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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices 79931 

to be re-applied to another cover sheet 

or invoice (transfer of funds). 

The electronic user fee payment 

request forms streamline the refund and 

transfer processes, facilitate processing, 

and improve the tracking of refund or 

transfer requests. The burden for this 

collection of information is the same for 

all customers (small and large 

organizations). The information being 

requested or required has been held to 

the absolute minimum required for the 

intended use of the data. Respondents 

are able to request a user fee payment 

refund or transfer online at https://

www.fda.gov/forindustry/userfees/ 

default.htm. This electronic submission 

is intended to reduce the burden for 

customers to submit a user fee payment 

refund and transfer request. 

In the Federal Register of April 26, 

2024 (89 FR 32445), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 2

FDA form No. No. of 

respondents 

No. of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

User Fee Payment Refund Request—Form FDA 

3913.

1,856 1 1,856 0.40 (24 minutes) .......... 742 

User Fee Payment Transfer Request—Form 

FDA 3914.

86 1 86 0.25 (15 minutes) .......... 22 

Total .............................................................. ........................ ........................ ........................ ....................................... 764 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Numbers have been rounded. 

Our estimated burden for the 

information collection reflects an 

overall increase of 525 hours and a 

corresponding increase of 1,274 

responses. We attribute this adjustment 

to an increase in the number of 

submissions we received over the last 

few years. 

Dated: September 25, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22443 Filed 9–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Solicitation of 

Written Comments on Proposed 

Healthy People 2030 Objectives 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary of 

Health, Office of Disease Prevention and 

Health Promotion. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

solicits written comments from the 

public on 12 new objectives proposed to 

be added to Healthy People 2030, and 

written comments from the public 

proposing additional new core, 

developmental, or research objectives or 

topics to be included in Healthy People 

2030. Public comment informed the 

development of Healthy People 2030. 

HHS will provide opportunities for 

public input periodically throughout the 

decade to ensure Healthy People 2030 

reflects current public health priorities 

and public input. The updated set of 

Healthy People 2030 objectives and 

topics will be incorporated on https://

health.gov/healthypeople. This updated 

set will reflect further review and 

deliberation by federal Healthy People 

topic area workgroups, the Federal 

Interagency Workgroup on Healthy 

People 2030, and other federal subject 

matter experts. 

DATES: Written comments will be 

accepted through 11:59 p.m. ET, 

October 31, 2024. 

ADDRESSES: Written comments should 

be submitted by email to 

HP2030Comment@hhs.gov. 

FOR FURTHER INFORMATION CONTACT: Erik 

Orta, Office of Disease Prevention and 

Health Promotion, U.S. Department of 

Health and Human Services, 1101 

Wootton Parkway, Suite 420, Rockville, 

MD 20852; Phone: 240–268–0823; 

Email: HP2030@hhs.gov. 

SUPPLEMENTARY INFORMATION: 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 12 new objectives proposed to 

be added to the current set of 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. 

The public now is invited to comment 

on 12 new objectives proposed to be 

added to Healthy People 2030. These 

new objectives were developed by 

Healthy People topic area workgroups 

led by various agencies within the 

Federal Government. They have been 

reviewed by the Federal Interagency 

Workgroup on Healthy People 2030 and 

are presented now for the public’s 

review and comment. They are: 

1. CKD–NEW–11: Increase the 

proportion of people with chronic 

kidney disease and diabetes who receive 

glucose-lowering medications based on 

the most recent guidelines. This 

objective is new to Healthy People 2030. 

Data source: National Health and 

Nutrition Examination Survey 

(NHANES). 


khammond on DSKJM1Z7X2PROD with NOTICES