue the child a Certificate of Citizenship before the child reaches age 18.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-600K (Paper filed) is 2,187 and the estimated hour burden per response is 1.71 hours; the estimated total number of respondents for the information collection N-600K (online filing) is 2,860 and the estimated hour burden per response is 1.14 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 7,003 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $649,801.

Many low-income communities lack adequate access to broadband internet, which presents barriers to community members seeking economic and educational opportunities. This is known as the digital divide. In 2015, HUD launched the Digital Opportunity Demonstration  1 to narrow the digital divide for students living in HUD-assisted communities by increasing access to broadband technology. Twenty-eight communities were selected to participate in the demonstration. Selected communities received various forms of support which included technical assistance from HUD headquarters and field office staff as well as from HUD's former nonprofit partner, EveryoneOn. Communities also had access to special offers made by private sector stakeholder organizations to EveryoneOn to support pilot communities' efforts. HUD also produced monthly newsletters and webinars designed specifically for participating communities. These provided the latest information on funding opportunities, research, best practices, and capacity-building related to digital inclusion. HUD also offered an annual two-day summit, which allowed communities to share best practices, learn from researchers or other practitioners in the field, and engage with HUD staff and staff from other federal agencies as well as private-sector stakeholders.

The demonstration program was rebranded in 2017 as ConnectHomeUSA (CHUSA) with an expanded goal of onboarding a cumulative total of 100 communities  2 by 2020.

Knowledge is a catalyst for upward mobility. Countries and local communities that cultivate access to global knowledge will thrive in an increasingly complex and technologically oriented world, while those that do not will struggle to keep pace. The adoption and use of broadband technology and associated programming are powerful tools to increase access to knowledge.

As in 2015, the jobs of tomorrow require robust technology skills. For example, over 80 percent of Fortune 500 companies require job seekers to register an account on the companies' online career site before even applying for an open position. 3 The digital divide disproportionately affects certain Americans. Over 43 percent of households with an annual income of less than $30,000 have no home broadband connection. 4 More than 31 percent of American Indian and Alaska Native, African American, and Hispanic households do not have home access to high-speed internet. 5 HUD serves these populations. 83 percent of HUD-assisted households have an annual income of less than $25,000 per year and 66 percent are African American or Hispanic (46 percent and 20 percent, respectively). 6

Research conducted by the U.S. Government Accountability Office highlighted several significant barriers that deter the adoption of broadband technology by the communities HUD serves. 7 These barriers continue to include:

• Cost: The most commonly-cited barrier to broadband adoption is the high cost of internet subscriptions and computer equipment.

• Perception: Many individuals are concerned that broadband does not provide sufficient utility to offset its high cost or believe that broadband is not relevant to their life.

• Skills: Lack of technology skills often present a barrier to broadband adoption for older adults and lower-income households.

• Infrastructure: Tribes and rural communities face the ongoing problem of lack of available broadband infrastructure. States with large rural areas tend to have larger digital divides. 8

This opportunity to join CHUSA comes at a time when the federal government is providing unprecedented levels of funding for broadband networking and digital equity through various programs including the Affordable Connectivity Program, the Broadband Equity, Access and Deployment (BEAD) Program, the Digital Equity Act (DEA) and other programs. 9 HUD will assist selected communities connect to these funding and other opportunities in order to minimize the barriers listed above, and close the digital divide.

This Notice seeks to further expand CHUSA and restructure its program model. The goal of this expansion is to add another 50 to 100 new communities. The program restructuring would adopt a three-tiered model, as described in this notice. This Notice and proposed restructuring also responds to Congressional interest  10 in having CHUSA reach more HUD-served communities.

HUD's goal is to identify new communities from urban and rural and Tribal locations with both small and large populations that have the capacity to effectively narrow the digital divide, including expanding programs and capabilities over time. HUD seeks communities where state, local or Tribal leadership has already taken steps to support the goals of CHUSA, as measured by both the community's participation in other complementary Federal initiatives such as the Affordable Connectivity Program  11 which enhance internet access in communities and by local broadband plans and strategies for implementation. HUD seeks to partner with new communities, as well as existing CHUSA communities that wish to continue their work, and provide technical assistance to these communities to identify financial, in-kind and other resources to accomplish the goals of CHUSA. In this vein, HUD encourages applicants to familiarize themselves with other Federal programs that are funding broadband, such as the Broadband Equity, Access and Deployment grant ($42.45 billion) and the Digital Equity Act grant program ($2.75 billion) by going to this comprehensive website: www.internetforall.gov.

The number of communities served by CHUSA will depend on the number of communities that commit to narrowing the digital divide and that meet certain criteria. Exhibit A below sets forth these proposed criteria to restructure the program to create optimal conditions to accelerate the adoption and use of broadband technology and expand this technology within new and existing communities.

HUD would restructure the program to establish three tiers. Each tier is intended to be flexible, recognizing the diverse set of communities being considered for or already participating in CHUSA. Tier 1 addresses new communities. Tier 2 concerns existing communities, including those that can assist new communities. Tier 3 are those communities that complete the criteria of Tier 2 and wish to further evaluate and refine their existing connectivity solution to ensure it best meets their community's needs. HUD will not solicit any Tier 3 communities at this stage.

There is no Congressional funding for CHUSA; the program implementation is contingent upon HUD resources such as staffing and technical assistance. As this expansion proceeds, HUD will continue to assess community interest and the availability of HUD staffing resources to support participation by additional communities. HUD will also assess the effectiveness of the selection criteria within the three tiers on an ongoing basis. Such assessment may expand the number of participating communities, revise the selection criteria, or both to reflect HUD's experience in implementing CHUSA.

HUD intends to extend the outcomes of CHUSA, with the goal of increasing the number of participating communities. To this end, HUD will work with entities across the government, its nonprofit partner, EducationSuperHighway, 12 and the research community to rigorously measure outcomes associated with the work of CHUSA to narrow the digital divide. 13 The participating communities are expected to participate in any efforts designed to identify and share best practices with other HUD-assisted communities. In addition, participating communities will be required to measure and report outputs and outcomes.

In accordance with 24 CFR part 10 and section 470 of the Housing and Urban-Rural Recovery Act of 1983 (42 U.S.C. 3542), HUD is seeking comment on this expansion and restructuring of the CHUSA initiative in this Federal Register notice for 60-days of public comment. The public comment period provided allows HUD the opportunity to consider comments and be in a position to commence implementation of the expansion following the conclusion of the 60-day period. [ Note: Do not submit application documents as public comments. See Section E in Exhibit A below for CHUSA application instructions.] HUD is also interested in receiving comments about specific areas. HUD will evaluate responses to the questions below and may modify the design of the program. If HUD decides to announce any changes to the program, HUD will provide notice to the public prior to requesting applications.

The primary focus of CHUSA addresses the three legs of the digital inclusion stool. HUD asks Tier 2 and Tier 3 communities to use their accomplishments in addressing the digital inclusion stool as a platform for helping residents achieve other outcomes by entering into agreements with quality-of-life partners. Should HUD ask communities to focus on other areas such as employment and education?

a. Is the support HUD describes sufficient for each Tier, or should HUD consider other forms of support? If so, what kind? To answer this question, HUD recommends reviewing paragraph B.3 in Exhibit A.

b. Should HUD consider other achievements in order for Tier 1 communities to be able to graduate to Tier 2 and for Tier 2 communities to graduate to Tier 3? To answer this question, HUD recommends reviewing paragraph C in Exhibit A.

c. The proposed focus of Tier 3 is connectivity; should Tier 3 focus on other elements instead or in addition to connectivity?

a. Staffing. During the implementation of both the pilot ConnectHome and expansion CHUSA programs, HUD found communities with dedicated staff support were generally more successful. For this reason, HUD is asking communities to identify a staff person who would be responsible for leading this work. HUD is interested in understanding whether this requirement is overly burdensome.

b. Data Collection. HUD is proposing that selected communities report on a quarterly basis the number of in-home internet connections, devices, and digital skills trainings residents complete each quarter. Is this frequency enough, is it burdensome, and what challenges to collecting this data should HUD be aware of? Should HUD consider other metrics? Finally, how should HUD share or display the data collected—should it be available to the public or shared only with participating communities?

c. Three-year commitment. HUD is asking communities to commit to a three-year program. Is this period long enough to help communities realize gains in each area of the digital inclusion stool or should HUD consider a different time period?

HUD is proposing a variety of digital badges to recognize programmatic achievements. Some of these badges will be required to graduate to a higher tier. Are there other ways HUD could recognize community achievements or other achievements HUD should recognize?

There are new federal funding resources available to address the three legs of the digital inclusion stool, such as the Affordable Connectivity Program which covers up to $30 for internet service (and up to $75 on tribal lands) for qualifying families. There are also forthcoming Digital Equity Act funds that will provide funding for the types of activities CHUSA communities undertake. In addition to these resources as well as access to HUD staff, HUD-provided technical assistance, and EducationSuperHighway's expertise, HUD is interested in understanding whether there are other resources that communities would find useful in order to implement a CHUSA program.

Are there other factors HUD should consider when evaluating applications?

This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on March 17, 2023 at 88 FR 16457.

Title of Information Collection: Housing Counseling Training Program.

OMB Approval Number: 2502-0567.

OMB Expiration Date: November 30, 2023.

Type of Request: Revision of a currently approved collection.

Form Numbers: SF-424; HUD-92910; HUD-2880; SF-425.

Description of the need for the information and proposed use: Eligible organizations submit information to HUD through Grants.gov when applying for grant funds to provide housing counseling training to housing counselors. HUD uses the information collected to evaluate applicants competitively and then select qualified organizations to receive funding that supplement their housing counseling training program. Post-award collection, such as quarterly reports, will allow HUD to evaluate grantees' performance.

Respondents: Not-for-profit institutions.

Estimated Number of Respondents: 42.

Estimated Number of Responses: 60.

Frequency of Response: One-time application and quarterly reports.

Average Hours per Response: 28.7.

Total Estimated Burden: 1,722 hours.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

HUD encourages interested parties to submit comments in response to these questions.

Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.

This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on July 26, 2023 at 88 FR 48259.

Title of Information Collection: Title I Property Improvement and Manufactured Home Loan Programs.

OMB Control Number, if applicable: 2502-0328.

Type of Request: Extension of currently approved collection.

Description of the need for the information and proposed use: Title I loans are made by private sector lenders and insured by HUD against loss from default. HUD uses information about Title I loan borrowers to evaluate individual loans on their overall program performance. The information collected is used to determine insurance eligibility and claim eligibility. HUD proposes adopting the URLA and amending forms 56001 and 56001-MH to capture Title I Loan program specific information which will simplify the form, avoid unnecessary duplication, and reduce the burden to the public. This information is necessary for HUD to capture information effective in determining overall program performance, insurance and claim eligibility and risk management.

Agency form numbers, if applicable: HUD-637, 27030, 55013, 55014, 56001, 56001-MH, 56002, 56002-MH, & SF 3881.

Respondents: The respondents are lenders.

Estimation of the total numbers of hours needed to prepare the information collection:

Estimated Number of Respondents: 510.

Estimated Number of Responses: 38,515.

Frequency of Response: On occasion, periodic.

Average Hours per Response: 10.01.

Total Estimated Burdens: 23,180.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

HUD encourages interested parties to submit comments in response to these questions.

Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.

This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on June 22, 2023 at 88 FR 40841.

Title of Information Collection: The Community Choice Demonstration.

OMB Approval Number: 2528-0337.

Type of Request: Revision of a currently approved collection.

Form Number: N/A.

Description of the need for the information and proposed use: The U.S. Department of Housing and Urban Development (HUD) has contracted with Abt Associates to conduct an evaluation of its Community Choice Demonstration (formerly Housing Choice Voucher Mobility Demonstration). This proposed information collection involves three instruments that will be administered to subsets of households participating in the Demonstration: a Home Assessment, a Child Assessment, and an Obesity and Type II Diabetes Risk Assessment. 1 The Home Assessment will assess how moving to an opportunity area affects exposure to pest allergens and indoor pollutants that may impact health conditions among low-income children. The Child Assessment will assess how moving to an opportunity area may affect children's conduct problems and physical and mental health. The Obesity and Type II Diabetes Risk Assessment will assess how moving to an opportunity area affects the risk of obesity and type II diabetes (primarily for the head of household and secondarily for one child in each household).