Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86807 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by December 2, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 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: Extension of a currently 

approved collection; Title of 

Information Collection: Financial 

Statement of Debtor; Use: When a 

Medicare Administrative Contractor 

(MAC) overpays a physician or supplier, 

the overpayment is associated with a 

single claim, and the amount of the 

overpayment is moderate. In these 

cases, the physician/supplier usually 

refunds the overpaid amount in a lump 

sum. Alternatively, the MAC may 

recoup the overpaid amount against 

future payments. A recoupment is the 

recovery by Medicare of any 

outstanding Medicare debt by reducing 

present or future Medicare payments 

and applying the amount withheld to 

the indebtedness. The recoupment can 

be made only if the physician/supplier 

accepts assignment since the MAC 

makes payment to the physician/ 

supplier only on assigned claims. 

The physician/supplier may be 

unable to refund a large overpaid 

amount in a single payment. The MAC 

cannot recover the overpayment by 

recoupment if the physician/supplier 

does not accept assignment of future 

claims or is not expected to file future 

claims because of going out of business, 

illness or death. In these unusual 

circumstances, the MAC has authority 

to approve or deny extended repayment 

schedules up to 12-months or may 

recommend to the Centers for Medicare 

and Medicaid Services (CMS) to 

approve up to 60 months. Before the 

MAC takes these actions, the MAC will 

require full documentation of the 

physician’s/supplier’s financial 

situation. Thus, the physician/supplier 

must complete the CMS–379, Financial 

Statement of Debtor. 

Section 1893(f)(1)) of the Social 

Security Act and 42 CFR 401.607 

provides the authority for collection of 

this information. Section 42 CFR 

405.607 requires that, CMS recover 

amounts of claims due from debtors 

including interest where appropriate by 

direct collections in lump sums or in 

installments. Form Number: CMS–379 

(OMB control number: 0938–0270); 

Frequency: Yearly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 500; Total 

Annual Responses: 500; Total Annual 

Hours: 1,000 hours. (For policy 

questions regarding this collection 

contact Monica Thomas, at 410–786– 

4292.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–25331 Filed 10–30–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Agency Information Collection 

Activities: Submission for OMB 

Review; Public Comment Request; for 

the State Annual Long-Term Care 

Ombudsman Report (OMB Control 

Number 0985–0005) 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) is announcing 

that the proposed collection of 

information listed above has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance as required under section 

506(c)(2)(A) of the Paperwork Reduction 

Act of 1995. This 30-day notice collects 

comments on the information collection 

requirements related to the proposed 

new information collection 

requirements relating to the State 

Annual Long-Term Care Ombudsman 

Report (OMB Control Number 0985– 

0005). 

DATES: Comments on the collection of 

information must be submitted 

electronically by 11:59 p.m. (ET) or 

postmarked. December 2, 2024. 

ADDRESSES: Submit written comments 

and recommendations for the proposed 

information collection within 30 days of 

publication of this notice to 

www.reginfo.gov/public/do/PRAMain. 

Find the information collection by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. By mail to 

the Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Bldg., 725 17th St. NW, Rm. 10235, 

Washington, DC 20503, Attention: OMB 

Desk Officer for ACL. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Laubert, Beverly.Laubert@

acl.hhs.gov, (202) 795–7364. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, ACL 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. The State Annual 


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86808 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 

Long-Term Care Ombudsman Report is 

needed to comply with Administration 

for Community Living/Administration 

on Aging reporting requirements in the 

Older Americans Act (OAA); and 45 

CFR 1324.21(b) (1) and (b)(2)(v). The 

Long-Term Care Ombudsman Report is 

used to measure the services and 

strategies that are provided to assist 

residents in the protection of their 

health, safety, welfare, or rights; 

advocate at the state and federal levels 

for changes needed to improve the 

quality of life and care in long-term care 

facilities; and effectively manage the 

Long-Term Care Ombudsman Program 

at the state and federal level. The 

National Ombudsman Reporting System 

(NORS) was developed in response to 

these needs and directives. Section 

712(c) of the OAA requires the state 

agency to establish a statewide uniform 

reporting system to: 

(1) Collect and analyze data relating to 

resident complaints and conditions in 

long-term care facilities for the purpose 

of identifying and resolving significant 

problems. 

and 

(2) Submit the data on a regular basis 

to the state licensing/certifying agency, 

other state and federal entities that the 

Ombudsman determines to be 

appropriate, the Assistant Secretary for 

Aging, and the National Long-Term Care 

Ombudsman Resource Center. 

Comments in Response to the 60-Day 

Federal Register Notice 

In accordance with 5 CFR 1320.8(d), 

ACL published a 60-day Notice in the 

Federal Register on August 6, 2024, at 

89 FR 63955–63956. 

Please see public comments received 

during the 60-day notice and ACLs 

response to comments listed below. 

ACL received comments from 

individuals and groups including the 

National Association of State 

Ombudsman Programs (NASOP); the 

National Association of Local LongTerm Care Ombudsmen (NALLTCO), 

the California Long-Term Care 

Ombudsman Association (CLTCOA), 

National Ombudsman Resource Center 

(NORC), and a gerontologist/researcher. 

Commenters who addressed the 

utility of the data and burden estimates 

supported the continuation of the NORS 

collection. NALLTCO recommended 

that ACL conduct a future study of the 

documentation burden on local longterm care Ombudsmen. 

NASOP recommended that changes in 

data elements be undertaken with ample 

time to adjust state systems and receive 

training before implementation, with a 

request for ACL grant funding for 

implementation costs. Both 

recommendations were deferred for 

future consideration if funding is 

available. Regarding recommendations 

specific to adding or removing data 

elements, ACL opts to hold those 

suggestions for future revision after 

further consideration and analysis of 

impact of the changes; including the 

impact on State Ombudsman programs 

that would need to change their data 

collection systems. Comments that ACL 

accepted were changes to instructions 

and examples and reporting tips for 

clarity. 

Most of the comments were requests 

to modify instructional examples and 

reporting tips. Some of the 

recommendations indicated 

misunderstandings that can be resolved 

with technical assistance, the below 

nine comments/recommendations were 

accepted. 

Comment 1: One respondent 

requested clarification on how to code 

complaint disposition when a resident 

dies before an outcome of the complaint 

has been obtained. 

Response 1: Reporting tips were 

changed to instruct the Ombudsman to 

report such instances as withdrawn 

when there is not a resident 

representative to determine resolution. 

Comment 2: One respondent 

requested revision to complaint type 

F01—Accidents and falls to update 

language from describing a resident who 

self-propels to a resident who uses a 

wheelchair independently. 

Response 2: The example was 

updated accordingly. 

Comment 3, 4: Two respondents 

recommended changing how volunteer 

representatives are counted to include 

all volunteers who were representatives 

during the reporting year. Current 

instructions are to count volunteers as 

the number on September 30 of the 

fiscal year. 

Response 3,4: The description was 

updated to ensure that all volunteer 

representatives are counted. 

Comment 5: One respondent 

requested that ACL allow newsletters 

and other forms of media to be counted 

as community education. 

Response 5: As use of social media 

and other electronic means of imparting 

information has increased, community 

education activities are under-reported 

within current instructions. A revision 

to the instructions was made to 

accommodate the request. 

Comment 6, 7: Two respondents 

recommended a change to the 

description of complaint type I03— 

Supplies, storage, and furnishings to 

include facility failure to properly store 

hazardous chemicals and other hazards. 

Response 6, 7: I03 is a complaint type 

about shortage of supplies. Instead, the 

examples and reporting tips for I01— 

Environment were revised to 

accommodate the comments. 

Comment 8: One respondent 

suggested modifying the description of 

program activity elements S64 and 

S65—Resident council participation to 

include instances of training to resident 

groups that might not be formal resident 

councils. 

Response 8: The modification was 

made to accommodate the suggestion. A 

corresponding change was made to S66 

and S67—Family council participation. 

Comment 9: One respondent 

requested that ACL remove the 

requirement to report expenditures in 

NORS or, in the alternative, specify that 

expenditures be reported as obligated. 

Response 9: ACL has worked to 

reconcile multiple means of financial 

reporting. The NORS requirement will 

not be removed because NORS is the 

source of publicly reported information 

about Ombudsman program resources. 

However, the examples and reporting 

tips were modified to instruct states to 

report using consistent accounting 

methods. 

ACL received the following comments 

and did not accept them for inclusion in 

NORS. 

Comment: One respondent 

recommended including ‘‘fear’’ of 

retaliation in the complaint type where 

retaliation is reported and adding a 

complaint code for theft of medications. 

Response: Because such problems can 

be captured within existing complaint 

codes, it is not necessary to add to the 

collection. 

Comment: One respondent suggested 

adding to the definition of complainant 

to capture referrals from legislators. 

Response: ACL will provide technical 

assistance about reporting entities that 

make referrals, which is different from 

complainants. 

Comment: Two respondents suggested 

removing the verification data element 

because Ombudsman programs work to 

resolve all problems expressed by 

residents. 

Response: Verification is key to the 

purpose of investigation and ACL will 

provide technical assistance if needed to 

supplement training provided by the 

NORC. 

Comment: One respondent suggested 

changing language from ‘‘perpetrator’’ to 

‘‘aggressor’’ when a complaint involves 

a resident living with dementia. 

Response: In the example described in 

the comment, the use of the abuse 

complaint type could be incorrect; ACL 

and NORC will provide technical 

assistance on how to code complaints to 


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Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86809 

reflect resident experience rather than 

changing a term that is commonly used 

in abuse investigations by other entities. 

Comment: Three respondents 

recommended modification to the 

psychological abuse complaint code to 

include social media posts and posting 

of photographs. 

Response: The current reporting tips 

include oral, written, or gestured 

language and are sufficient to include 

social media posts. Photos are also 

included in the reporting tips. 

Comment: Three respondents 

recommended adding language to 

complaint types in the category of 

autonomy, choice, and rights to address 

emergence of artificial intelligence to 

monitor residents. 

Response: This issue requires further 

review and will be considered for future 

revisions. 

Comment: One respondent suggested 

adding a reporting tip to complaint type 

F10- Rehabilitation services to instruct 

Ombudsmen how to report contractures 

as gross neglect. 

Response: Further review is needed, 

and this suggestion will be considered 

for future revisions. 

Comment: One respondent 

recommended that instruction be added 

to select staffing as a secondary 

complaint and to broaden the definition 

of staffing. 

Response: The use of secondary 

complaint codes when a resident or 

complainant has not expressed staffing 

as a complaint would be a significant 

change in practice with potential 

unintended consequences. This requires 

further review and may be considered in 

future revisions. The existing definition 

of J03—Staffing is sufficiently inclusive 

of staffing vacancies. 

Comment: Two respondents 

recommended adding language to the 

definition and examples for complaint 

type L01—Resident representative or 

family conflict to include other visitors 

with different types of relationships. 

Response: The complaint type as 

currently defined is specific to the 

nature of the relationships of family 

members and individuals that residents 

choose to be their representative; adding 

others could dilute the meaning of the 

data element. 

Comment: Two respondents requested 

the addition of a new complaint type for 

reporting resident-to-resident 

altercations that are not willful abuse. 

Response: ACL is not adding or 

removing data elements with this 

renewal but will consider this 

recommendation in the future after 

analysis of impact and alternatives 

within the existing collection. 

Comment: Three respondents 

recommended adding a new category of 

complaints and individual complaint 

types about discrimination. 

Response: ACL is not adding or 

removing elements but will seek 

additional input and consider this 

change in the future after analysis of 

impact. 

Comment: Two respondents suggested 

adding a new complaint category to 

allow for short-term collection of data 

for a special purpose. 

Response: ACL is not adding or 

removing elements with this renewal 

but will consider the recommendation 

after analysis of impact and alternatives. 

Comment: One respondent asserted 

that complaint/case terminology in data 

elements S01–S06 is confusing. 

Response: The data elements are text 

fields and provide flexibility for the 

State Ombudsman to describe 

complaints as they determine best. 

Technical assistance will be provided. 

Comment: One respondent requested 

clarification about reporting hours 

donated by volunteers when the 

volunteer receives travel 

reimbursement. 

Response: The Older Americans Act 

allows for reimbursement and travel is 

included in the current examples and 

reporting tips. 

Comment: One respondent requested 

clarification about removal or 

remediation of conflicts of interest. 

Response: How conflicts of interest 

are addressed is a matter of rule (45 CFR 

1324.21(b)) implementation and 

technical assistance will be provided as 

part of broader regulatory guidance. 

Comment: One respondent suggested 

the addition of a code for a specific type 

of expenditure. 

Response: ACL is not adding or 

removing data elements with this 

revision of NORS but will consider this 

change in the future. 

Comment: One respondent suggested 

clarification of local funds expended. 

Response: The instruction is written 

as intended and technical assistance 

will be provided. 

Comment: Four respondents 

recommended changes to routine access 

visitation reporting. 

Response: Routine access visits as 

defined are an important measure of 

resident access to their advocate 

separate from visits to handle 

complaints, as well as a measure of the 

impact of program funding. ACL will 

explore this request further and 

consider a change in the future; data 

elements are not being changed in this 

revision. 

Comment: Three respondents 

commented that instructions are vague 

about how to report the number of 

facilities and that closures have an 

impact on how routine access visits are 

measured on a quarterly basis. 

Response: The examples and tips are 

specific that the count of facilities is as 

of the last day of the federal fiscal year. 

Routine access is based upon the count 

of facilities as of the last day of the fiscal 

year. The data element is defined as 

intended, routine access does not 

include facilities that open after the first 

quarter or close before the fourth quarter 

of the fiscal year. Technical assistance 

will be provided. 

Comment: One respondent requested 

a new data element for reporting facility 

closures. 

Response: At this time ACL is not 

adding or removing elements but will 

consider this change in the future after 

analysis of impact and alternatives. 

Comment: Two respondents requested 

new Ombudsman program staffing data 

elements—statewide turnover rates, 

years of experience of Ombudsman 

representatives, and the staff-to-bed 

ratio of staff. 

Response: At this time ACL is not 

adding or removing elements but will 

consider this change in the future after 

analysis of potential methods of 

collection. 

Estimated Program Burden 

ACL estimates the burden of this 

collection of information as follows: 

Fifty-two grantees report to ACL using 

NORS. 

a. Number of respondents—52 

b. Frequency of response—1 

c. Total annual responses—52 

d. Hours per response—214 

e. Total burden hours—11,153 

Dated: October 28, 2024. 

Maura Calsyn, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2024–25358 Filed 10–30–24; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–0093] 

M13A Bioequivalence for ImmediateRelease Solid Oral Dosage Forms; 

International Council for 

Harmonisation; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


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