Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices 79929 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Individuals in households ....... Day1 Dietary Instrument; MEC Dietary Recruitment Scheduling Instrument; Dietary Front-End Instrument; Dietary Incentives and Scheduling Instrument; MEC Dietary Reminder Call-in Instrument; & Flexible Consumer Behavior 

Survey (FCBS) Instrument.

5,882 1 1 

Individuals in households ....... Day2 Dietary Instrument ........................................................ 5,882 1 36/60 

Individuals in households ....... Developmental Projects & Special Studies ............................ 3,500 1 3 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–22473 Filed 9–30–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10593] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

December 2, 2024. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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 N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

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). 

CMS–10539 Medicare and Medicaid 

Programs: Home Health Facilities 

(HHAs) and Supporting Regulations 

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. 

Information Collections 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare and 

Medicaid Programs: Home Health 

Facilities (HHAs) and Supporting 

Regulations; Use: Home health services 

are covered for the elderly and disabled 

under the Hospital Insurance (Part A) 

and Supplemental Medical Insurance 

(Part B) benefits of the Medicare 

program and are described in section 

1861(m) of the Social Security Act (the 

Act) (42 U.S.C. 1395x). These services 

must be furnished by, or under 

arrangement with, an HHA that 

participates in the Medicare program, 

and be provided on a visiting basis in 

the beneficiary’s home. They may 

include the following: 

• Part-time or intermittent skilled 

nursing care furnished by or under the 

supervision of a registered nurse. 

• Physical therapy, speech-language 

pathology, or occupational therapy. 

• Medical social services under the 

direction of a physician. 

• Part-time or intermittent home 

health aide services. 

• Medical supplies (other than drugs 

and biologicals) and durable medical 

equipment. 

• Services of interns and residents if 

the HHA is owned by or affiliated with 


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79930 Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices 

a hospital that has an approved medical 

education program. 

• Services at hospitals, Skilled 

Nursing Facilities (SNFs), or 

rehabilitation centers when they involve 

equipment too cumbersome to bring to 

the home. 

Under the authority of sections 

1861(o), 1871 and 1891 of the Act, the 

Secretary has established in regulations 

the requirements that an HHA must 

meet to participate in the Medicare 

program. These requirements are set 

forth in 42 CFR part 484 as Conditions 

of Participation for Home Health 

Agencies. The CoPs apply to an HHA as 

an entity as well as the services 

furnished to each individual under the 

care of the HHA, unless a condition is 

specifically limited to Medicare 

beneficiaries. Under section 1891(b) of 

the Act, the Secretary is responsible for 

assuring that the CoPs, and their 

enforcement, are adequate to protect the 

health and safety of individuals under 

the care of an HHA and to promote the 

effective and efficient use of Medicare 

funds. To implement this requirement, 

State survey agencies generally conduct 

surveys of HHAs to determine whether 

they are complying with the CoPs. Form 

Number: CMS–10539 (OMB Control 

Number: 0938–1299); Frequency: 

Annually; Affected Public: Private 

Sector (Business or other for-profit, and 

not-for-profit institutions); Number of 

Respondents: 20,765; Number of 

Responses: 12,300,588 Total Annual 

Hours: 870,000. (For policy questions 

regarding this collection contact Claudia 

Molinar at claudia.molinar@

cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–22536 Filed 9–30–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–1382] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Electronic User 

Fee Payment Request Forms 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 31, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0805. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Electronic User Fee Payment Request 

Forms—Form FDA 3913 and Form FDA 

3914 

OMB Control Number 0910–0805— 

Extension 

This information collection supports 

FDA user fee programs. Form FDA 3913, 

User Fee Payment Refund Request, is 

designed to provide the minimum 

necessary information for FDA to review 

and process a user fee payment refund. 

The information collected includes the 

organization, contact, and payment 

information. The information is used to 

determine the reason for the refund, the 

refund amount, and who to contact if 

there are any questions regarding the 

refund request. A submission of the 

User Fee Payment Refund Request form 

does not guarantee that a refund will be 

issued. FDA estimates an average of 0.40 

hours per response, including the time 

to review instructions, search existing 

data sources, gather and maintain the 

data needed, and complete and review 

the collection of information. The 

estimated hours are based on past FDA 

experience with the user fee payment 

refund request. 

In fiscal year 2023, approximately 

1,856 user fee refunds were processed 

for cover sheets and invoices including 

2 for Animal Drug User Fees, 2 for 

Animal Generic Drug User Fees, 3 for 

Biosimilar Drug User Fees, 1 for Color 

Additive Certification Fees, 1 for 

Compounding Quality fees, 32 for 

Export Certificate Program Fees, 7 for 

Freedom of Information Act requests, 94 

for Generic Drug User Fees, 730 for 

Medical Device User Fees, 219 for 

Medical Device Federal Unified 

Registration and Listing fees, 666 for 

Mammography inspection fees, 19 for 

Over-The-Counter Monograph Drug 

User Fees, 77 for Prescription Drug User 

Fees, and 3 for Tobacco product fees. 

Form FDA 3914, User Fee Payment 

Transfer Request, is designed to provide 

the minimum necessary information for 

FDA to review and process a user fee 

payment transfer request. The 

information collected includes payment 

and organization information. The 

information is used to determine the 

reason for the transfer, how the transfer 

should be performed, and who to 

contact if there are any questions 

regarding the transfer request. A 

submission of the User Fee Payment 

Transfer Request form does not 

guarantee that a transfer will be 

performed. FDA estimates an average of 

0.25 hours per response, including the 

time to review instructions, search 

existing data sources, gather and 

maintain the data needed, and complete 

and review the collection of 

information. FDA estimated hours are 

based on past FDA experience with the 

user fee payment transfer requests. 

In fiscal year 2023, approximately 86 

user fee payment transfers were 

processed for cover sheets and invoices 

including 0 for Animal Drug User Fees, 

0 for Animal Generic Drug User Fees, 1 

for Biosimilar Drug User Fees, 2 for 

Compounding Quality fees, 4 for Export 

Certificate Program Fees, 20 for Generic 

Drug User Fees, 6 for Medical Device 

User Fees, 37 for Medical Device 

Federal Unified Registration and Listing 

fees, 8 for Mammography inspection 

fees, 8 for Over-The-Counter Monograph 

Drug User Fees, 0 for Prescription Drug 

User Fees, and 0 for Tobacco product 

fees. 

Respondents for the electronic request 

forms include domestic and foreign 

firms (including pharmaceutical, 

biological, medical device firms, etc.). 

Specifically, refund request forms target 

respondents who submitted a duplicate 

payment or overpayment for a user fee 

cover sheet or invoice. Respondents 

may also include firms that withdrew an 

application or submission. Transfer 

request forms target respondents who 

submitted payment for a user fee cover 

sheet or invoice and need that payment 


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